The UK Supreme Court powerfully affirmed women’s right to autonomy in childbirth yesterday in the case of Montgomery v Lanarkshire Health Board. Allowing the appeal from the Scottish courts by a woman whose baby suffered shoulder dystocia in labour, the Supreme Court held that women have a right to information about ‘any material risk‘ in order to make autonomous decisions about how to give birth.
Mrs Montgomery, a pregnant diabetic woman with a large baby, was not informed by her obstetrician of the chance of shoulder dystocia. Although she had repeatedly expressed concerns about giving birth vaginally, the obstetrician said that she routinely chose not to explain the risk of shoulder dystocia to diabetic women because the risk of serious injury to the baby was very small and that if she did explain it, ‘then everyone would ask for a caesarean section‘. For diabetic women, the risk of the occurence of shoulder dystocia is about 9-10% and the consequent risk of serious injury to the baby is less than 1%. However, shoulder dystocia poses a variety of serious risks to the woman’s health, including post-partum hemorrhage (11%) and 4th degree perineal tear (3.8%). The doctor apparently did not consider that these risks were worth explaining to women.
The arrogance of the doctor’s assumptions clearly disturbed the Court. As Lady Hale said (para 111): ‘In this day and age, we are not only concerned about risks to the baby. We are equally, if not more, concerned about risks to the mother. And those include the risks associated with giving birth, as well as any after-effects. One of the problems in this case was that for too long the focus was on the risks to the baby, without also taking into account what the mother might face in the process of giving birth.’
From a legal perspective, the decision brings English and Scottish law into line with that of the United States and other common law jurisdictions by separating the question of informed consent from the traditional test for clinical negligence. The Court expressed the legal duty on doctors as follows (para 87):
‘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.’
It is therefore no longer appropriate to assess the adequacy of the doctor’s information sharing by reference to the standards of a reasonable medical professional; instead the relevant standard is whether the patient would attach significance to the risk. In its explicit recognition of patients’ rights to autonomy and informed choice, Montgomery hammers the final nail in the coffin of medical paternalism.
What are the implications for healthcare professionals?
Doctors will already be well-acquainted with the GMC guidance on consent, which was quoted with approval in Montgomery, and the case is a reminder of the importance of this guidance. The Court highlighted the following aspects of the process of informed consent that all healthcare professionals (and hospital managers) should take on board:
(i) Dialogue: in order for a patient to make an informed decision, there must be a conversation between doctor and patient. The doctor must ‘ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision.’ The information cannot flow one way and the doctor’s advice must be ‘sensitive to the characteristics of the patient‘ (Montgomery, para 89). Hospitals cannot rely on printed information leaflets to provide information; there should always be a personal discussion.
(ii) Material risks: a material risk is one to which a reasonable patient would attach significance. Statistics alone will not determine whether a risk is significant for a particular patient. For example, the risk of complications for future pregnancies after a c-section might be statistically small, but it would be more significant for a woman who wished to have multiple children than for a woman who did not.
(iii) Consent forms: the Court emphasised that the doctor’s obligation will only be discharged if the information is imparted in a way that the patient can understand. ‘The doctor’s duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form‘ (Montgomery, para 90). This is important guidance. Hospitals cannot rely simply on a completed consent form as evidence that a clinician has fully appraised a patient of the risks of a procedure.
Maternity care is already infamously litigious and accounts for nearly 50% of the value of all NHS negligence claims (see NHS Litigation Authority, ’10 Years of Maternity Claims’). The Supreme Court recognised that there is a risk that the Montgomery decision will increase litigation by women who claim that they were not adequately informed of risks. The Court gave an interesting response to this (para 93):
‘…in so far as the law contributes to the incidence of litigation, an approach which results in patients being aware that the outcome of treatment is uncertain and potentially dangerous, and in their taking responsibility for the ultimate choice to undergo that treatment, may be less likely to encourage recriminations and litigation, in the event of an adverse outcome, than an approach which requires patients to rely on their doctors to determine whether a risk inherent in a particular form of treatment should be incurred.’
Far from threatening doctors with more claims, proper disclosure of risks should protect the medical profession from litigation and lead to patients bearing responsibility for their own decisions. Respect for patient autonomy means that patients take responsibility.
An example: post-dates induction
Post-dates induction provides a useful example of how informed consent ought to work in practice.
- The obstetrician must make time for a genuine dialogue with the woman. Hospital information sheets on induction are not a sufficient basis for making informed decisions. During the dialogue, the doctor cannot not simply impart facts or hospital policy without taking account of the woman’s particular situation and wishes for the birth.
- The conversation must be personalised – it would differ between a first-time mother and a woman who has already had children; or between a woman who wants to give birth vaginally and a woman who is concerned about vaginal birth.
- The obstetrician should explain the risks of exceeding her due date using accurate and comprehensible information that does not put undue pressure on the woman (stating only that ‘your baby might die‘ would not be considered sufficient information).
- She should then be told of ‘any material risks‘ of induction to both herself and her baby. It is obvious that most women would wish to know the likelihood of success and failure of induction in that clinician’s experience at the hospital in question, and the risks should induction fail. These will include fetal distress, assisted birth, with consequent potential for perineal trauma, and emergency c-section.
- The obstetrician should suggest alternative courses of action, including waiting for natural labour to begin and elective c-section.
The Court in Montgomery made it clear that not only should the doctor have explained the risks of shoulder dystocia, but that she should have offered Mrs Montgomery an elective c-section. Lady Hale stated (para 111) that doctors should volunteer the pros and cons of vaginal birth and elective c-section ‘in any case where either the mother or the child is at heightened risk from a vaginal delivery.’ Following these comments, failure to offer an elective c-section where there are heightened risks to vaginal delivery may lead to legal liability for negligence.
Elizabeth Prochaska, Birthrights