England and Wales Court of Appeal (Civil Division) Decisions

IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM QUEEN'S BENCH DIVISION
MR JUSTICE IRWIN
U20070036

		Royal Courts of Justice Strand, London, WC2A 2LL
		11/03/2008

Lord Justice Latham:

1. On the 21^st January 2001, the respondent gave birth to a healthy baby girl. The birth was by elective caesarean section under a spinal anaesthetic block in the first instance, although ultimately a general anaesthetic was required. Unhappily, the respondent thereafter developed chronic adhesive arachnoiditis, that is inflammation of tissues within the spine, with severe neurological and physical consequences. After a trial limited to the issue of liability, Mr Justice Irwin found that the arachnoiditis was caused by contamination of the spinal anaesthetic, bupivacaine, with a cleansing agent, chlorhexidine at some stage during the anaesthetic procedure. He concluded that that could only have been the result of liquid to liquid contact between chlorhexidine, and the bupivacaine when in the syringe and needle prepared for delivery of the anaesthetic. And that could only have happened if there had been a breach of duty on part of the one or other of the two clinicians involved in the procedure. The appellant, their employer, appeals to this court on the grounds, essentially, that those findings were not open to the judge on the evidence.
2. The respondent was 40 years of age at the time. She and her partner had been living together for over ten years. Their first child unhappily died shortly after birth. Their second child was delivered by elective caesarean section in December 1992. The respondent underwent a spinal anaesthetic for that procedure, which was apparently straightforward. On the occasion with which we are concerned, however, it is common ground that it was not. For various reasons, although she had undergone the same procedure before, the respondent was anxious. She was not, however, in anyway an exceptionally nervous patient. Indeed she was described throughout as a level headed and sensible woman. She described the procedure as causing her considerable pain which was confirmed by her partner who was present. The judge found that that was because there were "multiple attempts" which were unsuccessful to insert the anaesthetic in the space between L2 and L3 in the spine before ultimately a successful attempt at the L3/4 level. The judge concluded that the result was that the "atmosphere was rather flurried" and, having described the necessary consequence of those failed attempts, concluded:

"I find that these conditions were conducive to something going wrong. On their own they establish nothing, but such a sequence of events does open up at least some possibility of error. In truth no one can recreate the precise sequence of events, whether there was a spillage here or there, whether one or other syringe was touching cleaning fluid, whether a syringe was dropped, whether a needle was in or out of the patient at any given point in the sequence or whether there was a jog of the trolley such as Mr Redfern QC for the claimants did suggest. Such detailed findings would be an over determination."

3. The evidence of the anaesthetist Dr Howard, as to her normal procedure when delivering spinal anaesthetic was as follows. Firstly the needles and syringes would be prepared. A syringe would be filled with lignocaine, or some other local anaesthetic and a fine needle attached. An introducer needle, which is inserted so as to be positioned immediately outside the spinal space into which the spinal anaesthetic is to be inserted, would then be prepared. Finally the syringe which would deliver the spinal anaesthetic would be filled and the appropriate needle attached. This needle would ultimately be inserted through the introducer needle, then through the heavy ligament protecting the spinal canal and into the cerebro-spinal fluid surrounding the spinal cord. Each of the syringes would have been filled from the relevant ampoule through a filtering needle before the needle used for the injection itself was placed on the syringe. The syringes would in turn have been placed on their wrappers on the trolley. All these steps would have been carried out by Dr Howard and checked by Mr Lindsay, an operating department practitioner who was assisting her.
4. Iodine and chlorhexidine, would be poured out from appropriate containers into depressions in a tray. The patients back would then be swabbed with iodine and then chlorhexidine. Although it is not entirely clear, it would appear that Mr Lindsay would then have placed the tray on the bottom shelf of the trolley. Once the cleansing agent had dried the anaesthetic procedure would begin. No criticism is made of the routine adopted by Dr Howard, who was described by the judge as "a highly experienced, conscientious senior consultant, who was a clear witness and ….. doing her best to help the court in the evidence she gave."
5. In her evidence, Dr Howard accepted that she had some memory of the events of the 21^st January 2001, although the judge found, perhaps not surprisingly, that her memory was not as detailed as that of the respondent and the respondent's partner. She remembered that there had been more than one attempt to place the introducer needle because of pain. She did not consider that there had been more than two attempts before the final successful placing of that needle. As far as she was concerned, nothing untoward had happened, apart from that, during the course of the procedure. She believed that once she had cleaned the respondent's back, the tray containing the iodine and the chlorhexidine would have been "put away" either by being placed on the bottom shelf of the trolley or elsewhere. Mr Lindsay also stated that the tray had been "put away". The judge was not, however, entirely happy with the way in which the evidence was given in this respect and said as follows in his judgment at paragraph 31:

"Next I find that I cannot be confident that the tray with the cleaning materials on this occasion was put in fact on the lower layer of the trolley or otherwise put right away. Undoubtedly, that was the usual practice on the part of Dr Howard and Mr Lindsay but it is not in the witness statements, and was not dealt with fully before they came to give their evidence at court and there was at least some degree of hesitancy on the part of Mr Lindsay about the evidence on this key point, although that may derive entirely (and certainly derived to some degree) from his anxiety about giving evidence."

6. For the purposes of this appeal, the appellants do not dispute that the cause of the arachnoiditis was some contamination of the spinal anaesthetic with chlorhexidine. There was before the court an agreed report from Dr Nelson of the Department of Neuroradiology in the General Infirmary at Leeds. His conclusion was as follows:

"In summary, it is my opinion on the balance of probabilities that the meningitic reaction, arachnoiditis and subsequent neurological injuries suffered by Angelique Sutcliffe after the spinal anaesthesia on the 22 January 2001 were not the consequence of any co-incidental idiopathic pathology, were not the consequence of any idiosyncratic response to the procedure normally performed or medications appropriately to be given and were not the consequence of the leakage of blood into the subarachnoid space or the inadvertent injection of infection into the subarachnoid space, but more likely were the consequence of some chemical contamination of the spinal anaesthesia either with some cleansing agent or with some medication inappropriately administered."

7. Two expert witnesses were called orally at the trial. Professor Pollard, the Professor of Anaesthesia at the Manchester Royal Infirmary was instructed by the respondent. Dr Gordon Lyons, Consultant in Obstetric Anaesthesia at St James University Hospital in Leeds was called by the appellants. In addition to their written reports, the court was provided with a document setting out the results of a meeting between them in July 2006. This is essentially a series of questions and agreed answers. The relevant ones are as follows:

"3. On the balance of probabilities was the injection of spinal anaesthetic: -

(a) the most likely precipitating event for the claimants arachnoiditis

(b) The cause of the claimants arachnoiditis?

Answer: Yes, we believe so.

…….

5. Was there potential for the use of the wrong drug or solution being injected during the course of the spinal anaesthetic and, if so, when and at what stage?

…………

(b) The evidence or inference which suggests thIS drug or solution was injected:

Answer: The development of arachnoiditis.

(c) Whether on the balance of probabilities is this drug or solution caused the claimant's arachnoditis.

Answer: Something which was injected caused the arachnoditis.

6. Was there potential for contamination during the course of the spinal anaesthetic, and if so, when and at what stage?

Answer: Yes we believe that there was.

If so, please indicate:

(a) The nature of the contamination and when during the course of the procedure it could have occurred;

(b) Answer: …. The sources of contamination on the tray that we can recognise are the chlorhexidine and iodine solutions or additional substances unknown. The contamination must have occurred while Dr Howard was preparing her equipment or whilst she was attempting the procedure.

(b) The evidence or inference which suggests that such contamination occurred:

Answer: the development of archnoditis.

(c) Whether, on the balance of probabilities, such contamination did occur.

Answer: We are unable to answer this question.

…..

8. On the balance of probabilities;

(a) Did something go wrong with this obstetric and anaesthetic procedure resulting in the claimant suffering arachnoiditis and, if so, describe the most likely sequence of events;

Answer: The occurrence of the arachnoiditis is the only evidence we have.

(b) Is the outcome inconsistent with the exercise of proper care?

Answer: Contamination can occur without the practitioner being aware despite otherwise exercising proper care. It is standard practice in many units to have open pots of cleaning solution on the tray."

8. Professor Pollard's report was essentially to the effect that there must have been contamination, but that he was unable to give any further particulars. Before he gave evidence, however, he carried out an experiment to see what happened if a syringe full of bupivacaine could have become contaminated with chlorhexidine if it came into contact with a quantity of chlorhexidine. Using a sugar mixture to simulate the bupivacaine, he placed a filled syringe into a jar containing 4mm of chlorhexidine. He also repeated the experiment with only a thin layer of chlorhexidine, as he described it, "just a drop". He found that there was liquid exchange between the chlorhexidine and the sugar solution within the syringe, even against gravity. Those experiments were carried out with a syringe which did not have a needle attached. He was cross-examined in particular to suggest that for this to have occurred there would have had to have been some gross clumsiness such as dropping a syringe into the bowl of chlorhexidine in the tray or some substantial spillage which would have been clearly apparent to Dr Howard and Mr Lindsay at the time. It was also pointed out that he did not carry out the experiments with a needle attached to the syringe. He was therefore asked by both counsel to see if he could repeat the experiment using a needle. He returned the next day to give the results of those experiments. He described how, provided that there was no air lock within the needle, liquid to liquid transfer took place. It was apparent to the judge that the consequence of these experiments may well have altered Professor Pollards' view as to causation, and asked him a number of questions, the relevant passage being as follows:

"Q. Now you've have told me that having listened to the evidence your view is that the most likely contaminant if there was contamination was chlorhexidine.

A. That is correct, My Lord.

Q. And I fully understand that. You've also told me that if there was such contamination it was in your view – could only have arisen through a breach of duty effectively?

A. I believe so My Lord.

Q. What I want you to do, please, is in the light of all the evidence to revisit the answer you gave with your colleague to 6(c.), you will remember that you were cross-examined about this by Mr Feeny?

A. Yes.

Q. And you gave three reasons why you were unable to say at that stage whether such contamination did occur, probably. Having heard the evidence do you change that answer?

A. Yes, I do believe that I do change that answer, on the balance of probabilities the most likely explanation would be that there was contamination, My Lord.

Q. It is important that you understand, of course, the significance of that ……

A. I do. Yes

B. .…. You are now giving an opinion which you didn't feel able to give then?

A. Yes, . Yes ,that's correct, I do understand that My Lord."

9. The evidence of Dr Lyons was to the effect that it was not possible with any degree of probability to determine how the arachnoiditis had occurred. Contamination by chlorhexidine was possible. But he did not consider that any of the evidence that he had heard suggested that there had been any fault on the part of Dr Howard or Mr Lindsay. He considered that there was clearly the possibility of contamination particularly contamination by minute quantities or smears, but that would not have caused the respondent's condition. He considered that in order for it to have had that effect there would have had to have been contamination by what he described as "a measurable quantity", which could start at 0.1 of a ml. There was no evidence in any literature that arachnoiditis was a recognised complication of a frequently performed procedure. Approximately 80,000 such spinal procedures were carried out per annum in the United Kingdom alone. For that the reason he discounted the possibility that the arachnoiditis was caused by a very small quantity of contaminant. There was however, clear evidence from the literature that a significant quantity of chlorhexidine could cause arachnoiditis.
10. In the light of all that evidence, both factual and expert, the judge made a number of significant findings, some of which I have already referred to. He concluded that the literature supported the conclusion that contamination was the overwhelmingly likely cause of the respondent's condition and the literature demonstrated that contamination by chlorhexidine could cause exactly this kind of outcome. He accepted Professor Pollard's evidence in relation to liquid to liquid transfer. He reminded himself of the fact that the procedure had not gone normally and had resulted in the syringe and needle containing bupivicane remaining exposed on the trolley for much longer than was normal. He considered the judgment of Brooke LJ in Radcliff –v- Plymouth and Torbay Hospital and Another [1998] Lloyds Law Reports Medical 162 and Delaney –v- Southmead Health Authority (1995) 6MLR 355. He concluded that res ipsa loquitur was not open to him "as the easy answer" in complex cases such as this. He expressed his conclusions as follows:

"So, having considered this matter rather anxiously but in the end with clear conclusions, I make the following findings relevant to liability: I am satisfied on the evidence, both factual and expert evidence, that there probably was contamination of the spinal injectate. There remain possibilities of malicious contamination or idiosyncratic reaction but on the facts of this case these possibilities are vanishingly remote and unlikely in the extreme. Next I find that the contamination was more likely than not to be chlorhexidine. Whatever contamination was mixed with the injectate it was in measurable quantities. This proposition that this outcome arose from tiny smear quantities can be excluded by the numbers of people who must have had such smear quantities injected into them. Next, I find that it is likely that contamination arose from some instance of liquid to liquid contact between the injectate that reached the sub-arachnoid space, which was probably bupivacaine, but possibly lidocaine and the contaminant. Next, I find that liquid to liquid contact should not have happened and that procedures which these high quality and responsible clinicians adopted were designed specifically to avoid such contamination. That is the point of those procedures. I therefore find that this conscientious clinician and this conscientious ODP, who were truthful and normally operated to a very high standard, on this occasion permitted some breach of procedures that allowed the contamination to take place. In summary, there is a probability that contamination through a lapse or breach of duty, which I cannot further specify, permitted liquid to liquid contact, the injectate was contaminated and the damage sustained as a result. Hence, there will be judgment for the claimant"

11. Mr Feeny, who has appeared for the appellants before us as he did before the judge, submits that the judge could not properly come to that conclusion on the facts. And, he submits, the judge's difficulty in identifying precisely what breach of duty occurred makes his point. He submits that when the evidence of Professor Pollard is analysed, it is apparent that the only mechanism which could have resulted in liquid to liquid contact of sufficient seriousness to produce contaminant in damaging quantity, namely substantial spillage, or indeed dropping the syringe and needle into the chlorhexidine depression in the tray could not be squared with his assessment of Dr Howard and Mr Lindsay. He submits that in view of the answers which Professor Pollard gave, in agreement with Dr Lyons, to the questions set out in paragraph 7 above, the findings of the judge cannot be supported. In essence, he submits, whilst properly warning himself that res ipsa loquitur could not, on the facts of this case, be used as a solution of the case, that is what the judge did.
12. The difficulty for Mr Feeny is that, although he does not expressly say so in his judgment, the judge clearly based his findings on the answers that Professor Pollard gave to the judge's own questions which I have set out at paragraph 9 above. That was evidence that the judge was entitled to accept even though it was clearly different from the views Professor Pollard had expressed before the trial. There is no reason to believe that the judge was not fully aware of the fact that the consequence ascribed significant fault to Dr Howard and Mr Lindsay despite his view of their general competence. Indeed he expressly said so.
13. There is, in my judgment, no basis upon which this court could interfere with the findings of fact which support the judge's conclusion. I would dismiss this appeal.

LONGMORE LJ: I agree.

BUXTON LJ: I also agree.