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.