The facts of Montgomery
Nadine Montgomery gave birth to her son, Sam, on 1 October 1999. As a result of an occlusion of the umbilical cord caused by shoulder dystocia, Sam's brain was starved of oxygen for some 12 minutes. Consequently, he was born with a dyskinetic form of cerebral palsy. He also suffered an avulsion of the brachial plexus, rendering his arm useless. His mother subsequently sought damages from Lanarkshire Health Board.
Mrs Montgomery was five feet tall, and was also diabetic, which often results in a larger foetus with weight concentrated around the shoulders. The Lord Ordinary (the judge in the Outer House of Scotland’s Court of Session, where the case was initially heard), was presented with expert evidence that where a diabetic woman gives birth via vaginal delivery, there is a 9%-10% risk that dystocia will occur.
The treating obstetrician hadn't warned Mrs Montgomery of the risk of shoulder dystocia, or offered her a caesarean section as an alternative. It was her view that if women were advised of the risk of shoulder dystocia they would opt for a caesarean. As far as she was concerned, this was not in the maternal interest.
Significantly, Mrs Montgomery had raised concerns about the size of the baby and the risk that it might be too big to be delivered vaginally. The obstetrician told the judge that Mrs Montgomery had not asked her about 'exact risks'.
The Scottish courts' approach
The Lord Ordinary held that the scope of a doctor's duty to warn a patient of the risks of treatment was normally determined by whether the doctor had acted in accordance with a practice accepted at the time as proper by a responsible body of medical opinion. This is known as the Bolam test, named after the case of Bolam v Friern Hospital Management Committee (1957) 1 WLR 582.
The risk of shoulder dystocia was significant, but the Lord Ordinary held that it did not itself require a warning, as in the vast majority of cases it could be dealt with by 'simple procedures'. The chance of severe injury to the baby was tiny. If the patient asks questions about specific risks, that is different, and the doctor must answer. But the Lord Ordinary did not accept that Mrs Montgomery had done so.
The decision was upheld on appeal to the Inner House. Supported by the GMC, which intervened in the case, Mrs Montgomery took her fight to the Supreme Court. Suddenly, the law pertaining to informed consent faced a comprehensive review by the UK's final court of appeal.
The appeal was upheld, and Mrs Montgomery was subsequently awarded over £5 million in compensation. The key aspects of the reasoning were as follows:
- The previously accepted model of the doctor-patient relationship no longer reflects reality. Patients are not incapable of understanding medical matters, or wholly dependent on information from the doctors. This is reflected in the GMC's long-standing guidance.
- Courts are increasingly conscious of fundamental values such as self-determination. The law treats patients, so far as possible, as adults capable of understanding that medical treatment involves risks, and of accepting responsibility for and the consequences of their choices.
- Doctors have a duty to take reasonable care to ensure that a patient of sound mind is aware of material risks inherent in treatment, and of reasonable alternatives.
- Assessing materiality of risk is fact-sensitive and cannot be reduced to percentages.
- In order to advise, the doctor must engage in a dialogue with the patient, who may not know there is anything to ask about. The information provided must be comprehensible, and the doctor's duty is not fulfilled by bombarding the patient with technical information which they cannot reasonably be expected to grasp. The duty is not discharged simply by obtaining a signature on a consent form.
- The therapeutic exception, whereby information can be withheld from a patient in certain circumstances to protect his or her health, remains but is limited.
The crucial passage of the final judgment - paragraph 87 - perhaps ought to be etched on the mind of any clinician when advising a patient as to the risks of any proposed treatment:
'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.'
At the heart of the Supreme Court's judgment is a repudiation of medical paternalism, which is replaced with the value of self-determination. The patient is no longer a passive recipient of medical treatment, but a partner in the provision of that treatment.
Gone is the old objective test of the reasonable doctor – the courts will apply an objective test focused on the reasonable patient, but this must be coupled with a subjective assessment of the circumstances, concerns, personality and idiosyncrasies of the particular patient. In considering 'materiality', doctors can no longer take refuge in percentages, and there is no need for the patient to prompt the flow of information through questioning.
The burning question is how to translate these lofty ideals into clinical practice.
Practical impact: Ten Commandments
There is no doubt that Montgomery makes life more complicated for the medical professional. Litigation around issues of consent remains unpredictable in the wake of the Supreme Court's judgment, but the following tips might help medical professionals to obtain a foothold in the legal quagmire:
- Make full notes. It is more important than ever that these specifically document the consent process. The patient's records in relation to consent and advice should consist of more than just a consent form.
- Discuss reasonable alternatives. Where appropriate, these must include the option of having no treatment at all. Doctors need not necessarily mention the pros and cons of every option in every case, but they should do so where there is a heightened risk to the patient (and/or to her child in the obstetric context).
- Ensure adequate time is set aside. This is easier said than done in a busy GP practice, a frantic emergency department or a hectic ward. But a meaningful consent process based around a real dialogue requires more time than might previously have been considered sufficient.
- Focus on the individual patient. Is it clear from the notes that you have taken steps to understand the concerns and wider circumstances of the individual patient before imparting advice? Is there a reference to relevant medical conditions or increased risk factors? Is there mention of the psychological state of the individual, or his or her family circumstances, where appropriate?
- Engage in a genuine, two-way dialogue, recording both sides of the conversation.
- Do not simply focus on percentages. Post-Montgomery, the scientific magnitude of risk is only a factor and should not determine what risks are discussed.
- Consider the risk of intervening events, not just catastrophic outcomes. These might include distressing, painful or dangerous intervening events.
- Think very carefully before relying on the therapeutic exception. If you have consciously decided not to share certain information with the patient in a purported exercise of the therapeutic exception, do the circumstances justify that approach in the light of the respect to be accorded to patient autonomy? Is the fact that information has been withheld for therapeutic purposes – and the reason for that – made clear in the notes?
- Patient understanding. Is it clear that the patient fully understood the advice given? Has it been delivered in a comprehensible way?
- Leafleting is not enough. Bombarding a patient with information does not discharge the duty, and the simple issuing of leaflets or factsheets does not constitute the required dialogue.
Of course, failing to obtain consent from patients is not just a concern from the perspective of potential civil claims or disciplinary action. In some cases it may also raise the spectre of criminal liability for assault and/or battery. These are the high stakes for the medical professional, and they necessitate require careful adherence to the relevant guidance from regulatory bodies.
Where are we now?
Montgomery does not change the fact that in order for consent failures to lead to damages, the claimant must be able to prove causation - that is, that those failures resulted in loss or damage. It is clear, however, that the law of informed consent has been redefined by the Supreme Court, even if it reflects a revolution that was already in train rather than one that suddenly came about in March 2015.
In the meantime, clinicians will continue to be wary of the pitfalls the case highlights, and ensure an approach to consent that is more patient-centric than ever before.