Tag Archives: Cancer Treatment

The present law is not clear

Opponents of the Bill say it is unnecessary because the existing law is clear and they need “more than anecdotes to justify changing the law”[1].

The 19,521  “anecdotal” responses to the Department for Health public consultation supporting the Bill are apparently not enough evidence for some that the Bill is necessary to make the law clearer.

But evidence is to be found in the decisions of the courts, if one looks for it. Take the very recent case of McGovern v Sharkey[2]. The Appendix to this Note contains extracts from the judgment in this case; the judge’s articulation of the special legal principles to be applied in cases of clinical negligence demonstrate that whatever the law on this area may be, it is neither clear, nor simple nor certain.

The case also illustrates how the present law assumes that every claim will involve the claimant and the defendant each hiring two or more doctors to oppose each other in the witness box. One reason why the law is so uncertain is that it depends on how impressive the two sets of witnesses are at trial.

Which is why at present claimants may be advised to sue whether they have a good case or not, because there is always a chance that they will have a “surprise win”; and key opponents of the Bill – notably Leigh Day & Co. – profit from running “no win no fee” cases relying on the uncertainty of the existing law[3].

The Bill will preserve the existing common law for cases where it is necessary and sufficient. But it will also add a new statutory procedure by which doctors and patients can achieve clarity and certainty at the point of treatment. By following the process set out in the Bill, doctors can be confident that a decision to depart from standard practice will be upheld as responsible by the courts, the regulatory bodies and others.

That will improve certainty for doctors and patients, who can concentrate on exploring sensible avenues towards innovative treatments for rare conditions, and bringing hope to patients where it is reasonable and responsible to do so.




 [42] Disputes about questions of fact depend on the usual burden and standard of proof. However in relation to clinical or professional judgment the position is different. Bolam v Friern Hospital Management Committee [1957] 2 All ER 118 established that, in determining whether a defendant has fallen below the required standard of care, regard must be shown to responsible medical opinion, and to the fact that reasonable doctors may differ. A practitioner who acts in conformity with an accepted current practice is not negligent “merely because there is a body of opinion which would take a contrary view.” In Hunter v Hanley 1955 SLT 231 at 217 it was stated that

“In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men … The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care … ”

That test in Hunter v Hanley, was approved in Maynard v West Midlands Regional Health Authority [1985] 1 All ER 635 and Lord Scarman also stated “It is not enough to show that there is a body of competent professional opinion which considers that theirs was a wrong decision, if there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances. … Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other, but that is no basis for a conclusion of negligence.

… I have to say that a judge’s ‘preference’ for one body of distinguished professional opinion to another also professionally distinguished is not sufficient to establish negligence in a practitioner whose actions have received the seal of approval of those whose opinions, truthfully expressed, honestly held, were not preferred. If this was the real reason for the judge’s finding, he erred in law even though elsewhere in his judgment he stated the law correctly. For in the realm of diagnosis and treatment negligence is not established by preferring one respectable body of professional opinion to another. Failure to exercise the ordinary skill of a doctor (in the appropriate speciality, if he be a specialist) is necessary” (emphasis added).

[43] In Bolitho (Administratrix of the Estate of Patrick Nigel Bolitho (deceased)) v City and Hackney Health Authority [1997] 4 All ER 771 it was established that a doctor could be liable for negligence in respect of diagnosis and treatment despite a body of professional opinion sanctioning his conduct where it had not been demonstrated to the judge’s satisfaction that the body of opinion relied on was reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field were of a particular opinion would demonstrate the reasonableness of that opinion. However, in a rare case, if it could be demonstrated that the professional opinion was not capable of withstanding logical analysis, the judge would be entitled to hold that the body of opinion was not reasonable or responsible. Accordingly the final arbiter as to whether there has been professional negligence is the court and not the medical profession. It is for the court to decide whether the requisite logical basis for a defendant’s expert medical opinion is absent. The legal question is as to what features particularly characterise an expert medical opinion as one that is “illogical”, “irresponsible”, and “indefensible”. It is clear that merely being a minority view of accepted medical practice does not, of itself, render that view “illogical” or “irrational” in the Bolitho sense. However it is suggested that a court would be more ready to find that the body of opinion was not capable of withstanding logical analysis if there was a dubious expert whose professional views existed at the fringe of medical consciousness, see Khoo v. Gunapathy d/o Muniandy [2002] 2 S.L.R. 414, at [63]. Another example would be “a residual adherence to out-of-date ideas” which “on examination do not really stand up to analysis” see Hucks v. Cole [1993] 4 Med. L.R. 393.

[44] It is however important to consider some limitations to the Bolitho test. A practice is illogical if there was a “clear precaution” which ought to have been, but was not taken. In this case the precaution that is suggested is that there ought to have been a diagnostic vitrectomy after one month given the risks of an unidentified tear of the retina and what is suggested was the lack of response to steroid treatment. However if there are risks attached to the precaution, in this case the risks associated with operating on an inflamed eye and the risk that the operation will not resolve the underlying problem, and one body of medical opinion considers that the risks ought to have been taken and the other does not then there is no “clear precaution” but rather a balancing of risks. In such circumstances both sets of expert opinion withstand logical analysis. For the plaintiff the expert opinion being that the risk of an adverse outcome, in that a tear was present in the retina, should have been prevented by taking the precaution of performing the vitrectomy. For the other body of expert opinion on behalf of the defendant, the precaution of performing a vitrectomy would have posed an unacceptable risk of operating upon an inflamed eye where given the diagnosis of ERD the operation would not have achieved a satisfactory outcome. This is merely a different weighing of risk rather than a determination that the defendant’s expert opinion is illogical. The precaution that is being suggested is not a “clear precaution” but rather a precaution which involves a balancing of risks and that is a matter of clinical judgment with a logical basis.

[45] Another feature of applying the Bolitho test is that it introduces a lack of symmetry as between the plaintiff and the defendant’s expert evidence. The defendant’s expert has only to persuade the court that his views are capable of withstanding logical analysis, but he does not have to satisfy the court that the views of the plaintiff’s expert are not capable of withstanding logical analysis. However, the plaintiff’s expert has to do both.

[46] If the case is one that involves clinical judgment to which the Bolam test applies, and if the medical practitioner does produce evidence that his practice was supported by a responsible body of medical opinion, then, in the words of Sedley L.J. in Adams v. Rhymney Valley DC [2000] Lloyd’s Rep. P.N. 777, at [41], “the judge or jury have to accept the opinion of a body of responsible practitioners, unless it is unreasonable [in the Bolitho sense]” (emphasis added).

Accordingly in an action involving clinical judgment there is a two-step procedure to determine the question of alleged medical negligence:

(a) whether the medical practitioner acted in accordance with a practice accepted as proper for an ordinarily competent medical practitioner by a responsible body of medical opinion; and

(b) if “yes”, whether the practice survives Bolitho judicial scrutiny as being “responsible” or “logical”.

[47] Questions of fact and the question as to whether there was negligence are not to be conflated. Questions such as whether in the event there was a right retinal tear or hole in December 2006 or whether there was inflammation in the right eye in 2007 or whether there was scleral thickening in the right eye are questions of fact to be determined on the balance of probabilities with the onus of proof being on the plaintiff. The question of clinical and professional judgment as to whether a responsible body of medical opinion would form the view, in say January 2007, that there was a right retinal tear or hole or that there was inflammation in the right eye or that there was scleral thickening in the right eye are all subject to the Bolam test as qualified in Bolitho. In some cases the determination of a question of fact may lead inexorably to a finding that the medical practitioner did not act in conformity with an accepted current practice. In others it may have no such impact. So for instance in this case if there was a factual finding, on the balance of probabilities, that on 26 December 2006 the first defendant was informed that the plaintiff had suffered a sudden and profound loss of vision in his right eye and that the plaintiff’s right eye was not assessed or if the plaintiff was not advised to have his right eye assessed that day then inexorably that would lead to a finding that the first defendant had not acted in conformity with an accepted practice. Inexorably because no logical accepted current practice would do or advise anything other than immediate action. However if the factual finding was that the first defendant was informed that the plaintiff had some extremely modest effect on his vision in conjunction with a history that drops had not been taken then (though there was a dispute about this) it might be that to delay an examination until 4 January 2007 and to recommend that the plaintiff use his drops was in conformity with a logical accepted current practice.

[1] “The law currently works and is fair and clear. I am afraid that I require more than a few anecdotes to justify changing the law.” – Suzanne White, Partner, Leigh Day & Co; http://www.clinicalnegligencelaw.co.uk/2014/07/20/innovate-innovate-saatchi-bill/ – accessed 4.1.15.

[2] [2014] NIQB 117 – http://www.bailii.org/nie/cases/NIHC/QB/2014/117.html

[3] “Do you take cases on a “no win, no fee” basis? Does that mean I won’t have to pay anything at all? Yes we do.” – http://www.leighday.co.uk/Illness-and-injury/Clinical-negligence/FAQs/Costs – Accessed 4.1.15.

Telegraph: ‘This isn’t quackery, it’s good practice’

The Bill Team’s Dominic Nutt talks to Prof Walker, University of Nottingham

Paediatric cancer specialist Prof David Walker’s work is a bittersweet affair. At times he is able to deliver the happiest of news to parents: that he and his team have saved the life of their child. Equally, he is the one who has to tell a fearful mother and father that there’s nothing more he can do, that their son or daughter’s cancer has spread beyond the reach of his drugs and the surgeon’s knife, and that their child will die.

Based at Nottingham University for the past 22 years, working at Nottingham Children’s Hospital and Nottingham Medical School, Prof Walker combines a passionate commitment to the welfare of his patients with a deep respect for scientific discipline.

He wants to see more and better therapies added to the armoury of paediatric cancer treatments, to save the lives of more children, and is frustrated by the obstacles that block the path to new cures for cancers.

Medical science decrees that no new treatment should be used until it has been thoroughly tested in randomised clinical trials. Trials are the gold standard, Prof Walker stresses, and where possible patients should be in a trial if one is available. “Research does require regulation to introduce new drugs and treatment safely,” he says.

But trials alone cannot meet the desperate need for new treatments, in particular for rare cancers. “There will never be enough trials, they take years, and in any event there are rarely trials for less common diseases. There just aren’t enough patients.”

Around one in 600 children under 16 are diagnosed with cancers. The most common, such as leukaemia, account for a third of cases, and treatment success rates are high. But some are hard to treat, other than with surgery, such as the highly malignant rhabdoid tumours, which start in the kidney. There are no standard therapies for these cancers and less than one in five children diagnosed with a stage III or IV rhabdoid tumour will survive beyond four years.

With such rare childhood cancers, it is hard to gather enough patients to form a trial in one country alone, and these have to be organised internationally.

“The problem is that there are many different tumour types and sub-types in childhood cancers, each having an unique biological signature justifying a unique scientific rationale for their treatment with modern drugs in development,” says Prof Walker. “They are all rare in the population and there is a huge element of luck as to whether in your child’s case there is a trial available.”

So, while potential new drugs may exist, they cannot be used. “A drug may be available, the scientific rationale for its use may exist, but patients cannot receive it if no trial has been organised to assess its effectiveness and toxicity,” says Prof Walker.

He also points out that the “big four” cancers – breast, bowel, lung and prostate – dominate media coverage as well as fundraising, research and trials. Researchers want to work on the common cancers because their research will be better funded, while drugs companies are more interested in this area as there is a bigger market, and a greater potential profit.

If you have a less common cancer – and there are hundreds – your chances of getting on a trial are limited and the chances of there being innovative treatments are, in many cases, zero. Yet taken together, less common cancers – defined as a cancer that affects five people or fewer in 10,000 – account for more than half of all British cancer deaths. One in six of us will develop and die from a rare cancer.

The lack of trials in this area means doctors who want to cure their patients, rather than just manage their deaths, are caught in a scientific circular argument. There is no evidence that a new treatment will work, so it cannot be used to find out if it does work.

Prof Walker believes that doctors should be able to try new treatments with such patients on an individual basis. Yet, he argues, the law, and the culture of defensive medicine which surrounds it, stands in the way of innovation. Doctors are protected if they stick to the well-worn path of “standard procedure” even if it leads to the death of the patient. But they may be vulnerable to legal action if they try something new and it fails.

Which is why Prof Walker supports Maurice Saatchi’s Medical Innovation Bill, currently going through a public consultation process by the Department of Health, which ends later this month. It seeks to provide legal protection for doctors who innovate in the interests of their patients. He argues that when patients are terminally ill and there is no trial for which they are eligible, a doctor should be free to innovate.

“We need to allow them to try new drugs outside of a formal trial and collect the data from those innovations to inform the next generation of trials,” he says. “The Saatchi Bill would protect individual doctors who try new, untrialled treatments, where there is a scientific rationale for their use, in patients who consent.

“This isn’t a licence for the maverick doctor acting alone – the Bill obliges the doctor to seek agreement from peers.”

The Saatchi Bill, he believes “will give the patients and their families additional choice and allow doctors to try new medicines in people who have nowhere else to go, and do it in such a way as we could all learn from it”.

Prof Walker also believes that even when an individual patient cannot be cured, this kind of innovation will advance medical science for future patients.

“When people are dying,” he says, “they all would like their passage through their illness to have some meaning and to learn from the loss of their life.”

He also explains that many cancer drug trials rightly focus hard on a tightly defined group of patients with the same tumour type, which has within it a particular cancer molecule, that the drug being tested is designed to block.

Using molecularly targeted drugs in patients with the same tumour drives robust results. But, says Prof Walker, “there is a weakness in the process, because it doesn’t tell you where else the new drug may work. It only tells you that the drug works on a very specific patient type with a very specific tumour which has within it that particular molecular target.”

The new drug may work in another rarer cancer with the same molecular target, he says. “But if I have a patient with a very rare cancer with the same molecular target, I can’t use it. Current rules require us to set up another trial in that tumour, and that’s expensive and requires collaboration with the drug industry, which may not wish to supply the drug for such a purpose if they don’t think it is commercially advantageous. So, in the meantime, the hospital won’t release that licensed drug for an unlicensed purpose because there’s no evidence that it works,” he says.

This is where the Lord Saatchi’s Medical Innovation Bill would help, he argues.

“If we could test drugs in a patient and record our results in an open-access database, this would contribute to our understanding of the application of this drug and perhaps help with selecting new drugs for clinical trial by identifying those with most promise; although it is important that the drug has already been tested fully on patients with a different cancer but with the same molecular signature.”

Opponents of the Bill argue that a law that supports doctors who want to try new treatments outside the trial process is a “quack’s charter”.

Prof Walker disagrees: “To offer an untried treatment and not learn from the process would be quackery.” “But to use untried treatment and to try to learn, responsibly, about the effect on the individual, and share that learning with others would seem to be not quackery, but actually responsible professional practice.”

Sign the petition for the Medical Innovation Bill: http://chn.ge/1pqY6lS


‘Why I back the pioneer Lord Saatchi,’ by Max Pemberton, doctor and Telegraph columnist


By Max Pemberton, doctor and Telegraph columnist

Doctors experience a strange conflict throughout their working lives. On the one hand, we are trained to save lives and alleviate suffering. On the other, medicine is incredibly conservative – slow to change and wary of ideas that challenge the status quo.

Indeed, there is an estimated average time lag of 17 years for a new treatment or research evidence to reach clinical practice. The reasons for this are long and complex: to do with processes and policy but also, in no small part, a reluctance by doctors to change their current practice.

Why should this be the case? If a treatment or procedure has been suggested to be of benefit, why not try it, especially as it might offer new hope to patients? The argument for this is particularly strong in the case of cancer treatment.

The reality is that doctors’ reluctance to go “off piste” when conventional treatment has failed is often due to their concern over being sued. Once doctors deviate from standard practice, they open themselves up to litigation. Indeed, the Bolam test – currently used to assess medical negligence – involves assessing what the average doctor would accept as standard procedure.

This inhibits innovation, it is argued, and Maurice Saatchi, the former advertising guru, is seeking to change this with his Medical Innovation Bill. Its origins lie in Lord Saatchi’s devastation as he watched his wife, the novelist Josephine Hart, die of ovarian cancer in 2011. He has managed to turn his loss into something that has the potential to bring untold benefit to future sufferers.

It is a tragic indictment of modern medicine that innovation is too often jettisoned in favour of the status quo for fear of legal action. Defensive medicine is at the heart of so much clinical practice today, but the Bill – if accepted into law – would deftly excise this, leading the way for doctors to feel free to strive for medical advancement.

This doesn’t mean that doctors would have free rein to experiment on a patient – they would still be bound by professional guidance and their duty of care would remain to their patient. Nor would it mean that the Bill would become a substitute for proper clinical trials.

But what it does mean is that, in cases where the evidence is shaky, wanting or not yet clear, the Bill would set out a code by which doctors could try alternatives. It would provide a legal framework by which doctors, in discussion with their patients, could try off-label drugs or a device, treatment or intervention that might have some clinical data supporting it, but has yet to be fully proven.

Initially, the Department of Health was sceptical, but since the Bill was launched it has gained considerable public, medical and legal support. Then, in November last year, Jeremy Hunt, the Health Secretary, gave it his backing, saying that “we must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment”, and commending Lord Saatchi as “a great example of a parliamentarian motivated by conscience”.

A public consultation is now planned, beginning later this month. This is tremendously exciting: the history of medicine is littered with innovators who flew in the face of received wisdom and dared to challenge orthodoxy.

If the Bill passes, it may well be that in years to come Maurice Saatchi will join their ranks, and will no longer be known as an advertising guru, but the man who helped doctors find a cure for cancer – and saved an untold number of lives.

→READ: Max Pemberton’s column