Recent headlines in The Times and Guardian along the lines that ‘Doctors must warn patients of all the dangers before every treatment’ reflect one of the biggest legal changes to the doctor-patient relationship in a generation.
The headlines were prompted by new guidelines issued by the Royal College of Surgeons (RCS), which themselves are a result of a Supreme Court ruling in 2015 that has not – until now – had the impact and publicity that it deserves.
This watershed ruling means that doctors must ensure patients are aware of all risks that each individual might want to know about, rather than those considered important by other doctors.
A brief background to the case:
The claimant, Mrs Montgomery, was pregnant and, being small and having diabetes mellitus, expressed concern to her doctor about the size of the baby and whether she would be able to deliver vaginally. She did not, however, ask ‘specifically about the exact risks’. Nor did her doctor discuss the potential risks of shoulder dystocia, which occurs in 9-10% of these cases, because, in her estimation, the risk of a grave problem resulting from a shoulder dystocia was small. The risk of a brachial plexus injury in such a case is 0.2% and the risk of cerebral palsy or death from complications is 0.1%. The doctor contended that if shoulder dystocia were mentioned to every diabetic patient, most women would ask for a caesarean section and in her opinion it was not in the interests of women to have caesarean sections.
However the birth was complicated by shoulder dystocia. Mrs Montgomery’s son was deprived of oxygen and subsequently diagnosed with cerebral palsy as well as Erb’s palsy. The Supreme Court reasoned that the doctor ought to have advised the patient of the substantial risk of shoulder dystocia and that if she had, the patient would have opted for a caesarean section. The judgement made it clear that patients in the UK now have a legal right to be informed of material risks before making a decision. These material risks are determined by the circumstances of the particular case, and whether a reasonable person in the patient’s position would be likely to attach significance to it.
In their new guidance, the RCS states:
‘Traditionally clinical practice in the NHS has considered that it is up to doctors to decide what risks to communicate to patients. The court in the Montgomery case changed this and held that doctors must ensure patients are aware of any and all risks that an individual patient, not a doctor, might consider significant. In other words doctors can no longer be the sole arbiter of determining what risks are material to the patient.’
So, in effect, doctors need to tell their patient all the options and risks, and let the patient choose. Those who ignore or withhold information from their patients, even about a very small risk, may now be breaking the law.
GMC guidelines on consent produced in 2008 influenced the judgment. They emphasised the need for a dialogue to ascertain the beliefs and values of the patient, enabling doctors to learn what risks and complications of each option would be considered to be material to the patient.
Until this ruling, established clinical practice as well as a large body of case law generally followed a more paternalistic approach. This was reflected in the Bolam principle, regarding medical negligence. This test asks whether a doctor’s conduct or action is supported by a responsible body of medical opinion. So the Bolam Test put the responsibility on the clinician to decide how and what information to impart.
The Montgomery case is the first ruling to find decisively against the Bolam principle and shift the focus to a more patient-centred approach. Now the law makes it clear that the key questions to be asked are: ‘Would a reasonable patient want to know this information?’ ‘Would this particular patient consider it to be important and relevant information?’
Time will tell whether the substitution of a ‘reasonable doctor’ for a ‘reasonable patient’ may swing the pendulum too far or whether it is a necessary re-balancing. It will probably add time to consent procedures and may lead to doctors practising defensively or giving too much detail to patients who might not have the capacity to process it or to make complex risk assessments.
Some patients will want to know every possible detail about what might happen to them, but others will not. Not all patients wish to carry the burden of weighing all the evidence and making these sorts of decisions.
More information on the way that the ruling should work in practice for surgeons and other health professionals can be found in these guidelines here.
However, an unexpected spin-off is that, in light of this new ruling, the process of consent for abortion procedures may justify more scrutiny.
There is no absolute legal requirement for the doctor to have seen a patient requesting an abortion, or to have a one-to-one conversation about personal values and beliefs. However the new ruling has now made it clear that in the consent process doctors should explore options with that specific patient in mind. Those who ignore or withhold information due to bias (or paternalism) are breaking the law.
It is also possible that doctors who withhold information on the risks of abortion, even if small, such as the now well recognised link between abortions and later preterm deliveries, and the link to adverse mental health consequences, and even on the possible link to breast cancer, evidenced in some research, may be at risk of now breaking the law (see our short briefing on the research here).
It seems that the case for independent abortion counselling and accurate information giving has just got stronger.