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You are here: BAILII >> Databases >> England and Wales High Court (Queen's Bench Division) Decisions >> A & Ors v National Blood Authority & Ors [2001] EWHC QB 446 (26th March, 2001) URL: https://www.bailii.org/ew/cases/EWHC/QB/2001/446.html Cite as: [2001] EWHC QB 446, [2001] Lloyd's Rep Med 187, [2001] 3 All ER 289, 65 BMLR 1, (2001) 65 BMLR 1 |
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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 - |
||
|
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 *
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 *
Mr W *
Mrs X *
JUDGMENT *
Mr Justice Burton:
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.
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.
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.
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.
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
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.
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
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:
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.
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'.
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.
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:
verify
or cross-check
its findings and increase the specificity of the process.
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.
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:
virus
itself had not been discovered or identified at the date
when the claims commence on 1 March 1988.
virus
in a donor's
blood
was even known of, certainly not available, until Ortho's assay, first publicised
in Spring/Summer 1989.
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.
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:
"[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."
"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 ..."
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'].
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."
"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."
"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."
"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."
THE STRUCTURE OF THIS JUDGMENT
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.
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).
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.
virtue
of the 90% concession agreement).
V)
VI)
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."
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 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.
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
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.
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.
various
possibilities:
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'.
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:
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]".
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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
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.)
"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.
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.)
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.
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.
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.
"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.
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."
view
to avoiding a defective
design.
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".
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."
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 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."
v
UK).
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 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 Issues Between the Parties.
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:
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).
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.
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.
v
UK, although, as discussed above, it was not in terms addressing the particular
issue here:
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:
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'.
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:
"(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.
various
distinguished academics which have been put before me:
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."
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."
"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."
"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."
"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.
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.
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".
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.
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."
"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.
"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)."
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."
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.
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.'
version
of the Directive, it was intended that
the most significant circumstances were those listed.
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.
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:
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.
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.
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:
"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.
view
that such
is not the case in Article 7(e).
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.
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.
virtue
of accessible information, then the non-standard product
can no longer qualify for protection under Article 7(e).
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.
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.
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.
blood
bags being concluded to be defective
within Article 6, and Article 7(e) does not avail.
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.
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.
The Defendants' Factual Witnesses
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.
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
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.
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.
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.
The Claimants' Factual Witnesses
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.
very
general
background, to the grant of such licences in respect of the Ortho assay in
this case. The Claimants' Expert Witnesses
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.
very
considerable
assistance of Counsel, to assimilate.
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.
Van
der Poel), New Zealand (Dr Woodfield), Spain (Drs Esteban, Hoyos),
and Sweden (Dr Widell).
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.
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.
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).
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).
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.
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.
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.
blood
supply, so that there
is no risk of there being no reserves of
blood
available in an emergency.
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.
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.
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%.
v)
above.And then the factors to be addressed by reference to the evidence:
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.
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. "
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."
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".
blood
is available, it should be taken, unless the disadvantages
outweigh the advantages.
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.
view,
if introduced,
they would not have been discontinued by that date.
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.
|
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.
"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.
view.
Some of them are highly respected and have never
been questioned; others have been subjected to criticism.
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.
very
well known, preconceived positions or
were 'arguing a corner', which they were perfectly entitled to do.
view
or another, but making up
my own mind, informed and enlightened by the evidence and the arguments.
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:
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."
"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."
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).
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.
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.
"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."
"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".
"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."
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."
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."
THE PROS AND CONS OF SURROGATE TESTING
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.
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.
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.
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.
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%.
virus,
was through raised
ALT in the recipient, so that it appears logical to identify raised ALT
in a donor as a potential risk.
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.
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".
blood
supply
after the introduction of the tests, notwithstanding the expressed concerns
prior to their doing so.
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.
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.
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.
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.
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.
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.
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.
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".
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.
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.
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".
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.
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
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.
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 |
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.
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
"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'.
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.
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".
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."
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.
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.
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.
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".
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.
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.
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.
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.
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.
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
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]".
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.
"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.
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.
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.
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.
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
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.
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
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.
"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."
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.
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):
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".
Conclusion on Routine Screening
very
shortly afterwards.
"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.
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.
blood
infected
with Hepatitis C was defective, on the Brown Case. I take into account all
the circumstances in the basket:
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".
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
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.
blood
was unscreenedness:
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.
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.
virus
if the Defendants had taken further or different steps.
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.
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."
"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.
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.
ISSUE IV: AVAILABILITY OF ARTICLE 7(e)
blood]
to be discovered.(Issue IVb)
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.
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".
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.
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.
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:
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.
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.
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%.
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).
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.
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
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:
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.
V
and
VI.
The most central publications were:
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
"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.
"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."
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.)
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:
"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.
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).
very
exceptionally indeed, be extra-hepatic complications, such as porphyria,
cryoglobulinaemia, glomerulonephritis and diabetes mellitus.
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.
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.
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.
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.
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.
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."
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.
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.
This
guide is also
vital,
for consideration of whether to carry out the existing
therapy.
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".
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.
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:
blood
donors than amongst those infected by Hepatitis
C).
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.
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."
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.
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.
v
Colina (29 July
1998), Kemp & Kemp, B2-008/1
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.
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.
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.
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.
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.
V,
this will not be a substantial
factor in these cases) e.g.:
The question not only of the availability of existing or imminent therapy, but of possible improved treatments may be filtered into consideration.
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.
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.
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:
victims
of
blood
transfusions, can or should in any way be associated in that regard.
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'.
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:
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.
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).
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:
Financial Products/Insurance Handicap
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.
view
that only
some 30% of the adult population actively sought to make such arrangements).
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.
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:
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.
"... 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.
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
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."
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".
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."
v
Cammell Laird
Shipbuilders Ltd [1990] 1 AER 854, a deduction equivalent to 14% was not
disturbed by the Court of Appeal.
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.
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".
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.
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".
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".
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.
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.
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.
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.
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.
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.
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."
vulnerability.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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:
vigorously
that she would still be prepared to try the treatment, even if they were
worse than last time.
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.
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.
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
v)
above.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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".
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.