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You are here: BAILII >> Databases >> Scottish Court of Session Decisions >> Duffy (AP) v Lanarkshire Health Board [2001] ScotCS 52 (7 March 2001)
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Cite as: [2001] ScotCS 52
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EXTRA DIVISION, INNER HOUSE, COURT OF SESSION
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Lord Prosser Lord Coulsfield Lord MacLean
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A2118/01 OPINION OF THE COURT delivered by LORD PROSSER in RECLAIMING MOTION in the cause KATHLEEN DUFFY (A.P.) Pursuer and Reclaimer; against LANARKSHIRE HEALTH BOARD Defenders and Respondents: _______ |
Act: Dorrian, Q.C., Cherry; Brodies, W.S.
Alt: Brodie, Q.C., Mitchell; R.F. Macdonald
7 March 2001
[1] In this action, the pursuer Kathleen Duffy seeks damages from the defenders, Lanarkshire Health Board, the employers of Dr. W.T.A. Todd, a consultant physician at Monklands District General Hospital. Dr. Todd was responsible for the treatment of the pursuer with Chloramphenicol, which can cause Aplastic Anaemia. In the pursuer's case, it did so. The issue in the case is whether Dr. Todd was negligent in prescribing Chloramphenicol. After proof, the Lord Ordinary held that it had not been established that Dr. Todd was thus negligent, and by interlocutor of 31 July 1998 he assoilzied the defenders. The pursuer seeks recall of that interlocutor, asking this court to hold that she is entitled to reparation for Dr. Todd's negligence. She seeks decree for £248,306, as provisional damages. It is not disputed that that would be the appropriate award, if negligence were established.
[2] It will be necessary to consider in some detail the events which led up to the prescription of Chloramphenicol. A brief introduction is, however, appropriate. In March 1992, the pursuer developed abdominal pains. She was referred to Hairmyres Hospital, where she was under the care of a surgeon, Mr. Thomson. Over the next six months or so, the pursuer was admitted and discharged on a number of occasions, undergoing inter alia two laparotomies, and being treated with antibiotics. Neither the clinical findings nor laboratory analysis revealed the underlying cause of the pursuer's symptoms, and Mr. Thomson called in Dr. Todd, a specialist in infectious diseases.
[3] After being seen by Dr. Todd at Hairmyres in October 1992, the pursuer became his patient, at Monklands. On 23 November, she was admitted there as an emergency. On 24 November, there was still no diagnosis; but the notes show that Dr. Todd was considering Chloramphenicol on that day, and the pursuer was put on a course of that drug the next day. Thereafter, the pursuer recovered from her abdominal problems, but contracted Aplastic Anaemia. It is not disputed that the Aplastic Anaemia resulted from the treatment with Chloramphenicol. The condition is irreversible, but curable by bone marrow transplant, which the pursuer received. She thus survived; but as the amount of agreed provisional damages illustrates, the loss, injury and damage suffered by her, through contracting Aplastic Anaemia, have been very great.
[4] In her Grounds of Appeal, the pursuer contends that the Lord Ordinary erred in eight separate respects. The last of these relates to a question of damages, and is not now insisted in. Of the remaining seven heads, the first identifies an alleged error of approach, which would require this court to consider matters de novo. Heads (ii) to (vii) raise a number of separate points upon which it is said either that the Lord Ordinary failed to give proper consideration to a particular question, or that he failed to take proper advantage of hearing and seeing the expert witnesses, or that having regard to the evidence, he erred in making, or in failing to make, certain findings. In presenting the reclaiming motion, counsel for the pursuer did not depart from any of the seven remaining Grounds of Appeal in any major respect; but the submissions advanced to this court, while reflecting much that is contained in the Grounds of Appeal, came to take a somewhat different form, and to focus upon a more limited number of issues. In our consideration of the evidence, therefore, we find it more convenient to discuss the particular contentions advanced in argument, rather than work our way through the specific points raised at heads (ii) to (vii) of the Grounds of Appeal. In relation to head (i), however, and the question of whether the Lord Ordinary's Opinion is flawed in such a way that this court must consider matters de novo, it is useful to say something at this stage.
[5] This head of appeal focuses upon the question of whether or not professional negligence had occurred. It is said that this was not a "jury question" or "jury issue", and that the Lord Ordinary erred in law by approaching it as if it was. By contrast, it is said that the Lord Ordinary ought to have determined what was the standard of ordinary competence in the circumstances of the case, whether Dr. Todd departed from that standard and if so, whether his doing so was such as would not have been done by an ordinarily competent doctor. It is said that he failed to address these questions. We do not really understand the point which is here being made, or the contrast which is apparently being drawn. Upon an issue as to whether or not professional negligence has occurred, it will be necessary for the judge at a proof, just as it would be for the judge at a jury trial, to identify the appropriate legal criteria applicable in the circumstances. But if these have been identified correctly, their application to the particular circumstances is indeed a "jury question". In the present case, the Lord Ordinary took as his starting point in law the words of Lord President Clyde in Hunter v. Hanley 1955 S.C. 2000: "It must be established that the course the doctor adopted is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care." After referring to certain observations of Lord Browne Wilkinson in Bolitho v. City and Hackney Health Authority 1999 A.C. 232 at page 243, his Lordship goes on to refer to Whitehouse v. Jordan 1981 1 WLR 246, where Lord Fraser of Tullybelton, in the context of error of judgment, says that error of judgment may or may not be negligent:
"It depends on the nature of the error. If it is one that would not have been made by a reasonably competent professional man professing to have the standard and type of skill that the defender has held himself out as having and acting with ordinary care, then it is negligent. If on the other hand it is an error that such a man acting with ordinary care might have made, then it is not negligent."
The Lord Ordinary says that this passage seems to him to summarise the tests he has to apply in the present case at the end of the day "it being a jury question". Thus far, there is no evident error of approach, or failure to distinguish jury questions from legal questions. However, as the matter was presented to us, the submission took on a rather different form. It was submitted that the Lord Ordinary should have treated the present case as one where deviation from normal practice was being alleged. It was of course acknowledged that there could be cases of professional negligence where one was not concerned with deviation from normal practice. In such cases, as we understood the submission, it was accepted that the test for professional negligence would be that adopted by the Lord Ordinary. But in regard to allegations of deviation from ordinary professional practice, the approach must be that set out by the Lord President in Hunter v. Hanley, with three facts requiring to be established:
"First of all it must be proved that there is a usual and normal practice; secondly it must be proved that the defender has not adopted that practice; and thirdly (and this is of crucial importance) it must be established that the course the doctor adopted is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care."
In relying upon the third of these matters alone, the Lord Ordinary had failed to deal with the whole question of whether there was a normal practice and a deviation from it. As will appear from what we say in discussing the substantive issue, we regard this argument as misconceived. The situation in which Dr. Todd found himself was not in our opinion, upon the evidence, one in which the evidence indicated any usual and normal practice, which Dr. Todd failed to adopt. General questions as to what other reasonably competent professional men, professing Dr. Todd's standard and type of skill, would have done in such a situation of course arise, in considering whether what he did was negligent. But that general context does not necessarily involve there being a "usual and normal practice", or turn the case into one of deviation from practice. In his identification of the appropriate legal criteria, which it would then be for him to apply in considering whether Dr. Todd was negligent, the Lord Ordinary has not in our opinion erred in the manner suggested on behalf of the pursuer.
[6] In this respect, counsel for the pursuer did not eventually insist that it would make any difference, whether one treated the case as one of deviation from normal practice, or simply as one of a failure to meet the tests identified by the Lord Ordinary. Even upon the latter approach, it would be appropriate, upon the evidence, to reach certain general conclusions as to the circumstances in which competent and careful consultants, comparable to Dr. Todd, might decide to treat a patient with Chloramphenicol. Dr. Todd's general competence was not questioned. But the question of whether upon this particular occasion he had exercised reasonable care required to be considered in the general context of what he and his peers might be expected to do in the situation with which he was faced.
[7] If one turned one's attention from the question of whether the Lord Ordinary had identified the appropriate legal criteria to the question of whether and how he had applied those criteria, in considering the reasons for Dr. Todd's decision to use Chloramphenicol, it was submitted that the Lord Ordinary's Opinion failed to demonstrate that he had in fact applied the legal tests which he had identified. Even if one could not say that he had applied some other, wrong test, and even if his reasoning took one much of the way towards his conclusion that negligence had not been established, there was nonetheless a gap in his reasoning, so that his conclusion was essentially unexplained. Referring to Dingley v. The Chief Constable Strathclyde Police, 1998 S.C. 548, counsel submitted that in the absence of such reasoning and explanation as would lead to that conclusion, the matter was open for the Appeal Court to assess the evidence de novo. The question of whether Dr. Todd's selection of Chloramphenicol was negligent or not depended upon a series of questions; but it was submitted that at the end of the day, the choice of Chloramphenicol would be negligent, if there was available an alternative which was equally or more likely to be effective, without the risk inherent in Chloramphenicol of a serious side effect. In the present case, there was evidence that Ciprofloxacin combined with Flagyl constituted such an alternative; and Dr. Todd had considered and rejected that alternative. The matter was raised, in a somewhat different form, in Ground of Appeal (iv). But it was submitted that upon any view, the Lord Ordinary in his Opinion had omitted to explain why he considered that the choice of Chloramphenicol, in preference to Ciprofloxacin and Flagyl, did not constitute negligence on the part of Dr. Todd. This court would require to consider that issue de novo.
[8] We have come to the view that in this respect, the Lord Ordinary does not in his Opinion sufficiently explain this part of his reasoning. We shall of course come to refer to his Opinion in this and other respects, in the course of our consideration of the submissions of the parties. But since this issue requires consideration de novo, and since upon most other issues the differences between the parties were less fundamental in the end of the day than they had been at earlier stages, we find it more convenient to discuss all matters upon the basis that the primary issue of negligence is now one which it is for us to determine de novo.
[9] In that context, and having regard to some of the arguments addressed to us, we think it useful at this stage to set out the history of the pursuer's symptoms and condition, and the investigation and treatment carried out at Hairmyres and Monklands, in some detail. The situation with which Dr. Todd was faced, and his decision to have recourse to Chloramphenicol, cannot be adequately or properly assessed without a full account of what had already happened.
[10] The pursuer was first admitted to Hairmyres Hospital on 13 March 1992 with a history of three days pain in the abdomen and a borderline pyrexia. She was also found to have a raised white cell blood count, which is an indication of some infectious inflammatory process. She was diagnosed as a likely case of appendicitis and a standard appendectomy was performed but the appendix was, when removed, normal. She was discharged home in ordinary course but on 21 March she was re-admitted. She complained that she had been unwell since she went home and had suffered recurrent abdominal colic and been sick and vomiting. On examination she was described as looking toxic and unwell and had generalised tenderness in the abdomen. Her white blood count was assessed at 31,000, which is a considerably raised figure. In the discharge letter written by Mr. Thomson, on 31 March 1992 it is stated:
"There was obviously something serious going on in her abdomen and she was taken for laparotomy. The findings were very odd. There was a large inflammatory mass at the origin of the small bowel mesentery. When this was opened there was found to be necrotic tissue and purulent material. This was drained.
There appeared to be no small bowel pathology and the lesion did not appear to involve the appendix base at all. A drain was inserted and the abdomen closed. She had been started on antibiotics and these were continued...
Histology of the material removed from the abscess is rather strange and has given cause for debate among the pathologists around town. There is no evidence of malignancy and there is a possibility that this originates from an odd Helminth infection which she may have picked up while on a trip to Japan in November of last year when she was eating raw seafood. I will be in touch again when the definitive histology report is available."
[11] As that letter indicates, the pursuer was treated at that time with antibiotics. The antibiotics were Cefuroxime and Flagyl which were given intravenously for five days and then orally for four days. Cefuroxime is an antibiotic which has a wide range of effect against aerobic bacteria, that is, those which depend upon oxygen for their survival; and Flagyl is the trade name of Metronidazole, an antibiotic effective against anaerobic bacteria. The use of these two antibiotics for a period of nine or ten days is, according to the evidence of Mr. Thomson, a standard post-surgical treatment. During the course of her time in hospital on this admission the pursuer was reported from time to time as "feeling better" and she was discharged without any further provision of antibiotics. Thereafter, she was seen as an outpatient and various examinations were carried out, including an assessment of her white cell blood count on 3 April 1992, which was reported as within the normal range.
[12] On 20 May 1992, however, the pursuer was re-admitted to hospital with a recurrence of similar symptoms. The examinations which were carried out, like those which had been carried out while she was an outpatient, pointed to some kind of bowel inflammation but did not point to any specific cause. She was again treated with a course of Cefuroxime and Flagyl for ten days and her notes record signs of improvement. There is again a report of a white cell blood count on 4 June 1992 which was within the normal range. She was eventually discharged on 19 June 1992 and at that time was described as "very well".
[13] Nevertheless on 6 July 1992 the pursuer was re-admitted to hospital complaining of abdominal pain and vomiting and with a raised temperature. The surgeon, Mr. Thomson, happened to be on holiday and the pursuer was treated with Cefuroxime and Flagyl intravenously for a period of 24 hours and was then allowed home. She was given a course of another antibiotic, Augmentin, an antibiotic of the Amoxycillin group which has a broad spectrum but it is not usually used in very serious conditions. The dose which she was given to take was, also, a small one at that stage. The pursuer was re-admitted on 13 July 1992 and seen by Mr. Thomson and again prescribed the same two antibiotics, Cefuroxime and Flagyl intravenously for a period of five days. It was decided that it would be necessary to carry out a further laparotomy and this was done on 5 August 1992. In his eventual discharge letter, of 17 August 1992, Mr. Thomson reported that on admission the pursuer had looked toxic and unwell and had been pyrexial with generalised tenderness but normal bowel sounds. She had been treated with intravenous fluids and antibiotics and her toxaemia gradually settled but she ran a persistently high white blood count and, among other signs, continued to complain of severe abdominal pain and required continuous infusion of opiates to control it. Mr. Thomson reluctantly decided that he had to carry out the second laparotomy and recorded that she was found to suffer from gross intra-abdominal peritoneal adhesions which were freed. His letter continues:
"The small bowel itself was completely normal with no evidence whatsoever of Crohn's disease. The colon was likewise normal with no evidence of Crohn's disease or ulcerative colitis."
[14] In other respects the pelvic organs were normal and later Mr. Thomson says:
"Apart from the adhesions, the pathology was limited to the mesentery and para-aortic region in the form of lymphadenopathy. There were isolated large lymph nodes in the small bowel mesentery and a large mass of necrotic nodes at the root of the small bowel mesentery. There were other more discrete large lymph nodes going up along the aorta."
[15] Samples of these abnormalities were taken for examination and the report of the examination is summarised as follows:
"The histological appearance of the lymph nodes shows multiple small stellate abscesses filled with polymorphs, many of which are necrotic. Around each abscess is a thick mantle of pale epithelioid cells including a few multinucleated giant cells. The appearances are very suggestive of infection with Yersinia. I understand these histological appearances can also be seen in lymph nodes affected by cat scratch disease and lymphogranuloma venereum. These are due to Chlamydiae but so far as I am aware Kathleen has not been in contact with cats and has had no superficial lymphadenopathy and as I have previously said there was absolutely no evidence at operation of any pathology in the womb, ovaries or tubes."
[16] Attempts were made to culture organisms or otherwise identify any infection but these were not successful. After the laparotomy, the pursuer's condition settled and on 10 August, for example, her white cell count was recorded as normal. She was eventually discharged home on 17 August 1992. It is evident, however, from the history, and was confirmed in his letter and in his evidence by Dr. Thomson, that there was no diagnosis of the cause of her condition, despite, as is obvious, serious efforts having been made to consider a wide range of possible causes.
[17] During September 1992, the pursuer was seen as an outpatient. Her condition seemed improved, so that, for example, on 1 September it was noted that she was "well, better than all year". There was also, on 14 September 1992 a normal white cell count. However, on 29 September 1992 she again attended Hairmyres Hospital, complaining of having been unwell for four or five days. At this time, Dr. Todd was contacted. He was first contacted by telephone and suggested the use of two other antibiotics, Rifampicin and Doxycycline. The former is an antibiotic which has been reserved primarily for use against tuberculosis and the latter is a member of the Tetracyline group which has a broad spectrum of effect against aerobic bacteria but is not usually employed for serious conditions because of its slow onset. Dr. Todd had in mind the possibility of brucellosis, which had been raised as a result of the pursuer mentioning to her general practitioner that she had visited Ireland and drunk unpasteurised milk. Dr. Todd visited Hairmyres Hospital and saw the pursuer on 1 October 1992. He adjusted the doses of Rifampicin and Doxycycline and suggested a variety of investigations, including testing directed to discover whether the pursuer's immune system was effective. These latter tests were positive and showed that there was no apparent defect in the operation of the immune system.
[18] In his note in the Hairmyres Hospital records Dr. Todd said, inter alia:
"This young lady has obvious mesenteric adenitis but we are left with the dilemma of no confirmed aetiology. I note the Japan visit and the link with unpasteurised milk etc. In simple terms I think, despite negative results so far the aetiology we are 'chasing' is either
Yersinia
T.B. (atypical organisms that are often not easily recognised)
Brucellosis
Chlamydial infections.
I think that the current Rx should continue but that the dose should be Rifampicin 300 mgBD, Doxycycline 200 mg daily. We have the option of adding Streptomycin, Chloramphenicol or Cotrimoxazole if clinically indicated."
[19] The note goes on to suggest tests directed to the functioning of the immune system and also a test for possible tuberculosis.
[20] The pursuer's notes thereafter record some modest signs of improvement. She was again seen by Dr. Todd on 14 October when it is noted that she seemed somewhat brighter and that her temperature had apparently settled; but she was still suffering from pain, anorexia, nausea and evidence of continued inflammatory response. Dr. Todd noted that the results achieved so far suggested a normal functioning of the immune system and he also reported an apparently negative response to the test for tuberculosis. He referred to a number of further possible investigations but ended by noting that it was important to continue to consider underlying non-infectious causes for the problem and mentioned sarcoidosis. There are further references to the pursuer doing well or feeling better in the notes thereafter and she was seen once more by Dr. Todd on 30 October 1992 when he recorded that she was improved/improving, that there was a normal ACE level but that the white blood count remained elevated. He said:
"I think Kathleen has reached a stage where discharge is the sensible option. I do not know the diagnosis but suspect an unusual granulomatous condition such as Lymphomatous Granulomata".
Dr. Todd referred to further tests and ended his note by observing that he would discuss the case with the pathologists and the general practitioner. The pursuer continued to show signs of improvement and she was discharged from Hairmyres Hospital on 2 November 1992.
[21] On 16 November 1992, the pursuer attended Dr. Todd's clinic, at Monklands Hospital. By that time she had completed the course of Rifampicin and Doxycycline, which had lasted for five weeks. The course was completed about ten days before she was seen on 16 November. Dr. Todd's note on this occasion recorded that she was still eating well and had gained weight but referred to some diarrhoea in the previous two days and noted that she still felt very tired and that there was some discomfort in her abdomen. On 23 November 1992 the pursuer was admitted to Monklands Hospital, under Dr. Todd's direct care, as an emergency. She had been vomiting for three days and her white blood cell count had risen. The admission was arranged as a result of a telephone call between her general practitioner and Dr. Todd, on the basis that she could not wait for an out-patient appointment. She was not immediately prescribed any further antibiotics and various tests were carried out or arranged on her admission. On 24 November 1992 she was seen by Dr. Todd whose note recorded that she was reasonably stable though clearly not as well as when seen seven days previously as an out-patient. The note refers to blood samples sent for repeat tests for Yersinia, Brucella and syphilis and to serology tests. The note concludes by saying: "Need to consider further Chloramphenicol Rx if temperature rises." (It is clear that this is a reference to further consideration of Chloramphenicol, not an indication that it had previously been used).
[22] The nursing notes for 25 November record "Commenced on Chloramphenicol". Dr. Todd's note on 26 November says that the pursuer was still feeling nauseated and mild pyrexia persisted. It then states "On Chloramphenicol" and further refers to a positive test for tuberculosis. There is no explicit record of the actual decision that treatment with Chloramphenicol was to be commenced; but its commencement is clearly recorded, and Dr. Todd accepted in evidence that this was on his instructions. The reasons for this decision are, as we have indicated, at the heart of the issue in this case and will be referred to later. It is also of very substantial importance to consider what Dr. Todd's assessment of the state of the patient was at this date and that also will be discussed in greater detail later. But as regards the history up to that date, it is important to note and bear in mind the pattern of repeated attempts to identify the cause or causes of the pursuer's condition, repeated attempts to find a suitable therapy, repeated partial success and repeated relapses. It is also of considerable importance to note that despite the extent of the therapies and investigations which had been carried out by November 1992 it had not been possible for the doctors to come to any conclusion as to what the true underlying cause of the pursuer's condition was.
[23] It may be added that in surveying the pursuer's history, care has been taken to refer to occasions on which, as was brought out particularly in the cross-examination of Dr. Todd on behalf of the pursuer, there were references to "improvement" or "feeling well" in the hospital records and on which the temperature or the white cell count (both of which if elevated indicate an inflammatory process) appeared to be normal. It should be observed, however, that Dr. Todd pointed out that over the whole period a total of 36 full blood counts had been carried out, the vast majority of which were abnormal, and that other tests such as the ESR were also abnormal during most of the period. Indeed, it was pointed out that there was almost no occasion during the whole period of the illness so far considered when all relevant indicators were normal.
[24] Much of the evidence led at proof had no bearing upon the reclaiming motion. We were, however, referred not only to the evidence of Dr. Todd, but also to the evidence of others who had been involved with the pursuer - Mr. Thomson, the microbiologist Dr. Baird and Dr. Maclay, a pathologist. A number of expert witnesses had also been led at proof - in particular, Dr. C.J. Ellis, a consultant in infection and tropical medicine at the Hartlands Hospital in Birmingham, the principal witness for the pursuer in relation to the alleged negligence. We were referred not only to his evidence, but also to substantial parts of the evidence given on behalf of the pursuer by Professor Ward, a consultant clinical pharmacologist from Leicester, and by Dr. W.R.C. Weir and Dr. Philip Wellsby, consultants led on behalf of the defenders, both having expertise in relation to infectious diseases. The evidence of those involved with the pursuer of course underlies the history which we have already set out in some detail. And the general observations which we shall make in relation to various drugs, and the circumstances in which it may or may not be appropriate to use them, derive from the evidence of the expert witnesses, along with Dr. Todd himself, and certain documentary material. But apart from the evidence of Dr. Todd, and that of Dr. Ellis (which provides the essential foundation for the pursuer's case) we have not in general found it necessary to make detailed reference to the evidence of individual witnesses.
[25] As we have indicated, there are quite a number of matters which were in issue before the Lord Ordinary, or indeed at the earlier stages of the hearing on the reclaiming motion, which are no longer of substantive significance. It is convenient to identify some of these at this stage.
[26] First, the fact that the pursuer's condition was still undiagnosed when Dr. Todd chose to use Chloramphenicol was apparently relied upon as in itself indicating that Chloramphenicol should not be used. That proposition appears to derive from an indication in the literature that the drug should "never be employed in undefined situations". However, counsel for the pursuer acknowledged that the absence of a specific diagnosis did not ipso facto entail negligence on the part of a doctor who decided that Chloramphenicol was the appropriate drug in given circumstances. The eventual proposition was rather that a decision to use Chloramphenicol would never be justified unless the doctor was dealing with an infective process of a type within the anti-bacterial capabilities of Chloramphenicol, and was reasonably confident that Chloramphenicol would be effective against that process. If these conditions were met, it might be legitimate to use Chloramphenicol if there were no alternative which was as likely to be effective.
[27] Secondly, the uncertainties as to whether there was a non-infectious disease, underlying the discovered abdominal infection, were covered at some length in the evidence. However, in relation to the question of negligence, the submissions ultimately advanced on behalf of the pursuer proceeded upon the basis that even if there were some such underlying disease (the treatment for which would not take the form of antibiotics), Dr. Todd's decision to treat the pursuer with antibiotics could not be criticised, as it would be appropriate to try to control the infection before having recourse to other means of dealing with any such underlying disease. To attempt to control the underlying disease first, by administering other forms of drug, might indeed exacerbate the infection in a dangerous way. The question is not therefore whether antibiotics should have been used, but which.
[28] Thirdly, in submitting that Chloramphenicol should not have been employed, counsel for the pursuer identified the combination of Ciprofloxacin and Flagyl as the alternative which a competent consultant, using reasonable care, would have adopted in the circumstances. In his evidence, Dr. Ellis had suggested that the appropriate course would have been to use the combination of Cefuroxime and Flagyl, which had already been tried. That suggestion was founded upon Dr. Ellis's view that when tried previously, this combination had not been persisted with for long enough, and that if it were tried again it might be expected to deal with the infection successfully. Further bases for using Cefuroxime and Flagyl again are to be found in Dr. Ellis's assessment of the pursuer's condition. Despite the pursuer's relapses after previous courses of this combination of drugs, Dr. Ellis saw it as having produced improvements, and in addition, he did not consider that on 23 to 25 November the pursuer's condition could properly be described as life-threatening. He thus saw an opportunity, as well as a reason, for trying Cefuroxime again, on the basis, as we understand matters, that if this did not succeed there could still be recourse thereafter to Ciprofloxacin (with Flagyl) which at that stage would be the appropriate alternative to using Chloramphenicol. Against the background which we have narrated, it does not appear to us that reversion to Cefuroxime would have been justified, and we are persuaded that other witnesses were well-founded in thinking that the time had come to try some other drug. If Ciprofloxacin were to be tried, it does not seem to us, having regard to the pursuer's condition, that it would have been appropriate to postpone that step until after a further course of Cefuroxime. But in any event, in spite of his views as to Cefuroxime, Dr. Ellis's evidence is clear, to the effect that as between Ciprofloxacin (with Flagyl) and Chloramphenicol, it would be negligent to opt for the latter. The question of which antibiotic should have been adopted, and whether it was negligent to adopt Chloramphenicol, comes down for practical purposes to a question between Chloramphenicol and the Ciprofloxacin/Flagyl combination.
[29] Fourthly, both in evidence and in submissions to the Lord Ordinary, questions arose as to whether the pursuer's condition on 24-25 November could properly be described as "life-threatening". And in the presentation of the reclaiming motion, the submission made on behalf of the pursuer was still that her condition was not life-threatening at that time. On behalf of the defenders, it was not submitted that the pursuer's condition was "critical", in the sense that there was an immediate risk of her dying within, say, 24 hours. But it was submitted that upon the evidence, the pursuer was likely to die within about a month unless the infection from which she was then suffering was brought under control by whatever course of antibiotic treatment was embarked upon at that date. There was not time for an unsuccessful course to be followed by another course, trying yet another drug which might be hoped to succeed. That being so, this was the last chance to save the pursuer's life, and "life-threatening" was in such circumstances an entirely appropriate description of her condition. The emphasis upon the expression "life-threatening" derives from the literature: as Professor Ward pointed out in a report prepared for this proof, the British National Formulary states that Chloramphenicol "should be reserved for the treatment of life-threatening infections". We shall return to what is said in the literature as to the use of Chloramphenicol; but at this stage, and in this respect, we would say that whatever the intended meaning of the expression in the literature, its use in the sense contended for by the defenders appears to us to be reasonable. In any event, whether one uses that expression or not, we are satisfied upon the evidence that the situation was a "last chance" one, in which it would be reasonable for the choice of antibiotic to be made upon the basis that if the chosen drug failed to bring the infection under control, the pursuer was likely to die without there being time for a further alternative course of antibiotics to be carried through. Notwithstanding the views which had been expressed by Dr. Ellis in evidence, it did not appear to us that counsel for the pursuer, at the end of the day, really submitted otherwise.
[30] Fifthly, while Flagyl had been involved in the "failure" of the previous courses on Cefuroxime, the evidence that it was time to change from Cefuroxime and try a different antibiotic was not accompanied by any suggestion that Flagyl should be dropped as the anti-anaerobic element in any new combined treatment, along with a drug such as Ciprofloxacin. The merits or demerits of that combination can accordingly be regarded as turning upon what might be expected of Ciprofloxacin itself, with Flagyl's ancillary role requiring no detailed consideration.
[31] Sixthly, while Chloramphenicol's known potential side-effect, with a risk of aplastic anaemia, would plainly have a bearing upon any choice between that drug and Ciprofloxacin/Flagyl, any undesirable side-effects which Ciprofloxacin may have (and the evidence suggests no more than that this is a possibility) do not appear to be such that they would have any material bearing upon a choice between the two drugs. That choice would therefore depend essentially upon an assessment of the likely efficacy of each of the two drugs, in the context of the known risk of aplastic anaemia if Chloramphenicol were to be adopted.
[32] Seventhly, while the gravity of aplastic anaemia is wholly undisputed, so that the risk inherent in using Chloramphenicol is a risk of a hugely detrimental side-effect, the risk of that side-effect actually occurring in any given case was the subject of some consideration in evidence, and of differences of emphasis, at least, in the submissions of parties. Dr. Ellis proceeded upon a figure of 1 in 8,000, while other witnesses proceeded on figures of 1 in 25,000 or 1 in 30,000. Dr. Wellsby adopted what may be called a mathematical approach, emphasising the consideration that if one used Chloramphenicol on many thousands of patients, only one would contract aplastic anaemia whereas many would derive the benefit which Chloramphenicol could give. In taking a decision in relation to a particular patient, it seems to us that the relevance of these figures is less a matter of whether many others would benefit, than a question of the odds against the side-effect occurring in the case in hand. At all events, it does not appear to us that it is necessary to adopt any one figure, or to say that the risk is small as opposed to great, or to adopt any other specific language. The figures in question show that a particular patient is much more likely not to contract aplastic anaemia than to contract it; but having regard to the gravity of aplastic anaemia, the risk is not merely one which must be borne in mind. The gravity of the possible side-effect is such that the risk, even if relatively small, cannot in general or ordinary circumstances be seen as "worth taking" on the patient's behalf, unless the doctor in charge of the patient has reasons for preferring Chloramphenicol to any alternative drug, in terms of what may be achieved and what is at stake, and moreover concludes that, weighing the potential benefits against the risk, use of the drug is justified in the patient's interests. There are, of course, many ways in which one may try to formulate, or give a structure to, the appropriate considerations which must be taken into account when setting such potential benefits against the risk of such a possible side-effect as aplastic anaemia. But so long as one expresses the matter broadly, it did not appear to us that there was any fundamental difference between the parties that this was the correct approach for any competent doctor exercising reasonable care.
[33] Lastly, before coming to matters which require more detailed discussion, we should refer to the Lord Ordinary's finding that "Chloramphenicol worked" - that the pursuer's original condition was in fact cured by Chloramphenicol. This is an inference from the subsequent disappearance of the condition. On behalf of the pursuer, it was submitted that the inference was not justified, but that in any event the matter was irrelevant to the question of negligence. Having regard to the history of events after Chloramphenicol was first prescribed, it appears to us that the issue may be a complicated one. As the issue of negligence in this case does not appear to us to turn upon the question of whether Chloramphenicol in fact "worked", we think it better simply to leave the question open, without considering the detailed history, or attempting to assess the probabilities. In so far as witnesses drew the same inference, and with hindsight regarded eventual efficacy as confirming prior potential efficacy, we are not persuaded that their opinions are undermined upon what is now the crucial issue. The position of counsel for the pursuer was not that Chloramphenicol could not, or might not have worked. Indeed, it was not really suggested that Chloramphenicol was less likely to work than Ciprofloxacin/Flagyl. Whichever was used might have worked, but that did not show that the other would not have done so. The crucial question is whether a competent doctor exercising reasonable care could prescribe Chloramphenicol as being more likely than Ciprofloxacin/Flagyl to deal with the pursuer's infection, and for that reason being the appropriate choice of drug, notwithstanding the known side-effect which might emerge. We would add that while the word "likely" was much used in the course of the submissions, the uncertainty as to diagnosis seems to us to have meant that a doctor could not perhaps be very confident that either drug was "likely", or could positively be expected, to be successful: the question is rather a comparative one - could Chloramphenicol reasonably be regarded as offering a better prospect of success than Ciprofloxacin/Flagyl? On behalf of the pursuer the submission was that if the alternative offered as good a prospect (however poor) as Chloramphenicol, then a competent and careful doctor would prescribe the alternative. We did not understand the defenders to dispute this test.
[34] In relation to both Chloramphenicol and Ciprofloxacin, there are of course certain objective facts which are beyond dispute. And again in relation to each, laboratory or clinical experience can identify particular categories or types of bacteria against which the drug is particularly active or successful, and other organisms which are not susceptible to it. Both Chloramphenicol and Ciprofloxacin are described as having a "broad spectrum", which is clearly of significance where no individual organism has been identified as the target and it would accordingly be appropriate to use an antibiotic which has the prospect of being effective against a wide range of different bacteria. In terms of overall breadth of range, the evidence does not seem to establish that Chloramphenicol has a significantly wider range than Ciprofloxacin (apart from its anti-anaerobic capacity, which Ciprofloxacin lacks, but Flagyl supplies). The fact that Chloramphenicol is a bacteriostatic drug, depending upon the patient's immune system for its efficacy, distinguishes it from Ciprofloxacin, which kills bacteria directly. But in the present case the distinction is not material, the pursuer's immune system having been sound. Both drugs are active against both Gram-positive and Gram-negative bacteria - in the case of Ciprofloxacin, particularly the latter. It is not suggested that a relevant distinction is to be drawn in this respect. There was evidence as to the suitability of each for certain specific organisms or diseases, but at a broad level it seems clear that Chloramphenicol and Ciprofloxacin could often be seen as alternatives, in the sense that either might be chosen but for the question of side-effects. And that being so, it is clear that in those situations where Chloramphenicol was used before its possible side-effect was known, and before Ciprofloxacin was available, Ciprofloxacin or some other drug such as Cefuroxime would now normally be used, and Chloramphenicol would not, because of its side-effect.
[35] Because of its potential side-effect, rather than any lesser efficacy, Chloramphenicol will thus be what one may call the rejected alternative in "ordinary" situations. This is apparent from the literature, and was not really disputed by any witness. Once its potential side-effect was known, it was obvious that it should no longer be used for trivial or minor infections, and although the language varies, that proposition is found more than once, as a basic starting point, in the literature. While this may be regarded as an absolute veto in relation to such infections, it is not really in point in the present case, as no one suggests that the pursuer was suffering from a trivial or minor infection. Equally, it is clear from the evidence and the literature that, notwithstanding the possible side-effect of Aplastic Anaemia, Chloramphenicol has continued to be regarded as the appropriate drug of choice in parts of the world where alternatives such as Ciprofloxacin might simply not be available - particularly but not solely in cases where it has been found to be highly effective, such as Typhoid Fever and Haemophilus Influenzae. Even in the United Kingdom, the Committee on Safety of Medicines in 1967 were of the opinion that the advantages of Chloramphenicol greatly outweighed its hazards in these particular cases. But just as we are not concerned in this case with the fact that Chloramphenicol is unacceptable for minor infections, so also we are not concerned with questions as to whether or when its use would be regarded as acceptable against these particular, diagnosed problems.
[36] Still treating the matter generally, the question is whether and when Chloramphenicol might be regarded as the appropriate drug, between these two extremes. Reading Dr. Ellis's evidence as a whole, we think that he generally rules out the use of Chloramphenicol for any problem other than those mentioned in paragraph 35 above, upon the basis that in terms of efficacy, it offers nothing that cannot be achieved by alternatives such as Ciprofloxacin or Cefuroxime. On the other hand, no two drugs are identical, and Dr. Ellis accepted that in in extremis, if all alternatives had plainly failed, he would regard a final attempt with Chloramphenicol as justified, notwithstanding the possible side-effect. And on behalf of the pursuer, the submission was essentially that this would be the view of any competent and careful consultant in infectious diseases. That is the construction which they would put upon a passage contained in the British National Formulary, which is in the following terms:
"Chloramphenicol is a potent, potentially toxic, broad-spectrum antibiotic which should be reserved for the treatment of life threatening infections, particularly those caused by Haemophilus Influenzae and also for Typhoid Fever.
Its toxicity renders it unsuitable for systemic use except in the circumstances indicated above."
It is, however, to be observed that this formulation does not limit use to the specific examples of Haemophilus Influenzae and Typhoid Fever, and appears to define the boundaries of appropriate use not in terms of specifically identified infections, but in terms of the threat to life posed by infection. Once the risk of death from the infection is put into the balance against the risk of Aplastic Anaemia, it becomes understandable that Chloramphenicol might have to be considered along with any other drugs which, in terms of expected efficacy, appear to offer a prospect of saving the patient's life. The clinical assessment of the patient's condition will therefore be crucial, as well as an assessment of the prospects of success with each of the alternative drugs.
[37] That approach appears to us to be vouched by the evidence, and by certain passages in the literature. For example, in Wintrobe, Clinical Haematology, 9th edition, Chapter 31 at page 919, after discounting possible ways of reducing the incidence of Chloramphenicol-associated Aplastic Anaemia, the authors say this: "Far more important is the initial judgment and restraint of the physician who prescribes the drug. With this, as with other potentially harmful therapeutic agents, the physician must weigh the risk against the possible gain." In 1986, D'Arcy and Griffin, 3rd edition, quotes the Committee on Safety of Medicines as saying that Chloramphenicol should not be used "except when careful clinical assessment, usually supplemented by laboratory studies, indicated that no other antibiotic would suffice." And in Garrod, Lambert and O'Grady (1992) it is noted that Chloramphenicol is still the drug of choice for Typhoid Fever and other severe infections due, inter alia to Rickettsia; but it makes it clear that there are differences of opinion in relation to other indications for use, and that the circumstances in which it is used, in combination, include intra-abdominal sepsis. After mentioning a number of particular uses, the authors go on to say "Treatment for other serious infections should be restricted to those organisms (now very uncommon) which are resistant or much less susceptible to other antibiotics."
[38] The BNF of 1992 says that the Gram-negative bacteria against which Ciprofloxacin is "particularly active" include Shigella and Pseudomonas, and also that it is "active" against Chlamydia. Its uses are said to include infections of the gastro-intestinal system. And it is worth noting that in the summary of antibacterial therapy, Ciprofloxacin is one of the suggested antibiotics for a number of infections of the gastro-intestinal system, whereas except for Typhoid Fever (for which both Chloramphenicol and Ciprofloxacin are suggested) Chloramphenicol is not a suggested antibiotic for any other infection in the gastro-intestinal category. (It is worth mentioning that in a comment related to Typhoid Fever, it is said that infections from the Indian subcontinent, the middle-east, and south-east Asia "may be Chloramphenicol-resistant and Ciprofloxacin may be more appropriate" - which appears to suggest that despite its side-effects, Chloramphenicol might otherwise be preferable to Ciprofloxacin against Typhoid Fever).
[39] Advice or expressions of opinion contained in the literature, however interesting or influential, would not be binding, in any sense, upon a consultant such as Dr. Todd. But in any event, we are not concerned in the present case with the question of whether Chloramphenicol might appropriately be used against infections which are not life-threatening. And on the hypothesis of a life-threatening infection, it seems clear that clinical assessment and a weighing of potential benefits and risks are regarded as the appropriate approach to any decision as to whether Chloramphenicol should be prescribed, rather than some alternative antibiotic.
[40] We return to this case, and in particular to Dr. Todd's assessment of the pursuer's condition, the attempts at diagnosis and the forms of treatment which were considered and adopted. During October, Dr. Todd had of course discussed the pursuer's condition with both Dr. Maclay and Dr. Baird, and it is clear that the situation was regarded as an unusual one in terms of the pathology, and a frustrating one with no identifiable organism having been recognised. Dr. Todd described the frustration as more than academic: it was clinical frustration, making him worried about the pursuer's ability to survive in the long term. Expressing a concern that any further delays in getting the situation under control could indicate a very dangerous position for the pursuer, Dr. Todd acknowledged that there had been episodes when the pursuer began to improve, but with further episodes of the problem, he drew a comparison with children in the Third World, and the vicious cycle of malnutrition and infection undergone by them, eventually ending up in a fatal outcome if there was no intervention. He said that his concern in October was that "we are clearly quite far down that road already", with the pursuer's general ability to withstand this ongoing onslaught becoming significantly reduced by every further episode.
[41] We see no reason to doubt that at the end of October the failure to reach a diagnosis, either of an underlying condition or of the serious, unusual and recurring infectious symptoms, was extremely worrying, and causing concern for the pursuer's life. The lack of progress towards diagnosis is well illustrated by a document in which Dr. Todd made a list of all the things he could think of that could cause the granulomatous reaction which had been found. Some of these were infections, such as he had listed originally in the case notes. Others were not infections. Even conditions which Dr. Todd was not seriously considering were nonetheless listed. So also were conditions such as Yersinia, although Dr. Todd's view was that that should have responded to the antibiotics that the pursuer had previously had. It is no doubt true in general, as Dr. Ellis observed in the course of his evidence that "when people start to find things are not responding as they would hope...people spread around the field in directions which become less and less plausible" and "tend to neglect the possibility that you're coming back to a comparatively straightforward situation". But we are not persuaded that Dr. Todd, and the others involved in the pursuer's care, had fallen into this type of error. When the pursuer ceased to attend Hairmyres and began to attend at Monklands, her condition, and in particular the granulomatous lymph nodes, appear to us to have had no evident explanation - which in view of the period of time that had elapsed, and the investigations and types of treatment which had been carried out, would rightly be seen as justifying concern for her long term survival. As Dr. Todd put it "we forget, because of antibiotics, what infections can do; and infections in situations around the world where antibiotics are not available produce the devastating sort of results which they produced in the pre-antibiotic era in this country. I think we forget that infections kill people, and sometimes quite rapidly...".
[42] When Dr. Todd saw the pursuer on her initial out-patient visit to Monklands, he was concerned that there were still abdominal symptoms and that she had other complaints. He took blood for tests, but pending the results arranged for her to come back in four weeks. When the results came, the white blood cell count was still raised, and the ESR (another measure of inflammation) was significantly, and rather worryingly, at 90, when it should not be over 20 at most, according to Dr. Todd. However, almost as soon as Dr. Todd received these results, he also received the General Practitioner's request that he should see the pursuer urgently, the symptoms having recurred. Dr. Todd's evidence was that he was considerably concerned that, with the background of what he described as "this relentless progress in a downhill fashion" they had another potential relapse on their hands. On her actual readmission on 23 November, her white cell count had risen, the ESR was still at 86, and Dr. Todd's evidence was that his concern was "re-ignited considerably" at this stage, that the whole process had not been dealt with appropriately and that the pursuer was continuing to progress down this downward slope. In that context he felt that they needed to intervene with antibiotic therapy again. As we have indicated, we do not understand the rightness of this decision to be disputed.
[43] The question of negligence of course turns upon the actual decision to use Chloramphenicol, and the immediate circumstances surrounding that decision, although as we have emphasised, the overall background and history also seem to us to be of crucial importance. Before turning to the actual decision and its immediate circumstances, there are two matters which require comment.
[44] The first relates to the hospital notes. As we have said, they contain no record of the actual decision to use Chloramphenicol, or of the factors which were considered, for or against, in reaching that decision. More particularly, they contain no reference to Ciprofloxacin. And in Dr. Todd's note of 24 November, concerning the need for further consideration of Chloramphenicol, he says "Rx. if temp. rises". The submissions advanced on behalf of the pursuer relied upon what was to be found (and not found) in the notes, both broadly as indicating an absence of proper or adequate consideration of the benefits or disadvantages of using Chloramphenicol or any alternative, and more specifically as indicating that no real consideration had been given to Ciprofloxacin. Moreover, it was submitted that a rise in temperature was seen as the event which would justify the use of Chloramphenicol, and no significant rise had occurred before it was prescribed. On this last point, Dr. Todd explained that this particular part of the note was essentially for the benefit of anyone who might be on duty when such a rise in temperature occurred, who might not have been a part of the team dealing with the pursuer otherwise. We see no reason to read it as a restriction on his own freedom, and indeed duty, to consider what was best for the patient at any stage, whether the temperature had risen or not. And in relation to the broader issues, and the absence of reference to Ciprofloxacin, the question of what happened depends upon the evidence as a whole. It would no doubt have been useful for the purposes of the present proceedings if the notes had said more. But it is important to remember that the notes were not written for the purposes of these proceedings, and we are not persuaded that their silence as to what was taken into account is to be seen as casting doubt upon the oral evidence given in relation to these events.
[45] The second matter which requires mention, before we turn to the decision and its immediate circumstances, relates to the basis of the Lord Ordinary's decision upon negligence. It is at this stage that in our opinion the Lord Ordinary's explanation of his decision is not set out fully enough in his Opinion, making the matter one for us. His Lordship says that counsel for the pursuer in her submissions went far to persuade him that "since at the very least the pursuer was not likely to die say within 48 hours, a more cautious and reasonable approach would have been to return to the original drugs...which failing, to add or substitute Ciprofloxacin..." It could thus be argued that Dr. Todd went too far too quickly against a known risk. However, he says that he is persuaded that the pursuer had failed to establish that Dr. Todd's decision, "which in my view was taken in a very careful and measured way after weighing up all the possibilities..." should be regarded as negligent. Saying that there is no suggestion that Dr. Todd took the decision "in haste or without due consideration", his Lordship mentions that Chloramphenicol remained on the market and available for use, albeit with caution. He says that he is satisfied as a matter of credibility that Dr. Todd had a reasonable belief that the drug was likely to be effective, and that his decision "can be rationally and responsibly supported...whatever may have been his alternatives...". And referring to his finding that the drug probably worked (and accepting that the decision might have been negligent if there had been no prospect of its working) he says that the fact that it did work "put the drug in the potentially effective category" at the time the decision was taken. As was submitted on behalf of the pursuer Dr. Todd's decision might be negligent, even upon the hypothesis that Chloramphenicol was potentially effective, or even likely to be effective. If there were possible alternatives, with no side-effects comparable to those of Chloramphenicol, the justification for using Chloramphenicol depended upon a comparison with those alternatives, and could not be upheld as non-negligent "whatever may have been his alternatives". Moreover, while his Lordship had said that the decision could be rationally and responsibly supported "for the reasons I have given in respect of my findings in fact" the findings in fact did not reveal his Lordship's conclusions as to why Chloramphenicol could thus be preferred to Ciprofloxacin/Flagyl, even in extremis. On behalf of the defenders, it was not disputed that, on an analogy with what was said in Bolitho v. City and Hackney Health Authority, the decision of an individual consultant must, like that of any group within the profession, be capable of withstanding logical analysis, and be seen as reasonable and responsible. And it appears to us that the Lord Ordinary was in principle adopting this approach to the question. But as we have indicated, his Lordship's discussion of that matter, and in particular of the final decision and the events surrounding it, does not sufficiently reveal why he regarded the prescription of Chloramphenicol, and in particular the rejection of Ciprofloxacin as a safer alternative, as satisfying this test. It is for that reason that we find it necessary to reach our own conclusion upon these matters.
[46] Dr. Todd pointed out that there had been five courses of different antibiotic therapies which had not apparently influenced the underlying process. With a potentially dangerous situation on his hands he was not really prepared to wait around and see if the pursuer developed more symptoms. It was important to "step in and treat" because they were reaching a situation where her ongoing well-being was significantly at jeopardy. He had in mind the risk factors in prescribing Chloramphenicol, and made the prescription in the knowledge of these risks. It was a grave risk but statistically and medically a low risk. Chloramphenicol had "a very good broad spectrum of activity that I could rely upon" and he was confident "that it would cover, if I can use that term, the possible infective causes of her ongoing, underlying pathology".
[47] In relation to Ciprofloxacin, he acknowledged that it had "good penetration" and that in relation to intra-abdominal infections, it made a "good team" with Flagyl. He did consider Ciprofloxacin when they were thinking about her treatment on 25 November. But at that stage he was trying to determine "an antibiotic treatment that I could rely on". The problem with Ciprofloxacin was that "it was a relatively new antibiotic which had not the proven track record against these atypical organisms, particularly Rickettsia and Chlamydia, which we had discussed as possible causes for her problem." He was asked if, with Flagyl added, the likelihood was that the patient would have produced a good, positive response. It is useful to set out his reply in full:
"Well, I don't know if that's the case because, as I've explained on a number of occasions, this was a new antibiotic, it did not have the same spectrum of activity as Chloramphenicol, even in conjunction with Metronidazole, and I have to simply say to you that in balancing the potential of another - 'fruitless' is rather a strong term, but another incomplete response to antibiotic therapy. When we got to the end of November I was significantly impressed with Miss Duffy's clinical condition to make the decision to go for an antibiotic that I knew to the best of my ability would have the appropriate activity spectrum, I could rely on it to work, and I believe it did. I could not 100% rely on the other choices, and as you have seen she has gone, now at the beginning of November, for seven months with a relentless progression in, to my mind, the wrong direction. I believed this lady to be suffering from a life-threatening condition and I believed that further periods of time with antibiotics that may or may not improve the situation, was an unacceptable clinical option."
Later, in reply to a question from the court, he said this:
"Again the problem with Ciprofloxacin, my Lord, is that now, in 1998, I might be more inclined to use it because the evidence is building that it has effectiveness against Chlamydia, for example, and Rickettsia, but my contention - and I stick by this absolutely - is that in 1992, after five years of usage, its effectiveness against those rather unusual organisms, which I was always considering as potential pathogens in her case, was not confirmed from clinical experience, and I was not prepared to undertake a further course of treatment that I wasn't going to be able to absolutely rely upon and I weighed up the balance of the rare side-effect which we've talked about against what I considered to be a drug I could rely upon to be effective".
In answer to a further question he added "I narrowed it down to the drug that I thought was going to be most effective in her case and carried the least risk of subjecting her to another course of incomplete therapy." (There is thus by this time a stark contrast with the position as it had been at 30 October, when Dr. Todd had been "cautiously optimistic" that they might have managed to deal with the underlying problem by what he called "empirical antibiotic therapy": her readmission on 23 November was an "extreme disappointment".)
[48] In relation to his eventual decision to use Chloramphenicol, Dr. Todd had pointed out elsewhere in his evidence that he had considered Chloramphenicol as a potential treatment from the beginning of October. In writing the notes after the readmission on 23 November, he did not recount the whole of the pursuer's significant illness up to that point in time, or his concern for her ongoing difficult inflammatory process. When he advised using Chloramphenicol, they had had a lengthy discussion on the ward round about her condition and his concern about her. He was taking the whole clinical picture into consideration, and could not recall an individual item that triggered the prescription. While the decision was of course for Dr. Todd, it is to be noted that Dr. Baird said that all the indications for Chloramphenicol in the last few years had become narrower with the arrival of newer drugs for certain purposes. But he went on to say that "for the type of condition which we've been discussing, it seemed then - and I must reiterate, seems to me today - to have been a very excellent choice and one which would have been expected above almost any other antibiotic to work, if one was going to work. And I think my reaction at the time would certainly not have been one of horror. I would have said 'Great!', you know, 'now let's see if we can get on top of this.' The side-effects are, after all, extremely rare. And we were faced with what seemed to be a very serious condition." Dr. Maclay described the combination of the abscess in the centre and the granulomotous response round the outside as curious: it was a recognised pattern, but a very uncommon one. Dr. Todd had asked Dr. Baird and himself to come and discuss the case, and see whether there were any things that they had forgotten about or had been overlooked in the whole process of examining the case. Such a long sit-down case conference on a single case was a pretty unusual event. He thought Dr. Todd was worried that if he didn't come to an adequate, precise conclusion as to what it was, or treat adequately, the patient might well die. Dr. Todd's list was a list of the things which might give rise to the pattern of what had been found. But the message from the list and the discussion was that, although there were these other things which might provide one with a pattern similar to the one they had seen, there were various facts which made them less likely. That left one with not only those infective causes which were on the list, but infective causes for which one did not know what the organism was at all.
[49] At a factual level, it does not appear to us that the evidence of outside experts provides any basis for doubting the account given by Dr. Todd as to the considerations which he took into account, and the reasons for his decision to prescribe Chloramphenicol. Moreover, there is nothing in the factual evidence itself, or in the evidence of the expert witnesses, which leads us to differ from the Lord Ordinary's conclusion that Dr. Todd's decision was taken in a careful and measured way, after weighing up all the possibilities. Dr. Weir observed that textbooks tend to restrict themselves to defined situations, by their very nature, and that undiagnosed situations "really throw themselves back on the clinician's own instincts". The "instincts" in question would no doubt require to be explained, where negligence is alleged, upon the basis of the clinician's knowledge, understanding and experience, and to have led him to a rational and responsible conclusion. But in considering the factual evidence as to what Dr. Todd did and considered, and turning to the question of whether he was negligent, we think it is important to bear in mind that what one is considering is a conclusion reached by an experienced clinician in relation to a patient who has been in his charge for a significant period and whose problems had been much thought about and discussed, before the eventual decision was taken.
[50] If there had been a diagnosis, identifying a particular organism with sufficient certainty to allow others to be ignored, a competent and careful consultant might be able to make his choice between, say, two drugs simply upon the basis that one was known to be more effective than the other. But even in such a situation, the question, or one question, might relate not merely to the apparent efficacy of each drug, but to the degree of confidence which the consultant had in each, having regard to what was known about them from clinical or laboratory experience. And where, as in this case, there had been no diagnosis, so that there was uncertainty as to whether the actual organism was one which would be susceptible to either drug, the consultant would clearly have to consider not only the question of whether the actual organism was more likely to be susceptible to one of the drugs rather than the other, but also the rather different question of the basis, in clinical or laboratory experience, for feeling confident that either drug was likely to be effective. It is clear from Dr. Todd's narrative, which we see no reason to doubt in this respect, that he was concerned not merely with what each drug could perhaps or probably do, but with how sure he could be, on the basis of their differing track-records, of the efficacy of each. In principle, this approach appears to us to be entirely rational and responsible.
[51] Chloramphenicol and Ciprofloxacin obviously had different track records. Chloramphenicol was a drug which had been in use for a long period, so that knowledge as to its efficacy in dealing with particular organisms, or particular kinds of organism, was based not merely upon laboratory analysis but upon very wide clinical use, experience and assessment. Ciprofloxacin on the other hand, in 1992, was still technically a "new" drug. Its use was of course already widespread and in addition to having been recognised as an antibiotic with a wide spectrum, its efficacy against certain particular organisms was also known. But in 1992, the simple fact was that there was much less clinical experience of Ciprofloxacin than there was of Chloramphenicol. That was confirmed by other medical evidence, and in particular by Dr. Wellsby. That being so, and in the absence of any indication that Ciprofloxacin was positively more effective than Chloramphenicol in any respect, it would be understandable if a consultant took the view that the latter was to be preferred to the former, simply upon the basis that its longer clinical track record gave him more confidence in the prospects of success. More specifically, however, that would be the case in relation to the particular situation which faced Dr. Todd, with the unusual granulomatous condition, which required treatment at this stage upon the basis or hypothesis that it was caused by infection, and having regard to the unusual types of organism which were suspected as the cause. We see no element of irrationality or irresponsibility in Dr. Todd's view that Chloramphenicol was the preferable drug in terms of efficacy; and in that situation, the conscious decision to take the risk of the side-effect cannot be regarded as irrational or irresponsible, given the inherent risk posed by the infection itself if the drug which offered the more reliable prospect of success were not to be used.
[52] In these circumstances, apart from the evidence of Dr. Ellis, we see no basis upon which negligence could be alleged. As regards the evidence of Dr. Ellis, part of the problem is of course that he appears to differ from those who had the care of the pursuer, as to whether a further unsuccessful course of antibiotic treatment could reasonably be embarked upon, having regard to the risk of the pursuer dying. One must try to apply Dr. Ellis's opinion on the choice of Chloramphenicol to the life-threatening situation which Dr. Todd had (in our opinion rightly) identified. Dr. Ellis's view was, or was very close to, a view that even in that situation Ciprofloxacin was to be preferred to Chloramphenicol, not because it had a better prospect of efficacy but because it had at least an equal prospect of efficacy without the same risk of a grave side-effect. It may be that if he had been in Dr. Todd's shoes, as the person in clinical charge of the pursuer, Ciprofloxacin would have been chosen, and might have achieved the same results. But in generalising his own view, to the level of saying that it would have been the view of any competent consultant exercising reasonable care, we are not persuaded that Dr. Ellis was well-founded, either generally in the light of the other medical evidence, or having regard to what Dr. Todd himself did. Generally, it appears to us that the matter was one for the judgment of the clinician in charge, in difficult and uncertain circumstances which inevitably make the matter a difficult one to assess from outside and in retrospect. But more particularly, Dr. Todd's greater confidence in Chloramphenicol in relation to the pursuer's unusual symptoms and the type of organism which might cause such an infection, which was based on his clinical experience of both drugs, does not appear to us to be controverted, or to be revealed as irrational or irresponsible, by anything contained in the evidence of Dr. Ellis.
[53] In the whole circumstances we come to the same conclusion as the Lord Ordinary: negligence has not been established. The reclaiming motion is accordingly refused.