ON APPEAL FROM QUEEN’S BENCH DIVISION
Her Hon. Judge Elizabeth Steel DL
Royal Courts of Justice
Strand, London, WC2A 2LL
Before :
LORD JUSTICE WARD
LORD JUSTICE RIX
and
LORD JUSTICE MAURICE KAY
Between :
EASTWOOD | Appellant |
- and - | |
WRIGHT | Respondent |
(Transcript of the Handed Down Judgment of
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Mr George Hugh-Jones (instructed by Messrs Eversheds) for the Appellant
Mr Christopher Limb (instructed by Messrs Lees & Partners) for the Respondent
Judgment
Lord Justice Ward :
The background.
This is a clinical negligence claim brought by the respondent, Mrs Stephanie Wright, against her anaesthetist Doctor Derek Eastwood. On 5th April 2004 after a trial of the question of liability only Her Hon. Judge Elizabeth Steel DL, sitting as a Deputy Judge of the Queen’s Bench Division in Liverpool, found in favour of the claimant and entered judgment for damages to be assessed. The defendant appeals with permission granted by Potter L.J.
Mrs Wright has over the years had a number of visits to hospital for investigations or operations under general anaesthetic. No clinical records survive for her first two visits in 1968 for cholecystectomy and in 1978 for the exploration of the bile duct with sphincterotomy. In 1979 she underwent a D & C procedure under general anaesthetic and the records for this examination were not available at the time of later operations and neither the claimant nor her G.P. were advised of any difficulties. The anaesthetic record was, however, produced to the experts instructed in the course of these proceedings and the records showed that following the administration of drugs including althesin 0.5 ml, the claimant developed breathing difficulty. The anaesthetist administered a muscle relaxant maintaining anaesthesia and hydrocortisone was administered intravenously and Mrs Wright made an uneventful recovery. The anaesthetic notes include the entry “??Althesin allergy”.
In 1989 she had a D & C without any problem. On 1st February 1995 she was admitted to the Murrayfield Hospital in Liverpool for a hysteroscopy examination under anaesthesia and a D & C. Again there were no problems. Doctor Eastwood was the anaesthetist on that occasion although he did not remember the admission at all. There was no reason why he should have recalled it.
On 14th June 1995 the claimant returned to the Murrayfield Hospital and underwent a total hysterectomy under general anaesthetic. Doctor Eastwood was again the anaesthetist and what happened on that occasion was under scrutiny at the trial. She was rendered unconscious through the injection of the anaesthetic propofol and maintained using nitrous oxide and halothane. The chosen muscle relaxant was atracurium and the analgesic was morphine. It is common ground that Mrs Wright suffered a bronchospasm before being taken into the theatre. That was effectively dealt with and the operation was successful. No criticism is made of the anaesthetic chosen, nor of the way Doctor Eastwood administered it or responded to the crisis. The claimant does, however, complain that he negligently failed to diagnose or to suspect that the symptoms and circumstances of the bronchospasm were, or could have been, due to an adverse drug reaction which should have caused him to refer her for investigation. Although after the operation she was seen by the defendant who told her of her “spasm” it is alleged that he negligently failed to warn her of the possibility of an adverse drug reaction in the future.
Her next visit to the Murrayfield Hospital was for the excision of the left submandibular gland in 1997. She mentioned the incident of the spasm in 1995. The anaesthetist had access to the previous records and did not use the same muscle relaxant as had been used in 1995. The operation passed without incident.
On 23rd March 1999 she was admitted to the Royal Liverpool Hospital for the excision of the right submandibular gland. She again told the anaesthetist of what she had been told following the hysterectomy in 1995 and the notes read “History of “spasm” after the hysterectomy operation – anaesthetist said patient gave him “quite a fright””. The notes from the Murrayfield Hospital were not obtained until after the operation. On this occasion the muscle relaxant used was cisatracurium. There was coughing and difficulty in ventilation by facemask. She was intubated. There was no wheezing but then the blood pressure fell suddenly and substantially. After adrenaline was given over a total of 60 minutes surgery was cancelled and the claimant was transferred to the Intensive Therapy Unit. A tracheostomy tube has had to be inserted leaving Mrs Wright with permanent and constant difficulty in breathing and very considerable impairment of her ability to manage life as she did. A subsequent investigation of the adverse reaction she suffered revealed that Mrs Wright is allergic to atracurium and cisatracurium which are associated drugs used as muscle relaxants in the 1995 and 1999 operations respectively.
Doctor Eastwood said that his diagnosis was that Mrs Wright had suffered an irritable reaction to intubation owing to her heavy smoking. Intubation is the process by which an airway tube is passed into the trachea in order to sustain breathing once the muscle relaxant drug has taken effect on the lungs. In the light of that diagnosis he did not advise further investigation. The crucial question for the judge to decide was whether or not Doctor Eastwood ought reasonably to have suspected that the bronchospasm suffered in June 1995 was a possible reaction to the anaesthetic drugs administered to Mrs Wright. The experts in the case had agreed that:-
“If a drug reaction had been suspected, it would have necessitated advice, warning, investigation and action in order to comply with responsible practice.”
The responsible practice had been published in 1990 by the Association of Anaesthetists of Great Britain and Ireland in a paper entitled “Anaphylactic Reactions associated with Anaesthesia” paragraph 5.1 of which recommended:-
“Any patient who has a suspected [the judge added this emphasis] anaphylactic reaction associated with anaesthesia should be investigated fully.”
It was further agreed between the experts that:-
“If a drug reaction had been suspected in 1995 (whether investigated or not), then Mrs Wright should have been informed and warned that the drug(s) suspected of being to blame should not be given to her on subsequent occasions. No reasonable anaesthetist told of a suspected adverse reaction to atracurium would subsequently have administered cisatracurium. Consequently, on the balance of probabilities, the reaction in 1999 and its consequences would have been avoided.”
On the basis of that agreement causation would be established.
The judge found that there was a reasonable suspicion that an adverse drug reaction was the cause and that once this was appreciated the obligation to investigate and warn arose. It was negligent of Doctor Eastwood not to have done so.
The events of 14 th /15 th June 1995 in a little more detail.
Mrs Wright was listed for operation in the afternoon list which started at 2 p.m. She would have been taken to the anaesthetic room outside the theatre shortly before that time. There was no dispute as to the process used by the defendant. He duly administered the anaesthetic, analgesic and muscle relaxant drugs. The atracurium usually takes effect 2-3 minutes after its introduction. In the short time before intubation oxygen and then nitrous oxygen were manually administered by “bagging”, i.e. using a mask over the patient’s mouth and nose and ventilating five or six puffs. The defendant had no recollection of the bagging being difficult though it has to be said, as the judge found, that the defendant was “naturally” unable to recall with any precision what happened nearly nine years previously. In his statement he had said:-
“In respect of my recollection of events of 14th June 1995 I have no independent recollection and I am relying upon my notes and usual practice although in view of what happened the operation does stick in my mind.”
What happened was that Mrs Wright suffered an acute bronchospasm preventing air entering the lungs. That was a crisis and the judge found that the defendant reacted appropriately.
“20. … One of the vapours he used was halothane that has some properties to assist with a tight chest. It is clear from the hospital operation record that the use of this vapour was a change from the one he originally started to write. Both are on the machine and the choice of which to use is that of the anaesthetist. The defendant could not recall why he had chosen halothane. That vapour on its own did not and was not expected to solve this particular problem. He injected intravenously aminophylline (a bronchodilator drug) that effectively eased the bronchospasm and the claimant was able to proceed into theatre for the operation. It was I have no doubt a frightening episode for all who saw it. Doctor Eastwood said in evidence that a bronchospasm is an extreme rarity and difficult to diagnose after giving drugs. He remembered the incident (though not the detail) because of this. …
The defendant recalls that the claimant responded dramatically to the aminophylline and was ready to go into theatre. … The post-operative record shows an uneventful recovery from the anaesthetic.”
On the following day, 15th June 1995, Doctor Eastwood spoke to the claimant but they recalled the conversations differently. The judge decided as follows:-
“25. The defendant recalls telling her of the incident in general terms and strongly advising her to give up smoking. The claimant remembers Doctor Eastwood introducing himself as the anaesthetist who provided the anaesthetic the day before. He asked how she was and she said she was fine. He said she had given him a “terrible” or “quite a” fright the day before and that he had not seen anything like it in his twenty-eight years practice. She was told that she had suffered a spasm reaction. His attitude was one of concern asking again if she was all right now. She said she was and he left.
26. On this point I prefer the evidence of the claimant to that of the defendant. She has a clear recollection. He does not. After all these years I would not expect him to have. She repeated on a number of occasions (each time she was due to have an anaesthetic) the information she had been given about the spasm occurring in the course of the anaesthetic and the reaction of the anaesthetist being “a terrible/quite a fright”. He may well also have mentioned smoking to her but this did not make any particular impression. His concern did.”
Only limited contemporaneous notes were available. On the operation record completed by the defendant at the time he noted:-
“At induction: acute bronchospasm.”
On the document giving discharge details and again under the heading “Operation” appears the record:-
“Acute bronchospasm on induction.”
On the other hand a nursing record made after the surgeon’s visit at 18.00 recorded:-
“Patient suffered bronchospasm whilst being intubated.”
The judge held:-
“30. There is no provenance as to how this nursing record came into being and from whom the information leading to this entry came. I am invited to ignore it. I do not do so but note that the immediate reaction of the defendant in the theatre was to use the word “induction” rather than “intubation”. This would represent his initial reaction and impression.
31. There is no doubt that the word intubated relates to the procedure when the tube is inserted into the trachea. The word “induction” would normally refer to the beginning of the process of anaesthesia although the defendant says that he would use the word in a more general sense to relate to the whole of the process thus covering both pre and post-intubation.”
The way the case developed
In the particulars of claim it was alleged that:-
“Acute bronchospasm occurred at induction of anaesthesia. Such is recorded in the operation report and in the discharge summary. The bronchospasm was successfully treated with intravenous aminophylline.”
That allegation was accepted in the defence. There was no suggestion that intubation was the significant event which triggered the bronchospasm. In his witness statement Doctor Eastwood again made no mention of intubation and described the timing of the event in terms his expert was later to concede he could not recognise and so would have had to have asked “What on earth do you mean by that?” Doctor Eastwood’s phrase was:-
“At the point of induction, Mrs Wright developed an acute bronchospasm.”
The case seems to have proceeded at least on the claimant’s side on that basis that “induction” described the initial loss of consciousness resulting from the administration of an induction agent such as propofol. Eminent experts were duly instructed on each side, Professor Aitkenhead for the claimant and Professor Hull for the defendant. Professor Aitkenhead clearly proceeded on the basis that “induction” was being used in the sense that the judge found it would normally be used namely to describe the initial loss of consciousness resulting from the administration of an induction agent such as propofol. That probably prompted Doctor Eastwood to file a supplemental witness statement on 18th December to clarify whether the bronchospasm incurred pre- or post- intubation. He said:-
“I would confirm, to the best of my recollection, that the episode of bronchospasm occurred post-intubation. It was for this reason, coupled with the ease with which I was able to treat the bronchospasm i.e. aminophylline and ventilation that I concluded that this was smoking related. If, on the other hand, the episode of bronchospasm had occurred pre-intubation then I would have associated the bronchospasm with a possible reaction to the anaesthetic agents that I had used. If this had been the case then I would have arranged for her to be investigated by arranging for samples to be sent for testing to a specialist unit. … Further, I would have been sufficiently concerned to have considered suggesting to [the surgeon] the operation should be abandoned.”
The experts met on 22nd December to agree the common ground. They were agreed about these matters, among others:-
Tracheal intubation would have been likely to occur no less than two minutes after loss of consciousness (in answer to question 2 of their joint report).
A bronchospasm as a result of an irritable bronchial tract was most likely to occur after intubation (question 5).
If the bronchospasm occurs before intubation then it would raise the anaesthetist’s awareness of the possibility of an adverse drug reaction (question 6).
In their practices a degree of bronchospasm caused by an irritable brochial tract as a result of smoking would be encountered in less than ten patients per year. Severe bronchospasm due to this cause is uncommon (question 8).
Intense bronchospasm causing significant impairment to ventilation of the lungs and oxygenation of the blood would cause an anaesthetist great concern. Mere wheezing would be unlikely to cause concern (question 9).
If the court found [and the court did so find] that Doctor Eastwood said he had been given a terrible or quite a fright, that suggested that the bronchospasm had been intense (question 10).
In their experience aminophylline was administered only if intense bronchospasm was present and had not responded to first-line treatment such as administration of a volatile anaesthetic agent, for example halothane (question 13).
The factors which increased the need to consider investigation of a drug-related cause would be timing (in relating to intubation), the intensity and the responsiveness to treatment (question 14).
If anything greater than simple wheezing was detected following the administration of the drugs and before tracheal intubation, then responsible practice dictated that an adverse drug reaction should be suspected and appropriate steps taken to investigate that possibility (question 15).
If there was an adverse drug reaction, it was to atracurium. If the court found that intense bronchospasm occurred prior to tracheal intubation, then an adverse drug reaction to atracurium was the most probable cause. If the court found that there was no bronchospasm until after tracheal intubation, then a drug reaction to atracurium was an unlikely cause (question 19). [Professor Aitkenhead in his oral evidence preferred to say that this was a less likely cause].
Further questions were then asked of Professor Aitkenhead and on 11th February 2004 he gave these answers:-
“1a. In the absence of a history of asthma and exercise intolerance, it is most unlikely that severe bronchospasm would occur on intubation. Professor Hull and I agreed (in answer to question 8) that in areas in which we worked (where smoking is common) a degree of bronchospasm would be encountered in a small number of patients per year (less than 10) in our practice. We agreed that severe bronchospasm is uncommon. To put this into perspective, although I have heard of a few instances of severe bronchospasm following tracheal intubation in smokers with no history of asthma or exercise intolerance, I have never, in 30½ years of anaesthetic practice, encountered bronchospasm following intubation in a non-asthmatic patient which was of such severity that I considered that the administration of an intravenous bronchodilator such as aminophylline was either indicated or necessary. Every case of bronchospasm which I have encountered in my clinical practice following intubation in a non-asthmatic patient has resolved spontaneously in response to ventilation of the lungs and administration of a volatile anaesthetic agent, and without any compromise of oxygenation of the lungs.
1b. Professor Hull and I agreed (answer to question 13) that, in our experience, aminophylline would be administered during anaesthesia only if there was intense bronchospasm which had not responded to first-line treatment. It follows, that, on our assessment, intense bronchospasm must have been present.
1c. In my opinion, and on the basis of my experience the severity of bronchospasm in Mrs Wright’s case was such that it is very unlikely that it was related to tracheal intubation. In the absence of a history of asthma, it is, in my opinion, overwhelmingly probable that it was due to a reaction to one of the drugs administered at induction. Consequently, it is my opinion that there must have been, on the balance of probabilities, bronchospasm prior to intubation.
1d. Professor Hull and I agreed (answer to question 15) that anything greater than simple wheezing before tracheal intubation should have led to an adverse drug reaction being suspected and to that possibility being investigated.
1e. In my opinion bronchospasm severe enough to warrant administration of aminophylline in a patient with no history of asthma required investigation for an adverse drug reaction because of the incidence of that degree of bronchospasm for any other reason in such a patient is so small.”
As a result of that further information the case appears to have been opened upon the basis that if the bronchospasm occurred before intubation then there was in the joint opinion of the experts the need to investigate and the claimant would succeed. That was the primary case. An alternative case was flagged up in the claimant’s opening statement statement that:-
“By reference to the evidence of Professor Aitkenhead it is the claimant’s case that a bronchospasm which was severe enough to require the use of aminophylline should have led to suspicion of adverse drug reaction at whatever stage of the process it took place (i.e. whether before or after intubation).”
The judgment.
Although the judge did not expressly identify the issues which called for her judgment she undoubtedly did address the primary case, posing the question:-
“Did the bronchospasm occur pre or post-intubation?”
Answering that question she held:-
“32. The time scale within which matters occurred is very tight. Intubation would normally take place about 2-3 minutes after atracurium had been administered (it would have to wait the muscle relaxant taking effect). A reaction to the drug would normally occur about 2-3 minutes after giving the drug [Prof. Aitkenhead’s evidence in relation to the time it occurred with his patient].
33. Anaesthetists vary in the speed with which they administer the drugs but the reaction time for the muscle relaxant drug taking effect will not depend on the individual anaesthetist. On the balance of probability I am satisfied that the bronchospasm occurred pre-intubation but almost immediately before that took place.”
She then turned to other topics, first the 1990 Guidance which I set out in paragraph 7 and secondly the experts’ evidence. She began by reciting points on which they agreed. It is common ground that she was in error in including as agreed the following two matters:-
“(i) The most likely explanation for the bronchospasm was that the claimant suffered an anaphylactoid reaction to histamine released from atracurium.
(ii) The reaction is likely to take 2-3 minutes from the time the drug was injected.”
The first may not much matter but Mr Hugh-Jones relies heavily on the second, submitting that this misunderstanding by the judge led her down a false path and fatally corrupted her thinking. Mr Limb for the respondent accepts she was in error in saying this was agreed though he does point out there was evidence to support a finding to that effect.
As for the differences between the experts, the judge observed:-
“39. The experts diverge as to whether if the bronchospasm occurred after intubation the defendant should have suspected that the bronchospasm was due to adverse drug reaction.”
She recorded their views as follows:-
“40. Professor Aitkenhead was clear. This was a very severe bronchospasm both by description and by the need to use aminophylline intravenously to relieve the condition. He had never come across a bronchospasm of that degree of severity in a patient who did not have asthma. This militates against the cause being irritability in a non-asthmatic smoker patient. …
42. Professor Hull pointed out that post-intubation with a heavy smoker with chronic bronchitis and chronic cough where any foreign object is introduced (tube) this could provoke a bronchospasm real fast. … Asked about bronchospasm he replied:
“This should be reported if can’t explain them and this would apply to one shortly after the drugs were administered.
If there is an unexplained bronchospasm with a series of possibilities it is prudent if there is no reasonable explanation to investigate further.
Because there is a post-intubation event it is hugely more probable that this was induced by intubation rather than a drug reaction taking a few minutes.”
Her conclusion was expressed in these final paragraphs:-
“43. Both refer to the 1990 guidance and all agreed that this was known and should be applied in 1995. The document is clear. The obligation to report and investigate arises if there is a suspicion there was an anaphylactic reaction. That obligation to report and investigate is not limited to cases where there is certainty such a reaction did take place. For the reasons set out by Professor Aitkenhead, whether or not the bronchospasm occurred before or after intubation, there should have been such a suspicion. The intensity of the bronchospasm, the way in which it was relieved and the fact that although a smoker the patient did not have any of the additional factors such as asthma that would explain such a reaction to irritable bronchial tract make an adverse drug reaction a distinct possibility. Added to all these factors is the time of the bronchospasm in relation to the administration of the drug and, if the reaction was noted only after intubation it would have been a very short time indeed after intubation.
44. I am satisfied on the balance of probabilities that the reaction was manifest before intubation. I accept that the defendant, after the crisis was averted and the patient went through surgery, was satisfied in his own mind that the diagnosis of irritable reaction to the insertion of the tube was the more likely explanation. He was naturally concerned about the claimant’s condition and reaction but failed to take into account all the factors that raised the alternative possibility of an adverse drug reaction.
45. A reaction of that severity was a very unusual irritable reaction in a non-asthmatic patient. An anaphylactoid (or anaphylactic) reaction to a drug is equally an unusual event. Both alternative diagnoses were credible and thus there was or should have been a suspicion that adverse drug reaction was the cause. Once this was appreciated the obligation to investigate and warn arose and this action should have been taken.
46. Thus I do find in favour of the claimant on liability.”
When the judgment, which had been reserved, was handed down and the defendant’s solicitor sought permission to appeal, he submitted that the balance of the evidence did not favour the findings that the event had happened pre-intubation and that “there was a transgression of time and that the reaction became apparent post-intubation”. He submitted there was no evidence advanced by either expert that that might well have been the most probable cause. When he submitted there was no evidence to support “your Ladyship’s findings as to the mechanism of events, that no expert evidence suggested (if I can put it like this) the overlap theory”, the judge observed, “I think you have misread me.” She then gave this additional ruling:-
“I do refuse the application for leave to appeal. All of the matters raised have been matters of evidence. I did take into account all the evidence and the expert evidence available. If it is helpful, I will seek to clarify one or two matters of possible confusion arising as a result of these submissions. Firstly, I spent some time dealing with the timing of this matter because, when one looks at timings, they are very tight. I am satisfied on the balance of probability and on the evidence which I heard that this reaction, the bronchospasm (as described) did occur pre-intubation but it must have been very close to intubation. …
The overlap theory is not a theory which I propound, but I do later in the judgment make this point, that the timings are very tight, that bronchospasm would have occurred immediately close to the moment of intubation, that of itself might well raise suspicions in the minds of the anaesthetist. There was a divergence of evidence between the experts’ as to the approach of an anaesthetist in a situation which goes beyond that which I have found, namely that the bronchospasm occurred clearly post-intubation, as distinct from clearly pre-intubation or at the point of or very close to, and on that point, Doctor Aitkenhead’s evidence as to the appropriate practice at that time was that that should have been reported, was suspicious and that reporting and investigation should have been undertaken in accordance with the 1990 guidelines.”
What were the crucial findings?
Upon analysis it seems to me that the judge made these findings:
She found the primary case proved because she found that the bronchospasm occurred “pre-intubation” (para. 33) and that “the reaction was manifest before intubation” (para. 44). She repeated that in her ruling when refusing permission to appeal expressing her satisfaction that the bronchospasm did occur pre-intubation.
In refinement of that decision she also found that the bronchospasm occurred “almost immediately before” intubation (para. 33) and “it must have been very close to intubation” and “occurred extremely close to the moment of intubation” (the permission ruling).
The time-scale and timings were “very tight” (para.32 and the permission ruling).
Nevertheless she seems also to have accepted that the defendant “was satisfied in his own mind that the diagnosis of irritable reaction to the insertion of the tube was the more likely explanation”.
She also found the alternative case proved: “Whether or not the bronchospasm occurred before or after intubation” there should have been a suspicion of adverse drug reaction (para. 43).
She reached that conclusion “for the reasons set out by Professor Aitkenhead”.
The grounds of appeal.
In attacking the judge’s primary finding of fact it is said that there was no real evidential basis for it. Alternatively that it was against the weight of the evidence. It is also suggested that the judge’s reasoning was flawed. It is then said that the judge was wrong to prefer Professor Aitkenhead’s view that even a post-intubation bronchospasm would have required reporting as an adverse drug reaction.
Whilst the appellant does not assert that no reasons were given by the judge for reaching her conclusions, the fact is that the judgment is not replete with detail. It has thus been necessary minutely to dissect the written and oral evidence and we have had to undertake a detailed analysis of the transcripts of the evidence given at the trial especially by the experts. The finding against this defendant is, as I readily appreciate, a serious matter and I have, therefore, read and re-read the transcripts in order to satisfy myself whether or not he can overcome the high hurdle which faces him in seeking to overturn findings of fact made by an experienced judge who has heard the witnesses and has preferred one side to the other. The appellant has to satisfy me that the judge was plainly wrong. It is not enough to show that on another day or before another judge a different conclusion might have been reached. He has to show that the judge came to conclusions which are outside the generous ambit within which judges may reasonably disagree about the facts to be found on the evidence before them.
Analysis.
The first point to make is that there is no appeal against the judge’s finding that Doctor Eastwood could not remember the detail of the incident. He honestly admitted that he had no independent recollection and had to rely on his usual practice and the notes, which he conceded were “vital” and to which he resorted “to remind himself that we didn’t have any major problem”. It transpired that the notes were not complete, and in some ways were misleading in that blood pressure figures and oxygen saturation readings did not, as may have been thought, relate to the time of the bronchospasm. In the result the judge could not rely on Doctor Eastwood’s recollection of what happened and was heavily dependent upon the views of the two experts between whom she had to choose. She preferred the claimant’s expert’s evidence.
The grounds of appeal assert that there was no evidence to support the judge’s primary finding. This is simply wrong. True there was no direct evidence upon which the judge could rely given the difficulties under which Doctor Eastwood laboured when he gave evidence of the event. Nonetheless there was evidence of the opinions of the experts and particularly the opinion expressed by Professor Aitkenhead in his note of 11th February set out in paragraph 18 above. There he asserted in para.1a that in the absence of a history of asthma and exercise intolerance it was most unlikely that severe bronchospasm would occur on intubation. Under cross-examination Transcript p.75) Professor Hull agreed with that save that he preferred to say it was simply unlikely rather than most unlikely. In answer to question 1(c), Professor Aitkenhead explained that in his experience the severity of the bronchospasm was such that it was very unlikely that it was related to tracheal intubation. Cross-examined about this Professor Hull said at p. 75:-
“… the probability of it being caused by or provoked by the intubation was hugely more probable than the likelihood of it being a drug reaction which had taken several minutes to develop.”
In other words one expert relied heavily on the severity of the incident, the other relied on timing. Either way there was evidence upon which the judge could take the decision and that ground appeal cannot succeed.
It is common ground that the judge made two errors in her recitation of the facts upon which the experts were agreed. The first was her saying there was agreement that the claimant had suffered an anaphylactoid reaction to histamine released from atracurium. An anaphylactoid reaction is a pseudo-anaphylactic reaction (i.e. similar to anaphylactic but not necessarily related to earlier sensitisation). An anaphylactic reaction occurs when there is an exaggerated reaction to a foreign protein in respect of which the patient has previously been sensitised. Sensitisation is the process whereby exposure to a particular antigen sensitises the host whereby subsequent exposures are capable of causing exaggerated reactions. As I have already indicated Professor Hull was of the view that the bronchospasm was probably caused by irritation due to intubation and heavy smoking. Reading the judgment as a whole, I cannot be satisfied that this made a crucial difference. As she recited in paragraph 42 of her judgment she was aware that Professor Hull was of the view that with a heavy smoker with chronic bronchitis and chronic cough the introduction of any foreign object can cause a bronchospasm “real fast”. The judge must have been aware of the agreement that it was impossible to know whether the 1995 reaction, if it was a drug reaction, was anaphylactic in origin. Professor Aitkenhead conceded in cross-examination (page 14) that it could have been either anaphylactic or anaphylactoid because one could not know when the antibodies were first introduced into the patient. I do not see this to be a point of any significance. Both are agreed that the presentation would be similar. Both are agreed that if that presentation was manifest before intubation, then if anything greater than simple wheezing was detected following the administration of drugs and before tracheal intubation, then responsible medical practice dictated that an adverse drug reaction should be suspected and the appropriate steps taken to investigate that possibility – see the answer to question 15. I do not see that this corrupted the judge’s thinking so as to lead her down a false trail.
Her second error, namely recording that it was agreed that the reaction was likely to take two-three minutes from the time the drug was injected does need closer analysis. There was no such agreement between the experts. There was evidence from Professor Aitkenhead that the drug reaction would become manifest two or three minutes after giving the drug because that was his experience. If she accepted that, and in paragraph 32 she did accept it, then the real question is whether her believing it to be an agreed fact was significant. I cannot accept that her misapprehension that it was an agreed fact made a significant difference to her thinking. The real question is whether she should have acted on the evidence which she did accept. That calls for a close analysis of timing.
Timing was one of three important factors to bear in mind and evaluate. The experts were agreed in their answers to question 14 that in the context of the case the factors which increased the need to consider investigation of a drug-related cause would be timing (in relation to intubation), the intensity and the responsiveness to treatment. Timing, as there discussed, was the question of timing which was the primary fact for the judge to find, namely whether the bronchospasm occurred before or after intubation. Timing, as there used, did not relate to how soon after the administration of the drugs an anaphylactic reaction would occur. This was dealt with in the oral evidence.
There was a conflict of evidence about this. Professor Aitkenhead said this:-
“It also depends on time since intravenous drugs were administered so that in the period shortly after induction of anaesthesia the time at which bronchospasm occurs the later it is the less probable it will be that an adverse drug reaction is the cause. But that does not mean necessarily that the possibility of a drug reaction should not be considered because it is a potentially preventable cause of future problems. So if you ignore the timing then the intensity and the responsiveness to treatment would still be important … (p. 8/9). …
It’s related to the time after the administration of drugs and the longer the time after administration of intravenous drugs the less likely that the sudden development of bronchospasm is related to an adverse drug reaction. But this has to be qualified by the answer to question 14, which is that the need to consider investigation depends on the timing and on the intensity and on the response to the treatment and, as I indicated, although anaphylaxis becomes less likely with the passage of time within a few minutes of administration of intravenous drugs it remains a possibility that it should be considered. So whether it is the most likely cause or not if the bronchospasm is severe and if it doesn’t respond to simple measures then in my view a drug reaction should still be suspected and investigated because of the importance of future administration if a drug reaction was responsible (p. 9). …
[The anaphylactic reaction] happens within the first few minutes (p. 12/13). …
[The anaphylactic reaction he witnessed] was two or three minutes after I had given the drug (p. 17). …
… If bronchospasm is then diagnosed immediately the tube is in place then I think that the possibility that the difficulty before intubation had been due to bronchospasm is that something that an anaesthetist should consider …
Q: He does not know when bronchospasm started does he?
A: No that’s precisely the point.
Q: So he is unlikely to say on his record acute bronchospasm, is he?
A: Well, that’s something I can’t answer on Doctor Eastwood’s behalf.
Q: No, but acute means of quick onset, does it not?
A: Acute means of rapid onset but a bronchospasm of this degree is going to be of rapid onset even if it is taking place over a minute or a minute and a half (p. 23). …
Judge Steele: In your own case of bronchospasm twenty years ago you say that it took between two and three minutes from the administration of the drug until the bronchospasm occurred, have I got that right?
A: Until it became detectable, yes.
Q: So we are talking about a very similar period of time [two or three minutes before intubation takes place] (p. 42). …
Q: Still on the question of general timing, in the case of a reaction to the insertion of the tube how quickly would you expect the bronchospasm to become manifest?
A: Usually very quickly indeed, it’s usually immediate (p.43/44).”
Professor Hull agreed with that last answer saying:-
“… Heavy smokers nearly all have a degree of chronic bronchitis which is manifest by chronic inflammation of the bronchial linings simply caused by the irritant effects of many noxious substances in tobacco smoke and many of them, although they deny it, have a chronic cough and when you put any foreign object into the trachea bronchial tree from the vocal cords downwards this is an extremely powerful stimulus and it simply provokes a reflex bronchospasm and, as Professor Aitkenhead I think said this morning, it happens real fast (p.53).”
As to the time for a drug induced reaction to occur he said this:-
“… If the responsiveness to treatment is extremely rapid and by implication the duration of the event is extremely short and the timing is becoming more distant from the moment of injection then the likelihood of this being an anaphylactic reaction becomes progressively less. It works the other way round also of course but when the reaction occurs very rapidly you tend to think drug reaction more frequently (p. 56).
… because this was a – I’m thinking as I go along – post-intubation event the probability of it being caused by or provoked by the intubation was hugely more probable than the likelihood of it being a drug reaction which had taken several minutes to develop. Now I accept drug reactions may build up over a period of several minutes, indeed for longer, but you usually see some sign of them quickly and certainly the anaphylactic reactions that I have been involved with occur extremely rapidly after injection of the drug (p.75).
If you say to me it is possible that an anaphylactoid reaction just happened to commence at the very moment that the patient was intubated, two minutes or so after the induction of anaesthesia, then I would have to say: Yes, there is a calculable chance that that is what happened but I think that all the time in any form of clinical practice you have got a weather eye on probabilities … (p. 87).
… if the treatment you apply is successful and confirms your expectations, your interpretation of what caused the event, then you do not go rooting in the shadows for very unlikely events (p. 87).”
In the light of that conflicting evidence it seems to me that it was open to the judge to accept that this bronchospasm manifested itself in the same way as had happened in Professor Aitkenhead’s experience, namely shortly before intubation. I am not persuaded that the differences between Professor Aitkenhead’s experience (different drug, young and fit non-smoking patient) and the instant case force the judge to discount his evidence of the time it took for the bronchospasm to manifest itself. Accepting that the longer the passage of time the less likely the adverse drug reaction being the responsible cause of the bronchospasm, within the short time frame with which the judge was concerned, that timing cannot in my judgment be said to be outside a permissible range of possibility she was entitled to find.
Turning now to another of the factors increasing the need to consider a possible drug related reaction, I consider the patient’s response to the use of aminophylline. In paragraph 43 the judge accepted that the way in which the spasm was relieved added to the possibility of an adverse drug reaction. This finding is again subjected to legitimate criticism. The criticism is that Professor Aitkenhead was wrong to rely on the use of and response to aminophylline as indicative of the possibility of such a reaction. He clearly did so:-
“Q: If the aminophylline had resolved it quickly smoking is the more likely cause post-intubation, is it not?
A: Well, in my view, the fact that it was so severe and required treatment with aminophylline made a drug reaction a distinct possibility, which warranted investigation (p. 34/35).”
The point made by the appellant is that the use of aminophylline would have been inappropriate to treat a drug-induced bronchospasm though wholly appropriate to treat a smoker’s bronchial irritation . This follows from a long passage in cross-examination as follows:-
“Q: Now you would not use aminophylline for an adverse drug reaction, would you, as a first port of call?
A: With bronchospasm?
Q: Yes.
A: In 1995 it was not the first line management for bronchospasm which was thought to be due to an adverse drug reaction.
Q: In fact on your reconstruction of what has actually happened an anaphylactoid reaction which is limited to the lung would suggest histamine being released from cells in the lung. Is that correct?
A: That would be one of the possible explanations, yes.
Q: That is the most likely, is it not for an anaphylactoid?
A: With atracurium, yes, it is.
Q: The aminophylline is a bronchodilator, is it not?
A: Yes.
Q: It has no antihistamine effects, does it?
A: No.
Q: The drug of choice in 1995 for anaphylactoid or anaphylactic would have been adrenalin, would it not?
A: Yes.
Q: The reason for that is that adrenalin will smooth or relax the muscles in the lungs. Is that right?
A: Well, adrenalin does a number of things … it works in effectively the same way as aminophylline on the bronchi, its a bronchodilator.
Q: Does it not also though switch off the cells that are releasing the histamine?
A: In anaphylactic reactions it does switch off the cells that are releasing histamine … Not really in anaphylactoid reactions where particularly with atracurium the release of histamine is shortlived.
…
Q: The adrenalin will probably, will it not, switch off the cells releasing that histamine?
A: But in anaphylactic reactions that is what happens because in anaphylactic reactions because the drug -- the antigen antibody complexes are still there for a long time the release of the histamine from mast cells is protracted and one of the reasons that adrenalin is used is to try to limit the duration of the reaction by switching off the mast cells.
Q: Are you saying that adrenalin has no effect on an anaphylactoid reaction?
A: No, I am not saying that at all. What I was saying is that an anaphylactoid reaction may well, particularly with histamine released in the lungs in response to atracurium, may be relatively shortlived in any event because the release of histamine is much more transient than in an anaphylactic reaction. Therefore it would be expected that either adrenalin or aminophylline could be effective in treating that bronchospasm relatively quickly (p. 27/28)”
As I understand that exchange, Professor Aitkenhead was accepting that aminophylline was not the first-line management drug and that adrenalin might have been more appropriate but his answer to the last question quoted does not exclude aminophylline as an effective remedy for treating an anaphylactoid reaction effectively.
Professor Hull’s evidence was to this effect:-
“Q: Can I ask you about aminophylline then, please? First of all is that used in an anaphylactic reaction?
A: It is a drug that one might sometimes use if you have, for instance, already given the patient considerable doses of adrenalin and the patient still has bronchospasm then you might consider using some aminophylline as a not exactly last ditch response but certainly a second phase response. You would not use aminophylline as your first drug (p. 56). …
Doctor Eastwood said that the bronchospasm was relieved extremely rapidly after the administration of what I have said is a small dose of aminophylline so I would say that the responsiveness element in this case was extremely favourable (p. 56). …
If this had been a seriously suspected drug reaction the correct treatment was adrenalin. The aminophylline was the correct and appropriate drug to use in the case of a bronchospasm of the type Doctor Eastwood suspected it to be. He gave treatment which was appropriate to that situation and he got the result that he was expecting, which reinforced his interpretation of what was in front of him (p. 87).”
Once again there was a difference of opinion but if the judge accepted Aitkenhead’s view that either adrenalin or aminophylline could be effective in treating an anaphylactoid reaction, then she was entitled to make the finding she did.
Accepting, as I do, that there were quite cogent arguments for finding in the defendant’s favour on the first two factors of timing and responsiveness to treatment, the third factor of the intensity of the bronchospasm is not unimportant. In this respect there was Professor Hull’s crucial agreement with paragraph 1(b) of Professor Aitkenhead’s letter of 11th February namely that in their experience aminophylline would be administered during anaesthesia only if there was an intense bronchospasm which had not responded to first line treatment and it followed that on their assessment an intense bronchospasm must have been present. It was not disputed that the bronchospasm was intense. Doctor Eastwood asserted it. In paragraph 1(c) Professor Aitkenhead expressed his view that the severity of the bronchospasm was such that it was very unlikely that it was related to tracheal intubation and in the absence of a history of asthma, it was overwhelmingly probable it was due to a reaction to one of the drugs administered at induction. Professor Hull agreed with 1(c) if it was a pre-induction event but if it was a post-induction event then he disagreed.
For Professor Aitkenhead the severity was an important factor. This emerges from these passages of his evidence:-
“Q: … so far as the use of aminophylline is concerned what does that indicate or not indicate as the case may be about the severity of the bronchospasm?
A: It indicates that the anaesthetist must have been very concerned and indeed Doctor Eastwood made that very clear, that he was very concerned because this was a severe bronchospasm (p. 6). …
I think that in bronchospasm that has not responded to a drug such as halothane and is still causing concern to the anaesthetist it is reasonable to administer aminophylline. But Professor Hull and I agreed that we would only use aminophylline if there was intense bronchospasm which had not responded to halothane and my interpretation of Doctor Eastwood’s evidence yesterday was that this was what I would describe as intense bronchospasm (p. 7/8). …
Q: You see how I was really comparing pre-intubation anaphylactoid reaction with a post-intubation bronchial smoking caused bronchospasm. Of those two pre-intubation anaphylactoid with a sole bronchospasm presentation and a post-intubation smoking caused bronchospasm statistically the smoking cause is more common, is it not?
A: I don’t know if it is or not. Severe bronchospasm is uncommon by either route, as I have indicated. In my total experience of anaesthesia I have never encountered bronchospasm of this severity due to irritation of the trachea in a smoker but I have encountered an anaphylactic reaction (p. 24). …
Q: A patient who smokes twenty cigarettes a day for thirty-five years is a candidate for such bronchospasm?
A: For, in my experience mild bronchospasm (p. 25).
Having heard Doctor Eastwood’s evidence it is quite clear that this was very severe bronchospasm. The point about the aminophylline in all the reports and the joint report is on the basis of evidence which was available at that time. What Doctor Eastwood has described is, and on his own account, very severe bronchospasm, for the bag was very tight (p. 26).
[The fact that aminophylline was given] indicated to me, together with what Mrs Wright has said about what she was told, that the degree of bronchospasm here was very severe (p. 31).”
Professor Hull did not disagree. He accepted (p. 54) that a severe bronchospasm due to smoking is uncommon – “responses of this kind are pretty unusual but they do occur.”
“Q: Would you put it in the severe category or the intense category?
A: I think from his description we would have to put this in the level of intense (p. 56).”
As I have read the whole of this evidence, and have re-read it, it seemed to me that the intensity of the reaction tipped the balance in favour of the diagnosis Professor Aitkenhead made. Although his thought process, and therefore the judge’s thought process, can be criticised as it has been by Mr Hugh-Jones, these criticisms do not so substantially undermine the conclusions that I am able to say that the judge was plainly wrong. This was pre-eminently a matter for her. She had a multitude of facts to take into account, some in the defendant’s favour but some in the claimant’s. Mr Limb relies, for example, upon the fact that the note made at the time by Doctor Eastwood was “at induction - acute bronchoscope”. The judge held in para. 30 that this “would represent his initial reaction and impression.” He submits that even if “induction” is given the appellant’s idiosyncratic meaning, not what the judge considered to be its normal meaning, his phrase used in his witness statement ,“at the point of induction”, hardly seems appropriate to describe the point of intubation or, as he invited the court to find, a moment some, albeit short, time after intubation. It is not clear from the judgment how the judge dealt with those arguments and it is impossible for me to say that they may not have weighed with her and helped tip the balance in the claimant’s favour. They are weighty enough to have done so. I may have sympathy for the defendant but sympathy is not enough and I am not persuaded that the judge was plainly wrong.
Even if the primary case should not have succeeded, there is the alternative case to consider. The judge found it established – see paragraph 45. She accepted Professor Aitkenhead’s evidence, the high point of which probably appears in this passage of his cross-examination at p. 34/35:-
“Q. You had accepted by this stage that a quick resolution of the aminophylline post-intubation in the anaesthetist’s mind drug reaction would be an unlikely cause, would it not?
A. It would -- if there was no suggestion of bronchospasm before intubation and bronchospasm was diagnosed after intubation of this severity then a drug reaction was less likely than stimulation by tracheal tube but it was not in my view a possibility that should have been either not considered or rejected.
Q: You have had time to reflect this case and make a report I think that is a relatively – again, a refined point not contained in your report. Can I just go back to judging him on the spot. Leaving aside hindsight, leaving aside retrospective analysis, there he is, aminophylline is used, quick response, reassured, you think that is reasonable, reassured, restored to the patient operatively. At that point in time a drug reaction is an unlikely cause for him to consider is it not?
A: It’s a cause which I believe he should have considered.
Q: To answer the question, it is unlikely, in his mind it would be an unlikely cause, would it not?
A: Either it’s tracheal irritation caused by the tracheal tube or a drug reaction would be an unlikely cause of this degree of bronchospasm.
Q: If the aminophylline had resolved it quickly smoking is the more likely cause post-intubation, is it not?
A: Well, in my view, the fact that it was so severe and required treatment with aminophylline made a drug reaction a distinct possibility which warranted investigation.
Q: If you look at question 19 on page 164, this is of course experts, I think it was the letter of reflection, I will not read the question but the answer is: “We agree if there was a drug reaction, if the court finds that intense bronchospasm occurred prior to tracheal intubation then an adverse drug reaction to atracurium was the most probable cause. If the court finds there was no bronchospasm until after tracheal intubation then a drug reaction to atracurium is an unlikely cause”. That was your agreement with Professor Hull and all I am putting to you is that once the anaesthetist has used the aminophylline, got a quick response, got the patient into theatre, in his mind the drug reaction is an unlikely cause?
A: But it is still a possible cause which requires investigation into trying to prevent recurrences.
Q: You do not think you are asking a bit much in the light of that clinical sequence?
A: Not in 1995. In the 1970s and 1980s I think that would be asking too much, by 1995 I think that five years following the publication of the Association guidelines the possibility of an adverse drug reaction in these circumstances is something that an anaesthetist should have considered and taken seriously.
Q: It seems that you are saying: No, no anaesthetist could be so reassured by the quickness of the response and the unlikeliness of a drug caused post-intubation that all anaesthetists should have canvassed and considered and reported the possibility of a drug reaction. That is your position?
A: Yes.
Q: You rely heavily on that for the severity it seems now, that is right, is it not? The severity mandated a reporting?
A: Yes, the severity, the fact that it was necessary to give aminophylline and the uncertainty that the bronchospasm diagnosed after tracheal intubation was not present before intubation because of the difficulties that may otherwise exist for ventilating the lungs.”
By contrast Professor Hull gave this evidence:-
“… So that if you have unexplained bronchospasm, just the same as if you have unexplained profound drop in blood pressure the same sort of time, then you are faced with perhaps a series of possibilities but they are all unlikely and you have to try and tease out the possibilities and under those circumstances it would be prudent if you have no reasonable explanation for these things happening to at least investigate a little further. Where you have got a perfectly reasonable explanation for what is after all a fairly common event then in the absence of any other confirmatory signs it would be difficult to pursue such a situation to full investigation because that definition would cover huge numbers of patients. In a case where you have, for instance, a sudden drop of blood pressure where there is some perfectly good reason for a sudden drop of blood pressure you would not write to the CSM about it. If you have bronchospasm where there is a perfectly good cause for the bronchospasm particularly if it was shortlived and highly responsive to aminophylline you would not waste their time (p. 69) …
Q: I am now onto 1(e): “Bronchospasm severe enough to warrant administration of aminophylline in a patient with no history of asthma requires investigation of adverse drug reaction because of the incidence and degree of bronchospasm for any other reason is so small”. You disagree I presume from what you have said already, I just wanted to go through it with you?
A: Well, I do because it means – I mean it would mean that there had been an awful lot of occasions in my own practice where I was similarly remiss (p. 76).”
This presented the judge with a stark conflict of approach between the two experts. Bearing in mind that they had agreed that the duty to report and investigate arose if there was a suspicion of an adverse drug reaction, she was, in my view, entitled to prefer the more cautious approach of Professor Aitkenhead. This was essentially a matter for her judgment and the appellate court must give due deference to the advantageous position in which the trial judge is placed where she has seen and heard the witnesses and clearly preferred one to the other. This ground of appeal must fail.
Conclusion.
Although it might have been better for the judge to have expanded upon her reasons for arriving at her conclusions and although, in the result, I have sympathy for this experienced anaesthetist, nonetheless, after long and anxious deliberation I am satisfied that the appeal must be dismissed.
Lord Justice Rix :
I agree.
Lord Justice Maurice Kay :
I also agree.