Ndri v Moorfields Eye Hospital NHS Trust

Mrs Idugu Ndri is a Turkish citizen, now back living in Turkey, and in August 2001 she was a patient at the Moorfields Eye Hospital, where she had a cornea graft to the right eye taken from a dead donor who was a 61 year old man, who had died in a hospice from stomach cancer. The tissue was infected with the bacteria Pseudomanas aeruginosa, and as a result she developed Endophthalmitis and lost the sight of the eye. This was a very rare, but known risk of cornea transplant surgery.

She now claims against the hospital both in negligence and for breach of the statutory duty, said to be imposed by the Controlled Substances Hazardous to Health Regulations 1999. She was a patient of Mr Dart, a consultant ophthalmic surgeon, and the operation is known as a right penetrating curtoplasti(?), and was performed in Mr Dart’s absence on leave by Miss Watson. No allegation of negligence in the conduct of the operation is made.

Tests were performed, and there is no doubt in this case that the infection came from the donor graft. Sadly, another patient who had a cornea graft from the donor’s other eye was similarly infected.

The process for making the cornea available for transplant is not in dispute. Firstly, the whole eye globe was removed from the body of the donor by a specialist technician. That is eneucliation. Then the eye was suspended in a container, in which there was a swab soaked in a sterile saline solution. Then the donor tissue was then transported to the Moorfields Eye Bank in a polystyrene container, with an ice or cold freezer pack. At the Eye Bank the eye was placed in a gallipot containing sulphermycin -- otherwise known as Framycetin -- to soak for three minutes, and that was the decontamination process. The Framycetin was then rinsed off with a normal saline solution, and then the corneas were removed and placed in a storage container, which contained an Optisol GS solution of Dextram and Condroitin Sulphate, Gentamycin and Streptomycin and was then kept at around 4 degrees Centigrade until it was needed.

The claimant’s central allegation is that the cornea tissue was decontaminated with antibiotics only -- that is the Framycetin -- when the practice at the time in all the other United Kingdom Eye Banks was to use the Antiseptic Povidone-Iodine, and which I will refer to as PI.

The claimant’s case is that, had PI been used the bacteria would have been killed. Her eye would not have become infected, and she would not have lost the sight in that eye.

In summary, the defence is that in 2001, what Moorfields Eye Bank did was one of a number of alternative and acceptable practices to be found in Europe, and in the United States of America. And on causation would not have prevented the infection. The defendants say the regulations were aimed at protecting employees and others from exposure to harmful substances in the work place, and have no application in the circumstances here.

The claimant’s case also, is that no or no sufficient risk assessment was made. Mr Whitfield, Queen’s Counsel, for the claimant relies on the hospital’s response to Mrs Ndri’s tragic loss of an eye. The director of the Moorfield’s Eye Bank was Dr Sybil Ritten, who wrote to Mr Dart shortly after Mrs Ndri’s operation suggesting a revaluation of the decontamination procedure, stating that:

“Most other eye banks use Povidone Iodine.”

In fact, PI was added to the Moorfields decontamination process in October 2001with 0.5 per cent PI being added to the .50 per cent of Framycetin.

Mr Whitfield also relies on answers given to him in cross-examination by Dr Britton. The Moorfields Eye Hospital should have conducted an audit into the efficiency of their decontamination procedure, some time between the formation of the Eye Bank in 1986 and 2001. If that had been done the probability was that they would have added PI to their procedures before 2001. Dr Britton also pointed out, however, that for 15 years they had used the antibiotic solution, and there had been no instances of infected Endophthalmitis.

The evidence shows considerable variation in the practice in the decontamination and storage of eye globes. Moorfields Eye Hospital was the only United Kingdom Eye Bank using antibiotics in 2001, and the other five United Kingdom Eye Banks: Bristol; Manchester; Norwich; East Grinstead and St George’s London, used PI in different solutions and for different times. However, in Europe about 25 per cent of the Eye Banks, 50 per cent if analysed on a country basis, where the enucleation procedure was used, did not use PI, and employed different methods, principally antibiotics and saline, or a sterile saline solution. In the United States of America where between 30,000 and 40,000 cornea graft operations were performed annually, most Banks did not use PI. It was not a question of resources in America or the United Kingdom where PI was, and is inexpensive and readily available. There is no evidence as to that in Europe. Of these American transplant operations only in 0.1 per cent were there cases of Endophthalmitis. Moorfields Eye Bank were members of the European Eye Bank association, as were all the United Kingdom Eye Banks, and Moorfields were also members of the American Eye Bank Association.

With that background I come to the expert evidence. The expert for the claimant was Professor Charles Goodwin, an honorary Professor in microbiology and an honorary consultant in microbiology. He has no experience of transplant surgery, and has not worked in a hospital where transplant surgery of any kind was carried on. He was visiting professor at St George’s Hospital, but was unaware that that hospital had an eye bank. His specialist fields are all types of infection, MRSA and anti-microbial therapy.

In his report he proceeded on the basis that Pseudomanas in this case existed externally. It is a species of negative bacteria found widely in moist areas such as taps and sinks. These bacteria are also able to form a bio-film on any surface which can serve to protect these organisms. His view, in his report was that it had been known for many years that the bio-film can protect Pseudomanas from the penetration of mild antibacterial agents such as antibiotics, even where, as in this case, the strain had been shown to be sensitive to antibiotics in the laboratory. However, an antiseptic such as PI will penetrate the bio-film and kill the bacteria. His report continues with this comment:

“The decontamination procedure after collection of a corneal graft must include an anti-bacterial agent that is able to kill Pseudomonas, even where a biofilm was present. It has been known for many years [at least since 1993] that PI was much more effective than antibiotics for this process, as it can penetrate a biofilm.”

He cites as evidence of this, an American paper in 1993 which referred to work done between 1983 and 1989 in Minnesota, and that is conveniently referred to as the Mindrop paper on better decontamination of donor globes, and that is taken from Cornea, a United States publication.

He next referred to a 1998 paper by Gopinathan and others, also published in Cornea, and reporting on work done in India on the antimicrobial effect of PI and Gentamycin in the decontamination of human globes. The conclusion was that PI was a better decontaminant choice than the antibiotics so far as virus and fungi were concerned; however, the authors recognised that their figures for Pseudomanas did not reach statistical significance. Professor Goodwin, however, relied substantially on this paper, and on Dutch research published in the United Kingdom, which is referred to as the Pells Report.

All this led him to give, in his opinion, that the Moorfields Eye Banks inadequate decontamination procedures up to 2001 meant that a tragedy was waiting to happen, because when a more resistant organism such a Pseudomanas, as a contaminant, the absence of PI in their decontamination procedure would result in untreatable Endophthalmitis.

In paragraph 3.11 of his report he answered the question that was posed to him:

“Do you consider there was a negligent failure to avoid the possibility of infection from the donated tissue?”

And his answer was:

“In view of the many reports since 1993 that Povidone-Iodine is much superior to antibiotics for decontamination for donor eyes, I regard the decontamination procedure in MEH in July 2001 to be below the reasonable standard to be expected of an institution such as MEH. Therefore there was a negligent failure to avoid the possibility of P aeruginosa infection from donated tissue of Mrs Ndri.”

In paragraph 4.3 he summarised his evidence in this regard:

“P aeruginosa is widely found in any moist area and is able to form a biofilm, which protects these bacteria from the penetrating action of antibiotics, but not povidone-Iodine. Since 1993 there have been numerous reports of the superiority of povidone-Iodine over antibiotics for the decontamination of donor eyes, and all other Eye Banks in England use povidone-Iodine. By 2001, MEH had not updated their decontamination procedure for donor eyes with povidone-Iodine to ensure that all bacteria, including P aeruginosa were killed off before the operation of keratoplasty. My conclusion is that the decontamination procedure in MEH in July 2001 was below the reasonable standard to be expected of an institute such as MEH.”

By the time of the joint telephone meeting some two weeks ago, he had changed his view and agreed with the other experts that the presence of a bio-film could be excluded. On the first day of this hearing he produced a supplementary report. In that, and in his evidence, he adhered to his view that the Pseudomanas was external. It was, he said, in mucoid form, and planktonic, that is, un-aggregated. If Povidone-Iodine was used, it probably would have killed all the planktonic Pseudomanas. Equally, along with the defence experts, he said that Povidone-Iodine would be ineffective to deal with internal Pseudomanas.

The first witness for the defendant was Professor Kate Gould. She is Professor of microbiology at Newcastle University, and has very considerable experience of organ transplants, specialising in heart and lung. She has been involved with committees on organ banks and their regulation.

Her report was in these terms:

“When the cornea is transplanted the recipient is given antibiotics to try to prevent any bacteria present causing any infection. Pseudomanas aeruginosa has PPI environmental bacteria, which are characteristically resistant to many anti-bacterial agents, and so tend to cause infections in patients who have already received many courses of antibiotics. They are all also resistant to some antiseptic agents. The agents used for disinfecting eyes prior corneal banking can be either antibiotics such as Framycetin, or Gentamycin, or disinfectants such as Povidone-Iodine. Both strategies have advantages and disadvantages. If antibiotics are used some colonising bacteria may be resistant to them, and the persistence of bacteria may occur. Antiseptics have a broader spectrum of antimicrobial activity, but most are deactivated by contact with organic material, and the Iodine can potentially cause staining.”

I interpose there to say, it is now common ground that there is no indication that Povidone-Iodine can cause staining and damage to the cells of the cornea.

“Thus, there is no consensus as to which approach is more effective. I have reviewed the protocols published by Moorfields Eye Hospital for Corneal Banking, and in my opinion they were entirely satisfactory. They took appropriate steps to disinfect the donor’s eyes by using solutions containing antibiotics, Framycetin, which is moderately active against Pseudomanas, MICH infection, and even that, serious enough to lose function in the eye is a recognised complication of corneal grafting. In my opinion Moorfields Eye Bank took appropriate steps to minimise the risk of donor acquired infection.”

She stressed in evidence that the dosage of Framycetin, .5 per cent, was a very, very heavy dose, and would not conceivably be used on a living human being.

She was asked whether she agreed with that passage of Professor Goodwin’s report that I have just referred to, and she disagreed. She said in 2001 there were a variety of different and acceptable methods of decontamination, and so far as Endophthalmitis being untreatable, she said it could be treated by drugs and surgery, although not always successfully. She said of Professor Goodwin’s revised theories in his second statement, she was very familiar with mucoid and non-mucoid strains of Pseudomanas. It was very unlikely that you would come across a mucoid of Pseudomanas, except in the lung. It was very unlikely that it was here a mucoid strain; a non-mucoid strain was the most frequently encountered. She did not think it relevant whether it was planktonic or not.

On the question of contamination of the cornea being external or internal, she said it was impossible to say here, which it was. It was a credible scenario with a man who had died of stomach cancer, that Pseudomanas in the gut could travel into and through the airways and into the eye, but that was only a possibility.

She was taken through the literature, Mindrop, Gopinatham and Pells. She agreed that Povidone-Iodine was effective in a relatively broad spectrum of microbes, but not entirely certain. In her second statement she said this, having been shown the result of the microbiology test on samples of fluid taken from Mrs Ndri, which showed her sensitivity to Neomycin, which is very similar to Framycetin and Gentamycin, she said this:

“Most studies suggest that the use of Povidone iodine reduces the rate of contamination prior to storage, to 35 per cent at best.”

And she quoted from the Pells’ Report.

“In Mrs Ndri’s case, the infected organism (Pseudomanas) was sensitive to both the agents used during the cleaning and storage of the graft prior to use. The fact that Pseudomanas persisted despite this regimen would suggest that the donor eye was very heavily contaminated.

Therefore it is, in my opinion because the Pseudomanas was sensitive to the antibiotics used by Moorfields Eye Bank in the decontamination process, even if the eye had been decontaminated with Povidone iodine, the outcome would have been the same.”

Of the Gopinatham paper she said it was of no statistical importance. It was the only paper which compared antibiotics with antiseptics, and she said:

“One paper does not mean that you alter your opinion as to the proper practice.”

The bottom line of her evidence was that, it was not mandatory in 2001 for a hospital or eye bank to use as part of the decontamination process Povidone iodine before a corneal graft, nor was it an unacceptable practice in 2001 for them to use Framycetin, Gentamycin and Streptomycin as part of that decontamination procedure. Lastly, she was taken very briefly to the regulations, with which she said she was very familiar, and she had never come across a case where it was asserted that they involved patients in hospital.

The other witness for the defendants was Professor Harminder Dua, Professor of Ophthalmology at Nottingham University, and head of the cornea transplant unit at the Queen’s Medical Centre, Nottingham for the last ten years. He had been a corneal transplant surgeon for 15 years, and a surgeon for 30 years, and he was on a committee which recommended standard operating procedures for corneal transplant surgery, as well as many other relevant committees.

He referred to the UK practice, and the European and American practice, and it is helpful if at this point I refer to the European Eye Bank Directory for 2001, which contains a passage on decontamination and sterility control in these terms:

“Decontamination before eneucliation was performed by 37 banks using different methods: rinsing with saline; Povidone-Iodine; antibiotics; Povidone iodine and antibiotics or ethanol”.

There is then a reference to cornea sterile incision, which is not relevant and it continues:

“In most cases with PVP Iodine, concentrations varying from 0.5 per cent to 10 per cent, sometimes antibiotics, sometimes a combination of both were used. Before the excision of the cornea sterile button in the eye bank the bulbs were decontaminated by rinsing with either tap water, or sterile saline, or immersion with PVP Iodine 0.2 to 5 per cent, antibiotics, or a combination, sometimes preceded by running tap water, or running sterile saline.”

He then continued:

“There are a large number of eye banks world wide, and although the general principles of eye banking are the same and applied across the world, many individual variations exist. The practice followed by Moorfields Eye Bank, that of cold storage in Optisol GS is not unique and is the practice of some banks in Europe, and almost all across North America where approximately 30 to 40 thousand corneal transplants are performed annually.”

In his answers to the questions at the joint experts’ discussion, he was in complete agreement with Professor Gould. It was not mandatory in 2001 to use Povidone-Iodine, nor was it unacceptable for Moorfields to use Framycetin, Gentamycin and Streptomycin.

In evidence he went further. Although his medical centre takes, and took in, in 2001, globes from Bristol and Manchester, which used Povidone-Iodine, he would have been happy to accept material from Moorfields, which did not use Povidone-Iodine, or from any bank, which now did not use Povidone-Iodine. The Moorfields Eye Bank protocol in 2001 was a perfectly acceptable protocol. It had served them well with no Endopthalmitis incidents in the 15 years before this. There was, he said, no evidence in the papers looked at to make them change their procedure. Their change in October 2001 to the use of Povidone-Iodine was a reaction without evidence. He was taken through these papers in cross-examination and his view was that they were not sufficient to provide evidence to justify change. He would not criticise Moorfields Eye Bank for including Povidone-Iodine in its processes, nor would he criticise them for not including it.

On causation he reviewed the papers we have all looked at, and gave his view that on the balance of probability it was unlikely that the use of Povidone-Iodine would have prevented the post-operative infection. Internal contamination was a real possibility. There was no evidence it came from outside. It was a real possibility, or even a probability that it came from the gut. If so, Povidone-Iodine would be of no effect. He described the same route talked of by Professor Gould to explain how Pseudomanas could move from the gut of a dying cancer patient to the eye. He too was carefully taken in cross-examination through the papers and said that they did not amount to sufficient evidence.

The law is not really in dispute. Both counsel referred to the case of Bolam v. Friern Hospital Management Committee [1957] 1WLR 52, where in his directions to the jury McNair J said this:

“I, myself, would prefer to put it this way, that he is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men, skilled in that particular art. ... Putting it that other way round, a man is not negligent, if he is acting in accordance with such a practice merely because there is a body of opinion which would take a contrary view.”

That direction was, in view of the law, was specifically approved in the case of Bolitho v. City of Hackney Health Authority,[1998] AC p232, and I read only one passage from that at page 243 Lord Brown-Wilkinson, who gave his speech of the judgment of the House in this case, he said this, having been referred to the relevant authorities:

“These decisions demonstrate that in cases of diagnosis and treatment there are cases where, despite a body of professional opinion sanctioning a defendant’s conduct, a defendant can properly be held liable for negligence. (I am not here considering questions of disclosure of risk). In my judgment that is because in some cases, it cannot be demonstrated to the judge’s satisfaction that the body of opinion relied upon is reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion. In particular where there are questions of assessment of the relative risks and benefits of adopting a particular medical practice, a reasonable view necessarily presupposes that the relative risks and benefits have been weighed by the experts in forming their opinions. But if, in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible.

I emphasise that in my view it will very seldom be right for a judge to reach a conclusion that views genuinely held by competent medical experts are unreasonable. The assessment of medical risks and benefits is a matter of clinical judgment which a judge would not normally be able to make without expert evidence.”

This, of course, does not mean that a doctor or hospital must follow what is preferred, or good practice. A hospital or doctor will only be negligent if they fail to follow what is reasonable and acceptable.

I have in connection with whether the practice is solely that in the United Kingdom been shown an unapproved version of Ebsworth J’s judgment in the Breast Radiation Cases, and Miss Mishcon for the defendants raised no objection to my seeing a judgment in that form, and I have read it and found Ebsworth J’s very clear exposition of the law helpful, but it is not necessary for me to make any citation from it.

I accept Miss Mishcon’s approach. The standard of care to be applied is the acceptable standard of care in an eye bank within the United Kingdom of similar standing to the Moorfields Eye Hospital. Because there are so few eye banks in the United Kingdom, it is permissible to look elsewhere, and I observe that the claimant relies on papers published on research in the United States, India and Holland.

Moorfields Eye Hospital was, in my judgment, on the whole of the evidence, using an acceptable decontamination process, which had been used since 1986 without any previous case of post-corneal transplant Endophthalmitis. It is a process used in 2001 and today, and ten out of twenty European countries, and 25 per cent of European centres and across the whole of the United States. Widely different decontamination processes are reported without adverse comment in the European Eye Bank Directory. I think all the eye banks in the United Kingdom, I think with the exception of Norwich, are members of this Association.

I accept Miss Mishcon’s submission that the duty of care was to formulate and follow and acceptable standard of operation, not just to do what the other United Kingdom Eye Banks do. In any event, they do not follow a uniform practice of time or strength of solution.

While the defendant’s witnesses accept that by 2001 Povidone iodine had been shown to be very effective against a wide range of organisms, there is no sufficient proof of effectiveness against Pseudomanas. Professor Goodwin’s report contains this statement, which I have already referred to:

“In view of the many reports since 1993 that povidone iodine is much superior to antibiotics for decontamination of donor eyes.”

A view which predicated his whole opinion that is, in my view, a misrepresentation of the few reports that deal with the subject, and brings me to my assessment of the experts.

I regret that I have to say that, I do not regard Professor Goodwin as a reliable expert witness. He expresses dogmatic views outwith his experience, and bases his reasoning on a number of papers, which I have been meticulously been taken through. He has overstated their effect, and couched parts of his report in an emotive and forensically inspired terms. For example:

“A tragedy waiting to happen.”

An example of his acting outside his experience comes from his references to the practice in Europe, which he regarded in sweeping terms as most of Europe, he had not taken into account until he spoke to his fellow experts, that where the French centres are reported and give data, they are dealing with in-situ excision, and that must be discounted. He had, between his first and second report, almost with out explanation, changed his whole approach, abandoning the bio-film, and substituting mucoid planktonic bacteria. It was a fundamental shift, and he prefaced his evidence by the production of a new statement explaining all this.

Before he was cross-examined by Miss Mishcon over Judge McDuff’s criticisms of him, I had, I regret to say, already formed an unfavourable view of this witness. Judge McDuff’s criticism came in a case that was tried in May of this year, and he said this:

“I have reached the firm conclusion that I prefer the evidence of Professor French. I found him to be a balanced and non-partisan witness. I regret to say I found Professor Goodwin to be, in some ways, an unsatisfactory witness. His evidence, in some respects, lacked objectivity and he appeared to see his role, in part, as an advocate for the Claimant. I have already mentioned that his evidence was not always consistent with what he said before.”

He was asked about this in cross-examination, and he said that the criticism was justified in part, but in his mitigation he said he had been let down by counsel. Those remarks by Judge McDuff are, I think, apt here. I infinitely prefer the evidence of Professor Gould and Professor Dua. They were balanced, fair and consistent, and above all, giving evidence in a field of which they have great experience. I thought them to be among the most impressive medical witnesses I have heard. In Bolitho terms it cannot begin to be said that their professional opinion was incapable of withstanding logical analysis. I therefore reject Professor Goodwin’s evidence, and accept theirs.

Not only does that impact on my view of liability, but also causation. For the claimant to succeed on causation it has to be proved on the balance of probability that the Povidone-Iodine would have eradicated the Pseudomanas (inaudible). It could only do that if the Pseudomanas was on the surface of the cornea. Therefore, it follows that the claimant had to prove that it was on the balance of the probabilities. That is indeed the thrust of Professor Goodwin’s evidence. I do not accept that evidence. I look at Professor Gould first. She said it was impossible to say whether it was external or internal, but put forward the credible scenario I have referred to, and Professor Dua’s(?) evidence was in similar terms. She could not say whether it was internal or external. In those circumstances the claimant, if successful on liability, could not show that the Pseudomanas was external.

Lastly, I should mention the answers obtained in cross-examination by Mr Whitfield from Dr Britton, which he says puts an end to the defendant’s case on liability. Those answers are I remind myself that, good practice required that there be an audit made of the Moorfields decontamination process before 2001, and if it had been carried out, it would probably have resulted in the introduction of Povidone-Iodine before 2001. That is, I think, a classic assertion in hindsight, and leaves open whether if, no case of Endophthalmitis had occurred, whether the 15 year period free of such infection would have been taken into account. Both Professor Gould and Professor Dua say that it was not a requirement of good practice in 2001, and Moorfields procedure was perfectly acceptable. I accept that evidence.

Like everyone involved in this case I have only sympathy for Mrs Ndri, but her case on common law and negligence must fail.

I turn to breach of statutory duty. This is an interesting, perhaps ingenious attempt to fix the defendant with absolute liability. If Mr Whitfield’s submissions are correct, then there must be that result, and a crucial precedent would have been created in personal injury litigation. They are, however, not correct. Mr Whitfield accepts that the general proposition the claimant must show the damage he or she suffered fell within the ambit of the regulation, namely; that it was of the type that the legislation was intended to prevent, and that the claimant belonged to the category of persons the regulations were intended to protect.

I agree with Mr Whitfield that I must, in deciding this, look at the wording of the regulation, and not at the Health and Safety Executive explanatory notes. The first thing to be observed is that the Control of Substances Hazardous to Health Regulation 1999 are made under the Health and Safety at Work Act 1974. Regulation 3 is in these terms:

“Where any duty is placed by these Regulations on an employer in respect of his employees, he shall, so far as is reasonably practicable, be under a like duty in respect of any other person, whether at work or not, who may be affected by the work carried on by the employer.”

Then follow words which are not material.

The words, “Any other persons” are clearly intended to cover non-employees such as sub-contractors or visitors to a place of work.

Regulation 6 deals with risk assessment, and I need not read that. Regulation 7.1 is in these terms:

“Every employer shall ensure that the exposure of his employees to substances hazardous to health is either prevented, or where it is not reasonably practicable, adequately control.”

Why is it said that Pseudomanas aeruginosa is concerned here, and the answer is simple from the Regulations, there is no doubt that a substance includes a micro-organism, and Pseudomanas aeruginosa is a biological agent, as it is a micro-organism - see Regulation 2.

Then I should refer to Regulation 5.1(c):

“Regulations 6 to 12 shall have effect with a view to protecting persons against risks to their health, whether immediate or delayed, arising from exposure to substances hazardous to health except -

(c)

where the risk to health is a risk to the health of a person to whom the substance is administered in the course of his medical treatment.”

It is clear, in my view, from the whole structure of the Regulations that patients in hospital are not to be included amongst the persons to be protected. 5.1(c) is perhaps not happily worded, but is clear enough to exclude patients. “Administered” is not particularly apt to describe the transplanting of an organ, but is sufficiently wide to cover it. It effectively excludes from the Regulation patients treated in hospital to whom a substance is administered. It is, in my view, inconceivable that it was the intention of Parliament to impose absolute liability in the circumstances of this case, and this way of putting the claim fails as well.

In the result there will be judgment for the defendants.