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Introduction to the second set of articles
In this second series of articles, we cover what’s new in consent and some legal views on the controversial subject of futility.
Paul Sankey – a lawyer – explains The ‘Montgomery’ Case, and its impact on how we should obtain consent from patients. The ruling legally formalises the concept that a patient should be aware of any risks that might be important to them as an individual. You can’t avoid telling a patient a risk just because you think they might not want to know. However, it doesn’t mean you can just recite a whole list of risks and then consider this informed consent!
Many would feel it wrong (for the individual, and to greater society in terms of care costs) to
Finally, Andrew Hannam – a lawyer – discusses the tragic case of
Doctors’ duties in obtaining consent: How the law has changed
Introduction
A doctor’s duty in advising patients changed significantly in March 2015 when the Supreme Court ruled in Montgomery v Lanarkshire Health Board. The decision is an important one for all doctors.
The facts
The case concerned obstetrics. Nadine Montgomery gave birth to Sam in hospital in Lanarkshire in October 1999. The risk of shoulder dystocia was high at around 9–10% because of her type 1 diabetes and small stature. Her obstetrician neither warned her of this risk nor suggested Caesarean section. Her reason was that most women like Mrs Montgomery would elect for Caesarean section in these circumstances, but this was ‘not in the maternal interest’. In effect, it was the doctor rather than her patient who decided, without consultation, what was best.
Unfortunately, the complication arose. Sam suffered a hypoxic injury from shoulder dystocia left him with cerebral palsy.
Mrs Montgomery alleged that she had not been adequately advised and that, given proper advice, she would have elected for Caesarean section. Her claim failed in the lower courts. The reason is worth examining.
Why the claim failed in the lower courts
The claim initially failed because the court applied the Bolam test regarding a doctor’s duty to advise. This test was developed in 1957 as a test of negligence. There was no negligence if a doctor acted in accordance with a practice accepted as proper by a responsible body of medical practitioners skilled in that art. In effect, it let the medical profession set its own legal standards as to what is acceptable practice.
The test was applied in Bolam not just for diagnosis and treatment but also to advise. The lower courts in Montgomery followed Bolam. They found that the obstetrician’s advice had been in line with that of a responsible body of obstetricians. The fact that a reasonable patient like Mrs Montgomery would have wanted to know more was irrelevant.
Allowing doctors to decide what a patient should be told might have seemed right in 1957, but today it sounds rather paternalistic. We now regard autonomy as an important value and people are used to having choice. In fact, the GMC advises doctors to [w]ork in partnership with patients. Listen to, and respond to, their concerns and preferences. Give patients the information they want or need in a way they can understand. Respect patients’ right to reach decisions with you about their treatment and care.
The Supreme Court decision: the new test
The Supreme Court recognised that it was time for the law to catch up with the GMC’s guidance. It found that Mrs Montgomery had not been properly advised and had therefore not given proper consent to vaginal delivery.
It rejected the Bolam test’s application to advice and consent (but not diagnosis and treatment). It laid down the following principles (the numbering and lettering is mine):
An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. If there is anything new here, it concerns choice. A doctor’s obligation is not just to obtain consent to treatment but also to advise options. Patients must be able to exercise choice, even if the only alternative to treatment is no treatment. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. Note that this is not an absolute duty. The duty is to do what is reasonable. It requires a doctor to explain the material risks of the various possible options. So what makes a risk material? The test of materiality is whether, in the circumstances of the case: (a) a reasonable person in the patient’s position would be likely to attach significance to the risk, or (b) the doctor is or should reasonably be aware that the patient would be likely to attach significance to it.
The test looks complex at first sight. Part (a) is a largely objective test. It asks what a reasonable patient like this patient would think significant. Part (b) applies where the doctor knows that a risk might be significant to this patient even though the ‘reasonable patient’ would disregard it.
The exceptions
The Supreme Court gave three exceptions to the general rule:
Where a patient tells a doctor that (s)he does not want to know the risks. The ‘therapeutic exception’: i.e. if disclosure of the risk would be seriously detrimental to a patient’s health; and Necessity: for instance, an unconscious patient requiring urgent treatment.
These exceptions should be regarded narrowly.
Some implications
Below are some suggested implications:
The consent process may need to take longer. The court expects you to take time to understand your patient’s concerns. You will need to know what is material to your patient and you can only do so through discussion with her. The courts expect there to be a process of dialogue. They may be sympathetic to doctors personally who feel they are allowed too little time with patients. But the right of patients to be properly informed will prevail. You should ensure that the patient has choice, even if the alternatives are ones you would not recommend. Of course, you can guide a patient to understand why one option is better, but the patient must know enough to make her own decision. The discussion should take place as early as possible. Your patient may need time to reflect. If possible, you should avoid leaving the discussion until just before surgery. In one case, a patient’s decision made immediately before surgery when she felt committed was found not to have been made freely despite her signed consent form. You should record not just risks but the dialogue with your patient. The court wants to know that a discussion has taken place and a consent form alone will not be enough. Your records should show that you have made an effort to listen to your patient. It would be wise to record her concerns as well as your advice. This means that consent forms will be of limited value. You do not have to advise of every risk. Assessing risk requires skill. It is not easy. You should not make it harder for your patients by telling them of every risk whether material or not. The court does not want patients blinded by science. It expects you to exercise judgement in the light of the discussion with your patient. How much advice is required for minor procedures? The answer is probably less than for major ones, but you must consider what the patient would consider material. The duty is to take reasonable care. What is reasonable will vary between patients and between different types of procedure. What about giving anaesthetics to facilitate another procedure? The Association of Anaesthetists of Great Britain and Ireland considers that a separate consent form is not required. However, consent must still be given whether oral or written.
Guidelines
The Association of Anaesthetists of Great Britain and Ireland produced new guidelines in January 2017. They are excellent and reflect the changed law following the Montgomery decision.
Conclusion
The decision in Montgomery represents a very significant change in the law. It redefines a doctor’s legal duty in advising and obtaining consent to treatment. It moves from a clinician-centred approach, where doctors within a discipline generally set the standard, to a patient-centred approach. What the Supreme Court thought it was doing was to bring the law into line with what GMC said was practice. To what extent it leads to a change on the ground probably depends on whether the GMC was right.
Paul.Sankey@enablelaw.com
Paul Sankey is an experienced medical negligence solicitor and partner at Enable Law. He acts for patients and has particular expertise in claims for adults with brain injuries, amputations and cases concerning the delayed diagnosis of cancer. He has lectured and published extensively particularly on consent to medical treatment. He is a member of the specialist AvMA (Action against Medical Accidents) and SRA (Solicitors Regulatory Authority) clinical negligence panels.
When clinicians think treatment futile but the family disagree: How to resolve the impasse
An elderly patient is admitted to hospital gravely ill. He has been declining physically and mentally over recent years. He has needed increasing social support and has had increasingly frequent hospital admissions. His family want to save his life. They want him to have the full gamut of interventions the Intensive Care Unit (ICU) can offer. As the ICU clinician, you think treatment futile, intrusive and overly burdensome. It would cause suffering and would not lead to survival to hospital discharge. You could not reverse the trajectory of decline. The patient lacks capacity. The family will not agree with you. You don’t want to be forced into a path of treatment you think inappropriate but fear a complaint or worse – a court claim or GMC action – if you do not accede to the family’s demand.
Who decides? What does the law say and how can it help to resolve the impasse?
The law: Who decides?
If a patient has capacity,1 a doctor can only treat them if they consent, and the patient can then decide which of the available forms of treatment to undergo. But those treatments must be reasonable options. Doctors cannot be compelled to provide a treatment they think simply should not be given.
If the patient lacks capacity, doctors still cannot be forced to provide inappropriate treatments. However, the situation relating to input from the patient’s side is more complicated.
The patient may have made an advance decision – most often about what treatments they do not want. If the decision is effective (the Mental Capacity Act 2005 sets out the requirements) and covers the issue, it will be binding. The patient may have granted a Lasting Power of Attorney (LPA). If so, the attorney can make the decision but must do so in the patient’s best interests (need JICS reference). If neither apply – there is no advanced directive, and no LPA – a decision must be made by others – normally the treating clinicians and the family together. Just as for the LPA, the treatment decision must be based on what is in the patient’s best interests.
The law: determining best interests
We have previously discussed the importance of best interest1 and how one might determine it.
The Mental Capacity Act 2005 (MCA) contains a checklist of factors to consider. Every case will be different and the checklist will lead to different results in different cases. In cases where clinicians feel that care is not in the patient’s best interests, the MCA suggests the following:
There should be no motivation to bring about the patient’s death: the question is not whether it is the patient’s best interests to die, but whether it is in their best interests to try to prolong life. Assumptions about the patient’s quality of life should not be made. For instance, just because a completely independent patient may be totally dependent if they survive treatment (living in a nursing home and tube fed), this should not automatically suggest that treatment be withheld.
There is a strong presumption that it is in the patient’s best interests to stay alive. Thus, whilst the courts place great weight on the sanctity of life, delivering life-sustaining treatment will not always be in the patient’s best interests (see The Charlie Gard case, below. However, this is only a presumption. It can be displaced by evidence to the contrary. A ‘holistic’ approach is required, which involves weighing past stated views and outlook, cultural, religious and social factors, prospects of recovery, and quality of life as well as longevity. Treatment may be futile, overly burdensome, painful or pointless. The patient’s wishes carry great weight but again they are only part of a bigger picture. They need to be balanced against other factors. The test is not therefore reduced to what the patient would have chosen.
There is no ‘simple formula’. Every case is different. Clinicians and the family may weigh these factors and come to different conclusions. What happens when this occurs, and when you and the family still cannot agree?
How to resolve disagreement
Meet the family and involve others in the Trust to help communication in a ‘Best Interest’ group. Undermine any feeling of ‘us and them’. Get a second and independent medical opinion. This can be reassuring for clinicians and provide the family with another view to consider. Try mediation. Mediators are independent third parties. They do not take sides but help the parties communicate and reach agreement. In one recent case, the judge commented on the fact that the family – who wanted treatment – had not understood until a late stage quite how unpleasant that treatment was. ‘The realisation that deep suctioning causes pain… has come late in the day’. One wonders whether better communication earlier would have resolved the dispute. If necessary, make an application to the Court of Protection. This is not an admission of failure. Until the recent decision of MvA Hospital (2017) EWCOP 19 (Peter Jackson J), an application was thought to be mandated where the decisions concerns withdrawal of clinically assisted nutrition and hydration from patients in permanent vegetative or minimally conscious state. There is now some uncertainty on the point (see The Charlie Gard case, below), but the best approach until the law is clarified is probably to make the application. For the family to engage lawyers may help them to reflect on their perspective and promote the patient’s best interests. Note that the Court of Protection can decide whether a particular treatment is in the patient’s best interests, but it cannot compel doctors to treat someone any more than the patient, had he or she had capacity, could have done. The Court of Protection can only consent to treatment to which the patient could have consented.
Don’t make the wrong decision for the wrong reasons. Patients should not be subjected to futile and overly burdensome treatment, because it seems like the easier option. Whilst the law upholds the sanctity of life, it recognises that there are times when the downside of treatment for the patient is just too high.
What about the urgent decision in the middle of the night
Suppose the elderly patient arrives in the middle of the night and a decision really needs to be made urgently. You don’t have time for long discussions and reflection. There isn’t time to mediate. The principles are no different:
Your aim must always be to act in the patient’s best interests bearing in mind the presumption in favour of preserving life – this may involve taking steps that preserve the status quo pending a considered decision being reached either by the Best Interest group or, in default of agreement by a judge (yes – they can be reached as emergencies in the middle of the night – see below). You should still do your best to reach a consensus with the family but if you cannot, neither the family nor the court can compel you to provide a treatment, which is not clinically justified. A second opinion from a colleague (consultant on call or another consultant) may help you know you have made the right decision and may help reassure the family. It is always better not to have to make these decisions alone particularly when it is late and you are tired. Ultimately if you cannot reach agreement on the patient’s best interests, your legal department should be available to make an emergency telephone application to the Court of Protection. There will be a judge available even in the middle of the night.
Paul.Sankey@enablelaw.com
The ‘Charlie Gard’ case: What are the medicolegal lessons?
Charlie Gard was born on 4 August 2016, a ‘perfectly healthy’ baby at full term. However, at about 1-month old, Charlie’s parents noticed that he was less able to lift his head and support himself than other babies of a similar age. He was diagnosed with a rare inherited disease – infantile onset encephalomyopathy mitochondrial DNA depletion syndrome (MDDS).
This condition causes progressive muscle weakness and brain damage. He developed respiratory failure and in October was transferred to Great Ormond Street Hospital (GOSH) where his condition deteriorated, and he subsequently became ventilator dependant. In February 2017, following 5 months of treatment, the hospital applied to the courts to withdraw life sustaining treatment as they felt that Charlie had a negligible chance of recovery, was ventilator dependant, and unable to react in any meaningful way although there remained the possibility he might experience pain. Thus commenced a 6-month court battle – culminating in a final decision from the European Court of Human Rights. Charlie’s parents were adamant that every conceivable medical avenue to sustain Charlie’s life was explored, and the hospital were defending their decision that any possible experimental treatments would not improve Charlie’s quality of life and the correct option was to withdraw life sustaining treatment.
What issues did this case raise?
The domestic Courts and the European Court of Human Rights were tackling the difficult and emotionally charged issue of when it was appropriate to withdraw life sustaining treatment for a child/when is it appropriate to expose the child to experimental treatment in the hope of saving/prolonging life. Proceedings began in February 2017 when GOSH made an application to the High Court for an Order stating that it would be lawful and in Charlie’s best interest for artificial ventilation to be withdrawn and palliative care provided. The application was opposed by the parents. The question of possible nucleoside therapy was raised by the parents as the proceedings progressed and additional information was put before the High Court. In its final judgement, the High Court Order included a third element that it would not be in Charlie’s best interest to undergo nucleoside treatment.
During the first High Court proceedings in April 2017, GOSH presented medical evidence that Charlie could not move, had no sleep/wake cycle and could probably experience pain but was unable to react to it in a meaningful way. They contended that there was no further treatment available, which could improve his situation.
Charlie’s parents obtained support from an expert in America who was prepared to offer Charlie nucleoside therapy. There was no suggestion that there could be any reversal of the structural damage to Charlie’s brain and the probability of benefit was described as ‘low but not 0’.
Charlie’s guardian, appointed by the High Court, argued that it was not in Charlie’s best interests to travel to America to receive purely experimental treatment with no real prospect of improving his condition or quality of life.
On 11 April 2017, Mr Justice Francis stated during his decision that the welfare of the child is paramount, with the starting point being the strong presumption of the sanctity of life, and a course of action which will prolong life. He confirmed that determining Charlie’s best interests required consideration of medical, emotional and all other welfare issues. He concluded that it was not in Charlie’s best interest for him to be taken to the USA – a process described as ‘problematic, but possible’. He went on to state that the independent judgement of the Court, exercising its objective judgement in the child’s best interest, overrides the will of parents.
The decision of the High Court was appealed to the Court of Appeal on the basis that the High Court Judge had made an error by relying on the ‘best interests’ test alone. It was argued that different approaches should be taken where the proposal contemplates a viable alternative option. The parents argued that if such an option were available, the preferred treatment should only be overridden if it is established that the option would likely cause the child ‘significant harm’. The parents were relying on Articles 2, 5 and 8 of the European Convention on Human Rights.
On 23 May 2017, the Court of Appeal found that the High Court was entitled to conclude that the nucleoside treatment option would be futile and would have no benefit. The case then proceeded to the Supreme Court where on 8 June 2017, it concluded that ‘the European Court of Human Rights has firmly stated that in any judicial decision the child's rights must be the paramount consideration. If there is any conflict between them the child’s interests must prevail’. The Supreme Court also reiterated the findings of the Court of Appeal that even if the ‘best interests test were replaced with a test of significant harm’, it is likely that Charlie would suffer significant harm if his present suffering was prolonged without any realistic prospect of improvement.
The family then appealed to the final arbiter in such decisions – The European Court of Human Rights.
The case was heard before the European Court on 27 June 2017 and concluded that it would not interfere with the domestic courts’ decision. The European Court did address the issue as to whether or not the appropriate test was whether the decision should be taken in the child’s ‘best interest’ or whether the Court should consider there is a risk of ‘significant harm’. In its judgement, it did say that there was a broad consensus in support of the idea that in all decisions concerning children their best interest must be paramount. The Court went on to say that the facts of the present case were exceptional and there was therefore a lack of guidance in the courts case law on this point. The Court concluded that it did not need to determine, which was the appropriate test, because it was clear from the decisions of the Court of Appeal and the Supreme Court that there was, in any event, a risk of ‘significant harm’ to Charlie.
The case came back once again before Justice Francis in July 2017 as a result of an application by GOSH for a reaffirmation of the original decision. This step was taken because of the possibility of further medical evidence, which might have changed the balance in favour of extending treatment. In particular, the possibility of nucleoside therapy in the USA or Italy being of benefit.
A multi-disciplinary meeting was held at GOSH, which concluded that further MRI scans were required. The scans suggested that Charlie was beyond any help even from experimental treatment and that it was in his best interests to be allowed to die. As a result, the judge confirmed the original decision to withdraw life sustaining treatment and appropriate court Orders were made.
The judge was very critical of the involvement of social media in the case and the number of ill-informed comments and even threats made to medical staff. He also reiterated his plea made at the end of the first substantive hearing for greater use of mediation in such cases. I recognise, of course, that negotiating issues such as the life or death of a child seems impossible and often will be. However, it is my clear view that mediation should be attempted in all cases such as this one even if all that it does is achieve a greater understanding by the parties of each other’s positions. Few users of the court system will be in a greater state of turmoil and grief than parents in the position that these parents have been in and anything which helps them to understand the process and the viewpoint of the other side, even if they profoundly disagree with it, would in my judgment be of benefit and I hope that some lessons can therefore be taken from this tragic case which it has been my duty to oversee.
A. In general, the most important test for considering continuation of care is what is in the patients’ best interest (regardless of age), but the issue of whether continuing care is leading to significant harm is also relevant. In this case, GOSH argued that continuing care was indeed leading to significant harm to Charlie, but the courts have not clearly ruled on whether in general this is a valid argument. Future cases may determine this.
Mr Justice Francis highlighted that the services of a mediator would likely have produced a greater degree of shared understanding, and potentially limited some of the heartache involved in the proceedings.
A. The best interest/significant harm issue is one that is likely to be considered in the future – in cases where there is a viable alternative treatment option.
A. It is clear from the domestic judgements in the Charlie Gard case and decisions proceeding it (such as An NHS Trust v MB (2006) 2 FLR 319) that the courts will meticulously examine cases where hospital trusts are seeking permission to withdraw life sustaining treatment and where the continuation of treatment is futile.
The consensus for decision making in general therefore remains what is in the (Child's) best interest. However, in limited circumstances, where a viable treatment option is available, the test for significant harm may be used. However, in Charlie’s case the potential treatment was considered neither viable (charlie's neurological condition was considered beyond any help) or in his best interests, as prolonging treatment would have caused him significant harm.
A. Yes, where the issue relates to cases where there is a potential viable alternative treatment (which may be quite experimental) and, if so, whether the appropriate test should be whether it would be in the child’s best interest or whether it would put the child at risk of suffering significant harm.
A. Both domestic and the European courts require extensive expert evidence and, whilst expensive, it is clear parties will be expected to provide this evidence to enable the court to reach its conclusions.
A. Mediation may be a useful approach particularly if used early in cases assisting in better mutual understanding between families and clinicians and therefore potentially avoiding the significant costs and trauma of a prolonged legal battle.
A related issue was raised in the case of MvA Hospital (2017) EWCOP 19 (Peter Jackson J) where there was consensus between the family and the treating clinicians about the appropriateness of withdrawing clinically assisted nutrition and hydration (‘CANH’) from patients in a permanently vegetative state (‘PVS’) or minimally conscious state (‘MCS’). The previously accepted wisdom was that in such circumstances the court had to be involved. In this case, however, the judge opined that: a decision to withdraw CANH, taken in accordance with the prevailing professional guidance – currently the GMC’s Good Medical Practice guidance, the BMA guidance ‘Withholding and Withdrawing Life-prolonging Medical Treatment’ and ‘End of Life Care’ and the Royal College of Physicians’ Guidance on Prolonged Disorders of Consciousness – will be lawful and the clinicians will benefit from the protection of s.5.
The consequence of this was that the court would not have to be involved. Unfortunately, these comments were not a required part of the decision and as such there is ongoing debate as to the effect of this comment. This may ultimately be an issue resolved by parliament which has before it the draft Mental Capacity (Amendment) Bill proposed by the Law Commission, which includes proposals to limit the scope of the s.5 MCA 2005 defence so as to enshrine more robust safeguards in law. For the moment, though, while judicial opinion appears to be moving in that direction it is a brave Trust lawyer that advises proceeding without Court sanction.
Andrew.Hannam@enablelaw.com
Andrew Hannam is a partner in the Enable Law team. He undertakes a broad range of Health Care work in the High Court, Court of Protection and Coroners Courts. He is a mediator with Trust Mediation undertaking a number of Clinical negligence mediations under the NHS Resolution scheme and an accredited mediator with the Civil Justice council.