Autonomybolam Andconsent the End of Medical Paternalism?

AutonomyBolam andConsent – the End of Medical Paternalism?

David Knifton examines the ground-breaking decision of the Supreme Court in Montgomery v Lanarkshire Health Board [2015] UKSC 11

The Bolam Test

Anyone who has ever undertaken a clinical negligence case will be familiar with the Bolamtest, as set out by McNair J in Bolam v Friern Hospital Management Committee [1957] 1 WLR 583:

“[Adoctor] is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art … Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view.”

That test essentially adopted the Scottish decision of Hunter v Hanley 1955 SC 200, in which Lord President Clyde heldthat the true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care. The Bolamtest was approved by the House of Lords in Whitehouse v Jordan [1981] 1 WLR 246, a case involving allegedly negligent treatment, and inMaynard v West Midlands Regional Health Authority [1984] 1 WLR 634, a case involving allegedly negligent diagnosis. The test is not restricted to doctors, but has also been held to apply to any profession or calling which requires special skill, knowledge or experience (Gold v Haringey Health Authority [1988] QB 481).

The test was qualified to some extent by the House of Lords’ decision in Bolitho v City and Hackney Health Authority [1998] AC 232. A court is not bound to hold that a doctor escapes liability for negligent treatment or diagnosis just because he leads evidence from a number of medical experts who are genuinely of the opinion that his treatment or diagnosis accorded with sound medical practice:

“the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis. In particular in cases involving, as they so often do, the weighing of risks against benefits, the judge before accepting a body of opinion as being responsible, reasonable or respectable, will need to be satisfied that, in forming their views, the experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter” (per Lord Browne-Wilkinson at p242-242)

Nevertheless, in the vast majority of cases, the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion, such that it will very seldom be right for a judge to reach the conclusion that views genuinely held by a competent medical expert are unreasonable.

Sidaway

In Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] AC 871, the House of Lords held by a majority that the Bolamtest also applied in relation to a failure to advise a patient of risks involved in treatment (as indeed was one of the allegations in Bolam). In Sidaway, a surgeon did not warn the patient about a less than 1% risk of damage to the spinal cord before undertaking an operation on her spinal column. Medical evidence supported his decision as being in accordance with accepted practice. Lord Diplock considered that decisions regarding the risks a patient should be warned about were as much an exercise of professional skill and judgment as any other part of the doctor’s duty of care, and hence fell to be considered by applying the Bolamtest. Although there was no obligation to provide patients with unsolicited information about risks, he recognised that a doctor might be under an obligation to provide information to a patient who asked questions. Likewise, Lords Bridge and Keith, whilst accepting that an adult patient of sound mind is entitled to decide for herself whether or not to submit to treatment, felt that a decision as to what degree of disclosure of risks was best calculated to assist a patient to make a rational choice must primarily be a matter of clinical judgment. Nevertheless, there would need to be a cogent clinical reason for not informing the patient about a “substantial risk of grave adverse consequences”.

In a dissenting speech, however, Lord Scarman emphasised that the patient’s right to make her own decision was a basic human right protected by the common law, and that her decision whether to consent to the proposed treatment might not depend solely on medical considerations. Thus, Lord Scarman considered that a doctor was under a duty to inform the patient of material risks inherent in the treatment. A risk was material, for these purposes, if a reasonably prudent patient in the situation of the claimant would think it significant. Even then, a doctor would not be liable for failing to warn if he reasonably took the view that a warning would be detrimental to his patient’s health. This so-called “reasonably prudent patient test” has been applied in a number of cases in America, Canada and Australia, but was rejected by the majority in Sidawayas being unworkable.

Criticisms of Sidaway

Changing attitudes towards the “doctor knows best” approach, together with dissatisfaction about placing the onus on the patient to ask questions about risks, when the patient may be in ignorance of such risks, hadled a number of judges to modify the Sidawaytest. In Pearce v United Bristol Healthcare NHS Trust [1999] PIQR P53, the Court of Appeal held that, if there is a “significant” risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for herself what course she should adopt. Thus, the question whether a consultant obstetrician ought to have warned an expectant mother of the increased risk of stillbirth before advising her to await a normal delivery rather than undergoing a caesarean section, was not one to be determined solely by the Bolamtest. On the facts, however, an increase in the risk of stillbirth from non-intervention of 0.1% to 0.2% did not fall within the category of “significant” risk. Likewise, in Wyatt v Curtis [2003] EWCA Civ 1779, the Court of Appeal recognised that a doctor must have regard to what may be the patient’s perception of a risk, before determining whether it is sufficiently substantial to require a warning to be given.

Montgomery v Lanarkshire

In Montgomery, a doctor declined to warn a diabetic woman who was expecting a larger than usual baby that she faced a high (9-10%) risk of shoulder dystocia, on the ground that the risk of grave harm to the baby was very small, and most mothers would elect for a caesarean section (which would not be in the maternal interests) if shoulder dystocia were mentioned. The claimant had expressed concerns about the size of her baby, and asserted that, had she been told about the risk of shoulder dystocia, she would have requested a caesarean section. It was agreed that, had she so requested, she would have been given a caesarean section. In the event, following induction of labour, the baby presented with shoulder dystocia, during which he was deprived of oxygen, leading him to be born with severe disabilities associated with cerebral palsy. The mother’s claim for damages on behalf of her son was rejected by the Lord Ordinary and the Inner House, applying Sidaway, upon the basis that the doctor had acted in accordance with accepted medical practice. The Lord Ordinary also concluded that, even if she had been advised about the very small risk of serious harm to her baby as a consequence of shoulder dystocia, she would not have elected to have a caesarean section.

She appealed to the Supreme Court, inviting it to depart from the decision in Sidaway. She further contended that the Lord Ordinary’s finding on causation was plainly wrong, or that he should have applied the approach adopted in Chester v Afshar [2004] UKHL 41. A seven-judge Supreme Court unanimously allowed her appeal, holding that it was incumbent on the doctor to advise the claimant of the risk of shoulder dystocia and to discuss with her the alternative of delivery by caesarean section. Whilst the risk of grave injury was relatively small, the risk of shoulder dystocia was substantial, with potential risks to the baby or to the mother, such that the exercise of reasonable care undoubtedly required that it should be disclosed. There was no question of the doctor being entitled to withhold such information on the grounds that it might be harmful to the patient’s health. It was the doctor’s responsibility to explain why she considered natural birth medically preferable to caesarean section, having taken care to ensure that the patient was aware of the considerations for and against each option.

On the issue of causation, the Supreme Court held that the lower courts had focused on the wrong issue, namely what the claimant would have done if she had been advised of the minimal risk of a grave consequence. The question should properly have been addressed to her likely reaction if she had been told of the 9-10% risk of shoulder dystocia. On that question, the evidence unequivocally indicated that she would have elected to have a caesarean section. The baby would then have been born unharmed. In those circumstances, it was unnecessary to consider the alternative basis for causation under Chester v Afshar.

The following key points emerge from the judgments:

1. Patients are now widely regarded as persons holding rights, and as consumers exercising choices, rather than as the passive recipients of the care of the medical profession. It is no longer tenable to regard them as medically uninformed and incapable of understanding medical matters (paragraphs 75-76).
2. Guidance issued by the GMC regarding professional practice emphasised the need for a doctor to explain the options to the patient, setting out the potential benefits, risks, burdens and side-effects of each option, including the option to have no treatment, so as to enable the patient to decide which option to accept (paragraphs 77-79).
3. The duty to involve the patient in decisions relating to her treatment has been recognised in judgments of the European Court of Human Rights (paragraph 80).
4. Such social and legal developments pointed away from a model of the relationship between the doctor and the patient based upon medical paternalism, or a model based upon a view of the patient as being entirely dependent on information provided by the doctor. Instead, the law should treat patients so far as possible as adults who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices (paragraph 81).
5. In the law of negligence, this approach entails a duty on the part of doctors to take reasonable care to ensure that a patient is aware of material risks of injury that are inherent in treatment (paragraph 82).
6. There is a fundamental distinction between, on the one hand, the doctor’s role when considering possible investigatory or treatment options (an exercise of professional skill and judgment, governed by the Bolamtest) and, on the other, the doctor’s role in discussing with the patient any recommended treatment and possible alternatives, and the risks of injury which may be involved. The doctor’s advisory role cannot be regarded as solely an exercise of medical skill without leaving out of account the patient’s entitlement to decide on the risks to her health which she is willing to run: “responsibility for determining the nature and extent of a person’s rights rests with the courts, not with the medical professions” (paragraphs 82 to 83).
7. A doctor is not obliged to discuss the risks inherent in treatment with a person who makes it clear that she would prefer not to discuss the matter (paragraph 85).
8. The decision in Sidaway, insofar as it treated the doctor’s duty to advise the patient of the risks of proposed treatment as falling within the Bolamtest, is overruled (paragraph 86).
9. The correct test is as follows:

“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. 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. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it” (paragraph 87).

1. The assessment of whether a risk is material is fact-sensitive, reflecting factors such as the nature of the risk, its effect upon the patient’s life, the benefits of the proposed treatment compared with alternatives, and the risks involved. The assessment of whether a risk is material cannot be reduced to percentages (paragraph 89).
2. The doctor’s advisory role involves dialogue, the aim of which is to ensure that the patient understands and is in a position to make an informed decision. The doctor’s duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp or by routinely demanding her signature on a consent form (paragraph 90).
3. A doctor is entitled to withhold information as to a risk from the patient if he reasonably considers that its disclosure would be seriously detrimental to the patient’s health, or in circumstances of necessity (e.g. where the patient is unconscious but requires treatment urgently) (paragraph 88). It is important, however, that this therapeutic exception is not abused, even where the patient is liable to make a choice which the doctor considers to be contrary to her best interests (paragraph 91).
4. Arguments that this approach was incompatible with the time typically available for a healthcare consultation, that it would be liable to result in defensive practices and an increase in litigation, and that the outcome of such litigation would be less predictable, were rejected (paragraphs 92-93).

Conclusions

The need for informed consent to medical treatment is now firmly part of English law. The age of medical paternalism is over. Whilst I have little doubt that there will be loud protests in some quarters of the medical profession, fears about the floodgates being opened are rarely justified. An approach which recognises the patient’s right of autonomy is to be welcomed. Rather than fearing an increase in litigation, medical professionals should recognise that an approach which involves the patient taking responsibility for choosingwhat form of treatment to adopt, having been made aware of the risks and benefits, may be less likely to encourage claims than an approach which requires the doctor to determine whether a risk should be incurred. Nor should it be thought that doctors will be unfairly disadvantaged by this change in the law. On the contrary, GMC guidance to similar effect has been in publication since the late 1990s. Indeed, even under the Bolamtest, it might be difficult to suggest that any doctor who failed to engage in discussions with their patient regarding the risks, benefits and alternatives to proposed treatment was acting in accordance with responsible and approved practice.

In any clinical negligence case, it is of fundamental importance that the experts address themselves to any contemporaneous published guidance or standards. In my view, even though the Bolamtest no longer applies in circumstances where it is alleged that, due to a failure to warn the patient of a material risk, the patient did not provide informed consent to the treatment, such evidence may prove helpful. Moreover, where the treatment results in an adverse outcome despite having been competently carried out, the claimant may be able to overcome any difficulties presented by the ‘but for’ test of causation by relying on Chester v Afshar. I am currently involved in such a case, in which it is alleged that, had the risks and benefits of an epidural for back pain been properly discussed with the claimant, she would have chosen to delay the procedure until further investigations had been undertaken, which would have shown that the epidural was unnecessary and unlikely to confer any benefit.

Two recent decisions may illustrate how the new approach will be applied. In A v East Kent Hospitals NHS Trust [2015] EWHC 1038, Dingemans J rejected a claim that a pregnant woman should have been warned that the small size of her baby might be due to a chromosomal disorder, leading her to undergo an amniocentesis and termination of the pregnancy, since any risk of a chromosomal abnormality was theoretical or negligible, rather than material, and the medical staff had been entitled to conclude that placental insufficiency was the likeliest cause of the reduction in growth. Moreover, the risks of having a disabled baby would have been greater from amniocentesis than from continuing with a pregnancy involving a negligible risk that the child might have a chromosomal abnormality. In Spencer v Hillingdon Hospital NHS Trust [2015] EWHC 1058, on the other hand, HHJ Collender QC held that a failure to warn a patient of the risk of deep vein thrombosis or pulmonary embolism following surgery to repair a hernia was negligent, since members of the medical profession had a duty to advise and inform patients of anything which the ordinary sensible patient would be justifiably aggrieved not to have been told when fully appraised of its significance. Although the risk was rare, the development of a DVT or pulmonary embolism was a potentially fatal condition that could be successfully treated if diagnosed early, such that it was a breach of duty not to advise the claimant to be aware of such symptoms and urgently to seek medical help if they developed.