Case studies and articles
Estimated read time: 6 mins
Consent is by no means a new topic – there are many articles that have been written on it and usually raise further questions from practitioners about their own consent processes. Consent is also a common topic on the Medical Protection advice line and clinicians sometimes need to understand how the pragmatic application of the principles apply to their practice.
With this in mind, I wanted to share some of the defining cases that have led to the current principles of consent as I think it is useful for all doctors to be aware.
A patient required electroconvulsive therapy (ECT) for treatment of a mental illness. No muscle relaxant was given, and Mr Bolam sustained multiple fractures. It was alleged that the doctor was in breach of duty for not giving muscle relaxant, when in fact this accorded with usual practice of others giving ECT and the court did not consider there had been breach of duty. This resulted in the following judgment which most clinicians are familiar with:
“He is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.”
Bolitho [1997] later refined the Bolam test by clarifying that the experts opining as the responsible body for the basis on which Bolitho would be supported must have logical reasoning.
Mrs Sidaway underwent cervical decompression which carried a risk of 1-2% of spinal injury, even if performed perfectly, along with risk of peripheral nerve damage. The case found that she was not advised of the risk of serious spinal injury and had she been warned she wouldn’t have undergone the surgery. It was also found that the patient was not advised that the operation was actually not necessary and there was an option of doing nothing. This case set the common law that a doctor must provide all material risks; that is those risks required to make a balanced judgement, unless there is considered to be exceptional reason not to – so called “therapeutic exception”.
The claimant in this case had a 6-year history of back pain, mobility issues and bladder incontinence secondary to disc protrusion. She opted to undergo surgery. The consent process did not include the information that the operation carried a 1-2% risk of paralysis and the patient underwent the operation which caused her condition to worsen. Whilst it was found that the procedure itself was not negligent, the claimant argued that had she been aware of the risk she would have delayed when she underwent the operation and it was found that the same operation, carried out on a different day, may have had a different outcome. This outlined that a patient no longer had to prove they would not have undergone the procedure.
Nadine Montgomery was pregnant with her first child. She was concerned about the risk associated with being a diabetic patient and explicitly expressed concern about the risk of the size of her baby and vaginal delivery. However, the risks of shoulder dystocia were not discussed and she was never offered the option of a caesarean section.
When Mrs Montgomery went into labour, a shoulder dystocia occurred and her son was born with significant cerebral palsy. Mrs Montgomery claimed for negligence and the case was ultimately heard in the supreme court after the treating clinician advised they had not discussed a caesarean section as they did not think it to be in her best interests.
The key finding in the judgment made at the supreme court was:
“The doctor is under a duty to take reasonable care to ensure that the patient is aware of material risks involved in proposed treatment, and of reasonable alternatives. A risk is “material” if a reasonable person in the patient’s position would be likely to attach significance to it. Or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”
Three further points were raised which highlighted:
the significance of risk is fact sensitive and cannot be reduced to percentages.
in order to advise, the doctor must engage in dialogue with their patient.
therapeutic exception is limited and should not be abused.
Following the case of Montgomery there have been a number of notable cases that have sought to clarify the extent to which the key principles of Montgomery can be applied. These have included themes of material risk, patient characteristics and alternative treatment options.
However, most notably in the case of McCulloch v Forth Valley Health Board [2023] the Supreme Court have clarified that the reasonable treatment options that should be discussed with a patient is not for the court to decide. Instead, we are brought back full circle to the principles of Bolam as to the correct test when considering which treatment options are clinically appropriate for the patient and should therefore be discussed.
This judgement will have provided relief for many doctors as this clarification ensures that there is no obligation to discuss endless treatment possibilities.
Consent must not be considered in isolation as a static process, but a journey which considers patient factors and those which are of importance to the patient. The assumed worst-case scenario from the doctor's perspective can no longer be considered as blanket consent for all “less severe” outcomes.
An example may be a patient undergoing ophthalmic surgery where there is a risk of blindness. The assumed position that this is the worst outcome may not be the case for a patient where diplopia renders them incapacitated. Even where the doctor may not normally consider diplopia as a frequent risk, it may be of such importance to the patient that, not discussing it, would be indefensible in court based on Montgomery and the clear message that consent has no place for medical paternalism.
When consent is delegated to other healthcare professionals, the same principles apply. The person taking consent must be able to sufficiently understand the risks which may be material to the individual patient, even where the risks may be small. Consent also relies upon the person taking the consent having adequate insight into whether they have sufficient experience to undertake the task.
Many doctors ask about the use of consent forms. Are they worth the paper they are written on? Are they needed for every procedure?
The key to this question is not the patient’s signature on a written consent, but the quality of the consenting discussion (what the procedure entails, risks, benefits, alternatives, no action if an option) which the clinician records themselves, e.g. in bullet point. When considering the Montgomery case, doctors should ensure they ask patients questions which focus on the specific concerns of the individual. This should be recorded and although prudent to use a consent form, space limitations may preclude a consent form being the most appropriate format. The importance of genuine dialogue rather than form-filling was underlined in the case of Thefaut v Johnston [2017]. There, the doctor sought to rely on the fact that they had obtained consent from the patient shortly before the surgery. The court held:
“It is routine for a surgeon immediately prior to surgery to see the patient and to ensure that they remain wedded to the procedure. But this is neither the place nor the occasion for a surgeon for the first time to explain to a patient undergoing elective surgery the relevant risks and benefits. …. There is no "adequate time and space" for a sensible dialogue to occur and for free choice to be exercised…”
This leads to a final consideration of whether a complication such as death from local anaesthetic should be disclosed to patients and whether written consent is required. This complication is astonishingly rare and there is debate as to whether local anaesthetic administration is a drug delivery or a procedure, but regardless, the principles of consent should still be considered on the basis that a patient is choosing whether or not to receive this drug.
It may be defensible to not discuss the risk of death but this would depend on whether the patient would consider this to be of significance to them, taking us back to the material risk to that individual. It could be argued that a patient with thanatophobia (a significant fear of death or dying) would want to know this risk but unless the question of importance and beliefs is explored, any practitioner should be mindful that importance cannot be presumed. However, the risk of allergic reaction may be of importance to many patients, and it could be argued where this is adequately explained it would encompass the extreme end of allergic reactions and therefore the risk of death.
Consent is a common theme in clinical negligence claims.
Clinicians should be mindful of the consent journey and record discussions with the patient in the records.
Inadequate space on a consent form is not a reason to not document discussions.
Risks cannot be considered purely as a percentage.
