Tag Archives: saatchibill

When relying on the Bill must medical experts who are offering their views to the doctor who is treating the patient actually see the patient?

It is often most efficient and effective for doctors to discuss the principles of treatment without examining each others’ patients.

This is not new and already happens currently.

Doctors will decide for themselves what information they need in order to offer views on treatment, and whether they need to see the patient – as is the case now.

GMC guidance or hospital protocols will also be relevant.

Why is there is no requirement that the other doctor must agree to or support the proposed treatment. The doctors may disagree.

The views must be recorded in the patients’ notes – no doctor who receives only negative responses will be safe in relying on the Bill.

To intentionally use known, supportive doctors and to exclude intentionally dissenting experts would be unreasonable and would expose the doctor to a claim of negligence.

No doctor who receives only negative responses will be safe in relying on the Bill.

However, the Bill does not allow one, single, dissenting doctor to effectively veto a novel treatment for which there is otherwise a clear consensus among other experts.

If a doctor makes out the Saatchi Defence, will this stop a judge applying either of the Bolam or Bolitho tests to find that doctor to have been negligent?

If a doctor has satisfied the reasonableness and responsibility requirements of the Bill, the Bolam and Bolitho tests will have been applied and satisfied at the point of treatment, so there will be no opportunity for lawyers to hire doctors to go into court and re-argue the issue in the hope of forcing a settlement from a risk-averse NHS budget-manager.

Is the Medical Innovation Bill different from the current legal requirement that a decision to treat is one which would be supported by a responsible and rational body of medical opinion?

It is a practical application of the existing hypothetical test which asks doctors to imagine what colleagues’ views would be, but not to ask them unless and until the matter comes to trial.

Under the Medical Innovation Bill the doctor will actually ask colleagues for their opinion at the point of 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.

 

APPENDIX

EXTRACT FROM JUDGMENT IN MCGovern v Sharkey

 [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.

Medical Innovation Bill is passed by Lords and sent to Commons at third reading

Maurice Saatchi’s Medical Innovation Bill was passed by the House of Lords and sent to the Commons following its third reading in the House of Lords on 23rd January 2015.

WATCH THE DEBATE

→READ: The full transcript of the debate in Hansard

→READ: The Bill as amended at third reading

There were two amendments tabled from Lord Winston and Lord Hunt both of which were supported and signed by Lord Saatchi.

We are thrilled that Lord Hunt’s amendment on the Medical Innovation Register was accepted.

This unprecedented register of innovation, which has been called for by many organisations and individuals, will make it a mandatory requirement for anybody using the Bill to register the treatment and the outcome, both positive and negative.

It moves treatments that without sharing and transparency could become just an anecdote into sharable evidence that can be used to treat other patients and inform clinical trials.

Oxford University have already offered to host the Medical Innovation Register and the Medical Innovation Bill team is consulting widely on how the register will be set-up, managed and funded. We will keep our website updated with all the latest developments.

The Bill has now moved to the House of Commons and is a step closer to helping patients receive novel and innovative treatments.

Thanks so much for your support so far.


During the third reading Lord Kakkar said:

“Clearly, providing transparency and the opportunity for sharing the outcomes of such innovations rapidly and broadly across clinical communities in this country and internationally is of so much importance.

It will allow colleagues to understand what has been achieved and not achieved; it will allow those with other ideas to build on knowledge gained from experience to date; and it will ensure that through transparency we have the best opportunity to ensure the greatest patient protection.”

Lord Kakkar is professor of surgery at University College London and a member of the General Medical Council.


During the third reading Lord Giddens said:

“Science is a collective enterprise. It depends on the accumulation of evidence. It is crucial that that be recognised formally somewhere in the Bill, with this embodied as part of the advancement of scientific progress more generally”


Media

Telegraph:  We now have hope of finding new ways to treat incurable diseases

Telegraph: How Lord Saatchi won over the critics

Telegraph: The law can’t cure cancer but it can help people who might

Daily Mail: New ‘experimental drugs’ law moves a step closer


Case study

Lord Ribeiro, a British surgeon who served as President of the Royal College of Surgeons of England from 2005 to 2008. Shared a very interesting case from the 1990s which demonstrates both the need and benefits of having a innovation register.

“My Lords, many noble Lords will remember the disasters that occasioned the introduction of laparoscopic cholecystectomy in the 1990s.

Quite a few patients suffered as a result of the innovation of our surgeons playing with a new instrument, new tools and a new operation.

At the time, I was secretary of the Association of Surgeons of Great Britain and Ireland.

In recognising the problems, we introduced a voluntary register of all surgeons undertaking the procedure and got a very good response.

Admittedly, it was not compulsory and not every surgeon introduced their data to it, but the net effect was that when we analysed our data we were able to identify where many of the problems lay.

That led to further research and proper control trials in the procedure. We were able to turn to that from an innovation used by a succession of surgeons as and when they felt necessary, without any good evidence on how best to use it.

On that basis, and mindful of the benefits that we saw in the 1990s, I would very much support some form of register to ensure that, if an innovation is introduced, we have the information, can go back and refer to it again, learn from the mistakes and improve the outcome.”

The Medical Innovation Bill will support evidence-based medicine

Prof Walker - Medical Innovation Bill
Prof Walker – Medical Innovation Bill

One of the key tenets of the Medical Innovation Bill is that it will oblige doctors to record and share the results of incidental medical innovations in the Medical Innovation Register.

This applies to both positive and negative results.

→READ: About the Medical Innovation Bill Register

As such, the Bill will begin to build data around innovations in a way never before seen in this country.

We know that medical innovation already happens – though this bill will encourage more innovation by setting a clear process for doctors to follow that will ensure patient safety and offer the doctor legal clarity.

But currently, there is no register for innovation, no database, no record of success or failure.

Medical Innovation Bill - Oxford University
We are working with Oxford University to produce an open access database of treatments and outcomes under the Bill.

So no one can replicate those successes and avoid the failures.

Recording such data would also allow doctors and researchers to follow up on promising new therapies.

Dr David Walker, professor of paediatric oncology at the University of Nottingham says:

“If evidence started to amass under the Medical Innovation Bill, that a treatment works then it would support the establishment of new trials.

“Historically medicine has a large number of situations where new treatments have been developed by repurposing drugs for a new indication.

“Currently this step is hard to make as people say that although the drug exists, is licensed, it cannot be used off license if there is no evidence as it would be  wasting money that could be spent on licensed drugs for licensed indications.

“This is particularly damaging for people with rare conditions where research is rare – this applies to cancers in particular.

“In childhood 60% of all drugs are off licenses many of our strongest treatments are a product of off license development or repurposing of drugs.”

The Medical Innovation Bill would could speed this process of re-purposing drugs up thereby enabling treatments to get to patients quicker.

Prof Walker added that this would create a system where the recording of pre-trial results of therapeutic innovation would become “a recognised and appreciated step in the drug selection process, particularly in rare conditions.”

“It could help to reduce the risks of failed trials”

→READ: About the Medical Innovation Bill Register

Dr David Walker is a Professor Paediatric Oncology
Children’s Brain Tumour Research Centre
Faculty of Medicine and Health Sciences
University of Nottingham
www.cbtrc.org
www.headsmart.org.uk

Telegraph: The law can’t cure cancer. But it can help the people who might

Telegraph-22nd-January-2015

Published in the Telegraph 22nd January 2015

Written by Lord Saatchi.

Cancer and its treatment is the number one cause of the untimely death of British citizens. There were around 165,000 cancer deaths this year – the same as last year and the same as next year.

Apparently, cancer is so complex that it is beyond the judgment and understanding of the human mind to comprehend all its variables.

This point was confirmed in a recent study by scientists at America’s distinguished Johns Hopkins University which concluded that many cancers are “just bad luck”.

The law cannot cure cancer. Parliament’s power, though awesome, is not sufficient. Only science can do that.

But the law does have the power to change the culture. Consider its impact on race, drink-driving, smoking in public places. No amount of exhortation or guidance from on high could have achieved what the law has done. No one would consider smoking in a restaurant today.

The Medical Innovation Bill, which tomorrow returns to the House of Lords for its third reading, does not offer some miracle treatment for a sofar incurable disease. But it will, I believe, encourage the men and women who will who find those cures.

This is why I hope the House of Lords will decide to pass the Medical Innovation Bill – a Bill that has been strongly supported by The Telegraph from the start – and send it to the House of Commons for approval.

This follows 18-months of line-by-line scrutiny by some of Britain’s greatest judges, doctors and scientists, with safeguards designed by Sir Bruce Keogh, Medical Director of the NHS and with the approval of the Government and many thousands of doctors and patients.

Here is the situation for many people today. When a patient with cancer or a child with a degenerative disease – such as Duchene muscular dystrophy – is handed a terminal diagnosis, when the doctor says there is nothing to be done other than offer standard treatments which are known not to work, two things happen.

First, the patient dies. Second, medical science is halted in its tracks by the repetition of the same, failed experiment. Doing the same thing, offering the same treatment, knowing it won’t work is madness.

Today, the law protects the doctor who carries out only standard procedures. It says that that doctor cannot be sued if – as it always will – the treatment fails.

My Bill won’t change that. A doctor can continue safely and legally prescribing the standard therapies if they wish. There will be no obligation to innovate. What the Bill will do is offer the same protection to a doctor who offers an innovative treatment to the dying patient – in advance of the treatment taking place, as long as they can get the support of at least one other relevantly qualified doctor.

It will encourage them to think beyond the standard treatment. It will allow them to see what else might – only might, for there are no guarantees – make a difference to the dying patient.

It will change the culture of defensive medicine to one where the balance of risk is gently recalibrated making it permissible to consider trying something new, something less well documented than the well-worn path to death.

And lest there be any doubt about what is responsible for the culture of defensive medicine, look at the facts. Last year we, the taxpayer, paid out £1.2bn to meet negligence claims against the NHS, a figure that has doubled in five years. According to the Treasury, we the people have a further liability for a staggering £26bn, up £2bn since last year.

Many who have had concerns about the Bill have pointed out that if it is to make a difference to medical science, then the results of innovations need to be documented and be shared so that other doctors and scientists can make use of the results – avoid the failures and try to repeat the successes by setting up full medical trials.

Yesterday, the Genetic Alliance UK wrote to Lords saying it was vital that “registries are created to enable the collection and exploitation of real-world patient data, and promote the sharing of research findings and best practice.” The Government agrees that the collection and sharing of new data derived from innovation will both advance scientific knowledge and provide the accountability and transparence required for patient safety

The Bill encapsulates what is seen as by the top hospitals as best practice – that is discussing innovative treatments with expert colleagues in advance of that treatment. Doing this means that doctors can formulate the best options – and calculate the risks to the patient. The Bill says if doctors do this and write it all down and get the patient’s consent, they will be legally protected.

This is why I hope today my Bill, soundly tested, forensically analysed line by line by my colleagues in the Lords who number among them some of Britain’s top legal and medical brains – and amended by them – will pass to the Commons.

And it is why Regius Professor of Medicine at Oxford University Prof Sir John Bell says: “There will be no cure for cancer until real doctors with real patients in real hospitals can attempt an innovation.”