Is it negligent not to warn pregnant women of possible clinical risks? This question is at the heart of a recent court case, which has significant implications for practitioners, as it lends legal weight to advice from national guidelines. Consent must be given voluntarily; the person must have capacity; and crucially, must be informed.
The Supreme Court—the highest UK court—has ruled that an obstetrician who failed to give information to a mother of the potential risks of shoulder dystocia was negligent (Montgomery v Lanarkshire HB, 2015). A shoulder dystocia did occur, and the baby, who was born in 1999, suffered significant disabilities. This case will have far-reaching consequences because of the now recognised legal duty to warn of risks. Previous advice about informed consent (e.g. NHS Choices, 2014) now has backing from the highest court in the UK.
The woman in this case is an insulin-dependent diabetic of short stature. The increased risk of fetal macrosomia is recognised in such cases and she ‘was told that she was having a larger than usual baby’ (para 13), but was apparently not informed that mechanical problems might result during the labour because of this. The obstetrician believed that the risk of shoulder dystocia causing serious problems was very small. Her line of reasoning was that if women are told of such a risk,
‘most women will actually say, ‘I'd rather have a caesarean section’… If you were to mention shoulder dystocia to every [diabetic] patient, if you were to mention to any mother who faces labour that there is a very small risk of the baby dying in labour, then everyone would ask for a caesarean section…’
(McLellan, cited at para 13).
While there is a recognised drive to reduce the caesarean section rate, the fact remains that some caesareans are necessary. How possible is it to identify the truly necessary ones in advance?
At 36 weeks, the mother was reportedly concerned about how big her baby was. Following an ultrasound scan, and based on the assumption that induction of labour would take place at 38 weeks because the woman was diabetic, the obstetrician estimated a birth weight of 3.9 kg. In the event, the baby was born just before 39 weeks and weighed 4.25 kg. While the obstetrician evidently underestimated the birth weight, the legal question is ‘What should she have done to prevent possible or likely complications?’ She stated:
‘I felt the risk of her baby having a significant enough shoulder dystocia to cause even a nerve palsy or severe hypoxic damage to the baby was low (so) I didn't raise it with her…’
(McLellan, cited at para 19).
The retrospectoscope grants us 20:20 vision in hindsight; having the necessary insight before the relevant events would be even better. Anticipating that the baby would not be so large as to cause clinical problems at the birth, the obstetrician did not discuss this with the mother, and planned a vaginal birth. In the event, slow labour resulted in augmentation and an attempt at a forceps delivery. When shoulder dystocia occurred an attempt to perform the Zavanelli manoeuvre was considered, but in the event, a partially successful symphysiotomy was followed by Dr McLellan pulling on the baby's head ‘with significant traction’. Twelve minutes elapsed between the appearance of the fetal head on the perineum and the eventual birth, and the baby suffered significant hypoxic and nerve damage.
Was it negligent of the doctor not to warn the mother of the possibility of this outcome? The family believed so, and sued. The original court judgement disagreed, holding that Dr McLellan had passed the ‘reasonable doctor’ test (Montgomery v Lanarkshire HB, 2010); a subsequent appeal in 2013 also failed. This second appeal to the Supreme Court was the last option within the UK court system.
A number of previous medicolegal cases have considered how much information about possible risks should be given to patients, and perhaps unsurprisingly there have been inconsistent opinions and judgements over the years. In the landmark case of Sidaway in 1985, it was held that risk disclosure should be along the lines of the ‘reasonably competent doctor’ test, crudely summed up as ‘doctors know best’. However, one of the judges in that case (Lord Scarman) disagreed, holding that patients should have much greater scope to decide for themselves; to do that, they need to have information. The question still remains: how small a risk should practitioners disclose? Is the onus on the practitioner to offer the information, or on the ‘patient’ to request it? It emerged in evidence in the Montgomery case that the obstetrician would have disclosed the relevant risks had the woman asked about them, but in the absence of such a request the information was not given.
Is risk disclosure really a means of ensuring compliance (Stahl and Hundley 2003)? Can informing someone of a rare risk cause anxiety, so making matters worse? This doesn't even touch on the issue of how different people conceptualise relative and absolute risk, or whether they appreciate that a 0.01% risk is more likely than something which has a 1 in 100 000 chance of happening. The language and presentation of risk are complex matters, and different people have different levels and modes of understanding.
The balance has changed over the years, as noted in Montgomery:
‘Patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising choices … it has become far easier, and far more common, for members of the public to obtain information about symptoms, investigations, treatment options, risks and side-effects…’
(per Kerr LJ, Reed LJ @ 75, 76).
Where once it was acceptable for doctors not to inform patients of risks (or even diagnoses), that is now regarded as patronising and unhelpful. The General Medical Council now advises doctors to ‘work in partnership with patients. Listen to, and respond to, their concerns and preferences. Give patients the information they want or need in a way they can understand. Respect patients' right to reach decisions with you about their treatment and care’ (GMC, 2013: 2). The revised Nursing and Midwifery Council's Code (NMC, 2015: 6) states that practitioners should make sure that they ‘get properly informed consent and document it before carrying out any action’.
The Supreme Court noted that there is growing case law in the UK and across Europe (based on the Human Rights Act 1998 and the European Convention on Human Rights) that emphasise the rights of patients to be kept informed. The old paternalistic days are gone. With very few exceptions (such as when disclosing information would cause serious harm to the patient's health) the expectation now is that risks—and not just the most likely ones—must be disclosed. Citing from another case (Rogers v Whitaker, 1992) in order to explain what this means, the judges noted:
‘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’
(per Kerr LJ, Reed LJ @ 75, 76).
The practicality of all this (e.g. the time available for this kind of detailed discussion) is something on which the law has not passed an opinion. However, 30 years on one landmark case is replaced by another: the reasoning behind Sidaway has given way to the more inclusive thinking of Montgomery.
The National Institute for Health and Care Excellence (NICE, 2011: para 1.1.1.1) guidance states that ‘pregnant women should be offered evidence-based information and support to enable them to make informed decisions about their care and treatment’. Montgomery provides the highest level of legal support for this position.