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.

Friday, 21 November 2014

Treating Children under the Saatchi Bill

If the Saatchi Bill is passed there will come a time when a child is seriously harmed by negligent treatment and the child receives no compensation because the doctor has a "Saatchi defence". Some supporters of the Saatchi Bill believe that its opponents lack compassion and are complacent. They are wrong. What is complacent is to assume that this Bill will produce nothing but good.

The Saatchi Bill applies to all doctors and to all their patients whatever their conditions. It applies to decisions to give treatment at the start of life and to withdraw treatment at the end of life. It applies to decisions to give alternative treatment and to cease mainstream, evidence-based treatment. And it applies to the treatment of children who are too young or too sick to make decisions for themselves.

The Bill is intended to encourage responsible medical innovation but seeks to achieve that end by changing the law in respect of treatment which departs from the existing range of accepted treatments. If such treatment, including treatment which no responsible body of doctors would support, harms a patient the bill removes the right of patients and their families to compensation. Treatment which is now regarded as negligent will no longer be negligent. Families of children who would have received compensation will no longer be entitled to compensation.

The one thing all parents wish for their children is good health.  Parents of children who have a terminal illness or an incurable and disabling condition are put through hell and back. A number of them have been persuaded that the Saatchi Bill will make available treatments which are not made available now because their children's doctors are fearful of being sued. The campaign in support of the bill has reached out to such parents, encouraging the belief that the Bill offers them hope.

Before too much faith is placed in the Bill, the following points should be considered:

1. Parents cannot insist on a doctor providing a specific treatment for their child. The doctor will of course take the parents' wishes fully into account but must act in what he believes are the child's best interests. On rare occasions a dispute about the best interests of the child has to be determined in court. The General Medical Council issues detailed guidance to doctors about treating children, consent and assessing best interests. That guidance recommends much wider consultation about proposed innovative treatment than is set out in the Saatchi Bill. The bill will not change that guidance or give parents an unfettered right to choose treatment for their child.

2. If there is compelling evidence that a new treatment will be likely to benefit the child, then the assessment of the best interests will be relatively straightforward. Doctors do not need the Saatchi Bill to tell them to try something new if there is evidence it may help the child. It happens now. As I understand it, paediatrics is one of the main fields where off label prescriptions are deployed. Again the GMC has issued detailed guidance about prescribing unlicensed drugs.

3. What if there is little evidence that  proposed treatment will work but there are good reasons to think it might help and will not cause harm? The GMC guidance says that when prescribing an unlicensed medicine a doctor must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety or efficacy. Perhaps that is where the Saatchi Bill might make a difference? Well in the case of Simms and Simms, Lady Butler-Sloss found that it was in the best interests of two patients, lacking capacity, who had vCJD to be given very new treatment for which there was no evidence or experience to support its use. She said that the Bolam test of negligence would apply such that the doctor giving the treatment would not be regarded as negligent. Why? Because giving the treatment in the desperate circumstances and with no other viable options was reasonable and rational. So, even without any prior experience of the effectiveness of the treatment a doctor may give the treatment if it is rational and reasonable to do so. Again the Saatchi Bill is not needed to allow doctors to do this. As the GMC told the government in response to a consultation on the Saatchi Bill :

"Medicine is a risky business. There are many people alive today due to the 
willingness of doctors to innovate, deal with uncertainty and take reasonable risks 
which are understood by, shared with, and consented to by, the patient." 

4. However if there is really no evidence or basis at all on which a rational and reasonable decision could be made to give treatment to a child, then how can it be said to be in the child's best interests to give the treatment? The Saatchi Bill requires that a doctor only act in what he or she believes is their patient's best interests. As can be seen the GMC, which regulates the medical profession, already has detailed guidance about that assessment. Trying something just for the sake of trying it will not be in a child's best interests and will expose the doctor to sanctions from their professional regulators irrespective of whether the doctor is sued in negligence. It might cause the child avoidable and serious harm but with no corresponding benefits. So the Bill will not allow doctors to give treatment to a child when there is no evidence and no basis on which to conclude that it will be in the child's best interests.

5. For any parent (are there any?) who wants a doctor to experiment on their child for research purposes, the Saatchi Bill is clear - treatment for the purpose of research is not permitted by the bill.

6. Who does the doctor think would sue him? Doctors are not sued by strangers but by their injured patients. A claim in negligence is a claim for compensation. It is not a disciplinary process. A doctor is not "found guilty" - they, or more often the NHS Trust they work for, are found liable to compensate for harm done by negligent acts or omissions. A claim for compensation is brought by the patient whom the treatment harmed, or their family if they have died. If a doctor says he is afraid that his patient will sue him for giving treatment, then he is clearly afraid that the treatment is unjustified and will cause harm. He is also saying that he does not trust the patient, or his or her parents, not to sue him if the treatment is unsuccessful.

7. Even if a doctor believes that innovative treatment is in the child's best interests, and lawful consent to the treatment is given, it does not follow that the child will be provided with the treatment. Someone has to pay for it. The NHS does not fund every available treatment, let alone every possible innovative treatment for which there is scant evidence of its effectiveness. It strikes me that the Saatchi Bill is really for those who can afford to pay privately for expensive treatment which is not within mainstream practice. It certainly does not unlock funding restrictions within the NHS.

Unintended Consequences

So why oppose the Bill if it will not change anything? The answer is the law of unintended consequences. Suppose parents are refused treatment for their child because the doctor does not believe it is in the child's best interests. Parents have an instinctive drive to do everything they can to help their child. Advice that there is nothing more that can be done is not easy to hear let alone to accept. Some parents will accept it. Others will go to another doctor, and then another until they find a doctor who agrees to try something else. They may think they have nothing to lose. They may go to a doctor in private practice who offers something different than the NHS offers. They may try to raise money to pay for treatment. In some cases the parents might turn out to be right: the treatment they sought might benefit their child. Unfortunately and inevitably there will be some other cases where the first doctor was right and the second doctor was negligent in offering the treatment. The result that no-one wanted happens: the treatment causes the child serious and avoidable harm.

This is where the Saatchi Bill becomes the enemy of the patient and the patient's family. At present a doctor who negligently treats a child in a way which no responsible body of doctors would condone, may be sued in negligence and found liable to compensate that child for the harm caused. A child may need life long professional care, specialist equipment and accommodation because of injuries caused by medical negligence. Under the Saatchi Bill that child's entitlement to compensation will be removed if the doctor has met with the bill's tests about making the decision to treat.

Treatment which is reasonable and has a sound, rational justification will not be negligent. This bill protects doctors who are negligent, not those who take reasonable care.  It replaces the current substantive requirement to give reasonable and rational treatment with a procedural requirement about how to make a decision to treat. Do parents really want that for their children?

Sunday, 16 November 2014

Perception and Reality

"In democratic politics, perception is reality" wrote Lord Saatchi in The Telegraph earlier this year. In his days in advertising and PR he learned all about the power of the word and of the image. We can all remember the line, "Labour Isn't Working" and the images of slashed purple silk used to promote Silk Cut cigarettes, campaigns which won Saatchi and Saatchi many plaudits and awards.

He is now using those skills to promote a change in the law which he claims will help doctors find a "cure for cancer". Virtually every article he has written about his Medical Innovation Bill details his own wife's treatment for cancer and his painful bereavement. His grief is to be respected but his response to those who have the temerity to oppose the bill is not. Supporters of the bill do not have a monopoly of suffering. Just because an opponent chooses not to make public their own private suffering, it does not mean that they are "complacent" or uncaring.

Words do indeed matter. The problem for Lord Saatchi is that judges in court are not interested in how a bill was promoted in the media before it was passed or how it was perceived by the public or politicians - they are interested in the words of the statute itself. 

Strangely, the Medical Innovation Bill does not even define "innovation" or "innovative treatment. I have asked the Saatchi Bill team and various champions of the bill to explain what they mean by "innovative treatment" but they either cannot or will not answer. 

The stated purpose of the bill is to encourage responsible medical innovation but it seeks to do so by introducing a cultural change whereby patients are prevented from suing doctors who harm them by departing from the existing range of "accepted treatments". This exemption could hardly have been drafted more widely. It applies to:

All patients - children and adults, those with capacity and those without.

All conditions - mental or physical, trivial or life-threatening, acute or chronic, curable or incurable.

All treatments - emergency or elective, surgical, medical, conservative or invasive.

All doctors - GPs and specialists, neurosurgeons and cosmetic surgeons, those in the NHS and those in  private practice. Those who believe in evidence-based treatment. Those who have adopted alternative therapies.

And it applies to negligent treatment which no responsible doctor would have given, otherwise there would be no point in the Bill. I am not convinced the definition of negligent treatment is that which falls outside the existing range of "accepted treatments" - the Bolam test is whether treatment was in accordance with a reasonable body of (relevant) medical opinion, it is not a test of what exists as a "standard" or even "accepted" treatment. In any event the Bolitho test exists to allow the courts to scrutinise whether the treatment decision was logical and rational.

When is a treatment "accepted" and when is it a departure from accepted treatment? "Accepted" by whom, by how many and in what manner? Is a small variation from an established treatment, a departure? There is no central register of "accepted treatments"so how will a Judge determine whether any particular treatment was an "accepted" one or not? If Lord Saatchi and his team cannot answer these questions, what chance is there for a doctor contemplating a decision to treat? Or a patient bringing a claim in negligence?

And then there is the wording of the provision requiring a doctor who departs from accepted treatments to make the decision to do so "responsibly". Under the bill the doctor has to "obtain the views" of another doctor who is expert and experienced in treating patients with the condition in question and to take those views into account in a way in which any responsible doctor would do. So, would any responsible doctor take into account whether the other doctor was a close colleague or business partner, had not seen the patient, had not seen the patient's notes, had given a generic view rather than one specific to the particular patient, had not put his views in writing, had no experience and expertise in the particular proposed treatment, or was not a "senior" doctor"? The bill is silent on these important matters. If a cosmetic surgeon in private practice asks his business partner what he thinks of the proposed treatment over a beer in the pub, and he takes those views properly into account, has he complied with the bill's requirements? If not, why not?

Again the Saatchi Bill team appears confused itself as to these requirements. As I write, its website still includes a piece on the legal meaning of "consult" - a word which does not appear in the bill since Lord Saatchi's amendments were accepted.  Elsewhere even after those amendments,  the bill's supporters have claimed that the bill requires doctors to "build a consensus of support" for the proposed treatment amongst other doctors or that a panel of senior doctors has to approve the treatement. Those are interesting readings of the words of the bill but not readings a Judge would be likely to accept!

My colleagues wonder why I am opposing this bill since it is likely to lead to more not less litigation. Many cases of alleged medical negligence will potentially involve examination of the Saatchi defence as well as the Bolam/Bolitho test (if the Saatchi defence fails, then the court will have to go on to consider the Bolam/Bolitho test of negligence). The wording of the bill raises far more questions than answers. Doctors will be less clear as to the law. Patients will be well-advised to ask every doctor who is giving them treatment whether they are proposing "accepted treatment" or not. If not, what steps has the doctor taken to obtain the views of other doctors? Cases are likely to take longer to resolve. Patients whose lives have been ruined by negligent medical treatment, or those who have lost loved ones, will not lightly accept that a doctor reasonably took into account the views of another if the end result was the provision of treatment which no responsible body of doctors would consider acceptable. The issue of consent to treatment will become even more complex, since it will involve providing more information to the patient about the process leading to the decision to treat.

Lord Saatchi has certainly stirred up debate. Not all of it has been edifying but what has emerged, I believe, is a consensus that the focus of attention should not be on the law of negligence but in improving the governance of clinical trials and of the regulatory process. If Lord Saatchi were to propose a commission to look into ways in which to promote responsible medical innovation, then his name could become associated with real and lasting progress.

Thursday, 6 November 2014

Causation, Bailey and Reaney

A recent High Court decision in Reaney-v-UNS NHS Trust raises several interesting issues about the causation and quantification of damages where a negligently caused injury follows from a non-negligently caused one. Perhaps the case will be subject to further analysis in the courts, but it is worth remarking on one aspect of the judgment which concerns the application of Bailey-v-MOD to the causation of loss and damage flowing from an injury or injuries. 

1.   Bailey-v-MOD [2009] 1 WLR 1052, [2009] EWCA Civ 1012 was a brain damage case. There was a single indivisible injury. There were cumulative causes. The negligent cause made a material contribution to the injury. Waller LJ held:

“I would summarise the position in relation to cumulative cause cases as follows. If the evidence demonstrates on a balance of probabilities that the injury would have occurred as a result of the non-tortious cause or causes in any event, the claimant will have failed to establish that the tortious cause contributed. Hotson exemplifies such a situation. If the evidence demonstrates that 'but for' the contribution of the tortious cause the injury would probably not have occurred, the claimant will (obviously) have discharged the burden. In a case where medical science cannot establish the probability that 'but for' an act of negligence the injury would not have happened but can establish that the contribution of the negligent cause was more than negligible, the 'but for' test is modified, and the claimant will succeed.”

2.     So, there are two questions to be asked before the question of material contribution arises.  Further, medical science has to be able to establish that the negligent event made a material contribution. The case clearly concerned causation of a single injury.

3.     Bailey has been applied in Canning-Kishver-v-Sandwell & West Birmingham Hospitals NHS Trust [2008] EWHC 2384 QB and Popple—Birmingham Women’s NHS Foundation Trust [2012] EWCA Civ 1628 Ward J at [78].  The latter case was an obstetric injury case involving the well known “ten minute” rule beyond which acute profound asphyxia will be damaging to the child. There was uncertainty as to whether the period of APA was 15 or 20 minutes in the particular case. If 20 minutes then there was a negligent and non-negligent contribution to the period of damaging hypoxia.  Ward LJ held that “If it did take 20 minutes, the damage done in the last five minutes must have made a contribution to the overall harm which was more than minimal. I cannot see why the Bailey principle does not apply.”

4.     In Dickins-v-O2 plc [2008] EWCA Civ 1144  Smith LJ, giving the lead judgment, questioned whether the trial judge had been right to apportion a psychiatric injury by reference to contributions from its negligent and non-negligent causes. The parties had not taken the point on appeal, but Smith LJ noted Bailey-v-MOD and observed that apportionment is only appropriate where the injury is divisible or where the negligence has exacerbated and existing injury or condition, which she thought might not be the case with a psychiatric injury. The implication is that Bailey may not be applicable in relation to divisible injuries or where the negligent event has aggravated an existing injury. In those cases the material contribution has to be quantified so as to identify the injury attributable to the negligent cause.

5.     There may be some cases where the Court will face difficulty in identifying whether an injury is divisible or indivisible. For example, in brain injury cases the severity of the injury may well be related to the period over which the claimant suffered hypoxia, or, following a brain tumour or injury, raised intracranial pressure. Some of that period may be caused negligently, some non-negligently. Does the difficulty of quantifying the exacerbation or contribution made by the negligent injury thereby identify the injury as indivisible? Is a Claimant better off if the experts say that they cannot quantify the exacerbation than if the experts make a guesstimate of, say 20%? 

6.     In some cases, therefore, the evidence may show that the injury would have been less severe had the negligence not occurred, but the evidence cannot show how much less severe, only that the negligence has made a material contribution to the final outcome.

7.     In the recent case of Reaney-v-University of North Staffordshire NHS Trust [2014] EWHC Civ 3016, the claimant had a pre-existing severe spinal injury but suffered pressure sores due to clinical negligent. The judge found that she had significantly increased care needs as a result. Interestingly however he said that even if he had found that the defendant’s negligence had materially contributed to the need for significant professional care, then following Bailey, the claimant would have recovered damages for such care in full:

“In my judgment, on the evidence, the Defendants' negligence has made the 
Claimant's position materially and significantly worse than it would have been but 
for that negligence. She would not have required the significant care package 
(and the accommodation consequent upon it) that she now requires but for the 
negligence. Had I had any doubts in this case about the issue of causation in the 
"but for" sense, I would have been inclined to find that the Defendants had 
"materially contributed" to the condition that has led to the need for the 24/7 care 
of the nature discussed earlier in this judgment and that the lack of any joint or 
concurrent tortfeasor as a potential direct compensator (and/or from whom a 
contribution might be sought by the Defendants) is no answer to a full claim 
against the Defendants: cf. Bailey v Ministry of Defence. However, as I have 
indicated, I consider that causation is established by what might be termed the 
more conventional route.” [71] Foskett J.

The remarks are obiter only but the Judge appears to have considered that the Bailey principle applied in the realm of quantification of losses and expenses arising out of an injury.  Although the Judge referred to a material contribution to “the condition”, the pressure sores were surely a wholly different injury from the pre-existing paraplegia. It was the care required as a result of both injuries that might have been regarded as indivisible and to which the negligence had made a material contribution. If he is right then that would have important consequences for claims where a negligently caused injury makes a material difference to the care and assistance which the claimant required as a result of a non-negligent condition, even where there are distinct injuries each contributing to the total amount of care and assistance required. That seems to me to be a development of the Bailey principle. It will be interesting to see if it is adopted in other cases in the future.

Friday, 24 October 2014

Protecting the Doctor-Patient Relationship

This week the media has constantly repeated the claim that the Saatchi Bill "protect doctors from litigation" if they try new treatments for terminally ill patients.

It is true that the bill seeks to protect doctors from being sued in negligence. But the following questions might be asked:

1. When could a doctor be sued in negligence?
     A doctor is negligent if he acts in a way which no responsible body of medical opinion would support or which has no rational basis. 

2.  Who would sue the doctor under the current law?
     Only the patient could sue the doctor, or their family if the patient died.

3.  Why would they sue the doctor?
     A patient can only sue a doctor in negligence if they suffered avoidable harm as a result of his or her treatment. The patient's family can sue if the negligent treatment caused the patient's death.

Responsible doctors who are not negligent or who do not harm or kill their patients do not need protecting. Doctors' representative bodies have told the government that the fear of being sued in negligence does not prevent doctors trying new treatments. Unlicensed drugs are commonly used by doctors. Untested treatments should be used with great care (think of Thalidomide if you wonder why). Provided the doctor is not negligent in using untested treatment, he does not need this bill's protection.

The bill protects doctors who act in a way which no responsible body of medical opinion would support and as a result harm or kill the patient they have treated.

As it happens the bill is not restricted to new treatments, nor to treatments of the terminally ill. It applies to any treatment which departs from the existing range of accepted treatment.

A patient who seeks out new, untested treatment; who fully consents to it, and who is then harmed by it is highly unlikely to sue his or her doctor, and even less likely to succeed in such a claim.

A patient whose doctor suggests to them, or sells to them, an untested treatment, which no responsible doctor would have supported, and which then harms them, is more likely to sue the doctor in negligence. This bill would provide that doctor with a "Saatchi defence".

So, the bill protects negligent doctors, and it removes protection from patients who are harmed by negligent doctors.

The Medical Protection Society has warned that this bill threatens the doctor-patient relationship. It is right.

Monday, 13 October 2014

Responsible Medical Innovation

The Medical Innovation Bill will shortly be in Committee stage in the House of Lords. Lord Saatchi has tabled amendments to produce a consolidated bill. Using all his PR experience he has persuaded most of the media (so far) to take a wholly uncritical look at his proposals.

The bill's purpose is to promote medical innovation. It targets clinical negligence law as being, in Lord Saatchi's view, the obstacle to innovation.  Clear evidence from representative bodies such as the BMA, the Academy of Royal Medical Colleges, the NHS Litigation Authority, the MDU and others, that litigation and the fear of litigation are not barriers to innovation has been ignored.

The bill has nothing to say about the regulation of new medicines and devices, about research protocols, professional regulation or funding. Its sole focus is on clinical negligence litigation.

The Current Law

The law of medical negligence is settled and well understood by judges, lawyers and doctors. The test of whether a doctor has been negligent was set down in the case of Bolam-v-Friern Hospital Management Committee [1957] 1 WLR 582 and adapted in the case of Bolitho-v-City and Hackney HA [1998] AC 232.

A doctor is not negligent if he provides treatment to a patient which is supported by a responsible body of medical opinion, even if there are other bodies of medical opinion who would not support it. A doctor is only negligent if no responsible body of medical opinion would support their treatment or if the treatment had no logical or rational justification. If that negligent treatment harms or kills the patient then the patient or their family will be entitled to compensation.

Hippocrates - Do No Harm

The current law does not mandate adherence to a standard treatment.  The Bolam test is flexible and allows for innovative treatment if a responsible body of medical opinion would support it. Clinical negligence law has not halted the incredible advances which have been made in medical practice over the past five decades since the Bolam decision.

The Medical Innovation Bill

The great majority of doctors providing innovative treatment are not negligent. They act in accordance with a responsible body of medical opinion and give treatment which has a rational basis. The Medical Innovation Bill is not intended to affect them.

Instead, the bill seek to change the way the law treats the small minority of doctors who are negligent and who do not act in accordance with a responsible body of medical opinion or who provide treatment which has no rational basis.  Lord Saatchi proposes that those negligent doctors should have an immunity from being sued by patients harmed by their treatment. In short, the bill's recipe for promoting responsible medical innovation is to protect negligent doctors from being sued.

Under Clause 1(2) of the bill a doctor providing treatment would no longer be negligent even if his treatment had no support from any responsible body of medical opinion, indeed even if no other doctor at all supported the treatment. The patients of those doctors will not be entitled to compensation however seriously they are harmed.

I want to be guinea pig 

The bill is heralded on the BBC news website and elsewhere as allowing doctors to give unlicensed drugs to dying patients. Elsewhere it has been said that the bill will allow doctors and patients to experiment with untested treatments. This claim involves several misconceptions.

First, doctors are already permitted to use unlicensed drugs on patients. The GMC guidance on doing so says it is common practice.

Second, the bill is not targeted at patients for whom "standard" treatments have failed, or who have a terminal illness. It applies to all treatment which departs from the existing range of accepted treatments. 

Third, the bill itself does not permit treatment which is purely for experimental purposes - the treatment must be in (what the doctor believes is) the best interests of the patient. If a treatment is "untested" how will the doctor know that it is in a patient's best interests. In other words, the bill does not allow anyone to become a guinea pig, the doctor cannot experiment but must act in the best interests of the patient, not in the interests of research. The doctor will have to rely on tests of the drug to obtain fully informed consent and to determine whether it is in the patient's best interests to give it. This is, in effect, the current position.

Fourthly, at present the only people who could sue a negligent doctor for providing experimental treatment would be the patient, or, if they died, their loved ones. If a doctor says to you that they cannot give a treatment for fear of being sued, they mean being sued by you! A patient who gives fully informed consent to an experimental treatment and who makes it clear they will not sue if something goes "wrong" will have a difficult time in court if they later bring a claim. Of course if the doctor misled them about the risks and benefits, or made a negligent error when administering the treatment, then that would be a different matter. The bill is not intended to affect those cases.

Fifthly, Lord Saatchi says his bill is intended to promote responsible not irresponsible medical innovation. Responsible medical innovation ought to be founded on a relationship of trust between doctor and patient. Why would any patient want to allow their doctor to provide them with treatment which had no rational basis or which no other doctor would support? 

Sixthly, the bill will not provide funds for treatment. Unless the NHS provides the drug or other treatment, a patient will have to pay for it. The bill will not unlock NHS funds for widespread experimentation. 

Finally, experimentation is useful only if it is carried out in a controlled manner where evidence is shared and lessons learned. In contrast this bill will allow individual doctors to carry out experimental treatment outside controlled trials and with no obligation to share information.

New Requirements

In seeking to protect negligent doctors from being sued, the consolidated bill will impose various requirements which are likely to affect all doctors. In response to concerns that the bill would expose vulnerable patients to harm from maverick doctors, the amendments now proposed set out a labyrinth of new procedural requirements. 

The consolidated bill requires that a doctor providing treatment outwith the existing range of accepted treatments must obtain the views of an appropriately qualified doctor and take full account of their views in a way in which any responsible doctor would be expected to take into account such views; that they consider the risks and benefits that are, or can reasonably be expected to be associated with the proposed treatment, the treatments that fall within the existing range of accepted treatments for the condition, and not carrying out any of those treatments, and any other matter that is necessary to consider in order to reach a clinical judgment; and that they take such other steps as are necessary to secure that the decision is made in a way which is accountable and transparent. 

So unclear are these requirements that they are highly likely to lead to more litigation and more red tape.