Montgomery in the Supreme Court: a new legal test for consent to medical treatment

The Supreme Court has handed down a landmark decision in the case of Montgomery v Lanarkshire Health Board after a hearing before a bench of seven Judges, (including the President and Deputy President) in July 2014. It is worthy of note that all 7 judges were in agreement in allowing the Appeal on all grounds.

The Appellant, Mrs Montgomery, brought this action on behalf of her son Sam who has cerebral palsy. She was represented in the Supreme Court by 3 Counsel and a team of Solicitors from Messrs Balfour & Manson LLP led by Mr Fred Tyler and Ms Joanna McCormack.

The team included both Scottish Advocates and an English QC Mr James Badenoch. Mr Badenoch QC presented the main argument on consent in the Supreme Court and Mr Colin MacAulay QC presented the causation argument. I had the privilege of presenting the first speech for the Appellant in the Inner House of the Court of Session, and I was Junior Counsel for the Appellant in the Supreme Court. Having taught consent for many years it did appear to me that this was an area of the law that required thoughtful review and modernisation.

The facts of the case are relatively straightforward. Mrs Montgomery, is a Type 1 diabetic mother of small stature. It is recognised that diabetic mothers can give birth to larger than average babies. As such they are at risk of complications from vaginal delivery such as shoulder dystocia. This is a condition where the baby’s head is delivered, and the shoulder is stuck on the pubis symphysis. Whilst in this position the baby is deprived of oxygen and this can cause brain damage. There are also risks of brachial plexus injury, and maternal injury should shoulder dystocia occur.

Mrs Montgomery’s pregnancy was managed as a high risk pregnancy by Dr McLellan, Consultant Obstetrician at Wishaw General Hospital. Dr McLellan was well aware of the potential for shoulder dystocia to occur in this pregnancy. It was agreed that that risk of shoulder dystocia was 9-10% in the case of diabetic mothers. Dr McLellan accepted that this was a high risk. She also accepted that shoulder dystocia, (even without injury) is an obstetric emergency and a frightening condition that no mother would wish to encounter.

Dr McLellan said that her practice was not to spend a lot of time, or indeed any time at all, discussing potential risks of shoulder dystocia. She explained that this was because, in her estimation, the risk of a grave problem for the baby resulting from shoulder dystocia was very small. She said that if the condition was mentioned, then everyone would ask for a caesarean section. She felt that it was not in the maternal interests for women to have caesarean sections.

Mrs Montgomery expressed concerns during her pregnancy regarding her ability to safely deliver her baby vaginally. It was accepted that at one clinic visit she specifically asked Dr McLellan what the risks of vaginal delivery were given she was small and the baby large. Dr McLellan’s position was that Mrs Montgomery had not asked her “specifically about exact risks”. Had Mrs Montgomery done so, she would have advised her about the risk of shoulder dystocia, and also about the risk of cephalopelvic disproportion (the baby’s head becoming stuck). Dr McLellan accepted that if Mrs Montgomery had requested an elective caesarean section, she would have been given one.

Mrs Montgomery went through a trial of labour and following delivery of the baby’s head the shoulder became stuck (shoulder dystocia). The staff appropriately performed manoeuvres to disimpact the shoulder. One of these involved cutting through the bone of the mother’s pubis symphysis. There was a 12 minute delay in delivery as a result of which the baby was asphyxiated. Following birth he had to be resuscitated and he now suffers from a brachial plexus injury and cerebral palsy.

Journey to the Supreme Court

This case first came before Lord Bannatyne in the Outer House of the Court of Session CSOH 104. At first instance the case proceeded on two failures by Dr McLellan. The first related to a failure in CTG monitoring during labour. It was argued that despite the fact this was a high risk delivery Dr McLellan failed to respond appropriately to the abnormalities on the CTG tracing and delivery the baby by caesarean section. There was also as a case based on her failure to properly discuss risks with Mrs Montgomery-the consent case. Although both cases were argued in the Inner House, the Appellant made a decision to only proceed with the consent case in the Supreme Court.

Lord Bannatyne based his decision in the consent case primarily on expert evidence of medical practice, following the approach laid down by the majority in Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital AC 871. In terms of Sidaway the medical profession can dictate by practice what risks should be discussed with a patient. It reinforces the application of the Hunter v Hanley 1955 SC 200, 206 or Bolam (Bolam v Friern Hospital Management Committee 1 WLR 582, 587) tests of negligence to the question of consent, unless a claimant can demonstrate that there was a ‘significant’ risk of adverse consequences that should have been discussed. It was only in such circumstances that a court could consider that there was a duty to disclose.In such situations expert evidence is decisive and in terms of the Bolitho test (Bolitho v City and Hackney Health Authority AC 232, 241-243), unless a claimant can demonstrate expert evidence led by a defender can be rejected as incapable of standing up to rational analysis they cannot succeed.

At first instance the Appellant also failed on causation. Mrs Montgomery had been asked in evidence what she would have done had she been advised of the risks and she stated she would have had a caesarean section. She was not challenged in evidence on this assertion by the defenders. Dr McLellan stated in evidence that had she told Mrs Montgomery about the risks of shoulder dystocia she would have no doubt asked for a caesarean section, and she would have given her one. Despite this Lord Bannatyne concluded that, even if Mrs Montgomery had been given advice about the risk of serious harm to her baby as a consequence of shoulder dystocia, it would have made no difference in any event, since she would not have elected to have her baby delivered by caesarean section.

The case was then heard by a bench of three judges in an Extra Division of the Inner House CSIH 3; 2013 SC 245. (Lord Eassie, Lord Emslie, Lord Hardie). When considering the issue of consent, the Inner House was also bound by the decision of the majority in Sidaway. In the Inner House the Appellant attempted to argue that Lord Woolf in Pearce v United Bristol Healthcare NHS Trust ECC 167 had advanced the law from the Sidaway position when he said there was a duty to disclose “a significant risk which would affect the judgement of a reasonable patient”. It was suggested that Lord Woolf had introduced a patient focused test to UK law and modified the test. In England there had been a departure from a strict interpretation of the diverse reasoning in Sidaway and this should be followed in Scotland. The Respondents stated that the law had not advanced from a strict interpretation of the Sidaway position and indeed there was no need to do so. The premise was that it was acceptable that a doctor could decide what risks a patient should be told about.

The Appellant also argued that the risk of shoulder dystocia was a significant risk. In this situation this was a risk that should have engaged the duty to inform the patient irrespective of professional practice. If the focus was the patient it was clear that any mother would wish to know of the risk of shoulder dystocia. The risk of injury following the occurrence of shoulder dystocia was something that was relevant to the consent process and discussion but this was not a risk that was relevant to the engagement of the duty.

The Respondents argued that although the risk of shoulder dystocia occurring was significant it was not that risk that engaged the duty to advise. The doctor could effectively ignore that statistical risk. The relevant risk was the risk of adverse consequence should shoulder dystocia occur. That was a small risk, although they did accept that the consequences included the devastating consequences of brain damage to the baby, brachial plexus injury, maternal injury.

The Inner House followed Sidaway. The evidence was that the profession did not uniformly disclose this risk to mothers and therefore liability could not be established on the basis of the Hunter v Hanley test. They did not accept that Lord Woolf had intended to make any change to the law in Pearce to focus on the patient. The remaining question was whether there was a risk was a significant risk of adverse consequences that would have required the obstetrician to inform irrespective of practice. The Inner House held that although the risk of shoulder dystocia was a significant risk, it was not this risk that engaged the duty of the doctor in law. In their view the risk that required to be considered, was the risk of adverse outcome should shoulder dystocia occur. The potential risk of brain damage was small and therefore liability was not established. They did not consider that the concerns expressed by Mrs Montgomery to Dr McLellan were sufficient to engage the duty to advise her of risks. They also upheld the view of the Lord Ordinary on causation.

The Appellant had a number of arguments on causation. The primary argument was that the Lord Ordinary was plainly wrong in his approach. However the Appellant also sought to argue that there should be strict liability in respect of causation in consent cases, failing which there should be a transfer of onus of proof to the defenders should the failure to provide the patient with the required information to make an informed judgement be proved following principles found in Chester v Afshar UKHL 41; 1 AC 134. Submissions were made on the nature of the approach in consent cases and whether it should be a subjective or objective approach or a combination of both. The Inner House rejected all causation arguments. They did not deal in detail with the causation arguments advanced since the had not been persuaded that they could set aside the decision of the Lord Ordinary.

The argument in the Supreme Court

The Supreme Court was asked to review the current UK law on consent to medical treatment. The journey to the Supreme Court was not automatic as the Appellant required Legal aid to enable him to proceed with his argument. The Respondents opposed the granting of Legal Aid in this case to enable Sam to pursuer his case. A bench of 7 judges was convened as the Supreme Court accepted that the Appellant could argue that the House of Lords case of Sidaway v Board of Governors for Bethlem Royal Hospital and Others 1 AC no longer represented good law and required to be overturned.

The court was invited to re-consider the duty of a doctor towards a patient in relation to advice about treatment. The Appellant invited the court to move towards a patient centred test on consent. The Appellant also argued that the application of the Hunter v Hanley test had no relevance to the issue of consent given the particular nature of this process. The General Medical Council, (GMC) Guidance on consent to medical treatment clearly provided what the professional standard should be. Given the professional standard was clearly stated the only question for the court was a factual one, namely whether the professional standard was met. The Appellant argued that applying a patient focused test the risk of shoulder dystocia was a significant or material risk, and one that any mother would wish to be advised of. The incidence of adverse consequences should that risk materialise was of relevance in the counselling process, but not relevant to engagement of the duty to warn.

The Health Board argued that the decision of Sidaway remained good law and the question was one for a responsible body of medical opinion (Hunter v Hanley test), and not one for the patient. Only “a substantial risk of grave adverse consequences” required the issue to be raised with the patient independent of practice. They claimed that in the absence of a patient asking about specific risks, it was not incumbent upon the doctor to advise of the risk of this risk. They argued that the Consultant had appropriately decided that the risk which engaged the duty to inform was the risk of adverse consequences should the shoulder dystocia arise (e.g. brain damage), not on the risk of shoulder dystocia.

Causation arguments

The Appellant renewed arguments on causation advanced before the Inner House. The primary argument was that the findings of the Lord Ordinary should be reversed on the basis that his treatment of the evidence was plainly wrong. It was also argued that, instead of applying a conventional test of “but for” causation, he should instead have applied the approach adopted in the case of Chester v Afshar. The Respondents argued that the decision of the Lord Ordinary should stand and there were no grounds for interfering with the decision.

Decision of the Supreme Court

In allowing the Appeal the Supreme Court has modernised the law on consent and introduced a patient focused test to the UK law. An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and his/her consent must be obtained before treatment interfering with his/her bodily integrity is undertaken.

The court has recognised that social and legal developments point away from a model of the relationship between the doctor and the patient based upon medical paternalism. The court commend a relationship where patients are treated 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.

It is recognised that a patient also has the right to advise a doctor that he or she does not wish to be advised of the risks of any procedure. It is also recognised that in some cases the doctor may withhold information on risks if it is considered that it would be seriously detrimental to the patient’s health, the so - called therapeutic exception. The therapeutic exception will apply in only exceptional cases.

In giving effect to the rights of the patient in this area the Supreme Court have taken account (as they were asked to do by the Appellant) of the provisions of the Human Rights Act 1998. The right to self determination is an important right as Lord Scarman pointed out in Sidaway. (see also S (An Infant) v S AC 24, 43 per Lord Reid; McColl v Strathclyde Regional Council 1983 SC 225, 241; Airedale NHS Trust v Bland AC 789, 864 per Lord Goff of Chieveley). The right to respect for private life is protected by article 8 of the European Convention on Human Rights. The resulting duty to involve the patient in decisions relating to treatment has been recognised in judgments of the European Court of Human Rights, such as Glass v United Kingdom (2004) EHRR 341 and Tysiac v Poland (2007) 45 EHRR 947. The same value is also reflected in article 5 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, concluded by the member states of the Council of Europe, other states and the European Community at Oviedo on 4 April 1997.

The Supreme Court has not applied the law retrospectively. What they have done is apply the standard of the GMC at the relevant time to the facts of this case. The GMC have made clear for many years clear what is expected of doctors in terms of consenting patients. Guidance is freely available on their website for those interested. The practical difficulty has been that the law has lagged behind. The Supreme Court has now given legal effect to what the GMC would wish as a professional standard from their doctors.

The Supreme Court was fortunate in having submissions from Andrew Smith QC on behalf of the GMC as interveners. The expectation of the GMC was that a doctor has a professional and ethical duty to fully advise a patient of the options for treatment, the risks of each option and the benefits of the option, and it was then for the patient, (not the doctor) to advise which option they wished to choose. The GMC submitted that an approach based upon the informed involvement of patients in their treatment, rather than their being passive and potentially reluctant recipients, can have therapeutic benefits, and is regarded as an integral aspect of professionalism in treatment.

An extract from the Guidance is repeated in the judgement and is useful in highlighting what is required from a doctor.

“The doctor explains 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. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them. The patient decides whether to accept any of the options and, if so, which one.”

The GMC document advises that the doctor must tell patients if treatment might result in a serious adverse outcome, even if the risk is very small, and should also tell patients about less serious complications if they occur frequently.

What then of the ‘Bolam’ or ‘Hunter v Hanley’ test of negligence? The Supreme Court have accepted the submission of the Appellant and firmly rejected the ordinarily competent practitioner test as applicable to the issue of consent. The key is the nature of the consent process and the fact that its exercise does not depend exclusively on medical considerations. The court accepted the argument that there was a fundamental distinction between, on the one hand, the doctor’s role when considering possible investigatory or treatment options and, on the other, the role in discussing with the patient any recommended treatment and possible alternatives, and the risks of injury which may be involved. Whilst skill may be involved in discussing risks this is not the skill of the kind with which the Bolam test is concerned. They said:

“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 (a decision which may be influenced by non-medical considerations). Responsibility for determining the nature and extent of a person’s rights rests with the courts, not with the medical professions.”

“Furthermore, because the extent to which a doctor may be inclined to discuss risks with a patient is not determined by medical learning or experience, the application of the Bolam test to this question is liable to result in the sanctioning of differences in practice which are attributable not to divergent schools of thought in medical science, but merely to divergent attitudes among doctors as to the degree of respect owed to their patients.”

The Supreme Court did accept that in England the lower courts in recent years had tacitly ceased to apply the Bolam test in relation to the advice given by doctors to their patients, and had effectively adopted the approach of Lord Scarman who was in the minority in Sidaway. They agreed that Lord Woolf had in fact moved away from and refined the Sidaway test in Pearce rejecting the Respondent’s submissions on this point in the Inner House. What the Supreme Court has done now is to remove any dubiety on this issue and provided a firm statement of the law. As Lady Hale said:

“A combination of the 2008 Guidance provided by the General Medical Council, the decision of the Court of Appeal in Pearce v United Bristol Healthcare NHS Trust PIQR P 53 and the decision of the House of Lords in Chester v Afshar 1 AC 134 meant that it could now be stated “with a reasonable degree of confidence” that the need for informed consent was firmly part of English law. This case has provided us with the opportunity, not only to confirm that confident statement, but also to make it clear that the same principles apply in Scotland.”

What must a doctor now do in exercise of his duty of care when consenting a patient? He must follow the guidance of the GMC since that is his professional standard. This is evidence of the standard and expert evidence is not required on this issue. There can be no logical expert opinion in any event that would suggest a doctor could ignore the GMC Guidance.

The doctor is 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. Evidence may be required from experts on the existence of risks. This would be factual evidence. Often risks of treatments are narrated in standard textbooks. The risks of the alternative or variant treatments should be explained to the patient. The question of what alternative treatments could be available is a question of fact. Expert evidence may of course be relevant on this factual issue. However the question is not what alternatives the ordinarily competent doctor would advise of. The expert evidence in my opinion can no longer be subjected to the Hunter v Hanley, Bolam or Bolitho tests. What the Supreme Court have done is to clearly state that this is not a question for medical experts nor the profession to decide.

The doctor must record details of the consent process including the risks and options discussed within the clinical notes. The requirement on record keeping is firmly enshrined in the GMC Guidance on Record Keeping. This is a professional standard that must be complied with.

The test of materiality has been refined and focused but again the focus is on the patient and what the patient would want to know. The focus is not what doctors generally consider are material risks nor what the “ordinarily competent” doctor would consider a material risk. 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. What is material to one patient may not be material to another and this requires that the doctor engage with the patient in question. The doctor requires to find out what it is that is of concern to the patient. It is not for doctors nor experts to decide what the reasonable patient in the patient’s position would want to know. This approach would simply to be reinstating Hunter v Hanley by the back door.

It is accepted law that where a patient asks a question the doctor must answer truthfully. Not all patients feel able to ask questions. These patients should not be relegated to a different class when receiving information from their doctor. The onus is not on the patient to find the correct expression of words to require a doctor to answer truthfully on risks. The onus is now firmly placed on the doctor to find out what their patients want to know.

The question of whether a risk is of importance is now not reduced to percentages or medical evidence on the statistical probability of a risk. This is important because lawyers and doctors often become focused on the issue of percentages as a justification for a failure to inform. The court has recognised that the significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available and the risks involved in those alternatives. The assessment is therefore fact-sensitive and sensitive to the characteristics of the particular patient. The doctor’s role is advisory and involves dialogue. The court has specifically stated that a patient must not be bombarded with technical information. A signature on a consent form will also not signify that a patient has been appropriately informed.

The question to be asked 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. Alternatively should the doctor have been reasonably be aware that the particular patient would be likely to attach significance to it. The court does not use the ‘ordinarily competent’ test we are familiar with in this context. Given what is said by the court such generalisations cannot be appropriate. I have read suggestions that this test in some way applies following the decision and I would respectfully suggest this premise proceeds upon a clear misunderstanding of the decision of the Supreme Court.

To conclude the Supreme Court have swept away the application of the Hunter v Hanley or Bolam tests of negligence which apply the ‘ordinarily competent” test to the law. This must be a correct approach, since as the Court states an application of the Bolam test to this question is liable to result in the sanctioning of differences in practice which are attributable not to divergent schools of thought in medical science, but merely to divergent attitudes among doctors as to the degree of respect owed to their patients. In the first judicial move away from Bolam they firmly state “There is no reason to perpetuate the application of the Bolam test in this context any longer.” Lady Hale stated that once the argument departs from purely medical considerations and involves value judgments of this sort, it becomes clear, that the Bolam test, of conduct supported by a responsible body of medical opinion, becomes quite inapposite.

Applying these concepts in Mrs Montgomery’s situation it is clear simply on the facts of the case that Mrs Montgomery did have the right to be advised of the risk of shoulder dystocia, and she had the right to make her own decision on what risks she was prepared to undertake in terms of the delivery. The court accepted her unchallenged evidence that had she been properly advised of risks she would have opted for caesarean section. In this situation there was no dispute that her child would have been uninjured.

The Supreme Court has recognised that the change in focus might not be welcomed by some healthcare providers, but commented that the reasoning of the House of Lords in Donoghue v Stevenson was no doubt received in a similar way by the manufacturers of bottled drinks.

In respect of causation the detailed causation arguments advanced by the Appellant the Supreme Court did not feel it required to address these since it was concluded that the Lord Ordinary had erred in application of traditional principles. The arguments made on causation by the Appellant remain live for another case and another separate article.