Monday, 8 September 2014

Innovation, Proton Beam Therapy, Ebola and Litigation



Does clinical negligence litigation operate so as to discourage medical innovation including proton beam therapy and new treatments for the Ebola virus?

The Bolam/Bolitho test applies to claims for compensation for injuries allegedly caused by medical negligence. It provides that a doctor is liable to pay compensation where a patient is injured or killed by the doctor giving them treatment which no responsible body of doctors would support.

Such litigation is nothing to do with professional regulation by the General Medical Council, or regulation covering the use of new drugs or other treatment, or wardship or Court of Protection proceedings. The threat of claims for compensation in negligence had no role to play either in the recent high profile case of Aysha King. The court's involvement arose when the parents took their son out of the hospital and the court was asked to take steps to protect the child from harm or the risk of harm. Aysha King's NHS doctors were not prevented from giving proton beam therapy by the threat of clinical negligence litigation. The NHS does not recommend or fund proton beam therapy for medulloblastomas because it does not believe there is evidence of its effectiveness, not because it fears being sued for injuring patients. There was no threat of a negligence claim by the child or parents against the Trust for providing innovative treatment - it is what the parents wanted the Trust to provide. 

Similarly the use of Z-mapp for treating patients with the Ebola virus was not precluded because of the fear that patients would sue their doctors for compensation if it was ineffective or even if it caused them harm. Its use might have otherwise been precluded by regulations governing the introduction of new treatments had the authorities not intervened. That is nothing to do with medical negligence litigation. 

It seems that doctors who wish to innovate are not discouraged from doing so by the fear of litigation. The British Medical Association has said that it "is not aware of any evidence which shows that the possibility of litigation deters doctors from pursuing innovative treatments or that uncertainty exists over the circumstances in which a doctor can safely innovate without fear of litigation." The bodies which defend medical negligence claims - the MDU, MPS and NHSLA, have all said much the same.

And yet there are some who have continued to claim that the Bolam test operates to impede responsible medical innovation. Some have even claimed that  the Aysha King and ebola virus/Z-mapp stories demonstrate the need to give an immunity to doctors from being sued in negligence for making treatment decisions which harm their patients -  which is the what the Medical Innovation Bill is designed to do. 

Lord Woolf has said that he was aware of cases from his time as a trial judge in which the law of  clinical negligence was in conflict with promoting innovative medical treatment. Unfortunately for informed debate on the issue, the names and reports of such cases have not been made public.  Nevertheless his statement is often cited as trumping the clear evidence of the BMA, NICE, the Academy of Royal Medical Colleges, Cancer Research UK, the medical defence organisations, APIL, AvMA and many others. 

Faced with such overwhelming evidence on the one hand, and personal recollections of un-named individual cases on the other, I have little doubt which way Lord Woolf the esteemed judge would have decided the argument.  

A trawl through the law reports has produced the following relevant cases. If there are other  cases where judgments are available then I will gladly publicise them on my blog.

In Sidaway-v-Board of Governors of the Bethlem Royal Hospital [1985] AC 871; [1985] 2 WLR 480, Lord Diplock said:
Those members of the public who seek medical or surgical aid would be badly served by the adoption of any legal principle that would confine the doctor to some long-established, well-tried method of treatment only, although its past record of success might be small, if he wanted to be confident that he would not run the risk of being held liable in negligence simply because he tried some more modern treatment, and by some unavoidable mischance it failed to heal but did some harm to the patient. This would encourage ‘defensive medicine'...  The merit of the  Bolam test is that the criterion of the duty of care owed by a doctor to his patient is whether he has acted in accordance with a practice accepted as proper by a body of responsible and skilled medical opinion. There may be a number of different practices which satisfy this criterion at any particular time. These practices are likely to alter with advances in medical knowledge. Experience shows that, to the great benefit of human kind, they have done so …”

So, as medical knowledge develops, the Bolam test is sufficiently flexible to take innovations  into account. But is it sufficiently flexible to deal with very novel or even untested treatments? The following cases suggest that it is. 

In Simms-v-Simms [2002] EWHC 2734; [2003] 2WLR 1465 Lady Butler-Sloss had to consider whether the best interests of two patients would be served by giving them previously untried treatment for variant Creutzfeldt-Jakob disease. The NHS Trust did not wish to give the treatment but the doctor involved wished to try it. The court sided with the doctor, deploying the Bolam test to give permission for the treatment. As Robert Francis QC has written "it was not the law that stood in the way of innovative treatment in that case - it facilitated it by explicit reference to the Bolam test. Indeed the doctor wanting to provide the treatment was no deterred by the fear of litigation. He was inhibited by his employer."

The courts have also supported doctors who have provided innovative treatment even where that treatment has in fact harmed their patients. In these cases it is fair to say that the injured patients have sued the doctors, but the courts have supported the doctors. The Bolam test was applied to support innovative treatment not to discourage it. These cases also show that the Bolam test can be applied even where there is not body of medical practitioners in UK who have actually given the treatment in question. 

In Waters-v-West Sussex HA [1995] 6 Med LR 362 the Court applied the Bolam test when dismissing a negligence claim where a surgeon had used a "unique" technique and the patients suffered paralysis following the operation. In Pollard-v-Crockard (unreported, 22nd January 1997) the High Court applied the Bolam test when a surgeon had used a technique 'previously unknown' in the UK. The surgeon was found not to have been negligent. 

If a doctor tells parents that he cannot give a certain treatment to their child because of "the lawyers" it does not follow that he is telling them he believes the parents would sue him for compensation for negligence if he gave the treatment. He might be referring to one of a number of ways in which the law restricts the treatment he may give. Or perhaps he is using the spectre of those "greedy lawyers" as an excuse to do what he thinks is right.

Before a well established common law principle is re-written by parliament, clear evidence and clear thinking are required.






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