Monday, 22 December 2014

The Saatchi Bill - True or False?

Here is the current version of the Medical Innovation Bill, following its Report Stage in the House of Lords in December 2014.

As the Bill approaches its Commons stages, the following statements about the Bill seem to me to be true. I don't flatter myself that Lord Saatchi, his professional support team or government ministers read this blog, so if you want to know whether they believe the following statements are true or false, you will have to ask them yourself. If you do extract a response, please post a comment.

1.     The Bill applies whether or not a patient has a terminal illness or degenerative condition.

2.     The Bill applies whether or not a patient has exhausted all "standard" or conventional treatments.

3.     The Bill applies to private treatment as well as to treatment within the NHS.

4.     The Bill does not change the regulation or funding of new treatments.

5.     If passed, the Bill will have the following consequences:

a)     A doctor who would now be found negligent for deciding to treat a patient in a way which no responsible and rational body of medical opinion would support, will not be negligent if he/she takes the decision to treat "responsibly" within the meaning set out at section 1(3) of the Bill (provided also that the doctor believes that the treatment is in the patient's best interests and that lawful consent has been given for the treatment) - the "Saatchi Defence".

b)     Hence, in some cases, patients or their families who would now be entitled to compensation for injury or death caused by negligent treatment will no longer be so entitled.

6.     If a doctor makes out the Saatchi Defence, the court cannot apply either of the Bolam or Bolitho tests to find that doctor to have been negligent.

7.     In order to make out the Saatchi Defence, a doctor must first obtain the views of one or more doctors who have appropriate expertise and experience in dealing with patients with the condition in question but:

a)     There is no requirement that the other doctor has seen or examined the patient in question or has seen the patient's records.

b)     There is no requirement that the other doctor must agree to or support the proposed treatment - the doctors may disagree.

c)     The Bill does not require that the other doctor is independent from the treating doctor.

d)     The Bill does not require the other doctor to have experience or expertise in the proposed treatment or mode of treatment.

8.     In order to make out the Saatchi Defence a doctor must take full account of the views obtained from another doctor, or other doctors, "in a way in which any responsible doctor would be expected to take account of such views" but:

a)     That may include rejection of the  views of the other doctor(s).

b)     This is a different requirement 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.

c)     This is a new legal requirement on doctors, previously untested in the courts. The treating doctor cannot be any more certain that he has met the test that he can be that he has met the Bolam/Bolitho test - whether he has done will be for the courts to decide. So the threat of litigation is not removed.

Thursday, 11 December 2014

A Fundamental Flaw

If your house is built on soft sand you will not prevent it falling down by mending the roof. The continuing attempts to amend Lord Saatchi's Medical Innovation Bill will not cure its fundamental flaw. This bill needs more than patching up, it needs to be be completely rebuilt.

The premise of the bill is that the current law of clinical negligence is a significant obstacle to responsible medical innovation. Lord Saatchi came to this view because he believed that negligence law mandates adherence by doctors to a standard treatment even when that treatment is known to fail. This extraordinary misunderstanding of the law gave rise to the Bill.

If the Saatchi Bill team has truly listened to doctors, researchers, lawyers and patients, it would know by now that the fundamental basis of the bill is flawed.

The first people who would report that clinical negligence law is an obstacle to innovation would be doctors and those who represent doctors in litigation. The Medical Protection Society and the Medical Defence Union have said in clear terms that they do not believe that doctors are prevented from innovating by reason of clinical negligence law. The British Medical Association and the Academy of Royal Medical Colleges concur. The NHS Litigation Authority and the Medical Research Council do not support the bill.

What of the experience of patients? I have not yet seen one convincing example of a patient from whom innovative treatment has been withheld because the doctor feared being sued. There have been examples cited where the NHS would not fund the treatment or the Doctor has said he would be subject to disciplinary proceedings if he gave the treatment, but those are irrelevant to this bill.

In any event, if a doctor told a patient that he/she would not give a certain treatment because the patient might sue them, that would suggest that the doctor thought that the treatment would not be in the patient's best interests, that the chance of any benefit was outweighed by the prospect of harm. A patient could not sue a doctor for giving beneficial treatment nor for giving innovative treatment where there were no other viable treatment options, there were grounds for believing that the innovative treatment might help, and the patient had fully consented to the risks. The Patients Association and AvMA have both opposed the Medical Innovation Bill as have several charitable groups such as the British Heart Foundation, the Motor Neurone Disease Association and Parkinsons UK.

If there are deficiencies in medical innovation, they are not due to the current law of clinical negligence. The bill has nothing to say about funding of research, resources for new treatments within the NHS, the regulation of new treatments or professional regulation of doctors.

If peers and MPs are willing to listen to the many doctors', researchers' and patients' bodies that have spoken out against this Bill, then they will ensure it does not become law. Perhaps there could then be a more sensible look at the true impediments to medical innovation.

It is now clear that Lord Saatchi has made the wrong diagnosis. It is time for parliament to call a halt to this Bill.

Thursday, 4 December 2014

Watering Down Patient Protection

The Medical Innovation BIll was promoted on the basis that patients would be protected by stringent requirements for doctors to secure agreement to proposed innovative treatment.

In its current form the Bill does not require doctors to obtain any agreement to proposed treatments and the Saatchi BIll team has now confirmed why. 

"There has also been pressure to turn the requirement to consult colleagues into a requirement to obtain colleagues’ written consent. These amendments do not give effect to that suggestion. Senior doctors consulted by Lord Saatchi expressed concern about giving formal written consent to another doctor’s proposed course of treatment, without knowing the full history and other circumstances, while they would be relaxed about expressing a view of the soundness of the doctor’s proposal as described to them. Lawyers consulted were also concerned about a possible new form of legal liability for consenting doctors. The requirement to record views in the patient’s notes should introduce the necessary formality, transparency and accountability, while avoiding both of these objections.
Saatchi Bill explanatory notes on amendments of 4.12.14

The Bill removes the possibility of patients obtaining redress if they are harmed by doctors who make a negligent decision to provide treatment which is not within the existing range of accepted treatments.

Fearful of removing the degree of patient protection the law of negligence provides, the Bill has at various stages of its gestation laid down other requirements for doctors to follow. Those requirements are very different now than they were at the time that Lord Saatchi passed to the Department of Health an 18,000 signature e-petition supporting the bill. We have come a long way from the original intentions:

" [The Bill] was drawn up with the help of the best legal and medical minds, and stipulated that, to innovate, doctors must have patient consent and the agreement of other senior medical experts and practitioners. "

Supporting the Bill in April 2014 Professor Walker was reassured that :

“... the Bill obliges the doctor to seek agreement from peers.”

Article by Dominic Nutt, The Telegraph, 14 April 2014

And Lord Saatchi in May this year:

"Following the consultation, the Bill that is presented to Parliament in its final form will go further than the Mental Health Act in safeguarding patients. The Mental Health Act requires the authorisation of two doctors before an abortion or sectioning in a mental institution can take place lawfully; the Medical Innovation Bill requires the Multi Disciplinary Team in the hospital to approve the proposed innovation in advance. This is a most severe test, but however severe, it is better than the current position in which any departure from standard procedure can lead to the end of a doctor’s reputation and livelihood."

Lord Saatchi Telegraph 1 May 2014

These previous statements are no longer relevant. The bill has changed significantly. All it requires a doctor to do is to obtain the views of one other suitably qualified doctor. There is no requirement for that other doctor to have seen the patient nor even to know the patient's full history and other circumstances. There is no requirement that the other doctor is independent.

If you supported the bill in its previous form, please take another look. 

Tuesday, 2 December 2014

Causation in Delay in Diagnosing Cancer Claims

Last week I represented the claimant at a trial at the High Court in Cardiff before Mr Justice Wyn Williams. On the fourth day of the trial the parties agreed a settlement  for an undisclosed sum. So a number of interesting issues in the case did not have to be determined by the judge. Although I cannot provide definitive answers I thought it might nevertheless be of interest to outline a couple of the issues because they are likely to arise in other cases in the future. Everything discussed below was canvassed in open court and the facts have already been reported in the press.

Breast Cancer Cell

The claimant was referred urgently by her GP for suspected breast cancer when aged 31. She had a discrete breast lump which had persisted for six weeks. A surgeon at the Princess of Wales Hospital, Bridgend, downgraded the referral to routine on the basis that she was under 35 and that there were no worrying features or "red flags" beyond the presence of the lump (this is the second case I have conducted recently in which the defendant has denied that it was negligent to apply different referral criteria from those recommended in the NICE Referral Guidelines for Suspected Cancer). As a result the breast cancer was diagnosed and treated five months later than would have been the case had the referral been confirmed as urgent. The surgeon did not inform the claimant's GP of the decision to downgrade. After evidence from surgeons at the hospital, the defendant admitted at trial that but for its negligence the claimant's treatment would have commenced five months earlier. It was agreed that on earlier diagnosis the treatment would have been exactly the same as was given on actual diagnosis. The question was whether, the claimant having sadly later relapsed and developed overt metastases, earlier treatment would have been more effective.

Two points of interest on causation were as follows:

1. The Use of Prognostic Tools

The experts agreed that the most useful model for assessing likely prognosis in this case was the PREDICT model based on a study of women in East Anglia and which the NHS makes available online. The PREDICT model indicates that in September 2010 when the claimant ought to have had treatment over 90% of women of her age and with her cancer characteristics (tumour size and grade, axillary node involvement, ER, HER2 and PR status) would have survived at least 10 years. The corresponding figure for February 2011. when treatment was actually given, was about 80%. Following her relapse in 2014 she now has a very limited life expectancy. Was the evidence of life expectancy as at September 2010 valid? The defendant's case was that the relapse showed that the claimant's cancer was unresponsive to treatment and that she would have relapsed at exactly the same time even with earlier intervention. The claimant's case was that the PREDICT model remained valid - relapse following actual treatment did not establish likely relapse following earlier treatment. During the period of delay the tumour had grown and the number of axillary nodes involved had increased. Both of those are known to be important, adverse prognostic indicators. Indeed the mortality rate had (just) more than doubled during the period of delay. The cancer was more advanced than it ought to have been at the time of treatment.

This issue is common to many delay in diagnosing cancer cases. Similar circumstances also arose in the first instance decisions in Adshead-v-Tottle and Cutting-v-Islam (both on Lawtel). In the last few months I have concluded several cases where the patient had already passed away following delayed treatment for cancer. In all but one the defendant has contended that the delay made no difference to the outcome. This then is an important issue in this field of litigation.

Where the outcome following actual treatment is known, it may well be wrong to categorise these as Gregg-v-Scott cases which some argue (wrongly in my view) should be dismissed because they are merely claims for a reduction in the chance of a cure. At the very least a reduction in median life expectancy can sometimes be established (compare with JD-v-Mather). Where there has been a relapse, then unless that fact wholly undermines the evidence of likely cure on earlier diagnosis, the comparison is between actual outcome after treatment (relapse and limited life expectancy) with probable cure on earlier treatment (with corresponding likely life expectancy) as demonstrated by the PREDICT or any other appropriate model. The contrary view is that the relapse proves that the cancer was particularly resistant to treatment - so much so that treatment was never gong to prevent a relapse, whenever given.

2. Material Contribution

Since the claimant had suffered a relapse, with the development of overt metastases requiring further treatment and consequent significantly shortened life expectancy, she had suffered a distinct injury. We contended that the delay in diagnosis and treatment had caused or materially contributed to that injury. Perhaps the claimant's cancer was particularly aggressive but the delay had at the very least, made a more than minimal contribution to the relapse. The development of overt metastases was an "indivisible" injury and there were cumulative causes of it, of which the negligent delay was a material one. There is some debate about the use of Bailey-v-MOD for "indivisible" injury following remarks by Smith LJ in the Atomic Vets case (which seem to contradict her judgment in O2-v-Dickens). If the negligent delay caused or made a material contribution to the relapse then, on the face of it, the claimant will have established causation. If the negligence causes or materially contributes to the relapse and the relapse accounts for the reduced life expectancy (or accounts for a death that has already occurred) then the claimant's case may be made out.

The settlement spared the court the task of sifting through many academic papers and several statistical analyses. These cases are not straightforward. It seems clear however that there is no one test for causation applicable to all delay in diagnosing cancer cases. What may be applicable in a case where prognosis remains favourable following actual treatment, may not suit a case such as this where there is a very poor prognosis.

My client listened to all these "interesting" arguments with great patience and dignity. Unfortunately the same arguments are likely to arise in other cases in the future.

I was instructed by Javid Asharaf of Beers LLP and my junior was Tom Goodhead of 9 Gough Square.

I published a series of posts some time ago on delay in diagnosing cancer.