- 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.
Causation
- 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.
Limitation
- 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:
"(a) the
injury complained of was significant; and
(b) it
was attributable, in whole or in part, to the acts or omissions which it is
alleged constitute negligence; and
(c) 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 [1997] 8 Med LR 125, 129-130
in the light of the earlier authorities he there reviewed:
"(1) 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;
(2) 'Attributable'
in this context means 'capable of being attributed to', in the sense of being
a real possibility;
(3) 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.
(4) 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 [1997] QB 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 [1996] 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:
- facts which he could
observe;
- facts which he could
ascertain;
- facts which he could
ascertain with the help of medical or other appropriate expert advice
which it was reasonable for him to seek".
- 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 [1957] 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 [1985] 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 SLT 213 at 217 can be bettered:
'In the
realm of diagnosis and treatment there is ample scope for genuine difference
of opinion and one man is clearly 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 a 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. ...'
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 [1998] AC 232, 243A Lord Browne-Wilkinson,
having considered earlier authorities such as Hucks v. Cole [1993]
4 Med. L.R. 393 and Edward Wong Finance Co. Ltd v. Johnson Stokes &
Master [1984] AC 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 [2001] 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" (emphasis added).
- 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.
Hypothermia
- 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:
(1) practically
all adult patients,
(2) all
those in whom coarctation does not present enough collateral circulation,
(3) all
those whose femoral pulses can be palpated even though slightly,
(4) all
patients with aneurysm at the level of the coarctation or one of the intercostal
arteries, and
(5) 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.
