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JISCBAILII_CASE_TORT
Case
No: 1998 A458
IN
THE HIGH COURT OF JUSTICE
QUEENS
BENCH DIVISION
Royal
Courts of Justice
Strand,
London, WC2A 2LL
Date:
Monday 26 March 2001
B
e f o r e :
THE
HONOURABLE MR JUSTICE BURTON
|
A
AND OTHERS
|
Claimant
|
|
-
and -
|
|
|
THE
NATIONAL BLOOD AUTHORITY AND OTHERS
|
Defendant
|
Michael
Brooke QC, Stuart Brown QC, Ian Forrester QC (Scotland) and Jalil Asif (instructed
by Deas Mallen for the Claimants on generic issues, and instructed by
Deas Mallen, DMH, Evill & Coleman, Freeth Cartwright, and Howard
Cohen & Co on lead cases)
Nicholas Underhill QC, Philip Brook Smith and Louise Merrett (instructed
by Davies Arnold Cooper for the Defendants)
JUDGMENT:
APPROVED BY THE COURT FOR HANDING DOWN (SUBJECT TO EDITORIAL CORRECTIONS)
THE
CLAIMANTS *
CAUSE
OF ACTION *
THE
DEFENDANTS *
THE
PROCEEDINGS *
SETTLEMENT *
BLOOD
TRANSFUSION *
HEPATITIS *
TESTING
IN RESPECT OF NANBH/HEPATITIS C *
Surrogate
Tests *
THE
CLAIMS *
THE
DIRECTIVE *
THE
CPA *
THE
STRUCTURE OF THIS JUDGMENT *
THE
SIX ISSUES *
ARTICLE
6 *
The
Common Ground *
The
Differences Between the Parties *
All
Circumstances *
Non-Standard
Products *
Boxes *
The
Status of the Defendants *
Travaux
Preparatoires *
Court
Decisions *
Academic
Literature *
Summary *
ARTICLE
7(e) *
The
Issues Between the Parties. *
Travaux
Preparatoires *
Court
Decisions *
Academic
Literature *
CONCLUSIONS
ON ARTICLE 6 *
Non-standard
Products *
Standard
Products *
CONCLUSIONS
ON ARTICLE 7(e) *
THE
RESULT IN LAW ON ISSUE I *
The
Consequence *
ISSUE
II *
The
Defendants' Factual Witnesses *
The
Defendants' Expert Witnesses *
The
Claimants' Factual Witnesses *
The
Claimants' Expert Witnesses *
The
Oral Evidence *
The
Literature *
The
Background Facts *
The
Approach to be Adopted *
The
Proper Analysis *
SURROGATE
TESTS *
The
Literature *
The
United States *
The
Rest of the World *
THE
PROS AND CONS OF SURROGATE TESTING *
The
Points In Favour *
The
Points Against *
Conclusion
on Surrogate Testing *
THE
ASSAY *
The
Chronology of the Introduction of the Assay in the UK *
The
Background Facts *
What
Had to be Allowed For *
Practical
Trials *
The
need for Evaluation of the Assay *
The
Need for Confirmation *
The
Need to Compare Ortho with Abbott *
Implementation
in the RTCs *
Funding
and Decision-Making *
Conclusion
on Routine Screening *
DEFECTIVE
WITHIN ARTICLE 6 *
NATURE
AND MEASURE OF DAMAGES *
ISSUE
IIIa *
ISSUE
IIIb: LOSS OF A CHANCE *
ISSUE
IV: AVAILABILITY OF ARTICLE 7(e) *
ISSUE
V: GENERIC ISSUES OF QUANTUM ARISING OUT OF THE LEAD CASES *
Evidence *
HEPATITIS
C: THE DISEASE AND ITS TREATMENT *
Clearance
of the Virus HREF="#_Toc509895072">*
The
course of the disease *
Prevalence
of Hepatitis C *
Transmission
of Hepatitis C *
Prognosis *
Treatments *
The
Effect of Hepatitis C *
ISSUES
OF DAMAGES *
Provisional
Damages *
Heads
of Damage *
PSLA *
'Stigma'
or Handicap *
Employment
Handicap *
Financial
Products/Insurance Handicap *
The
Provision of Gratuitous Services *
The
Claimants' Submissions *
The
Defendants' Response *
Discount
Rate *
ISSUE
VI: THE SIX LEAD CASES *
Mr
S *
Mr
U *
Miss
T *
Ms
V HREF="#_Toc509895094">*
Mr
W *
Mrs
X *
JUDGMENT *
Mr
Justice Burton:
THE
CLAIMANTS
- This
trial has concerned the claims of 114 Claimants for recovery of damages arising
out of their infection with Hepatitis C from blood and blood products through
blood transfusions from 1 March 1988. It has been the first and main trial
heard by me as the assigned Judge within the Hepatitis Litigation, which was
the subject matter of a Practice Direction issued by the Lord Chief Justice
on 30 July 1998. This trial has been limited to consideration of the case
brought by those Claimants infected with Hepatitis C from blood and blood
products who are making claims under the Consumer Protection Act 1987 ('CPA').
There is a small number of other Claimants within the group action whose claims
are not being dealt with by this trial, for example those not claiming under
the CPA and/or claiming in relation to infection as a result of the transplant
of body parts and/or with Hepatitis B: their claims are to be dealt with so
far as possible later this year. The 114 Claimants received blood transfusions
or blood products usually in the course of undergoing surgery, whether consequent
upon having suffered an accident or otherwise, or immediately after childbirth
or in the course of treatment for a blood disorder. The earliest date of infection
in respect of which claimants can make such claims is 1 March 1988, being
the date when the CPA was brought into effect. Most of the Claimants have
been identified by the Defendants' own admirable Look-Back programme, which
began in 1995. There were, fortunately, relatively few such sufferers, and
it should be said immediately that there is no question of their having received
'contaminated' blood, that is blood infected by some outside agent: the blood
they received was 'infected' because, exceptionally, the donor's blood was
infected by Hepatitis C.
CAUSE
OF ACTION
- The
claims the subject matter of this trial are not in negligence, but are put
against the Defendants by way of 'strict' or 'objective' liability by virtue
of the CPA, which implemented in the United Kingdom the European Union (then
the EEC) Product Liability Directive of 1985, being a Council Directive of
25 July 1985 ('the Directive'). The Directive is not, in any event in this
action, said to be directly enforceable against the Defendants by the Claimants,
who rely for their cause of action on the CPA. However, as below appears,
the European Commission complained, by application lodged at the European
Court on 20 September 1995, that the United Kingdom Government had not fulfilled
its obligations under the Directive and under the EC Treaty by implementing
the CPA in the terms it had. Although the European Court dismissed that application,
it is apparent from the judgment of the European Court, reported as European
Commission v United Kingdom ('Commission v UK') [1997] AER (EC) 481, that,
there not at that stage having been any decisions of the English courts, nor
indeed any facts before the European Court, the European Court was concluding
that, whatever be the precise terms of the CPA, the United Kingdom would so
implement and construe the CPA as to be consistent with the Directive - not
least by virtue of Section 1(1) of the CPA, which reads as follows:
"[Part
I] shall have effect for the purpose of making such provision as is necessary
in order to comply with the Product Liability Directive and shall be construed
accordingly."
Consequently
both parties have during this trial almost exclusively concentrated on the
terms of the Directive, on the basis that, insofar as the wording of the CPA,
in relation to matters which have been the subject matter of particular issue
in this case, differs from the equivalent Articles in the Directive, it should
not be construed differently from the Directive; and consequently the practical
course was to go straight to the fount, the Directive itself. As will be seen,
the arguments were directed mainly to the true and proper construction of
Article 6 of the Directive (the equivalent being Section 3 of the CPA) and
Article 7(e) (the equivalent being Section 4(1)(e)), and consequently it is
with those Articles, and not the relevant Sections, with which this judgment
will be primarily, if not exclusively, concerned. It is conceded for the purpose
of these proceedings that the blood or blood products by which the Claimants
were infected are products within the meaning of the CPA and the Directive,
and that the Defendants' production of blood was, for the purpose of the Directive,
an industrial process.
THE
DEFENDANTS
- The
National Health Service bodies responsible for the production and supply of
blood and blood products prior to 1 April 1993 in England (and also covering
northern Wales) were fourteen regional blood transfusion centres ('RTCs'),
controlled and administered by Regional Health Authorities. From that date,
by the National Blood Authority (Establishment and Constitution) Order 1993
(SI 1993 No. 583), the National Blood Authority ('NBA') was established, with
responsibility for the RTCs and both central blood laboratories (the Central
Blood Laboratory Authority ('CBLA'), which itself had responsibility for the
Blood Products (later Bio Products) Laboratory ('BPL'), and the Blood Groups
Research Laboratory ('BGRL')). Subsequently the National Blood Authority (Establishment
and Constitution) Amendment Order 1994 (SI 1994 No. 589) provided that all
rights enforceable by or against a Regional Health Authority in respect of
the exercise of functions which became exercisable by the NBA were to be exercisable
against the NBA. So far as Wales is concerned, those parts of Wales not serviced
by the Mersey RTC were covered by a transfusion centre in Cardiff operated
by the South Glamorgan Health Authority. Responsibility for that, and for
the provision of a blood transfusion service in Wales, was transferred not
to the NBA but to the Welsh Health Common Services Authority, and as from
1 April 1999 was further transferred to Velindre NHS Trust, which is now the
relevant Defendant so far as any liabilities to the Claimants in respect of
the balance of Wales is concerned. I shall refer in this judgment to 'the
Defendants' without taking into account the various changes of identity and
responsibility.
THE
PROCEEDINGS
- The
group action effectively commenced with a generic Order for Directions on
1 May 1998 made by Master Eyre, who was assigned Master, which set out the
basic rules for the conduct of the Hepatitis Litigation, gave leave to issue
an omnibus writ and provided for the maintenance of a Hepatitis Register.
The omnibus writ was issued on 1 May 1998. I was appointed as assigned Judge
in February 1999, and Master Eyre and I have made a number of orders since
then, which have, with the considerable co-operation of those representing
the parties, led to the identification and trial of generic issues and of
six lead cases. Each Claimant has been entitled to have his or her own solicitor,
but the generic aspects of the action have been handled, and the individual
cases co-ordinated, on the Claimants' behalf by Messrs Deas Mallen, instructing
Michael Brooke QC, Stuart Brown QC, Ian Forrester QC and Jalil Asif. The Defendants'
solicitors have been Messrs Davies Arnold Cooper, instructing Nicholas Underhill
QC, Philip Brook Smith and Louise Merrett. They have together worked extraordinarily
hard in order to achieve a miracle of good order and clarity, by slimming
down the issues, where at all possible, and managing to contain a myriad of
documentation within a relatively small compass and a relatively small number
of files. By the third Generic Order of 26 February 1999 I ordered that the
generic trial of issues to be agreed and/or determined take place in October
2000, and by dint of the co-operation and hard work to which I have referred,
this has occurred, and was more or less contained within the original time
estimate of three months: I have been enormously assisted by the way the case
has been both industriously prepared and skilfully, persuasively and economically
argued and presented. The generic issues effectively amounted to whether the
Defendants are liable to the Claimants under the CPA, i.e., whether the Claimants
as a whole can prove that (assuming injury, causation and loss can be proved
in respect of each Claimant) the Defendants are liable under Section 3 (Article
6) and not exonerated within Section 4(1)(e) (Article 7(e)), to which I shall
refer. I have also heard six lead cases, in which, on the assumption of having
established liability generically under the CPA, such Claimants have sought
to prove individual liability and quantum, both on their own behalf and in
order to resolve generic issues relating to quantum in such a way as to assist
in the subsequent disposal of the other cases. All the Claimants have, by
an unopposed order in May 1998, been entitled to remain anonymous, and the
six lead Claimants have been known by the codes of Mr S, Miss T, Mr U, Ms
V, Mr W and Mrs X. As will be seen, these six lead Claimants have been carefully
chosen (the equal balance of their sex is, I believe, a coincidence) to cover
and illustrate a spread of consequences from their Hepatitis C infection:
ranging from Mr S, now 17, who was infected by a blood transfusion after a
road traffic accident at the age of 7, but had the good fortune that the virus
spontaneously cleared his blood and has not recurred: through to Mrs X, a
lady of 56, who at the age of 45 was infected by a blood transfusion in the
course of routine surgery, and whose treatment for Hepatitis C was not successful,
such that her condition progressed to cirrhosis of the liver (severe damage
and/or scarring to liver tissue (fibrosis)), resulting in progressive deterioration
in liver function, and a consequent liver transplant, which to date has been
successful, although her Hepatitis C infection remains.
SETTLEMENT
- After
the case started, I was informed that it had been agreed between the parties
that the claims of almost all those Claimants already then party to the action
who were infected on or after 1 April 1991 would no longer be opposed, on
the basis that they would each receive 90% of whatever sum I should find (in
the case of those lead Claimants falling within such category, being Mr S
and Mr W), or as should thereafter be agreed or determined (in the case of
the other Claimants), in the light of my determination of the issues, and
my resolution of the amounts otherwise due in respect of the lead cases. This
agreement made the need for any detailed consideration of the facts relating
to the period subsequent to 1 April 1991 very much reduced. Its effect however
overall is that, subject to that somewhat foreshortened consideration of the
timescale, insofar as I have had to consider the factual history, the issue
of liability which I have to decide remains unaltered; but so far as concerns
two of the lead Claimants and nineteen of the other Claimants, their individual
liability no longer being contested, their dispute has become one as to quantum
only.
BLOOD
TRANSFUSION
- Organised
blood transfusion began in England and Wales in 1921. The practice (unlike
in the United States, where donors were paid until the 1970s) was of donation
by unpaid volunteers. By 1970 the fourteen RTCs (organised into three geographical
divisions as from 1978) and the South Glamorgan Health Authority were responsible
for the collection of blood from voluntary donors, the processing and testing
of blood donations and the supply of blood to hospitals within their area,
and on some occasions to other hospitals and bodies outside their region.
Each RTC was managed by its own independent medically qualified Regional Transfusion
Director, but, although there were some central co-ordinating arrangements,
there was no centralised administration until 1988, when the National Directorate
of the National Blood Transfusion Service ('NBTS') was formed, and Dr Harold
Gunson was appointed as Director. As set out in paragraph 3 above, this was
replaced as from 1 April 1993 by the NBA, with full central authority, and
Dr Gunson became National Medical Director, in which post he remained until
his retirement in July 1994, since when he has been a part time Consultant
to the NBA.
- Blood
is traditionally donated two to three times per year, by voluntary donors.
It is collected by encouraging the donor to bleed into a collection bag, where
the blood is mixed with an anti-coagulant. Each donor's blood will be kept
separate, and separately identifiable, though it may be retained and used
as whole blood, to be transfused to those suffering serious life-threatening
haemorrhages, or may be separated out into constituent parts, such as red
cell concentrates, white cell concentrates, platelet concentrates, fresh frozen
plasma or other blood products. Depending on how much blood or blood products
a patient subsequently needs, he may derive such blood or blood products from
a number of different donors. Blood is given to a patient in units, that is
bags, each from a single donor. Rarely, a single unit is supplied to a patient,
but for serious operations or illnesses many units, from different donors,
may be necessary. Autologous transfusion, that is the use of a patient's own
blood, which is a rare alternative method, though originally canvassed, did
not materially feature in the trial.
HEPATITIS
- Hepatitis
simply means 'inflammation of the liver'. It can result from a number of different
causes, including self-inflicted substance abuse. It has been known since
the 1940s that Hepatitis can be transmitted by transfusions of blood and plasma.
It quickly became apparent that there was a distinction between what was then
called infectious Hepatitis (now known as Hepatitis A) and serum Hepatitis
(now known as Hepatitis B). The Hepatitis A virus was identified by Feinstone
and others in 1973, and is transmitted almost entirely from the oral and faecal
routes, rather than by the transfusion of serum and plasma. The Hepatitis
B virus (found in the serum of an Australian Aboriginal and called the 'Australia
antigen') was identified by Blumberg and others in 1964. Tests to screen out
Hepatitis B in blood were pioneered in 1971, and were introduced for all blood
in the United Kingdom from December 1972. The combination of the exclusion
of paid donors and of blood donors tested positive for Hepatitis B led in
the United States to a substantial reduction in Post-Transfusion Hepatitis
('PTH'). However by 1975 an agent other than Hepatitis A or B was recognised
to be causing PTH, and it was found by Dr Harvey Alter (for many years the
doyen of research in this field, based in the United States), of the National
Institutes of Health in Maryland ('NIH'), that by 1985 PTH still occurred
in 7% to 12% of blood transfusion recipients in the United States. The condition
caused by this unknown agent was, as Dr Gunson put it, "for the want of
a better term", described by Dr Alter and others as Non-A Non-B Hepatitis
('NANBH'). The virus which caused NANBH was eventually first identified within
the research department of a US company called Chiron Corporation ('Chiron')
by Houghton and others, in Spring 1988, and was announced by a News release
by that company on 10 May 1988 which stated:
"Scientists
at Chiron Corporation have identified, cloned and expressed proteins from
a long-sought blood-borne hepatitis non-A, non-B virus and have developed
a prototype immunoassay that may lead to a screening test for hepatitis non-A,
non-B antibodies."
The
virus was hurriedly itself christened, perhaps inevitably, as Hepatitis C.
Its convenient shortening is Hep C. However it has also been regularly known
as HCV in the medical and blood professions, and the antibody to it, and hence
the immunoassay subsequently developed, known as anti-HCV, and indeed Hepatitis
B as HBV. This shorthand seems to me to be totally unnecessary and is responsible
for a great deal of distress, embarrassment and indeed potentially for economic
loss, because of the consequent association with the quite unconnected condition
of HIV - the human immunodeficiency virus related to AIDS. The resultant confusion
of sufferers themselves, of their relatives and friends, even of doctors and
dentists, certainly of employers and insurance companies, has been natural
and quite unnecessary. Though it is to be hoped that attitudes towards HIV
sufferers change, and that a treatment for HIV is developed and expanded,
nevertheless so far as Hepatitis C sufferers are concerned it is important
to distinguish between the conditions. So far as concerns the source of infection
by Hepatitis C, it can, on the evidence I have heard, almost never be transmitted
sexually. Insofar as its consequences are concerned, although it is and can
be a serious condition, leading in rare cases to eventual death, many sufferers
from Hepatitis C have few or no clinical symptoms, life expectancy is often
unaffected and little if any change in life-style results, unlike the present
position in relation to HIV sufferers. If this case and the publication of
this judgment do any good at all to anyone, the one achievement that can be
hoped for is the total and permanent abandonment of the shorthand of HCV,
anti-HCV and indeed HBV.
TESTING
IN RESPECT OF NANBH/HEPATITIS C
Surrogate
Tests
- As
appears above, there was neither identification of the NANBH virus nor, consequently,
development of any screening test or assay so as to eliminate such virus from
blood donations prior to their use, in the years up to 1988. There was however,
as will appear in more detail below, considerable research and academic discussion
in the medical journals about the problem of PTH, particularly in the United
States, which was still suffering from the aftermath of paid donors, and at
all times appears to have had a much higher incidence of PTH than Europe.
There was discussion as to whether to introduce in the United States what
became known as 'surrogate tests'; but after lengthy and detailed studies
carried out and reported by two prestigious groups, the Transfusion Transmitted
Virus Study ('TTVS') and the NIH Study (the latter including Dr Alter), published
in 1981 and subsequent years, and, after considerable discussion in committees
and in the medical journals, no surrogate tests were introduced. The two tests
that were being looked at by the two bodies were the ALT test and the anti-HBc
test. These were as follows:
- ALT.
This test measures the level of an enzyme, ALT (Alanine Aminotransferase),
in the blood. This was a test regularly used by hepatologists in the diagnosis
and treatment of liver diseases. Raised ALT in the blood could suggest abnormality
of liver function: it could indicate the presence of Hepatitis: it could
on the other hand, even where substantially raised, be an indicator of other
liver conditions or simply of high alcohol intake and/or obesity. An ALT
test therefore did not test for the presence of Hepatitis or the NANBH virus;
and a 'positive' test (about the marker for which there was in any event
no unanimity, because different 'cut-offs' were adopted in different laboratories
and in different countries) thus did not signify the presence of Hepatitis,
but was only a possible indicator of it. Hence a 'surrogate' test.
- Anti-HBc.
A virus or antigen can have an envelope containing a core. Thus there is
reference to surface antigen and core antigen. A healthy body develops antibodies,
which hopefully resist the antigens, by binding on them. Some tests identify
the antigen (whether the surface or the core) and some the antibodies. The
screening test introduced for Hepatitis B identified the Hep B surface antigen
(HBsAg). An additional test was also developed, but not used as the screening
test for Hep B, which could identify, not the Hep B core antigen (HBcAg),
but the antibody to the Hep B core antigen (anti-HBc). Such test therefore,
which was only identifying the antibody to Hep B, could plainly not identify
(what had in any event not been itself discovered) the NANBH antigen or
indeed antibody. However it was contended that it could provide what was
called a 'lifestyle marker'. Those who had had, but had recovered from,
Hepatitis B in the past (and thus would no longer test positive for the
Hep B antigen) would or could retain in their blood traces of the Hep B
antibody. It could thus be identified by the use of the anti-HBc test whether
someone had had Hepatitis B, and it was suggested that a donor with past
exposure to Hepatitis B would be more likely to have been exposed also to
the NANBH agent, e.g., by intravenous drug use. This was the other suggested
'surrogate test'.
- As
will appear in more detail below, the United States did not introduce either
of these surrogate tests after the detailed studies referred to above: ALT
testing (but not anti-HBc) was introduced in Germany as early as 1965 and
in Italy in 1970, but neither in the UK nor in any other country, so far as
is known to the parties in this case, was either test then introduced. The
United States however introduced both tests starting from September 1986.
As will appear, albeit that discussion continued, those responsible for blood
transfusion in the United Kingdom did not support, and did not introduce,
the surrogate tests, notwithstanding their adoption in the United States,
and, once Chiron had pioneered the assay in respect of Hepatitis C, they concentrated
upon whether and when to introduce that test.
- Anti-Hep
C Screening. After the identification of the Hepatitis C virus, development
speedily continued, as indeed was indicated in the Chiron News Release, of
an assay: well in the lead was a US company called Ortho Diagnostic Inc. ('Ortho')
(Chiron's licensee) followed some time later by another US company, Abbott
Laboratories Inc. ('Abbott') and, less successfully and later still, by others.
Known as anti-HCV, but, for the reasons I have given, to be resolutely called,
at any rate by me, anti-Hep C, this assay did not detect the antigen, but
was a test for the antibody to the Hepatitis C virus (a test to identify the
antigen took very much longer to develop, by means of polymerase chain reaction
('PCR') - later 'NAT' (nucleic acid testing) - and is not relevant to the
timescale which I am now considering). The anti-Hep C assay was an enzyme-linked
immunoabsorbent assay ('ELISA'). The details of the Ortho Elisa were disclosed
in April 1989 and were fully canvassed at a well-attended symposium organised
by Ortho in Rome on 14/15 September 1989, when it was given backing by, among
others, Dr Alter. Dr Gunson came away impressed, and reported back to the
two high powered committees on which he sat, the UK Advisory Committee on
Virological Safety of Blood ('ACVSB'), and the UK Advisory Committee on Transfusion
Transmitted Diseases ('ACTTD'), of which latter he was the Chairman. The factual
history will appear below in greater detail. At this stage it is sufficient
to set out as follows:
- At
this time the Ortho Elisa had only just been developed. It was a 'first
generation' test and there were concerns about its sensitivity (not catching
all it should) and its specificity (catching those it should not). There
was no supplementary or confirmatory test yet developed to verify or cross-check
its findings and increase the specificity of the process.
- No
export licence was obtained for export of the assay from the USA until the
end of November 1989, and the approval by the US Food and Drugs Administration
('FDA') for its use within the USA was not granted until 2 May 1990.
- Recommendations
to proceed with the introduction of the anti-Hep C testing were made by
the relevant UK Committee, the ACVSB, in July and November 1990, subject
to the holding of various trials. Ministerial approval was given on 21 January
1991 and a programme of implementation was then commenced for all RTCs.
The tests (by now second generation tests, and with a supplementary test
available for confirmatory purposes in place) were introduced throughout
England and Wales on 1 September 1991. However, as set out above, the Defendants
have accepted that the relevant date for these proceedings is 1 April 1991
and most Claimants who were infected on or after that date have received
an admission of 90% liability. Since the introduction of the tests on 1
September 1991, the problem of PTH in the United Kingdom has been all but
eliminated.
THE
CLAIMS
- The
claims in this trial have been that, pursuant to the CPA, those who received
blood or blood products infected by Hepatitis C subsequent to 1 March 1988,
when the Act came into effect, are entitled to recover damages: that is notwithstanding
that:
- the
Hepatitis C virus itself had not been discovered or identified at the date
when the claims commence on 1 March 1988.
- no
screening test to discover the presence of such virus in a donor's blood
was even known of, certainly not available, until Ortho's assay, first publicised
in Spring/Summer 1989.
- it
is not sought to be alleged (at least not in this trial) that the UK blood
authorities for whom the Defendants are responsible were negligent in not
introducing the screening tests until they did on 1 September 1991 (or now,
as a result of the agreed concession, 1 April 1991) nor that they were negligent
in not having introduced surrogate tests.
The
case which is put is that they are liable irrespective of the absence of any
fault, under the Directive and the CPA.
THE
DIRECTIVE
- The
Directive, resolved by the Council on 25 July 1985, had taken a long time
in coming. In the first instance this was because discussion of it, which
had begun in 1969/1970 in the light of the Thalidomide scandal, was held up
largely due to the impending arrival of a number of new members of the Community,
including the United Kingdom; but then because of the very lengthy processes
of discussion and negotiation, and of intergovernmental and parliamentary
discussion, which then took place. A number of matters appear to be common
ground between the parties to these proceedings:
- that
its purpose was to increase consumer protection.
- that
it introduced an obligation on producers which was irrespective of fault,
by way of objective or strict liability, but not absolute liability.
- that
its aim was to render compensation of the injured consumer easier, by removing
the concept of negligence as an element of liability and thus of the proof
of liability.
- that
it left an escape clause [in those Community jurisdictions, like the UK,
where such provision was desired] for products otherwise found pursuant
to the Directive to be defective, if the producer could bring himself within
what was, in the course of the 'travaux preparatoires,' described
as a 'development risks' defence.
- The
parties before me agreed to number what are in the published Directive an
otherwise unnumbered set of nineteen recitals. The significant ones for the
purpose of these proceedings have been as follows:
"[1]
Whereas approximation of the laws of the Member States concerning the
liability of the producer for damage caused by the defectiveness of his product
is necessary because the existing divergences may distort competition and
affect the movement of goods within the common market and entail a differing
degree of protection of the consumer against damage caused by a defective
product to his health or property;
[2]
Whereas liability without fault on the part of the producer is the sole means
of adequately solving the problem, peculiar to our age of increasing technicality,
of a fair apportionment of the risks inherent in modern technological production;
[3]
Whereas liability without fault should apply only to movables which have been
industrially produced; whereas, as a result, it is appropriate to exclude
liability for agricultural products and game, except where they have undergone
a processing of an industrial nature which could cause a defect in these products
..
[6]
Whereas, to protect the physical well-being and property of the consumer,
the defectiveness of the product should be determined by reference not to
its fitness for use but to the lack of the safety which the public at large
is entitled to expect; whereas the safety is assessed by excluding any misuse
of the product not reasonable under the circumstances;
[7]
Whereas a fair apportionment of risk between the injured person and the producer
implies that the producer should be able to free himself from liability if
he furnishes proof as to the existence of certain exonerating circumstances;
[11]
Whereas products age in the course of time, higher safety standards are developed
and the state of science and technology progresses; whereas, therefore, it
would not be reasonable to make the producer liable for an unlimited period
for the effectiveness of his product; whereas, therefore, liability should
expire after a reasonable length of time, without prejudice to claims pending
at law;
[13]
Whereas under the legal systems of the Member States an injured party may
have a claim for damages based on grounds of contractual liability or on grounds
of non-contractual liability other than that provided for in this Directive;
insofar as these provisions also serve to attain the objective of effective
protection of consumers, they should remain unaffected by this Directive;
whereas, in so far as effective protection of consumers in the sector of pharmaceutical
products is already also attained in a Member State under a special liability
system, claims based on this system should similarly remain possible;
[16]
Whereas, for similar reasons, the possibility offered to a producer to free
himself from liability if he proves that the state of scientific and technical
knowledge at the time when he put the product into circulation was not such
as to enable the existence of a defect to be discovered may be felt, in certain
Member States, to restrict unduly the protection of the consumer; whereas
it should therefore be possible for a Member State to maintain in its legislation
or to provide by new legislation that this exonerating circumstance is not
admitted; whereas, in the case of new legislation, making use of this derogation
should, however, be subject to a Community stand-still procedure, in order
to raise, if possible, the level of protection in a uniform manner throughout
the Community."
- It
is not in dispute between the parties that the Directive can and must be construed
by reference to its recitals and indeed to its legislative purpose, insofar
as it can be gleaned otherwise than from the recitals. The following points
are also not in dispute and are in any event clear:
- that
it is proper to look at travaux preparatoires to glean such purpose,
but with caution, always chary of early discussions or disputations which
may have been overtaken by later events, or of documents which may always
have been internal or confidential and not reflected in the decisions:
- that
it is important to bear in mind in construing a Directive that there may
be an 'autonomous' or Community meaning or construction for legislation
intending to harmonise and to be of effect in diverse jurisdictions within
the Community; and that some guidance can be obtained from other languages
in which the Directive was published, all of which are of equal weight,
the more so if some appear clear and congruent; and to some extent also
from the way in which a Directive has been implemented or applied in other
Community countries.
- The
relevant Articles are as follows:
"1.
The producer shall be liable for damage caused by a defect in his product.
4.
The injured person shall be required to prove the damage, the defect and the
causal relationship between defect and damage.
6.1
A product is defective when it does not provide the safety which a person
is entitled to expect, taking all circumstances into account, including:
(a)
the presentation of the product;
(b)
the use to which it could reasonably be expected that the product would be
put;
(c)
the time when the product was put into circulation.
6.2
A product shall not be considered defective for the sole reason that a better
product is subsequently put into circulation.
7.
The producer shall not be liable as a result of this Directive if he proves:
(a)
that he did not put the product into circulation; or
(b)
that, having regard to the circumstances, it is probable that the defect which
caused the damage did not exist at the time when the product was put into
circulation by him or that this defect came into being afterwards; or
....
(d)
that the defect is due to compliance of the product with mandatory regulations
issued by the public authorities; or
(e)
that the state of scientific and technical knowledge at the time when he put
the product into circulation was not such as to enable the existence of the
defect to be discovered; ...
8.1
Without prejudice to the provisions of national law concerning the right of
contribution or recourse, the liability of the producer shall not be reduced
when the damage is caused both by a defect in product and by the act or omission
of a third party.
8.2
The liability of the producer may be reduced or disallowed when, having regard
to all the circumstances, the damage is caused both by a defect in the product
and by the fault of the injured person or any person for him the injured person
is responsible.
9.
For the purpose of Article 1, 'damage' means:
(a)
damage caused by death or by personal injury ...
12.
The liability of the producer arising from the Directive may not, in relation
to the injured person, be limited or excluded by a provision limiting his
liability or exempting him from liability.
15.1
Each Member State may ...
(b)
by way of derogation from Article 7(e) maintain or ... provide in its legislation
that the producer shall be liable even if he proves that the state of scientific
or technical knowledge at the time when he put the product into circulation
was not such as to enable the existence of a defect to be discovered ..."
THE
CPA
- When
the United Kingdom implemented the Directive, it did so by way of the CPA,
which came into force on 15 May 1987, but with effect from 1 March 1988. There
have been few decisions under the CPA. I have been referred only to two -
one unreported in the Court of Appeal, Iman Abouzaid v Mothercare (UK) Ltd
21 December 2000 ['the Cosytoes case'] and one a decision of Ian Kennedy J,
which has been reported (Richardson v LRC Products Ltd [2000] Lloyds (Med)
280 ['Richardson']: I shall refer to them both. However in neither case was
there the need nor the opportunity for the kind of detailed consideration
of the CPA, and in particular of all the issues raised by Articles 6 and 7(e)
of the Directive (respectively sections 3 and 4(1)(e) of the CPA), that there
has been in this case. Apart from the evidence and its analysis, and from
the separate consideration of the lead cases, I have had the great benefit
of detailed submissions in writing, and some ten days of exegesis and argument
orally in opening and closing by leading counsel, just on the law, including
authorities and academic writings from France, Germany, Spain, Portugal, Sweden,
Denmark, Belgium, Italy, Holland, Australia and the United States, as well
as the United Kingdom and the European Court. In the light of the concession
in this case that blood is a product within the Directive, and the nature
of the issues for determination and the possible consequent knock-on effect
of this judgment, (subject always to any appeal to higher courts in this country
or on reference to Europe), I note without surprise that Professor Stapleton,
probably the most eminent and certainly the most prolific of the common law
writers on the topic of product liability, refers to the fact that this case
is pending in her introduction to the recent volume in the Butterworths Common
Law Series The Law of Product Liability edited by Professor Howells
['Butterworths Product Liability'].
- The
most authoritative consideration of the CPA has of course been in the case
of Commission v UK, to which I have referred in paragraph 2 above, and that
was consideration in principle, not by reference to the facts of any case,
and directed specifically to Article 7(e) (and Section 4(1)(e)). As I have
set out in paragraph 2, the Commission contended that the Section did not
properly or lawfully reflect the Article as it should. As will be seen below,
it adopts different wording from the Article, and this may result from the
United Kingdom's Government's own unilateral declaration that it made at the
time of the adoption of the Directive, namely:
"this
provision should be interpreted in the sense that the producer shall not be
liable if he proves that, given the state of scientific knowledge at the time
the product was put into circulation, no producer of a product of that kind
could have been expected to have perceived that it was defective in its design."
This
falls to be compared with the text of the Article, which I have set out in
paragraph 16 above. Section 4(e) of the CPA as enacted is as follows (I underline
the significant differences from the Article):
"In
any civil proceedings ... against any person ... in respect of a defect in
a product it shall be a defence for him to show ...
(e)
that the state of scientific and technical knowledge at the relevant time
was not such that a producer of products of the same description as the product
in question might be expected to have discovered the defect if it had existed
in his products while they were under his control."
- Whatever
the content of a unilateral declaration may be, a Community Government is
obliged in law to enact the Directive, and the Commission contended before
the European Court that the UK Government had not done so. The European Court
concluded that, notwithstanding that there was a difference of wording, it
could not be satisfied that it was intended by the United Kingdom to interpret
its statute differently from the Directive, nor was the United Kingdom entitled
to do so. At 490h, paragraph 25, the Advocate General (Tesauro) stated in
his Opinion:
"I
consider that I am unable to share the Commission's proposition that there
is an irremediable conflict between it and the national provision at issue.
Indeed, there is no denying that the wording of Section 4(1)(e) of the [CPA]
contains an element of potential ambiguity: insofar as it refers to what might
be expected of the producer, it could be interpreted more broadly than it
should. Notwithstanding this, I do not consider that the reference to the
'ability of the producer' despite its general nature, may or even must (necessarily)
authorise interpretations contrary to the rationale and the aims of the Directive."
- After
its own analysis of Article 7(e), the European Court concluded, at 495g -
496d, paragraphs 32-39:
"32.
The Commission takes the view that inasmuch as s4(1)(e) of the [CPA] refers
to what may be expected of a producer of products of the same description
as the product in question, its wording clearly conflicts with Article 7(e)
of the Directive in that it permits account to be taken of the subjective
knowledge of a producer taking reasonable care, having regard to the standard
precautions taken in the industrial sector in question.
33.
That argument must be rejected insofar as it selectively stresses particular
terms used in s4(1)(e) without demonstrating that the general legal context
of the provision at issue fails effectively to secure full application of
the Directive. Taking that context into account, the Commission has failed
to make out its claim that the result intended by Article 7(e) of the Directive
would clearly not be achieved in the domestic legal order.
34.
First s4(1)(e) ... places the burden of proof on the producer wishing to rely
on the defence, as Article 7 of the Directive requires.
35.
Second s4(1)(e) places no restriction on the state and degree of scientific
and technical knowledge at the material time which is to be taken into account.
36.
Third, its wording as such does not suggest, as the Commission alleges, that
the availability of the defence depends on the subjective knowledge of a producer
taking reasonable care in the light of the standard precautions taken in the
industrial sector in question.
37.
Fourth, the court has consistently held that the scope of national laws ...
must be assessed in the light of the interpretation given to them by national
courts ... Yet in this case the Commission has not referred in support of
its application to any national judicial decision, which, in its view, interprets
the domestic provision at issue inconsistent with the Directive.
38.
Lastly there is nothing in the material produced to the Court to suggest that
the United Kingdom, if called upon to interpret s4(1)(e), would not do so
in the light of the wording and the purpose of the Directive, so as to achieve
the result which it has in view and thereby comply with the third paragraph
of Article 189 of the Treaty ... Moreover s(1)(1) of the [CPA] expressly imposes
such an obligation on the national courts.
39.
It follows that the Commission has failed to make out its allegation, that,
having regard to its general legal context and especially s1(1) of the Act,
s4(1)(e) clearly conflicts with Article 7(e) of the Directive. As a result
the application must be dismissed."
- Although
the UK Government has not amended Section 4(1)(e) of the CPA so as to bring
it in line with the wording of the Directive, there is thus binding authority
of the European Court that it must be so construed. Hence, although I shall
in certain respects require to consider sections of the CPA, when dealing
with the issues raised before me of causation and/or quantum of loss, to which
I shall refer, the major discussions in this case, and all the areas of most
live dispute, have concentrated entirely upon the wording of Article 6 and
7(e) of the Directive, and not upon the equivalent sections of the CPA, to
which I shall make little or no further reference.
- In
those circumstances there is no need for me to set out in full Section 3 of
the CPA which implements Article 6, although it may be worth pointing out
that the words in Article 6(1)(a) 'the presentation of the product'
are helpfully expanded and clarified in the CPA in the following way "the
manner in which, and purposes for which, the product has been marketed, its
getup, the use of any mark in relation to the product and any instructions
for, or warnings with respect to, doing or refraining from doing anything
with or in relation to the product" (s3(2)(a); and that the words with
which s3(2) ends are perhaps a cogent way of expressing Article 6.2 which
I have set out above, and in particular the reference in the Article to "a
better product [being] subsequently put into circulation" namely:
"Nothing
in this section shall require a defect to be inferred from the fact alone
that the safety of a product which is supplied after that time is greater
than the safety of the product in question."
- I
shall set out below, when they fall for consideration, the two other sections
of the CPA to which reference was made in the course of the trial, with respect
to the issue which I have described as causation and/or quantification of
loss, namely Sections 2(1) and 5(1).
THE
STRUCTURE OF THIS JUDGMENT
- I
propose to adopt the following structure in this judgment. I shall begin with
the most significant legal questions, arising out of the construction of the
Directive. I should at this point make it clear that because I have heard
all the facts of the case upon which either side might wish to rely upon any
of the issues, I shall make the necessary findings, irrespective of my conclusions
in law. This is because both parties wish to take advantage of the very full
consideration which there has been so that, if there were appeals or references
leading to different conclusions of law in due course, there would be the
factual material for the substitution of a different result. In particular,
as will appear, if the Claimants be right about their construction of the
Directive, then little if any of the evidence that I have heard relating to
the factual history with regard to Hepatitis C and screening would be admissible
or relevant. I shall however resist the temptation, nor am I in any event
permitted by the approach of the parties, if I were to resolve such point
of law in favour of the Claimants, not to proceed to resolve the factual issues
which would then have become irrelevant. Equally, at any rate until there
was the 90% concession, which has meant that liability to some Claimants is
no longer in issue, it might have been that if I had found for the Defendants
on liability I would not have needed to go on to decide what I would have
awarded to the Claimants, had they been successful: but again, for similar
reasons, this is not a course that I have adopted. Accordingly whatever my
decisions on the various issues, I have proceeded to decide the further issues,
whether or not they continue to arise.
THE
SIX ISSUES
- This
raises the question of whether the Defendants are liable to the Claimants,
without consideration of the history of testing. The Claimants allege that,
upon the basis of a proper construction of the Directive and the agreed factual
common ground, the blood was defective under Article 6 and the Defendants
have no escape within Article 7(e), without need for further consideration
of the facts [Issue I]. This was described in the course of the hearing as
the 'Forrester case' or the 'Brown short case' (which descriptions derogate
from the role of Mr Brooke QC for the Claimants who ably married together
all the Claimants' arguments).
- Factual
case: Legitimate Expectation [Issue II]. Whether or not I find the Defendants
so liable, for the reasons I have set out above, I must proceed to resolve
the factual questions which the Claimants assert to be unnecessary - the 'Brown
case'. The Claimants assert, if they need to, that, in the light of the factual
history relied upon by the Defendants, the blood was defective within Article
6. I shall also make sufficient findings to resolve any factual issues under
Article 7(e), as to which see paragraph 28 below.
- I
must then resolve the issue of the nature and measure of damages under Article
6 in the event that the Defendants were found liable (and in any event, for
the reasons given above):
- on
the basis of my conclusions on Issue I [Issue IIIa]
- on
the basis of my conclusions on Issue II [Issue IIIb]
- I
must decide whether the Defendants escape any such liability under Article
7(e):
- in
the light of my conclusions on the construction of Article 7(e) on Issue
I [Issue IVa] and/or
- in
the light of my conclusions on Issue II [Issue IVb]
- I
shall turn then to the six lead cases. Subject always to the outcome of Issue
I, I may have made, in my consideration in respect of Issue II, findings as
to the date when tests could legitimately have been expected to be implemented
which might mean that, depending upon their date of infection, only certain
Claimants succeed, i.e., those infected after such and such a date, while
others do not. That apart, I have heard a good deal of evidence about Hepatitis
C and its prognosis and consequences generally, and in addition all the evidence
relating to the individual circumstances of the six lead Claimants (two of
whom, as previously discussed, will in any event receive compensation in accordance
with my conclusions on quantum, by virtue of the 90% concession agreement).
- I
shall, again even if I shall have found that some or all of the Claimants
fail (apart from those covered by the concession):
- make
findings on the generic issues raised relating to quantum arising out of
and by reference to the particular circumstances of the six lead Claimants,
including such matters as recoverability or otherwise of damages in respect
of alleged social or insurance or employment stigma resulting from their
Hepatitis condition, past or present. (Issue V)
- assess
damages, in the case of five of the lead Claimants by way of provisional
damages, on the basis of what have now, after considerable discussion and
argument, become agreed triggers for any potential future entitlement to
additional damages pursuant to Section 32A of the Supreme Court Act 1981,
and in the case of one of them, Mr W, at his request, final damages. (Issue
VI)
ARTICLE
6
The
Common Ground
- I
turn then to consideration of Article 6. There is a foundation of common ground:
- Article
6 defines 'defective', and hence a defect. A harmful characteristic
in a product, which has led to injury or damage, may or may not be a defect
as so defined, and thus within the meaning of the Directive. It is common
ground that the liability is 'defect-based' and not 'fault-based', i.e.,
that a producer's liability is irrespective of fault (Recitals 2, 6).
- The
purpose of the Directive is to achieve a higher and consistent level of
consumer protection throughout the Community and render recovery of compensation
easier, and uncomplicated by the need for proof of negligence.
Both
these propositions are expressed by Christopher Newdick in two published
articles, first in the Law Quarterly Review [1987] 103 LQR 288:
"Liability
for defective products is no longer to be dependent on fault, but rather
on the mere fact of defectiveness. The broad reasons of policy for the change
continue to be articulated by the injuries suffered by the thalidomide children.
By the attention it devotes to consideration of the alleged fault of the
defendant, the law of Negligence is unable to consider the interests of
the person for whom the action has been brought."
and
also in the Cambridge Law Journal [1988] CLJ 47(3) at 455 where, before
going on to deal with Article 7(e) as a possible exception, he states:
"The
... Directive introduces a new regime of strict product liability to the
Member States of the Community. Those injured by products may recover by
showing that the product is 'defective', i.e., that it 'does not provide
the safety which a person is entitled to expect ...' The advantage of this
approach for the individual is that liability turns on the existence of
a defect alone. Unlike the law of Negligence, no question of foresight of
the danger, or of the precautions taken to avoid it, arises for consideration.
Strict product liability depends on the condition of the product, not the
fault of its maker or supplier."
- The
onus of proof is upon the Claimants to prove the product to be defective.
- The
question to be resolved is the safety or the degree or level of safety or
safeness which persons generally are entitled to expect. The test is not
that of an absolute level of safety, nor an absolute liability for any injury
caused by the harmful characteristic.
- In
the assessment of that question the expectation is that of persons generally,
or the public at large.
- The
safety is not what is actually expected by the public at large, but what
they are entitled to expect. At one stage Mr Forrester QC contended
that the process was to discover what the expectation was, and then see
if it was legitimate; but, not least for the reasons set out in the next
following sub-paragraph, he no longer actively pursued that contention.
The common ground is that the question is what the legitimate expectation
is of persons generally, i.e., what is legitimately to be expected, arrived
at objectively. 'Legitimate expectation', rather than 'entitled expectation'
appeared to all of us to be a more happy formulation (and is analogous to
the formulation in other languages in which the Directive is published);
the use of that expression is not intended to import any administrative
law concepts.
- The
Court decides what the public is entitled to expect: Dr Harald Bartl in
Produkthaftung nach neuem EG-Recht described the Judge (as translated
from the German) as 'an informed representative of the public at large'.
Mr Brown QC did not like this, and preferred to suggest simply that the
Judge is determining what level of safety the public is entitled to expect,
but I do not consider the two descriptions inconsistent. Such objectively
assessed legitimate expectation may accord with actual expectation; but
it may be more than the public actually expects, thus imposing a higher
standard of safety, or it may be less than the public actually expects.
Alternatively the public may have no actual expectation – e.g., in relation
to a new product – the word coined in argument for such an imaginary product
was a 'scrid'.
- There
are some products, which have harmful characteristics in whole or in part,
about which no complaint can be made. The examples that were used of products
which have obviously dangerous characteristics by virtue of their very nature
or intended use, were, on the one hand knives, guns and poisons and on the
other hand alcohol, tobacco, perhaps foie gras. The existence of such products
was recognised in an exchange of Question and Answer by Mrs Flesch MEP to
the European Commission, answered by Viscount Davignon on behalf of the
Commission in June 1980. The question read in material part as follows:
"This
provision ought apparently to be interpreted in the sense that nobody can
legitimately expect from a product which by its very nature carries a risk
and which has been presented as such (instructions for use, labelling, publicity,
etc.) a degree of safety which this product does not and cannot possess,
with the result that this product would not therefore be defective within
the meaning of the future directive."
The
answer was:
"The
Commission agreed with the Honourable Member that nobody can expect from
a product a degree of safety from risks which are, because of its particular
nature, inherent in that product and generally known, e.g., the risk of
damage to health caused by alcoholic beverages. Such a product is not defective
within the meaning of ... the ... Directive."
This
does not of course amount to an exemption for such a product from the Article,
but simply an explanation of how the Article operates. Such obvious danger
or risk of injury is, not very felicitously, described by a Danish writer,
Borge Dahl, as 'system' damage. Professor Howells in Butterworths Product
Liability at 1.19 refers to this as a description of:
"The
risks which are inherent within a product which it is nevertheless considered
justifiable to market. Examples include the risk of being cut by a sharp
knife and the risk of illness associated with such otherwise pleasure giving
products [as] alcohol and tobacco ... The emphasis on the autonomy of the
individual and his free choice to expose himself to risks has generally
relieved the producer of ... liability. However this free choice must be
an informed choice and so there has been a need to define which types of
system damage users can be expected to be aware of from their general life
experience (i.e., that knives can be sharp) and those that they have to
be warned about (i.e., risks associated with drinking and smoking)."
Drugs
with advertised side-effects may fall within this category. The Defendants
point out that, with other such products also, the known dangerous characteristics
need not be the desired ones – e.g., carcinogenicity in tobacco.
- Article
6.2 means that such test must be applied as at the date when the product
is put into circulation, i.e., tested against the safety then to be expected.
It is apparent that a product may be compared with other products said to
be safer, but will not be condemned simply because another safer product
is subsequently put into circulation.
- There
is also important factual common ground. It has, as set out in paragraph
8 above, been known, at least since the 1970s, by blood producers and the
medical profession, primarily blood specialists, hepatologists and epidemiologists,
that there was a problem of infection by Hep C (formerly NANBH) in transfused
blood, and that a percentage of such blood – in the United Kingdom thought
to be between 1% and 3% – was infected with NANBH/Hep C. The Claimants say
that such knowledge by the medical profession and blood producers is on
the one hand irrelevant to Article 6, and to the public's expectation, and
legitimate expectation, and on the other rules out the producers from the
protection of Article 7(e). The Defendants say that such risks so known,
which they allege to be impossible to avoid or prevent, affect the legitimate
expectation of the public, such as to exclude Article 6, and, because they
were unavoidable, qualify them, if necessary, for Article 7(e).
The
Differences Between the Parties
- Having
set out what is common ground, I now summarise briefly the difference between
the two parties, some of which is already apparent from my setting in context
of the factual common ground:
- As
to Article 6, the Claimants assert that, with the need for proof of negligence
eliminated, consideration of the conduct of the producer, or of a reasonable
or legitimately expectable producer, is inadmissible or irrelevant. Therefore
questions of avoidability cannot and do not arise: what the Defendants could
or should have done differently: whether there were any steps or precautions
reasonably available: whether it was impossible to take any steps by way
of prevention or avoidance, or impracticable or economically unreasonable.
Such are not 'circumstances' falling to be considered within
Article 6. Insofar as the risk was known to blood producers and the
medical profession, it was not known to the public at large (save for those
few patients who might ask their doctor, or read the occasional article
about blood in a newspaper) and no risk that any percentage of transfused
blood would be infected was accepted by them.
- The
Defendants assert that the risk was known to those who mattered, namely
the medical profession, through whom blood was supplied. Avoiding the risk
was impossible and unattainable, and it is not and cannot be legitimate
to expect the unattainable. Avoidability or unavoidability is a circumstance
to be taken into account within Article 6. The public did not and/or was
not entitled to expect 100% clean blood. The most they could legitimately
expect was that all legitimately expectable (reasonably available) precautions
– or in this case tests – had been taken or carried out. The Claimants must
therefore prove that they were legitimately entitled to expect more, and/or
must disprove the unavoidability of the harmful characteristic. There would
need to be an investigation as to whether it was impossible to avoid the
risk and/or whether the producers had taken all legitimately expectable
steps. Insofar as there was thus an investigation analogous to, or involving
similar facts to, an investigation into negligence, it was not an investigation
of negligence by the individual producer and was necessary and, because
it was not an investigation of fault, permissible. If, notwithstanding the
known and unavoidable risk, the blood was nevertheless defective within
Article 6, then it is all the more necessary to construe Article 7(e) so
as to avail those who could not, in the then state of scientific and technical
knowledge, identify the defect in a particular product so as to prevent
its supply.
- The
Claimants respond that Article 7(e) does not apply to risks which are known
before the supply of the product, whether or not the defect can be identified
in the particular product; and there are a number of other issues between
the parties in respect of Article 7(e) to which I shall return later.
All
Circumstances
- Article
6 must then be considered against the background of this summary of the issues.
In the establishment of the level of safety, Article 6 provides that the Court
(on behalf of the public at large) takes into account all circumstances,
including:
- Presentation,
i.e., the way in which the product is presented, e.g., warnings and price.
As set out above, the expanded wording of s3(2)(a) of the CPA is helpful.
- The
use to which the product could reasonably be expected to be put,
e.g.:
- If
the product is not a familiar or usual one, such as a scrid, it will be
necessary to find out what its expected or foreseeable use is.
- If
it is expected and required to be dangerous in respect of its expected
use, e.g., a gun, then complaint cannot be made of that dangerousness;
but complaint could still be made of a different dangerousness, such as
if it exploded on the trigger being pulled.
- If
it is not expected to be dangerous in respect of its expected use, but
the use to which it is put is unexpected, then it may not be defective.
- The
time when the product is circulated, for example when the product
is out of date or stale.
- The
question arises as to the status of the circumstances enumerated in
Article 6. Are they exclusive? Neither side, rightly, now suggests that they
are. Indeed Mr Forrester QC, who had, at an interlocutory hearing, seemingly
run a contention to that effect, no longer pursued this, and indeed suggested
that some circumstances not specifically mentioned in the Article,
such as the circumstances of the supply of the product, may be relevant. That
the circumstances are not exclusive obviously seems right. Are they
then unlimited? There are various possibilities:
- that
they are to be construed eiusdem generis. This is asserted by Professor
Taschner, the leading European expert on the Directive, in his 1990 book
Produkthaftungsgesetz und EG-Produkthaftungsrichtlinie, at page 297;
but, despite diligent research, the Claimants' team was unable to find
any support for the proposition that such a rule of construction could be
exemplified in European law.
- that
they are to be construed as the most significant examples of the circumstances.
There was some support for this proposition, both by way of some exemplars
in European legislation – from which it could be suggested that European
draftsmen had considered that the matters actually set out as examples were
the ones most worthy of mention – and also by reference to the French language
version of Article 6, which used the word, before the list of the circumstances,
'notamment', and the German, which used 'insbesondere',
both of which I take to mean 'in particular' or 'especially' – although
other language versions use phraseology more similar to the English 'including'.
- that
they are to be construed as unlimited. Even Mr Underhill QC, I think, did
not so contend, but accepted that the circumstances would have to
be 'relevant' circumstances. Mr Forrester QC of course submits that circumstances
which are inconsistent with the purpose of the Directive would not be 'relevant'.
He also refers to Professor Rolland of Halle University, who, in his 1990
book Produkthaftungsrecht at 131 cites Professor Taschner in concluding
(translated from the German) that, in relation to the Article 6 circumstances,
"only such considerations are relevant which do not alter the meaning
of the safety expectations of the public at large, which are assessed on
the basis of objective criteria, but not the subjective necessities of the
producer, and also not those of the user of the product".
- The
dispute therefore is as to what further, if anything, falls to be considered
within 'all circumstances'. There is no dispute between the parties,
as set out in paragraph 31(i) and (ii) above, that consideration of the fault
of the producer is excluded; but does consideration of 'all circumstances'
include consideration of the conduct to be expected from the producer, the
level of safety to be expected from a producer of that product? The parties
agree that the starting point is the particular product with the harmful characteristic,
and if its inherent nature and intended use (e.g., poison) are dangerous,
then there may not need to be any further consideration, provided that the
injury resulted from that known danger. However, if the product was not intended
to be dangerous, that is the harmful characteristic was not intended, by virtue
of the intended use of the product, then there must be consideration of whether
it was safe and the level of safety to be legitimately expected. At this stage,
the Defendants assert that part of the investigation consists of what steps
could have been taken by a producer to avoid that harmful characteristic.
The Defendants assert that conduct is to be considered not by reference to
identifying the individual producer's negligence, but by identifying and specifying
the safety precautions that the public would or could reasonably expect from
a producer of the product. The exercise is referred to as a balancing act;
the more difficult it is to make safe, and the more beneficial the product,
the less is expected and vice versa, an issue being whether a producer has
complied with the safety precautions reasonably to be expected. This is contended
by the Defendants to be appropriately analogous to the 'risk/utility'
consideration familiar from United States law, particularly as summarised
in the US Second Restatement on Torts (1965). However:
- the
Claimants point out that, although the Advocate General in Commission v
UK at 488b para 17 records that the Commission's original proposal in 1976
drew its inspiration from the US model, it is clear from the travaux
preparatoires that when submissions were made that a United States style
formulation should be adopted, it was not: the rejected suggestions including
(from a body called UNICE in 1980) that "the fact that a product conforms
with generally accepted standards should be prima facie evidence that the
product is not defective" and, from the American Chamber of Commerce
in Belgium in the same year, that the proposed Article "should be amended
to include specific language concerning unavoidably unsafe but useful products
... In drafting this amendment regard should be paid to the wording of Comment
K to Section 402a of [the Second Restatement]".
- although
the concept of 'unavoidably unsafe' has meant that producers have
been found not liable in many states of the United States in respect of
infected blood (see e.g., Brody v Overlook Hospital 317 A 2d 392 (1974)
[subsequently affirmed by the Supreme Court of New Jersey]), the US Second
Restatement has led to, or allowed for, a result, at least in Illinois,
whereby there was strict liability imposed on the supplier of blood unavoidably
infected with Hepatitis (Cunningham v McNeal Memorial Hospital 47 Ill. 2d
443 Supreme Court of Illinois): which decision was dealt with statutorily,
as a matter of public policy, by the giving of immunity to blood banks –
a so-called 'blood-shield statute', passed in most states of the United
States.
- the
Defendants themselves accept that the risk/utility model adopted
in the United States cannot be applied in its entirety, because of the express
exclusion, so far as the Directive is concerned, of any question of liability
for negligence. Nevertheless the Defendants assert that there is a 'basket'
of considerations: the likelihood of injury resulting and the seriousness
of it if it results, the cost and the quality of the product, the efficacy
of the product (with and without safety precautions), none of which would
necessarily be contentious from the Claimants' point of view. For if it
were to be asserted by a producer that a product was very cheap, and thus
might have been expected to have been less safe, that might, on the Claimants'
case, be part of the presentation, if it were simply a question of
an alleged lowering of expectations by virtue of the cheapness; while on
the Defendants' case the questions would arise in their own right as to
what could have been practicable (or not) by way of safety precautions,
and/or then perhaps as to the cost of such precautions, and perhaps the
effect on the profitability of a producer. What would, on any basis, be
contentious would be the further contents of the Defendants' basket, namely
the avoidability or unavoidability of the danger, and the availability or
unavailability of alternatives.
The
contentions proceed as follows:
The
Defendants assert that, in looking at the product, it is essential to consider,
in deciding what level of safety could reasonably have been expected, what
more if anything could have been done: what precautions or tests could be
used/should have been used/were available to be used/can legitimately be expected
to have been used. If, the Defendants contend, the producer did not use obviously
available safety processes or precautions, then that itself must be a factor
to be taken into account against him, just as it would be in his favour if
all available safety precautions were adopted. They accept that the investigation
of what level of safety the public is entitled to expect may involve consideration
of factual issues which would also be relevant in a negligence enquiry, but
they say that this would be a matter of overlap rather than duplication, and
inevitable and acceptable.
The
Claimants however assert that, given that it is common ground that the Article
imposes liability irrespective of fault, the exercise of considering what
could or should have been done by the producer is an impermissible and irrelevant
exercise, which lets questions of fault back in by the back door. They say
that the consideration of what safety precautions should have been expected
to have been adopted simply amounts to the introduction of a standard of legitimate
expectability, rather than a standard of reasonableness, against which the
conduct of a producer must be set: while the Defendants may be asserting that
they accept that the consideration of the conduct of the individual producer
is not relevant, nevertheless by the very consideration of what steps could
legitimately have been expected to have been taken (against which what did
occur inevitably has to be set) the same result is achieved. The Claimants
contend that any consideration of the method or processes of production, including
the safety precautions taken or not taken, is irrelevant. They assert that
it is necessary only to look at the product itself (including comparison with
similar or identical products on the market), which would involve its expected
or intended use, without considering what more could have been done (and how
easy or difficult or cheap or expensive it would have been to have done it).
The safeness even of a scrid must be considered by reference to examination
of such a product and its intended or foreseeable use, not its method of manufacture.
The
Defendants counter that it would be impossible to carry out any comparative
exercise without understanding what steps were taken, and why certain steps
could or could not have been taken. If such comparison is with a later and
safer product, the producer would then rely on Article 6.2, to assert that
the greater safety offered by a subsequent model was not to be held against
him, pursuant to Article 6.2: to which a claimant could inevitably seek to
respond that, although the safer product was five years later, the producer
could have taken the same steps five years earlier.
Non-Standard
Products
- In
any event, however, the Claimants make a separate case in relation to the
blood products here in issue: namely that they are what is called in the United
States 'rogue products' or 'lemons', and in Germany 'Ausreisser' –
escapees or 'off the road' products. These are products which are isolated
or rare specimens which are different from the other products of a similar
series, different from the products as intended or desired by the producer.
In the course of Mr Forrester QC's submissions, other more attractive or suitable
descriptions were canvassed, and I have firmly settled on what I clearly prefer,
namely the 'non-standard' product. Thus a standard product is one which
is and performs as the producer intends. A non-standard product is
one which is different, obviously because it is deficient or inferior in terms
of safety, from the standard product: and where it is the harmful characteristic
or characteristics present in the non-standard product, but not in the standard
product, which has or have caused the material injury or damage. Some Community
jurisdictions in implementing the Directive have specifically provided that
there will be liability for 'non-standard' products, i.e., that such will
automatically be defective within Article 6: Italy and Spain have done so
by express legislation, and Dr Weber, in Produkthaftung im Belgischen Recht
1988 at 219-20, considers that that is now the position in Belgium also
as a result of the implementation of the Directive.
- Were
the infected bags of blood in this case non-standard products? The Claimants
say yes – 99 out of 100 are safe and uninfected as intended. The Defendants
say no – all blood, derived as it is from a natural raw material, albeit then
processed, is inherently risky. But the Claimants assert that persons generally
are entitled to expect that all blood and blood products used for medical
treatment are safe, and that they will not receive the unsafe 1 in 100. The
Claimants say that this will only not be the case if the public does know
and expect that blood, like cigarettes or alcohol, is or may be defective,
not because the public's expectation is limited to an expectation that legitimately
expectable safety precautions will have been taken.
- In
a jurisdiction where, unlike Spain and Italy, and perhaps Belgium, no legislative
distinction has been drawn between standard and non-standard products, the
distinction, even if I were to conclude that the blood bags in this case are
non-standard products, would not be absolute. Non-standard products would
not be automatically defective. A product may be unsafe because it differs
from the standard product, or because the standard product itself is unsafe,
or at risk of being unsafe. It may however be easier to prove defectiveness
if the product differs from the standard product.
Boxes
- United
States tort law has developed a difference between manufacturing defects,
design defects and instruction defects, (the last category being irrelevant
for our purposes). This was worked through in case law, though it did not
appear in the Second Restatement, published in 1965, but it has been expressly
incorporated into the Third Restatement, published in 1998 (section 2(a)(b)(c):
Categories of Product Defects). There is almost a separate jurisprudence for
manufacturing defects as opposed to design defects. A manufacturing defect
is defined as being "when the product departs from its intended design
even though all possible care was exercised in the preparation and marketing
of the product" and a design defect as "when the foreseeable risks
of harm imposed by the product could have been reduced or avoided by the adoption
of a reasonable alternative design by the seller or other distributor, or
a predecessor in the commercial chain of distribution, and the omission of
the alternative design renders the product not reasonably safe." The Claimants
say that, in terms of that dichotomy, the infected blood here is a manufacturing
defect – an error in production has led to a one-off. The Defendants say that,
if a defect at all, it is a design defect, because the process as designed
leads inevitably to the occasional failure as a result of an inherent defect
in the raw material. In this context, so far as the academics are concerned,
the Claimants appear to have the better of it. Professor Sole Feliu in his
book El Concepto de Defecto del Producto en la Responsabilidad Civil del
Fabricante (1997) at page 525, when addressing the question of whether
blood with hepatitis is to be considered a design or manufacturing defect,
following the view of American Professors Phillips and Pryor (Products
Liability (1993) Vol 1 at 392), concludes (as translated from the Spanish)
"since the defects occur only occasionally and since there is no design
whatsoever, and since the blood as such is processed and used for the transfusion,
these are rather manufacturing defects". Professor Howells (loc. cit.
at 1.14) considers that "manufacturing defects are caused by an error in
the production process or by the use of defective raw materials". However,
notwithstanding that there was some use of these American terms in the travaux
preparatoires, there is no place for them in the Directive. After some
discussion in the course of the hearing, I am satisfied, and indeed neither
Counsel contended to the contrary, that no assistance can be gained from what
Mr Underhill QC called the 'boxing', or categorisation, of defects in this
regard for the purpose of construction of the Directive, or the determination
of any of the issues before me, for the following reasons among others:
- As
referred to above, there are no such boxes or categories in the Directive,
unlike the Third Restatement.
- In
order to define whether the defects are manufacturing or design defects,
in most cases it would be inevitable that there would require to be consideration
of the precise processes adopted in production, which both sides accept
to be inappropriate.
- Consequently,
whatever may be the position in US jurisprudence, Article 6 directs consideration
of whether the product is defective, and as to what legitimate expectation
is as to the safeness of the product. Whether it is appropriate to define
the one infected bag of blood in one hundred as a manufacturing defect,
or as an inevitable result of a chosen design process which cannot guarantee
uniformity of product, the issue is still the same, namely whether the safety
was provided which the public was entitled to expect in respect of that
product.
- The
significance to my mind only arose at all in our discussions because, by virtue
of the fact that many European experts in product liability, both academics
and practitioners, have been steeped in the US jurisprudence, 'rogue products',
or rather what I now call 'non-standard products', have been almost automatically
defined by them as manufacturing defects. Given that there is a dispute between
the parties in this case as to what is meant by a manufacturing defect, it
seems to me sensible to concentrate simply on the concept of a standard or
non-standard product. As will appear, this does appear to me to make easier
the understanding of those few European decisions which there have been arising
out of the Directive. In the criminal field, the UK courts have responded
stringently to manufacturing errors: this appears clearly from the House of
Lords decision in Smedleys Ltd v Breed [1974] AC 839, where, notwithstanding
non-negligent quality control, there was strict liability at criminal law
where a caterpillar identical in colour, size, density and weight to the peas
in a tin survived the process in one out of three million tins: but that too
would be a non-standard product.
- If
the distinction is between a standard and non-standard product, the critique
of a non-standard product will be the same, namely by virtue of its difference
from a standard product, whether it is treated as a one-off manufacturing
defect or as a design defect resulting from a way in which the producer's
system was designed, which led to all the producer's product being subject
to the same risk. The approach to whether non-standard and standard products
are defective may however be different, primarily because non-standard products
fall to be compared principally with the standard product, while standard
products, if compared at all, will be compared with other products on the
market.
The
Status of the Defendants
- One
final point with which I should deal is the fact that the Defendants are required
to produce the product, in this case blood, pursuant to the obligations of
the NBTS, and thus, it is said, had no alternative but to supply it to hospitals
and patients, as a service to society. The Defendants submit that this is
a factor to be taken into account in the 'basket', not least because, unlike
commercial producers, they have no option to withdraw it from the market rather
than incur liabilities. Quite apart from the Claimants' overall objection
to the basket if it brings in a concept anything close to a risk/utility
test, the Claimants contend that, if Article 7(d) does not apply ("that
the defect is due to compliance of the product with mandatory regulations
issued by the public authorities"), as it is not suggested to do, then
there is no automatic reason why the public's expectation of safety should
be lowered, unless such product is known to be defective, or at risk of being
defective. Further there is, in any event, no necessary reason why a public
authority or a non-profit making organisation should be in any different position
if the product is unsafe (which proposition accords with the Opinion of the
Advocate General (Colomer) in Henning Veedfald v Arhus Amstkommune [the 'Danish
Kidney Case'] Case C-203/99 at para 27, which has not yet been considered
by the European Court). There is of course no 'blood-shield' statute in the
UK.
Travaux
Preparatoires
- There
is nothing much to assist in the travaux preparatoires, save for:
- The
rejection of the express US approach and risk-utility analysis (see
paragraph 35 above)
- The
fact that the strength of the contentions in support of a defence of state
of the art, and of protection for producers in the context of inevitable
risks, was directed first to the introduction into the drafts, and then
the expansion and exposition, of Article 7(e). It might well be said that
if those lobbying for extra protection for the producer had considered that
there was already substantial protection under Article 6 itself (which is
not mentioned in this context in the documents in evidence) they might not
have needed to fight so hard to introduce and retain Article 7(e). This
probably inadmissible approach is better expressed simply as the fact that
in the documents before me (and that in itself is an important caveat) there
is no discussion of whether the availability (or not) or adoption (or not)
of safety precautions by a producer is relevant, or a circumstance,
in the context of Article 6 (nor of course is such listed at any time among
the circumstances which are set out in the Article, notamment
or otherwise).
Court
Decisions
- I
turn to consider the few court decisions in Europe in which the Directive,
or these issues under the Directive, have been considered or touched upon.
As indicated above, these have not been many, notwithstanding the fact that
the Directive and implementing legislation within the Community countries
(save in France, which delayed its implementation, although its own local
laws were and remained in some respects more stringent) have been in force
for ten to fifteen years. Leaving aside any English decisions, to which the
ordinary rules of precedent would apply, so far as relevant, I would of course
pay particular attention to any European decisions, not because they are binding
upon me, but because not only does respect have to be paid, on the usual principles
of comity, to reasoned decisions of competent foreign courts considering the
same or similar issues, whatever the nature of the legislation, but particularly
so where Community courts are applying the Directive. In such a case, even
though Community courts are entitled to come to different views, particularly
on the facts, by reference to national and local conditions, and even though
the European Court can resolve and give a final opinion upon issues where
different views have been taken in different Community countries on the same
legislation, nevertheless harmony is desirable, particularly where it can
be said that an autonomous or Community approach or meaning is required. (See
most recently the Advocate General's Opinion in the Danish Kidney Case at
paragraph 30.)
- UK.
On the Article 6 issues which I have to decide, Richardson is unclear. Ian
Kennedy J concluded in relation to a condom, the teat end of which became
detached during sexual intercourse, resulting in the pregnancy of the claimant,
that "naturally enough the users' expectation is that a condom will not
fail". But he does not then appear to have gone on to consider the actual
question, being whether they were entitled so to expect. He appears to have
concluded that he could not identify a harmful characteristic, either occurring
in the factory (Article 7(b)) or at all. Whether that resulted from too
much concentration during the trial by both parties on the method of manufacture,
or whether there was an implicit finding that the fracture was caused by
misuse by the claimants, is not clear, but in any event he concluded, without
consideration of the issue of legitimate expectation, that the claimants'
claim failed. In the Cosytoes Case, the claimant was successful, where an
elastic strap for attaching a buckle to a baby's sleeping bag sprang back,
causing the buckle to hit the baby's brother in the eye. So far as concerns
the claim under the CPA, and hence for our purposes under Article 6, the
claim succeeded. Chadwick LJ at paragraph 44 emphasised that fault of the
producer is irrelevant:
"It
is irrelevant whether the hazard which causes the damage has come, or ought
reasonably to have come, to the attention of the producer before the accident
occurs. To hold otherwise is to my mind to seek to reintroduce concepts
familiar in the concept of a claim in negligence at common law into a statutory
regime which has been enacted in order to give effect to the ... Directive."
But
he does not appear to address in terms whether the conduct of any producer
would be relevant. Pill LJ left the position unclear at paragraph 27 when
he concluded "Members of the public were entitled to expect better from
the appellant": but Chadwick LJ at para 45 does address himself towards
the level of safety to be expected "in relation to child care products".
In neither of these two cases, however, does it appear that there was any
or any full argument on the points now in issue.
- Germany.
In what has been called the 'German Bottle Case' the Bundesgerichtshof,
(BGH), the German Federal Supreme Court, gave judgment on 9 May 1995, allowing
an appeal by a Claimant injured as a result of an exploding mineral water
bottle, resulting from a very fine hairline crack, not discovered notwithstanding
what was found to be a technical and supervisory procedure in the Defendant's
factory in accordance with the very latest state of technology (including
seven different inspections). Although the BGH dealt at some length with
the questions under Article 7(e), to which I shall refer below, it had no
difficulty, after what was obviously detailed consideration, in concluding
that the harmful characteristic was a defect within Article 6 (or the German
statute implementing it). The BGH concluded (translated from the German):
"The
Court of Appeal [was] correct in law to assume that pursuant to [Article
6] a product is defective if it does not guarantee the degree of safety
which may be expected when taking all circumstances into account. The Court
of Appeal also [assumed] correctly that a consumer expects a mineral water
bottle to have no obvious or even microscopic damage which might lead it
to explode. The fact that it is not technically possible to detect and repair
such defects in the bottle does not alter the consumer's expectations."
The
Defendants accept that the crack in that case was plainly a manufacturing
defect, capable of being described, as the BGH expressly did, as a rogue
product ('Ausreisser') and do not contend that the decision of the
BGH was wrong. They submit however that this logic does not apply to a bag
of blood, which they submit to share the same characteristics as all blood,
namely in that all blood bears – or bore – the 1% risk of being infected.
(The BGH also rejected the producer's arguments under Article 7(e), to which
I shall return.)
- Holland.
The County Court of Amsterdam (not an appellate court) gave a judgment on
3 February 1999 in the case of Scholten v The Foundation Sanquin of Blood
Supply. In this case the claimant received blood infected with HIV, after
the introduction of HIV screening tests in that country, because of the
(infinitesimal) risk in that case from blood which had been so screened
but must have been given by a donor who had only just contracted HIV, such
that his infection could not be detected by a test during what has been
called 'the window period'. The Court appears to have looked at the facts
in that case with some care. The claimant was pointing out that the Foundation's
leaflet suggested that the chance of being infected with HIV was so small
that one should consider that one would not be infected. The defendants
pointed out that the media had paid a great deal of attention to the fact
that blood products always carried a risk of transmitting infections, and
the defendants contended that (paragraph 6 as translated from the Dutch):
"the
Foundation carefully carried out investigations of the blood and followed
the correct and relevant Guidance, so that one is not able to expect a greater
safety of the blood product than that which can be offered by the proper
compliance with the relevant regulations."
The
Court concluded, in finding for the claimant in respect of Article 6 (or
the Dutch implementing equivalent), as follows:
"The
Court agreed with Scholten that, taking into account the vital importance
of blood products and that in principle there is no alternative, the general
public expects and is entitled to expect that blood products in the Netherlands
have been 100% HIV free for some time. The fact that there is a small chance
that HIV could be transmitted via a blood transfusion, which the Foundation
estimates at one in a million, is in the opinion of the Court not general
knowledge. It cannot therefore be said that the public does not or cannot
be expected to have this expectation. The fact that the Foundation acted
in accordance with the relevant Guidance, and that the use of an HIV-1 RNA
test at the time could not have detected the HIV virus does not have any
bearing on this."
The
Defendants contend that this decision of the County Court of Amsterdam,
which is obviously not in any way binding upon me, was wrong: but further
or in the alternative they contend that the decision which the Court then
went on to make which resulted in Scholten's claim failing by reference
to Article 7(e) (to which I shall return below) was right.
- France.
There are no decisions directly under the Directive in France, first because
in any event the Directive was not implemented until 1998, and secondly
because, as referred to above, the French national laws of product liability
are in some respects more favourable to claimants. In those circumstances,
although I have been referred to decisions severally in the Conseil d'Etat
(1995), the Lyon Administrative Court of Appeal (1997) and the Cour de Cassation
(1998) (in the last of which the Court said that they were interpreting
the relevant articles of the Code Civil in the light of the Directive),
in which claimants succeeded in product liability claims in respect of infected
blood, it is not helpful to consider them in any detail.
Academic
Literature
- As
I have indicated above, my attention has been drawn to a large number of learned
and perceptive academic writings, much of which has been relevant to the issue
before me, but upon which of course I must make up my own mind. I shall summarise
what seem to me to be the most relevant:
- Professor
Henderson (of Boston University), writing of the US law in the Columbia
Law Review (1973) Vol 73 at 1531ff, doubts in US terms the role for a judge
in adjudicating design decisions. However this seems to me not inconsistent
with – and may support – the conclusion that the only question should be
whether the product – as designed – is unsafe, given its use and presentation
and the injuries that have occurred – and not whether any other design could
have been adopted to improve the safeness of the product.
- Simon
Whittaker (now of St John's College, Oxford) in the early days of consideration
of the Directive, and before the CPA, raised, in an article in (1985) 5
Yearbook of European Law 233ff, the question as to whether safety standards
arise for consideration within Article 6, and concludes that they perhaps
do; but he rewrites the Directive to represent that it is asking whether
the product was 'reasonably safe', rather than using the words of legitimate
expectation. It is in that context that he considers that it may "look
as though there is no practical difference between liability in the tort
of negligence and liability under the Directive" (at 246). He postulates
the possibility, at 257, of evidence of compliance with safety standards
being "admissible but not conclusive" under Article 6, while asserting
that such "would not avail the Defendant of a defence under Article 7(e)".
On that basis, it seems to me illogical if the escape route provided should
be narrower than that which it is suggested may be a main defence: for a
producer would not need reliance on Article 7(e) if he had already succeeded
on Article 6. I return to this further below.
- Christopher
Newdick, to whom I have referred above, of the University of Reading, appears
to support the Claimants' case in articles in 1987 (103 LQR 288) and 1988
(CLJ 47 (31) 455); in the former at 296-7 where he concludes:
"To
excuse all ... production defects ... on the ground that they were undiscoverable
would be to emaciate the potential of the Directive. In this respect there
may be sufficient grounds for strict liability to be applied in the absence
of cogent reasons of policy to the contrary."
and
in the latter at 455 in the passage which I have already quoted in paragraph
31 above.
- Professor
Stoppa of Rome University appears to do so also, in an article on the CPA
in Legal Studies 1992 Vol 12 page 210, where he states at 212 (following
Professor Alistair Clark of Strathclyde University, at page 168 of his book
Product Liability (1989)): "the solution most consistent with the spirit
of the Directive would seem to suggest that all products which are unsafe
because of a flaw in the production process be considered defective, unless
there exist statutory provisions to the contrary." Stoppa however appears
to suggest that the position may be different in relation to what he is
encouraged by US jurisprudence to consider as a design defect (pp 213-217).
Thus he writes:
"In
relation to sophisticated or innovative design cases, it could be argued
that actual consumer expectations, which could be non-existent, are not
at issue, in that the Act refers to the safety which persons generally are
'entitled' to expect. But what are persons generally entitled to expect?
It would probably be a fair assumption to say that consumers are entitled
to expect, generally speaking, that all products be designed carefully and
intelligently in the light of all foreseeable circumstances, with a view
to manufacturing a product which is as safe as possible. Yet the questionability
of such a standard, or of a similar worded one, is self-evident ...
Indeed, it is submitted, a dual approach might also prove a workable solution
under the [CPA]. In many design defect simple cases, as where the failure
of the product [ensues] from its normal and intended use, the consumer expectations
test seems to be an appropriate test. A product which causes injury when
put to its core uses clearly disappoints consumer expectations, and liability
should be imposed accordingly. On the other hand, in more complex cases,
where a consumer expectations test is but a semantic veneer concealing each
court's own subjective assessment, a more structured balancing process of
some kind seems necessary. In these cases, a risk-utility analysis would
seem to be permitted by the wording of the [CPA], according to which, for
the purpose of determining what ordinary consumers are entitled to expect,
'all the circumstances' should be taken into account."
- Christopher
Hodges of Cameron McKenna, in his book Product Liability: European Laws
and Practice [1993] does not appear to support Professor Stoppa's approach
in relation to design defects. At 3.019 he states: "Strict liability
is likely to have a significant impact on design defect claims. A claimant
no longer has the difficult task of proving faulty conduct by a manufacturer
... The emphasis of the Directive is shifted to a judgment about the safety
to be expected of the product itself ... Liability is now imposed if something
is unacceptably dangerous without it being anyone's fault". His subsequent
paragraph at 3.023 appears not to contradict this, but simply to amount
to advice to manufacturers and designers with a view to avoiding a defective
design.
- Professor
Stapleton, to whom I have referred above, now of Australian National University,
asserts that the Directive does not in practice achieve strict liability.
She said so in her book Product Liability (1994) at 236: "Despite
the 'strict liability' rhetoric in its Preamble the Directive rarely imposes
more than a negligence regime on manufacturers. The origin of this surprising
and not obvious result is worth pursuing in detail because of the widespread
assumption in business and the legal profession that the Directive imposes
strict liability on manufacturers" and again at 271-272. At the passage
at page 236, she refers to the view of the then Lord of Appeal, Lord Griffiths
(in extra-judicial capacity), together with two members of the staff of
the Law Commission, prior to the implementation of the Directive in the
UK by the CPA, in an article in the Tulane Law Review, Vol 62 at 353ff.
The latter there opine (at 382) that "some element of balancing is necessary
to any proper analysis of the concept of a defective product", recite
the various elements which American Courts include in the risk-utility
analysis (including (footnote 122) "the manufacturer's ability to eliminate
the unsafe character of the product without impairing its usefulness or
making it too expensive to maintain its utility") and conclude that
"it does not seem likely that English judges would overtly adopt [a
risk-utility analysis], albeit they would as an educated response to
the facts of a particular case undertake a balancing exercise of an analogous
kind". Professor Stapleton simply concludes at 236 of her book, by reference
to Lord Griffiths' suggestion, "in other words the core of the 'defect'
enquiry will substantially parallel the issue which underlies the negligence
standard ... Practitioner handbooks fleshing out the standard in the Directive
will therefore look remarkably like current handbooks on the substance of
the duty in negligence. The only really important question to which manufacturers
will need an answer concerns the strictness of the behavioural standard".
- Such
a handbook in German however, by Count von Westphalen of Bielefeld University,
Produkthaftungshandbuch (1990) at paragraphs 23-24 states as follows,
in relation to the German implementation of Article 6 (as translated from
the German):
"Since
product liability ... is liability irrespective of fault ... the criterion
of Zumutbarkeit [translated as reasonableness and by Mr Forrester
QC as 'what the producer could be expected to do'] is irrelevant. In contrast
to product liability in tort ... , the producer cannot rely on the fact that
he could not be expected to produce a safe alternative construction, possible
according to the state of science and technology. The same applies if the
producer wanted to rely on the fact that the market did not accept a more
expensive but safer product, or that his competitors do not respect the required,
higher safety standard either. In extreme cases, the producer must stop producing
the insufficiently safe product. This makes it clear that the cost-benefit
analysis plays no role in determining defectiveness of a product."
Summary
- I
summarise the position:
- The
first question of law which I have to resolve in the light of my construction
of Article 6 and 7(e) is whether I need to consider and determine the issues
raised by the evidence, which I have in fact heard over more than twenty
days (including consideration of documents), from the Claimants and the
Defendants, at the Defendants' instance, on the 'Brown Case'; namely as
to whether in fact the Defendants did everything that could be legitimately
expected of them (what might be called their 'Zumutbarkeit' evidence).
If I consider that I do not in law need to do so, then I resolve the question
of defectiveness without such evidence ('the Forrester Case'). If I conclude
that in law the evidence is admissible (but, as it happens, in any event,
for the reason set out in paragraph 24 above, of possible appeals or references)
then I must proceed to decide whether the Claimants have shown that the
Defendants failed to do what was legitimately expected of them (the Brown
Case). If I find that the product was defective on the Forrester case, the
defect is, on any basis, infection by Hepatitis C. If however I find it
defective on the Brown Case, on the basis that the Defendants failed to
test or screen early enough, then the Claimants would say the defect is
the same, but the Defendants would then say that the defect is the 'unscreenedness'
of the blood. This dispute as to the precise description of the defect is
only relevant for the purposes of the issues of causation and/or quantification
of loss, to which I come below, and I shall return to it and resolve it
only in that context.
- The
onus of proof on Article 6 is on the Claimants. The Defendants submit that
if the Claimants were right about Article 6, because 'unavoidability'
would not then assist them to avoid liability, Article 7(e) should certainly
then be so construed as to exclude them from liability: and conversely if
Article 7(e) is too limited to enable them to be exonerated, all the more
should Article 6 be construed in their favour. I turn therefore to consider
Article 7(e) before I reach my conclusions.
ARTICLE
7(e)
- I
repeat, for the sake of convenience at this stage, Article 7(e):
"The
producer shall not be liable as a result of this Directive if he proves ...
that the state of scientific and technical knowledge at the time when he put
the product into circulation was not such as to enable the existence of the
defect to be discovered."
- This
defence, for such it is, being an escape clause for the producer, the onus
being upon the producer, has been called by the Claimants (as it is in most
academic literature) the development risks defence, which is how it
was usually described during the working through of the Directive, as is apparent
from the travaux preparatoires; and by the Defendants the 'discoverability'
defence, both because that concept is certainly an express and significant
part of the Defence, whatever it relates to, as will be seen, but also because
it aids, as the Defendants see it, their construction of the Article. I propose,
neutrally, simply to call it the 'Article 7(e) defence'. Once again there
is a great deal of common ground, not least because in relation to this Article
there is in certain respects binding authority and guidance from the European
Court (Commission v UK).
- Such
common ground is as follows:
- The
state of scientific and technical knowledge referred to is the most
advanced available (to any one, not simply to the producer in question),
but it must be 'accessible'. In response to a more extreme position being
taken by the Commission, the Advocate General answered as follows, in his
Opinion in Commission v UK at paragraphs 22-24, which, although not expressly
approved in the judgment of the European Court, is taken to be the state
of the law:
"22.
Where in the whole gamut of scientific opinion at a particular time there
is also one isolated opinion (which, as the history of science shows, might
become, with the passage of time, opinio communis) as to the potentially
defective and/or hazardous nature of the product, the manufacturer is no
longer faced with an unforeseeable risk, since, as such, it is outside the
scope of the rules imposed by the directive.
23. The aspect which I have just been discussing is closely linked with
the question of the availability of scientific and technical knowledge,
in the sense of the accessibility of the sum of knowledge at a given time
to interested persons. It is undeniable that the circulation of information
is affected by objective factors, such as, for example, its place of origin,
the language in which it is given and the circulation of the journals in
which it is published. To be plain, there exist quite major differences
in point of the speed in which it gets into circulation and the scale of
its dissemination between a study of a researcher in a university in the
United States published in an international English-language journal and,
to take an example given by the Commission, similar research carried out
by an academic in Manchuria published in the local scientific journal in
Chinese which does not go outside the boundaries of the region.
24. In such a situation, it would be unrealistic, I would say unreasonable,
to take the view that the study published in Chinese has the same chances
as the other of being known to a European product manufacturer. So, I do
not consider that in such a case a producer could be held liable on the
ground that at the time at which he put the product into circulation the
brilliant Asian researcher had discovered the defect in it. More generally,
the 'state of knowledge' must be construed so as to include all data in
the information circuit of the scientific community as a whole, bearing
in mind, however, on the basis of a reasonableness test the actual opportunities
for the information to circulate."
It
is not entirely clear what in practice is meant by the 'Manchuria exception'.
I put to Counsel, in the course of argument, that if in fact the product
in question were a product for which Manchuria was renowned, perhaps yoghurt
or fabric, then Manchuria itself would be a bad example: if however it were
a product of particularly high technology then it might well be wholly unlikely
that Manchuria would have thought something up. It seems to me that the
right approach is to look at 'accessibility' and to regard as Manchuria
perhaps an unpublished document or unpublished research not available to
the general public, retained within the laboratory or research department
of a particular company. Fortunately the issue does not arise in this case.
- The
Article is not concerned with the conduct or knowledge of individual producers.
As the Court made clear at paragraph 29:
"The
producer of a defective product must prove that the objective state of scientific
and technical knowledge, including the most advanced level of such knowledge,
at the time when the product was put into circulation, was not such as to
enable the existence of a defect to be discovered."
It
is clear from the passage which I have already quoted, in paragraph 20 above,
in paragraph 36 of the Court's judgment that: "the availability of the
defence [does not depend] on the subjective knowledge of a producer
taking reasonable care in the light of the standard precautions taken in
the industrial sector in question."
- The
relevant time to assess the state of such scientific and technical knowledge
is the time when the product was put into circulation.
- Whether
or not the defect for the purposes of Article 6 should be defined as 'unscreenedness'
as discussed in paragraph 46(i) above, there is no dispute that the defect
for the purposes of Article 7(e) is its infection by Hepatitis C (and of
course the Claimants rely on this, when this dispute becomes relevant, as
a further argument, based on consistency in the construction of the Directive,
why the Defendants' such definition of defect in Article 6 is wrong).
The
Issues Between the Parties.
- Must
the producer prove that the defect had not been and could not be discovered
in the product in question, as the Defendants contend, or must the producer
prove that the defect had not been and could not be discovered generally,
i.e., in the population of products? If it be the latter, it is common ground
here that the existence of the defect in blood generally, i.e., of the infection
of blood in some cases by hepatitis virus notwithstanding screening, was known,
and indeed known to the Defendants. The question is thus whether, in order
to take advantage of the escape clause, the producer must show that no objectively
assessable scientific or technical information existed anywhere in the world
which had identified, and thus put producers potentially on notice of, the
problem; or whether it is enough for the producer to show that, although the
existence of the defect in such product was or should have been known, there
was no objectively accessible information available anywhere in the world
which would have enabled a producer to discover the existence of that known
defect in the particular product in question. The crux of the dispute therefore
is as follows:
- The
Claimants say that once the defect in blood is known about, as it was, it
is a known risk. A known but unavoidable risk does not qualify for Article
7(e). It may qualify for Article 6, not because it was unavoidable (see
their contentions set out in paragraph 35 above) but if it could be shown
that, because the risk is known, it was accepted, and lowered public expectations
– like poison and alcohol. But otherwise once it is known, then the product
cannot be supplied, or is supplied at the producer's risk and has no protection
from Article 7(e). Hence an Article 7(e) defence is, as was intended, a
development risks defence; for if it is not known that a particular product,
perhaps a pioneering such product (such as a scrid), has or can have a harmful
characteristic, whether by virtue of its inherent nature, its raw materials,
its design or its method of manufacture, and then the defect materialises,
or is published about, for the first time, it has prior to that time been
a true development risk, and protection is available under Article 7(e).
However, once the risk is known, then if the product is supplied, and if
the defect recurs, by then it is a known risk, and, even if undiscoverable
in a particular example of the product, there is no escape. There is only
one stage of consideration, and if there be 'non-Manchurianly accessible'
knowledge about the product's susceptibility to a defect, be it a manufacturing
or design defect, there is no availability of Article 7(e). As it is common
ground in this case that there was such knowledge, the Defendants cannot
avail themselves of Article 7(e).
- The
Defendants say that if a risk is unavoidable, it falls within Article 6
(see their contentions in paragraph 35 above) but, if not, then it can still
qualify for protection under Article 7(e), if non-Manchurianly accessible
information cannot enable a producer to discover the defect in the particular
product. There may be no 'stage one' – i.e. knowledge of the risk – but,
even if there is, there is a 'stage two' – namely consideration as to whether
any accessible knowledge could have availed the producer to take any steps
which he did not take. The Defendants say there were none such here, or
at any rate that such a conclusion could only be reached after resolution
of the 'Brown Case'.
- Nothing
much can be gained by simply looking at the words of Article 7(e). The Claimants
assert that to establish the Defendants' construction the words 'in the product
[in question]' needs to be inserted after the words 'the existence of the
defect', while their construction does not need any additional words.
The Defendants assert that the words "existence of the defect" are
more apt to apply to the existence of a particular defect in a particular
product, and for the Claimants' construction to serve there should have been
the use of the word 'risk' such as "[risk of] the existence of the defect
to be discovered". Neither argument is to my mind determinative or would
stand in the way of either construction. The following points should be recorded:
- The
Claimants rely heavily upon purposive construction, that is that the Directive
and this Article must be construed in order to further the purpose of the
Directive, namely consumer protection and ease of recovery of compensation.
- The
Defendants counter that this is an express escape clause, specifically so
as to allow a level of protection for producers who are non-negligent. There
is provision for a Member State to exclude Article 7(e) from its legislation
if (Recital 16) it was "felt ... to restrict unduly the protection of
the consumer", so this is what the clause was aimed at: and they refer
also to Recital 7, whereby a "fair apportionment of risk between the
injured person and the producer implies that the producer should be able
to free himself from liability if he furnishes proof as to the existence
of certain exonerating circumstances".
- The
Claimants contend that it is clearly apparent from Commission v UK (to which
I shall refer further below) that Article 7(e) is intended to be construed
restrictively: and in any event there is as much a concept of Community
law as of the common law that a proviso, exception or escape clause should
be construed restrictively.
- The
Defendants rely on the fact that in Article 7(b), another of the exonerating
circumstances, namely whereby a producer can show that the defect did not
exist when the product left his factory etc., the defect being there referred
to must be a defect in the product in question, rather than in the population
of products. They assert that, at least by reference to English rules of
construction, such a usage in a neighbouring sub-clause throws light on
the meaning of Article 7(e).
- The
knowledge in Article 7(e) must be such as to "enable" the existence
of the defect to be discovered. The Claimants submit (and refer to other
languages of the Directive to support the proposition) that this simply
means 'permit' or 'give the opportunity for' this to occur: and that this
is less consistent with knowledge leading to the discovery of the defect
in a particular product than with knowledge enabling the existence of the
defect to be discovered generally, so that the risk of its being in the
particular product is thus known of, as opposed to being an unknown development
risk for which the producer could be excused. The Claimants also rely on
the fact that the passive voice is used: "to enable the existence of
the defect to be discovered" generally, rather than the issue being
whether it enables 'the producer to discover' the defect in a particular
product.
Travaux
Preparatoires
- When
the Commission first proposed a Directive, its suggestion was for the complete
reverse of how it eventuated, namely that there should be an express inclusion
of development risks, that is it should be made clear that the producer should
be made expressly liable even for the 'inconnu'. The proposed Article
(then Article 1) then provided that "the producer of an article shall be
liable for damage caused by a defect in the article, whether or not he knew
or could have known of the defect. The producer shall be liable even if the
article could not have been regarded as defective in the light of the scientific
and technological development at the time when he put the article into circulation".
There is no addressing there of the question as to whether the defect was
discoverable in the particular product, but the reference appears clearly
to be to there being no knowledge of the defect at all. The contest thereafter
by those seeking to introduce some protection for producers was first for
the successful deletion of the express inclusion of liability for the unknown
defect, and then, as set out in paragraph 43 above, the introduction of what
eventually became Article 7(e). There was, so far as I have seen from what
has been put before me, no consideration specifically of whether the availability
of knowledge in Article 7(e) related to the discoverability of the defect
in the particular product. But at almost every stage the reference is to the
'development risks' defence: "Inclusion of development risks could
have an inhibiting effect on innovation, because the cost of insuring such
unforeseeable risks is likely to be quite high". (Opinion of the Economic
Social Committee, 7 May 1979): "If liability for damage occasioned by development
risks was excluded ... the effect would be to require the consumer to bear
the risk of the unknown" (Explanatory Memorandum by the Commission dated
26 September 1979); and other such references.
Court
Decisions
- Clearly
the most significant of these is the decision of the European Court of Commission
v UK, although, as discussed above, it was not in terms addressing the particular
issue here:
- Commission
v UK. While clarifying that the knowledge to be imputed to a producer must
be accessible, i.e., not restricted within Manchuria, the European Court
nonetheless plainly intended to limit the escape clause. The fuller consideration
was in the Advocate General's Opinion. So far as there could be said to
be passages relevant to the issues now before me, consideration centred,
in the course of argument, upon paragraph 20, the material part of which
reads as follows:
"20.
It should first be observed that, since [Article 7(e)] refers solely
to the 'scientific and technical knowledge' at the time the product was
marketed, it is not concerned with the practices and safety standards in
use in the industrial sector in which the producer is operating. In other
words, it has no bearing on the exclusion of the manufacturer from liability
that no one in that particular class of manufacturer takes the measures
necessary to eliminate the defect or prevent it from arising, if such measures
are capable of being adopted on the basis of the available knowledge."
It
has first of all to be emphasised that the context in which the Advocate
General was setting out his Opinion was one in which the form adopted by
the UK Government in implementing Article 7(e), i.e., Section 4(1)(e) of
the CPA, seemed clearly to suggest a much more subjective and more negligence-orientated
defence than was provided for in Article 7(e); and the Advocate General,
and in due course the Court, while content to give the UK Government the
benefit of the doubt as to its intentions in implementation, was anxious
to stamp upon such a prospect. The aim of the Advocate General's paragraph
20 was obviously to emphasise that it could not excuse a manufacturer from
liability if he complied with the safety measures (or lack of them) prevalent
in the relevant industry. At first blush, the passage from paragraph 20
which I have quoted could be construed to mean: 'it has no bearing on
the exclusion of the manufacturer from liability that no one in that particular
class of manufacturer takes the measures necessary to eliminate the defect
or prevent it from arising provided that such measures are capable
of being adopted ...' If this were right then it could be argued that
it is a matter of significance as to whether there could be such measures,
and if there are not, i.e., if the defect is unavoidable, then the producer
might escape liability. However I do not consider that that is the right
construction of this paragraph:
- I
have taken note of the fact that the Opinion was given by Advocate General
Tesauro in Italian, and I have been shown the Italian version, where the
subjunctive is used ("se ... siano") in respect of the last clause,
so that in fact the translation should read 'if such measures were
to be capable of being adopted ...'. With or without that clarification,
however, I am satisfied that what the Advocate General is in fact saying,
by way of summation in this sentence beginning with the words "in other
words", is that 'it has no bearing on the exclusion of the manufacturer
from liability that no one takes the measures ... even if there were
any such measures available'. I also do not see any significance, such
as Mr Underhill QC suggests there to be, in the reference to 'elimination'
of the defect, particularly when the alternative of preventing it from
arising is also used: if a problem is known, as a result of non-Manchurianly
accessible information, then one would expect the one or the other, elimination
or prevention, and what is not being referred to is 'measures to inspect,
or discover the defect in, the particular product'.
- Paragraph
22 of the Opinion is however of assistance. The Advocate General there
states that "the producer has to bear the foreseeable risks, against
which he can protect himself by taking either preventive measures by stepping
up experimentation and research investment or measures to cover himself
by taking out civil liability insurance against any damage caused by defects
in the product" [my underlining]. The Advocate General is there
concentrating on foreseeability of risks rather than the discoverability
of particular defects, and the measures which the producer can take are
not limited to greater efforts to discover the defect in the particular
product. Thus, whether or not he can take preventive measures, the producer
can still be liable (and protect himself by insurance). In the paragraph
of its judgment (26) in which paragraph 20 of the Opinion is referred
to, there is not specific approval by the Court of the whole of it (nor
any mention of paragraph 22), but reference is once again made then and
throughout to 'knowledge', and not to the ability, as a result of the
knowledge, to discover the defect in a particular product.
- The
UK. In Richardson, Ian Kennedy J, albeit having dismissed the claimants'
claim, continued (obiter) to consider the Article 7(e) defence and
would have rejected it. He states (at 285) in a passage which, albeit obiter,
is obviously relied upon by the Claimants: "This provision is, to my
mind, not apt to protect a defendant in the case of a defect of a known
character, merely because there is no test which is able to reveal its existence
in every case".
- Germany.
The BGH in the German Bottle Case concludes (and is referred to by the recent
Commission Green Paper dated 28 July 1999 at page 23 as having concluded)
that Article 7(e) applies only to design defects, and not manufacturing
defects. Interestingly, this is what the unilateral declaration by the United
Kingdom at the time of the passage of the Directive had originally suggested
(I have quoted it in paragraph 18 above). But, as made clear at paragraphs
39 to 41 above, in my judgment there is no need nor call for differentiation
between manufacturing and design defects in the construction of the Directive,
and the BGH appears to have been working on the assumption, not an uncommon
one as discussed, that rogue or non-standard products are always manufacturing
defects. It is not perhaps surprising that Professor Stapleton in her recent
article in the Washburn Law Journal [2000 Wash LJ 3R/BL] at 381 described
as extraordinary that "the [BGH] merely asserted that the development
risk defence in the ... Directive does not apply to manufacturing errors".
But I do not consider either that the question of 'boxing' was central to
the decision of the BGH, or that that is all that the BGH decided, on a
careful reading of the judgment. I have already set out, in paragraph 44(ii)
above, that, in relation to the claim in respect of the exploding mineral
water bottle, the Court rejected the defence under Article 6. It is right
to say that the BGH categorised the undiscoverable crack in the bottle as
a rare and inevitable production defect, but they did so, with reference
to the word Ausreisser, as a rogue product or non-standard product,
as it seems to me, irrespective of the categorisation as a production defect;
and the relevant conclusion, as I see it, was that set out at II(bb) in
the judgment (as translated from the German) namely: "such rare and inevitable
[production] defects ('Ausreisser') are not defects for the purposes of
Article 7(e) of the ... Directive ... simply because they are inevitable
despite all reasonable precautions [my underlining]. The purpose
of the [Directive] is merely to exclude liability for so called development
risks." This proposition plainly supports the Claimants. The BGH continues
(again in translation) "Liability should only be excluded when the potential
danger of the product could not be detected because the possibility to detect
it did not (yet) exist at the time of marketing". As "the potential
danger of re-usable bottles filled with carbonated drinks has been known
for a long time" the Article 7(e) defence was not available. In those
circumstances the perhaps unnecessary repetition by the BGH of the words
"unavoidable production risks do not constitute development risks"
seems to me to be set into context. What the BGH was primarily saying is
that if the risks are known, unavoidability of the defect in the particular
product is no answer.
- Holland.
In Scholten, after resolving the Article 6 defence in favour of the Claimant,
the County Court of Amsterdam reached a conclusion supportive of the Defendants
on Article 7(e). The Court's conclusion on Article 7(e) at pages 7-8 (as
translated from the Dutch) is based upon the submission by the Foundation
that it was not liable because it was impossible to detect the infection
of the blood with HIV in the window phase, and that the new PCR test was
technically not yet fully developed to achieve such detection; it stated,
"Given the state of scientific and technical knowledge at the time of
the blood donation and the transfusion to Scholten, this leads to the conclusion
that it was, practically speaking, not possible to use the [PCR] test as
a screening test in order to detect HIV contamination in blood products.
This could therefore not have been expected of the Foundation". The
Claimants, while supporting the Court's decision on Article 6, do not agree
with its decision on Article 7(e), and the Defendants' position is the reverse.
It does seem to me however, on consideration of the judgment alone that:
- reference
by the Court in that passage to 'expectation' seems to me inapt. The expectation
test is relevant only to Article 6, which had been resolved in favour
of the claimant:
- it
is not clear whether the point in issue before me, and resolved against
the producer in the German Bottle Case, was argued.
- Australia.
I touch briefly upon this jurisdiction. The wording of Section 75AK(1)(c)
of the Trade Practices Act 1974, which is to the same effect as Article
7(e), is slightly different. In relevant part, the section reads as follows:
"(1)
In a liability action, it is a defence if it is established that:
(a)
the defect in the action goods that is alleged to have caused the loss did
not exist at the supply time; or ...
(c)
the state of scientific or technical knowledge at the time when they were
supplied by their actual manufacturer was not such as to enable that defect
to be discovered."
Such
wording allows more clearly for the Defendants' submission being made before
me, namely that the issue is discovery of the defect in the 'action goods',
i.e. the product in question, to be put forward. Even on that form of words,
however, it seems to me that the Claimants' construction, namely that the
reference to the defect was generic, could be argued. But we are not faced
with the Australian Statute. The reason why reference was made to Australia
is the existence of a decision of the Federal Court of Australia (Lee, Lindgren,
Kiefel JJ) of 9 August 2000, which was referred to by Mr Underhill QC. In
that case the Court concluded that the Judge below was right to construe the
question as being whether the state of scientific or technical knowledge was
such as to enable the presence of Hepatitis A virus to be discovered in the
particular oysters being sold, notwithstanding that it was or appears to have
been common ground that the risk of hepatitis in oysters generally was known.
The Judge found that there was no way of discovering the defect in the particular
oysters, and consequently dismissed the claim. Clearly this is an example
of an apparently strict liability statute resulting in the consumer failing.
However, insofar as I am to draw any further help than that from the case,
I am not convinced, because (a) the wording is different, as I have pointed
out (b) on a reading of the judgment it does not in fact appear to me that
the issue before me, and before the BGH, was being canvassed by Counsel: the
issue appears to have been whether discovery in the individual product could
only be done by a physical verification of each and every oyster, and it seems
to have been assumed (it may well be rightly, on the basis of the Australian
Statute) that it was indeed discovery in the individual product which was
necessary, which would beg our question.
Academic
Literature
- I
turn again to consider the learned, persuasive and interesting contributions
of various distinguished academics which have been put before me:
- Newdick's
article in the 1988 CLJ was written before the rejection by the European
Court in Commission v UK of the UK Government's arguments (apart from those
on accessibility, which he powerfully supports). He appears to have thought
that those arguments might be right, although, in the event of course, apart
from accessibility, they were not accepted. But that apart, his conclusion
(at 472) after setting out the arguments appears to support the Claimants:
"The
argument against such a view is that the defence is not available once the
possibility of the defect has been appreciated. If it were otherwise, this
reforming Act would simply repeat in statutory form that which is thought
to be inadequate in Negligence. Though the defence may inevitably protect
the case of the entirely unforeseeable defect, it ought not to be extended
further to cover problems of quality control. Rather than defending producers
who knowingly, but without negligence, put into circulation defective products,
a no-fault regime would commit itself to imposing liability ... The [argument]
is further assisted by comparing the position of those with rights in contract.
There, liability has never depended on the fault of the manufacturer or
supplier. Once the buyer has shown goods to be defective, strict liability
arises for their consequences. In the absence of clear words to the contrary,
[a] no less generous approach should be adopted on behalf of the consumer
by the no-fault regime of product liability."
- Professor
Clark in his 1989 book at 166-8 appears to come to a similar conclusion
in relation to known but undiscoverable risks, that is "a risk that is
known or suspected to be present in the product, but, effectively, both
the presence of the danger in particular samples of the product and the
means of elimination of the danger are undiscoverable".
- Professor
Freiherr von Marschall of Friedrich Wilhelms University, Bonn, citing Professor
Taschner, states in his 1991 article Deutschland: Bedenken zum Produkthaftungsgesetz
(PH 1 5/91 at 169) (as translated from the German) that:
"Contrary
to an occasionally voiced view, it is irrelevant whether the producer in
question was in a position to recognise the defectiveness in his product.
The decisive question is whether, on the basis of scientific and technical
knowledge which was accessible at the time the product was put on the market,
it was objectively possible to recognise the defectiveness, i.e., its potential
danger."
- Professor
Stoppa, in his 1992 article at 212-213, concludes that:
"The
defence should only be available in the case of entirely unknown and unforeseeable
risks, and should not allow the manufacturer to avoid liability in respect
of defects which are known to be potentially present, but are still ineliminable."
- Howells
(loc. cit.) at 4-242, in a short and unexpanded footnote briefly supports
the Claimants' proposition:
"Both
the Directive and the [CPA] refer to the defect, but in fact what is crucial
is knowledge of risks which lead one as part of the overall assessment of
the product to determine that it is defective."
- Whittaker
in his 1985 article states at 257:
"A
situation covered by 'present knowledge' would be where a drug could not
be tested for a certain effect, because there was no reason to believe that
it could have such an effect. Similarly a producer would not be liable for
impurities in his product such as a virus in blood products, which could
not be detected at the time of putting it into circulation."
This
passage is however unclear to me. Although, on the face of it, his statement
about a virus in blood products is unconditional, nevertheless he does not
seem to address the point in terms as to whether (by analogy with his drugs
example) Article 7(e) will only be available if "there was no reason
to believe that" the virus could be in the blood.
- The
most favourable to the Defendants appears to be Professor Stapleton in Chapter
10 of her 1993 book, at 237. She there states, as part of her proposition,
that the Directive "rarely imposes more than a negligence regime on manufacturers"
(236), that "the defence ... seems to shield a defendant in situations
in which the risks of a product are well known at the relevant time (such
as the risk of Hepatitis infection in donated blood) ...", although
I do not follow the rest of her sentence where she continues "... but
where, given available substitutes, it is regarded as not defective at the
relevant time". I do not follow this, first because I do not see how
there being an available substitute is relevant in the case of blood, and,
secondly, if in fact the product is not regarded as defective at the relevant
time, then the claim will not have passed the threshold of Article 6, and
Article 7(e) does not arise, as she herself points out later in the paragraph.
By her acceptance, and assertion, that the words "to enable the existence
of the defect to be discovered" were not intended to imply "to be
discovered by him" (238) and that "the Article 7(e) defence only
requires a defect to be discoverable by someone" (238), she seems perhaps
to negate a suggestion that the test is whether a defect could have been
discovered in the particular product (produced by the producer). Yet her
consideration of the Australian case of Graham Barclay Oysters (then only
reported in the court below) in her 2000 article at 382 suggests that she
construes the Australian statute no differently from the Directive (and
she is of course an Australian Professor) and is therefore influenced by
the result of that case in her construction of the Directive.
CONCLUSIONS
ON ARTICLE 6
- I
do not consider it to be arguable that the consumer had an actual expectation
that blood being supplied to him was not 100% clean, nor do I conclude that
he had knowledge that it was, or was likely to be, infected with Hepatitis
C. It is not seriously argued by the Defendants, notwithstanding some few
newspaper cuttings which were referred to, that there was any public understanding
or acceptance of the infection of transfused blood by Hepatitis C. Doctors
and surgeons knew, but did not tell their patients unless asked, and were
very rarely asked. It was certainly, in my judgment, not known and accepted
by society that there was such a risk, which was thus not sozialadäquat
(socially acceptable), as Professor Taschner and Count von Westphalen would
describe such risks: Taschner/Riesch Produkthaftungsgesetz und EG Produkthaftungsrichtlinie
[(2nd Ed.) at 291] and von Westphalen loc. cit. at 27. Thus
blood was not, in my judgment, the kind of product referred to in the Flesch/Davenant
Question and Answer in the European Parliament i.e., "... a product which
by its very nature carries a risk and which has been presented as such (instructions
for use, labelling, publicity, etc.)", "... risks which are ... inherent
in [a] product and generally known": nor as referred to by Professor Howells
(loc. cit.) at 1.17 as being risks which "consumers can be taken to have
chosen to expose themselves to in order to benefit from the product".
- I
do not consider that the legitimate expectation of the public at large is
that legitimately expectable tests will have been carried out or precautions
adopted. Their legitimate expectation is as to the safeness of the product
(or not). The Court will act as what Dr Bartl called the appointed representative
of the public at large, but in my judgment it is impossible to inject
into the consumer's legitimate expectation matters which would not by any
stretch of the imagination be in his actual expectation. He will assume perhaps
that there are tests, but his expectations will be as to the safeness of the
blood. In my judgment it is as inappropriate to propose that the public should
not 'expect the unattainable' – in the sense of tests or precautions which
are impossible – at least unless it is informed as to what is unattainable
or impossible, as it is to reformulate the expectation as one that the producer
will not have been negligent or will have taken all reasonable steps.
- In
this context I turn to consider what is intended to be included within 'all
circumstances' in Article 6. I am satisfied that this means all relevant
circumstances. It is quite plain to me that (albeit that Professor Stapleton
has been pessimistic about its success) the Directive was intended to eliminate
proof of fault or negligence. I am satisfied that this was not simply a legal
consequence, but that it was also intended to make it easier for claimants
to prove their case, such that not only would a consumer not have to prove
that the producer did not take reasonable steps, or all reasonable steps,
to comply with his duty of care, but also that the producer did not take all
legitimately expectable steps either. In this regard I note paragraph 16 of
the Advocate General's Opinion in Commission v UK at 487 where, in setting
out the background to the Directive, he pointed out that:
"Albeit
injured by a defective product, consumers were in fact and too often deprived
of an effective remedy, since it proved very difficult procedurally to prove
negligence on the part of the producer, that is to say, that he failed to
take all appropriate steps to avoid the defect arising."
- The
European Court in its judgment perhaps refers implicitly to this when it states
at paragraph 24:
"In
order for a producer to incur liability for defective products under Article
4 of the Directive, the victim must prove the damage, the defect and the causal
relationship between defect and damage, but not that the producer was at fault."
It
seems to me clear that, even without the full panoply of allegations of negligence,
the adoption of tests of avoidability or of legitimately expectable safety
precautions must inevitably involve a substantial investigation. What safety
precautions or tests were available or reasonably available? Were they tests
that would have been excessively expensive? Tests which would have been more
expensive than justified the extra safety achieved? Are economic or political
circumstances or restrictions to be taken into account in legitimate expectability?
Once it is asserted that it is legitimately expectable that a certain safety
precaution should have been taken, then the producer must surely be able to
explain why such was not possible or why he did not do it; in which case it
will then be explored as to whether such tests would or could have been carried
out, or were or would have been too expensive or impracticable to carry out.
If risk and benefit should be considered, then it might be said that, the
more beneficial the product, the lower the tolerable level of safety; but
this could not be arrived at without consideration as to whether, beneficial
or not, there would have nevertheless been a safer way of setting about production
or design. As Mr Brown QC pointed out, even if an alleged impracticability
is put forward by a producer, it would still be possible to go back further,
and see why it was impracticable, and whether earlier or different research
and expenditure could not have resolved the problem.
- Mr
Underhill QC submitted that he accepted that liability was irrespective of
fault and that investigation of negligence was inappropriate, and that that
was not the exercise he submitted the Court was involved in. No criticisms
were being made of the Defendants on the basis that they were negligent. The
investigation that was being carried out was not as it would have been in
a negligence action, as to what steps actually taken by these Defendants were
negligent, so that their individual acts and omissions were not being investigated.
However, many of Mr Underhill QC's submissions were indistinguishable from
those that he would have made had a breach of a duty of care – albeit one
with a high standard of care, so that breach of it might not carry any stigma
or criticism – been alleged against him. Did the Defendants act reasonably
in doing, or not doing, may often have been carefully replaced by 'can it
be legitimately expected that ...?': but often the language of reasonableness
– or Zumutbarkeit – crept in. I quote from his closing submissions:
"The
exercise necessarily involves concepts such as proportionality and reasonableness
which are encountered in the law of negligence, and in particular in relation
to the standard of care in a duty-situation. But it remains a fundamentally
different exercise, addressed to a different question. The Claimant does not
have to be concerned with the producer's conduct at all. He does not have
to adduce, or rebut, evidence about how the process or choice which led to
the product having the characteristic complaint. He has only to persuade the
court that a product with that characteristic fell below the level of safety
that persons generally are entitled to expect as the Community standard. English
law traditionally distinguishes between different degrees of reasonableness
(typically characterised as 'ordinary reasonableness' and 'Wednesbury reasonableness').
Such distinction should not be pressed too far in the exercise of judgment
required by the Directive. But it will be entirely legitimate for a Court
in deciding the correct standard in a given case to recognise that views may
legitimately differ as to exactly where the line is to be drawn and there
may be a range of reasonable responses (both as to substance and as to the
timing of the introduction of any safety feature)."
- Even
from this carefully argued passage it can in my judgment be seen that there
is no sufficient distinction between what Mr Underhill QC accepts is impermissible
and what he is inviting the Court to do. As Mr Brown QC pointed out, certain
of Mr Underhill QC's formulations differ hardly at all from that enunciated
by Lord Reid as being the issue in negligence in Morris v West Hartlepool
Steam Navigation Co Ltd [1956] AC 552 at 574, namely:
"It
is the duty of an employer, in considering whether some precaution should
be taken against a foreseeable risk, to weigh, on the one hand, the magnitude
of the risk, the likelihood of an accident happening and the possible seriousness
of the consequences if an accident does happen, and, on the other hand, the
difficulty and expense and any other disadvantage of taking the precaution."
- What
is more, I have the inestimable advantage of not addressing this hypothetically,
for the proof is in the pudding. In the twenty days or so evidence that I
have heard, it is clear to me that I am being invited to conclude what the
legitimately expectable [reasonable] producer would have been legitimately
expected to do [should have done] in relation to the safety of blood between
1988 and 1991: then I am being invited to set against what happened (no surrogate
tests and no screening until September 1991) the legitimately expected scenario,
albeit that would be the same, as the Defendants would assert, or would be
different and earlier, as the Claimants would assert. As was inevitable, the
carefully constructed distinctions occasionally blurred in the course of a
long trial and lengthy submissions, such that for example Mr Underhill QC
would perfectly understandably submit (Day 7, page 105 of the transcript):
"I think it would be unusual to have a situation in which you held that
everything we had done was reasonable, but nevertheless the public was entitled
to expect a different outcome". Having heard the evidence of Zumutbarkeit
over some twenty days, I pay tribute to the fact that both parties were careful
never to address head on the issue of negligence, the Claimants noteworthily
eschewing any such suggestion, and I am well aware that the investigation
would have been wider and longer if it had expressly been based in negligence.
- As
will be clear when I consider Issue II below, it is by no means easy to settle
on a test for what is to be legitimately expected in the way of safety precautions,
or extra or alternative safety precautions, assuming that to be appropriate.
Must they be taken if they are available, or reasonably available, or not
if there are two 'schools of thought', or only if as Mr Underhill QC put it,
it was "plainly the right thing for a blood transfusion service
to do"? It has been quite clear to me that the Claimants have had, on
the trial of the facts before me, to prove, on the Brown Case, that the Defendants
ought to have acted differently from the way they did: not on a day by day,
or month by month basis, assessing their individual conduct, but simply on
the basis that tests ought to have been introduced differently and earlier.
I am satisfied that Mr Forrester QC was right to refer to Senator Huey Long's
duck: namely 'If it looks like fault, and it quacks like fault then [to
all intents and purposes] it is fault.'
- I
conclude therefore that avoidability is not one of the circumstances
to be taken into account within Article 6. I am satisfied that it is not a
relevant circumstance, because it is outwith the purpose of the Directive,
and indeed that, had it been intended that it would be included as a derogation
from, or at any rate a palliation of, its purpose, then it would certainly
have been mentioned; for it would have been an important circumstance, and
I am clear that, irrespective of the absence of any word such as notamment
in the English language version of the Directive, it was intended that
the most significant circumstances were those listed.
- This
brings me to a consideration of Article 7(e) in the context of consideration
of Article 6. Article 7(e) provides a very restricted escape route, and producers
are, as emphasised in Commission v UK, unable to take advantage of it, unless
they come within its very restricted conditions, whereby a producer who has
taken all possible precautions (certainly all legitimately expectable precautions,
if the terms of Article 6, as construed by Mr Underhill QC, are to be cross-referred)
remains liable unless that producer can show that 'the state of scientific
and technical knowledge [anywhere and anyone's in the world, provided
reasonably accessible] was not such as to enable the existence of the defect
to be discovered'. The significance seems to be as follows. Article 7(e)
is the escape route (if available at all) for the producer who has done all
he could reasonably be expected to do (and more); and yet that route is emphatically
very restricted, because of the purpose and effect of the Directive (see particularly
paragraphs 26, 36 and 38 of the European Court's judgment). This must suggest
a similarly restricted view of Article 6, indeed one that is even more restricted,
given the availability of the (restricted) Article 7(e) escape route. If that
were not the case, then if the Article 7(e) defence were excluded, an option
permitted (and indeed taken up, in the case of Luxembourg and Finland) for
those Member States who wish to delete this "exonerating circumstance"
as "unduly restricting the protection of the consumer" (Recital 16
and Article 15), then, on the Defendants' case, an even less restrictive 'exonerating
circumstance', and one available even in the case of risks known to the
producer, would remain in Article 6; and indeed one where the onus does not
even rest on the Defendant, but firmly on the Claimant.
- Further,
in my judgment, the infected bags of blood were non-standard products. I have
already recorded that it does not seem to me to matter whether they would
be categorised in US tort law as manufacturing or design defects. They were
in any event different from the norm which the producer intended for use by
the public:
- I
do not accept that all the blood products were equally defective because
all of them carried the risk. That is a very philosophical approach. It
is one which would, as Mr Forrester QC pointed out, be equally apt to a
situation in which one tyre in one million was defective because of an inherent
occasional blip in the strength of the rubber's raw material. The answer
is that the test relates to the use of the blood bag. For, and as a result
of, the intended use, 99 out of 100 bags would cause no injury and would
not be infected, unlike the one hundredth.
- Even
in the case of standard products such as drugs, side-effects are to my mind
only capable of being 'socially acceptable' if they are made known. Mr Underhill
QC submitted in his Closing Submissions that blood products:
"are
drugs; they are given only by doctors; they are given typically in life-or-death
situations; they are a natural product derived from the blood of another person
and known therefore inevitably to carry the risk of transmitting pathogenic
agents from the donor. The known risk of the presence of a virus in a BP does
not represent a falling below intended manufacturing or production standards:
it is inherent in the nature of the product."
But
I am satisfied, as I have stated above, that the problem was not known
to the consumer. However, in any event, I do not accept that the consumer
expected, or was entitled to expect, that his bag of blood was defective even
if (which I have concluded was not the case) he had any knowledge of any problem.
I do not consider, as Mr Forrester QC put it, that he was expecting or entitled
to expect a form of Russian roulette. That would only arise if, contrary to
my conclusion, the public took that as socially acceptable (sozialadäquat).
For such knowledge and acceptance there would need to be at the very least
publicity and probably express warnings, and even that might not, in the light
of the no-waiver provision in Article 12 set out above, be sufficient.
- Accordingly
I am quite clear that the infected blood products in this case were non-standard
products (whether on the basis of being manufacturing or design defects does
not appear to me to matter). Where, as here, there is a harmful characteristic
in a non-standard product, a decision that it is defective is likely to be
straightforward, and I can make my decision accordingly. However the consequence
of my conclusion is that 'avoidability' is also not in the basket of
circumstances, even in respect of a harmful characteristic in a standard
product. So I shall set out what I consider to be the structure for consideration
under Article 6. It must be emphasised that safety and intended, or foreseeable,
use are the lynchpins: and, leading on from these, what legitimate expectations
there are of safety in relation to foreseeable use:
- I
see no difficulty, on that basis, in an analysis which is akin to contract
or warranty. Recital 6 ("... the defectiveness of the product
should be determined by reference not to its fitness for use but to the
lack of the safety which the public at large are entitled to expect")
does not in my judgment counter-indicate an approach analogous to contract,
but is concerned to emphasise that it is safety which is paramount.
- In
the circumstances, there may in a simple case be a straightforward answer
to the Article 6 question, and the facts may be sufficiently clear. But
an expert may be needed (and they were instructed in Richardson, Cosytoes
and the German Bottle Case). For Article 6 purposes, the function of such
expert would be, in my judgment, to describe the composition or construction
of the product and its effect and consequence in use: not to consider what
could or should have been done, whether in respect of its design or manufacture,
to avoid the problem (that may be relevant in relation to Article 7(e),
if that arises).
- In
the following analysis I ignore questions that may obviously arise, either
by way of 'exoneration' in respect of other heads of Article 7 or
in respect of misuse or contributory negligence (Article 8, set out in paragraph
16 above).
- The
first step must be to identify the harmful characteristic which caused the
injury (Article 4). In order to establish that there is a defect in Article
6, the next step will be to conclude whether the product is standard or non-standard.
This will be done (in the absence of admission by the producer) most easily
by comparing the offending product with other products of the same type or
series produced by that producer. If the respect in which it differs from
the series includes the harmful characteristic, then it is, for the purpose
of Article 6, non-standard. If it does not differ, or if the respect in which
it differs does not include the harmful characteristic, but all the other
products, albeit different, share the harmful characteristic, then it is to
be treated as a standard product.
Non-standard
Products
- The
circumstances specified in Article 6 may obviously be relevant – the
product may be a second – as well as the circumstances of the supply. But
it seems to me that the primary issue in relation to a non-standard product
may be whether the public at large accepted the non-standard nature of the
product – i.e., they accept that a proportion of the products is defective
(as I have concluded they do not in this case). That, as discussed, is not
of course the end of it, because the question is of legitimate expectation,
and the Court may conclude that the expectation of the public is too high
or too low. But manifestly questions such as warnings and presentations will
be in the forefront. However I conclude that the following are not relevant:
- Avoidability
of the harmful characteristic – i. e. impossibility or unavoidability in
relation to precautionary measures.
- The
impracticality, cost or difficulty of taking such measures.
- The
benefit to society or utility of the product: (except in the context of
whether – with full information and proper knowledge – the public does and
ought to accept the risk).
- Lord
Griffiths et al. in their 1988 article appear to accept (at 382) that an overt
approach by English judges to consider these latter factors would not be likely,
but I do not conclude that they enter into the exercise at all. This is obviously
a tough decision for any common lawyer to make. But I am entirely clear that
this was the purpose of the Directive, and that without the exclusion of such
matters (subject only to the limited defence of Article 7(e)) it would not
only be toothless but pointless.
- The
submissions of Mr Underhill QC threw up an anomaly. As part of his submission
that unavoidability is material, he contended that there may be a situation
in which a claimant might wish to suggest that a harmful product, supplied
with a warning, could yet have been manufactured or designed in other ways
in order to avoid the harmful characteristic of which the warning was given.
Mr Forrester QC eschews this opportunity on behalf of consumers. It seems
to me that is right. The issue of avoidability is as immaterial at
the instance of the consumer as it is of the producer (though of course the
consumer could always put forward an alternative claim in negligence if he
wished to shoulder the burden both of proof and evidential investigation).
The problem is most unlikely to arise in any event in relation to a non-standard
product, where the other, standard, products will in any event be pointed
to, and the warning would itself have to point out the risk of deviation from
the norm. However in relation to a standard product, the problem may again
not arise if there is an alternative product without the defect, with which
the product with the warning can then be compared, and the question of acceptance
of the risk or legitimate expectation of safety can be assessed, once again
without going into any questions of avoidability. However, even where no such
comparability is available, it seems to me clear that, whether or not there
could have been some other way of manufacturing or designing the product,
the social acceptability of the actual product, as it in fact was, must be
tested against the background of the warnings that were in fact given. Warnings
can never in any event amount to a waiver, because of Article 12.
Standard
Products
- If
a standard product is unsafe, it is likely to be so as a result of alleged
error in design, or at any rate as a result of an allegedly flawed system.
The harmful characteristic must be identified, if necessary with the assistance
of experts. The question of presentation/time/circumstances of supply/social
acceptability etc. will arise as above. The sole question will be safety for
the foreseeable use. If there are any comparable products on the market, then
it will obviously be relevant to compare the offending product with those
other products, so as to identify, compare and contrast the relevant features.
There will obviously need to be a full understanding of how the product works
– particularly if it is a new product, such as a scrid, so as to assess its
safety for such use. Price is obviously a significant factor in legitimate
expectation, and may well be material in the comparative process. But again
it seems to me there is no room in the basket for:
- what
the producer could have done differently:
- whether
the producer could or could not have done the same as the others did.
- Once
again there are areas of anomaly. The first is the same as I have discussed
in respect of non-standard products, where the claimant might have wished
to allege unavoidability. The second area arises out of Article 6.2, which
I repeat for convenience:
"A
product shall not be considered defective for the sole reason that a better
product is subsequently put into circulation."
In
the comparative process, the claimant may point to a product which is safer,
but which the producer shows to be produced five years later. Particularly
if no other contemporary product had these features, this is likely to be
capable of being established, and insofar as such product has improved safety
features which have only evolved later in time, they should be ignored, as
a result of Article 6.2. The claimant might however want to allege that the
later safety features could have been developed earlier by the producer. That
would obviously amount to the claimant running the evidence of 'should have
done', to which the producer would no doubt respond 'could not have done'.
This would however once again go to the issue of avoidability, which
I have concluded to be outside the ambit of Article 6, and so once again if
the claimant really wanted to do so he could run the point, but only in negligence.
- I
can accept that resolution of the problem of the defective standard product
will be more complex than in the case of a non-standard product. This trial
has been in respect of what I am satisfied to be a non-standard product, and
I see, after a three month hearing, no difficulty in eliminating evidence
of avoidability from Article 6. It may be that, if I am right in my analysis,
and if it is followed in other cases, problems may arise in the consideration
of a standard product on such basis, but I do not consider any such problems
will be insurmountable if safety, use and the identified circumstances
are kept in the forefront of consideration. Negligence, fault and the conduct
of the producer or designer can be left to the (limited) ambit of Article
7(e), to which I now turn.
CONCLUSIONS
ON ARTICLE 7(e)
- As
to construction:
- I
note (without resolving the question) the force of the argument that the
defect in Article 7(b) falls to be construed as the defect in the
particular product; but I do not consider that to be determinative of the
construction of Article 7(e), and indeed I am firmly of the view that such
is not the case in Article 7(e).
- The
analysis of Article 7(e), with the guidance of Commission v UK, seems to
me to be entirely clear. If there is a known risk, i.e., the existence of
the defect is known or should have been known in the light of non-Manchurianly
accessible information, then the producer continues to produce and supply
at his own risk. It would, in my judgment, be inconsistent with the purpose
of the Directive if a producer, in the case of a known risk, continues to
supply products simply because, and despite the fact that, he is unable
to identify in which if any of his products that defect will occur or recur,
or, more relevantly in a case such as this, where the producer is obliged
to supply, continues to supply without accepting the responsibility for
any injuries resulting, by insurance or otherwise.
- The
existence of the defect is in my judgment clearly generic. Once the
existence of the defect is known, then there is then the risk
of that defect materialising in any particular product.
- The
purpose of the Directive, from which Article 7(e) should obviously not derogate
more than is necessary (see Recital 16) is to prevent injury, and facilitate
compensation for injury. The Defendants submit that this means that Article
7(e) must be construed so as to give the opportunity to the producer to do
all he can in order to avoid injury: thus concentrating on what can be done
in relation to the particular product. The Claimants submit that this will
rather be achieved by imposing obligation in respect of a known risk irrespective
of the chances of finding the defect in the particular product, and I agree.
- The
purpose of Article 7(e) was plainly not to discourage innovation, and to exclude
development risks from the Directive, and it succeeds in its objective, subject
to the very considerable restrictions that are clarified by Commission v UK:
namely that the risk ceases to be a development risk and becomes a known risk
not if and when the producer in question (or, as the CPA inappropriately sought
to enact in Section 4(1)(e) "a producer of products of the same description
as the product in question") had the requisite knowledge, but if and when
such knowledge were accessible anywhere in the world outside Manchuria. Hence
it protects the producer in respect of the unknown (inconnu). But the
consequence of acceptance of the Defendants' submissions would be that protection
would also be given in respect of the known.
- The
effect is, it seems to me, not, as the BGH has been interpreted as concluding
(or perhaps as it did conclude, but if it did then I would respectfully differ)
that non-standard products are incapable of coming within Article 7(e). Non-standard
products may qualify once – i.e. if the problem which leads to an occasional
defective product is (unlike the present case) not known: this may perhaps
be more unusual than in relation to a problem with a standard product, but
does not seem to me to be an impossible scenario. However once the problem
is known by virtue of accessible information, then the non-standard product
can no longer qualify for protection under Article 7(e).
THE
RESULT IN LAW ON ISSUE I
- Unknown
risks are unlikely to qualify by way of defence within Article 6. They may
however qualify for Article 7(e). Known risks do not qualify within Article
7(e), even if unavoidable in the particular product. They may qualify within
Article 6 if fully known and socially acceptable.
- The
blood products in this case were non-standard products, and were unsafe by
virtue of the harmful characteristics which they had and which the standard
products did not have.
- They
were not ipso facto defective (an expression used from time to time
by the Claimants) but were defective because I am satisfied that the public
at large was entitled to expect that the blood transfused to them would be
free from infection. There were no warnings and no material publicity, certainly
none officially initiated by or for the benefit of the Defendants, and the
knowledge of the medical profession, not materially or at all shared with
the consumer, is of no relevance. It is not material to consider whether any
steps or any further steps could have been taken to avoid or palliate the
risk that the blood would be infected.
- I
am satisfied that my conclusions, if not all of my reasoning, are consistent
with the decision of the BGH, and with the views of the majority if not all
of the academic writers. Insofar as they are inconsistent with the views of
Professor Stapleton as to the effect of the Directive, I rather consider that
I have confounded her pessimism than disappointed her expectations.
The
Consequence
- In
those circumstances the Claimants recover against the Defendants because their
claim succeeds within Article 4, the blood bags being concluded to be defective
within Article 6, and Article 7(e) does not avail.
- But
I must, as set out above, proceed in any event to consider the Zumutbarkeit
or avoidability arguments (Issue II), which I have found to be immaterial
and unnecessary. The main issue is whether the public at large would legitimately
expect that different steps would have been taken by way of safety precautions
and in particular that:
- the
anti-Hep C assay would be introduced earlier than it was and/or as early
as January 1990, as the Claimants assert.
- surrogate
tests would be introduced in the UK by March 1988 and would continue until
at least April 1991: continuing alongside the assay if and insofar as the
assay were itself introduced prior to that date.
- In
the light of my construction of Article 7(e), and the conclusion that the
risk of Hepatitis C infection was known, the Article 7(e) defence does not
arise. However I must on a similar basis also nevertheless address Article
7(e), and decide, in the light of the same evidence, Issue IV, namely whether
the Defendants can prove that they would not have been enabled to discover
the existence of the infection in the particular product by virtue of the
scientific and technical knowledge at the time, i.e. the assay, as the Claimants
would assert as from 1 December 1989 (when Japan had introduced it), or surrogate
testing as from 1 March 1988.
ISSUE
II
- In
order to resolve the issues of fact, I have heard a number of impressive,
experienced and conscientious witnesses and read, with the assiduous guidance
of Counsel, a very substantial number of articles, reviews, papers, surveys
and reports in learned medical journals and from high powered and distinguished
medical conferences and symposia, in the fields of blood transfusion medicine,
hepatology, virology, microbiology and epidemiology.
- I
set out first the Defendants' witnesses, as, by agreement, the Defendants
led their evidence first, as they were most easily able to lay the factual
position before the Court:
The
Defendants' Factual Witnesses
- Dr
Harold Gunson, CBE, to whom I have referred to above, as can be seen by reference
to his career, is certainly the most experienced expert in blood transfusion
in the United Kingdom, but perhaps also in Europe. Dr John Barbara has been
the lead scientist in Transfusion Microbiology at the North London Blood Transfusion
Centre, and Microbiology Consultant to the NBA, and has recently been appointed
Principal of the National Transfusion Microbiology National Laboratories and
a member of the Advisory Panel on Blood Transfusion Medicine of the World
Health Organisation (WHO). He too is a man of the greatest distinction and
experience in the field of transfusion medicine. They were the main witnesses
of fact called by the Defendants, although it was difficult to distinguish
them from expert witnesses, save that Dr Barbara did not seek to disguise
his own well-publicised position of lack of support for the introduction in
the United Kingdom of routine surrogate testing. As will appear below, Dr
Gunson gave measured evidence of great authority, and was able, to the admiration
of, I suspect, both Claimants and Defendants, to admit, in retrospect, to
his concern that in the event routine screening for Hepatitis C was not introduced
in the United Kingdom until September 1991. The publications of these two
distinguished doctors are numerous. Apart from his seventy other publications
in this field since 1955, Dr Gunson was co-author of 'Fifty Years of Blood
Transfusion' (1996). Dr Barbara has authored or co-authored some 500 relevant
publications since 1973.
- The
other live factual witness was Dr Garwood, now the National Processing, Testing
and Issue Director of the NBA, who was called to give evidence of the requirements
and problems of the BTS in the implementation of the new assay. Statements
were also read, under the Civil Evidence Act, which were made by three witnesses
whose statements were originally served on behalf of the Claimants, but, after
a decision not to call them, were adopted by the Defendants. These were Dr
Reesink, Associate Professor in Hepatology in Amsterdam, and an experienced
Dutch blood transfusionist, dealing with the history of Hepatitis C screening
in the Netherlands, and two witnesses, Professor Stirrat and Mr Wright, respectively
clinician and consultant surgeon, whose evidence dealt, as did that of another
witness, whose statement was also read, Dr Wolff, a consultant anaesthetist,
with the extent of the knowledge of surgeons and practitioners about the risks
of transfusions, to which I have made general reference above.
The
Defendants' Expert Witnesses
- I
deal at this stage in my judgment only with those experts who gave evidence
on the generic issues, as opposed to the lead cases. Professor Zuckerman is
the doyen of UK microbiologists and virologists. He is Professor Emeritus
of Medical Microbiology at the University of London and Honorary Consultant
in Medical Microbiology and Clinical Virology at the Royal Free, Hampstead,
NHS Trust and the National Blood Authority. He has been a member of the WHO
Expert Advisory Panel on Viral Diseases since 1974 and is Director of the
WHO Collaborating Centre for Research on Viral Diseases. He was Principal
and Dean of the Royal Free University College Medical School of University
College, London, effectively from 1989 to 1999, and an adviser to the Department
of Health continuously for thirty years on matters concerning Hepatitis and
Microbiology. His expertise in the field of viral hepatitis is further apparent
from his having been the author of some eighteen textbooks and over one thousand
publications in learned journals. Although called as an expert witness, he,
like Dr Gunson and Dr Barbara, was intimately involved at committees and working
groups, symposia and conferences and in the presentation of papers, concerning
the topic of screening for Hepatitis at the material time. He, like Dr Barbara,
has not been a supporter of the introduction in the United Kingdom of surrogate
testing. I heard also from Professor Högman, retired Director of the
Department of Clinical Immunology Transfusion Medicine at University Hospital,
Uppsala, in Sweden, as to the history of screening in Sweden.
- In
addition, I heard from two further expert witnesses live, whose evidence was
hardly at all in the event contested by the Claimants, who indeed adopted
much of what they had to say. Dr Peter Simmonds, who is Reader in Virology
at the University of Edinburgh, has, like the others to whom I have referred,
an extraordinary publication list, of some two hundred learned publications
in this field. A particular expertise which he brought to the trial was to
explain the nature of genotypes, for the development of learning about which,
and research into which, he has, as I understand it, been substantially responsible.
There are now known to be at least six major genotypes, or sub-species, of
Hepatitis C. The differences between these genotypes depend upon variations
in their epitopes, which I understand to be stretches of amino-acids with
different sequences. From the result of this research it can now be appreciated
that there are certain differences in effect, discoverability and indeed,
as will be seen later, treatability (genotypes 2 and 3 responding better)
in relation to these different genotypes, depending upon which genotype of
the virus it is by which the blood in question, and hence the recipient of
it, is infected. It is now clear that the most frequent genotype of Hepatitis
C virus, at any rate found in the United Kingdom, (about 40% of all, according
to the Guidance Paper issued in 2000 by the NHS National Institute for Clinical
Excellence (the 'NICE Guidance')) is genotype 1: coincidentally as it happens,
none of the six lead case Claimants has that genotype (although the majority
of the cohort of Claimants, I am informed, does). As a result of genotype
testing carried out for the purposes of this litigation in respect of the
various Claimants, it has been identified that there are examples among them
not only of genotype 1, but also of genotype 2 (itself subtyped into 2a and
2b), 3 (also subtyped 3a and 3b), 4 and I believe also 5. Genotype 1 was,
as will be seen, the subspecies of the virus most easily discoverable by the
first generation screening test: indeed it was not controversial between the
parties that the finding of research carried out by Dr Simmonds and a Dr McOmish
was that the first generation test picked up about 90% of donations infected
by genotype 1, but only some 30% of those infected by the other genotypes.
- The
other expert witness called by the Defendants was Mr Andre Charlett, who is
also the distinguished author of a substantial number of publications: he
is an experienced medical statistician, employed by the Public Health Authority
Service. He gave substantially unchallenged evidence which indeed met with
approval by Professor MacRae, the Claimants' statistical expert, by taking
the Court through a number of the relevant published articles relating to
research into, and surveys of, the results of first generation screening and
of surrogate tests, ALT, and anti-HBc. He explained and exemplified, by reference
to those results, the adjusted efficacy of various tests. This is a method
of assessment of the tests, by reference to their specificity, and after the
making of certain established adjustments, so as to calculate statistically
how successful the tests would be in identifying the blood that is infected
with virus. Hence, in the context of this case, adjusted efficacy of 75% would
mean that for every 100 donations of blood infected with Hepatitis C screened
by a test, the test would identify 75 of them: i.e. had the test been operated,
75 out of 100 infected donations would have been screened out and would not
have infected recipients. Mr Charlett identified certain biases and caveats,
none of which were controversial, in the assessment of such efficacy by reference
to published studies; and, subject to making generous allowance for those
factors, and for the fact that the science of statistics can never be more
than a helpful guide, both parties and I have relied upon his figures.
- In
addition to these live witnesses, the helpful and enlightening evidence of
Dr Hay, a consultant haematologist and Dr Heptonstall, a consultant microbiologist
was agreed and read, as was that of Dr Taylor, a consultant in transfusion
medicine (to whom I refer briefly below).
The
Claimants' Factual Witnesses
- Professor
Dusheiko was described as a factual witness, but, to all intents and purposes,
as he did not play a personal role in any of the events to which primary attention
has been directed (save that he attended at the Ortho symposium in Rome, as
did Dr Gunson and Dr Barbara), he was really an expert witness. His expertise
also is very substantial. He is Professor of Medicine and Honorary Consultant
of the University of London, based at the Royal Free Hospital, an expert hepatologist,
and the author of lectures and papers presented at a substantial number of
national and international meetings and of more than two hundred learned publications
in the field.
- The
evidence of three other factual witnesses was agreed and read. Dr Ward had
made a statement about the practice and procedure of the development and regulation
of drugs manufactured by pharmaceutical companies, which was only of marginal
relevance by way of background: the evidence of Dr Kay, to which Dr Taylor,
to whom I have referred above, replied on the same issue, related to the marginal
topic, not in the event developed, as I have indicated, of autologous transmission:
the evidence of Mr Hardiman, Marketing Director of Ortho for Northern Europe
was produced during the hearing, and agreed, explaining so far as he could
the procedures of the United States Food & Drug Administration ('FDA')
insofar as they related to the grant of an Export Licence and a Full Product
Licence, thus giving the Court some understanding, by way of very general
background, to the grant of such licences in respect of the Ortho assay in
this case.
The
Claimants' Expert Witnesses
- Dr
Caspari, another distinguished expert in Transfusion Medicine, was employed
between 1986 and 1991 by the German Red Cross Blood Transfusion Service, in
Lower Saxony, and is now Research Fellow at the Department of Transfusion
Medicine in Greiswald in Germany. He has also published widely on blood transfusion
and hepatitis. He was able to tell the Court about the position in Germany,
where, although it has never adopted the anti-HBc test, which he personally
has not supported, there has been compulsory routine ALT testing of blood
since 1965, of whose benefits he spoke highly: Germany introduced anti-Hep
C screening, alongside ALT testing, by the beginning of July 1990. The Claimants
also called Professor MacRae, Professor of Medical Statistics at the European
Institute of Health and Medical Sciences at the University of Surrey, and
again a very substantial author in his field, who explained and developed
a number of statistical issues.
The
Oral Evidence
- This
has not seemed to me to be a case in which I have needed, or was indeed qualified,
to disbelieve or reject any evidence given by these highly experienced and
knowledgeable witnesses. What I have endeavoured to do, with the aid of Counsel,
and, in the fulfilment of my task as I have concluded it to be in law, is
to arrive at my conclusions by assessing that evidence, making allowances
as I have considered necessary for any over-enthusiasms and also both matching
the oral evidence with, and fitting it into, the substantial literature by
them and by others which I have endeavoured, again with the very considerable
assistance of Counsel, to assimilate.
The
Literature
- For
the purpose of the generic issues, there has been, as I have previously indicated,
a massive slimming-down exercise by both legal teams to arrive at a comprehensible
and manageable amount of documentation. Publications in this field over the
last thirty years about Hepatitis, and in particular NANBH or Hepatitis C,
have, I am told, run into four, or even five, figures. After considerable
additions, and deletions, during the course of the trial we have ended with
four (very fully filled) core files of learned publications: in addition,
some fairly frequent reference has been made to a number of minutes of, and
papers from, conferences, working groups and committees and other relevant
documentation in another 16 files or so. Much time has been spent during the
hearing in which I have been taken through these publications and documents
first by Counsel, and then, as appropriate, by the witnesses, in order that
I should become sufficiently educated to understand the issues. In the end,
much of what I have learned, all of which I believe has been necessary, has
not had to be spelt out in this judgment. However, I am satisfied that it
was essential for me to seek to understand as much as possible of the very
complex matters underlying the decisions I have to reach, in order for me
to be in a position to grapple with my conclusions. With the assistance of
Counsel and the witnesses, I have not had to read in detail every publication,
but I feel that I have had a very considerable education, and one sufficient
for my task.
- As
for those publications, many of them were, as would be expected, written by
the distinguished witnesses themselves. In addition I have already mentioned
Dr Harvey Alter from the United States, and his influential writings have
been heavily represented. I have had the benefit of publications, elucidated
before me, by other highly qualified and experienced authors of learned books
and articles from around the world. Apart from those whom I have mentioned,
they included publications from the United Kingdom (including those by Dr,
now Professor, Contreras, and Drs Cash, Dow, Follett, Garson, Gillon, Kitchen,
McClelland, Mitchell, Polokaff and Collins and Bassendine), the United States
(Drs Aach, Miriam Alter (no relation), Bayer, Dienstag, Donahue, Holland,
Houghton, Stevens, Seeff and Ms Koziol): and from Australia (Drs Cossart,
Morgan, Young), Canada (Drs Blajchman, Steinbrecher), Finland (Drs Eberling,
Leikola), France (Drs Aymard, Chataing, Janot, Jullien, Richard), Germany
(Drs Kühnl, Müller, Sugg,), Italy (Dr Tremolada), Netherlands (Drs
Katchaki, Van der Poel), New Zealand (Dr Woodfield), Spain (Drs Esteban, Hoyos),
and Sweden (Dr Widell).
The
Background Facts
- A
number of facts should be set out which I believe to be common ground, or
which in any event I find to be the case:
- The
brief history of NANBH has been set out in paragraph 8 above. It is clear
that, from the introduction of screening of Hepatitis B at the beginning
of the beginning of the 1970s, NANBH was responsible for most if not all
of the infection of blood by Hepatitis, and it is common ground that in
the 1970s and 1980s the infection by NANBH was the major complication in
blood transfusion.
- There
is still no immunisation discovered for Hepatitis C: it is not yet possible
to grow the virus in tissue, and, since the virus is highly resistant to
antibodies, the present prospects for an effective vaccine are not bright.
In the 1980s it was believed, as Professor Zuckerman confirmed in evidence,
that no one ever recovered from it. It is now known that there can be recovery,
and treatments have been pioneered in the 1990s, to which reference will
be made later. As will appear in more detail below, apart from those who
spontaneously clear or are (now) successfully treated, a substantial number
suffers chronic liver disease, of which a considerable proportion progresses
to cirrhosis.
- In
the 1970s and 1980s, the vast majority of NANBH sufferers were not diagnosed
as a result of clinical symptoms made known to hepatologists or practitioners,
but as a result of discovery by testing in laboratories. The most frequent
if not only symptom or indicator of NANBH was raised ALT in the blood. It
is common ground that there was substantial under-reporting of the condition
(and this was known at the time).
- Even
on the basis of what was reported, the prevalence (that is prevalence of
the virus amongst the donor population) and the incidence (that is the incidence
of the infection among recipients) were higher in the United States (assessed
by Dr Alter in the 1970s at between 7-12%) and, particularly, Japan, which
had an even higher incidence, than in the United Kingdom and Europe. The
United States' position improved during the 1980s for a number of reasons:
the abolition of paid donors: the introduction of screening tests for HIV,
which excluded a number of donors who would also have been at risk of NANBH:
more effective monitoring and self-exclusion of drug users, etc. The incidence
in the UK, which Dr Gunson believed to be the case at the material time
in 1986 and following, and which was generally accepted and was reported
by him to the Council of Europe, was 3%. (In fact when screening was introduced,
and more accurate assessment was thus able to be made, the incidence became
or was - and still remains - between 0.05 and 1%.) There are approximately
2.5m donations per year (each donor donating approximately twice per year).
The
Approach to be Adopted
- If,
contrary to my conclusions of law set out above, the question of avoidability
is a circumstance, then it must be introduced into what Mr Underhill
QC has called the basket. Although the evidence has largely concentrated on
the factual issue of avoidability, it is obviously essential that, after I
make the necessary findings of fact on that issue, it must be fitted together
with all the other matters or circumstances and weighed together in
the basket. I shall set out what seem to me to be the material factors:
- The
position of recipients/consumers. As has eloquently been put by Mr Brown
QC, they go to hospital for treatment, or resuscitation, but leave the hospital,
albeit cured or improved in respect of their original condition, now significantly
disabled as a result of the very treatment they received, leading (unless
they be one of the few very lucky ones) to a life with a permanent need
for medical oversight and at least a risk of serious deterioration and resultant
death.
- The
position of donors. They are volunteers, who altruistically donate blood.
Their interests must certainly be carefully fostered, not only in order
not to put off them and other potential donors, and thus put the blood supply
at risk, but also because of the duty on the BTS to look after them: if
for example they are simply told that their blood has been rejected, they
may be frightened or distressed, or may be stigmatised by the possible presence
of some uncertain and undiagnosed infection.
- The
possible shortened lifespan of the recipients. Set against the risk of infection
(3% incidence as then believed) is the statistic (which was not controverted)
that, with regard to those who received transfusions, either 50% of the
patients, or patients who received 50% of the blood (which it was unclear
to Dr Gunson, although it was recorded as being the former in his October
1986 paper to the UK Working Party on Transfusion-Associated Hepatitis ('WPTAH'),
which he set up) die in any event of their original condition within one
year of the transfusion.
- The
interests of patients generally: to secure the blood supply, so that there
is no risk of there being no reserves of blood available in an emergency.
- The
Defendants' own determination to give priority to NANBH/Hep C, particularly
given that it was, as set out, a major complication for them. By a letter
dated 7 February 1979 the Senior Medical Officer of the Medical Research
Council (MRC) confirmed that the Chief Scientist of the Department of Health
and Social Security ("the Department") had informed the MRC that NANBH was
being given high priority by the Department. The Department confirmed to
Dr Gunson on 8 March 1989, when it set up the ACVSB, that the United Kingdom
Health Ministers believed that it was of the utmost importance that the
UK Blood Transfusion Services acted in unison on the subject, and Dr Gunson
in response confirmed that he too thought the Committee very important and
had thus set up his own Committee, the ACTTD.
- The
fact that no warnings were given to the public or to patients or recipients
about the risk from the receipt of transfused blood or in particular about
the risk in question. I have already referred to the fact that I am satisfied
that neither the Defendants nor the Government nor the Press, insofar as
either of the latter were relevant, gave any or any sufficient warning to
the public of the risks: and that although medical practitioners knew of
them, and would advise patients if asked, they were rarely asked, and unless
asked, did not inform.
- In
fact, a substantial number of donors who had used drugs and who were thus
the most likely to be carriers of NANBH, did escape the net of self-exclusion
and give blood: many of these might have experimented briefly with drug
use many years before and forgotten or put it from their mind. Dr Barbara
estimated that 10% of those who gave blood should not have been giving blood.
Dr Gunson accepted that intravenous drug users had become donors, and Professor
Zuckerman accepted that the problem that amongst those giving blood were
those who had been drug users in the past was known at the time. In subsequent
research carried out after the introduction of screening, it was found that,
in that cohort, 50% of infected blood donations had been given by those
who subsequently accepted that they had been at one time or another intravenous
drug users. According to the NICE Guidance, the prevalence of Hepatitis
C among intravenous drug users is said to be up to 50%.
- The
last ingredient must, on these assumptions, be avoidability: which
has a number of sub-categories:
- What
is the risk? - seen as 3% incidence at the time.
- How
foreseeable? - known.
- What
is the priority for avoidance - see sub-paragraph (v) above.
And
then the factors to be addressed by reference to the evidence:
- What
is the seriousness of the consequence to the Claimants if the steps are
not taken?
- What
is the seriousness of the consequence to others if the steps are taken?
- As
to the precautions themselves - in this case the tests:
- What
steps are said to be available?
- How
reliable are they?
- How
efficacious (sensitivity: specificity: adjusted efficacy)?
- How
expensive are they to implement/continue?
- What
are the logistics for implementing them?
- What
is the proper analysis that should be adopted to conclude whether tests/precautions
are available? I turn to this.
The
Proper Analysis
- The
starting point is of course the difficulty that I inevitably have in finding
a distinction between negligence and the question of avoidability:
even if I be wrong in my conclusion that the very consideration of conduct,
or of what could or should have been done, is a subversion of the object of
the Directive, nevertheless to tread the tightrope which Mr Underhill QC has
laid out for me is not easy. Subject to that, a number of tests have been
suggested, largely by Mr Underhill QC, or in the course of my exchanges with
him, as he is the proponent of the issue to which the 'Brown Case' is put
forward by the Claimants as their answer. Not least of course of the problems
is that, in addressing the legitimate expectation of the public in respect
of the taking of precautions or the holding of tests, I have already indicated
that it is clear that the public itself would have had no such expectation,
might not have known of the need for any test, or, if they did, would simply
have assumed that all steps had been taken, so that the matter is left to
me as objective assessor.
- It
is clear to me that the analysis does not involve the following:
- As
indeed Mr Underhill QC has always made clear, the process does not involve
a detailed analysis of each act or omission of the Defendants.
- Equally
however, I am satisfied that this is not an exercise by way of 'Wednesbury
unreasonableness', or considering whether the Defendants came to a reasonable
conclusion, or made reasonable management decisions, or examined, or came
to proper conclusions in the light of, available expert opinion.
- Whereas
the conduct of other similar authorities in other countries may be of some
relevance, it plainly cannot be determinative, or an inhibition upon the
conclusion I otherwise reach.
- There
is no question of a conclusion that the public is legitimately entitled
to every marginal improvement.
- I
do on the other hand take into account, as an important part of the factual
context and circumstances within which I reach the decision, the attitude
and objectives of the Defendants, and the priority of NANBH to which I have
referred. In this regard Mr Brown QC referred to Dr Gunson's paper to the
Council of Europe in May 1987, reporting conclusions of a distinguished working
group of the Committee of Experts on Blood Transfusion and Immunohaematology
on which he served, in which the following statement (among others) was recorded:
"If
a stance is taken that blood should have maximum safety, then the tests [in
this case surrogate tests] would be introduced but the benefits derived
from testing would not be uniform throughout every country. "
- There
was some considerable discussion as to whether indeed it was the stance or
objective of the Defendants that blood should have 'maximum safety',
and indeed as to what that meant or would mean in any event. In the Guidance
for the Blood Transfusion Services in the United Kingdom 1989 at paragraph
1.10 it was recorded, in the context of the United Kingdom BTS achieving and
maintaining "the highest standard of operations", that there should
be "some uniformity ... in the determination of those procedures that will
ensure maximum safety of blood", and Dr Gunson confirmed that this concept
was not newly introduced in 1989, but had antedated it, as far as he was concerned.
A significant example can perhaps be given by reference to a study which he
initiated in 1988, and which reported in draft in October 1989, intended to
study raised ALT in recipients of blood at 3 RTCs (which has become known
as the 'Multi-Centre Study'). The draft report submitted to the ACVSB in October
1989 concluded as follows:
"In
the meantime, the desirability of ALT testing or otherwise remains an issue
of health economics."
Dr
Gunson's response to this, when asked about it by Mr Brown QC in cross-examination,
was:
"As
I said to you earlier, Mr Brown, I was never one for going on health economics.
I would like to know the cost of what we are doing, but not necessarily the
benefit related to it, because I felt that, if you had to do it, you had to
bear the cost."
In
its final form in March 1990, the report concluded:
"The
subject of cost-effectiveness has recently been reviewed, but if the desire
to ensure a 'minimum risk' product overrides the economical and logistic considerations,
ALT testing then becomes a serious contender ..." [as a matter
of fact by this time the question of introduction of ALT was being regarded
as academic, because main concentration was now being dedicated towards the
question of introduction of routine anti-Hep C screening].
Dr
Gunson preferred the concept of 'minimum risk' to 'maximum safety'.
However this became clarified when he was shown, or reminded of, a preliminary
discussion paper for the ACTTD prepared by Dr Barbara and Dr Contreras dated
23 January 1992, which read:
"The
attitude towards transfusion safety has veered away from the concept of 'maximum
benefit/minimal cost' towards the notion that if a procedure is shown to prevent
transfusion-transmitted infection and disease is available, it should be introduced."
He
responded as follows to Mr Brown QC's question about this:
"Q.
Were you aware of that shift in culture or do you think that that had always
been the position?
A.
I think it was probably always the position."
- A
number of formulations have been put forward:
- Mr
Brown QC was firm in his assertion of the inappropriateness of the test
in Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, whereby,
in a case of professional negligence, a professional acting in accordance
with a practice accepted as proper by a responsible body of professional
opinion is not negligent 'merely because there is a body of opinion which
would take a contrary view' (per McNair J at 587-588) [the 'Bolam Test'];
and Mr Underhill QC dissociated himself from the case that the Bolam Test
was apposite to the Directive. However it seems clear to me that that was
indeed the kind of formulation that he was articulating when he set out
the following in his Summary of his case, which I invited at an early stage
of the hearing from both sides:
"[Persons
generally] would only be 'entitled to expect' such screening if it was
plainly the right thing for a blood transfusion service to do."
Another
formulation by Mr Underhill QC was that the public was "not entitled
to expect safety precautions where there is a matter of such doubt and debate".
At another stage Mr Underhill QC put it that if some people think a precaution
is advantageous and others think it disadvantageous, "entitlement to
expect must arise from, if not a universal view, a better view that a precaution
should be adopted ... Where there is quite vehement controversy internationally
as to whether there is a good idea or a bad idea, it is a heavy thing to
say the public was entitled to expect this to be happening when, if the
public had informed itself, it would know that controversy was raging across
the world as to whether or not it was a good thing to do or a bad thing
to do".
- Another
formulation by Mr Underhill QC was that, in order for it to be legitimately
expected that a safety precaution would be taken, a "really substantial
benefit [must be] demonstrated".
- Mr
Brown QC, with an eye on the 1989 Guidance, and the evidence to which I
have referred in paragraph 104 above, formulated a proposition that "the
public was entitled to expect (at least in the absence of compelling/high
quality/local evidence) that, consistent with the objective of ensuring
maximum safety such tests would be introduced". He explained this by
indicating that there would have to be "really clear evidence the other
way". This of course is almost the mirror image of the first of Mr Underhill
QC's formulations, which I have recited at (i) above.
- The
broad-brush question of course is what tests or precautions it is reasonable
or appropriate or legitimate to expect that a defendant producer should have
adopted. In the light of Article 6, and the obvious emphasis on a weighing
exercise, taking into account all the circumstances, I interpret the
position as being that the Judge (whether as the representative of the public
or otherwise) simply weighs up the advantages and disadvantages, the pros
and cons, without the benefit of hindsight, and reaches his own decision,
neither reviewing the producer's decision, nor declaring that the producer's
decision was negligent. Accepting, but somewhat adapting, another of Mr Brown
QC's formulations, I would declare myself as prepared, while walking Mr Underhill
QC's tightrope, to adopt a formulation as follows. If a precaution shown to
prevent, or make a material reduction in, the transfer of transmitted infection
through infected blood is available, it should be taken, unless the disadvantages
outweigh the advantages.
- I
shall now accordingly, informed by the evidence, consider the pros and cons
on that basis. As indicated, there are two issues, first as to whether surrogate
screening should have been introduced (when it never was) and secondly whether
the anti-Hep C assay should have been introduced by way of routine screening
before it was on 1 September 1991, or (as now conceded as part of the settlement
agreement, to be the relevant date for consideration) 1 April 1991. I shall
thus reach my decision on the basis of my conclusions as to 'legitimate expectation',
as required by the need to resolve Issue II irrespective of the outcome of
Issue I: but nothing that I shall say or decide can, or does, reflect in any
way on the personal dedication, professionalism, integrity and conscientiousness
of those in the NBTS, the ACVSB and the ACTTD who were involved in their own
weighing exercise at that time.
SURROGATE
TESTS
- I
refer to the explanation of the two surrogate tests, which I have set out
at paragraph 9(i) and (ii) above. By way of further introduction to the issue
of surrogate tests, the following should be explained:
- As
will be seen, the question of surrogate screening really came to the fore
in the early 1980s as a result of the debate in the United States, and particularly
the thorough studies published, originally in 1981, by the NIH and the TTVS,
to which I have referred. The case for the Claimants is that the tests ought
(and I shall use that verb, or alternatively the tense 'should', as shorthand
for legitimate expectation) to have been introduced in the United
Kingdom by 1 March 1988, when the CPA came into effect. This is the case
which I shall primarily consider. It is clear that if the surrogate tests
were not in place by that date, or shortly afterwards, it becomes progressively
less arguable that they should have been introduced: as the discovery of
the Hepatitis C virus is first of all announced (May 1988), then its scientific
details published (April 1989) and thereafter as from April 1989 the Ortho
assay is publicised, evaluated and debated. The Claimants do assert that,
even if not introduced by March 1988, the surrogate tests should still have
been introduced later, particularly if the introduction of the Ortho assay
was to be delayed to as late as September 1991, but this is plainly a subsidiary
issue.
- The
USA introduced surrogate testing, as I have recounted, from September 1986,
ALT followed soon after by anti-HBc, and it introduced routine anti-Hep
C screening on 2 May 1990. The surrogate tests continued alongside the assay
until 1995. Whether or not there is a case that the surrogate tests, if
they had been introduced in the UK, should thereafter have been discontinued,
this issue does not arise for me, where consideration has in the event been
limited to the period up to 1 April 1991, and on any view, if introduced,
they would not have been discontinued by that date.
- As
will be seen, it was concluded by the US researchers, somewhat to their
surprise, that the blood identified by the ALT test as having elevated ALT,
and the blood identified by the anti-HBc test as containing Hepatitis B
antibodies, did not materially overlap. This was, it would seem, one of
the main reasons why in the event they introduced and retained both tests.
It seems to be accepted (as Dr Barbara explained) that where blood was positive
on both tests, it was the more likely to have been genuinely infected with
Hepatitis C.
- Routine
ALT testing was, as I have described, in effect in Germany from 1965. The
threshold for the test was higher in Germany than in the United States.
The cut-off in the United States test to indicate when ALT was elevated
was 45 international units per litre (iu/l). Germany used a different system
of measurement of international units. The cut- off there was also 45 iu/l,
but that equated to 90 or 100 iu/l on the US scale. The cut-off for which
the Claimants contend, on the basis that surrogate testing should have been
introduced in the UK, is that adopted by the USA, which was also the level
which was adopted for the investigations carried out by the Multi-Centre
Study in 1988/89 referred to above.
- Not
many countries apart from the United States (both tests) and Germany (ALT
only) introduced surrogate tests. The full picture is as follows:
Germany
|
1965
|
(ALT)
|
Italy
|
1970
|
(ALT)
|
USA
|
September
1986 onwards
|
(Both)
|
Luxembourg
|
October
1 1986
Mid
1987 (for new donors)
|
(ALT)
(anti-HBc)
|
France
|
15
April 1988
3
October 1988
|
(ALT)
(anti-HBc)
|
Switzerland
|
1
June 1988
|
(ALT)
|
Malta
|
Early
1989
|
(ALT)
|
There
was some partial routine ALT testing in certain centres in Austria, Belgium
and Spain, from about 1987, and Queensland (alone of the Australian states)
introduced compulsory ALT testing in about April 1989. Dr Högman told
the Council of Europe in 1987 that Sweden was to introduce anti-HBc testing
for first time donors, but he explained in evidence that this was intended
in fact as a supplementary Hepatitis B screening. No other countries, so
far as is known, ever introduced either test.
- An
important part of the background is the Council of Europe Working Group
Paper to which I have referred, the conclusions of which were as follows:
"1.
The use of non-specific tests [the surrogate tests in question] for
the purpose of reducing the incidence of transfusion association NANB Hepatitis
and [their] possible value as a public health measure remain a controversial
issue.
2.
If a stance is taken that blood should have maximum safety, then the tests
would be introduced; but the benefits derived from this testing would not
be uniform throughout every country. Also there is no guarantee, in a given
country, that there will be a significant reduction in the transmission of
NANB Hepatitis.
3.
The introduction of non-specific tests could lead in some countries to a severe
depletion of blood donors, which may compromise the blood supply; and this
is a factor that must be taken into account.
4.
When non-specific testing is introduced in a country, provision must be made
for the interviewing, counselling, and further medical examination and treatment
which may be required for donors found to have a raised ALT or who are anti-HBc
positive.
5.
The committee cannot give a general recommendation on the introduction routinely
of non-specific tests for evidence of NANB infectivity of blood donors. Individual
countries will have to assess the situation locally and decide upon the appropriate
action to take."
It
is of course the assessment of whether the UK as an individual country ought
to have introduced the surrogate tests that is before me. As for other international
or trans-national bodies, introduction of the test was, Professor Zuckerman
told the Court, never recommended by the WHO, nor was it recommended, as Professor
Högman explained, by the Council of Nordic Transfusion Services.
The
Literature
- Before
considering the actual pros and cons, I must summarise the literature on the
topic and its effect. It is important to weigh up the opinions set out in
that literature, but it is equally important not to over-emphasise it for
the following reasons:
- Not
all of it carries equal weight. Some are short letters, albeit from influential
and distinguished writers; some are fully researched and detailed surveys
or reviews; some articles falling somewhere between the two. Some of the
research cannot be assessed or examined on the basis of what has been published
in the articles, others are not only fully researched but their workings
fully disclosed to view. Some of them are highly respected and have never
been questioned; others have been subjected to criticism.
- Inevitably
the literature I have is selected or culled from a very much larger corpus.
Plainly it contains all which either side considers to be relevant, and
indeed has, most of it, been combed through during the course of this trial
and all material passages identified. Nonetheless, it cannot necessarily
be concluded to be a complete picture: it is also drawn from a number of
different countries, not all of which will necessarily be relevant to my
decision as to the United Kingdom.
- Many
of those who wrote had, often very well known, preconceived positions or
were 'arguing a corner', which they were perfectly entitled to do.
- At
the end of the day, and most importantly, I am not deciding this case on
the number of experts ranged on either side, but by reference to the arguments
that can in fact be drawn from the literature: and in particular I am not,
as I have concluded, deciding this case by reference to whether it was reasonable
for the Defendants to rely on one expert view or another, but making up
my own mind, informed and enlightened by the evidence and the arguments.
The
United States
- Consideration
of surrogate tests in the literature must inevitably commence from the United
States, and in particular the starting point of the studies by the NIH, and
the TTVS. The TTVS published its report in April 1981, the first named author
being Dr Aach, and the NIH published in August 1981, led by Dr Harvey Alter.
The two studies, both of them highly researched and very well respected, came
to much the same conclusion as to ALT tests, namely that they were worthwhile
considering in the context of reducing Hepatitis C and were capable of detecting
and avoiding some 30% of Hepatitis C infected blood, at a loss of what was
estimated to be 1.6% of donor units; i.e., 1.6% of donations would have to
be thrown away as a result of the test, but the effect was predicted to be
the reduction of transfusion associated hepatitis by some 30%. These studies
were both what are called 'predictive' studies rather than 'prospective' studies,
i.e., they looked back, e.g., by reference to identifying recipients with
raised ALT elevations in their blood, to see who their donors were, and then
identified whether those donors had raised ALT elevation, and so could have
been excluded had there been an ALT test in place: prospective tests would
involve running partial ALT testing, and then following up the consequences
for those who had received ALT tested blood as opposed to those who did not.
The USA did not immediately react by introducing ALT testing. A special report
by an Ad hoc Committee on ALT testing (containing, among others, Dr Harvey
Alter's co-author at the NIH Dr Holland) concluded in 1982 that "widespread
ALT testing [is not to] be recommended at present. Many important questions
have been raised and some appropriate studies are under way. Until more data
are available, we believe that the best interests of the many patients who
depend on a reliable supply of blood are best served by continued investigation
rather than a change in donor eligibility standards". The factors that
they set out will, with one exception, feature in my assessment of the pros
and cons below:
- ALT
was not a specific, or direct, test for Hepatitis C.
- There
had been no prospective studies.
- The
long term significance of Hepatitis C was unknown, and the associated liver
pathology was considered to be mild.
- There
was uncertainty about the cut-off level.
- The
methods for ALT testing needed to be evaluated [this is the aspect which
does not further feature].
- The
effect on the donor base was unknown and potentially detrimental.
- Nevertheless
the debate continued, and an important series of contributions by many of
the most well known international figures in the field appeared in the journal
Vox Sanguinis in 1983. Dr Aach was cautiously in favour of introduction
of ALT testing:
"A
decision must soon be made regarding donor ALT screening. Either the issue
is not resolved, and requires a properly designated randomised study which
should be initiated now, or a target date for routine ALT testing should be
set for those donor populations in which an association with NANBPTH has been
identified. It is unfair to postpone the decision, possibly indefinitely,
because of the expectation that a specific and sensitive NANB test will soon
come along to lead us out of the wilderness."
He
had some support from the French contributors, led by Dr Chataing. The German
view, firmly given by Dr Müller, was in favour of the introduction of
ALT testing. The other contributors, including Drs Bayer, Holland and Reesink,
and, from the UK, Drs McClelland and Mitchell, were against. In 1984, the
TTVS, led by Dr Stevens and Dr Aach, published its research in relation to
possible introduction of the anti-HBc test. The report concluded that the
introduction of such a test might reduce Hepatitis C by about one third, but
at a heavier loss of the blood supply than the introduction of ALT testing,
which the TTVS considered to be of greater efficacy than anti-HBc; and the
consensus of the group was to favour ALT screening over anti-HBc screening.
Later in 1984 Dr Harvey Alter and Dr Holland reviewed the recent TTVS study,
noted what they considered to be the "disturbing dichotomy" that the
two tests had identified different donors, and recommended the rapid institution
of a randomised controlled study, relating to the possible introduction of
both surrogate tests. Meanwhile, as Dr Harvey Alter published in early 1985,
he had himself introduced some partial routine ALT testing, which to his surprise,
failed to demonstrate any impact on reduction of PTH; and he once again recommended
a controlled study. In 1986 there was another article published in the United
States, by Drs Hanson and Polesky, which did not favour introduction of an
anti-HBc test, but in the same year the NIH published what seems clearly to
have been an influential article, led by Ms Koziol. The conclusion was to
recommend introduction of both surrogate tests, even without such controlled
studies:
"Prospective
studies indicate that at least 5% of transfusion recipients develop bio-chemical
or clinical evidence of NANBH. For an estimated 3 million blood recipients,
this percentage represents 150,000 cases of transfusion-associated NANBH in
the United States annually. If half these patients have chronic ALT elevation
and 10% of these develop cirrhosis, then up to 7,500 cases of non-A non-B
–related cirrhosis might be induced annually as a result of blood transfusions.
If, as predicted, surrogate screening of blood donors could prevent approximately
one third of these cases, then this could represent an annual reduction of
50,000 cases of Hepatitis and 2500 cases of cirrhosis. The potential to achieve
this degree of disease prevention now appears to outweigh the disadvantages
inherent in the adoption of surrogate tests for the non-A, non-B virus carrier
state."
In
an article in 1986 which he co-authored with Dr Dienstag, Dr Harvey Alter
wrote as follows:
"Because
of the cost and significant donor loss engendered, and because of recent introduction
of mandatory screening of all donor blood for antibody to [HIV], adoption
of yet another one or two donor-blood screening tests represents a very complex
and difficult decision. Nonetheless, increasing documentation of the chronic
sequelae of NANBH and the continued high incidence of this disease after transfusion
has tipped the balance in favour of adopting indirect assays for NANBH carrier
detection."
The
United States' introduction followed, later that year, of both surrogate tests.
In the absence still of a specific assay, and in the light of the introduction
in the United States of the two surrogate tests, Dr Harvey Alter published
his review in 1988 entitled 'Transfusion-Associated Non-A Non-B Hepatitis:
the First Decade'. He referred to the TTVS and NIH studies, and in particular
to the findings on their behalf more recently, by, severally, Koziol and Stevens,
of some efficacy for anti-HBc, and he also referred to a recent study by Dr
Sugg in Germany, whereby anti-HBc testing offered an additional 42% predicted
efficacy to prevent NANBH infection. He concluded:
"The
predicted efficacy for [anti-HBc] testing was 28%, diminished by the lower
efficacy in the large TTV Study. Based on these three studies, on prior data
relating to ALT, and on the evidence for significant chronic liver disease
following NANBH, the major blood organisations in the United States have elected
to adopt both the ALT test and the [anti-HBc] test as routine screening measures
for all blood donations. Although I am in agreement with this decision, I
wish to stress again that these are predicted efficacies, not proven efficacies,
and that, in countries that can do so, an effort should continue to be made
to perform a controlled, prospective study to demonstrate whether such costly
measures are truly indicated."
- This
was, subject to the European studies to which I shall refer, the state of
play at the time when it is suggested by the Claimants that the Defendants
should have introduced surrogate testing. It is right to say that Dr Harvey
Alter ten years later (his proficiency and his interest in the subject manifestly
undiminished) has written, in retrospect, in a 1998 joint publication with
Dr Seeff, as follows:
"The
TTVS and NIH Studies predicted that the combined use of ALT and anti-HBc testing
would prevent 40% to 50% of transfusion-associated hepatitis. There is now
some indirect corroboration of this prediction ... Although other changes
were occurring in the donor population simultaneously with the introduction
of the surrogate tests, it seems from both these analyses that surrogate marker
testing did accomplish its goal of recognising a significant number of HCV
carriers, and hence has prevented as much as 50% of transfusion-associated
hepatitis."
- This
of course is inadmissible with regard to the question which I am presently
deciding, although it has some influence on the question I must decide later
in this judgment as to the actual efficacy at the time of surrogate testing
if it had been introduced; because I must ignore what came after in deciding
what ought to have occurred in Spring/Summer 1988. For similar reasons therefore,
I must for this purpose ignore also the following:
- subsequent
lookbacks or articles viewing ALT and/or anti-HBc retrospectively with enthusiasm:
by Drs Morgan and Young (Queensland) (ALT): Dr Donahue (USA) (both): Dr
Jullien (France) (both): Dr McOmish (with Dr Simmonds et al) (UK)
(both) and Dr Blajchman (Canada), who started, but did not complete, because
of the introduction of the assay, the controlled study in Canada which Dr
Harvey Alter had wished someone could do (both).
- reports
which were unenthusiastic or unfavourable: by Dr Garson (UK) in 1990 (ALT):
Dr Esteban (Spain) in 1990 (ALT).
- four
further reports which, albeit nearer the time, appear too late for consideration.
Three of them were favourable to ALT, namely by Dr Van der Poel, with Dr
Reesink, (Netherlands) in August 1989, by Dr Janot (France) in September
1989 (relatively supportive of ALT though overtaken by the assay) and by
Dr Young (Queensland), submitted in April 1989 but published in 1990: and
one unfavourable, namely the report of findings as to ALT efficacy presented
at the Ortho meeting in Rome in September 1989.
The
Rest of the World
- I
turn therefore briefly to summarise the relevant contemporaneous literature
other than from the United States:
- Supporting
or favourable to ALT. Dr Richard (France), who published in 1987 a review
paper, which in fact supported introduction of both surrogate tests: Dr
Reesink (Netherlands), who supported it in 1988 [although in June 1989 –
just prior to publication of the Van der Poel/Reesink paper, which was further
supportive of ALT, as referred to above – the Dutch Health Council decided
not to recommend introduction of the test "at present" – albeit expressly
with an eye on the recently publicised assay]: and Dr Widell (Sweden) in
1988.
- Against
ALT: Dr Katchaki (Netherlands) in 1981: Dr Steinbrecher (Canada) in 1983:
Dr Woodfield (New Zealand) in 1988 and Dr Gillon (UK), (based in Scotland)
in 1988. Dr Gillon and his Scottish colleagues stated:
"The
Americans have concluded that a prospective randomised trial to test these
hypotheses will never be carried out, for logistical and ethical reasons
... We conclude that the introduction of these screening tests cannot at
present be justified. Further studies of recipient NANBH and the natural
history of the disease are necessary, and a properly conducted prospective
trial of screening for surrogate markers is essential. More extensive studies
of the donor population would be valuable, with a particular need for elucidation
of the apparent relationship between body weight and ALT level. Such studies
would prove useful in the management of donors, should the case for screening
ever be well enough established for its introduction to be considered necessary."
- In
favour of anti-HBc Testing: Dr Cossart (Australia) in 1982: Dr Sugg (Germany)
in 1988.
- Unfavourable
to anti-HBc: Dr Hoyos (Spain) 1982: Dr Aymard (France) in 1986 (though France
introduced it two years later): Dr Reesink (Netherlands) in 1988: and finally
in an article in 1988, Dr Kitchen of the UK, together with other English
colleagues, including Professor Zuckerman. They concluded:
"The
apparent lower incidence of reported cases of PTH in the United Kingdom is
demonstrated by the fact that during the last twelve months, in the area served
by the North Thames RTC, approximately 120,000 units of blood were transfused
and only three cases of PTH were reported for follow up of the implicated
donors. In the light of the findings of this study, and the very small number
of cases of PTH reported in the United Kingdom, we believe ... that at the
present time there is likely to be very little benefit in the introduction
of anti-HBc screening of blood donors. The loss of approximately 2% of available
donors because of deferment would cause problems for those transfusion centres
facing shortages of donors, especially those serving the Greater London Area.
The cost of testing donations for the presence of anti-HBc is high and in
the current financial climate would be hard to justify. A further consideration
is the need to counsel those donors found to be anti-HBc positive. Although
the introduction of surrogate testing may eventually be unavoidable, we believe
that only a controlled prospective study would provide the necessary information
to determine the significance of donor anti-HBc levels in relation to PTH,
especially NANB, in the United Kingdom."
Professor
Zuckerman was thus opposed to the introduction of anti-HBc, but seemingly
largely on grounds of a conclusion of a relative lack of seriousness of the
impact of Hepatitis C in the UK, together of course with the other factors
there set out. This must be seen together with the paper that he gave in Taipei
in December 1988, which he supplied to the ACVSB before its meeting in May
1989. He there concluded that ALT was a better prospect than anti-HBc "since
the corrected efficacy of anti-HBc as a screening test was slightly less than
that of ALT and the number of blood units lost would be twice those which
would be if ALT were used". However he concluded that "despite the
high specificity, the predictive value is only 42%. Thus almost two out of
three units with an elevated ALT level will not transmit NANB. ALT levels
vary with age, sex, alcohol and geographical region and therefore would not
be useful as a surrogate marker of NANBH".
- This
brings me to a brief consideration of the evidence given orally by the expert
witnesses, although I shall deal more fully with this when I come to set out
the pros and cons which became clear on the totality of the evidence. Professor
Zuckerman had been cautious about ALT as early as 1982, but never, it seems,
totally hostile; he then wrote "the benefits of ALT screening, which is
a non-specific test and which carries several problems ... must be carefully
weighed against the number of potential donors who would be excluded, the
overall incidence of hepatitis in recipients and the severity of the disease".
He repeated in evidence his lack of support, apparent from the other
quotations I have given above, for the introduction of surrogate testing,
for the reasons set out further below. In his important letter to Dr Rejman,
the Senior Medical Officer at the Department, of 19 December 1989 (admittedly
after the ACVSB had already, at its 6 November 1989 meeting, concluded that
its feeling was that there was no case for using surrogate tests (while supporting,
on terms that will appear later, the introduction of the assay)) he had however
simply said as follows:
"A
case can be made for the introduction of routine surrogate testing, particularly
for ALT elevations, for detection of early infection of Hepatitis C virus
... However this aspect of screening is also subject to debate in view of
the non-specificity of the test."
- Dr
Barbara is, and has always been, opposed to the introduction of surrogate
tests, although, as set out in paragraph 108(iii) above, he confirmed that
"the predictive value of surrogates increases if both the surrogate markers
are positive". In his 1983 textbook Microbiology in Blood Transfusion
Dr Barbara described the ALT test as "the most promising (though not without
difficulties) of the non-specific markers". By April 1987 however, he
had joined in a letter to the Lancet with Dr Contreras and others concluding:
"Before
we are forced to accept two screening tests of unproven benefit, which have
high revenue implications, we need a national study to assess the incidence
of raised ALT and anti-HBc in donors in different parts of the country. Also,
and perhaps more importantly, a study is needed to assess the incidence of
acute post-transfusion NANBH, and to assess how many of those affected develop
evidence of chronicity and serious clinical sequelae. If the true incidence
of post-transfusion NANBH and its serious clinical sequelae are at a much
lower level than reported from the USA, then screening of donations to reduce
the incidence of NANBH may not be cost-effective in the UK."
- This
letter (upon which he and his co-authors expanded, in a published article
in the June) was part of a run of correspondence to the Lancet in 1987 relating
to possible introduction of the surrogate tests. Letters to similar effect
were sent by other blood transfusionists. A second letter, from Dr Dow and
others, urged that because "99% of hepatitis cases are never brought to
the attention of transfusion centres, or are not considered to be hepatitis
by clinicians, or are not even thought to be serious enough for the patient
themselves to seek medical attention ... it would be prudent to do a UK study
to assess the real incidence of acute post-transfusion NANBH and to assess
the proportion of those chronically affected, before considering following
American surrogate testing policy". A third from Dr Gillon and others,
concluded that "the introduction of ALT/anti-HBc screening tests as an
indicator of NANBH carrier status in blood donors cannot at present be justified".
A fourth letter disagreed with these other three, and it was headed Testing
Blood Donors For NANBH Irrational, Perhaps, But Inescapable. It was written
by a number of senior Scottish transfusionists, including two, Dr McClelland
and Dr Mitchell, who had been participants in the Vox Sanguinis debate
four years before to different effect, as set out above (Dr Mitchell was also,
strangely, seemingly a signatory of Dr Dow's letter with which this letter
was taking issue!) and Dr Cash, National Medical Director of the Scottish
NBTS, and others. As is plain from the title of the letter, the signatories
recognised that there were disadvantages in the proposed tests, but recommended
their introduction. They considered that the time for any prospective controlled
studies had long passed, and concluded:
"Looking
at the three factors – producer's liability [by reference to the Directive]
competition, and value for money [being the cost of avoiding disease]
– we suggest that the decision that has to be made is when rather than whether
UK transfusion services follow the lead of the United States and other European
countries in donor screening."
- This
then, and in particular the 1986 introduction of surrogate tests by the United
States, Dr Gunson's paper at the Council of Europe, Professor Zuckerman's
paper and article and the controversial correspondence in the Lancet, was
the main background behind any consideration in later 1987 or early 1988 of
the introduction of surrogate tests.
THE
PROS AND CONS OF SURROGATE TESTING
- I
turn to consider the advantages and disadvantages of surrogate testing, or
points in favour and points against, as disclosed to me on the evidence.
The
Points In Favour
- First.
Whatever may have been said in some of the articles and letters to which I
have referred, it is common ground, on the evidence before me, that the tests
were relatively inexpensive. There was an express conclusion by the Defendants
in November 1987 that reproducibly accurate ALT results could be produced
"at low test costs with a minimum of technical expertise and operator interactivity",
and it was not suggested the position was any different in relation to anti-HBc:
indeed Mr Underhill QC conceded that cost was not a factor.
- Second.
As to the reliability of the ALT test, no criticism is made. With regard to
the anti-HBc test, Dr Caspari (with others) in a 1989 article criticised its
consistency and specificity, which criticism he confirmed in evidence; but
so far as the United Kingdom is concerned, in the Multi-Centre Study of 1988/89
this view was not shared; indeed, although recommending against its introduction,
in the light of the imminent assay, the report was not uncomplimentary to
the reliability of the test.
- Third.
No substitutes were available. By March 1988 there was no sign nor news of
the assay, although no doubt everyone was hoping that something would turn
up. In the light of the priority which had been given to hepatitis, as set
out above, as long before as 1979, it is not surprising that Dr Gunson was
"sufficiently troubled" to reconvene his WPTAH (which had petered to
an end in 1983 when no grant was obtained for the studies into surrogate testing
that they wanted to implement) at the end of 1986; and yet, as he accepted
in cross-examination, "between the Autumn of 1986 and the autumn of 1988,
apart from [his] own group looking at matters informally, nothing was
happening", so far as he knew.
- Fourth.
Prevalence in the United Kingdom was not known, but, as set out in paragraph
99(iv) above, Dr Gunson, on behalf of the Defendants, was operating on the
basis that it was in the region of 3%.
- Fifth.
The seriousness of the consequences to recipients who were infected by Hepatitis
C was not fully appreciated. However, as set out in paragraph 99(ii) above,
Professor Zuckerman confirmed that the belief at the time was in fact that
no one ever recovered from it, and that they knew it was an important problem.
There was a lack of understanding in the United Kingdom about the sequelae;
but Dr Barbara confirmed that he knew at the time that there was underreporting.
Dr Alter, in his 1985 article, had set out, in detail, his appreciation of
the sequelae, including his view that "an astounding number of acute NANBPTH
cases progressed to chronic hepatitis, at least as judged by persistent ...
ALT elevations" and "there is accumulating evidence that some cases
progress to severe chronic liver disease ... If we assume that 7% of transfusion
recipients develop biochemical evidence of hepatitis, that 50% of these manifest
chronic ALT elevations and that 10% of the latter develop cirrhosis, then
cirrhosis will eventually develop in 3-4 of every 1000 patients transfused
... This would represent 9,000-12,000 cases annually among the estimated 3m
transfusion recipients in the United States". Professor Dusheiko accepted
that clinicians were blind until the late eighties, and it was only the discovery
of the Hepatitis C virus that enabled a grip to be got on the size of the
problem. However, he confirmed that the chronicity and the potential for severe
disease were appreciated. The article by Dr Kitchen and Professor Zuckerman
from which I have quoted in paragraph 114(iv) above in 1988 referred, as there
appears, to "apparent low incidence of reporting cases of PTH ... very
small number of cases of PTH reported in the United Kingdom" [my underlining],
and yet, as I have set out above, Dr Barbara accepted that it was known that
there was underreporting.
- Sixth.
The United States had introduced the surrogate tests. No actual study of the
effects of such introduction in that country could sensibly have been made
at that stage, because of the fact that it followed so shortly on the heels
of the abolition of paid donors, the introduction of HIV screening and increased
self-exclusion, all of which would in any event have led to an improvement
in the donor panel and a decline in incidence. But there is no evidence of
any problem either with shortage of supply in the blood pool or with the donors,
notwithstanding the considerable anxieties in those regards, and others, that
were expressed prior to the introduction of screening. It is not simply the
fact that no evidence has been put before me that there were any such problems,
but that, given that the worries which had been expressed prior to introduction
in the United States appeared to be the same worries that were now being expressed
in the United Kingdom, it is itself perhaps a matter of significance that
no attempt was made to explore the position in the United States (or indeed
in Germany, where again there is no evidence of there having been any problem)
before the repetition of the same anxieties was allowed to prevail in the
United Kingdom.
- Seventh.
The studies in the United States had been only predictive. Although there
was discussion of the possibility of prospective studies, in fact it was soon
clear, at least in the United States (see Dr Alter's article referred to in
paragraph 111 above) that this was not going to be possible. In any event,
as the witnesses have recognised, it would not have been possible to do so
in the United Kingdom. Dr Gunson had applied for a grant to carry out such
a study in relation to surrogate testing, in 1982, which had been refused,
and when he made a further application in 1987, which was granted in 1988,
it had to be limited to looking at donors, and became the Multi-Centre Study.
The main reasons were two-fold: first there was or might have been, it was
concluded, an ethical problem by that stage in giving some patients tested
blood and others untested (plainly if there had been no question of any efficacy
of the surrogate test such ethical problem would not have arisen). Secondly,
the very real problem with prospective tests in relation to an infection with
low incidence, such as 3% or less, was the very large number of prospective
patients who would have to be studied, rendering it impracticable. It is in
those circumstances that Dr McClelland and his Scottish colleagues wrote their
'Irrational .. but Inescapable' letter. Dr Gunson considered that what
influenced the Americans in introducing the tests was that Dr Aach had said
in his statement in the Vox Sanguinis debate "we really have to
make up our minds; if we do not do a detailed survey then we should start
testing", and that, in the absence of such a detailed survey, that is
what had occurred in the United States.
- Eighth.
As for the efficacy of the surrogate tests, it was known at the time that
the incidence of NANBH in the UK (as in the rest of Europe) was less than
the United States, and efficacy in preventing it was likely therefore to be
less also. The evidence of efficacy really came substantially through the
assistance of Mr Charlett, who addressed most of the published research in
the trial papers for the purpose of assessing adjusted efficacy of the two
tests so far as he could. So far as the United States is concerned, Dr Stevens
in 1984, by reference to the two tests separately and together, had predicted
33% adjusted efficacy for anti-HBc, 47.5% for ALT and 61.2% for both together.
Mr Charlett has recalculated those at, respectively, 21%, 30% and 39%. As
for Ms Koziol in her 1986 article, Mr Charlett calculates adjusted efficacy
for anti-HBc, in relation to the two panels appearing in the article, at 42.7%
and 48.9%, and for ALT at 22%, and both together at 57%. Mr Charlett's calculations
for adjusted efficacy appearing from the European ALT studies is summarised
by Mr Brook Smith, on the Defendants' behalf, in a Schedule attached to the
Defendants' Closing Submissions; and I have carefully considered not only
his calculations, but also the caveats Mr Charlett makes in the course of
his evidence. I conclude, taking both the American evidence, as discounted,
and the contemporaneous European evidence into account, that the likely adjusted
efficacy of ALT at the material time on the balance of probabilities was 20-25%.
So far as the anti-HBc test is concerned, the figures are sparser, but, as
can be seen from the two main American studies, and in particular Koziol's,
they had a reasonably optimistic view of its efficacy, even though others
have thought, as set out in detail in the articles to which I have referred
above, that, at any rate in Europe, it was ALT which had the greater predicted
efficacy. On the other hand there are two particular surveys which Mr Charlett
studied, and where he calculated an adjusted efficacy for non-American research
into anti-HBc; in respect of the Cossart research in 1982 in Australia, Mr
Charlett calculated the adjusted efficacy as 48.5%, while in respect of the
Sugg research in Germany in 1988, he calculated it at 42%. The Claimants do
not suggest that anti-HBc alone should have been introduced as a surrogate
test. Their main case is for the introduction of ALT tests, which had the
well-respected pedigree, albeit with a higher cut-off, in Germany, and for
which there is reasonably substantial support among the articles to which
I have referred; while they accept that, not least because their own expert
witness, Dr Caspari, is not a supporter of anti-HBc, their case for that test
is much weaker. They contend however not simply – though primarily - for the
introduction of ALT, but for its introduction together with anti-HBc, namely
for the same reason as the United States, because it covers an additional
donor population and it increases efficacy. I do not therefore need to reach
a conclusion as to what adjusted efficacy anti-HBc would have had on its own.
I am however satisfied that, if the two tests together had been introduced,
the adjusted efficacy of the two combined would have been 40%.
- So
far as efficacy is concerned, the Claimants drew attention to Dr Alter in
an article in the Lancet in 1970, when he supported the introduction of Hepatitis
B screening, where he said that "granted that ... the exclusion ... would
prevent no more than 25% of these cases, this still represents a highly significant
decrease in hepatitis-related morbidity and mortality". Professor Zuckerman
accepted the evidence with a "lot of ifs and buts" that a 20% reduction
through the adoption of ALT screening would have been a worthwhile thing to
do.
- Ninth.
Finally I turn to the two tests themselves:
- There
was some advantage in introducing anti-HBc in being a supplementary back-up
for anyone infected with Hepatitis B who might escape the net of Hepatitis
B screening (HBsAg): this is clearly at best marginal.
- It
is important to recall that the way in which NANBH was diagnosed, in the
days before the identification of the Hepatitis C virus, was through raised
ALT in the recipient, so that it appears logical to identify raised ALT
in a donor as a potential risk.
- In
the light of what I have set out in paragraph 100(vii) above as to 10% or
so of drug users, or other unwanted donors, who slipped through the net,
anti-HBc would have been an additional method of identifying – by reference
to life-style, as set out in paragraph 9(ii) above – those who might fall
within that category. This was, as set out above, a problem of which the
Defendants were aware at the time. It is plainly an advantage to exclude,
so far as possible, such drug users, and to endeavour to identify them by
reference to those who had previously had Hepatitis B and thus retained
the antibodies, just as it was accepted practice to exclude known drug users,
those with jaundice or with HIV etc.
The
Points Against
- The
first is the loss to the blood supply. If ALT testing had been introduced,
at least 2.5% of donations would have been lost. As for anti-HBc, notwithstanding
what was written in some of the literature to which I have referred, it was
common ground that the loss resulting from that test would have been less.
A total loss in respect of the two tests of 4% was accepted, indeed propounded,
by Dr Gunson in his evidence and accepted by the Defendants in the course
of their submissions. 4% of 2.5 million donations is approximately a loss,
averaged over the year, of 8,000 per month. It is apparent from the figures
for blood stocks which were disclosed by the Defendants during the hearing
that this could on occasion have meant running the blood stocks very low.
The monthly records produced for 1990 and 1991 showed that reserves in fact
fell in January 1990 to below 18,000, and between May and June 1990 to below
20,000, and again fell below 18,000 in January 1991: and the Defendants point
to a passage in Dr Gunson's own co-authored Fifty Years of Blood Transfusion
where he states as follows:
"The
difference in quantities between a satisfactory supply and a shortage was
small. Whilst total daily red cell stocks were in the order of 25,000, approximately
2½ days' supply, there was rarely a need to transfer blood between RTCs. Below
this level there were shortages at one or more RTCs; above it there was a
surplus. The advantage of having a national dimension for the blood stocks
was that when the trend was downwards it was possible to initiate local, or
if necessary national, publicity to increase the blood supply before a major
shortage occurred."
The
Defendants referred to this in their submissions as indicating what they described
as a "danger level", but I do not consider that that is what that passage
says, and the words certainly do not appear in it. But Mr Garwood was concerned
about the adequacy of the blood supply in such circumstances, and said that
it could take up to two years to recover the loss. Dr Caspari in an article
in 1975 described donations lost as a result of ALT tests as a "sacrifice",
which it obviously was. It was only Dr Gunson's hard work, it is apparent,
and his constant attention, which achieved the security of supply meeting
demand throughout the country, including transfer if necessary of a blood
surplus in one centre to another centre which was short; and it is plain from
the conclusions of the Council of Europe Working Group, which I have quoted
in paragraph 108(vi) above, that it was foreseen that "the introduction
of non-specific tests could lead in some countries to a severe depletion of
blood donors which may compromise the blood supply and this is a factor which
must be taken into account".
- However:
- As
I have indicated in paragraph 125 above, there is no evidence that the United
States, with a higher incidence of NANBH, suffered problems in blood supply
after the introduction of the tests, notwithstanding the expressed concerns
prior to their doing so.
- It
is apparent that the pool could be increased by additional efforts – such
as for the purpose of the Gulf War (again made clear by Dr Gunson in a lecture
note disclosed in the papers in which he indicates that "we were successful
in increasing the blood supply. The normal collection level in England and
Wales is approximately 9,000 donations per day. On 18 January this rose
to 30,000 ... This experience shows ... that motivation will encourage voluntary,
unpaid donors to come forward to help others") and it is certainly the
case that the blood stock figures show such an increase during that period.
If there had been an emergency shortage of blood it would seem possible
that the missing 8,000 donations per month might thus have been found.
- But
the most significant factor in the evidence was that the man in charge himself,
Dr Gunson, was, although concerned, not saying that he could not cope with
a 4% loss to the blood supply. In re-examination, he said as follows, in
answer to Mr Underhill QC:
"Q.
What was the prediction for the loss that would have been caused by the introduction
of both forms of surrogate testing?
A.
Both forms, something in the order of 4% ...
Q.
What impact would that degree of loss have had on the blood supply in the period
between 1988 and 1991?
A.
That I consider to be a significant loss because it is added to ... the [12%
to 15%] annual loss of donors ... and this would have meant that we would have
been losing probably in the order of one-fifth of our blood supply each year
and this would have to be replaced by recruiting new donors ...
Q.
I think it may be suggested, as seems to be the thrust of the questioning, that
the improvements which you undoubtedly made ... would have meant that the loss
of this degree of donors would not have been a problem. What would you comment
on that?
A.
Well I find it difficult to decide whether it would have been a problem or not,
because it is purely speculative, but it would probably have been lessened by
the movement of blood throughout the country.
Q.
... Would it have been a source of concern to you at the time if you had been
told that this testing would be introduced and you would therefore lose about
4% of your donors?
A.
Well, yes, until I had been able to analyse the effect of the testing.
Q.
You would have had to see how it worked out?
A.
Yes, indeed."
In
my judgment, that indicates plainly a source of concern, but manageable.
- The
second point was the welfare of donors. The importance of not doing anything
to the detriment of donors is manifest and has been emphasised in paragraph
100(ii) above. There was some implicit suggestion in argument of a dichotomy
between a 'pro-donor' attitude, on the one hand, of the NBTS, intent largely
on safeguarding their donors and their blood supply, and a 'pro-recipient'
attitude, on the other, of clinicians interested in the patients. But I do
not consider that to have been the case, and indeed it is entirely clear to
me that Dr Gunson did, as he said, put the recipients at the top of his priority
list. There is, in any event, not, it seems to me, a tension, but rather a
balance: both of them have to be considered and provided for. Care manifestly
would have to have been taken, in the event of the introduction of surrogate
tests, not to create what was sometimes referred to as a new class of unhappy,
excluded donors, even 'lepers': indeed, there was some talk even of
possible litigation by stigmatised, rejected donors. It is absolutely clear
that proper consideration needed to be given to having proper procedures for
counselling in place, prior to any tests being implemented, just as in the
event took place in respect of the assay, and as indeed was once again foreseen
by the Council of Europe Working Group: "When non-specific testing is introduced
in a country, provision must be made for the interviewing, counselling and
further medical examination and treatment which may be required for donors
found to have a raised ALT or who are anti-HBc positive". Again there
does not seem to have been any evidence of any problem in the United States
after the introduction, notwithstanding prior expressed concerns. Dr Caspari
described the system adopted in relation to ALT testing, established for many
years, in Lower Saxony, where they only notified patients whose ALT is elevated
to 100 iu/l (which in fact as I understand it would be four times the US cut-off)
while in the case of those who were elevated above the 45 iu/l cut-off, but
not to that extent, they would, at least in the first instance, simply reject
the blood, while not notifying or counselling the donors. This was a process
which was not satisfactory to the British transfusionists and hepatologists
who gave evidence (nor to Dr Högman, the Swedish expert) who would certainly
have wished to ensure that all those with elevated ALT were notified, rather
than simply having their blood rejected, as a matter of what they firmly considered
to be medical ethics, which I of course accept; although I do note Dr Gunson's
account of United States practice, in paragraph 49 of his statement (as to
which he was not cross-examined), whereby, albeit at a lower cut-off rate,
a somewhat similar system of levels for discarding and notifying, and for
discarding but not notifying, was adopted.
- However,
even assuming adoption of the tests on the basis of full notification of anyone
whose test, be it ALT or anti-HBc, was positive, I see no reason whatever
why, given the necessary introduction and implementation of procedures, this
should not have been manageable. There would be approximately 2.5% of donors
with elevated ALT and approximately 1.5% with anti-HBc. I am entirely satisfied
that this could have been sensibly dealt with:
- As
to those positive for anti-HBc, all that needed to have been said was (as
was the case) that they had antibodies to Hepatitis B, i.e., they had previously
had Hepatitis B. What would have then needed to have been said (and no doubt
previously recorded in literature) was that, like those with jaundice etc.,
those who had in the past had Hepatitis B could not give blood. This would
not seem to me likely to have caused either confusion or distress, nor probably
to have given any information that the donor did not already have, albeit
he might have forgotten about it, and would certainly not result in any
stigma.
- As
to ALT, there would be no question of any diagnosis of any condition: the
test was not, and would not have been represented as being, a Hepatitis
C test: nor could it have been represented as being a test for HIV, for
which donors would in any event have been separately tested. Thus there
need have been no question of their being 'lepers' or stigmatised
by unknown infection. They would simply have been told that they had elevated
ALT, which might indicate some liver condition or simply obesity or excess
alcohol, but that anyone with elevated ALT was again one of those who were
excluded from donating blood. Professor Dusheiko at any rate (though Professor
Zuckerman was less sanguine) did not consider that any resulting referrals
would not have been coped with.
- One
of the advantages if the two tests had been combined, would have been that
different consideration could be given to counselling of those, if any,
who showed positive on both tests, as they would (as Dr Barbara made clear)
be more likely in fact to be suffering from Hepatitis C.
- The
third point is the case that neither anti-HBc nor ALT are 'specific' tests,
that is they do not test for NANBH (I would prefer, because of the multiple
meanings of the words 'specific' or 'specificity', to recategorise the criticism
as 'indirect', as opposed to 'direct'). I have already quoted in paragraph
114(iv) above from Professor Zuckerman's paper at the second International
Symposium on Viral Hepatitis at Taipei in December 1988, and he repeated his
view in evidence that there was no sufficient connection between either test
and diagnosis of NANBH. Further criticisms were that the ALT test had a variable
cut-off, as discussed above. Dr Caspari's support for ALT should be discounted
because (a) Germany has a higher cut-off (b) Germany, having introduced the
test in 1965, never addressed any of the questions, considered in the 1980s,
as to whether the test could or should have been introduced specifically with
a view to filling the gap in the absence of a specific test for NANBH, but
was simply keeping in place an already existing test. As to anti-HBc this
test was, as set out above, not supported by Dr Caspari, although, at least
as to its reliability, there is no evidence that there was publication in
regard to this at the time, and, as appears in paragraph 121 above, when the
Multi-Centre Study did look at it, it does not seem to have reached the same
conclusions as Dr Caspari.
- The
'indirectness' of both tests is plainly of concern. However:
- The
very availability of a variable cut-off meant that, if the test had been
introduced, it could have been adjusted if it turned out there was an unacceptable
loss to the blood supply.
- There
would on any basis have been an increase in prevention of NANBH if one or
both tests had been adopted, due to what was, as appears in paragraph 127
above, adjusted efficacy in respect of NANBH infection of between 20% and
40%.
- Past
drug users, who would otherwise have donated, would be more likely to be
eliminated from the pool.
- Dr
Caspari's lack of support for anti-HBc might be explained by the fact that,
as he accepted, the donor population of his area was "rural, which contains
almost no risk groups, that is drug addicts for example or other people
who have a high likelihood of having Hepatitis B and C from the same source".
In answer to Mr Brown QC he agreed that his conclusion might have been different
if he had been doing work in a German urban centre as opposed to a Red Cross
rural population.
- The
fourth point is the case that the US studies which had led to the introduction
of the tests in the United States were predictive studies, and were therefore
not as reliable as prospective studies (although Professor MacRae gave evidence
that predictive studies were nevertheless valuable). The United States had
introduced the tests under what was described as political pressure, which
Dr Caspari and Dr Barbara both believed related to public fears about AIDS,
and which was described as follows in the June 1989 decision by the Dutch
Health Council, to which I have referred in paragraph 114(i) above, namely
that "[the American Blood Bank Organisations] changed their mind, which
was partly due to pressure from the public and the risk from damage claims
as a consequence of liability". The crux of the argument is that the simple
fact that the United States had introduced these tests should not mean that
the United Kingdom should follow. The view of the first reconvened meeting
of Dr Gunson's WPTAH on 24 November 1986, quite clearly adopting or favouring
the view of Professor Zuckerman, was that "the USA experience did not relate
to the UK. The [Hepatitis B] rates in the USA were higher, and any
NANB viruses prevalent in one country were not necessarily going to be equally
prevalent in the other ... limited UK data did not of itself warrant introduction
of anti-HBc/ALT screening at this time". This was a view similar to that
which had been consistently held by Professor Zuckerman, and indeed stated
by him in a 1982 publication shortly after the original TTVS and NIH studies,
namely that "it is difficult to extrapolate these observations to other
countries and to countries with different blood transfusion practices".
Again, the final conclusion in the seminal report of the Council of Europe
Working Group, itself post-dating the United States introduction was that:
"individual countries will have to assess the situation locally and decide
on the appropriate action to take".
- However:
- Even
if it was 'political pressure' in the United States which caused the introduction
of the surrogate tests – or even fear of litigation – that does not seem
to me necessarily to be outside the sphere, but possibly even to be the
result, of legitimate expectation of the consumer. However it is far from
clear that that was the case: there appear, as set out above, in fact to
be two more substantial reasons:
- Pursuant
to Dr Aach's position in the Vox Sanguinis debate, as postulated
in evidence by Dr Gunson, since a proper prospective study could not now
be carried out, therefore the United States had had to proceed to testing
on the basis of what they had, namely the predictive studies. It is clear
that the United Kingdom had reached a similar position, so far as any
detailed prospective studies are concerned, from the very same meeting
of the WPTAH on 24 November 1986 to which I have just referred, for it
was there "agreed that a full prospective study of a group of recipients
of all transfused blood ... along the lines of the USA TTV study would
be too expensive and inappropriate in the UK". The logistical and
likely ethical problems have been referred to in paragraph 126 above.
- Dr
Alter's stance on the introduction of the surrogate tests in the United
States seems to be that recorded in his jointly authored 1986 article,
to which I have referred in paragraph 111 above, namely that the "chronic
sequelae of NANBH and the continued high incidence of this disease after
transfusion have tipped the balance in favour of adopting indirect assays
for NANB carrier detection". A similar view was expressed by Drs Dienstag
and Seeff in a 1988 editorial, when the authors wrote as follows:
"This
decision [to introduce surrogate testing in the US] was based in
part on new data about the value of anti-HBc as a surrogate test; [viz.
Koziol]; however these data were also retrospectively derived and not
substantially different from those in earlier reports, which they confirmed.
Undoubtedly the decision was also rooted in mounting concern over the recognition
that serious chronic liver disease could follow transfusion-associated NANBH."
This
was plainly the case in the United Kingdom also, through the eighties.
- In
fact it is not necessarily the case by 1987 or 1988 that the postulated
incidence in the United Kingdom of 3% was much if at all less than that
of the United States, which had fallen during the 1980s for the reasons
discussed in paragraph 125 above. In 1987 Dr Richard of the National Blood
Transfusion Centre in Paris wrote that the actual relative risks "are
obviously different from one country to another, but for most developed
countries the available data suggests that fundamental differences do not
exist". Dr Gunson confirmed in evidence that "by the end of
the 1980s the prevalence of [Hepatitis C] in the donor population
in the United States [was] very broadly the same as the believed
prevalence in the United Kingdom".
- The
fifth point is simply the case that more tests should be carried out first,
and/or that it was right to wait for a specific assay to be developed, which,
it was believed, had to happen soon. The question of what further tests could
be carried out has been canvassed above. The only work that was done in the
United Kingdom after the autumn of 1986 was the Scottish work by Dr Gillon,
referred to in paragraph 114(ii) above, and the Multi-Centre Study, which
itself was not able to start until mid-1988, reporting in draft in October
1989. Neither of these recipient-based studies was likely to reach any fresh
conclusions. There could be no direct tests until the NANB virus itself could
be identified, which had still not yet occurred. Set against that is the priority
set for NANBH, and the adjusted efficacy, based on the predictive studies,
of the surrogate tests.
- The
sixth point was the burden on centres of two new tests. This was canvassed
in closing submissions by Mr Underhill QC, but I saw no evidence to support
it. In any event, logistics would be a factor to be taken into account, and
no particular difficulties have been identified.
- The
seventh point is that so few other countries adopted it. The countries that
did have been set out. This is obviously a relevant matter, not least if it
were the case that the tests being canvassed were so outrés that the
United Kingdom would be out on a limb if they had introduced them. It seems
to me that it is no answer, however, if the United Kingdom public can otherwise
legitimately expect the tests to have been adopted. The re-establishment of
Dr Gunson's WPTAH in autumn 1986, followed by the vivid correspondence in
the Lancet, might well have been expected to lead to implementation in 1988,
in the United Kingdom, just as did a similar process in the United States.
The Council of Europe left the decision to individual countries to make.
Conclusion
on Surrogate Testing
- The
pros and cons in respect of the introduction of surrogate testing must be
assessed and weighed and then placed, together with the other circumstances,
into Mr Underhill's Article 6 basket. I have not found this an easy task and
it has required very careful deliberation. After such thought, I am left in
no doubt that what I have in the preceding paragraph categorised in almost
every case as a 'However' outweighs or neutralises the contrary arguments
that have been set against the arguments in favour, and I am clear that the
scales have come down in favour of the introduction of these surrogate tests,
and indeed of both kinds of surrogate test, both ALT and anti-HBc. The United
States and France, the major countries who introduced surrogate tests at that
time, introduced them both, and I am clear that, notwithstanding the lesser
expert support for the latter test, once ALT testing is to be introduced,
the addition of anti-HBc adds little by way of extra disadvantage, cost, blood
loss or inconvenience, and may be of substantial advantage. It was, in my
judgment, at least very likely to decrease the number of donors who were in
any event unwanted, a factor which does not seem to have been discussed at
any ACVSB or ACTTD or other meetings to which my attention has been drawn.
Further, if the US research was right, the two tests did not, or not materially,
overlap, and in any event the combined efficacy of the two together, on the
basis of the predictive studies, was clearly greater, and there may additionally
have been advantages, as discussed in paragraph 133(iii) above, in relation
to counselling and diagnosis. It is both difficult, and, in my judgment, unnecessary,
for me to decide a particular time for such introduction. I am however satisfied
that it ought to have been at some stage after the introduction of the surrogate
tests in the United States and the subsequent consideration given to them
in the United Kingdom, and before, or at any rate by, 1 March 1988.
- No
question therefore arises as to the subsidiary and alternative issue, whether
surrogate tests, if not introduced by 1 March 1988, should have been introduced
after that date. Certainly no different considerations would have applied
if it were a matter of only a few months after that date, but, once it was
apparent that a screening test had actually been pioneered, I would have thought
it difficult to suggest that the United Kingdom ought then to have introduced
the surrogate test, when the proper and inevitable concentration would have
been at that stage had been upon when to implement the assay, to which I now
turn.
THE
ASSAY
- I
set out first a timetable of when various countries which we have considered
in this trial commenced anti-Hep C screening:
November
1989
|
Japan
|
February
1990:
|
Australia
|
March
1990
|
France
(1 March): Luxembourg (new donors only, 1 March)
|
April
1990
|
Finland
(1 April – all donations: partially started 1 February)
|
May
1990
|
USA
(2 May): Austria: Amsterdam (other Netherlands Centres later)
|
June
1990
|
Canada:
Germany (by 1 July)
|
July
1990
|
Belgium
(1 July)
|
August
1990
|
Switzerland
(1 August)
|
September
1990
|
Luxembourg
(all donors)
|
October
1990
|
Italy
(many centres): Spain (all by 12 October, some started earlier)
|
1990/91
|
Norway
|
January
1991
|
Sweden
(legal requirement published 24 January to start as soon as possible)
|
March
1991
(not
before March)
|
Portugal
(mandatory, some earlier): Cyprus: Greece: Hungary: Iceland: Malta
|
April
1991
|
Netherlands
(mandatory 1 April)
|
June
1991
|
Denmark
|
August
1991
|
Italy
(balance)
|
September
1991
|
UK
(1 September)
|
September/October
1991
|
Ireland
|
- The
table of dates does to a certain extent speak for itself. Certainly in relation
to this issue, unlike the surrogate testing, Mr Underhill QC was not assisted
by drawing comparisons or contrasts with other countries. As a result of the
90% concession agreement, the Defendants do not seek to support a date later
than 1 April 1991, which would notionally push the United Kingdom to further
up the table.
- I
shall now set out a narrative of the most material events of what did occur
in the United Kingdom with regard to implementation of the assay. This is
recounted only to show what did occur, and not as a preface to any criticism
with regard to each individual step. Although Mr Brown QC did indulge occasionally
in what he called 'poison and prejudice', he recognised the limits of the
ambit which Mr Underhill QC has himself laid down by virtue of his submissions
(which I have primarily found to be unsuccessful) as to what a court can and
should consider with regard to steps which a producer could or should have
taken. As discussed in paragraph 102 above, this would not involve, as would
what Mr Underhill QC would call a negligence inquiry, or Mr Brown QC a full
blooded negligence inquiry, a detailed critique of every incident. What is
to be done is, as against what did occur, to set out what I may be persuaded
should have occurred, in the round. This involves my looking realistically
as to how much time it is legitimately to be expected that the producer should
have taken to introduce the precaution which he did rightly introduce, but,
as the Claimants allege, later than he ought to have done had he taken all
legitimately expectable steps.
- So
far as my approach is concerned in arriving at this picture in the round,
I shall look at the steps which it is legitimately expectable that a producer
in the position of the Defendants would have taken, and the period of time
which it is legitimately expectable they ought to have taken. If there were
any particular outside circumstances either affecting the United Kingdom generally,
i.e. such as the Gulf War, or locally, such as to make it evident that either
nationally or in one particular area it would not at a material time have
been possible to have taken a particular step, then that would and should
be taken into account. But in the event neither such eventuality arises.
The
Chronology of the Introduction of the Assay in the UK
- At
a meeting in August 1988 in Manchester, Drs Gunson, Barbara and Contreras
(among others) discussed what was then called the 'Chiron test' and hoped
to carry out some trials. In a December 1988 Newsletter, Dr Barbara discussed
the position as follows:
"Scientists
at [Chiron] have recently announced that ...[researches] appear
to have borne fruit in the shape of an ELISA for antibody to NANBH: this test
will be marketed by [Ortho]. Although not yet the subject of a formal
report in a scientific journal, many NANBH researchers (such as Dr Harvey
Alter, ... [etc]) seem confident that we are dealing with the first
specific assay for antibody to the major post-transfusion NANBH agent ...
Dr Alter reports complete consistency of the test ... Samples for two donors
at the North London [RTC] were sent to the USA ... found to be [anti-Hep
C] positive when tested blind ... Even if, as seems likely, this assay
proves to be specific (and sensitive) for [anti-Hep C], there will
still be 'gaps' in our ability to detect NANBH ..."
At
a meeting on 29 March 1989, Drs Gunson, Contreras, Barbara and others discussed
how trials were to take place of the then newly developed Ortho assay; Dr
Barbara met a representative of Ortho on 13 April 1989, and on 19 May, he
reported to the second meeting of the recently established ACTTD as to the
progress of testing the Ortho assay. Dr Gunson reported to the second meeting
of the also recently established ACVSB on 22 May 1989 that the assay "may
... make surrogate testing obsolete, provided that the [NBTS's] and
other studies confirm the promising results so far reported, and assuming
that the cost/benefit analysis is satisfactory": and the members of the
ACVSB "regarded the matter to be a priority". On 30 June there was
a symposium in Paris, organised by Ortho, from which Dr Barbara returned with
a positive reaction. He was concerned about the absence of confirmation, i.e.
of a confirmatory or supplementary assay, and by the inconvenience that would
be caused if the duration of the tests was, as it then appeared, some three
hours, but had otherwise concluded, and reported, that the test seems "reproducible,
robust and meaningful", which he explained in evidence as meaning of good
specificity, reliable in operation and clear, rather than indeterminate, in
its results. The report was given to the third meeting of the ACVSB on 3 July
1989, by Dr Mortimer, who had also attended Paris, that "he considered
the findings represented a persuasive case that the Chiron test results were
reliable'.
- The
limited evaluation that was then being carried out of the assay appears to
have been co-ordinated by Dr Contreras and Dr Barbara (although in addition
the already commenced Multi-Centre Study, set up to examine ALT testing, was
now also looking at the assay), and they wrote together to the Lancet in August
1989. The letter made a number of points. It began by agreeing that the assay
was specific (i.e. 'direct') for NANBH, and thus "clearly superior to all
previous attempts at an assay for NANB virus and [it] provides a welcome
advance over surrogate markers for infection with this virus". However
the writers advised that "in the context of donor screening, precipitate
action should be avoided". They pointed out that (even in the absence
of a confirmatory or supplementary test) they had evaluated that 0.5 to 1%
of blood donations had been found to be repeat-reactive and "excluding
such blood donors might not seem to be a problem". However they pointed
out that contacting and counselling 12,500 to 25,000 donors would "be an
enormous and costly undertaking, especially when the significance of a positive
test in a healthy person is as yet unknown". Meanwhile Dr Lloyd, Director
of the Newcastle RTC wrote to his Regional Health Authority on 20 July, and
Dr Cash, National Medical Director of the Scottish NBTS (who had reached a
similar conclusion to Drs Barbara and Contreras about 0.5 to 1% repeat-reactives)
wrote to a number of his colleagues, including Dr Gunson, on 3 August 1989,
urging planning for implementation, and particularly plans for counselling,
although, as will be seen, none then materialised.
- As
referred to in paragraph 11 above, the Rome symposium took place on 14/15
September 1989. Dr Barbara joined with Dr Alter and others in reporting after
the Rome symposium that "results obtained using this assay indicate that
it is a specific and sensitive test ... and ... represents a valuable screening
test for blood donations that would otherwise transmit NANBH following transfusion".
Just prior to the third meeting of the ACTTD on 9 October 1989, Professor
Zuckerman wrote in the British Medical Journal that "the most recent published
seroprevalence studies of [anti-Hep C] antibodies using the assays
developed by the Chiron Laboratories confirm the apparent specificity and
(relative) sensitivity of the assays ... The ability to detect [anti-Hep
C] antibodies, generally only several months after acute infection, is
an important advance that is expected to provide not only a clinical diagnostic
test but also a screening procedure for blood donations ... Preliminary serological
surveys of healthy blood donors indicate average rates of [anti-Hep C]
antibodies in 0.5 to 1% in the [NBTS] of Britain, with a similar rate
in several other industrial countries that use a voluntary blood donation
system. Nevertheless, important problems remain. Many of these serological
findings should be interpreted with some caution in the absence of a confirmatory
test ... The urgent and important problem is the lack of confirmatory assays".
- The
Scottish evaluation of the Ortho assay, completed by a report on 5 October
1989 by Drs Dow, Barr and Mitchell, reaching a similar conclusion as to reliability
("the test itself was 'user friendly'") and as to the percentage of
repeat-reactives, was reported to the third meeting of the ACTTD, at which
a draft paper from Dr Gunson reporting on the Rome meeting was, after a number
of changes, approved for submission to the ACVSB. Mr Brown QC made considerable
play with the changes in this document, from the draft which Dr Gunson originally
presented through to that which was presented to the ACVSB at its fourth meeting
on 6 November 1989. What is clear is that Dr Gunson's own greater enthusiasm
for the new assay was toned down in the final draft, as a result of Committee
discussion. In some respects it was more favourable, in that the reference
to the three-hour duration of the test was excised. However it is certainly
true to say that Dr Gunson's originally expressed view that "it will be
difficult not to introduce routine screening of blood donations for [anti-Hep
C] since there is, even from the earliest studies, the possibility that
the incidence of transfusion-transmitted NANBH will be significantly reduced.
Although this disease is usually mild with recovery, some patients may develop
cirrhosis of the liver" was replaced by "routine screening of blood
donations ... should be introduced when practical, since there is, even from
the early international studies, the probability that the incidence of transfusion-transmitted
NANBH will be reduced". Nevertheless the primary conclusion remains the
same, namely that the ACVSB was "asked to approve the routine testing of
blood donations for [anti-Hep C] in principle, and request the National
Directors in England and Scotland to arrange for the simultaneous introduction
of the tests at an appropriate time when a policy for counselling and management
of the sero-positive donors, has been defined". The conclusion of the
ACVSB meeting on 6 November 1989 was summarised in paragraph 28 of the Minutes
as follows:
"The
feeling of the Committee, as summed up by the Chairman [Dr Metters of
the Department] was that the test represented a major step forward, but
that the Committee need to know a great deal more about it, and acknowledged
the need for a confirmatory test. It was agreed that while the UK would not
want to go on in advance of an FDA decision, it could prove difficult if the
FDA does not decide in favour of the test. Nevertheless, it was felt that
if the UK do put the test into general use, RTCs will need to have had experience
with it, and therefore pilot studies should go on in Birmingham, Sheffield
and Brentwood, to show the feasibility of adding this test to routine practice."
At
the next meeting of the ACTTD on 22 November, chaired by Dr Gunson, the result
of its report to the ACVSB was reported back as follows:
"It
was agreed that the [anti-Hep C] test was a major step forward in identifying
those who could potentially transmit [Hep C]. The ACVSB had noted the
need for a confirmatory test either before or shortly after any routine testing
of donations. They also agreed that routine screening should not commence
until the FDA had granted a licence, which may be June/July 1990."
- The
pilot study at the three Centres took place and was completed by 18 December.
Dr Gunson reported on it to the fifth meeting of the ACVSB on 17 January 1990:
repeat-reactives varied from 0.18% in Sheffield up to 0.61% at Brentwood and
"all commented that the test was straightforward and easy to perform".
Meanwhile, although this was not reported to the ACVSB meeting, on a date
which Dr Gunson said in evidence he believed was 23 November, and as he was
notified by Ortho on 27 November, the FDA approved an Export Permit for the
Ortho assay, which meant, as explained by Mr Hardiman's evidence, that Ortho
was then and thereafter free to make the assay available for routine blood
donor screening in the United Kingdom; the United Kingdom being one of the
twenty one countries identified in US legislation as being permitted recipients,
once an export licence was granted, of a drug or biological product in advance
of a grant by the FDA of a full product licence for its use within the United
States. The ACVSB meeting received Dr Gunson's paper on the results of the
pilot studies, and a costing paper estimating the cost of introduction of
routine screening at between £5m and £7m per annum. They also received a copy
of what I have referred to, in paragraph 115 above, as Professor Zuckerman's
important letter of 19 December 1989, to which I shall return below: in the
course of discussion of which it appears that Professor Zuckerman indicated
that "he felt that it was unlikely that the FDA would licence the Ortho
test in the absence of a confirmatory test, and it would be difficult for
[the UK] to approve a test which was not approved in its country of
origin". The general consensus of the meeting was again summed up by Dr
Metters, and included the statement that routine testing should not be introduced
in advance of the FDA decision.
- In
February 1990 a supplementary test, which had been pioneered for the purpose
of providing some confirmation of the assay ("RIBA 1") was sent by Ortho to
Drs Barbara, Mortimer and Follett, for evaluation by them. Although at the
next meeting of the ACTTD on 16 March 1990 [as it turns out, the last such
meeting until 8 January 1991], when the ACVSB decision to defer introduction
of routine screening at their last meeting was reported, Dr Follett was present
and Dr Mortimer, although absent, represented by a Dr Parry, there was no
mention of RIBA 1 at the meeting. Dr Barbara was asked in evidence about what
work was done by him or by Dr Follett in relation to evaluation of the RIBA
1 at that stage, and he could not remember what was done, but he certainly
confirmed that nothing was published by him or, so far as he knew, by Dr Follett,
at least until many years later. There was no reference in evidence to any
report presented to the ACVSB or otherwise of any evaluation of the new supplementary
test, whose absence had formed such an important part of the critique of the
assay by Dr Barbara and others, as set out above. Had the evaluation been
carried out and/or published or reported on, I have no reason to doubt that
it would have been favourable. First of all and most significantly, Mr Underhill
QC concedes that, although it was to be substantially improved once a second
generation RIBA materialised in 1991, it is not his case that it was necessary
to wait for RIBA 2, or that RIBA 1 was not a sufficient answer at least at
that stage, to the need for a supplementary test. Secondly Dr Ebeling in Finland
did in fact carry out, with others including Dr Leikola, an evaluation of
the RIBA which satisfied her, as she reported in the Lancet in a letter published
on 21 April 1990.
- On
24 April 1990, there was the sixth meeting of the ACVSB. Dr Mortimer and Professor
Zuckerman reported on an Ortho symposium that they had attended in London.
Dr Mitchell reported on a symposium held by Abbott, who had not yet marketed
their own assay, at Chicago, and Professor Zuckerman reported on a Hepatitis
Conference in Houston. He reported that RIBA had been assessed. He "remarked
that RIBA was not good enough to use routinely as a confirmatory test":
he made clear however in evidence that his objection to RIBA was not its
unreliability per se, but to the fact that it was not a genuinely confirmatory
test, as it also tested for the antibody. It was reported to the meeting by
Dr Metters that France, Belgium and Luxemburg had introduced routine screening.
There was concern about the specificity of the test (to which I shall refer
further below) and that there were reports of 'false positives'. Both Dr Gunson
and Dr Mortimer wanted to have trials of both the Ortho assay and the anticipated
Abbott assay, and there were plans for a prospective study involving 25-50,000
donors. Dr Metters' summing up of the discussion was, by reference to there
being inadequate scientific data to support the introduction of the test,
the lack of a confirmatory test, and the fact that the FDA had not yet approved
the assay (although the American Blood Banks' Guidance for Planning the Implementation
of the assay was before them) effectively of a decision to take no action
to implement the assay. However a sub-group was to be set up to prepare a
protocol for a substantial pilot study.
- On
2 May, the FDA granted a full product licence. On 11 May the RIBA test was
available, as Ortho informed Dr Gunson by letter of that date. So far as there
had been three conditions or concerns expressed at the ACVSB meeting of 6
November 1989, they had all now been satisfied, successful pilot trials in
December, FDA full Product Licence and now (although not strictly a confirmatory
test but only a supplementary one) the existence of the RIBA. The seventh
meeting of the ACVSB (brought forward from the end of July) took place on
2 July. The Department were and remained very concerned about the cost implications
of routine screening. A memorandum from Mr Canavan of the Department dated
14 June 1990 records:
"I
am returning to the cost/benefit question as it seems likely the ACVSB will
recommend [anti-Hep C] screening at is specially convened meeting of
2 July. You will see from the draft minutes of the last meeting that a pilot
study was the preferred next step at that time. However our experts now seem
to think advances in knowledge about the [anti-Hep C test] and
the means of confirming the result make it very difficult to resist the introduction
of screening. A number of countries have already done so."
In
fact the 2 July meeting did not recommend immediate introduction of screening,
notwithstanding the fulfilment of the previous conditions. Dr Metters summed
up the decision as being that the UK should introduce Hepatitis C testing,
but the decision as to which Hepatitis C test to use would be made after the
results of a pilot scheme to compare the Ortho test and the Abbott test (which
was about to become publicly available) to see which was the better test for
the RTCs: it was estimated that the overall time scale for the study would
be approximately four months, after finance had been agreed. These tests,
in Glasgow, North London and Manchester, were carried out, once funding became
available in September, in the months of October and November, and, because
they were expanded to include a trial and assessment of the RIBA confirmatory
test, continued through into December.
- On
21 November 1990 the ACVSB held its eighth meeting. There was a report on
the, not quite completed, pilot scheme, and a paper from Dr Gunson indicating
the need for a UK wide consensus to be sought on a policy of counselling of
donors, once the tests were implemented. The decision was made to recommend
introduction of routine screening as soon as practicable (and the RTCs would
decide individually whether to use the Ortho or Abbott test). Recommendation
was to be sent to Ministers for their approval, which was eventually given
on 21 January 1991. Meanwhile there had been a sixth meeting of the ACTTD,
the body primarily concerned with implementation, the first, as I have set
out in paragraph 152 above, since March 1990. Plans and arrangements were
now made in respect of implementation, and on 22 January 1991 Dr Gunson wrote
to all RTCs, the decision having been made for uniform introduction throughout
the country, seeking from them their earliest start dates. In the light of
the information received, Dr Gunson settled on a start date of 1 July 1991.
- On
25 February 1991, at the ninth meeting of the ACVSB, the fact that there were
now about to be available second generation Ortho and Abbott assays, obviously
improvements on the first generation assays, was considered, and, at the 25
March 1991 meeting of the ACTTD, a decision was made to postpone introduction
of routine screening until after an opportunity had been provided to evaluate
the new second generation assays. Hence the RTCs were informed on 3 April
1991 of the revised start date of 1 September 1991, to allow such evaluation.
Dr Lloyd of Newcastle, impatient to start, in fact started up routine screening
at his RTC in advance of the rest of the country, somewhat to the disapproval
of his co-Directors, using the second generation assay, and his screening,
together with tests at Leeds, Liverpool, Sheffield, Bristol and Glasgow, was
used for the purpose of the evaluation of the second generation assays referred
to above.
- Routine
screening was introduced throughout the country on 1 September 1991. I have
already indicated that, in the light of the 90% settlement agreement, so far
as what actually happened within the United Kingdom is relevant at all (and,
as discussed, it is only so because of the need for consideration as to what
legitimately expectable steps had to be taken and how long it was legitimately
expectable they should take) I am not invited to consider the period after
1 April 1991.
The
Background Facts
- The
issue in relation to the assay is of course a substantially different one
from that relating to surrogate tests, because it is not a question of whether
the assay should have been routinely introduced, but of when, i.e., whether
it should have been introduced earlier than it was. I set out the following
facts or factors which I believe to be either entirely or substantially common
ground, but which in any event I find to be the case:
- The
same factors demonstrating priority to be given to steps to prevent or reduce
transfusion-associated hepatitis are relevant in relation to the introduction
of the assay as in relation to the question of consideration of surrogate
testing. Hence I refer to paragraph 100(v) above and the very fact of the
existence of, and detailed discussions by, the ACVSB and ACTTD and its members.
In addition, however there was the very fact that the discovery of a specific
test for NANBH had for so long been looked for – or, as Professor Zuckerman
put it in 1985 "awaited with breathless anticipation": Professor
Zuckerman confirmed in evidence that such words had "simply tried to
convey... the urgency and the importance".
- The
Ortho assay was published and evaluated internationally as from April 1989.
Details of it were published in Science in April 1989 under the lead
of Dr Kuo and jointly authored by, among others, Drs Alter, Dienstag, Miriam
Alter, Stevens and Houghton. Dr Alter published separately in detailed and
commendatory terms in the same month in Transfusion Medicine Reviews,
concluding that "the discovery of [Hep C] is a fundamental breakthrough
in virology ... the [anti-Hep C] assay is an important adjunct to
our anti-viral armamentarium and should be immediately implemented for donor
screening when licensure is achieved": and Dr Esteban and others from
Spain and Drs van der Poel and Reesink and others from the Netherlands both
published separate very supportive conclusions in the Lancet in August 1989.
- There
had, it appears, been at least thought to be 'false dawns' before, but,
it seems quite clear, nothing to compare with both the assay itself and
the detailed approval now so widely given. I have already referred, in paragraph
147 above, to Dr Barbara's favourable reaction after Paris ("reproducible,
robust and meaningful") and to Dr Mortimer's; and Dr Gunson came away
from Rome with a "positive reaction", although he was worried
about specificity, and thus false positives, in the absence of a confirmatory
test. Professor Zuckerman too, in the October 1989 article from which I
have quoted in paragraph 149 above, described the test as "an important
advance".
- France
carried out its own evaluation of the Ortho assay very speedily. Dr Gunson
told us that France had tested 25,000 donations by the time of the Rome
symposium. Hurried on no doubt by the state of public opinion in France,
France introduced routine screening, as set out above, on 1 March 1990:
unlike the United Kingdom it had already had in place, in the interim, both
surrogate tests.
- There
has been no challenge to the sensitivity of the assay.
- Although
the second generation tests considerably increased the specificity of the
tests, substantially reducing the number of false positives, the loss to
the blood supply caused by the first generation assay was never regarded
as a problem (nor relied upon as such before me). The blood donations that
were discarded were those which were repeatedly reactive and the percentage
for that appears above, settling down at considerably below 1%. Dr Barbara's
concern, which he expressed in evidence, about the 0.7%, which he accepted
was known or believed, from a very early stage, to be the likely impact
on the blood pool, was not, or at any rate, nothing like to the same extent,
shared by Dr Gunson and his colleagues.
- As
to the efficacy of the first generation assay, I heard considerable evidence
about this, but in the end it did not become a central issue as to precisely
what percentage this was. The informed view, both at the time and on further
exploration in evidence before me, was that the efficacy ranged between
65% and 85%. My conclusion, having heard the evidence of Professor Zuckerman
and Dr Caspari, but even the more sceptical evidence of Dr Barbara, and
also the considerable assistance, drawn from the literature, of Mr Charlett,
would be for a percentage of in the region of 75%. But I do not need to
reach such a conclusion. On any basis it was bound to have a substantial
effect on the reduction of Hepatitis C. In fact, since the research by Drs
Simmonds and McOmish, it is now known that the efficacy of the first generation
test was greater with regard to genotype 1, where it picked up 90% of those
with the virus, than in respect of genotypes 2, 3, 4 and others, where the
success rate was only some 30-32%. This differentiation between genotypes
is something that was not known at the time, and only goes to confirm, given
the fact that it would appear that, at any rate in the United Kingdom, genotype
1 is the most frequent genotype, the overall percentage efficacy for all
Hepatitis C virus, as set out above.
- Just
as there is no case made by the Defendants with regard to loss to the pool,
so there is no case made by the Defendants in relation to the cost of introduction
of the assay.
- I
have already set out that the supplementary test, RIBA 2, was available
from 11 May 1990. It is common ground that it substantially reduced false
positives. There is no suggestion that it was not a good enough supplementary
test, and it was expressly conceded by Mr Underhill QC that the Defendants
make no case that the United Kingdom should have waited for RIBA2 (although
in the event, at least from the end of March 1991, that is indeed what occurred).
What
Had to be Allowed For
- Against
the background above, the battleground between the parties has been as to
what was legitimately expectable for a blood transfusion authority to allow
for, to wait for, or to provide for before the introduction of routine screening,
on the one hand, so as to arrive at a legitimately expectable period, and
on the other, from the Defendants' point of view, so as to justify the period
to 1 April 1991.
Practical
Trials
- The
first factor to be allowed for was for appropriate tests to ensure that the
assay could be used at the RTCs. There is no issue that these tests took about
two weeks in December 1989, and that this was a reasonable time. In fact they
were decided on on 6 November 1989, finished by 18 December 1989 and reported
on to the ACVSB on 18 January 1990. Whereas of course there must be some allowance
for decision-making and indeed reporting back to the appropriate body, the
timetable does not seem to me to justify a delay in this regard until the
middle of January 1990. There appears to have been no pre-planning, certainly
no testing to the extent that there was in France, and very little evaluation
of the assay during the period between April, or even, allowing for the Paris
meeting, June of 1989 and Rome in September 1989: and there was in itself
a delay after Rome. I see no reason whatever why the period of two to four
weeks for the carrying out of, and reporting on, practical trials should not
have started and completed considerably earlier than it did, not least in
the light of the very full publicity and coverage from April 1989 onwards.
The
need for Evaluation of the Assay
- This
is the second matter that is put forward by Mr Underhill QC, and it is put
forward as an additional point to the carrying out of the practical trials.
It seems to cover what was originally run as a separate point, but then became
subsumed under the heading of evaluation, namely the need to wait, or at any
rate the justification in having waited, for FDA full product approval. The
lack of a very persuasive reason for waiting until after FDA approval was
perhaps the reason why Mr Underhill QC did not run it as a separate point,
but only as part of his case that there needed to be time for evaluation,
for the word that featured most often in any explanation was the word 'embarrassment'.
In evidence, Dr Gunson said as follows in answer to a question from me:
"Q:
Why did you need to wait for the US domestic test, to be done, when it seemed
the FDA regarded it as sufficient [I was referring here to the existence
of the November export permit] to allow you to have it on the understanding
that you carry out your own tests, which you were perfectly capable of doing?
A:
The Department ... was anxious to have the FDA approval before we started
testing, because it was a test that had been developed in the United States
and they considered it would be very embarrassing if we had started testing
using this test and the FDA came along and said, 'This test is deficient and
you cannot use it in the United States'."
I
have already quoted something to similar effect from Professor Zuckerman in
paragraph 151 above. Professor Zuckerman also wrote in his 19 December 1989
letter that "introduction of the current test for routine blood donor screening
in the United Kingdom should await the decision on licensing by the FDA in
the USA, due at the end of March 1990 [in fact it was 2 May]".
- However:
- In
the first draft of Dr Gunson's report on the Rome symposium, prior to its
emendation by the ACTTD, he had put it only as low as "it could be argued
that the routine use of the test for blood donations in the UK should not
commence before such a licensing procedure is effected". It is certainly
the fact that the UK did not wait for FDA full product approval previously
with regard to the HIV tests, nor, subsequently, prior to the introduction
of the second generation anti-Hep C assays.
- Professor
Zuckerman, it seems, did not know anything about there having been an FDA
export licence the previous November, or indeed the nature or relevance
of it. Dr Gunson, however, did. I asked him about it:
"Q:
Just before you [move on] I want to be sure about this, and you may
say 'I do not know' – please do not let me go forward on a false basis –
[do] you believe the USA or the FDA do some tests, maybe not as many
as they eventually do, before they are prepared to give an export licence
to countries which they then expect, because they are what is called 'sophisticated',
to do yet further tests of their own?
A: Yes, When the test was introduced in the middle of 1988, it was for research
purposes only, and all the work that was undertaken had to be reported [by]
Ortho and they then put in a summary of their preliminary results to the
FDA. I think it was November 23 or something like that in 1989, that they
said the tests could be exported to other countries."
Mr
Hardiman confirmed that an Export Licence would not have been granted if
there had been an objection from the United Kingdom Department of Health.
In any event, of course, there had been the published articles, and the
Paris and Rome symposia.
- If
in fact a delay until May 1990 was simply in order to rely on evaluation
by the United States, notwithstanding the fact that the Export Licence had
been issued on the basis that the United Kingdom would be able to do its
own evaluation, then, particularly given the priority to which I have referred,
I can see no reason why such evaluation should not have been done; and Dr
Gunson confirmed that the Department may well have been satisfied not to
wait until FDA licence if suitable testing had been done by the UK. The
opportunity was there for such UK tests to be done, by virtue of the early
knowledge of the assay referred to in paragraph 147 above, and the limited
evaluation that was done by Drs Contreras and Barbara, referred to in paragraph
148 above; and Dr Gunson accepted that some countries did commence testing
before FDA approval, having carried out their own trials. The reports from
the pilot studies in December 1989 made no mention of the need to wait for
FDA approval (the only suggestion of any need for delay being by Mr Fuller
of the Procurement Directorate of the Department, namely that in the light
of what was suggested to be the impending arrival of the Abbott test (which
in fact was seven months later) "a monopoly-based supply decision would
be precipitous at this stage". I am satisfied that, had the Defendants
carried out their own tests, they would have been happy with the efficacy,
would not have been offput (subject to what I say hereafter about counselling)
by the percentage of repeat-reactives, and would have been entirely content
with the assay's sensitivity, to which no material objection was ever raised.
I have already referred to the favourable report by the Finns published
on 23 April 1990. Dr Barbara was asked in evidence when he considers that
it would have been appropriate to introduce the assay, and he stated that
he could not give a date, but his feeling was:
"that
once we had tests that were reliable, that would be sensitive, and we were
able to confirm and we would not be jeopardising the donors, we could then
provide the service to the patients without impact on the donors, and that
would continue a good donor supply."
In
those circumstances, I am clear that Dr Barbara would have had no objection
to going ahead, provided that the impact on donors was minimised, to which
I shall turn below.
- If
the point now being made is that waiting until FDA licence was obtained
was in fact waiting for the USA to do the evaluation, and that that is the
justification for the passage of time, then concomitant to that would be
that the Defendants would have regarded the grant of FDA licence as being
equivalent to such evaluation, and would have then proceeded to introduce
the assay on that basis. However it is clear that they did not regard the
grant of the FDA licence as the green light, or as the effective evaluation
of the product, for, as has been seen above, in the ACVSB meeting, held
in fact two months after the grant of the licence by the FDA, the decision
was made then to go ahead with trials, although by this time it was to be
comparative trials as between the Ortho and Abbott assays.
1. I
conclude that, on a legitimate expectation basis, there was no need for the
delay until 2 May in respect of evaluation, and certainly none after that. The
right course would have been for any trials by way of evaluation, over and above
that which was required for the pilot studies, to have been carried out speedily,
and without waiting for the FDA product licence.
2. The
Need for Confirmation
- The
third factor put forward is the need for a confirmatory or supplementary test
as an additional cross-check or filter in respect of repeat-reactive donations.
The worry was about the counselling that would be required to be given to
donors, in the light of the quantity of false positives. Unlike the position
which I have set out in paragraph 133 above in respect of what would, or could,
have been said to donors whose blood tested positive on either of the two
surrogate tests, an apparent positive test on a specific anti-Hep C test would
be a different matter, because it might suggest (subject always, of course,
to the known substantial number of false positives) that the donor was a carrier
of Hepatitis C. Dr Gunson highlighted the problem in his evidence:
"A
donor whom you did not call for ... his or her usual donation, may phone the
centre and would have to be told there was an abnormality in one of the tests
and that is why we were not doing it; because you had to be honest with such
donors and over the telephone was not the best way of doing it. You were better
doing it face to face. Therefore I felt that we must have some positive policy
on what we should tell the donors. I agree that the major consideration for
the transfusion service is the care of patients, but the care of donors has
to be carefully balanced with this, because, if you lose donors unnecessarily,
then the care of patients becomes more difficult."
Mr
Underhill QC emphasised the potentially devastating impact of an uncertain
diagnosis of Hepatitis C, especially in 1990, when so little was known about
it. It was apparent that donor counselling was going to be necessary, and
indeed in the report given by the West Midlands RTC in December 1989 of the
pilot studies, the authors, while concluding that a 0.38% loss of the panel
by virtue of the repeat-reactives would not be difficult to replace, stated
that "donor counselling by BTS consultants and further investigation by
local hepatologists will require significant human resources". But the
issue relating to the confirmatory test, given that repeat-reactives could
be coped with so far as the effect on the blood pool was concerned even prior
to the introduction of such a test, related to a desire to reduce the number
of false positives, in the interests of donors.
- The
issue therefore, is whether to delay the implementation of screening until
a supplementary test, in fact the RIBA test, was available:
- It
is clear that the Defendants knew that the RIBA would soon be available.
Ortho wrote to Dr Cash on 27 November 1989 to inform him of the completion
of production of prototype RIBA tests, upon which they were seeking "feedback
from several labs throughout the world ... so that we can use this information
to introduce our confirmatory tests during the first quarter of next year".
The minutes of a meeting of the National Management Committee of the NBTS
on 4 January 1990, record that "some progress had been made towards a
confirmatory test using the same antigen in block form, and this may be
available at the end of January". In fact, as set out in paragraph 152
above, it was sent to Drs Barbara, Mortimer and Follett in mid February
1990, and tests could have been done (as did the Finns), but it seems that,
if evaluation there was, it was of no great moment; and I have already there
set out my conclusion that, had it been carried out, the United Kingdom
opinion would have been as favourable as was that of the Finns. Professor
Zuckerman's objection, to which I have referred in paragraph 153 above,
was not to RIBA per se, but simply to the fact that it was not a
true confirmatory test, and his evidence, contained in his witness statement,
was that it was a useful test.
- The
United States did not at any time say that it was going to delay FDA approval
(indeed, according to Mr Hardiman, the fact that there were "only six
months" between the granting of the export licence and the full product
licence, indicated rapid movement on the part of the FDA) until the RIBA
test was available, although it was in fact available shortly afterwards,
and the Defendants submit this was no coincidence. But the Claimants submit
that the United Kingdom did not have to wait for the RIBA test actually
to be available before introducing routine screening. There was a certain
amount of confusion in the evidence between what seem to be two different
questions: the question on the one hand of introducing routine screening
prior to the RIBA test being actually available, and on the other hand of
deferring the informing and counselling of donors. That seems to have risen
from a somewhat ambiguous paragraph in Professor Zuckerman's 19 December
1989 letter. The passage read:
"The
data available to date indicate that the current test will identify a significant
number of chronically infected donors. The number of false reactions cannot
be determined, but all reactive donors may be deferred temporarily until a confirmatory
test, or a test for another marker of Hepatitis C virus becomes available, probably
within twelve months."
3. Prior
to Professor Zuckerman's evidence, it seemed that this was being interpreted
literally, indeed by Dr Gunson himself, who, in examination in chief by Mr Underhill
QC, said:
"Mr
Underhill, I was not happy with that suggestion [of deferring telling donors],
particularly if it was for a prolonged period. You see, I think in the previous
meeting, he [Professor Zuckerman] said even up to twelve months."
4. Dr
Van der Poel did suggest, in an article in the Lancet in March 1990, that notification
of donors could be postponed until after a confirmatory test became available
(and it is clear that, at least in that part of Germany in which Dr Caspari
has had experience, such deferment was there regarded as legitimate, save where
an unconfirmed anti-Hep C test was accompanied by an excessively raised ALT
elevation). But Professor Zuckerman, in evidence, firmly explained that (even
if that is how the paragraph had read) it was certainly not what he meant, nor
would he approve of such lengthy deferment of information to donors. However
what Professor Zuckerman did say is that "if pushed very hard" he would
have accepted a few weeks' temporary deferment of information to donors.
- The
reality seems to me to be as follows:
- Notwithstanding
early discussion about the need for counselling procedures to be put in
place as early as July and August 1989, as appears in paragraph 148 above,
nothing much at all was done in relation to the setting up of such procedures,
and in particular Dr Gunson accepted that, in retrospect, the fact that
no preplanning was done for a year was obviously not satisfactory. Had there
been counselling procedures in place, it appears to me that the system might
have been able to cope, albeit with difficulty, as the West Midlands Report
had indicated in December 1989, even without the confirmatory test, based
on approximately 0.3 to 0.7% of repeat-reactives. There is no evidence of
any difficulty in France or any other country which introduced routine screening
before the availability of RIBA.
- However,
whether by virtue of a short deferment of information to donors, or simply
by a more adequate and well prepared exercise of introduction of counselling
the additional false positive donors, the option of starting screening without
RIBA immediately available was open to the Defendants. The evidence was
persuasive. Dr Gunson agreed with Mr Brown QC that "as long as you knew
[the RIBA test] was coming, you can go ahead without it, provided
you knew it was on the way, as everybody [did ... although] they
were not quite sure when". This was consistent with his published position
in 1987 in relation to HIV screening. Dr Gunson was reminded of his report
to the ACTTD on 22 November 1989, that the ACVSB "had noted the need
for a confirmatory test either before or shortly after any routine testing
of donations", and of his report to the Special Management Committee
of the NBTS on 4 January 1990, to which I have referred above, whereby "with
regard to the absence of a confirmatory test, Dr Gunson advised the Committee
that the ACVSB did not see this necessarily as a barrier to the introduction
of routine screening, but the ACVSB would insist that any test for routine
use must be licensed by the FDA". Dr Gunson's evidence was, in summary,
that the need was to have a confirmatory or supplementary test available
"within a relatively short time of commencement of routine [screening]".
I am satisfied that it was, in all the circumstances of priority, and in
the light of the need to protect recipients, not necessary to wait to implement
routine screening until after the RIBA test was actually available.
The
Need to Compare Ortho with Abbott
- The
fourth matter that is raised as an essential aspect to be taken into account
in the time scale is the question of comparison between the Abbott and Ortho
assays. This, as appears in paragraph 162(iii) above, was seemingly in the
mind of the Department as early as December 1989, when the Abbott test was
very far from being available, and was introduced as a matter of substance,
as appears in paragraph 153 above, at the 24 April 1990 meeting of the ACVSB,
still two to three months before the Abbott test became available, in July
1990 – more than twelve months after the Paris symposium, when the Ortho test
was given its full public airing. Mr Underhill QC emphasises that it must
be appropriate for the Defendants to have considered the question of pricing,
of quality and of security of supply, so as to avoid the Defendants being
locked into a monopoly situation, and Professor Zuckerman confirmed in evidence
that the ACVSB had considered that it was important to test the Abbott and
Ortho test against each other, and then have them further tested by RIBA and
PCR, before proceeding to the introduction of screening.
- However:
- Dr
Gunson accepted, with hindsight, that the comparative test could have been
done as part of routine screening once implemented:
"An
alternative would have been to introduce the test using Ortho at some centres
and Abbott at other centres, and then combine the results of that screening
... into a formal study. That with hindsight is a possibility that could
have been done."
- In
fact, it would appear, there would have been no irrevocable act carried
out, tying the Defendants in to one supplier rather than another, and thus
putting at risk security of supply or encouraging a monopoly situation;
since, first of all, the equipment – be it Ortho or in due course Abbott
– was in fact, it appears, to be hired rather than purchased, and secondly,
negotiations with Ortho sensibly included provision for a 90-day break clause.
I
do not consider that, once again considering all the circumstances,
delay ought to have been incurred, while a three month, or even two month,
comparative assessment was first funded, then carried out and thereafter reported
on and assessed.
Implementation
in the RTCs
- The
fifth matter is the question of implementation. Criticism was made by Mr Brown
QC of such matters as inadequate or delayed or infrequent meetings, but, for
the reasons set out above, I am not concerned with making findings in that
regard. What I have to look for is what in fact was legitimately expectable
as a time scale. In order to introduce routine screening, additional equipment
would almost certainly be necessary, perhaps additional accommodation, either
by way of extensions or possibly new buildings (with no doubt temporary arrangements
in the meanwhile); additional staff would need to be recruited and trained.
The view of the RTCs, when asked by Dr Gunson in January 1991 as to how long
they needed, varied between four and six months (although he said in evidence
that he thought six months somewhat long):
- The
first question is whether that amount of time is necessary. It is clearly
appropriate that matters should not be unsafely or skimpily rushed, as Mr
Garwood warned. Equally in some centres there might have needed to be additional
building (there was only evidence of such need in relation to one centre);
although, as set out above, there is no reason why temporary space could
not have been made available if such building was going to take a considerable
period of time. It does not seem to me to be per se objectionable
to attempt to introduce routine screening simultaneously throughout the
United Kingdom: criticism has been made that it appears that the basis of
the thinking behind this was to avoid litigation, but the principle does
not necessarily seem to me to be unacceptable, and allows for a co-ordinated
national policy. It is obviously important to have a date for commencement,
rather than leaving the whole thing flexible, because if staff had to be
recruited and trained, it would need to be known by what date this was to
be completed, in order to avoid wastage and delay. Mr Garwood estimated
four to six months as appropriate. However Dr Barbara, in his explanation
of the introduction of new screening tests, did not allow for anything like
such a long period. He explained that there would need to be national approval
for the equipment (in this case Ortho) and there would then require to be
"local validation, the setting up of information technology systems,
production of standard operated procedures, staff training, assessment of
staff training and a final process qualification". He estimated that
those elements would in his opinion "require one to two months to occur
... especially ... where you had a new marker rather than a replacement
test for an existing marker". This was in examination in chief: in re-examination
he concluded that this "may be a little optimistic" and that "it
depends upon the experience within the centre, the staffing that they have
in the centre, what structures they have for staffing, what building facilities
... It would vary from centre to centre and some centres would – might have
found it quite tight to comply within that time period for that local qualification".
- Quite
apart, however, from how long would be required for such implementation,
there would be the question as to from what date such implementation should
be started. Apart from the delay which Dr Gunson accepted, in hindsight,
had occurred in relation to the devising of policies and procedures in relation
to counselling, in the chronology of the United Kingdom's introduction of
screening, which, as can be seen, carried through from Rome in September
1989 to September 1991, the implementation period of six months comes at
the end, namely in fact from February to August 1991. In Mr Underhill QC's
submission there requires to be tagged on, at the conclusion of whatever
period should be allowed, a justifiable implementation period of six months.
Thus, on his case, based on 1 April 1991 as notional commencement date,
such 6 month implementation period would start in November 1990, more or
less on the heels of the comparative Ortho/Abbott trials, assuming that
those themselves had started a little earlier than they did. But that allows
for no preplanning, and for no overlap between implementation and such trials
and evaluations as could or should have been carried out. Even leaving aside
preplanning, a start after Rome, not to speak of before Rome, like France,
upon the evaluations would have led to a much speedier implementation. Mr
Underhill QC in re-examination elicited from Dr Gunson the answer that "the
same sort of timetable" would apply for implementation even had they
"pressed the button immediately after Rome". But that in itself,
of course, introduces a substantially earlier timescale, and I note the
answer that Dr Gunson gave to Mr Brown in cross-examination when asked,
if the question of the need for a prior confirmatory assay were left aside,
when routine screening could have been introduced, namely that he would
not like to be committed on whether the centres could have been ready for
the introduction of screening as early as the beginning of 1990, but "certainly
early in 1990".
Funding
and Decision-Making
- The
sixth and last factor raised by Mr Underhill QC, was what he called funding
and decision-making. Clearly there has to be funding, and decisions have to
be made. But there is no reason why funding should not be pre-arranged and
then provided whilst the process is continuing, rather than holding it up:
and there seems to me to be no need in estimating a time-scale for anything
other than full allowance that decisions must be taken by those who are fully
informed, as opposed to building in positive delays for fixing up of such
meetings or the obtaining of ministerial decisions.
Conclusion
on Routine Screening
- Mr
Brown QC's date, albeit originally allowing for the possibility of December
1989, settled down in the end as 1 January 1990. Mr Underhill QC's date was
1 April 1991. The basic requirements to be fitted in are, I am satisfied,
the carrying out of pilot studies and evaluations, the planning for counselling
and implementation, and the execution of that implementation in respect of
equipment, staff and building works. I am satisfied that it was not appropriate
or necessary, or legitimately expectable, that the screening should wait until
after FDA approval if, as I am satisfied should have occurred, sufficient
evaluation had taken place to allow for the United Kingdom's own decision
to be made, like that of Australia and France and the other countries which
started prior to FDA approval within the United States. I am also satisfied
that it was not necessary to wait to implement until after the confirmatory
test was in place, provided that, as Dr Gunson, and to a substantial extent
Professor Zuckerman and indeed the members of the ACTTD allowed, it was known,
as it was, that the RIBA test would be available very shortly afterwards.
- I
have already referred to Dr Gunson's evidence, subject to the question of
a confirmatory assay as to "certainly early in 1990", in retrospect.
Later in cross-examination, he said to Mr Brown QC:
"Mr
Brown, I have now said three times – I think I did say to His Lordship yesterday
– that in retrospect we should have done it a different way."
Mr
Underhill, of course, points out what is in any event particularly relevant
in cases of negligence, namely that the use of hindsight is dangerous, and
very often introduces too stringent a test. But my task, on Mr Underhill QC's
case, examining all the circumstances, is to conclude, looking back
on the full picture, what the public was entitled to expect, and I conclude
that in fact, Dr Gunson, a supremely fair man, is in fact looking back with
my spectacles.
- Bearing
in mind all the circumstances, including the priority given to the
elimination or reduction of PTH:
- My
primary conclusion is that routine screening ought to have been introduced
by 1 March 1990. That in my judgment would have allowed sufficient time
for pilot studies and evaluation, particularly if, as I conclude should
have been the case, rather more work had been done prior to Rome, but even
if it had not been. If pilot studies had been more promptly carried out,
even in the context of a wider evaluation, I am satisfied that a decision
could have been taken which would have given at least three months lead
time for implementation by the Centres before the introduction of routine
screening. This date would accord with Dr Gunson's "certainly early in
1990"; would be slightly before the date of "sometime after April
1990", which Dr Cash had gambled on on 3 August 1989, in the course
of his own evaluation of the assay; and would accord with the date of implementation
of routine screening by France and for new donors in Luxembourg, and would
post-date Japan, Australia and much of Finland. This would mean that the
RIBA test would be known to be relatively imminent and would in fact have
followed some two months later. In that interim period, either there could
have been deferment of donors, for what even Professor Zuckerman would have
accepted to have been a short period of time, or for that short period of
time an extra burden on the newly instituted counselling procedures.
- I
have concluded that surrogate testing should have been in place by March
1988 and thus, like France, the United Kingdom would have run the new routine
screening alongside the surrogate tests from 1 March 1990 onwards. However,
balancing the various circumstances and applying so far as I can
Mr Underhill QC's test, which I have already found to be inappropriate in
law on the proper construction of the Directive, if, but only if, surrogate
tests had been in place, then I might have been prepared to find that, in
those circumstances only, the scales might have come down in favour of a
delay of the assay until May 1990 with the RIBA test actually in place.
But I am satisfied that, with the position as it was, with no surrogate
tests in place, and indeed with the deliberate decision made by the ACVSB
in November 1989 to defer any further consideration of surrogate tests,
while concentration was dedicated towards implementing routine screening,
which did not in fact take place for another 22 months, routine screening
ought to have been introduced at the earliest practicable time, which I
have concluded to be 1 March 1990.
DEFECTIVE
WITHIN ARTICLE 6
- In
the light of these findings of fact, I can now decide whether the blood infected
with Hepatitis C was defective, on the Brown Case. I take into account all
the circumstances in the basket:
- Those
set out in paragraph 100 in sub-paragraphs (i) to (vi): as to sub-paragraph
(vii), I take into account the Claimants' pleading, by a late re-amendment
to their Reply, for which I gave leave during the hearing without opposition
from the Defendants, being paragraph 4(h)(i), of the specific circumstance
that "past intravenous drug users were continuing to donate blood, which
was being processed and supplied to patients".
- The
fact that the precautions of the introduction of surrogate testing and earlier
introduction of routine screening were not taken.
I
conclude that, taking into account all circumstances, such blood so
infected on and after 1 March 1988 did not provide the safety which persons
generally are entitled to expect.
NATURE
AND MEASURE OF DAMAGES
- Now
that I have found the Defendants to be liable, I must address the basis upon
which damages are recoverable under Article 4 (and s2 of the CPA). I deal
first with two short points:
- Time
scale. I have found the Defendants liable (generically) for supplying defective
blood on the basis of the proper construction of the Directive: alternatively,
on the broader consideration of circumstances, I have in any event
found the Defendants liable in respect of the period from 1 March 1988 (surrogate
testing and subsequently also routine screening). No question therefore
arises as to differentiation between the Claimants by reference to their
date of infection.
- What
is the defect? Although Mr Underhill QC pursued his submission, referred
to in paragraph 46(i), that the defect in the blood was unscreenedness:
- He
conceded that he could not make such a submission if the Claimants succeeded
on the 'Forrester Case', which would not depend upon whether there was
or was not screening or testing. This has, of course, arisen.
- With
regard to the pursuit of his contention even with respect to the 'Brown
Case', he quickly recognised the difficulties pointed out both by the
Claimants and, indeed, in the course of argument, by me:
First,
if he be right, then the definition of defect for the purposes of Article
6 must be different from its definition for the purposes of Article 7(e).
In the latter Article, defect plainly applies to the impugned condition
– infection by Hepatitis C in this case – which either is, or is not, known
or is, or is not, capable of discovery. It is not the 'existence of the
unscreenedness' which is, or is not, to be discovered. Whereas it is always
possible to argue that a word or words may have different meanings in different
sections or sub-sections of the same statute or directive (and that may arise
in relation to words in Article 7(b) as discussed in a different context in
paragraph 51(iv) and 74(i) above) that cannot in my judgment possibly arise
in relation to words central to the Directive. Defect is referred to
in the operative Articles 1 and 4, and defined in Article 6, with relevant
escape clauses in Article 7, and must be consistent in its meaning.
Secondly,
as Mr Brown QC pointed out, if unscreenedness be the defect, then all
blood bags must be defective, when none is screened: only 1 in 100 blood bags
would be defective and harmful. This creates a quite unnecessary additional
tier of argument and proof.
The
only purpose for Mr Underhill QC to put forward the proposition of 'unscreenedness'
was to assist him in the argument and presentation of his case that the Defendants
could not be liable for all the damage otherwise flowing from the infection
(a contention to which I shall now come), by reference to a case that the
Claimants should only be entitled to recover damages insofar as they flow
from the unscreenedness and not from the infection. The peg of unscreenedness
however is too fragile to withstand the weight of such argument, and the argument
must stand on its own or not at all. I am afraid that unscreenedness
suffers from the defect of unpersuasiveness.
ISSUE
IIIa
- In
the light of my conclusions on Issue I, the blood was defective by virtue
of its infection with Hepatitis C, notwithstanding and in the light of all
relevant circumstances. As Mr Brooke QC succinctly put it in argument,
the defect was the virus in the blood and the damage was the
virus in the patient. Mr Underhill QC does not contend, having lost on the
Forrester Case, for any other result, nor that his "loss of a chance" case
applies in this regard.
ISSUE
IIIb: LOSS OF A CHANCE
- If
I were wrong in my conclusions on Issue I, then the Claimants have only succeeded
on the Brown Case, and Mr Underhill QC contends, as summarised above, that
the Defendants are not liable for all the consequences of the infection, but
only for that damage which results from the failure to introduce surrogate
testing and/or to implement routine screening earlier. Thus he asserts that
it would be necessary to arrive at the percentage chance by reference to the
findings of fact I have made, that the Claimants would not have been infected
by the virus if the Defendants had taken further or different steps.
- He
puts his case as follows:
- He
prays in aid the speech of Lord Hoffman in Banque Bruxelles Lambert SA v
Eagle Star [1997] AC 191 ['BBL']. He refers to the following passages in
particular:
"A
plaintiff who sues for breach of a duty imposed by the law (whether in contract
or tort or under statute) must do more than prove that the defendant has
failed to comply. He must show that the duty was owed to him and that it
was a duty in respect of the kind of loss which he has suffered [211g]
... How is the scope of the duty determined? In the case of a statutory
duty, the question is answered by deducing the purpose of the duty from
the language and context of the statute. [212c] ... There is no reason
in principle why the law should not penalise wrongful conduct by shifting
on to the wrongdoer the whole risk of consequences which would not have
happened but for the wrongful act ... But that is not the normal rule [212g-213a]
... Normally the law limits liability to those consequences which are attributable
to that which made the act wrongful [213c]."
As
the Claimants here are only entitled to the loss which resulted from the
failure to screen, and as they would or might have suffered from Hepatitis
C in any event, their damages must be reduced accordingly.
- The
proposition is by reference to, and in accord with, the speech of Lord Diplock
in Mallett v McMonagle [1970] AC 166 at 176:
"In
assessing damages which depend upon its views as to what ... would have
happened in the future if something had not happened in the past, the Court
must make an estimate as to what are the chances that a particular thing
will or would have happened and reflect those chances, whether they are
more or less than even, in the amount of damages which it awards."
- If
on no other basis than justice or fairness, the Defendants ought not to
be liable for, and the Claimants not entitled to recover, loss, which they
would or might have suffered in any event. The example that was given by
Mr Underhill QC, was of a product, which was dangerous, but would not have
been found to be defective within Article 6 if a clear warning had been
given by way of a label: and where the claimant, who is blind or illiterate,
would not in any event have been able to read the label and thus would have
suffered the same damage. It would, submits Mr Underhill QC, be wrong for
such a claimant to recover for loss which would still have been suffered,
even had the product carried the label, and would thus have been found,
on the hypothesis postulated, not to be defective.
- So
far as comparison is drawn with contract, the analogy is not with a product
which is found to be not fit for its purpose, or not of merchantable quality,
but one in relation to which there has been found to be a breach of a warranty
that it had been screened.
- I
prefer the submissions of the Claimants, which I summarise and adapt below:
- BBL
is wholly inapt. This is not a case of breach of duty, but a claim for compensation
in the context of strict liability for the supply of a defective product.
Even if (for the purpose of the argument) avoidability and hence
conduct is an issue, such conduct was not (on Mr Brown QC's case nor, on
the basis of his disavowal of investigation of fault, Mr Underhill QC's)
wrongful.
- The
claim is based simply upon the product being defective. The conclusion is
that it is defective. What made it defective is not in the end of relevance:
it is simply that it does not provide the safety which a person is entitled
to expect, just as if it were not of merchantable quality or were unfit
for its purpose.
- The
issue of conduct and avoidability, even if admissible (with the careful
avoidance of such epithets as wrongful, negligent or faulty), is only part
of what has to be included in the basket or weighed in the balance. In the
hypothetical case of the blind or illiterate claimant, suggested by Mr Underhill
QC, it was postulated that one factor, lack of warning, was or would have
been determinative. That may or may not have been the case (warnings in
the context of Articles 6 and 12 will not be a straightforward matter),
but the conclusion would nevertheless be that the product was defective.
In any event, in this case, it is not the case that screening/testing was
the only factor in this case, as is clear from paragraph 173 above – indeed
it was not even the only area of contested fact, for questions of seriousness,
incidence, efficacy and the nature of donors have had to be considered.
- The
structure of the Directive and of the CPA is supportive of the Claimants'
case, and of Mr Brooke QC's aphorism set out in paragraph 175 above. As
far as the Directive is concerned, Article 1 enunciates liability for damage
caused by a defect: Article 6 defines when the product is defective: Article
4 requires "the injured person ... to prove the damage, the defect and
the causal relationship between defect and damage". The structure seems
to me to admirably simple and not to encourage complicated compartmentalisation
of the damage. So far as concerns the CPA, I indicated, in paragraph 23
above, that I would set out the two relevant sections:
"2(1)
Subject to the following provisions of this part, where any damage is caused
wholly or partly by a defect in a product, every person to whom subsection
(2) below applies shall be liable for the damage.
5(1)
Subject to the following provisions of this section, ... 'damage' means
death or personal injury or any loss or damage to any property (including
land)."
The
damage to be compensated to the claimant is the damage caused by a defect
in a product, and not by any conduct, wrongful or otherwise, or breach of
duty.
- No
issues of fairness or justice such as are contended for by Mr Underhill
QC, for the purpose of his loss of chance argument, can be supported within
the context of a Directive such as this, at least without consideration
of the objectives of the Directive. If such are to be examined, it might
be more appropriate to consider:
- that
the Directive was intended to increase or improve the recovery of compensation
for consumers:
- that
it was intended to remove rather than increase any onus of adducing evidence
to prove fault on the part of the producer; which would not encourage
a court to investigate yet more evidential questions relating to the conduct
of the producer, such as what precise loss flowed from what aspect of
such conduct and what did not:
- that
fairness to the producer may be considered to be sufficiently provided
for by the express exonerating circumstances of Article 7, and the contributory
negligence aspect of Article 8.
- These
persuasive arguments are, in my judgment, sufficient to outweigh and answer
the submissions of the Defendants. The Claimants had two further contentions,
with which I do not feel it necessary to deal, in the light of my conclusion
that the loss of a chance argument does not arise:
- The
Claimants contend, in the light of Section 5(1) of the CPA, which I have
just set out, and in any event, that there can be no recovery under the
Directive for economic loss, except insofar as it is consequential to, or
parasitic upon, damages for personal injury, and that a claim for loss of
a chance is a claim for economic loss.
- They
further submit that, where the claim is for personal injury, and by analogy
with such claims as medical negligence, the issue of loss of a chance is
not, in any event, available; but the issue must be one of causation, and
thus either total success or total failure: they refer to Hotson v East
Berkshire Health Authority [1987] AC 750, and especially per Croom-Johnson
LJ at 769 (CA) and per Lords Bridge and Mackay at 782d-e, 785-6 (HL), and
to Judge v Huntingdon Health Authority [1995] 6 Med LR 223.
- I
accordingly resolve Issues IIIa and IIIb in favour of the Claimants: no reduction
to their damages is to be made by reference to any loss of chance argument.
ISSUE
IV: AVAILABILITY OF ARTICLE 7(e)
- I
have already made clear, in paragraphs 74-77 and 82 above, that in the light
of my conclusions on the construction of Article 7(e), the defence is not
available to the Defendants (Issue IVa). However I must turn, as foreshadowed
in paragraph 84 above, to decide the issue of the availability to the Defendants
of the Article 7(e) defence on the assumption that, contrary to my conclusions
in law, the Defendants' construction of Article 7(e) prevails: namely as to
whether, on the basis of my findings on Issue II, the state of scientific
and technical knowledge at the time when [the Defendants] put the product
into circulation was not such as to enable the existence of the [infection
in the particular bag of blood] to be discovered.(Issue IVb)
- The
first question is what is meant by "such as to enable the existence of
the defect to be discovered" in the particular product, in the context
of my findings as to surrogate testing and earlier screening.
- As
for routine screening, this was of course, as explained in paragraph 11
above, not a test which discovered the virus or antigen itself (this came
only later with the expansion of the limited early technology of PCR testing,
and the development of NAT), but identified the antibody to Hepatitis C.
Unlike with Hepatitis B, where an antibody can continue in the blood long
after the virus has disappeared, it is, or at any rate, was, before treatments
were developed, not usual for Hepatitis C virus to clear from the blood
or in any event from the body, so that the presence of Hepatitis C antibody
is likely to carry with it a high degree of certainty of the presence of
Hepatitis C virus. That may be his reason, but in any event Mr Underhill
QC does not seek to take the point that to screen for and discover the antibody
is not to discover the virus.
- So
far as surrogate testing is concerned, he does however pursue what has been
called a 'technical defence'. As is apparent from the detailed consideration
in this judgment, neither the ALT test nor the anti-HBc test, being 'indirect',
were intended to identify the Hepatitis C virus. They were used so as to
identify blood which might be infected by the Hepatitis C virus, and which
would, in any event, if it failed either of the two tests, be discarded
and not supplied to recipients; whereby the risk of transmission of infection
by Hepatitis C was reduced. Mr Underhill QC submits therefore that, assuming,
as I have found, that surrogate tests should have been introduced, they
were not such as to "enable the existence of the defect to be discovered".
- I
conclude as to the 'technical' argument as follows:
- The
purpose of the Article 7(e) defence, as interpreted by both sides, is to
see whether the defect could be, as it was put by the Advocate General in
Commission v UK eliminated or prevented from arising (paragraph
20 of his Opinion). Certainly it is fundamental to Mr Underhill QC's submission
(which for this purpose must be deemed to have succeeded) that it is the
lack of opportunity to discover the defect in the particular product which
is essential to Article 7(e), so that diligent producers can be excused
and encouraged. I conclude that the Article should be construed purposively,
that is in order to assist the purpose of the Directive (and further that
the ambit of the Article 7(e), escape route or exception should be construed
restrictively), such that the existence of the defect is discovered
in the actual product if it is eliminated or removed or prevented from arising.
Even if the nature of the defect is not specifically identified, the defect
to my mind would be discovered if the precaution was taken which in fact
eliminated the defect.
- Further,
as set out in paragraph 51(v) above, it is to be recalled that enable
is conveyed in other languages of the Directive by words equivalent to permit.
It seems to me that it can be said that surrogate testing would permit
or enable the discovery of the defect, either because there is simply
the assumption that blood is or may be infected by Hepatitis C as a result
of a positive test, so that there is for these purposes a 'provisional'
discovery of the defect, or that, more indirectly, it would enable
or permit subsequent discovery of the virus if the blood were retained
(as will very regularly have been the case) for subsequent research and
later, perhaps more direct, testing.
Accordingly
I reject the 'technical' defence.
- The
next question is to determine the time when the accessibility of the
state of scientific and technical knowledge must be tested:
- Surrogate
testing was available prior to March 1988, and because that date is the
first date for claims under the CPA, there is no need to look at any other
date, and the information was plainly accessible as from that date.
- Screening.
I have concluded that routine screening ought to been introduced within
the United Kingdom as from 1 March 1990. Information about such tests can
however be said to have been accessible, on a non-Manchurian basis,
since April 1989, when there was the publication referred to in paragraph
158(ii) above, or from the Paris or Rome symposia, or from the first introduction
of such a test, namely in Japan in November 1989. I find it a difficult
question as to which date to take. My conclusion has been that on a proper
construction of Article 7(e) it is not the precautions, which could have
been taken to discover the defect in the particular product, which are relevant.
I am satisfied that it is the knowledge, which thereafter puts the producer
at risk if he then supplies. The fact that he only acquires, or could have
acquired, the knowledge shortly before the supply of the product would not
absolve him from liability, provided that the knowledge was accessible.
If, on the other hand, the issue is the accessibility of precautions which
might have discovered the existence of the defect in the particular product,
which precautions were available in Japan or the United States, but which
would inevitably take some time for him to implement, then it makes less
sense for him to be immediately imputed with the knowledge of precautions
about which he can then do nothing, and more sense to suggest that there
must be some period of time for him to implement the precautions. It is
clearly against that background that Mr Underhill QC made the submission
that "the virus only became discoverable as from the date at which it
became reasonably practicable to introduce a routine screening test in the
UK". If I am compelled to accept the Underhill Case, for the purposes
of determination of Issue IV(b), then:
- it
makes much more sense to have an identical date in both Article 6 and
Article 7(e), the date by which the Defendants should have implemented
the precaution, but
- that
means to my mind a clear undermining of the stringent approach to accessibility
emphasised in Commission v UK. Mr Underhill QC pointed to paragraph 24
of the Advocate General's Opinion, as if it supported the proposition
that some time was to be allowed after acquisition of the knowledge –
"more generally, the 'state of knowledge' must be construed so as to
include all data in the information circuit of the scientific community
as a whole, bearing in mind, however, on the basis of a reasonable test,
the actual opportunities for the information to circulate": but I
am quite satisfied that that is referring to the opportunities to circulate
in the sense that if the information is locked within Manchuria it has
no such opportunities: and not to some implication of a reasonable period
of time for dissemination of the information.
I
am quite clear that this very discussion emphasises why the Claimants' construction
of Article 7(e), which I have accepted, is the right one. If however I must
adopt the Defendants' construction for the purposes of Issue IVb, then, with
some misgiving, alleviated by the fact that if my first conclusion is right
then no harm is done, I will adopt the same date for Article 7(e) as for Article
6, namely 1 March 1990, as the date of what Mr Underhill QC calls discoverability
with regard to the introduction of screening.
- I
turn then to the central question, namely whether the Defendants can show
(the onus of proof being upon them) that the state of scientific and technical
knowledge at the time was not such as to enable the existence of the defect
to be discovered in the particular product.
- I
deal first with the period from 1 March 1988 to 1 March 1990.
- If
the surrogate tests had been in operation, what would the consequence have
been? I have already concluded that at the material time the contemporaneous
research showed an adjusted efficacy of 40% for both tests. If they had
been introduced, what effect would they actually have had? I refer to paragraphs
112 and 113, and to the favourable 'look-back' research that was carried
out. Can I now conclude that the efficacy was in fact higher than 40%? I
just do not feel that, on the basis of the selective academic literature
I have seen, and particularly without the benefit of any further evidence
from Mr Charlett (who of course in any event, was the Defendants' witness),
that I can be sure, on the balance of probabilities, that the adjusted efficacy
of both surrogate tests together was higher than 40% during the material
period, namely from 1 March 1988 until the notional commencement of routine
testing by 1 March 1990. Mr Underhill QC's case on that basis is that he
can satisfy the onus of showing that, even with the implementation of the
then most up-to-date precautions available, namely both surrogate tests,
since only 40% of blood infected with Hepatitis C would then have been caught,
on the balance of probabilities infection in the blood supplied to the Claimants
would not have been detected.
- Mr
Brown QC submits that I should not be restricted to the 40% who would have
been picked up by the surrogate tests, but that I should add a further factor
for unwanted donors who were giving blood (see paragraph 100(vii) above).
However whereas I can entirely see the relevance of this to the question
as to whether the blood was defective within Article 6 (see paragraph 173
above), I do not accept its relevance to this aspect of the case. Although
of course the onus is on the Defendants, not only was there no case pleaded
by the Claimants, but no case ever adequately or at all explored with the
relevant witnesses, that there was any other step that the Defendants could
or should have taken in relation to the elimination of such donors, in addition
to the implementation of the missing tests, and in the absence of any such
suggestion, together with an assessment or estimate of what further proportion
of infected blood might thus have been removed, I cannot simply add a notional
figure to the 40%.
- Mr
Brooke QC submits as a matter of law that I cannot accept the proposition
that, because the predicted efficacy of the tests was only 40%, therefore
the Claimants' defective blood would not, on the balance of probabilities,
have been discovered, but that the Defendants must show, by reference to
each bag of blood and each Claimant, that in fact a test would not have
detected the virus in their blood. He refers again to Hotson per Croom-Johnson
LJ at 769:
"In
his closing speech, the Plaintiff's Counsel said: "It is our submission ...
that the loss of a chance, even a less than 50% chance, is enough to found
a claim for damages in tort ... damage is proved by proving on the balance
of probabilities the loss of a 25% chance". Put simply that way, the proposition
is unsustainable. If it is proved statistically that 25% of the population
have a chance of recovery from a certain injury and 75% do not, it does not
mean that someone who suffers that injury and who does not recover from it,
has lost a 25% chance. He may have lost nothing at all. What he has to do
is prove that he was one of the 25% and that his loss was caused by the Defendants'
negligence. To be a figure in a statistic does not by itself give him a cause
of action."
It
is my conclusion however that that logic, apply as it may do in the case of
whether a claimant can establish a cause of action for loss of a chance (I
have left that matter over for reasons appearing in paragraph 179 above),
does not apply in a case such as this. In this case the Defendants have to
prove an escape route on the balance of probabilities. There does not seem
to me to be a fundamental issue of jurisprudence at stake, but more a question
of evidence. Am I satisfied that, in the absence of specific evidence about
what in fact happened to the particular Claimant's blood donor or donation,
the Defendants can still prove on the balance of probabilities that a test
would have done no good, if, in fact, such tests do, more often than not,
do no good? That is the conclusion I reach here (although, unless my earlier
conclusions are wrong, the decision is of academic interest only); namely
that the Defendants would, on their construction of Article 7(e), establish
that in respect of the period between 1 March 1988 and 1 March 1990, the introduction
in the UK of surrogate testing would not have led, on the balance of probabilities,
to the discovery of infection in a particular donation, such that they would
be entitled during that period to the protection of Article 7(e).
- I
now apply the same approach to the period from 1 March 1990 onwards:
- On
the basis set out above, routine screening was accessible/ discoverable
from 1 March 1990. I am satisfied that, on the balance of probabilities,
blood infected by genotype 1 would have been discovered by the first generation
tests, because it is common ground that the efficacy of such tests in relation
to genotype 1 was 90%. Thus on the balance of probabilities, the Defendants'
case under Article 7(e) fails in regard to those infected by the genotype
1 virus, even on their own construction.
- With
regard to genotypes 2 to 4, the screening on its own would only have had
an efficacy of 32%, according to the unchallenged evidence from Dr Simmonds
and from the research of Dr McOmish and himself. However I have concluded
that surrogate testing should have been implemented and would have continued
alongside routine screening at least until 1 April 1991, now the relevant
date. Again on the basis of the unchallenged evidence from the genotype
experts, it is clear that the combined efficacy of screening and surrogate
testing would be well over 50%. The figures from Dr McOmish appear to be
95% for genotype 1, 70% for genotype 2 and 86% for genotype 3, the other
genotypes being more or less identical.
In
these circumstances in respect of the period from 1 March 1990 onwards, the
Defendants' case under Article 7(e) would in any event fail.
ISSUE
V: GENERIC ISSUES OF QUANTUM ARISING OUT OF THE LEAD CASES
- I
turn to the six lead cases. I deal first with general questions of quantum
which are raised by them and which will also be relevant to the claims made
under the CPA by other Claimants within the group action.
Evidence
- The
evidence given in respect of Issues I to IV was of course to a certain extent
relevant to Issues V and VI, and in particular there was specific reference
back to the evidence given by Professor Dusheiko, which specifically straddled
what might in general terms be called liability and quantum. In addition,
however, there were of course particular witnesses dedicated to the six lead
cases and to the general issues of quantum:
- Factual
Witnesses. The six Claimants in the lead cases each gave evidence, together
with relevant members of their families. The Defendants called no factual
witnesses. So far as care was concerned, which related to the circumstances
of Mr W and Mrs X, although detailed assistance was provided from Mrs Maggie
Sargent RGN for the Claimants and Richard Ryland of Care Providers Ltd for
the Defendants, in the event their evidence was co-ordinated and agreed,
so that neither of them had to be called. Accountancy evidence in the case
of Mrs X was provided by the late Alan Bragg FCA, whose evidence was read.
- Medical
Expert Witnesses. As in relation to the evidence given on the liability
issues, all the witnesses were extremely distinguished and experienced.
For the Claimants, in addition to Professor Dusheiko's evidence, there was
evidence, both generically and in respect of the particular circumstances
of the six Claimants, from Dr Ryder, Consultant Physician in Hepatology
and Gastro-enterology at the Queen's Medical Centre, University Hospital,
Nottingham, with very considerable clinical experience, and more than twenty
publications in the relevant area. Dr Dinshaw Master was called in relation
to the psychiatric issues raised, to which I refer below. He is a Consultant
Psychiatrist at Guy's Hospital, and Senior Lecturer at Guy's, King's and
St Thomas' Schools of Medicine and Dentistry, and he too has published widely.
Evidence of Professor Day, of the Freeman Hospital, Newcastle, which would
have been called as to the cost of treatment, was agreed. His agreed evidence
related to the cost of either six months (twenty four weeks) or twelve months
(forty eight weeks) of treatment for Hepatitis C. As will appear below,
the present recommended and most successful treatment is what is called
'combination therapy'. Originally there was 'monotherapy', by the use of
Interferon alfa alone. This is an artificially made clone of natural interferon,
to fight viral infection, taken by self-injection. Combined with this, unless
its use is contra-indicated in respect of a particular patient, has been
for some time a viral inhibitor, taken by tablet, called Ribavirin, and
the two together are called 'combination therapy'. Recently there has been
a sophistication of the Interferon, by virtue of the use of what has been
called 'pegylated Interferon', which involves a module made artificially
more massive by the addition of polyethylene glycol molecules. Its effect
is to slow down the rate at which interferon is filtered out of the body:
there is one weekly self-injection instead of three. The cost of standard
combination therapy was agreed, in accordance with Professor Day's evidence,
at £6006.10 for six months, and £11458.20 for twelve months: and of pegylated
combination therapy as, respectively, £6631.10 and £12708.20. Additionally
Mr Terrence Hope, Consultant Neurosurgeon at University Hospital, Nottingham,
was called to give evidence in the field of cerebro-vascular disease, which
is his speciality, with regard to the specific circumstances of Mr W. For
the Defendants I heard the impressive evidence of Dr Alexander, who is Lecturer
in Medicine at the University of Cambridge School of Clinical Medicine (Addenbrooke's
NHS Trust), where he is Honorary Consultant Physician/Hepatologist, again
with very considerable clinical experience: and he has more than 200 publications
in the field between 1980 and 2000. Evidence of Dr Kelly, a Consultant Paediatric
Hepatologist from Birmingham Children's Hospital, was read. Lastly there
was called by the Defendants, on the psychiatric and related issues, Professor
Simon Wessely, Professor of Epidemiological and Liaison Psychiatry at Guy's,
King's, St Thomas' School of Medicine and Institute of Psychiatry, Honorary
Consultant Psychiatrist at Kings College and Maudsley Hospitals and Director
of the Chronic Fatigue Syndrome Research Unit: he has a veritable library
of more than 300 publications to his name.
- Other
Experts. The Claimants adduced the evidence of an employment expert, Clive
Langman of Langman Human Resource Development Ltd, who prepared his evidence
by reference to questionnaires sent to a large number of the Claimants and
to his own experience, whose statement was, in the event, read. Three witnesses
were called in relation to insurance and financial services; two for the
Claimants, Miss Susan Daniels, of JTA Financial Services, an Independent
Financial Adviser ('IFA'), specialising in obtaining insurance and other
financial products particularly for those with medical problems, and Mr
Eric Purdy, Chief Underwriter and Underwriting Manager at the M & G
Group; and one for the Defendants, Mr Roy Brimblecombe, of Aon Consulting
Ltd., formerly Executive Director and Chief Actuary of the Eagle Star Insurance
Group, and a former Chairman of the Life Insurance Council of the Association
of British Insurers and Member of the Board of LAUTRO and Chairman of its
Monitoring Committee. During the course of the hearing, and again by dint
of a good deal of work behind the scenes, the three co-operated in an extremely
clear and lucid Joint Report, cross-referring to the original reports of
all three of them and reaching joint conclusions: in the circumstances Mr
Purdy did not need to give any evidence, but supplementary evidence was
orally given by Miss Daniels and Mr Brimblecombe.
- Literature.
Apart from publications and studies by the witnesses who were called, there
was reference both to the four core files of medical literature used for
the liability part of the hearing and to a fifth produced specifically for
Issues V and VI. The most central publications were:
- The
NICE Guidance referred to in paragraph 90 above.
- The
Consensus Statement of the EASL [European Association for the Study of
the Liver] International Consensus Conference on Hepatitis C (Paris 26-28
February 1999), (the 'International Consensus Statement') in which, together
with others, such as Drs Alter, Miriam Alter and Esteban, Professor Dusheiko
participated.
- Articles,
published in 1997 (described as "landmark" by Dr Alexander) 1998
and 2000, by Dr Poynard and others.
- Articles
by Drs Fraser and others (Israel 1996), Hoofnagle of the NIH (1997), Fattovich
and others (1997), Gane (Auckland Hospital, New Zealand 1998), Foster
(St Mary's, London, 1999), Rodger and others (Australia 1999), Goh and
others (Ireland 1999), Caronia and others (1999, including Dr Alexander),
Mason and others (1999, also including Dr Alexander) and Knobler and others
(Israel 2000).
I
have drawn on all this literature, and on the evidence given by the witnesses
to whom I have referred, and their publications, in my attempt to summarise
and make findings about the relevant scientific, epidemiological and medical
background of Hepatitis C, as set out below.
HEPATITIS
C: THE DISEASE AND ITS TREATMENT
- The
key word which Mr Brooke QC continually dinned into my ears throughout the
course of this hearing – and it is fully supported by all of the evidence
- is uncertainty. The medical profession is still learning about Hepatitis
C, and we have had the benefit of evidence and input from some of the leading
protagonists. Dr Dusheiko said as follows:
"I
think it is most important that we have a balanced view of the natural history
of Hepatitis C, [not least] from the point of view of deciding which
patients need therapy in acquiring resources for treatment. If one is to understate
the disease, that may be detrimental from terms of public health, and the
management of the disease. If we are to overstate the disease, that would
again also be detrimental."
It
may be that even this very case has contributed to the learning about Hepatitis
C, both by virtue of the detailed consideration of the circumstances of the
more than 100 Claimants within the group, and by the examination of the full
picture for the purposes of this hearing. The outlook is far less gloomy than
it was in 1988-9, as was made clear by Dr Alexander. Of course Hepatitis C
was only identified in 1988, and the earliest date of infection of these Claimants
was 1 March 1988, by virtue of the fact that they are making claims under
the CPA; and so the longest period of time for which any of them has been
infected by Hepatitis C is thirteen years, and it is, as will be seen, a disease
with a potential duration of fifty years or more. Out of the cohort of Claimants,
I am informed that six have died of Hepatitis C related liver disease and
one, as it happens one of the six lead Claimants, Mrs X, has had a life-saving
liver transplant.
Clearance
of the Virus
- Hepatitis
C can spontaneously clear, and does so in relation to 20% of those who are
infected by it. Why that is so is unclear – it was suggested by Professor
Dusheiko that there may be a genetic cause. In answer to questions from me
he said as follows:
"Q:
Is there any indication of what gives you a better chance of being in the
20% than in the 80%?
A:
There is some evidence that there is a genetic basis for this. Certain individuals
with particular HLA types, determining their genetic type, seem much more
likely to clear the virus. It clearly depends upon an appropriate cellular
and human immune response, and we are just beginning to gain an understanding,
but those individuals who are infected with Hepatitis C and mount a vigorous
immune response ... do seem to be able to clear the virus.
Q:
Presumably ... it might be that the secret of why these 20% clear the virus
might unlock a cure?
A:
It is a study – a very active area of research at the moment."
- The
way in which such 'clearance' of the virus can be identified is by the use
of a PCR, that is the form of blood test, now much more fully available than
it was in the 1980s, which can test for the virus (not the antibody) in the
blood. Indeed there is now a 'qualitative PCR', which identifies whether there
is virus in the blood (' PCR positive') and, if there is, there can then be,
if required, a 'quantitative PCR', which can calculate the amount of virus
in the blood, that is the quantum of viraemia or 'viral load', which has a
relevance to prognosis and to treatment. Apart from such spontaneous clearance,
the aim of the treatment to which I have referred above, monotherapy or combination
therapy, whether pegylated or otherwise, is of course to achieve such clearance.
On occasion blood can test PCR negative during or after such treatment, but
nevertheless revert to PCR positive (this disappointment occurred for Miss
T). However if it remains PCR negative for six months or more after treatment,
it is regarded as clear, and, as will be seen below, reversion to positivity
thereafter is very rare indeed. The virus may still remain in the blood, but
at such a low level that it cannot be measured by PCR, or it may be entirely
absent from the blood but still remaining in tissue, be it liver or pancreas:
but if treatment has been successful, the patient is clear and the prognosis
is excellent. As I understand it, whereas there is no evidence of a case in
which spontaneous clearance has ever subsequently reverted, so far as those
whose blood is cleared of the virus as the result of treatment, late reversion
has, rarely, been experienced; but although strictly it is a matter not of
clearance but of 'control' of the virus, they too, subject to the possible
need, hopefully decreasing, for the occasional check-up or blood test, can
be regarded as cured. (I refer to this further below, when dealing with the
question of provisional damages.)
The
course of the disease
- Approximately
20 to 25% of those who are infected by the Hepatitis C virus have, during
the period of acute infection, jaundice, the specific and obvious symptom;
the others being 'anicteric' (without jaundice). The jaundice clears fairly
quickly: there may be some inter-relation between those who have jaundice
and those referred to above who spontaneously clear (research is continuing).
In any event, the main issue is not acute Hepatitis but chronic Hepatitis.
As set out in paragraph 191 above, 20% of those infected do not proceed to
chronic infection, but spontaneously clear. But, subject to the development
of combination therapy, and some considerable ongoing research and study into
other treatments, it is the balance of 80% who suffer, in varying degrees,
from Hepatitis C for the rest of their lives. The prognosis is very variable:
- Approximately
one third of those with chronic Hepatitis C ('Category A') will be largely
asymptomatic during their lifetime. They may have relatively minor symptoms,
such as will be discussed below, affecting their quality of life, but they
will not suffer from any, or any material, liver disease. Any lesions to
their liver will be benign and of no materiality.
- Approximately
a further one third ('Category B') will suffer from mild to moderate liver
disease, with necro-inflammatory lesions and mild fibrosis, progressing
slowly, if at all, to serious liver disease. Fibrosis is measured by a number
of different systems, each with a level, either from one to five or one
to six, but, on all such systems, levels one and two, and often three, are
regarded as benign, and such fibrosis will have no deleterious effect on
liver function. Professor Dusheiko described fibrosis as follows:
"For
reasons that are not clear, because we do not understand the pathogenesis
of the disease, it is a disease characterised by a sort of creeping fibrosis
of the liver, where scar tissue, known as fibrosis, is laid down in a particular
architectural distribution, starting with a small amount of fibrosis, if
present at all, with the portal tracts: gradually then extending from portal
tract to portal tract in the liver, linking [them], which is known
as linking or bridging fibrosis, gradually then encircling the nodules of
the liver."
At
present the only effective way in which to estimate the extent and development
of the fibrosis is by a biopsy.
- One
third ('Category C') will suffer from more serious liver disease – chronic
liver disease ('CLD'). Some progress slowly and some more quickly, as the
fibrosis increases, if it does, and, in doing so, it gradually encircles
the nodules of the liver, as discussed above. Cirrhosis is simply extensive
fibrosis, leading to a nodular change in the liver, with gross nodules visible
to the naked eye and a gradual abnormality of the texture of the entire
liver. In the Poynard studies, to which I have referred in paragraph 189(iv)(c),
the median estimated duration of infection through to cirrhosis was thirty
years. It is now estimated that, of those with chronic Hepatitis C, 20%
(i.e. about two thirds of Category C) will develop cirrhosis in twenty years,
and another 10% in thirty to fifty years. Cirrhosis itself can be asymptomatic
for some time so far as its effect on liver function is concerned: it is
gradual and can reach a plateau. There is a period during which the liver
can cope, which is called 'compensated' cirrhosis. The later stage is called
'decompensated' cirrhosis: Professor Dusheiko describes it as follows:
"Compensated
cirrhosis means the presence of cirrhosis histologically, proven by a liver
biopsy, but where the patient has not suffered any gross sequelae of cirrhosis.
So the patient is never presented with a variceal bleed, never presented with
ascites, accumulation of fluid [in the peritoneal space within the abdomen],
never presented with encephalopathy, the coma states that accompany it, never
presented with any oedema or swelling in the legs. Decompensated cirrhosis
is where patients begin to be hospitalised for complications such as those
I have mentioned ... you could also use a biochemical test of liver function
to start to recognise decompensation."
Those
in Category C are also at a small risk of liver cancer (hepatocellular carcinoma).
- There
can, very exceptionally indeed, be extra-hepatic complications, such as porphyria,
cryoglobulinaemia, glomerulonephritis and diabetes mellitus.
- For
those with serious decompensated cirrhosis or liver disease, a liver transplant
may be considered and carried out, as with Mrs X. Although there can be a
risk of immediate rejection, and a very small risk of what is called late
acute rejection, there is no reason why such transplants should not be successful,
and indeed in the case of Mrs X it has been so. However a liver transplant
simply replaces the diseased liver, but it does not eradicate the virus. There
is an inevitability of re-infection of the new liver while the virus remains
in the blood, and the present figures are of a 10% risk of cirrhosis within
five years of the transplant, with a 60% survival rate for ten years from
transplant.
Prevalence
of Hepatitis C
- The
global prevalence of chronic Hepatitis C was estimated in the International
Consensus Statement in 1999 as 150 million (I note that Dr Gane had earlier
given an estimate of 300 million infected) and as 5 million in Western Europe.
The NICE Guidance estimates 200,000 to 400,000 in England and Wales. Hepatitis
C accounts for some 20% of acute hepatitis worldwide and 70% of those with
chronic hepatitis (no doubt because of the relative absence of treatment or
cure for Hepatitis C), for 40% of those with decompensated cirrhosis and for
30% of all liver transplants. Up to 50% of intravenous drug users suffer from
Hepatitis C.
Transmission
of Hepatitis C
- The
main method of transmission of Hepatitis C is through intravenous drug use.
According to the International Consensus Statement, its transmission by blood
products has been reduced worldwide to near zero. Apart from drug use, there
are other methods of 'horizontal' transmission of Hepatitis C. There is a
small risk through tattooing, body piercing, electrolysis, and acupuncture.
- It
is common ground between the experts that the risk through sexual transmission
is very small indeed. Dr Ryder stated that "sexual transmission can occur,
but it is very uncommon: the evidence is that sexual transmission is most
likely to occur in individuals with multiple partners and high risk sexual
practices, and the transmission in a stable monogamous relationship is very
uncommon, and there is a fair amount of data from both the haemophilia cohorts
and also the immunoglobulin D-spread cohorts that sexual transmission is uncommon
in that setting". In a group that he has studied, he could only identify
sexual transmission as the sole probable mode of transmission in 1.3% of the
cohort. Dr Alexander considered that there was a very rare risk of transmission
if a patient had a very severe venereal infection, in which case the number
of leucocytes in semen or vaginal fluid would increase; such that there might
be a small risk if there was a high leucocyte count, and significant abrasions
to the vagina or penis. But in other circumstances his view was that sexual
transmission did not occur at all, and his experience in Cambridge was that
they had screened many, many people, and never found it. His conclusion was
that, excluding those involved with drug use, there was no risk of sexual
transmission at all, and that the very small percentage risk, below 5%, mentioned
in literature, could all be accounted for by the factors of drug use or venereal
disease.
- As
for vertical transmission, that is infection passed from mother to baby through
pregnancy (there is no association at all from breast-feeding), it was common
ground that there is a very low risk indeed. Dr Ryder put it at less than
5%: his, very wide, experience was certainly of substantially less than the
5-6% risk quoted in literature, and in his cohort of thirty children born
to Hepatitis C positive mothers, he and his colleagues had not seen a single
infected child. Dr Alexander adds further, while agreeing about the smallness
of the risk, that children have a low risk of liver disease relating to Hepatitis
C, certainly through the early years of childhood, so that the risk of any
liver damage would be small, and further, that a baby or child infected would
be the most likely to respond successfully to therapy.
Prognosis
- As
set out above, the condition can be all but asymptomatic for many years, and
the most likely outcome is no serious liver disease. Cirrhosis may take between
twenty to fifty years to develop, if it develops at all, although, it can,
as in the case of Mrs X, who was 45 at the date of her infection, occur much
more quickly. As for progress to fibrosis and cirrhosis, Dr Poynard predicated
that this was linear. It seems now that there is considerable doubt about
that. Though slow to start, it may speed up: it may speed up with the onset
of age, it may be quicker if (as in the case of Mrs X) the patient is older
when infected. There are five predictive factors, which have developed and
been generally accepted as the clearest indicators of the likelihood of worsening
progression of liver disease and hence prognosis:
- Age
at time of infection: those who are young have a better prognosis and a
slower rate of infection: over 40 is the yardstick.
- Degree
of inflammation (and/or ALT score) on the first – or 'index' – biopsy (normally
now taken about one year after infection): Dr Alexander explained that there
is an 85% chance on index biopsy of accurately forecasting the development
of the liver over the next five years.
- Male
gender: a much greater risk than female.
- Alcohol
intake: worse with intake of more than five units per week: Dr Alexander
in particular would encourage less.
- Co-infection
with Hepatitis B or HIV: and possibly the degree of steatosis (fatty liver).
This
is a very helpful guide indeed for those estimating prognosis within the rest
of the group actions, and is well exemplified in the lead cases by reference
to Miss T and Ms V.
Treatments
- As
set out in paragraph 193(ii) above, biopsies at present are an essential tool
for diagnostic and predictive purposes. Index biopsies are normally after
one year, and then there is normally a need for follow-up biopsies, although
hopefully the less regularly as time goes by (to which point I return below),
because of their invasiveness and discomfort. They are certainly needed on
a fairly regular basis after any transplant, and there would need to be a
biopsy before the onset of any treatment or therapy. It is very much hoped
and believed by Dr Ryder, Professor Dusheiko and Dr Alexander that there will
soon be successful development of non-invasive methods as a substitute for
a biopsy. Dr Ryder estimated that the existing research may well produce such
methods over the next five to ten years. Dr Alexander considered that, although
he did not think that within five years there would necessarily be a substitute
for the index biopsy, follow-up biopsies might certainly be substituted by
blood tests during that period; and he did not think it was optimistic, but
reasonable, to expect that a significant proportion of his patients would
be taken out of the schedule for follow-up biopsies on that basis. As for
treatment by Interferon, combination therapy (or monotherapy in the event
of contra-indication, or intolerance, of Ribavirin) has been given specific
approval in the NICE Guidance, which licenses the use by Health Authorities
of such products, with the exceptions and expansions there set out. In particular:
"1.1 Interferon
[alfa] and ribavirin as combination therapy is recommended for the
treatment of moderate to severe Hepatitis C (defined as histological evidence
of significant scarring (fibrosis) and/or significant necrotic inflammation)
at standard doses for patients over the age of 18 years as follows:
1.1.1:
All treatment naive patients (that is, those who have not previously had Interferon
[alfa] monotherapy or combination therapy) and all patients who have
been treated with Interferon [alfa] monotherapy, and have had some
response but have since relapsed. Such treatment should be continued for six
months for all patients.
1.1.2:
A further six months combination therapy is recommended only for patients
infected with Hepatitis C virus of genotype 1, who respond to therapy by becoming
clear of circulating viral RNA as detected by ... PCR in the first six months.
1.1.3:
Those in whom liver biopsy poses a substantially increased risk (such as patients
with haemophilia) may be treated on clinical grounds without histology.
1.5:
... The recently licensed pegylated Interferon monotherapy has not been considered
in this Guidance."
- It
is anticipated that pegylated combination therapy will replace standard combination
therapy in what Professor Dusheiko called the "not too distant future".
Dr Ryder considered that it would be licensed for use as an NHS product by
summer of this year, although it will not necessarily be an immediate part
of the NICE Guidance, with the result that not every authority will be able
or prepared to fund its use, as would be the case if it were incorporated
expressly into the NICE Guidance. Dr Ryder himself had not had a problem in
funding standard combination therapy prior to NICE, but he accepted that that
would not have applied to all authorities.
- Other
treatments are being urgently researched, priority already having been given
over the last few years by drug companies. Dr Ryder foresaw at least ten years
before there would be effective alternative treatments, but Dr Alexander,
who is actively involved in their research, looked, although without certainty,
to an availability within four or five years.
- As
for the present combination therapy, there are once again predictive factors,
first advanced by Poynard and now generally accepted, for the likely success
of such treatment:
- Genotype.
There is a very marked greater likelihood of success of the treatment for
those with genotypes 2 and 3: genotype 4 less successful, and genotype 1,
as is apparent from the provision in the NICE Guidance for a twelve month
rather than six month treatment, much less likelihood of success.
- Age
at time of treatment: again those under 40 have the better chance.
- Those
with a lower viral load at time of treatment: certainly those with less
than 2,000,000 copies per millilitre of virus in the blood have a better
chance.
- Once
again male gender is a worse indicator than female.
- Degree
of existing fibrosis.
This
guide is also vital, for consideration of whether to carry out the existing
therapy.
- Not
all patients are suitable for the treatment, and of course the indicators
above will be a factor for consideration, as will be the NICE Guidance, particularly
so far as funding is concerned. The Interferon treatment itself is not pleasant.
It requires self-injection (three times per week for standard or once per
week for pegylated), monitoring and blood tests, and it has, in most cases,
side-effects: most frequently complained of are flu-like symptoms, headaches,
fatigue, dizzy spells or nausea, nosebleeds, appetite loss. In addition there
is the risk of hypo- or hyper- thyroidism (from which Miss T temporarily suffered),
and a 15% risk of clinical depression (from which fortunately none of the
lead Claimants suffered). According to the NICE Guidance there is a 10-20%
discontinuance of the treatment. However its success level, particularly for
those of genotypes 2 and 3, is very promising, and indeed improving. So far
as non-pegylated standard combination therapy is concerned, the figures for
genotypes 2 and 3 appear to be around 60% success, and for all genotypes between
35% and 47%. Dr Alexander has a rigorous system of supervision, because he
believes that much of the failure rate results from non-compliance by patients,
and his overall success rate (the majority of his patients being genotype
1) is 55%. As for pegylated combination therapy, results of recent trials
for genotype 1 appear to be improving from 30% up towards 40%, and for all
genotypes to 53%: the common ground as to the success rate for genotypes 2
and 3 appears to be 80-85%. Indeed Dr Ryder referred to infection with genotypes
2 and 3 as "in general now ... almost a curable disease".
The
Effect of Hepatitis C
- Quality
of Life. The effect of Hepatitis C, apart from the possible development of
serious liver disease, may be, or include, irritability, nausea and headaches.
It may include fatigue and lethargy (to which I refer below). There may be
worry and stress about the future and prognosis, at least unless and until
there is a more certain prediction derived from clearance of the blood
or from a favourable biopsy or otherwise (what has been called the 'Sword
of Damocles' factor). There is the need for fairly regular medical supervision
– perhaps six-monthly blood tests, perhaps biopsies every three to five years,
more often if there is evidence of some deterioration, or if treatment is
being considered. There is the possibility of social 'stigma', to which I
refer again below. There may be worry about sexual transmission, although
the risk, as set out in paragraph 198 above, is agreed by the experts to be
extremely small, and the firm and unanimous advice of the experts is that
no extra or different precautions are necessary – for stable relationships
no precautions that would not otherwise be taken are needed, while in the
case of multiple relationships, the use of precautions would be recommended
in any event, even apart from Hepatitis C. There may be worry about vertical
transmission, again notwithstanding the very small risk. There is an effect,
which Dr Foster has sought to identify and estimate in his published study,
using approved questionnaires, on the 'Quality of Life'. Of course if and
when CLD were to ensue, then there would be other and specific symptoms.
- Fatigue.
Plainly fatigue is one of the possible, and indeed very common, complaints
of those suffering from Hepatitis C, as is confirmed by the clinicians, who
have seen so many. Fatigue is, however, as Dr Alexander pointed out, common
among patients of all kinds, and certainly so among liver patients (though,
according to Dr Ryder, not normally with those suffering from Hepatitis B).
The question which was proposed by Professor Wessely, which it is necessary
for me to resolve, is whether fatigue is an automatic concomitant of Hepatitis
C. The report he prepared was accepted by all his fellow experts to be extremely
learned and persuasive. He agreed that there was a clear aetiology for fatigue,
which would lead to its being a regular feature among Hepatitis C sufferers:
- Fatigue
is common in any event (although he referred to the NIH study by Dr Hoofnagle,
which showed that there was apparently a higher indication of fatigue among
his cohort of healthy blood donors than amongst those infected by Hepatitis
C).
- Fatigue
is a very likely consequence of stress and worry, such as would be inevitable
from learning and awareness of Hepatitis C infection: a number of studies
indicate a tie-up between knowledge of Hepatitis C and fatigue.
- Fatigue
will be a symptom of deteriorating CLD (characterised by Dr Alexander as
'exhaustion').
- Fatigue
will, or may, accompany depression or psychiatric disorder.
- However
Professor Wessely did not consider – and I accept his persuasive evidence
– that fatigue was an automatic concomitant and a necessary symptom of the
Hepatitis C condition. Of course, if a Hepatitis C patient is found to be
suffering from fatigue, then that will be so, in his or her case. But it is
not to be presumed or assumed as automatic. The consequence, as Mr Underhill
QC has submitted, is that not only will it be necessary to establish, and
prove, a period or periods of fatigue or indeed a continuity of fatigue, if
such be the case, in the case of any particular Claimant, rather than simply
assuming it, but also:
- if
fatigue be proved, it may well be more likely to have occurred only after
knowledge, and to improve if and as the stress and anxiety caused by such
knowledge ameliorates, either by habituation to the condition or as a
result of the advice of a favourable prognosis;
- if
it is a concomitant to depression, then it may ameliorate as the depression
improves or is recovered from;
- if
it is a symptom of the liver disease then it may, for example, improve
upon treatment or even disappear after a transplant.
This
assessment, and in particular the linking of fatigue either to the date of
knowledge of infection or to the onset of CLD, was fully exemplified, in my
judgment in the facts of the lead cases. Fatigue in the case of Mrs X was,
in my judgment, plainly associated with the early onset of CLD (and there
has been a dramatic improvement since her transplant). In the case of those
who had interferon treatment (T, U, V, W), or an adjustment disorder, it was
a likely concomitant or side-effect. But otherwise it improved or evaporated
once stress and anxiety were alleviated by a successful treatment and/or a
favourable prognosis.
- Vulnerability
to Depression. Three of the lead Claimants, and no doubt others of those within
the group action, have suffered a period of depressive disorder, and that
is a matter for specific consideration. However an issue has been raised by
Dr Master with which his colleague Professor Wessely specifically disagreed
and I must resolve it. Dr Master expressed the opinion that once a person
has been infected by Hepatitis C, which is a 'life event', then, irrespective
of whether such person recovers from any psychiatric disorder that may result
from that life event, or indeed puts it entirely from his mind, he has an
objective vulnerability to further life events, of whatever kind, so as to
be the more liable to suffer psychiatrically in future. He put it in this
way in answer to Mr Brooke QC:
"A:
We probably all have a threshold for developing mental illness. It depends
on the product, in rough terms, of the vulnerability, and the significance
and impact of any given life event. So my postulation is that, having suffered
from Hepatitis C infection, the vulnerability factor is increased.
Q:
[by me]: Are we talking about a vulnerability to the onset of Hepatitis
C, then knocking him down yet further ten years later, or are we talking about
a greater vulnerability generally, so that if his grandmother dies, he is
then knocked down; which is it?
A:
It is the latter. I think there is a general increased vulnerability to develop
further episodes of mental illness."
Then
further in cross examination by Mr Underhill QC:
"Q:
One of the things you were saying, the most general thing you were saying,
is that the impact of adverse life events, as regards their liability to lead
to psychiatric illness is cumulative. That is, the more adverse life events
you suffer, the more likely you are to develop a psychiatric illness next
time one comes along ...
A:
As a general proposition, I would say that ...
Q:
At one point, I thought you were qualifying it by saying that you are only
really concerned with continuing life events ... That would ... deal with
those people who treated the knowledge of their Hepatitis C infection as a
continuing problem for them, but it would not explain those people, who had
as far as one could tell, entirely put it behind them. By the end of your
evidence it was clear you were saying that even for the latter group, there
was an increased vulnerability?
A:
Yes, I am ...
Q:
The consequence is ... that every one of these Claimants would be entitled
to have some element of their damages to reflect an increased risk of developing
psychiatric illness compared with if they had never been infected?
A:
Yes."
- Professor
Wessely accepts, as of course Dr Master confirms, that there may have been
people who would not have been able fully to recover from the effect of the
first life event – i.e. a continuing 'sword of Damocles' effect - but he does
not accept that there is any such objective vulnerability as Dr Master postulates.
A person is dealt what he called a 'hand of cards', derived genetically, or
from his or her early development (he draws this from his own published studies
and also from the seminal work of Brown and Harris Social Origins of Depression).
A person who suffers from a life event may be rendered vulnerable by that
circumstance to succumb to another life event, to which he might not otherwise
have succumbed. On the other hand, it is equally if not more frequent that
a person is rendered more resilient by suffering, so that, having succumbed
on the first occasion, he is the less likely to do so on the second and future
occasions. It all depends. If Dr Master were right as a matter of course,
then, as it is commonplace for everybody to suffer more than one life event,
if only by losing more than one parent, there would be what Professor Wessely
described as "an ever accelerating spiral" or "an accelerating cascade
of psychiatric disorder, because after each life event, you will be continually
upping the stakes, as it were, until finally ... everybody would break down,
because we all encounter adversity. So I do not accept that life events themselves
feed onto the risk for the next life event". This tournament between Master
and Wessely, if I may allude to the similarity of the latter's appearance
to that of a well known irascible tennis player, was, in my judgment, won,
game, set and match by Professor Wessely. If a Claimant has suffered prior
to trial from a psychiatric disorder then he is entitled to be compensated
for it, and if (which has not been the case for any of the lead Claimants)
it be a continuing disorder, then on that basis. My judgment is however that
there is no automatic continuing vulnerability in the absence of specific
evidence in that regard. If in the future a Claimant were to suffer from psychiatric
disorder which he could bring within the agreed provisional damage 'triggers',
to which I shall refer below, so as to be able to claim additional damages,
then those damages will arise out of such fresh disorder.
ISSUES
OF DAMAGES
Provisional
Damages
- Mr
W, who is nearly 72, does not seek provisional damages. In the light of the
uncertainties, to which I have referred above, all the other lead Claimants,
and, I anticipate, most if not all of the other Claimants, will seek to take
advantage of the sensible and flexible provisions of s32A of the Supreme Court
Act, 1981, which "applies to an action for damages for personal injuries
in which there is proved or admitted to be a chance that at some definite
or indefinite time in the future the injured person will, as a result of the
act or omission which gave rise to the cause of action, develop some serious
disease or suffer some serious deterioration in his physical or mental condition".
Pursuant to Part 41.2 of Civil Procedure Rules, I can only make an order for
an award of provisional damages if I am satisfied that the section applies,
and if the particulars of claim included a claim for provisional damages (which
they did). If I make such an order, I must specify the disease or type of
deterioration in respect of which an application may be made at a future date,
and specify the period within such application be made, although such period
may be the duration of the life of the Claimant. My attention has been drawn
to two relevant authorities, Willson v Ministry of Defence [1991] 1 AER 638,
and Thurman v Wiltshire and Bath Health Authority [1997] PIQR Q115. The Defendants
did not oppose in principle the making of an order for provisional damages,
although there was a good deal of disagreement between the parties as to the
trigger or triggers for any such future damages. This led to a considerable
amount of submission and exchange, and various and continuing amendments to
the proposed triggers, but resulted in five triggers which satisfied, as I
understood it, all the objectives and objections of both sides. I am entirely
satisfied, as I must be, that this is a suitable case for provisional damages.
I am also satisfied that the five triggers eventually resolved upon are sensible
and necessary. I shall set them out below, together with a short explanation
of each. I was satisfied that each trigger could only be used once (by each
Claimant) and therefore it was not possible to have one trigger containing
more than one possible event (unless they were alternatives); and hence that
all five triggers, none of which of course may be necessary in the case of
any one Claimant, are required in case there is one Claimant, who, during
a lengthy lifetime, might qualify under more than one trigger as time goes
past. I am satisfied that the duration referred to in Part 41.2 of the CPR
should indeed be the duration of the life of each Claimant:
Trigger
1: "Testing Hepatitis C RNA Positive in blood, having always tested RNA
negative in blood in the past or having tested RNA negative in blood for at
least twelve months following anti-viral treatment, leading to a prognosis
materially worse than at the date of assessment of damages".
As
discussed in paragraph 192 above, there is a risk, presently considered to
be very small, that one who has tested negative for such a period that it
can be assumed that there has been clearance of the blood may subsequently
revert to testing positive. This might simply occur because of the development
of some even more sensitive test, so that it could be concluded that, although
there has been a positive test, it does not in the circumstances lead to a
materially worse prognosis. But, such unlikely circumstance apart, on the
assumption that on any reasonable basis the particular Claimant is now to
be regarded as positive rather than, as before, negative, then that will,
if not falsify, certainly change the basis upon which damages will have been
assessed: e.g. PCR negative, never likely to deteriorate or suffer material
liver disease, no further treatment, no or no further social, employment or
insurance handicap (so far as that may be relevant, as I discuss further below),
no further biopsies or follow-ups etc. Notwithstanding the smallness of the
risk - seen by all the experts as perhaps between 1 and 2% - I am satisfied
that this is an appropriate trigger, and enables me to assess damages for
those, like Mr S and Mr U, who have cleared the virus, on that positive
(or rather negative!) basis.
Trigger
2: "Developing decompensated cirrhosis and/or liver cancer and/or serious
extra-hepatic complications resulting from Hepatitis C".
This
speaks for itself. I am therefore able to assume that all those Claimants
who have not done so already will never deteriorate to decompensated cirrhosis.
There is, as I have indicated, a small risk of liver cancer, and a very small
risk of the extra-hepatic complications which I have set out in paragraph
194 above, and again notwithstanding the smallness in particular of the last
named risk, I have been satisfied that it is appropriate to have a trigger
making specific reference to them.
Trigger
3: "Developing decompensated liver disease and/or cancer and/or serious
extra-hepatic complications resulting from Hepatitis C after transplant".
The
need for this separate and otherwise repetitive trigger results from the factor,
referred to above, that each trigger can, it seems, only be used once.
Trigger
4: "Onset of late rejection of a liver transplant".
Once
again this was a very small risk, as seen by all the experts, perhaps 1% to
2%, but needs to be provided for, in my judgment, so that it would be possible,
for example in the case of Mrs X, to assess her claim on the basis that there
will be no, very exceptional, late rejection of her liver transplant.
Trigger
5: "Recurrence of, or onset of a fresh, serious psychiatric condition as
a result, whether direct or indirect, of the Claimant's Hepatitis C condition".
The
reason for this is really fully apparent from my discussion of the evidence
of Professor Wessely. It is to be noted that, in order to comply with the
statute, the condition, if it were to arise, would have to be a "serious"
one.
Heads
of Damage
- Mr
Brooke QC has submitted that general damages for pain, suffering and loss
of amenity ('PSLA') should in this case be split out into sub-categories.
This is, he says, a modern trend, but in any event is desirable in this case
because of the fact that there are here lead cases and lead Claimants, and
assistance may be drawn from findings and separate assessments of sub-categories
when coming to consider the cases of other Claimants. The Defendants have
not opposed this as a matter of principle, and I am prepared to follow this
course, subject to some slight emendation, as will appear below. But it is
important, as the Defendants have submitted, and I accept, to appreciate that
it may be that once each such sub-category of damage is added up, the total
of general damages for PSLA will not be simply the aggregate of them. It is
essential, as has been pointed out on numerous occasions by higher authority,
that general damages be looked at in the round and that, in particular if
there be sub-categories, there should not be in the end any overlap or duplication:
one example of reference to such overlap by the Court of Appeal is contained
in an authority relied upon in one of the lead cases, Curi v Colina (29 July
1998), Kemp & Kemp, B2-008/1
PSLA
- Infection
Simpliciter: It is obviously necessary in assessing such damages first to
identify the condition, to conclude whether there has been clearance
of the virus and if so at what stage, and to decide whether the assessment
is to be on the basis of provisional damages: then to assess the prognosis,
treatability and treatment, the symptoms identified so far and continuing,
and the state of mind, whether optimistic, resilient, pessimistic, anxious
or fearful, and the circumstances of the Claimant. Mr Brooke QC speaks of
'infection simpliciter'. But the meaning of this is not entirely clear.
I take it to mean that it excludes any specifically liver disease-associated
symptoms, or any identifiable psychiatric disorder. But he also seeks to extract,
as a separate head, fatigue. That seems to me to have been put forward on
the basis, which I have not accepted, that there will almost automatically
be fatigue as a concomitant to Hepatitis C, such that in a particular case
there might be specific evidence of fatigue for separate identification. I
conclude, in the light of my decision on the question in paragraphs 207 and
208 above, that fatigue, if it is shown to exist for any period in relation
to a particular Claimant, ought to be included as part of 'infection simpliciter'.
It seems to me very difficult indeed to sever off questions of fatigue from
those of stress or anxiety or irritability or from any other factors counting
by way of diminution of the quality of life. Subject to this adjustment, I
accept Mr Brooke QC's invitation to sub-categorise by reference to 'infection
simpliciter'. The assessment of it, taking into account questions such as
the general need for monitoring and any specific concerns or worries of the
individual Claimant, will be carried out on the basis, discussed above, of
the likely prognosis of that Claimant, but upon the assumption that he or
she will not reach the next relevant trigger: e.g. that Mr S and Mr U will
remain PCR negative etc. I shall assess the sums for each Claimant in such
a way I hope, that, particularly as the lead Claimants have been so well chosen,
there will be assistance in quantifying the claims of others. However I do
not consider it helpful or appropriate to give a bracket of damages, as was
at one stage canvassed, but not, I think in the end vigorously insisted upon
by Mr Brooke QC.
- Biopsies
etc.
- Mr
Brooke QC invites me, and the Defendants do not oppose this in principle,
as I have indicated, to put a separate figure on past and future biopsies.
This is not an easy task, as neither side has been able to find any relevant
authorities. Mr Brooke QC has taken me to examples in Kemp & Kemp
of minor injuries, but I accept Mr Underhill QC's submission that, where
there has been some minor accident or assault leading to minor injuries,
and requiring compensation, that cannot, being the totality of the claim
in the particular case, be of much help in relation to a case where there
is a much larger claim, one of the incidents of which is the need for occasional
hospitalisation. Given the relative rarity of the compartmentalisation of
damages for which Mr Brooke QC contends, it is perhaps not surprising that
there are no precedents that either side can find. A hospital visit is planned
and expected and, in the case of biopsy, is short or relatively short, and
does not carry with it the trauma, minor though it may be, of an accident
or assault. The figures which he showed from Kemp & Kemp were
for minor injuries, resulting in cuts, bruises, discomfort or nervous reaction
for up to a week or so, for which in the region of £500 or so has been awarded
for the totality of the incident: the valuation of the biopsy is however
collateral. In valuing the biopsies, obviously it is necessary to bear in
mind the particular circumstance relating to the individual Claimant: whether
it was a short visit, whether the Claimant remained overnight, whether there
was or was not general anaesthetic and whether there was more than usual
pain or discomfort. As for future biopsies, an assessment must be made whether
the particular Claimant will require any, and if so how regularly.
- Evidence
was given both about further biopsies, and indeed about follow-up treatment
generally, which it seems appropriate to deal with now, as a matter of general
application.
- With
regard to follow-up, evidence was given by Dr Ryder, in cross-examination
by Mr Brook Smith, by reference to the circumstances of Mr S, one of the
lead Claimants who has cleared the virus, as follows:
"Q:
[Mr S] is currently on annual tests. He has cleared the virus completely.
Can you contemplate a time when, if his tests remain as well as they currently
are, ... there will no longer be a need even for annual tests, that he
could come back for three-yearly tests or even five-yearly tests?
A:
At the moment, it is very difficult to give a definite answer to that,
as our knowledge accumulates. One could say that it could be that we would
be more reassured as time goes on, and therefore what you suggest is perfectly
reasonable, but equally if more data becomes available such as that from
the Edinburgh Group about the significance of intra-hepatic Hepatitis
C, one may have to do more. I am afraid I can't really speculate on what
we may do in the future. I think it is safe to say that over the next
five to ten years a yearly check is likely to be required."
Dr
Ryder however also agreed, when cross-examined by Mr Underhill QC, that
after another five years had gone by he might well think in terms of either
discharging those who had successfully responded to treatment altogether,
or at any rate making the follow-up much less frequent than annual.
Dr
Alexander said, in chief, when questioned by Mr Underhill QC about his
anticipation for the follow-up regime for the next few years for those
lead Claimants, Mr S and Mr U, who had cleared the virus, as follows:
"I
think on the current levels of evidence I would want to see those patients
on an annual basis. There are several reasons: one can be checking to
see if they remain PCR negative; one might also want to update them on
any new information that has come around. I cannot foresee us doing that
in the long term, because I do not think the majority of patients would
need to be followed up in the very long term. I think what we are waiting
for is strong evidence that we can allow some of these patients to be
discharged from our clinic, and I think as soon as we have that we would
be happy to do that ... I think we need someone to prove conclusively
that a large number of patients who are PCR negative for five years never
get liver disease. I suspect that evidence will come quite soon, and then
we will have the confidence to do it ... I would imagine in five years
we would be able to make those comments ... I think if we have a patient
who is consistently negative in blood ... four or five years from now
I am sure we would be able to discharge those patients, particularly when
they have had liver biopsies showing no significant liver damage."
I
conclude, preferring, insofar as there is a marginal difference, the evidence
of Dr Alexander, that it is highly likely that, after five years, the
regularity of such check-ups of those who have been PCR negative in blood
for five years will substantially reduce, such that in the calculation
of any damages relating to such ongoing follow-ups in the future there
must be a discount. The letter received by Mr S, who has been PCR positive
for five years, discharging him from further review, quoted below, appears
to support this.
- As
for biopsies, I am satisfied that they are only relevant to those who
remain at present PCR positive. Dr Ryder gave clear evidence in respect
of those, such as Miss T and Ms V, who suffer from mild, if any, liver
condition and may hereafter have further therapy. His evidence was that
if such treatment was successful, and the patient became and remained
PCR negative after six months, then they would be treated as having cleared
the virus and thus require no further biopsy (and Dr Alexander agreed
in terms): if the treatment was unsuccessful, then monitoring would continue,
just as if they had not had the therapy, but such patients would also
never again have to have a routine biopsy. This too therefore will be
relevant in the assessment of damage for those such as Miss T and Ms V,
for whom, on the assumption that they will not deteriorate to cirrhosis
(covered by a trigger), there need be no provision for any further routine
biopsy, if I am persuaded to decide that they will have further therapy.
There may further need to be consideration of, and discount for, the availability
of non-invasive alternatives to, or substitutes for, biopsies within five
years or so, as set out in paragraph 201 above.
- Interferon
Treatment. Again I am invited separately within PSLA to assess damages for
those Claimants who have gone through past therapy, and also for those Claimants
with regard to whom I conclude there will be future therapy. As set out in
paragraph 205 above, Interferon is not pleasant. It requires self-injection,
and carries with it the risk, if not the certainty, of the side-effects there
set out. As it happens, none of the Claimants in this case has suffered from
any Interferon-related depression, which I do not need separately to assess,
as I would otherwise have done. However the circumstances of each Claimant
need to be looked at: for what period of time they had the treatment, what
side-effects they suffered, how badly affected by them they were. Mr Brooke
QC invites me to assess a different figure in relation to therapy which has
been unsuccessful as compared with that which was successful. I do not accept
the logic of this. If the treatment was, and remained, successful, then of
course the damages of that Claimant would otherwise reduce, by virtue of the
more favourable prognosis. If it was, or soon afterwards was seen to have
been, unsuccessful, then the damages for that Claimant will increase, because
of the more unfavourable prognosis. But each of them will have gone through
the same discomfort, if discomfort it was, with regard to the therapy at the
time. I can see that if there is some particularly identifiable trauma arising
in respect of the disappointment of a particular Claimant as a result of failed
treatment, then that might be separately compensable.
- Future
Treatment. This is relevant under two heads. The first is in respect of PSLA.
If in fact there is the chance of future treatment, then that may impact upon
the general damages.
- The
prognosis of the individual Claimant may take into account the chance of
success of such treatment (although given the existing good prognosis for
the only relevant lead Claimants, Miss T and Ms V, this will not be a substantial
factor in these cases) e.g.:
- The
prognosis may improve.
- Any
continuing stress or worry may be capable of being alleviated.
- The
duration of any existing anxiety state or of fatigue, or of social 'stigma'
(if applicable) etc. may be shortened. Assessment of general, and indeed
of any special, damages may well be affected if a shorter period than
the whole of life is being looked at. I refer again to Dr Ryder's reference
set out in paragraph 205 to infection with genotypes 2 and 3 almost being
a curable disease.
The
question not only of the availability of existing or imminent therapy, but
of possible improved treatments may be filtered into consideration.
- On
the other hand there will be future discomfort from any such treatment to
be allowed for, as mentioned in paragraph 215 above.
- There
is then the fact that there is a separate head of damage sought by the relevant
Claimants in respect of the cost of future treatment. What is said by the
relevant Claimants is that, insofar as they have not yet for any reason attempted,
or have previously attempted but failed, combination therapy or in particular
pegylated combination therapy, they should be compensated by the Defendants
in respect of the cost of such therapy, as and when appropriate in the future.
There are three issues:
- Is
it reasonable for such treatment to be provided for in respect of a Claimant?
That would be a question of assessment of the medical evidence. It would
seem to me not to be reasonable if medically contra-indicated, as it is
suggested to be for example in the case of Mr W, or if it were pointless
(or a combination of the two).
- It
will not be recoverable unless the Court is satisfied that in fact the treatment
will be taken by the Claimant. That may to an extent be only a refinement
of (i), for if it were contra-indicated medically, it would be unlikely
that it would be taken by a Claimant: and certainly in the case of unpleasant
treatment, such as Interferon, it might be unlikely that it would be attempted
if it were clearly pointless.
- The
third question is whether such treatment, if to be attempted by a Claimant,
will be provided and accepted on the NHS, and therefore not be required
to be paid for by the Claimant (and hence not claimable from the Defendants).
There is in the event no issue between the parties as to the law in this
regard, although Mr Brooke QC did make reference in opening to the Law Reform
(Personal Injuries) Act 1948, s2(4) (as amended), whereby "in an action
for damages for personal injuries ... there shall be disregarded, in determining
the reasonableness of any expenses, the possibility of avoiding those expenses
or part of them by taking advantage of facilities available under the National
Health Service Act 1977". The relevant question is, as both parties
have accepted, more by reference to Harris v Brights Asphalt Contractors
Ltd [1953] 1 QB 617 (per Slade J at 635: "I do not understand s2(4) to
enact that a plaintiff shall be deemed to be entitled to recovery of expenses
which in fact he will never incur") and Cunningham v Harrison [1973]
1QB 942, (CA) (per Lawton LJ at 957f: "the defendant cannot say that
he could avoid that expense by falling back on the National Health Service
... What she can, however, submit is that he will probably not incur such
expenses"). I accept Mr Underhill QC's submission that, if in fact the
pegylated therapy is available on the National Health Service at the time
when the relevant Claimant seeks to take advantage of that treatment, and
it is available to him within the NICE Guidance, then it is likely that
he will indeed accept that treatment on the National Health Service rather
than seeking to pay for it himself, which would, whatever might be the case
in other circumstances, gain him nothing in this case, as confirmed on the
evidence.
- But
the issue is rather whether, at the material time, pegylated combination therapy
will indeed be so available, given that, at this stage, even pegylated monotherapy
is not yet available within the NICE Guidance. It will be a matter for consideration
in each case whether I conclude, given the relevant time scale, that pegylated
combination therapy will be so available within the NICE Guidance. My conclusion
is that it is likely within two to three years to be so available. However
it is quite a different and additional question as to whether a particular
Claimant is likely to qualify within the NICE Guidance for such treatment.
For example, it would seem to be common ground that, for differing reasons,
none of the lead Claimants, as things stand at present, would qualify within
the existing Guidance. That will have to be looked at in relation to each
Claimant: and of course there is the further element, which again will have
to be considered in relation to each Claimant, as submitted by Mr Underhill
QC, namely that it may be that in relation to some, or even all such Claimants,
the only circumstance in which they will seek combination therapy, given its
unpleasantness, will be if an existing acceptable condition and prognosis
were to deteriorate, rendering it advisable or desired to have such therapy.
In that case such Claimant would then be likely to qualify within the Guidance.
However Mr Brooke QC's case in relation to the existing lead Claimants is
that the desire of those such as Ms V to have such therapy in the future is
not conditional upon any change in their condition, but simply because, in
her case for example, she has not until now felt able to take on the treatment,
given her other family responsibilities, but believes that she will in the
future wish to do so.
'Stigma'
or Handicap
- Use
has been made in the course of opening and closing submissions of the word
'stigma'. It falls into three areas: 'social stigma', 'employment stigma'
or 'insurance stigma'. I do not see them as similar, and the word itself seems
to have crept into play by analogy to 'stigma damages' as coined in respect
of the entirely different case of Malik v BCCI [1977] ICR 606. As for 'social
stigma', what this is said to relate to is to possible prejudice suffered
at the hands of others – and there is some evidence in relation to the lead
Claimants in relation to the experience of some of them with boy- or girl-friends
or their families or with dentists – as a result of their Hepatitis C condition.
There is of course no need or justification whatever for such 'stigma' or
prejudicial treatment as:
- There
is a distinct and sad inter-connection between Hepatitis C and drug use,
but none of the Claimants, all of whom are the innocent victims of blood
transfusions, can or should in any way be associated in that regard.
- The
reality, I suspect, is that the prejudice towards, and such treatment of,
the Claimants insofar as it occurs, results not from any disapproval, justified
or otherwise, but from fear. The sooner that there is education about, and
familiarity as to, the condition of the 200,000 to 400,000 Hepatitis C sufferers
in this country, and it is understood that in fact there is almost no risk
of horizontal transmission from them, and that they are likely to be around,
unchanged and almost completely non-infective for another fifty or so years,
the better.
- If
however, unless and until there be such education and familiarity, any Claimants
can establish the suffering, past or future, of some slight or prejudice arising
out of their Hepatitis C condition, then that can and must form part of their
PSLA 'infection simpliciter' damages. In any event I would prefer to call
it 'social handicap' than 'social stigma'. 'Employment stigma' is, however,
completely different. Although it was submitted by Mr Brooke QC, in his opening,
that this amounted to a different head or type of damage from 'Smith v
Manchester' damages, in the event he accepted – and Mr Underhill QC did
not contest otherwise – that it was simply an exemplification of that head
of damage. If it can be established, in a particular case, that a Claimant
is less likely to obtain, or more likely to lose, employment because of his
or her Hepatitis C condition, then that is not 'employment stigma' or, at
any rate, is better described as 'employment handicap' or 'loss of earning
capacity'. Finally 'insurance stigma'. This is even less a question in my
judgment of 'stigma', as the loss, if it can be shown, does not seem to arise
out of some act of personal prejudice, but arises, if it does arise, out of
underwriting judgments, which may be misguided (and, if so, it is to be hoped
that this case may further educate them) or may be inevitable, for actuarial
or other reasons. Thus 'insurance stigma' is plainly not so, but also should
rather be described as 'insurance handicap' or 'loss of insuring capacity'.
Employment
Handicap
- In
my judgment it is clear that the case that is put forward is not different
from a Smith v Manchester case, although in relation to some Claimants
it may not be the normal such case, where a claimant is in employment and
is fearful of losing such employment and being left handicapped on the labour
market:
- It
is not an essential pre-requisite in a Smith v Manchester claim that
the claimant must, at the date of trial, be in employment. A dictum to that
effect by Browne LJ in Moeliker v Reyrolle [1976] ICR 253 at 261, was corrected
by the judge in the Weekly Law Reports' report ([1977] 1 WLR 132 at 140),
and was then recited by him in the subsequent case of Cook v Consolidated
Fisheries Ltd [1977] ICR 635 at 640, so as to read: "this head of damage
generally [corrected from only] arises where a plaintiff is
at the time of the trial in employment". Other cases were cited by Mr
Brooke QC in which the claimant was not in employment at the time of trial,
including Mitchell v Liverpool Area Health Authority (13.6.85 Kemp &
Kemp 6-611) and Goldborough v Thompson and Crowther [1996] PIQR Q86.
- Where
the employee is not in employment, there is no need for the two stage approach
to risk of loss, namely the risk of losing the present job followed by subsequent
risk on the labour market, but there is simply one test, whether there is
a real risk of loss at some stage on the labour market – which need not
apply to any particular employment. Of course it will be necessary to show
that the difficulty in earning employment relates to an employment which,
but for the Hepatitis C, the Claimant would have hoped or expected to attain.
- As
there is no established loss, but simply evidence of a risk of potential
loss, the claim cannot be specifically quantified, but is in respect of
a loss of earning capacity (see Foster v Tyne & Wear County Council
[1986] 1 AER 567). Such loss must be calculated "in the round" (Smith
v Manchester Corporation itself [1974] 17 KIR 1 at 8) or "plucked from
the air" (Moeliker per Stephenson LJ [1977] 1 WLR 132 at 144).
- There
must be evidence of such handicap or loss of earning capacity from which such
rough and ready estimate of the loss can be arrived at. It has to be said
that (and this is perhaps fortunate) not much has been found. Mr Langman was
very frank: "It is recognised that proving stigma is by no means an easy
matter and the existence of stigma in relation to Hepatitis C and its impact
on an individual's current and future job prospects must be a matter for the
courts to decide on the basis of the available evidence. The results of this
research suggests that the majority of [claimants] to date do not appear
to have experienced discernible disadvantage in the labour market, and, whilst
there may be specific examples amongst the sample of [claimants] who
may be adjudged to have been disadvantaged, this could be due to any number
of other factors, such as the individual's background and skills, qualifications
and experience, the level of competition for the jobs applied for, the individual's
age and, in some cases, any previous medical history". Any question of
prejudice or bias against those with Hepatitis C in the employment field must,
of course, be set against the existence of the Disability Discrimination Act
1995. Such prejudice would be irrational (unless grounded on genuine fear
as to hygiene or the risk of horizontal transmission, which would appear either
to be extremely unlikely or at any rate to be capable of being easily resolved
and coped with) and possibly illegal. The area of real concern would seem
not to be in respect of dismissal from existing jobs but the difficulty of
obtaining new jobs, and there are said to be some examples of such problems
in the cases of Mr S, Miss T and Ms V. Mr Langman, at the end of the day,
appeals to what he calls common sense: "It is also suggested that common
sense has regularly prevailed with the courts recognising that if two people
go for a job, and are otherwise equal applicants, if one has a possible investigatable
blemish in their history, then [he/she is] unlikely to be the selected
candidate". There is some anecdotal evidence given by Mr Langman, drawn
from his questionnaires, which is of doubtful admissibility or reliability,
although I pay it some regard because it is evidence that could have been
called (albeit it would then have been cross-examined), and there is some
general opinion about risk, loss or prejudice to those with Hepatitis C drawn
by Mr Brooke QC from Professor Zuckerman and Dr Ryder. Mr Langman also throws
out the possibility that those with Hepatitis C may be regarded as less satisfactory
employees, either because they may be suffering from fatigue or lethargy or
because they may be absent from work due to medical attendance or treatment.
At the end of the day:
- There
is no question of any automatic claim to damages for employment handicap
or stigma by a Claimant affected with Hepatitis C. Evidence either from
the Claimant or factual witnesses or by way of expert opinion must be called
in each case.
- The
most significant evidence of any risk would be in the event of there being
a risk of any 'rational' objection by a potential employer rather than an
'irrational' one: but Mr Langman, though he leaves the door open, and emphasises
the need for precautions, states that "ostensibly there is no reason
why an individual with Hepatitis C should not continue working in, or apply
for, jobs involving food-handling/catering, hairdressing or teaching".
- The
particular circumstances of each Claimant must be looked at, relative to
the person, his or her age or stage of life, his or her stage and type of
employment. Plainly, direct evidence is not necessary, but inferences may
be sufficient.
Financial
Products/Insurance Handicap
- This
is an allegation of loss, as discussed in paragraph 219 above, of a different
kind:
- It
may have already been suffered prior to the hearing – and such a case is
made out in respect of Ms V. Insofar as not yet suffered, I do not see the
difference in principle and do not regard it as in any way a revolutionary
new head of loss (although no previous examples have been drawn to my attention).
Mr Underhill QC in any event did not seek to submit that it was objectionable
in principle, but simply that, with the exception of Ms V's past loss, no
loss was established on the evidence.
- It
is necessary for the purpose of the claim to identify the specific area
of additional expense or loss resulting from the unavailability, or more
restricted availability, of financial products. It will be important, for
example, not to allow such a claim to be a substitute for, or a duplication
of, a lost years claim, by way of an inability to recover life insurance.
- There
must be evidence of the fact that a product would otherwise have been sought
and obtained by a Claimant – e.g. a mortgage would perhaps have been unlikely
in the case of one who had no intention to purchase private housing (see
the evidence of Mr Brimblecombe, that applications for mortgages to buy
houses have slowed down since the 1980s) and life assurance would not necessarily
be taken out by everybody (again I note Mr Brimblecombe's view that only
some 30% of the adult population actively sought to make such arrangements).
- There
must further be evidence that such products, if sought by the relevant Claimant,
would not be available or would be available only at a disadvantage to the
Claimant. The products which have been canvassed by the experts in this
case include life insurance (term or whole of life), critical illness cover,
permanent health insurance, private medical insurance, mortgage protection,
unemployment insurance, travel insurance, and internal private or public
company insurance benefit or pension arrangements. So far as the last is
concerned, the issue is particularly speculative, because much may depend
upon whether the company in question, or its insurer or pension fund, does,
or does not, insist on the filling out of medical information in respect
of existing or any employees. Travel insurance is also much more speculative,
not least in the light of the fact that a number of the Claimants in this
case (all those, I think, who have wished it) have been successful in obtaining
it, and there is, it seems, a real marketing opportunity for sensible travel
insurance companies: like Prudential, which was prepared to offer unconditional
travel cover to Mrs X. However in general in relation to such products,
the question will be whether such cover was, or was not, available on the
same terms that it would have been if the Claimants had not suffered from
Hepatitis C, which they would of course be obliged to disclose in any application.
The various possible answers would be unchanged cover: no cover: less benefit:
higher premiums: special terms: unavailability of automatic increase in
benefits or of waiver of premiums.
- Once
again, as with 'employment handicap', this loss, if established in a particular
case, is one difficult to quantify and must be seen 'in the round'. Mr Asif,
on the Claimants' behalf, skilfully drew attention to Mr Purdy's evidence
about likely standard premiums, to exemplify what a loaded premium might
entail, but this could only be part of a hypothetical exercise.
- I
have had the benefit of very helpful evidence from the three experts, and
particularly the joint report referred to above. I shall have to make my mind
up in relation to each specific Claimant. However, the following appear to
me to be general points to be made:
- As
set out in paragraph 220 above, this does not seem to me to be a matter
of stigma or irrational prejudice. Underwriters are entitled to make their
own judgments. It will be extremely important to make sure that such underwriters
are fully educated generally about Hepatitis C, and informed in particular
as to the individual circumstances and prognosis of an applicant.
- Some
insurance and financial service companies are already more aware both of
their obligations and their opportunities in this area, as is clear from
the evidence by our experts. In particular it would seem that a compassionate
and realistic and educated view has been taken by Norwich Union and Sun
Life, and to some extent also by Swiss Re, M & G, and Medicals Direct,
and, Ms Daniels also told the Court, by Allied Dunbar. It is to be hoped
that those and other companies, and other underwriters like Mr Brimblecombe
and Mr Purdy, are now becoming more educated about Hepatitis C, so that
they will be able to take sensible economic judgments and still provide
financial products to those with Hepatitis C. Ms Daniels is no doubt not
alone in being an IFA who has the specific expertise to help those such
as Hepatitis C sufferers to obtain satisfactory insurance. It is plain that
with what was called a 'cushioned' approach, i.e. an approach to a particular
and sufficiently senior person at a relevant insurance company or underwriters,
with the right amount of information, an application is more likely to succeed.
- Though
Ms Daniels was less sanguine, Mr Brimblecombe was relatively confident of
an improvement in the position:
"...
This is something which is new ... and there is not too much experience of
Hepatitis C. Clearly the life assurance industry and underwriters are careful
and therefore decisions generally on these issues are taken at a high level.
Insurance companies ... once they get a broader experience of Hepatitis C
may take a different approach."
There
also seems to me room for a more sophisticated approach from insurance companies,
for example by doing what they apparently do not do at present, namely giving
cover, for example in respect of critical illness or health, with exclusions
in respect of Hepatitis C; this must surely occur, or occur more frequently,
once the insurance industry appreciates that, unlike the position in HIV where
there are so many interrelated illnesses, with the exception of the very rare
extra-hepatic conditions to which I have referred in paragraph 194 above,
all the complications resulting from Hepatitis C relate to the liver.
- Subject
to all the above however, the evidence from the experts was clear. A Hepatitis
C sufferer is at present only likely to obtain cover on normal terms if he
or she has cleared the virus for at least two to three years. In any other
case with chronic infection, even with mild symptoms, cover is only likely
to be obtained subject to a substantial loading, with no mortgage protection
or critical illness or private health insurance cover.
The
Provision of Gratuitous Services
- Such
a claim arises primarily in the case of Mrs X (though also of Mr S and Mr
U), but I consider it at this stage in general terms, since two issues are
raised by the parties for decision which will be of general impact:
- If,
as in the case of Mr X, Mrs X's husband, a spouse has given up work, can
he claim, in lieu of the commercial cost of care, his loss of earnings,
benefits and pensions (in excess of such costs)?
- If
the appropriate basis of recompense be commercial cost, does there fall,
in respect of provision by a loving spouse of household or nursing services,
to be a deduction from such commercial cost (in this case not suggested
by the Defendants to be more than 25%)?
- Housecroft
v Burnett. Although not of course the first decision in this area of recompense
for gratuitous services (e.g. Cunningham v Harrison [1973] QB 942, Donnelly
v Joyce [1974] QB 454), the central starting point is of course Housecroft
v Burnett [1986] 1 AER 332. The seminal passages are those in the judgment
of O'Connor LJ:
"Where
the needs of an injured plaintiff are and would be supplied by a relative
or friend out of love and affection (and, in cases of little children where
the provider is a parent, duty) freely and without regard to monetary reward,
how should the Court assess 'the proper and reasonable costs'? There are two
extreme solutions: (i) assess the full commercial rate for supplying the needs
by employing someone to do what the relative does; (ii) assess the cost at
nil, just as it is assessed at nil where the plaintiff is cared for under
the National Health scheme ...Very often we find rates being agreed and, as
is shown by the approach of the judge in the present case, regard is had as
to what it would cost to buy the services in the open market, but it is scaled
down. ... Once it is understood that this is an element in the award to the
plaintiff to provide for the reasonable and proper care of the plaintiff and
that a capital sum is to be available for that purpose, the court should look
at it as a whole and consider whether, on the facts of the case, it is sufficient
to enable the plaintiff, among other things, to make reasonable recompense
to the relative. So, in cases where the relative has given up gainful employment
to look after the plaintiff, I would regard it as natural that the plaintiff
would not wish the relative to be the loser and the court would award sufficient
to enable the plaintiff to achieve that result. The ceiling would be the commercial
rate. In cases like the present I would look at the award ... and ask: is
this sufficient to provide for the plaintiff's needs, including enabling her
to make some monetary acknowledgement of her appreciation of all that her
mother does for her? I would also ask: is it sufficient for this plaintiff
should her mother fall by the wayside and be unable to give as she gives now?
... The court is recognising that part of the reasonable and proper costs
of providing for the plaintiff's needs is to enable her to make a present,
or series of presents, to her mother. Neither of the extreme solutions is
right. The assessment will be somewhere in between, depending upon the facts
of the case."
The
Claimants' Submissions
- Mr
Brooke QC effectively submits as follows:
- There
is no binding rule of law, notwithstanding that passage from O'Connor LJ,
that the commercial rate is the ceiling. Stuart-Smith LJ, in Fish v Wilcox
[1994] 5 Med LR 230 at 232, said: "If the plaintiff had had to give up
highly paid work in order to look after her daughter, then no doubt she
would have recovered that figure by way of loss of earnings, rather than
the figure which the Judge in fact assessed, subject, as O'Connor LJ said
in the Housecroft case, to the ceiling, being the cost of providing professional
care. It may that if the plaintiff's earnings had been slightly in excess
of the cost of providing professional care, it would nevertheless have been
reasonable for her to give up that employment to look after her child".
In Lamey v Wirral Health Authority, a first instance decision of Morland
J, reported only in Kemp & Kemp (A4-120), Morland J said: "I
do not understand O'Connor LJ as meaning that [sc. the ceiling of the
commercial rate] is a rule of law but that as a guideline it is an upper
limit. It will be particularly an upper limit in cases of routine care of
the physically or mentally disabled by a carer with professional qualifications".
- The
award must, as Morland J also said in Lamey, be assessed "not only quantitatively
but also qualitatively", and care by a loving spouse is just as valuable
as that by a commercial carer, but provides additional value by way of love
and support. Mr Brooke QC, referring to the case of Mrs X, submitted in
closing as follows:
"What
you have is ... Mrs X being looked after by her husband, from clearly a
long and strong marriage, who is her best friend, who knows her inside out,
who can meet her needs before she actually expresses them, who knows the
house backwards, who knows the family; and so the quality of the care she
is given by him is clearly far better than the quality of care she would
get from a series of day nurses."
- Where
it is in those circumstances reasonable for the loving spouse to have given
up work, the recompense is restitution of the loss so caused to the spouse.
In the case of Mr X this is claimed as his loss of earnings, his loss of
pension and his loss of a tax-free cash sum to which he would otherwise
have been entitled had he remained in employment.
- If
(contrary to the Claimants' submission) it is not appropriate to reimburse
the lost earnings and benefits, but to adopt the cost of commercial care,
then in the light of the authorities it is neither necessary in law to make
any deductions nor, if deductions be made, to deduct 25%. In Lamey a sum
of apparently more than the commercial rate was awarded to the Plaintiff's
parents, in Housecroft itself the reduction was not expressed in a percentage,
but can be calculated out at about 18%, and in McCamley v Cammell Laird
Shipbuilders Ltd [1990] 1 AER 854, a deduction equivalent to 14% was not
disturbed by the Court of Appeal.
- In
Biesheuvel v Birrell [1999] PIQR Q40, Eady J at Q43 was not satisfied that
a distinction could be very readily drawn between 'companionship' and 'care'
and, in a case where the Claimant himself was contending for a 25% discount
and the Defendants for a greater one, he took account of the "level and
intensity of the care required" especially by the mother of the plaintiff
who was a tetraplegic, in accepting the 25% discount contended for by the
Claimant.
The
Defendants' Response
- Mr
Underhill QC responds as follows:
- The
logic of Housecroft is quite clear, that the "extreme solutions"
(full commercial costs on the one hand and nothing on the other) are normally
both inappropriate.
- Fish
makes clear (at Court of Appeal level) that if there is any flexibility
in O'Connor LJ's ceiling, it is a minimal one.
- The
test for recovery of a sum for reimbursement of gratuitous care is of reasonable
recompense: thus per Megaw LJ in Donnelly at 461-2 "the proper and reasonable
cost of supplying those needs", in Housecroft itself per O'Connor LJ
at 343e "reasonable recompense to the relatives" and in Hunt v Severs
[1994] 2 AC 350 at 363 per Lord Bridge "the reasonable value of gratuitous
services rendered to him by way of voluntary care by a member of his family".
- In
Lamey the care given was recognised as having been extraordinary: (per Morland
J) "The many many hours of care for her over more than eleven years ...
I have no doubt, have caused Mr & Mrs Lamey real and significant distress.
Care and supervision have been required day and night. Not surprisingly
through broken sleep, worry and anxiety Mr Lamey has been fatigued and unable
to concentrate and put as much into his business as he had done before Elizabeth's
birth. Mrs Lamey has been depressed and required medication ... Both [experts]
found it difficult to suggest what was suitable recompense for Mr &
Mrs Lamey's care for Elizabeth at night, which involved putting her back
to sleep several times a night, and most nights having to change her bedding
when wet ... Miss Smalley's figure of £42,982, did not take into account
night care. Both Miss Smalley and Miss Buckle did not regard a paid sleeper's
rate, currently £25 per night, as appropriate for parental nightcare. With
that view I agree". Even in that case Morland J rejected a claim based
on alleged loss of profit in Mr Lamey's business as a proper basis for the
cost of care; and it was in those circumstances that the sum awarded was
slightly over the outsider's rate – but a rate which the Judge, and the
experts, clearly thought was not commercially appropriate.
- In
McCamley although the Court of Appeal left the Judge's award unaltered,
O'Connor LJ said as follows: "The defendants say that the judge has applied
the full commercial rate and that we should interfere and reduce it, perhaps
by half. The judge has in fact reduced the amount suggested by Mrs Watkins
by some £4000. We confess that we regard the judge's assessment as very
high. On the other hand there is no doubt that, certainly in the early stages,
a very great burden was put on Mrs McCamley ... The present case is near
the bone, but the judge has made some reduction and we do not feel it would
be right to interfere".
- The
substantial justification for the deduction from the amount that is actually
charged for commercial care, on the evidence of experts, is in respect of
tax and national insurance, which is of course not paid to or in respect
of a gratuitous carer. This is well established, but is particularly clear
from Fitzgerald v Ford [1996] PIQR Q72 (CA) (a case in which a claim based
on loss of earnings was rejected), where Stuart Smith LJ indicated: "The
gross cost of employing a carer ... obviously ... is not the relevant figure.
It should be the net cost, which, after a reduction of 25% for tax and national
insurance, comes to about £82,000".
- I
accept the submissions of Mr Underhill QC, and am satisfied that the following
is the position:
- The
appropriate question is reasonable recompense for the carer. The carer is
however, not the victim of the tort, and is not entitled to his or her own
claim for reimbursement of loss caused by all and any reasonable steps taken
in mitigation or in consequence. The claimant is the victim; and the issue
is what is reasonable to pay for his or her care to the gratuitous provider
of such services.
- It
is clear that the care given by a loving spouse may be additionally supportive,
and may be preferable from some points of view to outside qualified care:
it may also involve considerably more dedication, concentration and effort
than would, on the facts of a given case, be given by an outsider. It is
plainly right that the services must be valued qualitatively as well as
quantitatively. However the kind of services that are indicated in Lamey,
or indeed in other cases involving care for an extremely physically handicapped
or mentally handicapped claimant, fall into such a category. There is no
authority relied upon by the Claimants which would support the proposition,
nor in my judgment is it the case, that simply giving to a claimant the
same services, but with greater affection, would justify payment over and
above commercial cost.
- The
justification for the discount is substantially the saving of tax and national
insurance (although there may be additional justification for discounts,
if, for example, the level of the care is inevitably less than a commercial
cost because of the absence of special qualifications possessed by a commercial
carer). If such discount is not allowed for, then the recipient is receiving,
by way of a gross sum including provision for tax and national insurance
for which he or she will not in fact have to account to the Revenue, that
amount more than the cost of commercial care.
- In
Nash v Southmead Health Authority [1993] PIQR Q156, a deduction of one third
of the commercial rate was made by Alliott J in respect of care provided
by the plaintiff's parents in respect of dressing, bathing and eating. In
Fairhurst v St Helens and Knowsley Health Authority [1995] PIQR Q1 at Q4,
Judge David Clark QC made a 25% deduction, rather than a one third deduction,
because "caring for [the plaintiff] undoubtedly involves special
skills over and above those normally possessed by Crossroads assistants
or nursing auxiliaries". In Petrovska v Mullings (13.8.99 unreported)
I concluded "that there ought to be a discount of one third, which is
or has become the norm for discount from the commercial rate, save where
special skills are required (and allowing for the absence of incidence of
tax or national insurance)". On that basis, if a 25% deduction is adopted,
which is all that in this case the Defendants contend for (the defendants
in Biesheuvel having contended for a greater discount), then there is already
a slight uplift to allow, if not for special qualifications, then for extra
love and support; although, as pointed out in the course of argument, love
and support must be the inevitable basis of the provision of almost any
gratuitous services that can be contemplated, so, if material, it would
follow that it would be likely to apply in every case.
- In
the absence of any special evidence of any exceptional circumstances, I conclude
that the proper recompense for gratuitous services in these cases will normally
be commercial cost, less a deduction to allow at least for tax and national
insurance, which in this case is conceded to be no more than 25%; and that
it is not appropriate to allow recovery in respect of loss of the gratuitous
carer's earnings or benefits of more than that amount.
Discount
Rate
- The
final point of general interest raised by the Claimants in respect of quantum
was Mr Brooke QC's contention that, notwithstanding, or in the light of, the
decision of the House of Lords in Wells v Wells [1999] 1 AC 345, and notwithstanding
the absence of any exercise by the Lord Chancellor of his powers under s1
of the Damages Act 1996 to set a rate, I should adopt, for the purpose of
calculation of the multiplier in respect of future loss, a discount rate of
2%, rather than the 3% adopted by the House of Lords. I dealt at a little
length with a similar submission made by Counsel for the claimant in the case
of Petrovska, in that case allowing the belated admission of what was, in
the event, agreed actuarial evidence in support of such contention, and rejected
it. Although my decision in Petrovska was not appealed, there has subsequently
been a binding decision of the Court of Appeal in Warren v Northern General
Hospital Trust [2000] PIQR Q284, which firmly concluded that there were no
grounds in law, and in any event none in fact, to alter the discount rate
of 3% set in Wells v Wells. In the event that I had entertained Mr
Brooke QC's submission, Mr Underhill QC indicated that he would have sought
to adduce evidence in opposition to the belated evidence to be adduced by
Mr Brooke QC. I indicated that there was no need for him to do so, as I rejected
Mr Brooke QC's contention. In those circumstances, the position of both sides
is preserved so far as concerns any appeal: but I shall continue to adopt
the 3% rate, for the reasons given both by me in Petrovska and more conclusively
by the Court of Appeal in Warren.
ISSUE
VI: THE SIX LEAD CASES
- I
turn to consider each of the six lead cases, and to resolve the outstanding
issues of quantum with regard to each.
Mr
S
- Mr
S is now 17. He gave evidence, as did his father and mother, with whom he
lives, and his elder brothers, who have now left home. He was hospitalised
with a head injury and a broken leg from a car accident when he was aged 7,
and in the course of treatment for his injuries on or about 3 April 1991 he
received a blood transfusion, which was infected with Hepatitis C virus. He
was informed of his having been infected in November 1995, as a result of
the Defendant's Look-Back programme, referred to in paragraph 1 above. He
tested positive by ELISA for Hepatitis C antibodies, but has always, as from
the first PCR test in November 1995, tested PCR negative, and his ALT was
normal. He is thus one of the 20% referred to in paragraph 191 above, who
spontaneously cleared the virus. He had three negative PCR tests, and never
required a biopsy, and by a letter of 16 March 1999 Professor Day wrote to
confirm that "he has completely cleared the virus and is therefore not
at risk of chronic Hepatitis C". He has had no physical symptoms and has
normal liver function, but he has been diagnosed by Dr Master, and confirmed
by Professor Wessely, to have been suffering from an adjustment disorder for
a three and a half year period, ending on receipt of Professor Day's letter.
He has never been tested for genotype, and therefore it is unknown. His prognosis
is excellent, and his worst case risk is of a 1% chance of developing some
symptoms in more than thirty years: he must, of course, like all those who
are opting for provisional damages, in any event be viewed on the basis that
he will always remain in a condition short of activating any of the five triggers,
for in that event (which in Mr S's case is wholly unlikely anyway) he could
in any event apply for further damages: I direct, by agreement, that all five
triggers apply to him. He received a letter dated 7 July 2000 from his consultant,
after his last review which states: "As always he is very well indeed.
He is now 17 years old and we have been following up for five years because
of Hepatitis C positive antibodies. In that time his Hepatitis C PCR has always
been negative and his liver function tests have always been entirely normal.
I repeated his blood tests again today and as before his liver function test
and Hepatitis C PCR were negative. I think therefore that we can conclude
that [he] has cleared his Hepatitis C and I have not arranged to review
him again."
- The
Issues. There are the following issues between the parties in Mr S's case.
I propose in relation to all the Claimants not to record all the items of
damage which have been agreed prior to the hearing or during the course of
the trial, unless there is some particular relevance:
- Quantum
of general damages for PSLA by reference to the sub-categories of (a) infection
simpliciter (b) adjustment order (c) vulnerability.
- Employment
handicap.
- Gratuitous
care.
- Follow-up
costs.
- PSLA
- There
is no suggestion in the case of Mr S that he has suffered from fatigue.
His problem was rather the reverse, namely that he became aggressive, ill-tempered
and moody. He was upset about being told about the infection, and, particularly
in those days before quite as much was known about horizontal transmission,
about the fact that it could be contagious: he was anxious about the precautions
that he was told he had to take, which affected his relationship with his
young nephew, and he was concerned about his future and about parenthood.
He had a panic attack when he cut himself in a woodwork class at school
and a teacher tried to help, and similarly, later, at his work when he cut
his head. He was, until his final reassurance by Professor Day in March
1999, fearful that the virus could flare up at any time. He suffered a certain
amount of worry about telling people his condition; for example he was anxious
about going away on holiday with a school friend without telling him or
his parents about it, and an ex-girlfriend's mother was unpleasantly rude
to him about his condition.
- It
is, in my judgment, impossible in Mr S's case to differentiate, in assessing
his total condition and his damages, what is categorised as the infection
simpliciter from the adjustment disorder; for in his case the latter lasted
through to the date when he was reassured, and in fact tied up with, or
led to, the aggressive and other unacceptable behaviour which were the only
outward symptoms he had, and which were plainly the external manifestations
of his own internal concerns and worries. In effect, he had three years
of bad behaviour, aggression and intolerance towards his parents and brothers.
It seems to have affected his home life rather than his school time, for
he did not absent himself from school, and although his school records indicate
a distraction and a lack of co-operation and attention, with a number of
reports for poor behaviour, it amounts to nothing that is much worse than
one could expect of many teenage schoolboys. But at home he was very difficult:
picking quarrels with his mother in particular, fighting with his brothers
and his father and being totally unco-operative. Professor Wessely agreed
that "he developed what is best described as an adjustment disorder,
associated with conduct and emotional disorder. I would agree that whilst
many, perhaps even all, adolescents experience mood changes and argue with
their parents, this was out of the ordinary and amounts to a recognised
psychiatric disorder". His father, mother and brothers gave evidence
of his unacceptable behaviour, of locking him into his room and of frequent
temper tantrums and fraught discussions. I note also the breakages, whose
cost has been accepted by the Defendants.
- I
accept and find all that. However I also accept and find as follows:
- He
was advised by Dr Ryder that he did not need to adopt any different practices
with regard to alcohol, or to sex, than he would otherwise do: that he
was at no risk at all of sexual transmission.
- It
is not an easy life to be the youngest of three brothers, and it would
seem they had been considerably better behaved teenagers than he, which
was no doubt frequently pointed out to him, and they, and in particular
the middle brother, Raymond, were not prepared to accept any cheek from
him.
- He
was not as a result of his condition inhibited from playing football,
which he continued to do as long as he wanted, although by the time he
was fifteen he had ceased to be interested in playing for the local team
and preferred other activities.
- I
do not put his relatively unsatisfactory school performance (which was
reflected in similar comments even before his knowledge of his infection)
down to his condition or his awareness of it.
- Even
after he had had the good news from Professor Day, and his adjustment
order was at an end, he continued to be occasionally obstreperous and
provocative at home. His middle brother was asked to carry out the somewhat
difficult task of assessing "what proportion of his total behaviour
you think was due to his natural character?" to which he answered:
"I would say at least 25-30% of him, of his cheekiness and everything,
out of the whole proportion, but the rest of it was pure nastiness, I
think."
- He
is now able to put behind him not only the teenage years but also the
fears which have now been totally resolved by the prognosis.
- Vulnerability.
I refer to my conclusions in paragraph 209 above. There was no suggestion
but that Mr S is a perfectly resilient young man, now facing the future
with confidence, as Dr Master and Professor Wessely agree. However Dr Master
sought to promote his theory by ascribing vulnerability to him "in statistical
terms" or "all in a statistical sense". For the reasons I have
given I do not accept this, and make no provision for vulnerability. Of
course the fifth trigger is there for him, in the unlikely event that it
is required.
- I
have been referred to authorities and references relating to quantum for
my guidance by both parties. The Claimants, on this and other cases where
an adjustment disorder is relevant, namely U and V, have referred to Ross
(1991) Kemp & Kemp C4-058 (Master Topley), Waller (1993) Kemp
& Kemp C4-051 (Judge Peppitt QC), Khan (1996) Kemp & Kemp
C4-066/1 (Judge Altman), Watson (1998) Kemp & Kemp C4-049 (CICB),
Long (1999) Kemp & Kemp 2000 C.L. 118 (CICB), and the CJD Litigation
(unreported, 19/6/98) (Morland J). The Defendants have taken me to the fifth
edition of the Judicial Studies Board ('JSB') Guidelines, updated in late
2000, since the June issue of Kemp & Kemp, relating to psychiatric
damage. These important guidelines split up psychiatric damage into Severe
Psychiatric Damage, Moderately Severe Psychiatric Damage, Moderate Psychiatric
Damage, and Minor Psychiatric Damage, and set out material factors to illustrate
the suggested categories and also broad bands for quantum (in relation to
the last two categories, £3000 to £9500 and £750 to £3000). The Defendants
suggest that Mr S's three year adjustment disorder falls within the last
of the four categories. They also refer not only by reference to Mr S, but
also the other lead cases, to Slimings (1992) Kemp & Kemp C4-111
(Scott Baker J), Evans (1992) Kemp & Kemp C4-109 (D. J. Evans)
and Howell (1995) Kemp & Kemp C4-074 (D. J. MacMillan) and, with
regard to the adjustment disorder, to Szulc (1995) Kemp & Kemp
C4-113 (Judge Alton) and Carpenter (1997) Kemp & Kemp C4-114
(Judge Lorriston). I have also noted Rubens (1997) Kemp & Kemp
L3-052 (Judge Peppitt QC). I invited the parties to put forward their suggested
figures. The Claimants submit £10,000 for infection simpliciter plus £10,000
for adjustment disorder, namely a total of £20,000: the Defendants put forward
£1000 for infection simpliciter plus £3000 for adjustment disorder, thus
a total of £4000.
- I
have considered these cases and the parties' submissions. For the reasons
I have given, I find it impossible in the case of Mr S to sever out infection
simpliciter from adjustment disorder, as I have been invited to do. Apart
from the adjustment disorder and the behaviour exemplifying it, as to which
I must obviously pay close regard to the JSB Guidelines, I take into account
in addition the fact that Mr S was actually infected (rather than simply fearing
he was infected as in Slimings, Evans and Howell), albeit that there was a
lack of physical symptoms and a spontaneous clearance of the infection before
he was aware of it; his anxiety and concerns; his embarrassment with his friends;
and the fact that the adjustment disorder lasted three and a half years. My
conclusion as to damages in total, and having looked in the round and paid
regard to his good prognosis and the fact that (unlike in the CJD Litigation)
the damages are provisional on the basis discussed, is a sum of £7000. If
I had to split this sum, notwithstanding that the same underlying behaviour
and symptoms relate to each of the aspects of the award, I would, with some
reluctance, split it equally; but the total sum would better reflect the correct
answer in respect of the whole period, effectively of three and a half years
from discovery to total reassurance.
- Employment
Handicap. I refer to paragraph 222 above. The Claimants claim £2500 and the
Defendants respond with nil. Mr S has been working in the catering trade now
for some time, and without difficulty. He had filled in a health questionnaire
before joining, which he did, after advice from his parents, without problems.
He would like to be an estate agent, having worked for one on a work placement,
and is in the process of applying. If he were to remain in catering, there
is in fact no sufficient evidence from Mr Langman (rather the reverse, as
appears in paragraph 222(ii) above) that this would create any difficulty,
and, in any event, he will by then have a proven track record of working in
the catering industry. Estate agency would seem to create no problems at all.
The crux in any event so far as Mr S is concerned is that he spontaneously
cleared the virus and has been PCR negative for five years. I can see no evidence
of, nor grounds for inferring, any risk on the labour market. I make no award.
- Gratuitous
Services. I refer to paragraph 231 above. I do not see any grounds in this
case for not making a Housecroft deduction, which in this case the Defendants
concede at 25%. In fact, by making a 25% deduction I suspect more is being
paid than the commercial rate, simply by virtue of the fact that the commercial
rate incorporates tax and national insurance at a percentage likely to work
out at rather more than that. In any event, Mr S's parents are being recompensed
for devoting more time and effort than can have been expected from normal
parents, and that is why they are being paid at all. I agree with the Defendants
that there is insufficient allowance, if payment were provided for in respect
of one hour per day at the net commercial rate, for the fact that the behaviour
with which they were dealing was to an extent that of an obstreperous teenager,
overlaid by his disorder. His teenage years were a worse experience for them
than those of either of his elder brothers, but I suspect that that is very
often the position with the youngest of three boys, and, given the teenage
character of Mr S, I conclude that there would have been a good deal of coping
with tantrums and aggression in any event, as perhaps Raymond recognised.
The fact that this is the case is further underlined by Mr S's continuing
behaviour after March 1999, which I do not ascribe to his condition. That
supports my conclusion that to allow for one hour per day throughout for coping
with behaviour caused by the adjustment disorder would overcompensate, so
that it falls to be reduced by the 25% allowance for which the Defendants
contend; it also leads to my acceptance of the Defendants' contention that
there should be no recovery after 31 March 1999. The rates are agreed, but
they must be net of the Housecroft deduction. The figure, after the further
allowance and disallowing the period after 31 March 1999, is £3512.25, which
is the sum I award.
- Follow-Ups.
I refer to paragraph 214(ii). The cost of an annual follow-up is claimed.
The Defendants discount the figure by 50%, to allow for the probability that
there will not be an annual follow-up in respect of those, such as Mr S, who
will have been PCR negative for many years. In his case there is the additional
factor of the receipt of the letter of 25 July 2000, which I have set out
in paragraph 234 above. I accordingly accept the Defendants' figure of £56.08,
adopting the agreed multiplier.
Mr
U
- Mr
U is now 32, and gave evidence. He has a wife, who also gave evidence, and
two young children, with whom they live. He was infected in January 1991,
while hospitalised with orthopaedic injuries after a road traffic accident.
His infection is by genotype 3a. He also learnt of his infection as a result
of the Look-Back programme, in March 1996, and tested PCR positive. He had
biopsies in 1996 and 1998. He underwent Interferon monotherapy in 1996-7 over
a period of nine months, and briefly responded, but soon thereafter reverted
to PCR positive again. He had combination therapy for six months, starting
in December 1998, which was successful. He is still PCR negative after tests
in November 1999 and May and October 2000. He has therefore cleared,
or has 'controlled', the virus: there is the very small risk that he may be
one of the very exceptional cases who revert to positive, as discussed in
paragraph 191 above, but, for the purpose of provisional damages, because
of the existence of the first trigger, it must be assumed that he will not
do so. He has no liver damage, as was made clear by the biopsies, and Dr Ryder
put his worse case scenario as a 5% risk of liver disease in twenty years.
Mr U described himself in evidence as 'back to 100%'. He was diagnosed
by Dr Master, and confirmed by Professor Wessely, to have had an adjustment
disorder for a short period of two months from March to May 1996, immediately
after the discovery of the infection, and a very short further transient period
in May 1999. He too opted for provisional damages, and I so direct, with all
five triggers applicable; so that he is to be assessed on the basis (as indeed
is overwhelmingly likely to be the case, given his favourable prognosis) that
he will remain short of the conditions there provided for.
- The
Issues
- Quantification
of General Damages for PSLA in the sub-categories of (a) infection simpliciter
including fatigue. Adjustment disorder is agreed between the parties at
£1000. As for vulnerability to future disorder, this is thus not a separate
issue and in any event the 'Master theory' does not arise, and Professor
Wessely's view, which I accept, was that Mr U would only be at risk of a
further problem if it were to be that he had not cleared the virus, which
he has (and/or the trigger(s) will provide for it): (b) the two biopsies:
(c) the two Interferon treatments.
- Employment
handicap.
- Insurance
handicap.
- Gratuitous
care, past and future.
- Follow-up
cost
- PSLA
- Mr
U was devastated, as anyone would be, to learn of his infection. It affected
his sleep and his appetite. He became lethargic and anxious about the fate
of himself and his family. He was of course, until his second Interferon
treatment, PCR positive, and he was very worried about his prognosis. His
relations with his wife were affected by their worry about infection and
they used contraception, although not always, as is clear from the conception
of their second daughter in 1997. Like Mr S, he had a worrying time with
a cut finger.
- His
evidence about his fatigue and lethargy, which plainly arose from his inevitable
stress and anxiety (and no doubt also during, and because of, his short
adjustment disorder) has, I am satisfied, its limits however. He asserted
that it was because of fatigue that he left his senior job with a courier
firm, in respect of which he also made a claim for loss of earnings. After
he had begun to be cross-examined about the latter topic, he abandoned his
claim for loss of earnings; and I am satisfied that the reason he left the
courier company was rather to further his business opportunity to work for,
and soon after go into partnership in, a music business, which has substantially
prospered. As a result of two promotions in the courier business, he was
in fact doing much less manual work, if any at all; although he may have
been labouring under a degree of 'middle management stress'. However it
is clear that he was not driven to leave by the need of a break from work,
due to fatigue, but rather went straight into his new business. In those
circumstances I discount the evidence he has given about fatigue, although
I accept the evidence, to which I refer below, that he, like others, suffered
from tiredness during the period of his Interferon treatment.
- There
is no doubt that he and Mrs U were worried about intimate relations. But
this is now, it is hoped, resolved. With the benefit of advice to the effect
referred to in paragraph 197 above, both of them are prepared to reconsider
and readdress their concerns.
- His
morale is now restored and, having been PCR negative for more than a year,
he can put it all behind him. He was not back to his 'old self' in 1998
(no doubt because of the Interferon treatment to which I shall refer) but
he is now '100%'. He confirmed too that "the tiredness is not
there any more, no lethargy any more".
- As
to quantum in respect of infection simpliciter including fatigue, the parties
refer to the same authorities. The Claimants put forward a sum of £12,500
for infection simpliciter and £2250 for fatigue, totalling £14,750: the
Defendants £2500 for infection simpliciter, and nothing for fatigue.
- He
had two biopsies as set out above, under local anaesthetic and without having
to stay overnight. The site was sore, but he was not frightened. As for
quantum in respect of the biopsies, I refer to what I have said in paragraph
214(i) above. The Claimants put forward £500 per biopsy (thus £1000 in all),
and the Defendants £250 each, £500 in all.
- As
to Interferon, he had two treatments, the first lasting nine months and
the second six months. The side-effects were as discussed in paragraph 215
above. He suffered flu-like symptoms, lost appetite and lethargy: on the
second occasion also loss of weight and hair – both of which were restored
after the treatment. He did not self-inject, and so his wife carried out
his three-times weekly injection for him. He continued to work throughout
both courses, and was reported contemporaneously as having coped very well
with the first course. He confirmed in evidence that "you tend to get
used to it" but he described it as "horrible stuff". Although
disappointed by the failure of the first course, I do not conclude on the
evidence that such disappointment needs to be separately compensated (see
paragraph 215 above). The second course too he managed to adjust to, by
developing his strategy for minimising the problems. As for quantum in respect
of the Interferon treatments, the same point applies as in respect of biopsies,
namely the effect of its being only part of an overall condition; but of
course their duration was considerably longer than a biopsy. The Claimants
refer to a case which was, but it seems is no longer, in Kemp & Kemp
called Ashworth v Jackson (March 24, 1970, CA) which is a case involving
the accidental contraction of brucellosis by a 36-year old man producing
disturbing and unpleasant symptoms over a period of five months: the Court
of Appeal approved a figure of £200, which I am informed would now be equivalent
to £1834. The Claimants put forward figures of £5000 in respect of the first
treatment and £2500 in respect of the second, namely totalling £7500. The
Defendants' figure is £1500 plus £1000, totalling £2500.
- As
indicated above, the adjustment disorder is separately dealt with by the agreed
sum of £1000, and I am not prepared, particularly in this case, to assess
fatigue separately. I take into account that the knowledge of the infection
lasted longer than it did in respect of Mr S, whose virus cleared spontaneously,
although the adjustment disorder was far shorter in this case, and is being
separately provided for. I note the favourable prognosis, the fatigue now
cleared up and the fact that the periods with Interferon are also separately
assessed: and again the fact that the damages are provisional. My figures
are, for infection simpliciter (including fatigue) £5000: for the biopsies
£250 each, and for the Interferon treatments £2000 for the first and £1500
for the second, totalling £9000. These sums, plus the agreed £1000 for the
adjustment disorder, result in a total of £10,000 in aggregate, which I approve
and award, and it is that total sum which falls to be compared with the figures
awarded in the cases referred to in paragraph 236(v) above.
- Employment
Handicap. The Claimants put forward £5000: the Defendants nil. In the light
of the factors that (i) Mr U had a successful job in the courier business
which he left voluntarily (ii) he is now self-employed and is making a success
of the music shop business, with an additional shop opened recently (iii)
he is and will have continued to remain PCR negative, there is no evidence
before me, nor inference that can be drawn, of any risk to him of loss of
earning capacity by virtue of his condition. I make no award.
- Insurance
Handicap. The Claimants put forward £1500: the Defendants nil. He has prudently
made his own insurance arrangements already, as he explained, including three
policies with Allied Dunbar, and he has already remortgaged. In any event,
the evidence from the agreed joint experts' report is that further cover is
likely to be available to him, whether for five or fifteen years life cover,
or five or fifteen years critical illness protection, at normal rates: indeed
Norwich Union have offered both, and accidental death cover, at a nil rating.
I make no award.
- Gratuitous
Services. Mrs U has been a great support to Mr U. For the reasons given in
paragraph 227 to 231 above however, I consider that insofar as she may be
entitled to recompense in respect of time spent over and above that spent
in ordinary course by a wife's support and companionship of her husband, there
should be the Housecroft deduction, conceded by the Defendants to be 25%.
As with others, the excess over what has been called 'wifely support' is not
recognised by a wife being paid an excessive amount, but rather by her being
paid at all, and there is no justification for more than the net commercial
rate. The Defendants have however limited this recompense to the period of
Mr U's actual adjustment disorder. I consider that Mrs U should also be recompensed
in respect of her assistance during his periods of Interferon treatment, when
she injected him and no doubt gave other additional support. My conclusion
is of an extra one and a half hours per week for sixty five weeks at £4.80
per hour less 25%, namely £351 additional to the £123.12 conceded. I see no
grounds whatever for allowing any further care in the future, in that he is
back to 100%, and not likely to have any further treatment.
- Follow-Up
Cost. I refer to paragraph 214(i), and for the reasons there given it is right
to discount, as the Defendants do, for the probability that there will not
be annual check-ups at least for very long, and, in any event, as it is neither
reasonable nor appropriate to provide for attendance by Mrs U. I agree with
the Defendants' figures of £52.77 on the agreed multiplier.
Miss
T
- Miss
T is now 20, and gave evidence. She lives with her parents, and her mother
gave evidence: a statement was provided from one of her former teachers. She
is now a legal secretary at a firm of solicitors, having been promoted in
December 1999, after two years as office junior. She was infected on 16 February
1990 when, aged nine, she was given a blood transfusion during treatment for
a kidney disease. She is genotype 4. She was identified by the Look-Back programme
in September 1995, and tested PCR positive. She has had two biopsies, both
under general anaesthetic, because she was fearful of them, in October 1995
and December 1997. She underwent combination therapy for a year, starting
in May 1999, and tested PCR negative in April 2000, but reverted to PCR positive
some three months later. She has had no physical symptoms, nor fatigue otherwise
than during the Interferon treatment, when she suffered not only the 'usual'
side-effects, but also from hypothyroidism, a risk from Interferon as appears
in paragraph 205 above, which required to be separately, and successfully,
treated by thyroxine. Her prognosis is very good, with no fibrosis and only
minimal inflammation shown on the biopsies. Her worst case scenario, according
to Dr Ryder, is that she may develop liver symptoms after twenty years, but
more likely after more than fifty years: according to Dr Alexander the risk
is "close to zero". She is agreed to be psychologically resilient,
and has suffered from no disorder. She also opts for provisional damages,
and I so direct, with all triggers applicable, save the first (she already
being PCR positive).
- The
issues in her case are:
- Quantification
of general damages for PSLA in the sub-categories (a) infection simpliciter
(b) biopsies and (c) the Interferon combination therapy.
- Whether
she is to have further therapy, in say one year's time, in which case the
agreed cost of pegylated combination therapy, if it has to be paid for,
is, discounted, £12,340: but she claims additional general damages for the
period of the treatment (also discounted).
- Employment
handicap.
- Insurance
handicap.
- Follow-up
costs and future biopsies.
- Further
Interferon. It is in my judgment essential first to decide, in the case of
Miss T, whether I am satisfied that she should have, and recover in respect
of, further, pegylated, combination therapy in one year's time, because this
then sets in context some of her other claims. As for the Poynard predictive
factors, referred to in paragraph 204 above, she is young, female and with
no existing fibrosis, but she is genotype 4, which renders success in treatment
somewhat less likely than in respect of genotypes 2 and 3, but more likely
than genotype 1: and of course, although initially responding, which was in
itself, as I understand it, a good sign, she relapsed to positive and was
therefore unsuccessful, on the last occasion. She would not undergo combination
therapy again, but was emphatic in evidence that she would be prepared to
try a new course of treatment, such as the pegylated therapy. Dr Ryder would
not be recommending her to undergo pegylated treatment, because, as he put
it, "she has very mild liver disease. There is no data in this situation
to give her any realistic idea at the moment of what the chance would be ...
The risk of progression without treatment ... in her case ... is very low".
The factors against her having the therapy are clear, apart from Dr Ryder's
own such view. The side-effects are likely to be unpleasant again, although
it may be that they may be less worrying, not least because, with pegylated
therapy, there is only need for one injection per week as opposed to three,
and it appears to be the immediate effect of the injection which is the most
difficult to cope with. There is a 90% chance of her suffering again from
hypothyroidism, as she did before, and Dr Ryder considers that, this time,
there would be a slightly greater than 50/50 chance that it would be permanent.
She would certainly not like it at all if she had to have a biopsy, prior
to the carrying out of any such treatment. However:
- She
knows the side-effects are likely to be unpleasant, and yet confirmed vigorously
that she would still be prepared to try the treatment, even if they were
worse than last time.
- She
is prepared to take the risk of hypothyroidism, which in any event was controlled
by thyroxine.
- Dr
Ryder confirmed that, in fact, it would probably not be necessary to carry
out a biopsy before further treatment: although he would feel slightly uncomfortable
in not knowing where he was starting from, he would certainly be able to
carry out further treatment without one, and I suspect that would certainly
be so in the case of Miss T, where he is already satisfied as to her present
condition, as set out above.
- She
is plainly a very determined young lady, as indeed are her parents, as is
clear from the endeavours they took to ensure that, notwithstanding initial
resistance, she was taken onto Professor Bassendine's trials on the last
occasion.
It
seems to me clear, as I shall set out below, that Miss T's only real surviving
worry, but it is a very substantial one, is about vertical transmission, the
possibility of transmitting the virus to a child if she became a mother. Quite
apart from the smallness of that risk, which I have already addressed and
shall refer to below, and the probability that in any event her concerns can
be substantially if not wholly alleviated, I consider that, if further therapy
were successful in rendering her PCR negative, that would remove the last
hurdle to her self-assurance. I am satisfied that she will have the further
therapy, and that it is reasonable that she should do so, and indeed that
it may well be successful. It is clear that pegylated therapy is more likely
to be successful than standard combination therapy; she was nearly successful
last time, she will be very compliant with the treatment, unlike perhaps some
patients, as Dr Alexander has recognised, and she is not a genotype 1. As
for payment, I am sure in the light of the evidence that pegylated combination
therapy will be licensed and available under the NHS, if not in the next few
months then certainly by the time that Miss T undergoes the therapy in a year's
time. However it seems to me clear that she would not come within the NICE
Guidance, and that I cannot be at all sure that there would be any trials
available to which she would be likely to be admitted without charge. Accordingly
I award the £12340 sought.
- PSLA.
- As
set out above, she has had no symptoms of fatigue resulting from her condition;
her prognosis is very good, irrespective of the success of the further therapy;
she may clear the virus as a result of such therapy and/or her prognosis
may further improve; and in any event well before fifty years time it seems
to me likely there will be a cure. She is, as has been pointed out, a very
positive person. I cannot ascribe her scholastic under-achievement to her
condition, not least in the light of her own very graphic description as
to how it is that she found herself, as so many teenagers do, involved in
a peer group for whom studying was not a priority: given the lack of psychological
or physical symptoms which might explain it, and the fact that even prior
to the diagnosis of her condition there is some sign of her lack of attention
in school, any such suggestion cannot be supported. She is not inhibited
by the slight restraint on her alcohol consumption, and is able, and has
the energy, to go clubbing and dancing as she wishes. The only example of
embarrassment caused to her by her condition, and it was obviously distressing,
was in respect of requiring dental treatment: it seems to me that this should
be urgently addressed by the professional body of dentists, so that dentists,
too, can become sufficiently educated, such that it is to be hoped that
such embarrassment will not recur. The real and central problem, as I see
it, is her initial anger, and now her worry about the risks partially in
respect of sexual transmission, but more centrally with regard to the possibility
of vertical transmission. It is clear in fact that Miss T has had very little,
if any, advice about this, namely a short discussion with Professor Bassendine
about the small risk of transmission to a partner or child. Miss T's reaction
is that a small risk is too much, and that before she went ahead to become
pregnant she would have to feel certain about the position. I have already
set out, in paragraph 197 above, what the real position appears to be, not
only in relation to the very small risk of transmission, but even with regard
to the consequence to the baby even if such very small risk in fact ensued,
not to speak of the ever improving methods of treatment available. However,
at least at present, Miss T has this lingering worry, which will become
more pressing as and when (still quite some way into the future) questions
of possible parenthood become relevant, at least unless the further therapy,
which I have allowed, renders her PCR negative. The Claimants put forward
a figure of £20,000. The Defendants have put forward £5,000.
- As
for the two biopsies, as I have set out they were both under general anaesthetic,
because she was frightened about what was going to happen: indeed she worried
for about two weeks before each biopsy, and found it difficult to sleep.
As a result, she was required to stay in hospital the night before and the
night after each biopsy. She had considerable pain for some time afterwards,
and indeed after the second biopsy intended to return to work two days after
the biopsy, but needed an extra day off because of the pain, missing the
firm's Christmas dinner. The Claimants claim in respect of each biopsy £2000.
The Defendants suggest £500 each.
- The
Interferon lasted between May 1999 and May 2000, with self-injection three
times per week. Her side-effects were headaches, pain on opening her eyes,
loss of appetite, dizzy spells, muscle spasm, sore throat, fever, nosebleeds
and weight loss and hair loss. The symptoms were primarily after each injection,
which she carried out on a Tuesday, Thursday and Sunday, with the effect
that she had no energy to go out on those evenings, with consequent detriment
to her social life: but she was able to go to work, and indeed to go away
on holiday. Her fatigue was exacerbated by the hypothyroidism which developed
shortly before Christmas 1999, and continued through until it was completely
controlled by thyroxine in January, whereafter both it and its symptoms
resolved: but while she was affected by it she was totally lacking in energy,
indeed such that she went to bed halfway through her own birthday party.
Apart from the period of hypothyroidism, it is apparent that she became
used to the side-effects, and coped reasonably well both at home and on
holiday. When, shortly after the completion of the treatment, her PCR reverted
to positive, she was disappointed, but said in evidence that she had always
known that there was a 50/50 chance, and had prepared herself for the worst,
and was not as upset as she had been when she was refused for the trials
originally, because she had given it the best chance she could. The Claimants
claim £7500 in respect of the twelve-month period combination therapy including
the transient hypothyroidism: the Defendants suggest £3000.
- I
have considered again the authorities, and all the circumstances and submissions.
Apart from her very real anxiety about vertical transmission, to which I
have referred above, her problems and symptoms have been very few; she indeed
accepted that she had only been ill with the Hepatitis C while on the treatment
and after biopsies, for which of course separate provision is being made,
subject always to the overall figure. She has suffered, treatment apart,
no fatigue and no adjustment disorder, being resilient and positive; but
she continues, unless the further therapy is successful, as I trust and
hope it will be, PCR positive, albeit with the very good prognosis, about
which I am sure she would cease to worry, if only, and when, her worries
about parenthood are either at an end or proved unnecessary. If they are
not resolved, then particularly in the event, and for the duration, of any
pregnancy, they may obviously be acute. Those worries apart however, I am
satisfied that her concerns, and indeed thoughts, about her Hepatitis C
condition will gradually recede to the background, and certainly so if her
therapy in a year's time is successful. I conclude that the proper figure
for infection simpliciter, making due allowance for her concerns, is £12,500,
to which I add £500 in respect of the first biopsy and £750 in respect of
the second and, as the Interferon therapy was both longer than Mr U's, and
complicated and exacerbated by hypothyroidism, I award in respect of that
£3500. The total figure, which I have already considered in the round in
building it up, is £17,250. To this needs to be added future general damages
in respect of the further therapy, which I have concluded she will and should
have. This will again last twelve months because of her genotype 4 and her
previous failure. There is the risk of hypothyroidism, and even permanent
hypothyroidism, to which I have referred. It is in my judgment likely to
be less unpleasant in its side-effects than the previous therapy, simply
because the injections will only be once a week. I conclude that the appropriate
figure, after allowance for one year's accelerated discount, is £3250, making
a total for general damages in all of £20,500, which I consider, having
looked at it in the round, to be an appropriate aggregate figure.
- Employment
handicap. Miss T is perfectly successful at present as a legal secretary,
after her promotion, and her condition gives her no problems at all. She has
previously had to complete two health questionnaires in respect of employment,
which caused her no difficulty. The relevant problem is that she would like
to become an air hostess, although she has not yet started making applications.
Some enquiry has been made in general terms of airlines, and a not wholly
unoptimistic response in very general terms has been received, at least from
one airline, although that airline would require rather better educational
qualifications than Miss T, at least at present, has, apparently a good conversational
ability in a second language, which she does not have. It seems to me, in
those circumstances, that she might well not be qualified as an air hostess
in any event, at least without improving her qualifications, because I am
not at the moment prepared to assume that other airlines would necessarily
be less demanding, once it came to an interview. There is also the fact, as
pointed out to her, that if indeed she would not be content with the office
life, there are many jobs in travel that might be available other than being
an air hostess. There is the further factor that the position may change for
the better in any event, if next year's therapy is successful, and she becomes
and remains PCR negative, and is able so to inform a potential employer. The
Claimants seek as an uplift, or in any event, an ingredient, of a Smith
v Manchester award, what they call 'loss of congenial employment'. But
of course I have to be satisfied not only that there is a more than speculative
chance of such a loss, but also that she would have attained the so called
congenial employment in any event. They claim £7500, and the Defendants put
forward £2000. Given the very broad brush nature of the Smith v Manchester
jurisdiction in relation to quantification of the speculative loss, I
am just prepared to say there is some evidence of a possible loss, and to
value it at the figure put forward by the Defendants in the sum of £2000.
- Insurance
handicap. The Claimants put forward £3000, and the Defendants a nominal 'jury
award' of £500. The likely result of any application now by Miss T for insurance
would be deferral, as is the unanimous view of the experts; and in any event
that makes absolute sense, not just because Miss T is neither of an age, nor
certainly an income, to consider such products now, but also because it must
obviously make sense to wait until after the further therapy in a year's time,
which may well be successful in causing her to clear the virus:
- It
is highly speculative as to whether Miss T would want to apply for any products
at all, and certainly not for some time in any event.
- If
the treatment were unsuccessful and/or she remains positive, then on the
evidence she will still be able to obtain life insurance because of her
good prognosis, even if at some loading. Miss V has of course been able
to obtain such insurance at a loading, as referred to below. It can be concluded
from Mr Purdy's report that Miss T might have paid £5 per month for a twenty
five year mortgage protection which would, if she were to remain PCR positive,
increase to perhaps £20 – an additional £180 per annum, and that there is
a similar position in respect of critical illness cover, though I consider
it unlikely that Miss T would have taken out the latter, in a relatively
low paid occupation.
- If
she were to become PCR negative as a result of successful treatment then,
albeit not immediately but after a few years of continuing negativity, and
certainly by the time she would be looking for insurance products (if she
does), I am satisfied that, like Mr U, and Mr S, she would be likely to
have no loading.
I
am almost minded not to award anything 'plucked from the air' in respect of
alleged insurance handicap, not least because (a) I am hopeful that her therapy
will be successful; (b) I am confident that with her very good prognosis,
even if she remained PCR positive, the insurance market will be sufficiently
educated in due course to give her, when and if she were to apply at some
stage in the future, a normal or near to normal rating. However I award £1000.
- Follow-Ups
and Biopsies. So far as follow-ups are concerned, the Claimants have provided
for twice annually. I agree however that there should be the 50% discount
for which the Defendants contend, both for the reasons set out in paragraph
214(ii) above, in the event that therapy were unsuccessful, and because of
the possibility that it will be successful, and in any event by virtue of
her very good prognosis. Consequently I award the discounted sum, at the agreed
multiplier, of £432.90. As for future biopsies, the Claimants claim a sum
(undiscounted) of £15,000, while the Defendants put forward a nominal sum
of £100. I am sure that Miss T herself hopes that no further biopsies will
be necessary, in the light of her dislike and fear of them. Once again the
further therapy is relevant. I have already referred to Dr Ryder's view that
a biopsy prior to such treatment would not be necessary, and I am satisfied
that it will not be carried out. If her treatment were successful, then it
is apparent that no further biopsies need to be provided for, as with the
others who have cleared the virus. If it were unsuccessful, and she
remained PCR positive, then too she would be unlikely to need a further biopsy,
as appears in paragraph 214(ii) above; but additionally, with specific reference
to Miss T, Dr Ryder gave evidence that it would be "pretty doubtful about
whether it would be worthwhile subjecting her to a biopsy", even in five
years. Once we are looking beyond five years, then I am satisfied that, particularly
given Miss T's own perfectly understandable reluctance, in the light of her
very good prognosis, it will be considered that ultrasound may be sufficient,
and/or that by that time non-invasive techniques would be in place, to which
reference has already been made in paragraph 201 above. I accept the Defendants'
£100.
Ms
V
- Ms
V, who is 36, gave evidence, as did her mother. She lives with her partner,
who also gave evidence, and their twin sons aged eleven and their daughter
of five. In the course of the birth of the twins on 16 May 1989 she became
anaemic, and received a transfusion which was infected with Hepatitis C. She
is infected with genotype 2a (or possibly 2b). She was lethargic for two months
after the birth of her twins, and then recovered entirely. I am satisfied
on the evidence that this did not result from her infection. She learnt of
the infection through the Look-Back programme in November 1995, and tested
PCR positive in December 1995. She has had three biopsies, on 3 April 1996,
18 December 1997 and 1 April 1998 (the last with ultrasound). She declined
Interferon treatment for two inter-connected reasons: one that her condition
was relatively mild and the other that she did not want at that stage to have
the treatment, because she wished not to be rendered tired and lethargic by
the side-effects, of which she was warned, when she had young children to
look after. I quote from her Registrar's letter on 16 November 1998: "We
have discussed possible Interferon treatment in the past, but felt in view
of the relatively low efficacy, together with quite considerable side-effects
associated with treatment, that it would be very reasonable to defer any decision
regarding the need for therapy, pending her more recent liver biopsy and pending
possible improvements in anti-viral therapy, such as combination treatment":
and then again on 24 February 1999: "she herself remains asymptomatic and
not particularly keen on undergoing anti-viral therapy unless there is a good
clinical indication. I have discussed this with her in the clinic today and
my feeling is that, in the absence of any clear evidence of histological progression,
there is no pressing need to undertake anti-viral therapy at present, as it
may well be she is one of those patients who have a non-progressive form of
liver insult related to their infection". She agreed that effectively
the position was that she was "not enthusiastic, and they were not pushing
it". She thus remains PCR positive. Her prognosis is however very good.
She has no fibrosis and it is, according to Dr Ryder, exceptionally unlikely
that she will progress to significant fibrosis, whether in the short or medium
term, and it is highly likely that she will never progress to cirrhosis. The
worst case is CLD in more than twenty years. She has had no physical symptoms
from her Hepatitis C condition. However she has been diagnosed by Dr Master,
and confirmed by Professor Wessely, to be suffering from an adjustment disorder
for a period which Professor Wessely originally estimated at two years in
the light of his discussion with her, but was prepared in the event to accept,
from Dr Master's view, may well have been as much as three and a half years.
She was depressed during that period, although the most critical period was
the two to three months after her diagnosis. She was very worried, with disturbed
sleep, had a panic attack at work in April 1996, and had throughout a negative
attitude, frequently tearful: Dr Master considered that an episode of weight
loss and epigastric pain in 1996 was associated with her psychiatric condition.
Her present outlook is however more positive, and she is feeling fit and well
and she had a very good last report from her clinic in February 2000. She
also opts for provisional damages, and I so direct, with all but the first
trigger applicable, and so she too must be deemed, as indeed is wholly likely
to be the case, to remain short of any conditions provided for in the triggers.
- The
issues are as follows:
- Quantification
of general damages for PSLA in the sub-categories (a) infection simpliciter,
(b) adjustment disorder (c) biopsies.
- Whether
she is to have Interferon therapy in about six to seven years time when
the children are older; in which case the agreed cost of pegylated combination
therapy, together with agreed attendance by either her mother or her partner
would be, discounted, £6870; but she also claims general damages for the
period of the treatment (discounted).
- Employment
handicap.
- Insurance
handicap including loss to date.
- Further
biopsies.
- Future
Interferon Treatment. Once again it is sensible to decide first the question
of whether it is, on the balance of probabilities, likely that she will have,
and ought to be entitled to recover, in respect of further therapy. By reference
to the Poynard predictive factors, Ms V is genotype 2, female and has, at
any rate at present, no fibrosis. She mentioned in evidence intending to have
the further therapy in some seven years time when her daughter was twelve.
The parties appear to have agreed a somewhat complicated formula of discounted
cost in relation to a period in six years time. In any event I conclude that,
if Ms V is to have the treatment, she should have it earlier rather than later,
because of Poynard's further predictive factor of age, namely that those under
forty have the better chance. Ms V will be forty in four years time.
-
Do I conclude that it is likely that Ms V will have the treatment? There must
be, given her previous history, a risk of her having Interferon-related depression
(as appears from paragraph 205 above, there is estimated to be ordinarily
a 15% risk), and, given the mildness of her disease and the very favourable
prognosis she has, there is certainly no need for her to go through the treatment,
not only with that risk but also with the other possible or probable side-effects
suffered by the other lead Claimants, and apparent from the literature. On
the other hand, she stands a good chance of clearing the virus, and
told me in evidence that she was 80 to 90% sure that that was what she would
do, having previously made the decision to defer it until her children were
of an age that she could cope with it. In any event, it seems to me that in
six years time it is not only highly possible that pegylated therapy will
be more efficient in its results, giving her an even better chance of success,
but even possible that, with ever improving treatments, a way might have been
found of mitigating, or even avoiding, the side-effects, which will of course,
in any event, as discussed in the case of Miss T, be less obtrusive, simply
by virtue of there being only one injection per week in pegylated therapy,
rather than three. I conclude that it is likely that she will have the treatment,
that it is reasonable for her to do so, and indeed that the chances of success
are very good, indeed are likely to be better than the 40% chance indicated
by Dr Ryder, which was, as I take it, in any event, a reference to standard
therapy. I shall return later to the sum to be awarded.
- PSLA
- Infection
Simpliciter. Once again it is extremely difficult to extract the question
of adjustment disorder out of the generality, but I shall endeavour to do
so at the request of Mr Brooke QC. Nevertheless, it is right to say, as
in the case of Mr S, that the reality is that the symptoms which might ordinarily
be looked at as being part of infection simpliciter – anxiety, stress, upset,
etc. – are in this case those which form the basis of Dr Master's conclusion
of an adjustment disorder, and there is little to add, so far as general
state of mind is concerned, for the purpose of assessing damages for infection
simpliciter. She was certainly extremely upset by her discovery about the
infection – and her panic attack in April 1996 was an obvious consequence.
She was upset about the uncertainty: it appears that at one stage she was
told that liver disease would be likely to onset within fifteen years of
the infection (i.e. dating from 1989), which seemed worryingly close, and
certainly is not the prognosis that she in fact has. She suffered what might
be called 'social stigma', i.e. embarrassment and distress, in two respects,
once when she felt upset in overhearing how junior doctors in an ultrasound
department discussed their liver patients, and once, in particular, when
her daughter's childminder declined to continue to look after her daughter
in case her daughter (who had not at that stage been tested) turned out
to have Hepatitis C, which she said might invalidate her insurance as a
childminder. She has had a certain amount of worry about her relationship
with her partner, becoming somewhat tentative towards him (although sexual
relations did continue after a period, because she conceived in 1996). She
confirmed that things were almost back to normal now between her and her
partner; the one restraint she found was that she was still worried about
kissing, but she has now been given complete reassurance by Dr Ryder that
there is no risk in normal day-to-day activities such as kissing. So far
as concerns the 1996 pregnancy, her evidence was that she was concerned
about how her partner could cope with the three children if she became ill
or indeed died. After a good deal of heart searching she had a termination.
She said that, in her mind, the Hepatitis C was the "deciding factor",
but accepted that to have had the baby would in any event have been difficult,
for a whole host of reasons, and she just did not know whether the same
decision would have been made if she had not been infected with Hepatitis
C. It is plain to me, having heard and considered all the evidence, that
the reason for such termination was not her Hepatitis C condition, nor any
fear of vertical transmission, but rather that with the other three children,
a small house and a limited income, she did not feel able to cope. However
what is equally plain is that the worry about Hepatitis C was a factor which
featured in, perhaps exacerbated, a decision which would have been a difficult
one for her to take in any event, even though I am satisfied that she would
have made the same decision. On the other hand, be it adjustment disorder,
or be it simply the worry in the back of the mind, it is equally plain that,
not least because she has had no physical symptoms nor any fatigue resulting
from the condition, she has got on with her life quite normally, once having
made the decision to shelve the Interferon treatment. She has indeed looked
after the three children, but in addition she has worked, and has not been
off work as a result of the condition or indeed the adjustment disorder.
She was working with Marks and Spencer when diagnosed: she disclosed her
condition to them and had no problem as a result, and continued to work
(save for food tastings) as a sales assistant. Recently, and again it seems
without difficulty both as to obtaining the new employment and in disclosing
the position, as she has done, to her new employers, she changed jobs to
one that was more satisfactory so far as the children's holidays were concerned
(after qualifying in the meanwhile on a computer course), namely to become
an IT support technician at a sixth form college. Although, because the
court case is still going on, she feels that nothing has settled down at
the moment, nevertheless, as set out above, she described herself as 'fine
and healthy', and as having been so for some time, and she was thrilled
at the very good prognosis which she has now understood.
- With
regard to the adjustment disorder, Dr Master refers to her "generally
negative outlook, [which] persisted until about three to four months
ago, when there was a gradual turn for the better. She thinks that the improvement
is because in this period she has learned more about the illness and about
her prognosis ... She understands now that the outlook is not as bad as
she had feared". Professor Wessely concludes, and I accept, that "as
a result of learning that she has Hepatitis C the [Claimant] developed
symptoms that are suggestive of an adjustment disorder. This was never very
severe, in that she managed to keep working, but I agree was still sufficient
to justify a psychiatric diagnosis". As for any question of continuing
vulnerability, I have already indicated that I do not accept the 'Master
theory': there is some pre-history which is relevant to Professor Wessely's
'hand of cards', such that, as he puts it in his report, "she is [not]
at any more increased risk of psychiatric disorder than before. Whatever
it was that increased her vulnerability to psychiatric disorder, for example
her genetic risk, remains true for the future should she again encounter
adversity, but has not been increased by the adjustment disorder". For
that reason, I ignore any question of vulnerability: but in any event, if
there be in the future an adjustment disorder which can be shown to result
from her Hepatitis C condition, directly or indirectly, then it may be that
the fifth trigger would arise; but I must assume, for the purposes of assessment
of provisional damages, that it will not so arise.
- The
Claimants put forward figures for infection simpliciter of £12,500 and for
adjustment disorder of £7500, totalling £20,000: the Defendants suggest
£5000 and £3500, in the latter regard referring to the JSB Guidelines for
moderate or minor psychiatric damage. Again both Counsel referred to the
cases set out in paragraph 236(v) above.
- So
far as the biopsies are concerned, the first of the three was under local
anaesthetic and did not involve an overnight stay, but Ms V described it
as the most pain she had ever experienced, far worse than childbirth (and
she had had twins by forceps). The second was also by local anaesthetic,
but on this occasion she stayed overnight (as it happened the biopsy was
ineffective). On the third occasion she was particularly worried about it
in anticipation as, given the fact that the second had been unsuccessful,
she feared that she might have to go through it again, but in fact it was
not a problem: again she had a local anaesthetic and stayed overnight. The
Claimants put forward the sum of £3250 for the three biopsies (undifferentiated),
while the Defendants put forward a total of £750, being £400 for the first,
£200 for the second and £150 for the third.
- I
turn then to my conclusions as to quantum. It is clear that the adjustment
disorder has not been a serious one, has not required any treatment, does
not impact upon future vulnerability and has not affected the Claimant's
ability to cope with her life and work. It is in my judgment in the lower
bracket of the JSB Guidelines, although allowance must be made for the fact
that it went on for up to three years. The Claimant has a Hepatitis C condition,
but it is one that involves no physical symptoms, no fibrosis, a very good
prognosis and a very good chance of clearing the virus. Nevertheless I take
into account the fact that she has been worried about her relationship with
her partner, about her future and that of her family if she were seriously
ill (and she has not always been enabled to be as clear about the prognosis
as she now is); it was a factor in the difficult decision of termination;
she has suffered some embarrassment; and she is left, subject to the possibility
of successful treatment, with a possible lifetime with the condition, albeit
that it is unlikely that she will suffer any physical symptoms, and therefore
her concerns should soon recede even further. I conclude that the appropriate
figures are £3500 for the adjustment disorder and £6500 for the infection
simpliciter, such that the total amounts to £10,000, added to which there
will be £600, £300 and £350 for the three biopsies, totalling £1250. I conclude
that the figure of £11,250 in aggregate is appropriate, and does not involve,
or has taken into account, any overlap.
- The
Future Therapy. Although I am satisfied that by six years' time the pegylated
Interferon therapy will be available on the National Health Service, since
I do not conclude that Ms V will deteriorate during that period, I do not
consider that she is likely to fall within the NICE Guidance, or the equivalent
then in force, because, although I conclude that it is reasonable for her
to have the treatment, I suspect that it will not be medically recommended.
The question then arises as to whether she will have to pay for it. I am sure
that there will be new treatments being developed. Dr Ryder confirmed that
Ms V "would undoubtedly fit within the criteria of many clinical trials
of treatment". I propose to discount the figure of £6870 to £6250 to allow
for the possibility that the treatment may be available otherwise than privately
paid for. As for general damages in respect of her undergoing in the future
the therapy, the Claimants seek a sum of £4530 which, as I understand it,
is £5000 discounted. This does not seem to me to be an appropriate sum. The
treatment is only a six month treatment (she being genotype 2 and without
previous failure): as indicated above, the therapy may well have improved
by six years time, but in any event it is only a one injection per week treatment:
and the trigger would be there if there were a serious psychiatric condition
triggered by the Interferon. I allow a figure of £1750, discounted by what
I understand to be the appropriate multiplier of 0.8131, rounded up to £1450.
- Future
Biopsies. The Claimants put forward a figure of £5000 on the basis of continuing
regular biopsies, but the Defendants submit a figure of £100, on the same
basis as in relation to Miss T in paragraph 255 above. I reach the same conclusion
as I did in relation to Miss T, by reference primarily to the matters set
out in paragraph 214(ii). Ms V too will have, as I have concluded, therapy
which will either be successful (no biopsies) or unsuccessful (no routine
biopsies thereafter); and in any event even more so in the case of Ms V, where
we are looking six years ahead, it is even more likely that non-invasive techniques
will be the norm in lieu of a biopsy. I am sure that, as in the case of Miss
T, a biopsy will be avoided in the case of Ms V if at all possible, and indeed
I note that she was recently asked to attend for an ultrasound just to see
the shape and size of her liver which, I am satisfied, given her previous
condition, will have raised no concerns, and will have been a perfectly satisfactory
procedure. I am satisfied that the nominal sum of £100 is all that is appropriate.
- Employment
Handicap. The Claimants put forward £5000 and the Defendants deny that any
sum is appropriate. As appears above, Ms V has successfully changed jobs recently
without any problem. There is no evidence of any risk to her in the labour
market. She has a very good prognosis, has revealed her condition to two employers
without a problem and has a reasonably good chance of in due course clearing
the virus in any event. I do not consider any award is appropriate.
- Insurance
Handicap. Ms V has already taken out life assurance, when she and her partner
had the opportunity to buy their council house in late 1998/early 1999. The
life cover that she obtained by way of mortgage protection was at a premium
of £24.53 instead of £11.61, which it would have been but for her condition,
an annual increase in premium of £155.04. It was taken out in respect of mortgage
protection, and she and her partner have recently remortgaged, and obtained
further life insurance by way of mortgage protection at a rated premium, such
that she is currently paying £30.12 per month in all, instead of some £12.04,
a 150% overall loading and an annual increased loading of £216.96. The Claimants
claim, in addition to the excess premia paid to date in the sum of £284.24,
which is admitted, a future loss of £216.96 per annum, at an agreed multiplier
of 17.19, namely £3729.54. The agreed joint experts' report recites that Mr
Purdy and Mr Brimblecombe agree that from the market she should be able to
do better than the £30.12 she is currently paying, and that, if the policy
is left in place for two to three years and her condition remains the same,
a review at that stage should result in better underwriting terms, and a reduction
in premium loading to 100%, rather than 150% as at present. The Defendants
assert that both in respect of the duty of the Claimants to carry out reasonable
mitigation of loss, and by virtue of a reasonable expectation of what is likely
to occur, there should be a substantial discount in respect of this claim
by virtue of (i) the fact that Ms V will be able, on that basis, to obtain
more favourable terms, either from her existing insurers or from an alternative
and/or (ii) what they refer to as the chance of her cure in the future, and
improvement in the insurance market generally. The Claimants submit that Ms
V should be under no obligation to reinsure, in case she put at risk the existing
cover and/or by virtue of inconvenience and possible expense. I am satisfied
that on both the two grounds put forward by the Defendants there should be
a reduction. I conclude that there is an obligation to mitigate. As set out
in paragraph 224(ii) and (iii) above, I am also of the view that the insurance
market generally in relation to Hepatitis C, at least with regard to those,
like Ms V, with a very good prognosis, will become more enlightened: and in
any event, as set out above I am satisfied that Ms V has an extremely good
chance of clearing the virus when, in six years time, she undertakes
the therapy, as I have now been persuaded that she can, should and will; and
she would then, if such occurred, be able to take advantage in due course
of the nil rating, which, on the basis of the agreed joint report, is already
available to Mr S, and will soon be available, insofar as relevant, to Mr
U. I accept the figure of £2000.
- In
addition, the Claimants point to the fact that Ms V was, when granted life
assurance cover by way of mortgage protection, refused the critical illness
cover which she also sought. Ms Daniels has sought this cover from two companies,
and in the course of the hearing renewed her application to one of them on
a 'cushioned basis', but without success. Mr Purdy and Mr Brimblecombe agree
however that it should be possible to obtain in the market even at present,
notwithstanding Ms Daniels' two failures, cover at a 150% loading, and, indeed,
from Friends Provident and Swiss Re, at a 100% loading. On the basis of Mr
Purdy's calculations in respect of Miss T, the effect of a 100% loading on
a standard premium for a fifteen year critical illness policy might be an
additional £10 per month, being £120 per annum. It is plain that we are not,
in relation to Ms V, in the realms of the hypothetical, because she has actually
sought critical illness cover, and at present only her partner is so covered,
as a result of the refusal of it to her. I consider that it is appropriate
to make an award in respect of future loss by way of insurance handicap, in
relation to the loading in respect of critical illness cover; but it is clearly
appropriate to make the same discounts, for the same reasons, as have been
made in relation to the life assurance. The sensible course is for Ms V in
any event to defer making any application until after the outcome of her further
therapy. The Claimants claim an additional sum of £3000, in addition to the
future loss in respect of life assurance, by virtue of insurance handicap
with regard to the critical illness cover, but also possible handicap in respect
of permanent health insurance and/or employee benefits. I consider the last
item entirely hypothetical on the basis of the present evidence, and her employment
and its prospects, and no mention was made by either her or her partner of
any intention or desire or indeed ability to afford or consider permanent
health insurance. The Defendants put forward a suggested figure of £200 to
£500. I consider the appropriate sum by reference to the critical illness
cover is £1000.
Mr
W
- Mr
W, who is 72 on 30 March, gave evidence: he was a coalminer until his retirement
in 1984. He lives with his second wife. His children and step-children are
grown up, and he has grandchildren and great grandchildren. He was infected
on 3 May 1991, when he received a blood transfusion after a triple coronary
artery bypass graft operation. He is infected with genotype 3a. He had two
subsequent operations in 1995, successively a cholecystotomy and a laparotomy
for gallstones, and then in December 1995 he was informed of his infection
as a result of the Look-Back programme. He had three biopsies, on 28 March
1996, 3 July 1997 and 24 February 1999 (and an endoscopy in October 2000).
He underwent Interferon treatment commencing on 3 June 1996, until 8 August
1997, but he did not respond and remained PCR positive: although he was an
encouraging genotype, he did not bode well in relation to the other Poynard
indicators, in being well over forty, male and suffering from severe fibrosis.
That fibrosis, it is now agreed between Dr Ryder and Dr Alexander, has, at
some stage after the last biopsy in February 1999, but prior to October 2000,
progressed to cirrhosis, though still compensated. He suffered fatigue after
the bypass, clearly consequent upon his heart condition and the operation,
and never recovered his original energy levels, though he took up a part time
driving job for a printing firm in about 1997, which he carried on until last
October, stopping by agreement when he unfortunately drove through a red light:
and he still does the gardening in his garden at home, from which he derives
great pleasure, and takes his dog for short walks. The depression which affected
him (not amounting to an adjustment disorder) is also ascribed by the experts
to the cardiac condition and not to the diagnosis of Hepatitis C, which it
antedated. He is inevitably now suffering from fatigue as a result of the
deteriorating liver disease. In June 1999 he was diagnosed as suffering from
diabetes, which he controls both with pills and diet, and there is an issue
for me to resolve as to whether this was associated with the Hepatitis C condition.
His prognosis so far as concerns his liver condition appears to be of something
more than a 20% chance of decompensated cirrhosis over five years and something
less than 50% in ten years, though Dr Ryder, with all of whose opinions relating
to the prognosis of Mr W Dr Alexander agrees, points out that his speed of
progress from point of infection to cirrhosis was relatively quick, and that
it is probable that the speed of progress to cirrhosis is likely to be a predictor
of the speed of progress on to decompensated cirrhosis. Dr Ryder considers
that by reference to the literature, and particularly to the paper by Fattovich
(referred to in paragraph 189(iv)(d) above), Mr W has an 80% chance of surviving
ten years by reference to his progressive liver disease alone: he is not a
candidate for a liver transplant. Unfortunately however there are added complications.
He had transient ischaemic attacks (mini-strokes) resulting in a diagnosis
in June 1999 of atherosclerosis (furring up or blockage) of the carotid arteries,
a similar process to that which had occurred in his coronary artery, leading
to the bypass. It was found that he had bilateral carotid stenosis (narrowing)
on the right side as to 68% and on the left 73%. Although he had had, as shown
by an MRI scan, at some stage an old silent stroke on the left side of his
brain, and had chronic lack of blood flow in both cerebral hemispheres, the
mini-strokes had been caused by blood clots detaching themselves from his
right artery, the one that was slightly less narrowed, and moving from there
into the brain; and it was thus upon the right artery which Mr Hope carried
out the carotid surgery. The surgery was major, but Mr Hope considered that
the risk of future strokes was far greater than the operative risk. Mr Hope
concluded that it was neither necessary nor sensible to operate on the left
artery, and if it further narrows Mr W may be able to depend upon the newly
cleaned out right artery, to its exclusion. However he concluded from the
literature that Mr W has a stroke risk of 30% or more over five years, and
increasing thereafter by at least 6% annually. As he further confirmed, the
presence of the silent stroke is a warning that the condition of the arteries
on the left hand side could cause a stroke at any time; there can be a stroke
without any warning, or alternatively there can be a whole series of events
that are what Mr Hope called a "red card to the vascular surgeon",
and it is simply chance whether such a clot as had detached itself from his
right artery, and might similarly now do so from the left, would cause damage
to the brain. In addition Mr W may still have arterial disease in his heart,
and the prognosis for further cardiac disease is less good in his case than
the norm for his age. As Dr Ryder stated, "it is very difficult in someone
of 71 with ischaemic heart disease and cerebrovascular disease to say what
impact his liver disease is going to have on his survival". Mr W does
not wish to seek provisional damages, but a final award.
- The
issues in this case are as follows:
- Is
the diabetes a consequence of the Hepatitis C condition?
- Will
he have, and/or is he entitled to recover in respect of, further Interferon
therapy in two years time?
- The
quantification of general damages in respect of his Hepatitis C condition,
after taking into account the matters which are not the subject matter of
assessment, such as those caused by or connected to his cardiac and carotid
problems.
- His
future loss. It is common ground that he will not need any help with the
gardening for two years. After that, the cost of providing a gardener is
agreed at £1125 per annum. There is then a dispute. The Claimants say that
Mr W has a life expectancy of eight and a half years (although the figures
which they have supplied to me appear only to provide for seven and a half)
and the gardening, once started in two years' time, should last until his
death, at a multiplier of 4.85 totalling £5459.46; care and attendance should
start after three years, to be provided commercially at rates agreed by
the two experts, and increasing each year in respect of the number of hours
per week, over a postulated period of four and a half years, totalling (again
on the figures provided by the Claimants), as discounted, £35,753.28. The
Defendants deny that he is entitled to recover in respect of care at all,
because he will not require any care due to his liver condition, but rather,
if at all, due to his carotid and cardiac problems and/or will die from
those problems, or simply from old age, before the need for care resulting
from his liver condition arises.
- Diabetes:
The following is common ground:
- Mr
W was not suffering from diabetes in October 1994, when there was a normal
glucose tolerance test taken. The issue between Dr Alexander and Dr Ryder
is as to when the Claimant did at the earliest have diabetes, given its
diagnosis in June 1999. No conclusion can be drawn about the position in
1997, when there was a serum glucose test, because it is agreed that, if
the test was taken when Mr W was non-fasting, then it would be within the
normal range, although Dr Alexander would have been suspicious, and might
have wanted it followed up with further investigation, and there is no indication
that it was taken when Mr W was fasting.
- Mr
W's mother had diabetes and there was therefore a genetic or familial predisposition.
- The
risk of diabetes increases with age.
- Dr
Alexander has made a particular study of the relationship between diabetes
and Hepatitis C, and is the co-author, as set out in paragraph 189(iv)(d)
above, of two of the relevant papers on the topic, which were studied in evidence.
Dr Ryder also of course has extensive clinical experience. It was clear from
their evidence, and the detailed discussion of the topic which occurred, both
by consideration of the Caronia, Mason and Knobler articles, referred to in
that sub-paragraph, and otherwise, that there is a particular connection between
cirrhosis and diabetes, because cirrhosis appears to be an inhibitor of insulin
and to cause glucose intolerance. If it was necessary for Mr W to have progressed
to cirrhosis before he could contract diabetes, then, given that he had not
progressed to cirrhosis by February 1999, the date of his third biopsy, that
would give a very short time indeed for the development of diabetes. On the
other hand it is clear from the literature, and indeed conceded by Dr Alexander,
that there is also an association between diabetes and Hepatitis C and in
particular that diabetes can be found in Hepatitis C sufferers before cirrhosis,
namely, as appears from the Knobler article in particular, at the stage of
advanced fibrosis, to which on any basis Mr W had progressed well before 1999,
and that the risk of diabetes increases very significantly with the degree
of fibrosis. The two rival contentions are summarised as follows: first by
Dr Ryder:
"My
view of the literature and of this particular case is that there are a number
of factors which increase the risk of someone developing diabetes, and those
would be their age, family history, the presence of Hepatitis C and advancing
fibrosis in their liver. My view is that overall I feel that the evidence
supports the fact that if one has a genetic predisposition ... to getting
diabetes, and has Hepatitis C, it is much more likely actually to happen.
If you translate that into do I think on the balance of probabilities the
Hepatitis C caused his diabetes at an earlier stage than it would have done
naturally, then I would say: yes. If you are saying that on the balance of
probabilities, do I think the Hepatitis C is the cause of his diabetes per
se, then I think it probably is, but I would completely accept that that is
a very difficult judgment to make."
Dr
Alexander's position he summarised as follows:
"The
proportion of patients with a family history of diabetes who go on to develop
non-insulin dependent diabetes exceeds any of the data for patients with early
stage cirrhosis or stage 4 fibrosis, so on a balance of probabilities his
genetics are more likely to have caused his non-insulin dependent diabetes
mellitus than the Hepatitis C. If, of course, he had been at a more advanced
stage of the cirrhosis, when the instance of diabetes rises to 50%, then I
would argue it the other way round, but he is not, so I think on balance you
would have to say that the genetics are the major factor."
Dr
Alexander concluded his evidence, in answer to Mr Brooke QC:
"Q:
I have put to you Dr Ryder's position and you still disagree with him
A:
As it happens, I think Hepatitis C causes diabetes, but I think to say that
in bald terms without the evidence being there is a big step to take ...
Q:
... I take it that you still disagree with him?
A:
I do. I do not have the confidence that he has, I am afraid."
Reluctant
as I am to tread into such an interesting dispute, I must do so. I conclude
that, given the presence of the two important predisposing factors of family
history and age, it is extremely likely that Mr W would have suffered from
diabetes anyway. However I am satisfied that it is likely, on the balance
of probabilities, that the progression to severe fibrosis caused by the Hepatitis
C condition was the trigger, and thus caused an earlier onset of diabetes
than would otherwise have occurred. All this fascinating dispute in the end
has very little impact, however, on what I have to decide: for, first of all,
in the light of my conclusion, it is probable that in a very few years Mr
W would have had diabetes anyway, and secondly, as Dr Alexander pointed out,
well managed, the diabetes is going to be the least of Mr W's problems. It
is clear to me that it is being well managed, and is causing Mr W relatively
little inconvenience. He is not having to inject himself, but is taking Metformin
pills twice daily, he is monitored once a year by his GP (and takes his own
readings) and, because his wife is now used to cooking for him with Canderel,
there is, as Mr W puts it, virtually no difference, now that she had got around
to that way of doing it.
- Further
therapy. The case put forward is that Mr W would like to have a further course
of Interferon therapy, in, say, two years, when he will be 74. The way it
was put in evidence by him (in somewhat of a stark contrast to the way in
which it was put by Ms V) was that he would want to do it, because it might
make him better. He will of course be even further down the list by reference
to Poynard's indicators than last time, with the additional contra-indicator
that he will have failed previously, although he would now be receiving pegylated
combination therapy. Dr Ryder put the chances at 5%, and does not recommend
the treatment. Dr Alexander also advised against it, but in his case, in the
light of Mr W's cardiac and carotid conditions (symptomatic heart disease
and severe heart disease are listed as contra-indicators to such therapy in
the International Consensus Statement), by virtue of his concern at the risk
of hypotension resulting from the therapy. Dr Ryder did not put his opposition
on that ground, he did not consider that a risk: and Mr Hope too had no concerns
for his patient arising out of hypotension. The fact remains, however, that
the expert for neither side recommends the treatment. Mr Brooke QC's Closing
Submissions read, somewhat strikingly, as follows:
"It
is probable that Mr W will undergo combination therapy with its complications,
and the treatment is likely to fail."
I
am entirely clear that for a man in Mr W's state of health, indeed looking
forward a further two years, when it is extremely likely that his cirrhosis
will have progressed further (decompensated cirrhosis is also a contra-indication
listed in the International Consensus Statement), it is quite inappropriate
for him to have the burden of a further twelve months Interferon therapy.
In two years time, he will be further down the line of what the Claimants
themselves predict is only another eight and a half years, and, I anticipate,
even less able to withstand the treatment, and certainly overwhelmingly likely
to gain nothing whatever from it. Whatever the precise state of his cardiac
or carotid condition and whatever the precise risk to him from the treatment,
it is clear to me that he will not, and/or in any event should not, do it
and should not recover for it, on one or other of the bases set out by me
in paragraphs 217(i) and (ii) above.
- Prognosis
and Future Care. I refer to the detailed picture of Mr W and his future, as
it appears from the medical evidence set out in paragraph 266 above. It is
appropriate for me to set out my conclusions as to prognosis and life expectancy
at this stage, although it in fact leads to the calculation of the future
cost of care, because, to an extent, it impacts upon my conclusions as to
general damages, which I set out below. I conclude, on the balance of probabilities,
that, as indeed is common ground, the Claimant will have a further two years
in which he will continue to be able to do his gardening and will not significantly
deteriorate. He will then need the help of a gardener, for which both sides
have made provision. After one year of such gardening help, I conclude he
will need some attendance by a carer, because of a continuing deterioration
in his liver condition, and the first year's agreed provision, as set out
in an agreement between the parties, drawn from the care experts' reports,
will then commence, of seven hours per week, to be discounted, because it
will only start after the conclusion of three years from today. My conclusion,
on the balance of probabilities, is that Mr W will not in the event die of
the ever-deteriorating liver condition and of decompensated cirrhosis, but
of a stroke which will become, as indeed Mr Hope accepted, ever more likely
as he gets older and indeed as his physical condition deteriorates. I conclude
that, after the three years to which I have referred, he will live for a further
four, and will die of a stroke before he enters into the fifth of the periods
provided for in the care experts' report. Life expectancy is accordingly,
in my judgment, seven years. His entitlement is to five years of gardening,
deferred for two years, and to four years of increasing care, deferred for
three. I leave it to the parties to calculate the appropriate sum on the basis
of the agreed rates and the agreed hours and the relevant multiplier on the
basis of 3% discount: and to calculate the sum for the agreed incidental costs
of £98.80 per annum, also upon the basis of the relevant multiplier.
- General
Damages. This is a final award, and I am not asked to compartmentalise, so
I must ensure that I take everything into account. I am satisfied that Mr
W did not suffer from any symptoms, physical or mental, which in any way related
to his Hepatitis C condition, until after his awareness of it in December
1995. Since then, he has had just over five unpleasant years. Although a number
of the important features of that unpleasantness, such as depression and,
until the recent onset of more severe fibrosis to which it can be ascribed,
fatigue, and his hospitalisations, cannot be attributed to the Hepatitis C,
nevertheless it has caused him to be anxious and angry and to face an uncertain
future for himself and his family, and, more recently, to become fatigued
very quickly: he has had three biopsies: he has undergone Interferon treatment
for fourteen months, self-injecting, which he did not like, which caused him
the 'usual' side-effects, such as, in his case, flu like symptoms for days
at a time, skin problems and low moods. Apart from the Interferon, he has
not suffered from physical symptoms as a result of the Hepatitis C, and he
still, as can be seen, has been able to take a considerable amount of exercise,
though he rests in the afternoon. He has had a somewhat earlier incidence
of diabetes, with its attendant inconvenience and irritations. His prognosis
from his liver condition is of progressive deterioration over the rest of
his life, without hope of a transplant, and in some two years he will not
be able to do his beloved gardening. The period to come, as Mr W progresses
towards decompensated cirrhosis, is likely to bring to him the same discomfort
and debilitation as it brought to Mrs X, without the saving grace of her transplant.
- The
Claimants claim £40,000 for general damages: the Defendants put forward £10,000.
I must bear in mind that, included in whatever figure I decide for general
damages in total, there must be allowed some £3250 for the three biopsies
and the fourteen month Interferon treatment, in order that Mr W should not
suffer as compared with the others from non-compartmentalisation of his damages.
A number of authorities have been drawn to my attention by both sides in relation
to Mr W and Mrs X. At this stage I mention only those which may have some
bearing on both, and leave aside for a moment those which were only specifically
relied upon in relation to the case of Mrs X. The relevant decisions were
those in Baker (1985) Kemp & Kemp F3-013 (Jupp J), Re
M. J. [a provisional award] (1987) Kemp & Kemp L3-051 (CICB)),
James (1996) Kemp & Kemp F2-033 (Judge Stephenson), Glendinning
(1997) Kemp & Kemp F2-040 (Morland J), Sutcliffe (1997)
Kemp & Kemp F2-035/1 (Dyson J), Snell (1998) Kemp &
Kemp F2-037/1 (CA) and H (1998) 1999 CL 211 (CICB). The important
distinctions between this case and all of those stem not simply from the age
of Mr W, because a number of the asbestosis cases there referred to related
to claimants in their seventies. They comprise also the relative shortness
of the time during which Mr W has suffered as a result of the condition, namely
five years to date and now his remaining life expectancy, a total of some
twelve years, compared with, for example, the thirty years or more of the
life of the claimant in H: and, crucially, the impact of the other
conditions affecting Mr W. Albeit that for the future, as from about two years
time at any rate, the most significant effect upon his daily life will come
from his liver disease, it has not yet been his major problem, and I have
concluded that he is most likely to die of his carotid or cardiac conditions,
with one or other of which he has had to live for many years. I conclude that
the appropriate figure to award for general damages, to include the accelerated
diabetes, is £27,000.
Mrs
X
- Mrs
X is now 56, and gave evidence. She lives with her husband of 36 years, who
also gave evidence; and has three grown-up children, two sons, and a daughter,
who is a staff nurse, who also gave evidence, and six grandchildren. She was
infected on 6 June 1990, while undergoing a laparotomy for a cystic mass in
the ovary. Her infection is by genotype 2(b). She had a subsequent cholecystectomy
in October 1991. It appears that, in her case, the progress of the disease
was very speedy, and by summer 1994 she was suffering from fatigue and nausea,
sufficient to make her consult her GP, and, after blood tests, she was diagnosed
in August 1994 as infected with Hepatitis C; and after a biopsy on 7 September
1994 she was confirmed as suffering from cirrhosis, which of course explained
the symptoms of lethargy and fatigue. She underwent Interferon treatment between
27 March and 11 September 1995, but the virus did not respond, no doubt due
to her age and the advanced stage of her liver disease, and she remained PCR
positive. She collapsed on two occasions in late 1994, feeling dizzy and nauseous;
once on arrival at work, when she was admitted to hospital for three days,
where they tried unsuccessfully some fourteen times to give her a lumbar puncture,
leaving her back 'black and blue'; and once when she was out shopping
with her daughter. She was a successful manageress of a wine store, which
involved some shifting and lifting, as well as considerable management skills,
as the branch, under her control, increased in size and in turnover, and in
importance to the business. By September 1995 however, she felt simply unable
to carry on the job, and retired on the grounds of ill-health on 1 October
1995. She had a holiday for six weeks in the United States, when, probably
because she had finished the Interferon treatment which had, as with the other
Claimants, caused her unpleasant side-effects, she felt better. From then
on, however, her condition gradually deteriorated, as she suffered from stomach
pain, swelling in the stomach and ankles, dizziness, nausea and breathlessness,
and found herself more and more confined to bed. In 1996 an endoscopy confirmed
the advanced stage of her liver disease, and, by December 1998, she had developed
fluid retention, and her condition gave her doctors such cause for concern,
by reference to the decompensation of her cirrhosis and to her life expectancy,
which they then estimated at less than four months, that she was referred
for a transplant assessment. She and her husband, who took early retirement
from his job as an electricity meter reader at the end of August 1996, in
order to spend more time with and look after her, waited, ever more anxiously,
for the availability of a suitable donor, hoping every time the telephone
rang that it would be the hospital. On 28 February 1999 a transplant opportunity
was available, and she had the operation, remaining in the hospital for approximately
four weeks before she was discharged home: she took at least three months
to recover from the surgery. The operation was entirely successful, and since
then her condition has greatly improved. She is still prevented from doing
heavy work such as gardening, or picking up heavy pans when cooking, or holding
bags or selecting heavy articles when shopping, accompanied by her husband
and her daughter.
- Although
her tiredness and fatigue is much improved, she still has to have a nap most
days, but Dr Ryder is clear that a major inhibition to her recovering her
full energy has been the immuno-suppressant drugs, which she has been required
to take since the transplant, and the quantum of the drugs, and in particular
of Tacrolimus, has recently been reduced, specifically in order to give her
what he called a "further benefit in terms of her energy level". Dr
Master has described her as in his view having had a 'personality change'
since the transplant, which he puts down also to the immuno-suppressant drugs.
I prefer Professor Wessely's description, who agrees that "there has been
a slight change in her personality since the liver transplant, in that she
has become more irritable, which was not present prior to the surgery, and
must be either a post-surgical sequela, or a side-effect of immuno-suppression".
She has, in contrast to her temperament before the transplant, since it been
'volcanic' on occasion; though much I think may be ascribed to the
fact that, since her improvement in health, she has found herself becoming
irritable with her husband's well-intentioned efforts to continue what he
had been doing for her when she did not have her strength. In his words: "after
the transplant she was obviously a lot better than what she was before, and
I still find myself [taking over and talking for her] which irritated
her ... and I think this was where a lot of the volatile nature came in now
and again. I found it very difficult to adjust after ... I have more time
on my hands, and I found I was still trying to do the same things [for
her as I had done previously] and I used to get under her feet".
- It
appears to be common ground among the experts that the reduction in immuno-suppressant
drugs is likely to benefit the Claimant, not only in respect of her tiredness,
but also in respect of her irritability and volatility. She herself considers
that her energy levels are a great deal better than they were in 1994/1995
before she stopped work, and probably back to what they were when she first
consulted her GP in the summer of 1994. As she put it "as time is going
on it is ... getting better and better". She has, it seems to me, effectively
returned to life, like Lazarus, from the very edge of death. She of course
remains PCR positive, such that, as set out in paragraph 195 above, there
is a certainty of reinfection of the new liver. However, Dr Ryder makes clear
that she has normal liver function, that she is unlikely to be in the category
of patients who develop accelerated Hepatitis C post-transplantation, and
that "the most likely outcome is that her life expectancy may be modestly
reduced compared with a member of the population of similar age and gender
who did not acquire Hepatitis C and require a liver transplant". In the
words of one of the doctors who reported upon her soon after the transplant
"this lady is doing brilliantly": she did in evidence feel she was
doing brilliantly, and she confirmed that she is definitely "approaching
[the future] with some pleasure". In any event she seeks only provisional
damages. She is thus deemed not to develop cirrhosis, or indeed liver cancer
(or, as to which the risks are in any event all but non-existent, extra-hepatic
complications or late acute rejection of the transplant) during her life time,
and I direct the applicability to her of the last three triggers, not of course
the first two, as she is already PCR positive, and has had the compensated
cirrhosis prior to her transplant.
- The
issues in her case are as follows:
- A
global provisional award of general damages for PSLA, which is not sought
to be sub-categorised.
- Gratuitous
care by Mr X (there is, as will be seen, no issue about gratuitous care
provided by their daughter).
- Future
and past loss: trips to town (the recovery of Mrs X's loss of earnings past
and future to aged 65 and loss of pension etc is agreed, and thus not in
issue: save that as to pension loss there is a surviving and unexplained
difference of 38p (at a multiplier of 10.87), for which the parties will
be best advised to toss a coin).
- Insurance
handicap.
- PSLA.
The following issues arise to be taken into account, against the background
which I have set out in paragraphs 271 to 273 above.
- As
there appears, Mrs X suffered from tiredness, pain and discomfort and gradual
debilitation from 1994, as her liver disease deteriorated, and tiredness
also during her Interferon treatment; and of course exhaustion prior to
the transplant, of the kind graphically described by Dr Alexander, when,
as discussed in paragraph 207 above, he differentiates the fatigue complained
of by many patients, including liver patients, arising from their knowledge
of their condition and the accompanying stress and worry, from the "overwhelming
exhaustion one sees with cirrhosis ... a clear sleep reversal. These patients
are not fatigued; they are exhausted, and exhaustion of that nature is in
my view an indication for a liver transplant. But it is quite different
from the symptoms that people describe in the earlier stage of the disease".
Subsequent to her transplant, there has then been the fatigue which has,
it is now clear, been caused, or caused primarily, by the immuno-suppressant
drugs, and is hopefully now being alleviated, and in due course even eliminated.
Together with that, of course, has been the irritability or volatility which
has not only upset her family – though they have, as she confirmed, been
prepared to make allowances – but inevitably upset her also.
- Of
course right from the beginning, when she, wrongly, thought that she had
cancer, and continuing up to the transplant and the waiting for the telephone
call, she suffered from inevitable fear and anxiety, although she has coped
with this by virtue of her "very positive outlook on life, always ...
very good at dealing with adversity": her religious faith has assisted
considerably, and she made pilgrimages to Lourdes in 1995 and 1997. She
has suffered from sleeplessness, which has resulted in her moving into a
different bedroom from her husband, but that too Dr Ryder considers will
probably get better.
- She
gave up her job, which she loved, and has not been able to return to it,
or indeed to any employment, and she has less of a relationship with her
grandchildren than she would have liked, because of her inability to expend
as much energy upon them. She has had dietary constraints, because of the
immuno-suppressant drugs, although, because she can still go out to eat
at her favourite restaurant, which makes special arrangements for her, this
has not been any real problem to her, and in any event Dr Ryder has advised
that she need not be so concerned. The need to cut down or eliminate alcohol
has not caused her a problem, because she has, it seems, "never been
much of a drinker". She has been more concerned about any possible inhibition
on travelling on holiday with her husband, because travel is something she
and he love. The problem is not travel insurance, for she has obtained it,
nor the ability to travel physically, because she has been able to go recently
on holiday in Spain with her husband for two weeks, but what she believes
to be a problem in relation to going any country where vaccination or injections
are necessary. Once again Dr Ryder has advised that "she does not need
to worry as much as she does about these sorts of things, the vaccinations,
eating various foods and so on. Those should not apply to her. There are
some vaccines that have to be avoided by anyone who is immuno-suppressed
... for most of these there is an alternative and there are actually very
few live vaccines used, so for the majority of people this is not really
a major issue". She has been upset from time to time by what has loosely
been described, as discussed in paragraphs 219 to 220 above, as 'stigma'.
Her employers, fellow employees and family have all been very supportive
(except briefly for one sister-in-law, who was soon put right) but she has
experienced ignorant, and hence hurtful, reactions from people she has met
on holiday, and from the family of an ex-girlfriend of her son.
- So
far as concerns what one might call the medical side, for which, as with
Mr W, allowance must be made even in the absence of compartmentalisation,
there was a biopsy in September 1994 for which she had to stay in overnight,
but which she said did not particularly hurt (similarly perhaps therefore
to Mr U). Although she has not had any further biopsies since, it would
seem likely that she will, as in the case of other transplant patients,
have to have an occasional biopsy thereafter, although in her case it may
well be that the non-invasive techniques will be in place and available.
There were the unsuccessful attempts at a lumbar puncture in October 1994,
to which I have referred. As to the Interferon treatment, she described
it as "horrible". She was very much of a "mustn't grumble"
kind of a person, and therefore did not make a great deal of fuss about
it to her medical advisers during the course of it, but she did feel unwell,
and, like the other Claimants, (and again perhaps similarly to Mr U) she
had such uncomfortable side-effects as flu-like symptoms, fatigue, pain
and swelling, and in her case also halitosis, although this may have been
more a symptom of the underlying condition, as her liver deteriorated. Like
others, because the injections were three times weekly and the symptoms
appear to have followed closely upon them, she had "peaks and troughs"
during the week. As for the transplant operation itself it was of course
painful and it left scars, although these in fact only cause her any embarrassment
when she is in a swimming pool changing room.
- She
is now left with a residual fear of going out alone, no doubt because of
the two incidents in 1994. I have every confidence, and conclude, that this
will soon pass, given the kind of person she is, and as her personality
returns even more to normal. As for her continuing inability to carry out
the heavy work in the house and the gardening, that is resolved by the agreed
care provision by nine hours per week to deal with the domestic chores.
- The
Claimants claim a sum of £80,000 for PSLA: the Defendants propose £20,000.
I have looked at the cases referred to in paragraph 273 above, and in relation
to Mrs X, the Defendants add the following: Alon (1982) Kemp & Kemp
A3-009 (Judge Lipfriend), Mitchell (1989) Kemp & Kemp E3-001 (Judge
Bates), Read (1991) Kemp & Kemp A3-008 (CICB), Routledge (1992)
Kemp & Kemp E3-002 (Otton J), Re G (1998) Kemp & Kemp
B2-007/1 (CICB) and Curi v Colina (1998) Kemp & Kemp B2-008/1 (CA),
to which I made reference in paragraph 212 above. The purpose of the Defendants
in referring me to those decisions was to contrast the amounts that were there
awarded to claimants with very much more serious injuries and consequences,
including paraplegics, with the sum of £80,000 which the Claimants have put
forward, so as to indicate that that sum is wholly excessive. The Court of
Appeal in Curi v Colina, for example, approved, while describing it as "not
a generous award", general damages, which, as up-dated, would be £64,000,
given by way of final award to a claimant of 22 with very serious injuries
and a long deteriorating prognosis over a full life expectancy. This, and
the other cases, would suggest a sum considerably lower than the Claimants'
figure; particularly given that the sum to be awarded to Mrs X is by way of
provisional damages, and that she now has both a relatively favourable prognosis
and, not by virtue of any substantial attenuation of it as a result of her
condition but simply by virtue of her seniority in years, a much shorter life
expectancy. I have looked again in particular at the Claimants' cases of James
(updated as £42,000), Glendinning (updated as £29,000), Sutcliffe (updated
as £34,000) and Snell(the Court of Appeal decision, updated to £33,000: described
by the C.A. as the "top end of the permissible bracket"). Given the
pleasingly positive outcome for Mrs X, but making full allowance for her seven
or so miserable years, her escape from death and her relative disability to
come, my figure is £45,000.
- Gratuitous
Services. There is agreement between the parties as to the amount of hours,
and the rates, on the basis of past and future care (after exclusion of the
period when Mrs X was in hospital), if it is to be recovered at commercial
rates. The Claimants however seek (i) recovery of Mr X's lost earnings, pension
and tax-free sum from his past employment, amounting to substantially more
than the commercial rate (ii) that in respect of Mr X's gratuitous services,
although not those given by their daughter, if he is to be remunerated by
reference to the commercial rate, there should be no Housecroft deduction.
I refer to paragraphs 227 to 231 above. The circumstances in which Mr X gave
up his job were described by him in his witness statement as follows: "Whereas
I had been [her] companion and partner, I became her carer. As her
condition deteriorated prior to the transplant, she became so fatigued that
she could only manage to wash and dress herself. As I have indicated, [most
of] the domestic chores were done by me ... However the demands placed
on my time became too great with my full time job, so I took early retirement
in 1996 ... Once I had ceased working, caring for [Mrs X] and looking
after our home became a central part of my life, and in a sense filled the
void left by my retirement from my job". They did not consider the possibility
of employing anyone to do the domestic chores as an alternative: "it never
came into the equation because there were other factors involved, not just
the hours involved. It was other factors like being with my wife and giving
her support and also we did not know how long we had got together". Mrs
X explained that she would not have wanted "a stranger to come in and do
the chores ... I needed my husband's support at that time and I needed him
to be there ... just to give me a cuddle or to talk to when I needed some
support". What he did then, Mrs X makes clear, was perform most of the
household chores, the cooking, the housekeeping and the shopping: although
he also helped her in and out of the bath, as she became weaker. In fact,
the consensus from the two experts, after they had considered all the evidence
as to past care, was that, when Mr X gave up work in August 1996, the hours
per week that he was giving by way of gratuitous care, for which he would,
on the usual principles, be entitled to be reimbursed, were only seven, rising
to eleven in 1997 and fifteen in 1998. The time when he gave virtually full
time care (estimated at 26 hours per week, over and above what could normally
be expected of a husband) was the period in April and May 1999, when Mrs X
returned from hospital.
- Mr
X was obviously very supportive, and still is. However it seems to me clear
that, even if there were any leeway, or any exceptional circumstances, that
could be allowed for within the authorities which I have considered in full
in paragraphs 227 to 231 above, there is nothing on the facts of this case
which could so qualify. In Lamey, relied upon by Mr Brooke QC, not only were
the services obviously exceptional, but the experts themselves confirmed that
they should be valued at more than the commercial rate, because they amounted
to more than the commercial carer would do. There is no such evidence here
in relation to the housework performed by Mr X. His emotional support was
obviously invaluable to Mrs X, but it could and would have been given in any
event, had a stranger been employed to carry out the chores. I can see no
ground either for going above the Housecroft ceiling or for awarding more
than the net commercial rate, or rather, given that, as I have indicated,
it is in any event probable that, by only making a 25% deduction, more than
the net commercial rate is in fact being paid, for reaching any other conclusion
than that the Defendants' 25% reduction should be made.
- Trips
to town. It is claimed by the Claimants that in respect of the period from
1 January 1994 to 1 October 2000 Mrs X should be entitled to recover the cost
of three trips per week by car because of her Hepatitis C illness: and there
is also a claim for recovery of three such trips per week continuing for the
rest of her life expectancy, on the basis of a whole life multiplier of 18.58.
When asked about whether there were three such trips, she answered "probably,
yes". Plainly of course it can only be a rough estimate. However, quite
apart from whether such period is justified in starting as early as January
1994, when no complaint of fatigue was made to her doctor until June 1994,
it is apparent to me that there can be no justification for such a case while
she was still continuing to work; indeed she explained in evidence how, from
time to time, she would pop out to the butcher or the chemist after her own
shop closed. In respect of the period after she retired and was at home, it
is apparent that, particularly as she became more and more confined to bed,
it was her daughter and her husband who did the shopping. Indeed this was
one of the household chores which she said that Mr X took over. I conclude
that the broad-brush response by the Defendants, to allow for an average of
one visit per week throughout the claimed period is realistic, if not generous.
However, so far as the period since her operation is concerned, clearly in
the early weeks she would have been too ill to go out at all. Now it is the
case that her husband or her daughter takes her shopping, and she chooses
the articles, while her companion loads the shopping bag. That relates to
what one might call the 'weekly big shop'. However she says, as referred to
in paragraph 278(v) above, that she is nervous of going out alone, and so
there will be other occasions when, even though she might not need help for
heavy lifting, she would need assistance in going into town. As set out above,
I am confident that this fear will be transient. I would allow two trips per
week in respect of the period starting in June 1999, when I suspect she began
to be up and about again after the transplant, and lasting through to June
2002; but thereafter I conclude that, as in relation to the period from January
1994 through to January 1999, the Defendants' proposal of one trip per week
is appropriate, and no more: I shall leave it to Counsel for the parties to
calculate the correct sum in respect of one trip per week from 1 January 1994
to 31 December 1998, none from 1 January 1999 to 31 May 1999, two from 1 June
1999 to 31 May 2002, and thereafter, at the relevant multiplier, of one trip
per week for the future.
- Insurance
handicap. The Claimants suggest 'a maximum of £500'. Clearly there is no evidence
of any detriment or loss to the Claimant in respect of life insurance or other
products, no suggestion that but for the condition she would have applied
for any, and certainly now, at age 56, no intention or opportunity to do so.
The only point which is raised relates to travel insurance. I have referred
to this in paragraph 223(iv) above. Mr & Mrs X have been on holiday this
year in Spain and, after making full disclosure, received unconditional travel
cover from the Prudential without any addition to the premium, and Mrs X confirmed
that she would be able to obtain international insurance on the same basis,
if her destination were other than Spain. On the evidence before me, and upon
the basis of my belief and presumptions about the travel insurance market,
and certainly in the absence of any evidence from experts to the contrary,
I see no case made, by way of evidence or inference, of a risk of loading
of premiums. I make no award.
JUDGMENT
- I
wish to conclude by giving my thanks to solicitors and Counsel for their considerable
help in relation to the achievement of a full, but also expeditious, hearing
of this action, and for the efficiency and completeness of the evidence adduced
and of their submissions; to the expert witnesses for the clarity of their
information and exposition; to the transcribers from Livenote, whose dedicated
concentration and expertise, in dealing with often complicated legal and technical
evidence and submissions, provided 49 superlative daily transcripts, which
made my work very much easier; and finally to my Clerk for her long hours
of enthusiastic and conscientious preparation of the transcript of this judgment.
For the reasons set out at length during its course, I give judgment for the
Claimants on the issues before me. So far as concerns the individual lead
Claimants, an order will need to be drawn up, in compliance with Part 41.2(2)
of the CPR, and containing the triggers for provisional damages which I have
set out in paragraph 211: including, in respect of each lead Claimant, the
amounts reflecting the conclusions which I have reached, some of which require
some arithmetical calculation by Counsel, together with the various sums which
the parties had agreed in respect of each Claimant, and which therefore did
not need to form part of my judgment: and with appropriate allowance for the
settlement agreement in respect of Mr S and Mr W.
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