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You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Lillywhite & Anor v University College London Hospitals NHS Trust [2005] EWCA Civ 1466 (07 December 2005) URL: http://www.bailii.org/ew/cases/EWCA/Civ/2005/1466.html Cite as: [2005] EWCA Civ 1466 |
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COURT OF APPEAL (CIVIL
DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEE'NS BENCH
DIVISION
MR JUSTICE JACK
HQ02X02464
Strand, London, WC2A 2LL | ||
B e f o r e :
LORD JUSTICE LATHAM
and
LADY JUSTICE
ARDEN
____________________
LILLYWHITE & ANOR |
Appellant | |
- and - |
||
UNIVERSITY COLLEGE LONDON HOSPITALS' NHS
TRUST |
Respondent |
____________________
Terence Coghlan QC & John Whitting (instructed
by Messrs Hempsons) for the Respondent
Hearing dates : 27/28th July 2005
____________________
Crown Copyright ©
Lord Justice Latham :
Introduction
Holoprosencephaly
"2.1 The normal foetal brain consists of two halves, each half is called a cerebral hemisphere and each hemisphere contains a ventricle (a thin fluid filled space). These ventricles communicate towards the front of the brain and then there is a midline channel through which fluid passes (third ventricle) which then communicates with the posterior part of the brain (cerebellum). There is a further fluid space within the cerebellum (fourth ventricle) which communicates with the outside of the brain and this is where the fluid (cerebral spinal fluid) leaves the brain and then is absorbed over the surface of the brain.
2.2. In holoprosencephaly the process by which the brain separates into two halves does not occur. The result is a spectrum of abnormalities in which many of the mid line structures are absent and there is a variable shaped single ventricular cavity. The brain usually separates into two halves during the fourth and fifth weeks of pregnancy. There are three main types of holoprosencephaly.
2.3 The most severe type is alobar holoprosencephaly. In this condition there is a single ventricular cavity and the thalami are fused. There is also absence of the midline structures such as the cavum septum pellucidum, corpus callosum and falx. This diagnosis of holoprosencephaly is quite straightforward as the brain is severely disordered and there is a large central fluid filled space within the brain.
2.4. Semi lobar holoprosencephaly is a more difficult diagnosis to make, however once again there is a single ventricular cavity around the thalami, which are partially fused. The anterior parts of the ventricles are fused in a sickle or horse shoe shape and there is absence of the corpus callosum, cavum septum pellucidum and anterior portion of the falx. The posterior parts of the lateral ventricles will appear relatively normal.
2.5 Lobar holoprosencephaly is the least severe form and in this condition the ventricles are almost normally formed however there is fusion of the most anterior parts of the lateral ventricles. The corpus callosum, cavum septum pellucidum and part of the falx are absent.
2.6. It should be noted therefore that in all forms of holoprosencephaly there is absence of the cavum septum pellucidum. In both lobar and semi lobar forms there is absence of the anterior horns of the lateral ventricles."
Alice's Condition
The History
"The history in detail- On 28 November 1991 Mrs Lillywhite attended at the West London Hospital for a routine abnormality scan. This was carried out by Mrs Janet Wright, the superintendent radiographer in charge of ultrasound services at the West London and Charing Cross Hospitals. Mrs Wright graduated as a radiographer in 1976 and in 1982 obtained a diploma of medical ultrasound. She was an able and experienced sonographer but did not have the training of a doctor. Mrs Wright remembers the scan for two reasons: first because Mrs Lillywhite was anxious that she might have an abnormal child because of her age (she was 36), and second it was the first and only time that Mrs Wright had not found a cavum septum: she remembered it as "the case of the absent septum pellucidum". Mrs Wright used a Hitachi EUB 340 machine, which she described as not one of the latest but a very good machine. Despite a careful search in the course of which, as was usual, she recorded pictures, she could not find a cavum septum. She thought that the front of the brain was filled with brain tissue. Her pictures are available and three relate to the skull and brain. They would not show the same definition and differences of shading as would have been apparent to Mrs Wright on the screen and they may have deteriorated with age. Each gives a single view as opposed to the multiple views Mrs. Wright would have obtained as she moved the probe.
- Mrs Wright scanned the skull and brain of the fetus in the axial or transverse plane, that is, so that she obtained a sonographic image of it at the level across the skull at which she was directing her probe, which represented a horizontal slice at that level. She found that she was able to obtain echoes which visualised the structures in the posterior brain. She found the midline echo representing the third ventricle but she could not find a cavum septum nor could she find the anterior horns of the lateral ventricles. She did not refer to the anterior part of the falx either in her evidence or expressly in the note she made on the examination form. That note read: 'unable to visualise septum pelucidum and normal anatomy in the anterior brain. ? absent corpus callosum ? normal'. Mrs Wright described how she found the cerebellum at the back as a marker and then moved up, in tiny movements, of perhaps 5 mm. She did not find echoes to represent the cavum. She took measurements for the biparietal diameter and the head circumference at the level at which she assessed that the cavum septum should have been. She measured the diameter as 39 mm, which I mention to give an idea of the size of the fetal head at this stage of development. She said that she tried moving the probe through a number of angles trying to find the cavum septum. She went on until she was satisfied that she could not find it. She did not try a coronal view, that is, to take vertical slices across the head, parallel to a line drawn ear-to-ear. She did not see that there was a single ventrical across the midline of the fore-brain. It would have shown up as a single fluid-filled cavity, had she been able to see it. She thought that the frontal part contained brain tissue only as it did. She did not identify a small choroid plexus cyst, which was later found by Doctor Meire and by Professor Rodeck, but her recent training had been that these were of no importance at 18 weeks. Mrs Wright did not have any technical difficulties in obtaining a satisfactory picture. Mrs Lillywhite was not of a weight where her size presented any problem. Although that was raised in advance of the trial, it was accepted at the trial that with a body mass index of just under 25 Mrs Lillywhite's build should not have been the cause of any sonographic difficulty. Mrs Wright said that she extended the time she spent on the examination beyond the normal. Mrs Lillywhite said that the examination seemed to take a long time and was longer than the subsequent examinations by Dr Meire and Professor Rodeck.
- Following her examination Mrs Wright spoke to Mr Pawson, the obstetric consultant in charge. She believed that the absence of a cavum septum might mean the absence of the corpus callosum, but was uncertain as to the seriousness. It was her intention, with which Mr Pawson agreed, that he should refer Mrs Lillywhite to Professor Rodeck at University College Hospital. Such a referral was standard in such a situation. Mrs Wright had made numerous referrals to Professor Rodeck. She had a high opinion of him. The referral was made by Mr Pawson by telephone while Mrs Lillywhite was still at the West London Hospital and was for 3 December. The University College Hospital referral sheet was completed by Professor Rodeck's personal assistant, from what Mr Pawson told her. She noted 'can't visualise septum pelucidum. ?anterior horns. ? small head ? microcephaly'. The last two originated with Mr Pawson and were not matters which Mrs Wright had raised.
- Mrs Lillywhite had some discussion with Mrs Wright as to the outcome of the scan and knew that Mrs Wright had not been able to find the brain structures which she wished to find. Mrs Lillywhite made a note of the words 'corpus callosum'. She was very anxious and was concerned that, if she was to have the pregnancy terminated, it should be done as early as possible. She felt she could not wait to see Professor Rodeck on 3 December and so telephoned the Portland Hospital and arranged to see Dr Hylton Meire privately on 29 November. Dr Hylton Meire was consultant radiologist at Kings College Hospital and was also in charge of the ultrasound service at the Portland. He was a specialist in ultrasound scanning, both obstetric and non-obstetric. In 1991 his work was about 70% non-obstetric. He had written widely on ultrasound, and was the editor of a leading text book. He had lectured on ultrasound and Mrs Wright had attended his lectures. He had and has a high reputation.
- The Portland accepted Mrs Lillywhite without any formal referral but obtained the details of her G.P. Mr. Lillywhite accompanied her to see Dr. Meire. Mrs Lillywhite explained to Dr Meire why she had come, telling him what she could of the outcome of the scan by Mrs Wright. I find that he did not have any written report from the West London Hospital: for Mrs Lillywhite did not have that. It is nonetheless clear that Dr Meire understood that Mrs Wright had failed to find the appropriate structures in the fore-brain. That is what he proceeded in particular to examine though he scanned the whole fetus. Dr Meire has no recollection of carrying out the scan. He would have recorded a large number of pictures, between 20 and 30. These have been destroyed following the policy of the Portland to destroy such pictures after 6 years if they had not been examined in the interval. Dr Meire was unaware of that policy until he requested the pictures to assist with this case. Mrs Lillywhite's evidence was that she told Dr Meire of her appointment with Professor Rodeck on 3 December. Mr Lillywhite's oral evidence supported that. I will revert to this and I conclude that the probability is that Dr Meire did know.
- Mrs Lillywhite's recollection was that Dr Meire told her that the baby was high in the uterus and he had not got a good view, but overall it looked fine. He told her that he had seen a choroid cyst. Mr Lillywhite's recollection was that Dr Meire was fairly reassuring although he said that he had not got a good view. Mr Lillywhite remembered feeling unhappy that it was costing money but Dr Meire wasn't getting a clear view. He said that he did not feel particularly reassured but his wife was more cheerful following the appointment.
- Dr Meire wrote a report of his examination as follows:
The fetal size is consistent with a gestation of just over 18 weeks. The fetal head was high in the fundus and imaging was not easy with reverberations partially obscuring the proximal hemisphere. The gross cerebral anatomy is normal and I was able to identify the thalami, septum pelucidum, falx, third ventricle and lateral ventricles which appear normal. There is a small (and probably insignificant) cyst within the left choroid plexus.
If doubt about the cerebral anatomy persists a further scan in about 2 weeks would almost certainly be more informative.
- It is clear that Dr Meire considered that he had seen echoes representing the cavum septum, the falx and the lateral ventricles. He would have used the echo of what he believed to be the cavum septum to give him the level at which to measure the biparietal diameter. But Alice had no cavum, no lateral ventricles nor did the falx extend into the front of the skull, which is where Dr Meire would have identified it. Dr Meire said that he would have tried to obtain a coronal view as well as the standard axial view. There was some discussion at the trial of the significance of the last sentence in his report, beginning 'If doubt persists ..'. Dr Meire said that this referred to the scan being two weeks earlier than he considered optimal, which was at 20 weeks. (I should say that there has been a shift of opinion as to the optimal time moving from 18 weeks to 20 weeks. Skull thickness does not begin to be a problem until 24 weeks. The downwards factor is the date by which any termination should be carried out.) He also said that it was a routine phrase which was not specific to Mrs Lillywhite. The question arises as to who was to have the doubts if Dr Meire himself was confident for neither Mrs Lillywhite's GP nor obstetrician was in a position to question his conclusion. If Dr Meire knew that Professor Rodeck was seeing Mrs Lillywhite in four days, it is puzzling that he referred to the possibility of a further scan in two weeks. This has led me to question whether Mrs Lillywhite is right that she told Dr Meire of the further appointment. It seems to me that someone might be reticent in telling one consultant that they were seeing another consultant for the same purpose in a few days. I have also wondered what Mr and Mrs Lillywhite would have done if Dr Meire had told them that he was confident that Mrs Wright was correct: would they have still gone to Professor Rodeck for a third view? On the other hand some explanation was required why Mrs Lillywhite had come to see Dr Meire privately without a proper referral in a situation where it was standard procedure for there to be a referral to a tertiary referral centre. On balance I should accept that Mrs Lillywhite's recollection that Dr Meire knew of her appointment with Professor Rodeck is accurate.
- Dr Meire stated that his practice in cases where he could not be certain was to offer the patient a further scan without payment. He said that this happened in between 5 and 10% of cases. He said that he did not do that here because he was content in his mind that he had seen the structures he expected to see: if he had been uncertain, he would have offered a further scan. In the situation here, if he had been uncertain, there was also the forthcoming appointment with Professor Rodeck. He did not sound any note of uncertainty to be passed to Professor Rodeck. Nonetheless I conclude that the opening of his report on the scan he carried out and its closing do suggest that the scan was rather less satisfactory than it might have been. Mr. Lillywhite was left with that impression and was less reassured than his wife.
- Professor Rodeck has been Professor of Obstetrics and Gynaecology at University College London since 1990, and is Head of Department. When at King's College Hospital he had set up what was probably the first unit in the world devoted exclusively to fetal medicine. In 1986 he moved from King's to Queen Charlotte's Hospital where he established a second such unit. He then established the fetal medicine unit at University College Hospital. He has published very widely and has been involved with a number of developments in fetal medicine. He is a man of considerable distinction. In 1971-2 he was a research fellow at University College Hospital in fetal and perinatal pathology, so he is well-grounded in the anatomy of the normal and abnormal brain.
- Mr Lillywhite was not able to accompany his wife to Professor Rodeck on 3 December. Professor Rodeck has some recollection of the examination despite the passage of time, almost certainly because of his involvement after the birth of Alice. He said that when he heard how Alice was affected it came as a great shock and he went back to his records and had thought long and hard how it might have been possible that he had not diagnosed her condition.
- The paperwork which Professor Rodeck had, consisted of the referral sheet prepared by his personal assistant, and Dr Meire's report. I can be confident of the latter because it was included in the University College file for Mrs Lillywhite. She had been given a copy of the report at the Portland and must have provided it, or a further copy, to Professor Rodeck. Professor Rodeck had the assistance of Dr Martin Haeusler while he carried out the scan. Dr Haeusler is now consultant obstetrician and gynaecologist at the University of Graz in Austria. In 1991 he was senior clinical research fellow at University College Hospital and worked with Professor Rodeck in the fetal maternal unit from February 1991 to March 1992. Dr Haeusler completed most of the form recording the results of the scan.
- The record shows that Professor Rodeck measured the biparietal diameter, the head circumference, the distances of the lateral borders of the anterior and posterior horns of the lateral ventricles from the midline as against the distance from the midline to the skull at the same points (10/22 and 9/22 respectively), and the inter-orbital distances (30/14) and the nuchal fold. The record made by Dr Haeusler shows that Professor Rodeck revised his initial measurements for the biparietal diameter and the head circumference, which Professor Rodeck suggested showed the care he was taking. He clearly located what he thought were echoes representing the cavum septum and the anterior and posterior horns of the lateral ventricles. All the measurements were normal. Professor Rodeck said that he would have checked the cavum septum and the anterior horns in the axial and also the coronal planes. It was unusual to take the intra-orbital measurements. If the eyes had been closer than they should have been, which is named hypotelorism, that would have been an indication of semilobar holoprosencephaly. Professor Rodeck said that it occurred in between 2/3s and 3/4s of cases of semilobar holoprosencephaly. The distances were normal. The nuchal fold is increased in a number of abnormal conditions, which might include semilobar holoprosencephaly. In this case was not. Although there is no record, Professor Rodeck would also have found an echo which he took as representing the anterior falx. In addition to measuring the intra-orbital differences Professor Rodeck looked carefully at the echoes representing the face. Facial abnormalities are particularly associated with alobar holoprosencephaly, but may also be present with semilobar holoprosencephaly. Professor Rodeck found no facial abnormalities, and there were none for him to see.
- Professor Rodeck said that the image quality he obtained was good average: it was not poor or he would have made a written comment. The machine he was using was a Acuson XP128, which was as good as was then available and was better than the machine used by Mrs Wright. The machine would not produce images of the clarity produced today. In his evidence Professor Rodeck referred to the difficulty facing anyone conducting a fetal scan of this nature. If they conclude mistakenly that the brain is abnormal, it is likely that the pregnancy will be terminated with the loss of a healthy child. If they fail to diagnose an abnormality, a severely disabled child may be born to the mother. He said that here, after a long and detailed examination, he could not conclude that the fetus was other than normal. He had seen echoes consistent with the structures I have mentioned; he had found none of the abnormalities which are often associated with holoprosencephaly. He had felt confident in his conclusion. He described ultrasound as an elusive art and stated that there were few conditions that could be diagnosed with absolute certainty. He said that semilobar holoprosencephaly could sometimes be diagnosed. He said later that with ultra sound there was always a small question mark: it might be very small: he would not leave a patient with concerns if there was no real ground for them.
- Professor Rodeck did not record pictures during the scan. That accorded with the practice at that time at University College Hospital when the diagnosis had been one of normality. This practice was changed by Professor Rodeck following Alice's birth. There are thus no pictures recording any part of the images that were seen by Professor Rodeck and by Dr Meire during their scans.
- During the scan Professor Rodeck confirmed the presence of the choroid plexus cyst found by Dr Meire. He suggested a further scan in 5 weeks to check it. Because Mrs Lillywhite was visiting Australia it was arranged that the further scan should take place on 18 February 1992. It was carried out by Dr Haeusler. Dr Haeusler came from Austria to give evidence. He had no recollection of either scan with which he had been concerned. The record of his scan shows that he carried out a full scan involving the whole body of the fetus. He measured the biparietal diameter and the head circumference. He took measurements for the posterior horns of the lateral ventricles, but although he noted an 'A' for anterior he did not record a measurement for the anterior horns he left a blank. He did not measure the intra-orbital distances. He did examine the facial profile. He found that the cyst was gone. His letter to Mr Marwood, Mrs Lillywhite's obstetrician at the West London Hospital, stated that 'Ultrasound examination revealed no obvious fetal malformation.' 'Obvious' must have been used in the sense of 'observable'.
- In a statement signed on 8 September 2003 Dr Haeusler said that he had scrutinised both the brain and fetal anatomy, that the measurements were reassuring, that he had specifically visualised the posterior horns of the lateral ventricles as this would have been where the cyst was if it still existed. He said it was not his practice to measure the anterior horns unless he suspected a cerebral abnormality, which he did not. On that basis I would not have expected him to have written an A with a space for the measurement. He suspected that he had not specifically sought the fetal facial profile but had obtained a good view and documented it for completeness. In a further statement signed on 28 September 2004 Dr Haeusler said that to measure the biparietal diameter and head circumference, he first identified the cavum septum to get the right level. He said that, if he had not identified it, he would have noted it and referred Mrs Lillywhite to Professor Rodeck. He also said that he was sure that he had seen the anterior horn of the lateral ventricle because, had he not done so, he would have noted it.
- Dr Haeusler said in his evidence that he had conducted a meticulous scan because he was aware of the referral. He would have been reminded of the referral by the record of Professor Rodeck's scan which was in the adjacent column on the sheet to his own and by the original referral sheet made out by Professor Lillywhite's personal assistant (which he had because he noted his letter to Dr Marwood at the bottom as having been sent with Mrs Lillywhite). Mrs Lillywhite herself recollected that Dr Haeusler took a long time with the scan. He struck me as a somewhat formal but very meticulous man. He said that at 29 weeks the picture would not be as clear as at 18 or 20 weeks because of the increased skull thickness, but he obtained echoes that he was happy with. He accepted that his knowledge of the outcome of Professor Rodeck's scan could have had a reassuring effect.
- It was sought on behalf of the claimants to contrast Dr Haeusler's two statements suggesting that it was not credible that he had seen what he referred to in the second but omitted from the first. Given the medical technicalities which the case involves and the difficulties of dealing with a statement by telephone I do not think that the contents of the two statements are surprising. The second elaborates the first, explaining what was involved in the exercise which Dr Haeusler carried out. The only point on which I feel a degree of uncertainty is in relation to the anterior horn of the lateral ventricle.
- Alice was born on 26 April 1992. The birth itself was without difficulty. But it was later noticed that her head might be small and her forehead unusually sloping. Alice was X-rayed on 27 April. Because Mr and Mrs Lillywhite were unhappy at the treatment she was receiving, they arranged for Alice to be seen by Dr Meire at the Portland on 30 April. He examined her by ultrasound through the fontanelle. He reported as follows:
The corpus callosum is absent and there is partial fusion of the bodies of the lateral ventricles. The anterior horns could not be confidently identified but I suspect are present but contain no csf [cerebrospinal fluid]. The posterior horns are present and normal and contain normal choroid plexus.
The thalami and caudate nuclei are present and appear normal and the third ventricle appears filled with a large massa intermedia.
The cerebellum and fourth ventricle are normal.
There was no discussion at the trial of the ease or difficulty of making findings by this method at such a stage.
- It is plain that Mrs Lillywhite must have reminded Dr Meire that he had examined Alice as a fetus. He has, however, no recollection of this second examination. He said that he was amazed that he did not remember.
- It appears from a manuscript note made by Professor Rodeck's personal assistant and addressed to him that Dr Meire telephoned to report the result of the scan. I deduce that from the medical language used in the note and the statement 'Hilton Meire will be at home tomorrow Friday [telephone number] if you need to speak to him'. The note states that Dr Meire had confirmed agenesis of the corpus callosum. This must have come from Dr Meire himself because that diagnosis was not in his written note. The notes held by the University College Hospital were attached for Professor Rodeck. Professor Rodeck stated in his evidence that he did telephone Dr Meire at some point. He had no recollection of their conversation. He thought that they also had a meeting, but again he could not recollect it.
- Agenesis of the corpus callosum describes a different condition to holoprosencephaly. In this condition the division of the brain into two halves does occur. However the lateral ventricles are widely separated and are attenuated at the front giving them a drawn-out tear drop shape. There is no cavum septum or corpus callosum. The falx is present. The finding by Dr Meire that the lateral ventricles were partially fused appears inconsistent with this diagnosis, but the point was not raised during the trial.
- It was submitted that if the two men had thought that they had been misled by structures which had genuinely mimicked the echoes of the structures which Alice did not have they would have had much to discuss and that the case might have been written up. It was suggested that they would both have wanted to study Dr Meire's pictures. The point was made on the basis that the two men had each located a cavum septum that was absent, anterior horns that were absent from what should have been the lateral ventricles, and a falx that was absent. At this time, that is April 1992, the diagnosis was not of holoprosencephaly but of agenesis of the corpus callosum. So it was then thought that the anterior horns were present and that the falx was present. I refer to paragraph 3.2 of Dr Twining's report. On that basis the point may carry less weight. It is clear that both Professor Rodeck and Dr Meire were concerned that they had not diagnosed Alice's condition. Such a concern does not point to an appreciation that they had been negligent: it is equally consistent with a responsible approach to their work. Professor Rodeck later used Alice's case in his teaching as a warning of false positives appearing in ultrasound.
- When Professor Rodeck was informed of the problem with Alice he telephoned Mrs Lillywhite at her home. He made contact with her on 5 May and they had a conversation about which he remembers a little. He expressed his sympathy and said that Alice's condition could not always be detected in utero. Mrs Lillywhite was unhappy with the treatment that she had been receiving and Professor Rodeck wrote a letter of referral to Dr John Wilson at Great Ormond Street Hospital. In that letter he said 'I have spoken to her and had an initial discussion about the difficulty of antenatal diagnosis and also the variability in prognosis. I would be grateful if you would be able to fit her in as soon as possible and to have a word with you beforehand.' On 11 May 1992 Mr and Mrs Lillywhite went to see Professor Rodeck for a discussion of Alice's case. One of the questions which they had prepared to ask him was for his comments on the fact that Mrs Wright had raised the absence of a corpus callosum. In her statement she says that she asked if Alice's condition was detectable antenatally and that Professor Rodeck replied that radiology was an imprecise science: that he was disappointed at the failure to detect the abnormality. Professor Rodeck's concern for Mrs Lillywhite after Alice's birth caused her to write and thank him in December 1992 before she moved to Australia.
- On 7 August 1992 Alice was examined by means of an MR scan at Great Ormond Street and the diagnosis of semilobar holoprosencephaly was made. No additional abnormalities were found."
The Trial
"At the trial it was soon apparent to me and, I think to all involved that on 3 December 1992 Professor Rodeck had conducted an apparently painstaking scan and must have seen echoes which he took to represent the cavum septum and the anterior horns of the lateral ventricles. That followed from the measurements that he took. It was not suggested that such echoes could have been "artefact" that is, a product of the ultrasound alone not representing any actual structure in the brain. In the absence of any pictures of what the Professor saw, it was a matter of considering what structures could have produced echoes mimicking the structures Professor Rodeck was seeking, and whether he should have realised the echoes were mimics. This question had not been considered by any of the witnesses in the written material served prior to the trial"
The Judge's Conclusions as to the Expert Evidence
"68. The evidence of Professor Griffiths, Dr Twining and Mr Walkinshaw was that any echoes the "beak" might have provided would have been in the wrong position and of the wrong shape to have been taken by a careful sonologist for the cavum septum. I was initially impressed by this: it was clear and forcefully put. It was said that it was over the thalami which was the wrong place, and the thalami were visible. Dr Meire recorded that he could identify the thalami but that does not mean that he could see the outline of the whole: the posterior parts could have been visible but not the anterior. The whole does not show up clearly on Mrs Wright's pictures. So I am unconvinced that I should take the thalami as a rock upon which Dr Rodeck should have built.
69. Taking the evidence as a whole, I do not think that the cavum septum always appears as the clear landmark that one might expect from some of what I heard. One line may be missing. The lines may not be sharp and neatly aligned. I have also to bear in mind the size of the brain under examination and the very small distances involved between the position of the cavum septum and the supposed position of the beak at 18 weeks. I fully accept that the structure of Alice's monoventrical was well established by the time of the scans, but do think that there is at least room for doubt as to where precisely where it and its beak was proportionately positioned at the time. Several witness emphasised the lack of knowledge as to the processes of development of abnormal brains. I think that, if I limit that by saying "proportional development" there are good grounds for it. I have to bear in mind also Dr Russell's cases A and D, particularly D."
The Judges Conclusions
"It is the task of the claimants to satisfy me on the balance of probabilities that, if he had exercised the skill and care to be expected of him, Professor Rodeck would have recognised the echoes as mimics."
"I have to put all these matters together in the whole context of the case, and decide whether on the balance of probabilities negligence is established. My answer is that it is not. I do not want to detract from the wider consideration of the issues which I have set out, but if I try to summarise my main reasons they are that the records suggest that Professor Rodeck approached his scan with particular care, the forceful circumstances that three experienced scanners reached a conclusion contrary to the correct conclusion of Mrs Wright, and that an investigation of what might have produced mimicking echoes has provided possible answers which do not point with clarity to negligence in failing to distinguishing them."
The Appeal
The Law
"For my part, I am doubtful whether it is of much assistance in medical negligence, at any rate when all the evidence in the case had been adduced. But even if Mr Stembridge is right in saying that at that stage the maxim applies, it is always open to a defendant to rebut a case of res ipsa loquitor either by giving an explanation of what happened which is inconsistent with negligence or by showing that the defendant exercised all reasonable care."
"Res ipsa loquitur is not a principle of law and it does not relate to or raise any presumption. It is merely a guide to help identify when a prima facie case is being made out. Where expert and factual evidence is being called on both sides at trial its usefulness will normally have been long since exhausted. "
"(3) In practice, in contested medical negligence cases the evidence of the plaintiff, which establishes the res is likely to be buttressed by expert evidence to the effect that the matter complained of does not ordinarily occur in the absence of negligence.
(4) The position may then be reached at the close of the plaintiff's case that the judge would be entitled to infer negligence on the defendant's part unless the defendant produces evidence which discharges this inference.
(5) This evidence may be to the effect that there is a plausible explanation for what may have happened which does not connote any negligence on the defendant's part. This explanation must be a plausible one, and not a theoretically or remotely possible one, but the defendant certainly does not have to prove that his explanation is more likely to be correct than any other. If the plaintiff has no other evidence of negligence to rely upon, his claim will then fail.
(6) Alternatively the defendant's evidence may satisfy the judge on the balance of probability that he did exercise proper care. If the untoward outcome is extremely rare, or was impossible to explain in the light of the current state of medical knowledge, the judge was bound to exercise great care in evaluating the evidence before making such a finding, but if he does so, the prima facie inference of negligence is rebutted and the plaintiff's claim will fail. The reason why the courts are willing to adopt this approach, particularly in very complex cases, is to be found in the judgments of Stuart-Smith and Dillon LJJ in Delaney ."
Conclusions
Lady Justice Arden:
i) He performed the ultrasound with great care. The records of his examination were made by Dr Haeusler, who was also in attendance, and they show that at one point Professor Rodeck revised his initial measurements for the biparietal diameter and head circumference, which in the judge's judgment showed the care he was taking (judgment, paragraph 19).
ii) The judge found that Professor Rodeck located what he thought were echoes representing the cavum septum and the anterior horns, and indeed taken normal measurements of the distance between them. The judge also accepted that, although there was no record of his doing so, Professor Rodeck would also have found an echo which represented the anterior falx. This was Professor Rodeck's evidence, which the judge accepted (judgment, paragraphs 19, 30 and 63). On the appellant's case, there were no structures that he could have measured.
"As I have described, the disagreement between the expert witnesses was whether Professor Rodeck should have discovered that the echoes he must have taken as representing the cavum septum, the anterior horns of the lateral ventricles and the anterior falx were in fact mimics of those structures and not echoes of those structures. I saw "must have taken" because there is no record of what Professor Rodeck saw, and it is a matter of deduction as to what occurred. It is the task of the claimants to satisfy me on the balance of probability that, if he had exercised the skill and care to be expected of him, Professor Rodeck would have recognised the echoes as mimics." (Judgment, paragraph 62)
"Turning to execution to that high standard, I am satisfied that in the prevailing circumstances it was not enough to visualise a bladder simply by reference to shape and position. I accept that no more could necessarily be expected in the course of a standard anomaly scan. I write 'necessarily': the evidence showed that some practitioners would routinely go further, but I cannot find that that which was seemingly done was outwith the range of conduct appropriate for the standard anomaly scan. This , however, was not such a scan, it was a scan with a focus and I am satisfied that with care and skill commensurate to that focus and its importance that which was mistakenly identified as a bladder could have been exposed as something other than that organ. I accept Dr. Loughna's contention (as to which there was really no dispute) that with persistence that which was visualised as a bladder could have been checked for filling and emptying a test seemingly definitive. Again, with like persistence as demanded by the importance of the issue, the shape could and should have been checked by scanning in different planes and the Doppler could have been activated so as to obtain the guidance that can be furnished by visualising the relationship between the organ in question and the umbilical arteries. Granted that no one involved in the Leeds scans has now any real recollection of such, and granted that all now say that they must have been alive to the potential for cloacal exstrophy, it is worrying (whether or not significantly) that there is no reference to this condition in the contemporaneous documentation that none of the images depicts that which was visualised as a bladder; and that the terms of the letter of the 6th May are as cited. Finally, the Claimant is entitled to point to the fact of cloacal exstrophy and to visualisations at Whitby correctly consistent with such: there is a heavy burden on Leeds when seeking to reconcile its incorrect visualisations with the exercise of all reasonable care and skill."
"60. I do not think that the law provides any difficulty. It was considered by the Court of Appeal in a case which has some analogies with the present in that it was concerned with examination and interpretation of cervical smears, though there the smears were still available for examination. The case is Penney, Palmer and Cannon v East Kent Health Authority [2000] PNLR 323. In the course of his judgment Lord Woolf MR quoted the following passages from earlier authorities as setting out the relevant law:
(a) Hunter v Hanley [1955] SLT 213 per Lord President Clyde:
In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men The true test for establishing negligence in diagnosis or treatment on the part of the doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care.
(b) Maynard v West Midlands Regional Health Authority [1984] 1 WLR 634 at 648 per Lord Scarman:
that a doctor who professes to exercise a special skill must exercise the ordinary skill must exercise the ordinary skill of his specialty. Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to another: but that is no basis for conclusion of negligence"
(c) Bolitho v City and Hackney Health Authority [1998] AC 232 at 11588H per Lord Browne-Wilkinson:
"In my view the court is not bound to hold that a defendant doctor escapes liability for negligent treatment or diagnosis just because he leads evidence from a number of medical experts who are genuinely of the opinion that the defendants' treatment or diagnosis accorded with sound medical practice the court has to be satisfied that the exponents of the body of opinion relied on can demonstrate that such opinion has a logical basis. In particular in cases involving, as they often do, the weighing of risks against benefits, the judge before accepting a body of opinion as being responsible, reasonable or respectable will need to be satisfied that in forming their views, the experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter.""
"(4) The position may then be reached at the close of the plaintiff's case that the judge would be entitled to infer negligence on the defendant's part unless the defendant adduces evidence which discharges this inference.
(5) This evidence may be to the effect that there is a plausible explanation of what may have happened which does not connote any negligence on the defendant's part. The explanation must be a plausible one and not a theoretically or remotely possible one, but the defendant certainly does not have to prove that his explanation is more likely to be correct than any other. If the plaintiff has no other evidence of negligence to rely on, his claim will then fail."
"Next, what does the evidence that is available suggest that Professor Rodeck may have seen? At the end there was largely agreement between Mr Walkinshaw, Mr Howe and Dr Russell. The only candidates that survived were the echo of the monoventrical beak, to mimic the cavum septum, the 13-90 echoes to which mimic the anterior horns of the lateral ventricles, and the small piece of midline on Mrs Wright's picture (vi) for the anterior falx. I have said largely agreed because there was not agreement as to the last. But I do not think that the idea that Professor Rodeck (or Dr Meire or Dr Haeusler) located the forward end of Alice's actual falx bears scrutiny. It ran out at the highest point of the cranium and has disappeared in the last coronal view on the MR scan (9 of 16) where the beak of the monoventrical appears, or as Professor Griffiths said, at the line of the ears."
"Yes, my reason for defining that is there is this perception that we should see the falx and know it is the falx because it hits the skull and actually it is a midline structure, and it does not, as we have seen on the images, always although it clearly does anatomically extend to the skull, on the ultrasound image it is not a requirement to see it extending anteriorly to the skull to know it is the falx." (Day 7, page 88)
"On the basis of the evidence which I heard it is possible that these echoes [the 13-90 echoes] were produced in Alice's case and no other candidate to mimic the anterior lateral ventricular horns was established. It is not known how they would appear in a case where there were no anterior horns. Further, in the absence of horns it would not be so easy to distinguish them from echoes of the horns: for the contrasting structure is not there." (Judgment, paragraph 70)
"The linear echoes that it is suggested could mimic the anterior horns we know do exist and therefore I think it is reasonable to put forward the proposition that they would be included in a view that also contained a pseudo cavum septum pellucidum, the thalami and the third ventricle.
Jack J: I am sorry, I need to ask you to repeat that. The linear echoes could suggest mimicking the anterior horns - ?
A. These linear echoes that we know are the anterior margin of them in the normal stance from the roof of the lateral ventricle, including the anterior horn as we know they exist and that they are there. I do think that in Alice's case it is reasonable to propose that they would be in a position that could mislead in the absence of the anterior horns. " (Day 9, page 62)
"We know that holoprosencephaly is a very difficult diagnosis to achieve, because we have evidence from the literature which we have reviewed in this court which illustrates that in secondary and tertiary centres that this is not a diagnosis that, despite the skill and experience of the operator, that is always achieved. So whilst the abnormality may well be barn door [viz.obvious] once it has been diagnosed and we have got a magnetic resonance image, that is not the same as saying that it is barn door in ultrasound diagnostic terms at the time at which the attempted diagnosis is made." (Day 9, page 101)
"The need for appellate caution in reversing the judge's evaluation of the facts is based upon much more solid grounds than professional courtesy. It is because specific findings of fact, even by the most meticulous judge, are inherently an incomplete statement of the impression which was made upon him by the primary evidence. His expressed findings are always surrounded by a penumbra of imprecision as to emphasis, relative weight, minor qualification and nuance of which time and language do not permit exact expression, but which may play an important part in the judge's overall evaluation."
Lord Justice Buxton :
The duty of care
"The Greek tragedian Aeschylus addressed the unforeseen predicaments of human frailty in terms of the sport of the gods. In a modern scientific age, the wisest of experts will sometimes have to say: 'I simply do not know what happened'. The courts would be doing the practice of medicine a considerable disservice if in such a case, because the patient has suffered a grievous and unexpected outturn from a visit to a hospital, a careful doctor is ordered to pay him compensations as if he had been negligent in the care he afforded to his patient ..In this case however the judge made the positive finding that the anaesthetist had performed the spinal injection in the appropriate place with all proper care. In those circumstances any possible inference of negligence falls away. "
How do you test whether this act or failure is negligent? In an ordinary case it is generally said you judge it by the action of the man in the street. He is the ordinary man ..But where you get a situation which involves some special skill or competence, then the test of whether there has been negligence or not is not the test of the man on the top of the Clapham omnibus, because he has not got this special skill. The test is the standard of the ordinary skilled man exercising and professing to have that special skill.
And indeed the parties in the present case were agreed that skill as well as care was in issue. As the judge recorded in his paragraph 61:
There was no dispute here as to the standard of care to be exercised by Professor Rodeck. It was the ordinary skill of his speciality, that is, as a consultant sonologist at a tertiary referral centre.
"(4) The position may then be reached at the close of the plaintiff's case that the judge would be entitled to infer negligence on the defendant's part unless the defendant adduces evidence which discharges this inference
(5) This evidence may be to the effect that there is a plausible explanation of what may have happened which does not connote any negligence on the defendant's part. The explanation must be a plausible one and not a theoretically or remotely possible one, but the defendant certainly does not have to prove that his explanation is more likely to be correct than any other. If the plaintiff has no other evidence of negligence to rely on, his claim will then fail."
"In the absence of any pictures of what the Professor saw, it was a matter of considering what structures could have produced the echoes mimicking the structures Professor Rodeck was seeking, and whether he should have realised the echoes were mimics"
In following that agenda, it is necessary first to look at the way in which that evidence emerged, and then to consider whether it did indeed perform the task that the defence attributed to it.
The emergence of the evidence
The Witness: I feel, my Lord, quite strongly that this is a proposition that should have been put to Professor Griffiths who has significant knowledge of the anatomy of the brain over and above the knowledge that the other four experts have and I am not sure why this possibility was not broached when he was here.
Counsel for the NHS Trust: I can tell you it was not put because it was not something which, to be absolutely frank with you, that my experts had thought about at that time.
Counsel's observation says all that needs to be said about the nature of the process into which the court and the witnesses were drawn.
The case in negligence
"what does the evidence that is available suggest that Professor Rodeck may have seen? At the end there was largely agreement between Mr Walkinshaw, Mr Howe and Dr Russell. The only candidates that survived were the echo of the monoventrical beak, to mimic the cavum septum, the 13-90 echoes to which mimic the anterior horns of the lateral ventricles, and the small pieces of mid-line on Mrs Wright's picture (vi) for the anterior falx. I say largely agreed because there was not agreement as to the last"
"We have it here in black and white in the literature that is being presented to us that this is a well recognised pitfall. This is not something that should be a surprise to any expert who is carrying out a scan. This is in black and white, written in 1990"