By Claudia Carr, Senior Lecturer, University of Hertfordshire

Further developments in informed consent and information disclosure: the Supreme Court case of Montgomery v Lanarkshire Health Board (Scotland) 2015

By Claudia Carr, Senior Lecturer, University of Hertfordshire

Introduction

The recent successful appealto the Supreme Court inMontgomery v Lanarkshire Health Board (Scotland)[i]appears to provide both medical professionals and patients with greater clarity where the test of informed consent is concerned. The judgment, however, should not be seen as a novel breakthrough rather than the next instalment in the development of informed consent in Scotland, which began with Sidaway v Board of Governors of the Bethlem Royal Hospital[ii] in England in 1985.

The facts - Montgomery v Lanarkshire Health Board (Scotland) 2015

Mrs Montgomery was a highly qualified, intelligent scientist who wasslight of stature and an insulin dependent diabetic. Her son was born naturally on 1stOctober 1999 but during labour he suffered complications when his shoulders became lodged in Mrs Montgomery’s pelvis[iii], as a result of which, the umbilical was obstructed, either completely or partly which deprived him of oxygen. As a result of oxygen deprivation, he suffered from cerebral palsy affecting all four limbs together with paralysis of the arm. Mrs. Montgomery sought damages for the injuries he suffered during his delivery, alleging that Dr McLellan, the consultant obstetrician and gynaecologist whose care she was in and who delivered the baby, was negligent.

The issues

Mrs Montgomery alleged that she should have been advised of the increased risk of difficulty of the baby’s shoulder passing easily through her pelvis and therefore should have been advised of the alternative of a caesarean section. If the baby had been delivered by caesarean section, he would have been born free of injury.

This was Mrs Montgomery’s first baby and in cases where women are insulin dependent diabetes, they are likely to have larger than normal babies with an increased risk of 9-10% of dystocia occurring. Whilst in non-diabetic women, it is usually the baby’s head which is the widest part, in the case of diabetic women; the widest part may be the shoulders. During labour, the head could be delivered, but the shoulders could then be too wide to move through the pelvis, creating a medical emergency, known as shoulder dystopia which was described by one medical expert as ‘a major obstetric emergency associated with a short and long term neonatal and maternal morbidity..’[iv]

In cases of shoulder dystocia there is an 11% risk of the mother suffering a post-partum haemorrhage and a 3.8% risk of fourth degree perineal tears. Although various manipulations can be carried out to free a baby suffering from shoulder dystocia, there are associated risks for the baby such as a broken shoulder or nerve damage. In a very small amount of cases (0.1%) there is also the risk of the umbilical cord becoming obstructed which can then cause the baby to suffer from hypoxia, resulting in cerebral palsy or death.

Mrs Montgomery had been advised that she was having a larger than normal baby and although Dr McLellan accepted the degree of risk of shoulder dystocia during labour was 9-10%, she argued that the subsequent risk of a ‘grave’ problem was so small that she did not advise her patients of the risk of shoulder dystocia. Her reasoning was that if she advised the mother of the risk, she would ask for an elective caesarean section, which Dr McLellan considered was not in the maternal interest.

Despite Mrs Montgomery’s concerns about the size of the baby, she had not asked specifically about the precise risks, although in evidence it was accepted that had she asked she would have been told about the risks of shoulder dystocia. Had she been told, Mrs Montgomery said she would have asked specific questions and if she thought it was a significant risk to her, she would have asked to be delivered by caesarean section.

The judgments in the Scottish Courts

At first instance in the Scottish courts,the Lords Ordinary considered Lord Bridge’s speech in Sidaway. Here, Lord Bridge suggested there could be circumstances where disclosure of a particular risk would be obvious where there was a ‘substantialrisk of grave adverse circumstances’. This approach was later reconsidered in Pearce v United Bristol Healthcare NHS Trust[v] by Lord Woolf who opined that the approach regarding disclosure should be whether there was a significant risk that would affect the judgment of a reasonable person. However, in these circumstances, and following the judgment of Jones v NW Strategic Health Authority[vi] a case similar on the facts, the court held there was no breach of duty as the risk of shoulder dystopia (0.1%) was an insufficient risk for the mother to be informed of and in any event, she had not ‘raised questions of specific risks[vii]’ involved in a normal delivery. On appeal, the Inner House of the Court of Session upheld the lower courts judgment - the relevant risk, whichwas of the grave consequences of umbilical cord occlusion, resulting in hypoxia and subsequent cerebral palsy and death, was so minute that there was no breach of duty of care in the failure to warn of the risks. Given that expert evidence for the defendant Hospital was capable of withstanding logical analysis[viii], the claimant, Mrs Montgomery was unable to prove either breach or causation.

Consideration of the development of information disclosure by the Supreme Court

Mrs Montgomery appealed to the Supreme Court which took the opportunity to consider the development of the law on informed consent. Perhaps it is useful at this point to remind the reader of the case of Bolam v Friern Hospital Management Committee[ix] whichconcerned, amongst other aspects, the failure to advise of the risks involved in the patient’s therapy. The importance of this case lies in Mr Justice McNair’s dictum wherein the test for breach of duty of care was (unintentionally) established. A doctor could not be found guilty of negligence if she or he ‘had acted in accordance with a practice accepted as proper by a responsible body of medical practitioners skilled in that particular art’.

The case of Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital[x]some years later was seminal in its consideration of when a patient should be advised of the risks of a procedure or treatment. Lord Diplock sought to retain the status quo, stating that the Bolam test should be retained and applied in situations where advice was given to a patient stating that:

‘To decide what risks the existence of which a patient should be voluntarily warned….is as much an exercise of professional skill and judgment as any other part of the doctor’s comprehensive duty of care to the individual patient’.

But, Lord Diplock added, there was no duty on the doctor to advise the patient of the risks where the patient did not ask. His justification for this was that where a doctor had decided what was in the best interests of the patient and then mentioned risks to a patient, the effect could be to deter the patient from proceeding with the recommended plan of medical treatment.

What was particularly interesting about the judgments in Sidawaywas the polarisation of views. Whilst Lord Diplock represents the majority decision, Lord Scarman took an entirely opposing view and opined that where information disclosure is concerned it was ‘the patient’s right to make his own decision[xi]’. The point that Lord Scarman makes is that whilst the doctor may have objectives regarding the benefits of a certain process or procedure to the patient’s health, a patient may have other considerations, in addition to the medical opinion which would be relevant to the patient when considering the doctor’s advice. In other words, Lord Scarman’s approach appears to be a more holistic rather than purely medical approach based upon a patient’s self-determination.

The Supreme Court recognised the value in Lord Scarman’s dictum stating

‘The relative importance attached by patients to quality as against length of life, or to physical appearance or bodily integrity as against the relief of pain will vary from one patient to another…The doctor cannot form an objective, ‘medical’ view of these matters, and is therefore not in aposition to take the ‘right’ decision as a matter of clinical judgment’[xii].

Although the recognition of the importance of a patient’s self determination to make decisions regarding their own medical treatment, (whichthey can only do once they have been fully informed of all the risks) is not novel in England and Wales, Scotland has historically favoured Lord Diplock’s ‘Bolam’ approach to information disclosure.The Supreme Court however referred tothe Court of Australia in Rogers v Whitaker[xiii] which had already explored the question of informed consent saying that

‘A risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it’

The Supreme Court then considered the case of Pearce v United Bristol Healthcare[xiv] where a woman who was pregnant with her sixth child was overdue her due date by 14 days. Although she had asked for a caesarean section she accepted the doctor’s advice against such a procedure. She was not however, advised of the risk of a 0.1-0.2% risk of a stillbirth which was not considered to be significant. Once the baby was stillborn, the risk having materialised, Mrs Pearce took an action in negligence against the defendant hospital for failure to warn. Although the court found against the claimant, Lord Woolf took the opportunity to review the law. Lord Woolf MR observed that

‘In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course he or she should take in relation to treatment….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 him or herself as to what course he or she should adopt’

Although Mrs Pearce was unsuccessful, the judgment represents a fundamental shift in judicial opinion towards informed consent.

The Supreme Court also considered the House of Lords case of Chester v Afshar[xv] was relevant and indeed,instrumental in confirming the court’s understanding of the importance of informed consent by imposing a ‘patient-centred approach’. Here, the court found in favour of the claimant who sustained significant nerve damage despite a non-negligently performed operation. Mrs Chester’s successful claim lay in the fact that she had not been informed of the 1-2% risk of nerve damage resulting from this specific operation even where it was performed to the correct standards. She alleged that had she been informed of the risks, she would not have had the operation of that specific day, even though, she did accept that she would more than likely had the operation on another day, albeit with the same surgeon. Lord Bingham explained that the doctor has been under a duty to advise of the 1-2% risk of a serious outcome of the operation as the duty ‘enable(s) adult patients of sound mind to make for themselves decisions immediately affecting their own lives and bodies’[xvi] and that a patient was entitled to information which could have any effect on the lives. Significantly, the case also comes some 20 years after the case of Sidaway during which period ‘the importance of personal autonomy had been more and more widely recognised’[xvii]

The Supreme Court’s judgment

The Supreme Court considered the changing nature of the relationship between the medical professional and the patient[xviii]. Although Lord Templeman’s view in Sidaway was that the danger of giving too much information to the patient could stand in the way of the patient’s recovery, the contemporary view is that ‘patients are now regarded as persons holding rights, rather than as the passive recipients of the care of the medical professions’[xix]. Such a view is endorsed by the General Medical Council in their Guidance entitled Good Medical Practice 2013 by explaining that doctors must ‘give patients the information they want or need in a way they can understand’. Moreover, the Supreme Court referred to Consent: patients and doctors making decisions together 2008 which explains that once the doctor has set out the risks, burdens and benefit or any or no treatment, it is then for the patient to weigh up the medical advice together with other matters which are relevant to them and then decide whether to accept or reject the doctors advise.

There was also a wider picture to take into account; with the introduction of the Human Rights Act 1998, the Courts are obliged to recognise the relevance and importance of fundamental values, such as self-determination, values which had already been expressed by Lord Goff in the earlier seminal case of Airedale NHS Trust v Bland[xx] .Indeed, cases such as Glass v United Kingdom[xxi]andTysiac v Poland[xxii] in the European courts had already recognised the need to involve patients in the decision making process.

The Supreme Court acknowledged that the current approach was ‘instead of treating patients as placing themselves in the hands of their doctors,….treats them 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[xxiii]’

With this in mind the Supreme Court set out the correct test to be applied to cases involving consent to treatment as follows:

‘The correct position, in relation to the risks of injury involved in treatment, can now be seen to be substantially that adopted in Sidaway by Lord Scarman, and by Lord Woolf MR in Pearce, subject to the refinement made by the High Court of Australia in Rogers v Whittaker….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.’

In order that the patient was able to decide for herself, 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’

What is‘a material risk’? The Supreme Court explained that a material risk cannot be ‘reduced to percentages’[xxiv] but 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’[xxv]

The Supreme Courtfurther adopted Lord Scarman’s definition of ‘therapeutic privilege’ from Sidaway stating that a doctor could withdraw information from a patient if the doctor reasonably considered that disclosure would be ‘seriously detrimental to the patient’s health’[xxvi].

Having established there was a breach of duty of care, the court turned to the question of causation. The relevant question to ask, was what would Mrs Montgomery have done had she been advised of the risk of shoulder dystocia and its potential complications?The answer appears to be that she would have wanted a caesarean section, which is precisely the reason why Dr McLellan did not advise her of the risks. It was not in dispute that had the baby been delivered by caesarean section, the injuries would not have occurred.

Conclusion

Gone is the era of medical paternalism which the case of Chester v Afshar reinforces and as the court was at pains to explore, it is the patient who must determine for herself whether to accept or reject medical treatment, having been advised of all the material risks. The General Medical Council confirms that the decision making process in treatment is reached by both doctors and the patient and now, the case of Montgomery v Lanarkshire Health Board brings the law of Scotland in line with the law in England and Wales. It is possible however, that future cases will test what amounts to a ‘material risk’, particularly in light of the fact that their Lordships would not comment on what percentage of risk amounts to a material risk. Moreover, what measures must a doctor go to in order that he ‘should reasonably be aware’that a risk is one that the patient would wish to be aware of and therefore, to what extent must the doctor delve into the patient’s private life? These issues, and probably some unforeseen ones, will undoubtedly go before the courts in the light of Montgomery v Lanarkshire Health Board but the case establishes once more the triumph of a patient’s self-determination and autonomy of their own decision making over medical paternalism.