Ipsofactoj.com: International Cases  Part 4 Case 1 [QBD]
QUEEN'S BENCH DIVISION
- vs -
Birmingham Health Authority
MR JUSTICE EADY
31 JULY 2001
Mr Justice Eady
AN OVERVIEW OF THE CLAIM
The Claimant, Mr Asad Raza Mirza, is now 29 years old and in these proceedings, begun by writ on 3 September 1998, is suing the Birmingham Health Authority for alleged negligence in the carrying out of a heart operation 25 years ago on 3 August 1976. The surgeon concerned is Mr Keith Roberts, who is now aged 78 and has no specific recollection of the patient, or of the operation, but has pieced together his evidence in the light of the available medical records and of his practice generally during the relevant period. He was appointed a Consultant Cardiac Surgeon in 1959 and retired on 1 April 1988 after a long and (it is not disputed) distinguished career specialising in paediatric thoracic surgery.
The Claimant was born on 7 March 1972, weighing only three pounds, and unhappily suffered from a number of congenital problems including coarctation of the aorta and a patent arterial duct. He became ill with pneumonia and, following admission to hospital for treatment, the coarctation was discovered after written consent was given on 6 June for cardiac catheterisation. Mr Roberts operated on the Claimant, for the first time, on 16 June. He resected the narrowed section of the aorta and performed an end-to-end anastomosis. He also closed the arterial duct.
The aorta is the main artery of the body and coarctation involves a local stricture, usually located distally to the origin of the left subclavian artery. To a greater or lesser extent, coarctation inhibits the flow of blood to the lower parts of the body. It is a serious and potentially life-threatening condition and, until surgery became possible in the middle of the 20th century, many of those born with the defect would die in infancy and few would live beyond the age of 40. The main consequence is that blood pressure is raised in the upper body, above the stricture, giving rise to a greater than usual risk of cerebral haemorrhage and heart failure. The surgical procedure of resection and anastomosis, first performed in 1944, consists of clamping the aorta on either side of the stricture, cutting it out and rejoining the ends by sutures.
Mr Roberts carried out his first such operation in June 1953 and had carried out, he estimates, approximately 200 similar procedures by the time he came to operate on this Claimant for the second and critical time in August 1976. Although the operation had become relatively common by that time, and was treated in some respects as routine, its drastic nature needs hardly to be stated. Once the aorta is clamped, the blood supply to the lower part of the body is greatly restricted and the equilibrium is only restored once the loose ends are joined and the clamps removed. My attention was drawn to the following words from the Textbook of British Surgery, edited by Sir Henry Souttar and J.C. Goligher (1956), which appear in Mr Norman Barratt's chapter "Surgery of the Heart and Great Vessells":
Resection of coarctation is probably the most dramatic and the most potentially frightening operation in surgery today .... Resection of a coarctation is difficult, exacting and dangerous.
One of the risks attaching to a resection operation, believed to be under 0.5 per cent, is that ischaemia of the spinal cord will lead to paraplegia. The cord, the kidneys, the liver and other organs can stand ischaemia for a certain length of time (apparently varying significantly according to individual circumstances), but the longer the clamp-time the greater the risk that deprivation of oxygenated blood will lead to the death of cells and to neurological damage. It is important to recognise that this consequence is very rare. Mr Jaroslav Stark was appointed as a Consultant Cardiac Surgeon in 1971 to the Great Ormond Street Children's Hospital and retired in 1999. After 37 years of experience as a cardiac surgeon altogether, and direct involvement in literally hundreds of paediatric coarctation and recoarctation operations, he has never come across a case of ischaemic damage resulting in paraplegia. Nor, as he emphasised several times, does the literature contain any other example of a child under 10 suffering such consequences following recoarctation. Correspondingly, therefore, there is very little hard evidence on which surgeons can safely rely in predicting or avoiding the risks.
The first operation on the Claimant, in June 1972, was apparently successful so far as it went, but he remained in poor health generally and required regular medical attention for a number of reasons. As time went by, it became apparent in the course of his monitoring that there were signs of further aortic stenosis (as is by no means uncommon). A recurrence of the condition was firmly diagnosed shortly after he returned in 1975 from a five month visit to Pakistan. It was characterised as 'mild' by Dr Rigby on 27 August 1975. It was thought sufficiently serious to merit further catheterisation and, on 9 September, an angiogram was recorded on cine film. This investigation confirmed recoarctation at the site of the first operation, although no urgency was perceived at that stage, and a case conference was convened of which a brief record survives. The identity of those attending was not recorded, but Mr Roberts thinks it quite likely that he himself was present. He had introduced the practice of case conferences to the Birmingham Children's Hospital following visits to cardiac units in North America. They would normally be attended by cardiac surgeons, cardiologists and radiologists for the purpose of reviewing the results of investigations carried out and to decide on future action. It was noted at the case conference by Dr Silove (a consultant cardiologist) that the coarctation was 'moderate'. Its diameter was described as approximately (plus or minus) the same as that of the subclavian artery (probably in the range of 0.5 to 0.7 cm.).
Ultimately, on 19 May 1976, Mr Roberts saw the Claimant and advised his parents that he would need to undergo further surgery for the recoarctation. It seems to be accepted by all relevant experts that a second operation is likely to be more difficult and to a degree more hazardous than the first.
One of the experts called on behalf of the Claimant (Professor David Hamilton) described how, after a first operation, the healing of wounds would naturally lead to fibrous union of the layers and structures so that landmarks are obliterated. He drew the analogy of opening a suitcase to find that one's clothes have been stuck together with glue and with no free planes existing between them. Similar evidence was given by Mr Stark for the Defendant. Second operations will often, therefore, require even greater patience and delicacy on the part of the surgeon. Accordingly, they may take longer and will be less easy to predict, both as to timing and outcome. Sometimes the wall of the aorta will be thicker and sometimes thinner and more friable (thus presenting difficulties for suturing at the stage of anastomosis). This does not necessarily mean, however, any significant lengthening of the clamp-time itself. I note, for example, that in a 1995 article by Anthony C. Ralph-Edwards and others ('Reoperation for Recurrent Aortic Coarctation'), based upon experience at the Hospital for Sick Children in Toronto, it was observed that: "It is difficult to discern from the literature what the risk of paraplegia may be for recoarctation surgical intervention. There is a general belief that it will be higher than the risk at initial repair, although there are little data to substantiate this". By contrast, the view had been expressed in The Journal of Thoracic and Cardiovascular Surgery for September 1972 (Brewer and others) that the risks of cord paralysis were undoubtedly increased second time round, and this view was repeated in Thorax in 1975 (Ross and others).
What seems to be reasonably clear is that, following the second operation, carried out on 3 August 1976 in accordance with Mr Roberts' advice, the Claimant suffered a number of problems associated with neurological deficit and, in particular, partial paraplegia. It is agreed that this, in turn, is most likely to have been brought about by ischaemic damage to the spinal cord: see e.g. the joint report of Mr Franks and Mr Lincoln following a meeting on 12 May 2000. The unhappy outcome in this case was itself referred to in an article in 1985 by J.W.L. Puntis and S.H. Green in Archives of Disease in Childhood ('Ischaemic spinal cord injury after cardiac surgery'). It is the Claimant's contention that this damage was avoidable and caused by a negligent omission by Mr Roberts.
There was some debate over interpretation of the available records (inevitably involving a degree of speculation) as to how long precisely the clamps remained in place. I shall need to return to this issue in due course. The clamps might have been placed at 10.33 a.m. or 10.37 a.m. and they could have been removed at 11.00 or even (on one view) as late as 11.10. This suggests a possible range of total clamping times between 23 and 37 minutes. There can at this stage be no definitive answer but only an assessment of likelihood. It is unfortunate that, in a case in which a few minutes could be critical, there should be no accurate record and that the gap should be as wide as 14 minutes.
Patients vary enormously in their tolerance of ischaemia and it is accepted that a few minutes could have made all the difference in this case. The Claimant's paraplegia is, although devastating in its consequences, only partial. It is fair to assume, it is submitted, that the neurological deficit can be traced to the latter end of the clamping period (whatever its length). The experts are agreed that, if it occurred early on, it is likely to have been more profound and to have rendered him totally incapable of motor activity and control of the lower half of his body. As it is, the Claimant is capable of walking short distances although with a spastic gait.
So it comes about that much of the debate between the experts in the course of the hearing focused upon what (if anything) could or should have been done to minimise the risk of ischaemic damage to the spinal cord over the critical period (quite possibly, over the last few minutes of clamping).
I have to address two preliminary issues only, in accordance with an order to that effect made on 2 November 1999. Apart from this vexed question of liability over ischaemic damage, there is also in view of the many years that have elapsed a live issue as to the impact of the Limitation Act 1980. I was also invited by both parties to hear submissions on causation and to make findings accordingly. It will be convenient, and perhaps also logical, for me to consider first the disputes over what happened at the operation, and thereafter causation, limitation and liability.
Before I do so, I should like to record my indebtedness to the very experienced Counsel on both sides, and to their legal teams, for the efficient and lucid presentation of their respective cases. I was greatly assisted also by the distinguished expert witnesses called on each side. What happened on 3 August 1976?
The original of the anaesthetic chart for the second operation has survived and was given close attention during the course of the trial. There is at least one inconsistency in the data, which I am asked to resolve. The chart was kept by a doctor who, according to the consultant anaesthetist, Dr Beasley, would have been a registrar or senior registrar. He wrote down that the clamps went on at 10.33, but he also put an arrow on the chart pointing to a spot just after the vertical line connoting 10.35. The witnesses divided more or less on "party lines", Dr Beasley and Dr Scallan suggesting that 10.37 was the more likely time because the chart showed the blood pressure rising significantly afterwards; whereas Dr Abbott thought the positive act of writing 10.33 was more likely to be reliable. He thought that the arrow might have been jotted down by mistake between the wrong vertical lines.
Dr Abbott was asked why the blood pressure would only go up after a delay, as would have to be the case on his thesis. He referred to the fact that the pressure readings were only being taken at five minute intervals (approximately) and to the delay in obtaining the information by means of the traditional right arm cuff. There can be no definitive answer, but on the whole I prefer to treat the written entry of 10.33 as more reliable. A doctor recording data in this kind of operation would appreciate the importance of noting the clamp time accurately and would look at the clock when the surgeon announced that they were going on. It is not likely that, having looked at the clock, he would then write down the figure '3' by mistake for '7'.
There is also a dispute as to when the clamps came off. The arrow on the chart would appear to indicate that they were removed at 11.00 a.m. The halothane was lowered at that point from three down to one half per cent. Dr Beasley explained that this would be done just prior to the clamp being removed so as to prevent a sudden drop in blood pressure. There was then a gap before the Claimant suffered a cardiac arrest at the stage when Mr Roberts was suturing the mediastinal pleura. There seems to be agreement among the surgeons that there would normally be a period of about 10 minutes between the clamps coming off and the sewing up of the mediastinal pleura. Certainly Mr Roberts' evidence to this effect was not challenged. Such a delay is required because one would need to wait and see if there was unacceptable bleeding from the area of the anastomosis. Dr Scallan seemed to think that the gap might be nearer to five minutes, but I accept the consensus among the surgeons that a rather longer period would be required.
What does seem clear from the chart, however, is that the record ceased abruptly at 11.05, suggesting strongly that the cardiac arrest occurred between those entries being recorded and the time for the next periodic readings (i.e. 11.10). All hands would have turned to the priority of resuscitating the patient. This seems a very likely explanation and tends to support the estimates of Mr Roberts and Dr Beasley that the clamps must have been removed at about 11.00 a.m.
The only snag about this interpretation of events is that it would not, at first sight, seem to tie in with the fact that blood pressure continued to rise for some minutes after 11.00. One would expect it to fall once the clamps were removed. It is necessary once again, however, to remember that the chart only represents the periodic blood pressure readings via the cuff. Thus the pattern may not be quite as consistent or clear cut as it seems. Moreover, Dr Scallan offered a possible explanation why the blood pressure might have gone up even though the clamps had been removed. He had observed over many years a tendency for heart surgeons to busy themselves during the 10 minute waiting time to which I have referred and, on the basis of his experience, he thought it quite likely that Mr Roberts would have been inserting chest drains at this point rather than standing about. This would have an impact on a patient who would be, by this time, relatively lightly anaesthetised. It would provide a stimulus that could have the effect of keeping the blood pressure up. This is a possible explanation. But certainly, in my judgment, the crucial facts in assessing the time of the clamps' removal are:
that the arrest occurred while the pleura was being sutured;
that this stage could only have been reached after a gap of 10 minutes from clamp removal; and
that the arrest probably occurred at or before the time for entering the data at 11.10.
In these circumstances, I find on the balance of probabilities that the removal of clamps took place within a minute or two of 11.00. It seems to me to follow from my earlier finding, about the clamps going on, that the overall clamping time was just under 30 minutes. This is consistent with the evidence of those who were present and with the experience of others in this type of operation. Mr Lincoln, for example, said that he had never known a coarctation procedure to last beyond 30 minutes (in more than 30 years of practice). Moreover, the evidence appears to suggest that Mr Roberts was known to be an efficient and brisk surgeon. Dr Abbott, for example, described him as "very good and quick". Although Mr Lincoln did not like the adjective "quick" when applied to surgery, and preferred to speak in terms only of "skill", some surgeons are no doubt rather quicker than others in general terms. If Mr Roberts is one of these, as the evidence tends to suggest, that too would be consistent with the finding of 27-30 minutes for this case rather than 40 minutes. At all events, it does appear that the critical part of the operation took somewhat longer than Mr Roberts' average of 15-20 minutes. Nonetheless, as Dr Scallan and Dr Abbott noted, the literature certainly records much longer cross-clamp times without spinal cord damage.
The starting point is to record that it was agreed between Mr Franks and Mr Lincoln on 12 May 2000 that cord ischaemia was the cause of the Claimant's paraplegia. While the aorta is clamped, perfusion of the spinal cord and lower parts of the body can only take place by one of two means. Either there is surgical intervention so that oxygenated blood can by-pass the clamped aorta, or it will be carried naturally through collateral circulation. Since there was no by-pass in this instance, Mr James Badenoch Q.C. argues that it must follow that the Claimant's collateral circulation was insufficiently developed to keep the cord supplied. The Defendant submits, however, that on the balance of probability the ischaemia was not caused by inadequate collateral circulation but rather by an individual abnormality of blood supply to the spinal cord (such as is discussed in general terms in an article by Brewer and others in The Journal of Thoracic and Cardiovascular Surgery in 1972).
This did not loom large in the Defendant's expert reports in advance of the trial and really surfaced in the course of the oral evidence. The thought seems to have been prompted by the statistics, which suggest that there is no other recorded example of a comparably young child having suffered paraplegia over such a short clamp time. The argument was buttressed also by reference to the Claimant's other congenital defects, but it seems to me speculative. This may have been a contributory factor but it does not seem to me that there is sufficient evidence to justify such a conclusion on the balance of probabilities; in other words, I am unable to exclude inadequacy of collateral circulation as the true explanation. Indeed, the evidence points in my judgment to this being at least the major cause.
The important consideration for causation is that the neurological deficit is due to ischaemic damage. The measures which the Claimant submits should have been taken would have either avoided ischaemia or prolonged the body's capacity to withstand it without suffering damage. There is no evidence before me to suggest that, even if the Claimant was suffering from a congenital abnormality as to his blood supply, it could not have been countered by one of the by-pass options or by hypothermia, in the sense that it would have enabled him to survive ischaemia for a sufficiently longer time to prevent the deficit.
It is notoriously difficult pre-operatively to make a reliable assessment of the adequacy of a young patient's collateral circulation. Adolescents and adults will normally have developed collateral blood supply quite naturally in the course of their growth. It seems that the age of seven represents a significant staging post in the process of developing collaterals. Before that stage, however, it would seem that what is required is a sufficient stimulus to the development of collaterals and time for them to develop in response. A tight coarctation would almost certainly provide the stimulus to collateral development but it would take time to have its impact.
Mr Badenoch attaches significance to the fact that there was no note anywhere in the records as to the viability of the Claimant's collateral circulation. Although he derives some support from Mr Franks, Mr Lincoln did not find this at all unusual, adding that he had never seen any clinical notes recording pre-operative conclusions about a patient's collaterals. It was not something ever discussed at his regular case conferences.
It is possible, and no doubt prudent, to make some prior assessment of collateral circulation, but the pre-operative indicators can only provide very crude guidance. Mr Stark, for example, stated that the 'safe' level of measured pressure is not known. He has cited a range of 40-70 mm. Hg., although Mr Lincoln seemed content with a reading as low as 30 mm. Hg. Moreover, Mr Keen concluded in his 1987 study that there is no guarantee that such a procedure will prevent paraplegia. It would seem to emerge also from the paper of D. Glen Pennington and others that spinal damage can occur notwithstanding the presence of apparently strong collaterals: The Journal of Thoracic and Cardiovascular Surgery (1979), at p.227. This was also a matter of agreement between the anaesthetists Dr Scallan and Dr Abbott.
We know that the original obstruction in this case had been removed in 1972 (without any division of intercostal arteries) and the process of recoarctation was not perceived as requiring urgent attention in August or September 1975. The tighter the stenosis the greater the stimulus to collateral development. By that time, it was only 'mild' or 'moderate'. We know too that in February 1976 there were still palpable femoral pulses, although they had been noted to be rather weak as early as 1973. So far, one could conclude no more than that the narrowing of the aorta would be providing some degree of stimulus to collateral development. By the beginning of August 1976, the femoral pulses were not readily detectable; from which it is reasonable to assume that there had been further narrowing and thus some increase in stimulus to collateral growth. Mr Franks emphasised, however, as I accept, that one cannot infer the strong development of collaterals from the mere absence of femoral pulses. It is certainly an indicator of stimulus but it could take months to have its impact.
It is important also in this context to bear in mind Mr Roberts' own evidence to the effect that "... I would not have expected to see any change in the collateral circulation between September 1975 and August 1976". He is not suggesting, therefore, by any means, that the absence of femoral pulses on 2 August 1976 would in itself demonstrate that a strongly developed collateral circulation had leapt into operation fully formed. In the light of the most unfortunate consequences of ischaemic damage, immediately after the operation, it is now possible to infer in my judgment that the Claimant's collateral circulation turned out to be inadequate. In fact, the relevant part of the aorta was measured post-operatively and appeared to have narrowed to 0.25 cm. Even allowing for some 'shrinkage' this would suggest a significant reduction since the angiogram almost a year earlier. It may be that this led to a significantly decreased flow, thus increasing the stimulus to collateral development over the intervening period. Mr Badenoch accepts that there must have been some collateral flow (not least because, after the clamps went on, the rise in blood pressure was relatively modest). His case is that it was not up to the task.
There may also have been a congenital abnormality of blood supply. It is difficult in light of the evidence to come to any conclusion as to how such a deficiency would have inter-related with his collateral circulation. But, in the light of the material before me, I must conclude that if the Claimant's collateral circulation had been better established, he would have most likely avoided the neurological deficit. It is thus possible to conclude, again on the balance of probability, that if measures could have been taken safely to avoid ischaemia, or alternatively to give the body prolonged tolerance to its effects, then the Claimant would have avoided his partial paraplegia. In particular, if steps had been taken pre-operatively to reduce his body temperature to (say) 33-34°, he would probably have been given sufficient protection against ischaemia to see him safely through the operation (subject to the risk of ventricular fibrillation to which I shall return later). I find the evidence of Mr Franks and Professor Hamilton persuasive in this respect. I am conscious, of course, that Mr Stark does not agree that "the tragedy could have been avoided by electively lowering the body temperature to 32-33°C". Nonetheless, it seems to me that the balance of evidence before me would so indicate.
I must emphasise, however, that my conclusions are based on the expert evidence available to me in 2001 and that I have been able to reach them with the benefits of hindsight. It is necessary to remember that even in 1991 there had been discovered "... no reliable method for predicting or avoiding this catastrophe": Myers and Waldhausen, "Management of Complications Following Repair of Coarctation of the Aorta, Patent Ductus Arteriosus, Interrupted Aortic Arch, and Vascular Rings" (chapter 15 of Complications in Cardiothoracic Surgery). It is the Defendant's case that paraplegia is so rare a consequence that there was at the time no material before Mr Roberts to indicate that the operation was other than routine or such as to require special protective measures. I shall return to this issue when I address liability.
It is contended by the Defendant that the primary limitation period expired on 7 March 1993 (i.e. the Claimant's 21st birthday). The Claimant's contentions are twofold.
The primary submission is that for purposes of ss.11 and 14 of the 1980 Act the Claimant only acquired the relevant knowledge on or about 19 February 1998 and that, accordingly, the proceedings are not out of time.
Secondly, and in the alternative, it is argued that the Court should exercise its discretion under s.33 of the 1980 Act, so as to disapply the usual limitation provisions.
It is clear from s.11(4) of the statute that the primary limitation period for personal injury cases (i.e. three years) runs from the accrual of the cause of action or the date of the Claimant's knowledge of the relevant personal injury, if later. It is the Defendant's case that the Claimant had the relevant knowledge prior to 3 September 1995; that is to say, for more than three years before the issue of the writ on 3 September 1998.
In order to identify the "relevant knowledge" it is necessary to turn s.14 of the Act. The critical date is that when the Claimant knew that:
the injury complained of was significant; and
it was attributable, in whole or in part, to the acts or omissions which it is alleged constitute negligence; and
the identity of the defendant.
It is irrelevant whether or not the Claimant was aware that the acts or omissions did, or did not, as a matter of law, involve negligence.
Here the critical question is when the Claimant knew that his paraplegia was attributable to the specifically pleaded omissions of Mr Roberts in the preparations for the operation on 3 August 1976 and in its execution. Those omissions are clearly matters involving a sophisticated knowledge of surgical techniques available at the time; did he know prior to 3 September 1995, for example, that his disability might have been attributable to the admitted non-use of manometric measuring, left heart by-pass, shunt graft or hypothermia?
It is probably now unnecessary to go further than applying the guidance afforded by Brooke L.J. in North Essex District Health Authority v Spargo  8 Med. L.R. 125, 129-130 in the light of the earlier authorities he there reviewed:
The knowledge required to satisfy s.14(1)(b) is a broad knowledge of the essence of the causally relevant act or omission to which the injury is attributable;
'Attributable' in this context means 'capable of being attributed to', in the sense of being a real possibility;
A plaintiff has the requisite knowledge when she knows enough to make it reasonable for her to begin to investigate whether or not she has a case against the defendant. Another way of putting this is to say that she will have such knowledge if she so firmly believes that her condition is capable of being attributed to an act or omission which she can identify (in broad terms) that she goes to a solicitor to seek advice about making a claim for compensation.
On the other hand, she will not have the requisite knowledge if she thinks she knows the act or omission she should investigate but in fact is barking up the wrong tree: or if her knowledge of what the defendant did or did not do is so vague or general that she cannot fairly be expected to know what she should investigate; or if her state of mind is such that she thinks her condition is capable of being attributed to the act or omission alleged to constitute negligence, but she is not sure about this, and would need to check with an expert before she could be properly said to know that it was.
On the facts of this case, it seems clear that it is the fourth of these principles that is of primary importance. The evidence of the Claimant's father as to what he was told in 1976, shortly after the unhappy consequences of the operation became apparent, is in effect that it was "just one of those things" or an unfortunate side-effect which sometimes follows such a surgical procedure. He was apparently told by a nurse that a machine supplying oxygen had stopped at some point during the operation. He was also seen by a Dr Green on 12 August 1976, although he now has no recollection of this. He is recorded as having told him that the neurological damage was probably due to ischaemic damage but that things would improve. He was by no means fully familiar with the English language at that stage. He was thus at some disadvantage in grasping the implications of a conversation with a medical expert in circumstances that were no doubt very distressing for him in any event. I can well believe that he was given no inkling that his son's paraplegia was attributable to an "omission", or that it might have been avoidable by the application of known and available surgical techniques. He had to glean what he could from a brief interview.
Mr Badenoch drew my attention to the following remarks of Stuart-Smith L.J. in Forbes v Wandsworth Health Authority  Q.B. 402, 411 G-H:
In many medical negligence cases the plaintiff will not know that his injury is attributable to the omission of the defendant alleged to constitute negligence, in the sense that it is capable of being attributable to that omission, until he is also told that the defendant has been negligent. But that does not alter the fact that there is a distinction between causation and negligence; the first is relevant to section 14(1), the second is not. The fact that in such cases it may be necessary for the plaintiff also to know of the negligence before he can identify the omission alleged to have been negligent is nothing to the point.
Neither the Claimant nor his father could possibly have had knowledge of the relevant "omissions" now relied upon without detailed and expert advice in the light of a reasonably full knowledge of what had actually taken place in 1976. For this purpose, at least some of the medical records would need to be consulted. We know that these were requested in January 1995 and that they were supplied in dribs and drabs over the next two years. Until these were available, it was not reasonable to expect any expert to offer a meaningful opinion. Eventually, a preliminary view was obtained from an expert (Mr Franks) on or about 19 February 1998. Only then, submits Mr Badenoch, can the Court attribute the relevant knowledge to the Claimant. In the light of the authorities, this seems to me to be correct.
I need to address another aspect of limitation; that is to say, the matter of constructive knowledge. This received little attention in the course of submissions largely because, as Mr Forde pointed out, on the facts of the present case very similar considerations apply to the issues of actual and constructive knowledge. It is necessary to address the objective test of whether it was reasonable for the Claimant to seek advice on the facts and circumstances of the case (but excluding the individual Claimant's traits): see s.14(3) of the Act. This is relevant to consider, as a matter of public policy, for the reasons explained by Colman J in Parry v Clwyd Health Authority  P.I.Q.R at P4:
The function of that subsection is to prevent the plaintiff from remaining inactive in circumstances where, although he does not have actual knowledge of facts which show that his injury is, as a matter of a real, as distinct from a fanciful, possibility, capable of being attributable to the act or omission of the defendant, he might reasonably be expected to acquire such actual knowledge from:
Once a solicitor has been consulted, the Claimant would be fixed with knowledge of information which his adviser ought reasonably to have acquired. Solicitors were first consulted in 1993 but they seemed to think that any claim would simply be time-barred. The Claimant approached other solicitors in November 1994 and they shortly afterwards approached the Defendant to obtain all relevant records. In this case, I cannot see that any relevant information could have been acquired prior to the receipt of the medical notes in 1997.
Submissions were also addressed to me on the discretion to disapply under s.33 of the Act. In the event, I need say little about this issue. I would have exercised the discretion had it been necessary to do so. I am quite satisfied that the material period of delay has not rendered any evidence less cogent. The Defendant's case does not seem to me to have been prejudiced in any way. It may well be that the cine film record of the angiogram went missing in or about 1998, as the evidence of Tracey Lucas suggests, but it is difficult to see what difference it would have made. Moreover, it is clear that all records were being sought from early 1995 onwards and that this, if it still existed, should have been produced well before 20 May 1998 (the date put forward by Miss Lucas).
My conclusion is that the Claimant succeeds on his primary limitation argument.
PRINCIPLES OF LAW RELEVANT TO LIABILITY
There is little room for dispute between the parties over the principles of law applicable to a claim such as this. I was rightly reminded of the leading authorities and I set out below some of the well known passages relied upon. It goes without saying that I must apply, so far as I am able, with the assistance of the experts, the professional standards relevant to August 1976 and that I must not be distracted by advances in knowledge or techniques over the intervening quarter of a century. The starting point is perhaps to refer to the words of McNair J in Bolam v Friern Hospital Committee  2 All E.R. 118,122:
A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art .... Putting it the other way round, a doctor is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view. At the same time, that does not mean that a medical man can obstinately and pig-headedly carry on with some old technique if it has been proved to be contrary to what is really substantially the whole of informed medical opinion.
More recently Lord Scarman discussed the same principle in Maynard v West Midlands Regional Health Authority  1 W.L.R. 685, 638:
A case which is based on an allegation that a fully considered decision of two consultants in the field of their special skill was negligent clearly presents certain difficulties of proof. It is not enough to show that there is a body of competent professional opinion which considers that theirs was a wrong decision, if there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances. It is not enough to show that subsequent events show the operation need never have been performed, if at the time the decision to operate was taken it was reasonable in the sense that a responsible body of medical opinion would have accepted it as proper. I do not think that the words of Lord President Clyde in Hunter v Hanley, 1955 S.L.T. 213 at 217 can be bettered:
I would only add that a doctor who professes to exercise a special skill must exercise the ordinary skill of his speciality. 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 the other: but that is no basis for a conclusion of negligence.
In Bolitho v City and Hackney Health Authority  A.C. 232, 243A Lord Browne-Wilkinson, having considered earlier authorities such as Hucks v Cole  4 Med. L.R. 393 and Edward Wong Finance Co. Ltd v Johnson Stokes & Master  A.C. 296, summarised the position in the following important passage:
These decisions demonstrate that in cases of diagnosis and treatment there are cases where, despite a body of professional opinion sanctioning the defendant's conduct, the defendant can properly be held liable for negligence (I am not here considering questions of disclosure of risk). In my judgment that is because, in some cases, it cannot be demonstrated to the judge's satisfaction that the body of opinion relied upon is reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion. In particular, where there are questions of assessment of the relative risks and benefits of adopting a particular medical practice, a reasonable view necessarily presupposes that the relative risks and benefits have been weighed by the experts in forming their opinions. But if, in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible.
I emphasise that in my view it will very seldom be right for a judge to reach the conclusion that views genuinely held by a competent medical expert are unreasonable. The assessment of medical risks and benefits is a matter of clinical judgment which a judge would not normally be able to make without expert evidence. As the quotation from Lord Scarman makes clear, it would be wrong to allow such assessment to deteriorate into seeking to persuade the judge to prefer one of two views both of which are capable of being logically supported. It is only where a judge can be satisfied that the body of expert opinion cannot be logically supported at all that such opinion will not provide the benchmark by reference to which the defendant's conduct falls to be assessed.
Most recently, in Calver v Westwood Veterinary Group  Ll. L.R. Med. 20, Simon Brown L.J. applied the test in the following words (at paragraph 32):
I come, therefore, to the critical question arising on the appeal: was the judge entitled to regard this as one of those 'rare case[s]' in which one body of veterinary opinion (represented by Mr Vogel) demonstrated that the other (represented by Mr Hughes and Mr Greenwood) was not capable of withstanding logical analysis, or was it not one of 'the vast majority of cases' where the reasonableness of Mr Hughes' opinion was demonstrated by the fact that it was shared by Mr Greenwood, a distinguished expert in the field?
His Lordship continued at paragraph 34:
Taken as a whole, it seems to me impossible on the evidence here to condemn the body of professional opinion represented by Mr Hughes and Mr Greenwood as illogical and there is frankly nothing in Mr Vogel's evidence which justifies, let alone compels, so extreme a view. Although the judge expressly disavowed the benefit of hindsight, his judgment to my mind depends upon it. Of course there are differences between the experts: Mr Vogel clearly treats animals more defensively than Mr Hughes and Mr Greenwood. Both opinions, however, seem to me clearly capable of logical support and in that situation there is no room for a finding of negligence.
I shall identify shortly the pleaded criticisms levelled at Mr Roberts over his preparations for and conduct of the operation on 3 August 1976. In the light of these authorities, I need to focus on the extent to which his conduct was consistent with a body of competent professional opinion then prevailing. If there was such a body of opinion, then the subsidiary question arises of whether the practices thereby sanctioned can be held to be incapable of withstanding logical analysis and thus, correspondingly, to be unreasonable or irresponsible. I must not judge Mr Roberts' acts or omissions by the standards of a counsel of perfection, nor yet with the benefit of hindsight.
THE BREACHES OF DUTY ALLEGED
The criticisms made of Mr Roberts were summarised by Mr Badenoch as follows:
It was known that this type of operation carried a risk of paraplegia through ischaemia because, during the clamping period, diffusion of the lower body was dependent, without adjuvant surgical techniques, on alternative anatomical channels ("collateral circulation") of uncertain adequacy.
The degree of the risk was not ascertained, and/or ascertainable, with confidence pre-operatively.
Once the clamped aorta was cut through, it would be necessary to complete the surgery as quickly as possible, but one could not be sure how long this would take.
It was thus necessary for a careful surgeon to find out as much information as possible, before severing the aorta, as to the adequacy of collateral circulation.
It was possible to achieve sufficient knowledge by a simple measuring device, inserted below the clamp prior to cutting, so as to obtain a reading of blood pressure on an oscilloscope (not used in this case).
If it should emerge from such measurement that there was a significant possibility of inadequate distal perfusion, a competent surgeon in 1976 should have adopted one or both of two protective measures:
Prior to severing, the clamped section should be by-passed by a temporary 'jump-graft';
The patient should have been cooled to (say) 32-33°.
It was negligent for the surgeon to proceed to surgery on the "assumption" that the collateral circulation would be sufficient. In so far as a competent and responsible body of surgeons was proceeding in accordance with Mr Roberts' practice (as described above), this was not capable of withstanding logical analysis. Mr Badenoch characterised it as "diving in and hoping for the best" and as "operating blind".
SURGICAL ATTITUDES GENERALLY TO PROTECTIVE MEASURES IN 1976
Mr Badenoch has speculated that cardiac surgeons in general might have been under-reporting the incidence of neurological damage following such operations through an unwillingness to reveal their failures. There may be an element of this, but the assessment of Mr Roberts' conduct in 1976 has to be made not only in the light of the available literature and statistical information but also in the light of his personal experience.
He was one of the very first surgeons to specialise throughout his consultancy career in paediatric thoracic surgery and the treatment of congenital heart disease (as was Mr Stark at Great Ormond Street). There is no reason to suppose that he was under-reporting neurological damage - nor for that matter Mr Stark or Mr Lincoln. For a judge in my position, doing his best to appraise matters through the eyes (and fingers) of an experienced cardiac surgeon operating 25 years ago, it is necessary to remember what such experience would have taught them by that time. That I must do in the light of the evidence I have received from the five eminent cardiac surgeons who have provided statements and/or reports and been tested skilfully in the witness-box. In other words, I must not be tied too closely to the literature - instructive and informative though much of it is.
I need to remember that articles such as those by Hughes (1971), Brewer (1972) and Ross (1975) contained opinions and tentative advice from people who would not necessarily have been perceived by Mr Roberts, Mr Stark or Mr Lincoln as being so experienced, wise or authoritative that practice had immediately to be changed in the light of them. As Mr Stark noted,
.... for a surgeon who tries to make evidence based decisions, the interpretation of [Brewer's] findings is rather questionable.
Mr Roberts was as experienced as anyone and was able to make his own judgments as to the value of these articles and the weight to be attached to them. As everyone recognised, there is a fundamental distinction between evidence and opinion, for these purposes; the latter requires careful appraisal by the individual practitioner according to personal judgment and experience.
Mr Stark made the important point that experienced paediatric specialists in the field are wary of extrapolating from data about adolescent or adult patients to applying the information in the case of children.
It is notable that when Mr Roberts did change his practice in 1978, so as to adopt some protective measures, it was not as a result of his experience in this or any other individual case. He was influenced by advice from Mr Keen of the Bristol Infirmary, whose thinking has been considerably guided over the years (as is confirmed in his 1987 Thorax article) by medico-legal factors. He has been concerned to an extent to proffer advice to his colleagues on steps that might be taken not so much for the benefit of patients but primarily to avoid findings of negligence. I must remain cautious, it seems to me, because this is something of a distorting influence.
I was invited by Mr Badenoch to infer from Dr Brewer's 1972 paper, and from a survey carried out by Mr Stark very recently, that most cardiac surgeons would have taken one or more protective measures in the mid-seventies. I am afraid that this anecdotal material is too imprecise for me to do this. There are difficulties of interpretation. Indeed, Mr Stark recognised that parts of his questionnaire were themselves confusing - let alone the answers. It is impossible to establish the circumstances in which any of the individual surgeons questioned would have opted for any specific course of action. In particular, I can come to no conclusion as to how closely such circumstances would approximate to those confronting Mr Roberts in August 1976. It is vital that I compare like with like.
Mr Lincoln was asked what protective measures he would have taken if operating in this case, in the light of the information now available; he replied that he would probably have taken none. Mr Stark offered the opinion that neither he nor his Great Ormond Street colleague, Professor de Laval, would have considered using any "extra precautions" in such a case. Indeed, Professor Hamilton accepted in the witness-box that what Mr Roberts did in this instance was in line with what other respected and responsible surgeons were doing. It thus begins to look as though the weight of the evidence points to the conclusion that Mr Roberts was acting in accordance with a body of competent specialist opinion at that time. Nevertheless, each criticism should be individually addressed. Failure to use electromanometric measurement
Dr Scallan and Dr Abbott were asked the question whether steps should have been taken by Mr Roberts, in order to comply with acceptable standards of practice at that time, to measure and/or monitor the blood pressure in the distal segment once the aorta had been occluded. They agreed that manometric methods were available at the time but that their use was not routine.
This seems consistent with the 1987 Thorax article by Mr G. Keen of the Bristol Royal Infirmary. He recorded that he received 74 completed questionnaires in March 1985 from the 90 members of the Society of Thoracic Cardiovascular Surgeons of Great Britain and Ireland whom he knew to have had personal experience of such operations. Of these, 42 replied that in 1980 they did not use electro-magnetic measurements in the distal aorta after cross-clamping but relied upon digital palpation. It appears that by that date some 27 of those approached were measuring routinely. Mr Keen, therefore, drew the conclusion that, since by 1980 the majority clearly did not use electromanometric measurements, failure to do so could not be regarded as an unusual or unacceptable practice at the time. Mr Badenoch points out that this would be to go beyond the function of an expert witness and would, were Mr Keen giving evidence in the case, constitute an encroachment upon the role of the judge. The article is relied upon by Miss Jean Ritchie Q.C., however, for the data rather than the conclusion.
The matter is touched upon also by Dr D. Glen Pennington and others in their 1979 study in The Journal of Thoracic and Cardiovascular Surgery, "Critical review of experience with surgical repair of coarctation of the aorta". They studied available data for 164 patients on whom coarctation repair had been carried out in Boston, Massachusetts, from July 1947 to July 1976. It appears that over the final 10 years of that period intraoperative manometric measurement had been used to determine adequacy of collateral circulation and that data were available for 33 patients.
Mr Lincoln relied on digital palpation but said that he had never come across any case in all his experience where his findings were such as to make any difference to his conduct of the operation. There was, it appears, a school of thought (to which he, Mr Stark and Mr Roberts clearly belonged) which took the approach that that the time-scale of this type of surgery was so short that, whatever measurements could reveal about collateral circulation, there was nothing in either their extensive personal experience of paediatric cases, or in the literature, to justify taking any of these protective measures. Mr Stark did regularly use electromanometric measuring but was still of the same view.
Mr Lincoln was asked specifically what he would have done himself, if he had found upon measuring that the distal pressures appeared to be lower than desirable. He said that he would probably have taken no special steps because his experience showed the clamp time was so short as to give rise to no significant risk of ischaemic damage. This was, of course, consistent with the literature. I am invited to conclude that, if the Claimant's distal pressure had been measured accurately after the clamps were put in place, this would have revealed a worryingly low result. Mr Badenoch argues that this was Professor Hamilton's view and it was not challenged. In my judgment, that cannot be more than speculation. I do not consider that the evidence would justify my reaching such a conclusion. In any event, there is a wide spread of views as to what would be worryingly low.
There was a widespread view (based on both literature and personal experience) that if the clamp-time was going to last no longer than 30 minutes there was no reason to take specific precautions against the risk of paraplegia. Indeed, Miss Ritchie argues that such an approach is borne out by the later article of Nevin M. Katz and others in The Journal of Thoracic and Cardiovascular Surgery (1981) under the title 'Incremental risk factors for spinal cord injury following operation for acute traumatic aortic transection'. This was based on experience at the University of Alabama between 1967 and 1980, involving 35 adults who had suffered acute trauma of the upper descending thoracic aorta. Although the circumstances leading to surgery were, of course, quite different it contains nothing to cast doubt on Mr Roberts' approach.
My attention was drawn, in particular, to a chapter contributed to a textbook on congenital heart disease in 1979 by Aldo R. Castaneda and William I. Norwood ('Residual Coarctation of the Aorta: Surgical Experience'). I was also provided with an e-mail of 2 April 2001 from Dr Castaneda, which confirmed that he had not used femoro-femoral by-pass or hypothermia. Yet he had only experienced one case of transient paraplegia in the case of a 14 year old boy (lasting no longer than two days).
I was also invited to consider the experience of A.C. Ralph-Edwards of Toronto (as recorded in his 1995 article 'Reoperation for Recurrent Aortic Coarctation'). This yielded no instance of paraplegia in any of the 29 patients (between 1976 and 1993) who underwent repeat surgical intervention for recoarctation without by-pass or shunting.
Everyone agrees that paraplegia occurs very rarely in coarctation surgery. That is confirmed, of course, in the Puntis and Green article (1985), to which I have referred. Moreover, of all the cases analysed by Pennington, only one had suffered permanent neurological complications. This was an obese 19 year old who suffered permanent paraparesis in 1967. He had large collateral circulation and his distal aortic pressure after the cross-clamping was well within acceptable limits (60-65 mm. Hg.). It is important to note, however, that his cross-clamp time was as long as 75 minutes and that, for two thirds of that period, the subclavian artery was also clamped.
It is to be noted, moreover, that with the advantage of hindsight it can be said even today that apart from the instant case there would appear to be only one example of spinal complications occurring where the clamp-time was under 30 minutes: see Krieger and Spencer, 'Paraplegia after repair of coarctation of the aorta', Surgery (January 1985).
Another paper which is of some relevance in this context is that of David B. Lerberg and others (1982) 'Coarctation of the Aorta in Infants and Children: 25 Years of Experience', which suggests that the mean length of cross clamp-time in cases where such complications have been recorded is 49 minutes (with a range between 40 and 72 minutes).
It is fair to say that there was at the time nothing in the combined experience of Mr Stark, Mr Lincoln or Mr Roberts to suggest that a cross-clamp time of under 30 minutes would lead to neurologic damage in a young child. Nor in the literature. This was a major factor in their approach and explains why manometric measuring of distal pressure was not something that loomed large their thinking. The evidence does not permit me, still less compel me, to hold that such opinions and practices were unreasonable or irresponsible. The absence of any form of by-pass
It is perhaps convenient to address the by-pass options compendiously, rather than addressing shunt-grafts or left heart by-pass separately, since they both would have the same objective; that is to say, ensuring that the spine and lower parts of the body continue to receive oxygenated blood more or less as normal. It is necessary to note, however, that Professor Hamilton (the Claimant's expert) made the following separate observations in his report of 31 May 2001.
First, with regard to shunt-by-pass he said:
Some condemn the system as too dangerous and too difficult to set up. Provided adequate access is achieved to the upper aorta it can be of great value to the surgeon and patient alike.
(It was Mr Lincoln's view that with a small child the adoption of by-pass techniques can lead to cluttering of a small space and thus hinder access.)
Secondly, Professor Hamilton commented with regard to left heart by-pass:
Again some will suggest that this is a dangerous method with hazards and risks but this does offer safekeeping to the spinal cord during the period of time the aortic occlusion clamps are in situ.
This would appear to acknowledge that there was a competent and responsible body of surgeons who genuinely thought that the risks attaching to the by-pass options outweighed the possible advantages. That would appear almost to conclude the matter in light of Bolitho principles. Mr Badenoch, however, suggested that all Professor Hamilton was there intending to convey was that risks might arise if the methods were applied by less skilled hands than his. I cannot read his evidence in this way, either written or oral, but in any event such a proposition would still be consistent with the recognition of risks.
Some reliance was placed on an article by Hughes and Reemtsma in The Journal of Thoracic and Cardiovascular Surgery (1971) entitled 'Correction of coarctation of the aorta'. They were recommending measuring of distal pressures and, where this showed less than 50 mm. Hg., the adoption of a by-pass technique. It is, on the other hand, of significance that this article did not in itself lead Professor Hamilton to change his own practice. He adapted his methods in the light of his unfortunate experience with a particular patient the following year.
Moreover, with regard to the Ross paper (1975), Mr Roberts did not accept that like was being compared with like. He accepted that one of the cases cited by Ross, involving an aneurysm, was such that he too would have used by-pass.
It is interesting to note also what is said in the joint report prepared for the purposes of this case between Mr Lincoln and Mr Franks, in September 2000. One of the facts agreed was that protection of the spine and lower body was possible by the use of shunts, grafts or by-pass. On the other hand, they accepted that in 1976, for a patient weighing 12 kg, the disadvantages and potential complications of those techniques outweighed the benefits. Although Professor Hamilton did not agree, he specifically recognised that this was a responsible point of view. It seems to me that this concludes the matter. There were simply "differences of opinion and practice", as contemplated by Lord President Clyde and Lord Scarman in the passages cited above. As Dr Scallan observed, there was in 1976 no agreement about either the diagnostic tests or the utility of the various protective measures.
What is said on the Claimant's behalf is that relatively mild surface hypothermia would be virtually risk-free and that it would be likely to give the spinal cord significantly longer tolerance to ischaemia. Assuming that the partial paraplegia from which he suffers derives from the final few minutes of clamping, says Mr Badenoch, hypothermia would have afforded him protection over that critical period. I have already indicated that, so far, I agree with him. It might have involved, as the anaesthetist Dr Beasley told the court, taking the operation out of a routine list and making special arrangements to accommodate the procedure, but that was a minor inconvenience when set against the terrible consequences of paraplegia. More recently, she recalled some cardiac surgeons asking her, during similar procedures, to let the patient's temperature "drift down", but this was after Mr Roberts' retirement (on 1 April 1988).
Mr Badenoch accepts that there are serious risks attaching to profound hypothermia, normally used for open heart surgery at the time, where a patient's temperature can be reduced as far as 18 or 20°. He argues, however, that no comparable dangers could be associated with the mild hypothermia proposed. There seemed to be a degree of uncertainty among witnesses on the Claimant's side, during the course of their evidence, as to exactly the level of hypothermia proposed. The pleaded case, and the one which ultimately they were all prepared to support, was that a reduction to 32-33° would have achieved the desired objective. This would have involved a lowering of the temperature in the operating theatre, if this was sufficiently within the control of the surgical team; the use of ice packs placed at strategic points on the patient's body; and the passing of cold water through a blanket underneath his body.
This was by no means standard practice at the time in procedures such as coarctation surgery, although the potential benefits of cooling were well known as a matter of basic biological principle. Moreover, the techniques I have referred to were obviously not "rocket science" and would have been readily available to those operating in any normally equipped cardiac unit. Miss Ritchie, however, has emphasised that one will search in vain in the contemporary literature to find any recognised or recommended bracket for cooling. There was no universal recognition that 32-33° was appropriate. She suggests accordingly that there is an element of hindsight underlying the experts' ultimate recommendation.
There can be little doubt that there was a body of competent and responsible thoracic surgeons in the mid-seventies who were not using hypothermia and saw no reason to do so. The question, therefore, ultimately to be addressed is similar to that posed by Simon Brown L.J. in Calver; namely, is this one of those "rare cases" in which the approach of one body of surgeons and anaesthetists is not capable of withstanding logical analysis, or is it one of the "vast majority of cases" in which the reasonableness of Mr Roberts' practice of not cooling is demonstrated by the fact that it was followed and endorsed by others (such as Mr Jaroslav Stark of Great Ormond Street and Mr Christopher Lincoln of the Brompton, both of whom were called on behalf of the Defendant).
It is to be noted also that, at the material time, the Claimant's expert Professor Hamilton was not himself using hypothermia for operations of this kind and did not apparently do so until the very late seventies or early eighties. Moreover, Mr Roger Franks (at that time a senior registrar still) had not seen it used for the purpose. He later worked with Professor Hamilton and was aware of his using the technique, so far as he could recall, in about 1980. That is despite the fact that he (Professor Hamilton) had himself undergone the memorable and unpleasant experience of having an 8 year old patient rendered paraplegic in 1972 and confined to a wheelchair for the rest of her life. (It is fair to say, on the other hand, that he thereafter generally favoured a by-pass solution for the avoidance of ischaemia.)
It is not a question of a simple and uncontroversial idea not having been spotted, or simply ignored because people could not be bothered to use it. There is no doubt that some responsible and experienced surgeons did not use hypothermia in this type of surgery for the reason that they did not accept that its use would have been justified or indicated by a risk-benefit analysis. The evidence of Mr Lincoln and Mr Stark (each of whom has well over 30 years experience as a paediatric cardiac surgeon, with hundreds of coarctation operations between them) was to the effect that there was nothing in their experience (or for that matter, any hard evidence in the literature) to suggest that a competent surgeon should have used hypothermia at the relevant time.
Mr Lincoln was naturally very familiar with the two main articles prayed in aid on the Claimant's behalf, namely that of Lyman A. Brewer III and others in The Journal of Thoracic and Cardiovascular Surgery for September 1972 under the title "Spinal cord complications following surgery of coarctation of the aorta" and that of J. Keith Ross and others in Thorax (1975) under the title "Late complications of surgery for coarctation of the aorta". He said that the Brewer article was unsatisfactory and problematic in a number of respects. It required a discriminating judgment. Moreover, what was offered was merely the authors' opinion. He, Mr Lincoln, being a paediatric specialist in the field, preferred to base his own opinion on his personal experience. As to the Ross paper, his language was strong and dismissive (even though on friendly terms with at least one of the authors). He described it as "a terrible paper" and the conclusions as "preposterous". I have no doubt that this represents his genuine opinion.
A third paper relied on by the Claimant, namely that of Hughes and Reemtsma (1971), does not mention hypothermia as a protective measure at all.
Mr Lincoln said that he would not have used hypothermia and gave a number of reasons. It is important, however, to see all the evidence of the experts in the light of the case put forward on behalf of the Claimant. It was not being suggested that hypothermia should have been used routinely for coarctation surgery in the mid-seventies. The case put was that it should have been used selectively. What was less clear was how the criteria were to be identified on which any given surgeon was required, for a specific patient, to depart from routine practice and to opt for hypothermia.
It is generally accepted that there was no satisfactory pre-operative method of identifying the extent to which collateral circulation had become established (particularly in the case of a 4 year old child weighing only about two thirds of the average weight - according to Dr Scallan). This was obviously a problem of general application. In itself, therefore, it would not justify the use of hypothermia, on Mr Badenoch's case, since that would entail the adoption of routine hypothermia. A critical question thus emerged, namely how one could identify what it was about this patient which should have led a competent surgeon in 1976 to adopt, exceptionally, the precaution of cooling him to 32-33°. What were the indicators that took him outside the boundaries of a routine coarctation patient? I asked Mr Lincoln the question at the close of cross-examination. He replied that the only such factor he could identify was that the Claimant had suffered cardiac arrest at the first operation in June 1972 (when three months old). That, to him, was an individual factor which, if he had been asked to consider hypothermia for the second operation in August 1976, would have been a contra-indication.
The point was made by Mr Badenoch that this answer of Mr Lincoln, to the question I raised, was not reflected in his report. Mr Lincoln's response was that he had been thinking about the case on and off, by the time of the trial, for some two years and that new angles will inevitably occur from time to time. What seems to me to be important is that the question had to be asked in the light of the way the Claimant's case was being put. If hypothermia should have been used, but on a selective basis only, it is necessary to establish with care the special factor or factors concerning this patient which required its application in his case.
Mr Lincoln said that there were no indications about this patient which required or suggested the use of hypothermia. He regarded it in general terms as "intellectually messy" and "imprecise". There was a tendency to drift down from the targeted temperature, and the lower the temperature goes the higher the risk. A particular risk attaching to hypothermia (even to moderate surface cooling to 32-33°) is, in his view, that the patient might suffer ventricular fibrillation. This risk was dismissed as fanciful by the Claimant's experts, but the fact remains that Mr Stark gave unchallenged evidence of having seen three cases of fibrillation in patients at around 33°.
It was in this context that Mr Lincoln attached importance, as I have said, to the fact that the Claimant had suffered the cardiac arrest in 1972 (as, of course, he also did after the clamps were taken off in 1976). This was a factor which, in his opinion, might reasonably be seen as pre-disposing the Claimant to fibrillation. This phenomenon has been described as the heart ceasing to beat and writhing, rather like a "can of worms", but the important aspect of it is that output from the heart ceases and requires to be restored. It is therefore best avoided.
The hypothermia approach was supported by the expert anaesthetist called on behalf of the Claimant. This was Dr T. R. Abbott who retired in December 1999 but had great experience in participating in cardiothoracic operations between 1968 and his retirement. From 1968 to 1986 he was a consultant anaesthetist with the United Liverpool Hospitals and from then onwards, until 1999, with the Southampton University Hospital. As it happened, he had worked with some of the cardiac surgeons who were expert witnesses in this case.
What he was recommending was that the patient should have been cooled to approximately 33° which, allowing for "drift", could have been achieved by taking off the ice packs when the temperature had been lowered to 35 - 36°. He recognised that hypothermia carried some degree of risk and, in particular, with regard to the possibility of arrhythmias and decreasing the contractility of the heart. In his view, in the former case the risk was minimal above 30° and, in the latter case, above 32°.
In Dr Abbott's opinion there was no reason here not to apply hypothermia and it could quite possibly have avoided the spinal damage flowing from ischaemia. Dr Abbott fairly recognised, however, that many surgeons in the mid-seventies would not have taken this precaution with this patient.
Mr Badenoch also drew my attention to various extracts from the textbook by Kirklin and Barrett-Boyes and, in this context, to a passage at page p.31:
The assumption is that hypothermia, without itself producing damage, reduces metabolic activity to the extent that the available energy stores in the various organs maintain cell viability throughout the ischaemic period of total circulatory arrest and thus allow normal structure and function to return after recovery of the arrest period. It is also assumed that the magnitude of the reduction of oxygen consumption is directly related to the 'safe' duration of total circulatory arrest.
In chapter 53 ("Acute traumatic aortic transection") hypothermia is cited, at p.1463, as one of the methods of minimising the incidence of paraplegia after aortic cross-clamping and resection. It is said that:
Hypothermia clearly prolongs the safe ischaemic time for the spinal cord, just as it does for all other organs .... This was demonstrated about 40 years ago by Hufnagel and Gross and later by Beattie and colleagues and reaffirmed by the elegant experimental study of Pontius and colleagues. These studies of Pontius and colleagues as well as those of Beattie and colleagues and Parkins and colleagues indicate that the spinal cord can recover normal function after ischaemia of 60 minutes' duration at a whole body temperature of 30°C. The studies of Coles and colleagues indicate that profound cooling of the spinal cord itself imparts the same protection.
In chapter 34 ("Coarctation of the aorta and aortic arch interruptions"), at p.1048, the following passages appear:
Since there is always uncertainty about the collateral circulation in a young infant with coarctation, after anaesthetic induction the body temperature is allowed to drift down to a nasopharyngeal temperature of about 33°C. This downward drift is helped by reducing the operating room temperature to about 18°C (65°F), and by use of the cooling mode in the heating-cooling pad under the child. The blood pressure in the right arm in monitored either by the usual cuff method or by Doppler techniques, but an indwelling radial or brachial catheter is used in particularly critical situations ....
If by now the nasopharyngeal temperature has not dropped to 33°C, the left pleural space is lavaged with ice cold saline for the few minutes that are required to accomplish this ....
Miss Ritchie pointed out that the context of this passage (dating from 1986) was a form of surgery developed well after 1976 and known as "subclavian flap aortaplasty". Moreover, she argued that the "downward drift" method of cooling was itself a technique which evolved after the relevant period. She urges caution, therefore, over the benefits of hindsight. Mr Badenoch responds by observing that the fundamental principle has not changed and would have been just as valid in the mid-seventies.
It is not easy to establish to what extent hypothermia (or, for that matter, any of the other suggested protective measures) were in fact being used by competent and responsible paediatric thoracic surgeons in the mid-seventies. Reference was made to the Brewer paper and to the responses received to his enquiry. It is very difficult to know how much weight to attach, for present purposes, to this largely anecdotal material. The information is not set out in the article with crystal clarity; nor does one know the precise circumstances in which the respondents were using the various techniques. Especially, of course, there is little guidance as to how closely the circumstances would have corresponded to those in this case. Mr Badenoch submitted that it was possible to draw the inference from the article that some form of protective measure (i.e. either by-pass or hypothermia) was used by "all or most" of the combined groups from whom Brewer had sought the information. Mr Lincoln, however, disagrees profoundly and says that this inference was not supported at all by the material in the Brewer article. It appears that only 29 out of 77 surgical groups responded. Of those, it appears, only 10 used hypothermia. While some used it routinely, others used it "rarely".
Dr Michael Scallan, the anaesthetist called on behalf of the Defendant, said that he had never seen hypothermia used in a recoarctation operation up to 1977, at which date he became a consultant anaesthetist. He has considerable experience of coarctation operations by now, having worked on approximately 250 such procedures. He considered that, from the information available, this Claimant was not in a high risk group or low risk group. He fell somewhere in between. One factor pointing towards increased risk, in his case, was the fact that he had apparently a hypertrophied ventricle. In his view the majority of coarctation cases at that time were done without hypothermia and, what is more, the indications for its use then were by no means clear.
Dr Scallan acknowledged that it was now common practice to cool patients down to the level of approximately 34°, for coarctation surgery, but this was a technique that had evolved largely in the nineties. (He observed, with detachment, that he was not quite sure why.) From his own observation of surgeons, at the material time, protective measures would not have been used in most cases provided the recoarctation itself was regarded as relatively uncomplicated.
Reference was also made to a Symposium Article entitled "Side Effects of Mild Hypothermia" by Armin Schubert, published in 1995 in the Journal of Neurosurgical Anaesthesiology. The author is based at the respected Cleveland Clinic Foundation in Ohio. The article records the fact that mild hypothermia was, by 1995, increasingly "touted" as a low risk clinical measure for brain protection. It set out to consider potentially adverse effects. In its very general Table 1, summarising "Risk considerations for clinical decision making regarding mild hypothermia", the category of patients described as being at "minimal risk" consisted of those less than 60 years of age, without coronary disease, and having normal coagulation and immune status. Some reliance was placed on this by Mr Badenoch since the Claimant, it is not disputed, falls within that very broad category. The text adds the following comment:
Until the clinical benefits of mild hypothermia are more clearly delineated, a careful consideration of its adverse effects should enter into any decision to employ this technique for protection of CNS components at risk. Many of the risk factors can undoubtedly be neutralized by a highly organized and experienced team of anaesthesiologists, intensivists, and surgeons. However, the individual patient can be sufficiently complex as to warrant careful considerations of all risks and benefits. Mild hypothermia is easily achieved, is widely prevalent in operating rooms, and as yet has not been proven to carry excessive risk. These are not, however, sufficiently compelling reasons to expand its use routinely to all patients at risk for neurologic injury.
One of the risks highlighted in the article is that mild hypothermia can be expected to pre-dispose to coronary ischaemia in susceptible patients. It was recorded that hypothermia of 34-35° markedly decreased porcine left ventricular contractility and neonatal cardiac output (by 39%). It also has been seen to impair diastolic relaxation. Furthermore, the efficacy of cardiovascular medication may be impaired during mild hypothermia. Various other factors are also cited although of no direct relevance to the circumstances of this Claimant.
Mr Badenoch relied too on the practice of a well known French practitioner called Dubost. It is recorded in the Brewer article that he had, by 1972, probably obtained the greatest experience in its use. He had operated upon over 900 patients with coarctation and had from the beginning of his professional experience used surface hypothermia, apparently, in the following categories:
practically all adult patients,
all those in whom coarctation does not present enough collateral circulation,
all those whose femoral pulses can be palpated even though slightly,
all patients with aneurysm at the level of the coarctation or one of the intercostal arteries, and
all patients requiring reoperation for any reason.
Mr Lincoln pointed out that the basis for these conclusions is simply "personal communication". In his view, statements of any significance ought not to be made in a learned article on such a basis. Very little had apparently been published by Dubost and, accordingly, none of the statements attributed to him had been subjected to rigorous analysis or peer review. Mr Lincoln's view was that a broad recommendation for the use of surface hypothermia in all the categories listed above ought not to have survived peer review. Quite simply, he says, there is no evidential basis for it. Nor could any responsible surgeon in the mid-seventies possibly be criticised for not adopting it in such circumstances. Mr Stark commented that Dubost's experience mainly related to adults and adolescents. The number of infants and young children operated upon in his unit was very small.
One of the least satisfactory aspects of the Brewer article was Table VIII which received a good deal of attention in the course of evidence and submissions. The uninformative comment is made that, out of 35 cases in which hypothermia was used, two patients died. Nothing is given to indicate the cause of death or the role, if any, which hypothermia played. There is a note under the table indicating that the two deaths referred to did not represent the total mortality rate. There is some implication, therefore, that the two deaths in question were singled out for mention because there was some (albeit unspecified) connection with the hypothermia. Accordingly, Mr Roberts and Mr Lincoln were of the opinion that any responsible cardiac surgeon reading the Brewer paper, in the mid-seventies, would have been inclined to take a cautious approach on the basis that the Brewer research disclosed at least some risk of mortality attaching to mild hypothermia.
The truth is, of course, that no one knows. It is simply one example of the article's lack of rigour. Mr Stark in his report of 6 April 2001 observed that the suggestions made by Brewer (including for hypothermia) were not followed by the majority of surgeons in the United States, the United Kingdom or the continent of Europe. In his view the reason was that the suggestions were based on assumption rather than evidence. To apply the test propounded by Mr Badenoch of 'the concerned parent', it seems to me that such a person would receive little assurance if told that the surgeon was going to operate on his or her child on the basis of material that was so hard to pin down. Without proper disclosure of the data relating to the patients who died, it is impossible to make any informed decision on the risks of mortality.
One factor that does emerge from the Brewer article is that spinal cord complications can still occur when hypothermia (or any other protective measure for that matter) is deployed.
It was agreed between Professor Hamilton and Mr Stark in their recent joint report (dated 26 June 2001) that there was a substantial number of surgeons in the mid-seventies who did not use hypothermia. Also, in the joint report of Mr Franks and Mr Lincoln dated 12 May 2000, it was recognised that "few surgeons were using hypothermia in 1976". Mr Franks felt that "cooling was very simple, easily achieved and may well have been to significant benefit" but recognised that the contemporary medical publications showed that "cooling was not in common usage". (I have already referred to the personal communication from Dr Castaneda.) Mr Stark commented that:
What protection the temperature of 33°C would give the spinal cord is not known. Some surgeons speculated that the incidence of spinal cord injury may be reduced by hypothermia. Yet, many surgeons never used hypothermia and never experienced spinal cord injury.
I am quite unable to find that the omission to plan ahead for the use of surface hypothermia could, in the light of the information before him, be categorised as a breach of duty on Mr Roberts' part.
CONCLUSION ON THE ISSUE OF LIABILITY
The Claimant's father told me that he became worried about his son's future and especially as to how he would fend for himself with his serious disability. This was why it was decided to pursue this claim for compensation. Unhappily, as the law stands, it is necessary for the Claimant to demonstrate that Mr Roberts fell below the accepted professional standards applicable in 1976. In my judgment, that burden has not been discharged. I am unable to accept that this is "one of those rare cases" in which the approach taken by him, and a significant number of other surgeons, was incapable of withstanding logical analysis. There was nothing to lead him to the conclusion pre-operatively that this surgical intervention should be treated other than as a routine operation for recoarctation. It was reasonable at that time to conclude that special protective measures were not indicated. In the result, I am bound to give judgment for the Defendant.
North Essex District Health Authority v Spargo  8 Med. L.R. 125
Forbes v Wandsworth Health Authority  Q.B. 402
Parry v Clwyd Health Authority  P.I.Q.R at P4
Bolam v Friern Hospital Committee  2 All E.R. 118
Maynard v West Midlands Regional Health Authority  1 W.L.R. 685
Bolitho v City and Hackney Health Authority  A.C. 232
Hucks v Cole  4 Med. L.R. 393
Edward Wong Finance Co. Ltd v Johnson Stokes & Master  A.C. 296
Calver v Westwood Veterinary Group  Ll. L.R. Med. 20
Limitation Act 1980: s.11, s.14, s.33
Authors and other references
Textbook of British Surgery, edited by Sir Henry Souttar and J.C. Goligher (1956)
Anthony C. Ralph-Edwards and others, 'Reoperation for Recurrent Aortic Coarctation', 1995
Ross and others, Thorax (1975): "Late complications of surgery for coarctation of the aorta"
J.W.L. Puntis and S.H. Green, Archives of Disease in Childhood ('Ischaemic spinal cord injury after cardiac surgery'), 1985
Brewer and others, The Journal of Thoracic and Cardiovascular Surgery, 1972
Myers and Waldhausen, "Management of Complications Following Repair of Coarctation of the Aorta, Patent Ductus Arteriosus, Interrupted Aortic Arch, and Vascular Rings" (chapter 15 of Complications in Cardiothoracic Surgery)
Dr D. Glen Pennington and others, "Critical review of experience with surgical repair of coarctation of the aorta" in The Journal of Thoracic and Cardiovascular Surgery (1979).
Nevin M. Katz and others, "Incremental risk factors for spinal cord injury following operation for acute traumatic aortic transection" in The Journal of Thoracic and Cardiovascular Surgery (1981)
Aldo R. Castaneda and William I. Norwood, 'Residual Coarctation of the Aorta: Surgical Experience', 1979
A.C. Ralph-Edwards, 'Reoperation for Recurrent Aortic Coarctation', 1995
Krieger and Spencer, 'Paraplegia after repair of coarctation of the aorta', Surgery (January 1985)
David B. Lerberg and others, 'Coarctation of the Aorta in Infants and Children: 25 Years of Experience', 1982
Hughes and Reemtsma, "Correction of coarctation of the aorta" in The Journal of Thoracic and Cardiovascular Surgery (1971):
Armin Schubert, "Side Effects of Mild Hypothermia" in the Journal of Neurosurgical Anaesthesiology (1995)
Mr James Badenoch Q.C. and Mr Martin Forde for the Claimant (instructed by Irwin Mitchell)
Miss Jean Ritchie Q.C. and Mr Andrew Post for the Defendant (instructed by Bevan Ashford)
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