In 1999, Nadine Montgomery was pregnant with her first child, Sam. She has type 1 diabetes and was concerned during her pregnancy that the size of her baby might lead to difficulties with a vaginal delivery. She expressed general concerns throughout her antenatal care. The risk of shoulder dystocia (the baby’s anterior shoulder becoming stuck behind the mother’s pubic symphysis) occurring was not discussed and a plan was made for vaginal delivery.
During her son’s delivery, shoulder dystocia occurred and, despite the best efforts of the obstetric team, there was a twelve minute delay between the delivery of his head and his shoulders. Over this time the blood flow through the umbilical cord was compromised and Sam suffered a significant hypoxic injury which resulted in brain damage and cerebral palsy.
The case was made that as the consultant had not discussed the risk of shoulder dystocia, the potential significant consequences of it occurring and the alternative option of a Caesarean section that negligence had occurred as far as consent is considered; Mrs Montgomery was not able to make a fully informed decision without full information on all the options. The consultant stated that the risk of shoulder dystocia occurring in a woman with diabetes was 10% but that the risk of a serious consequence from said shoulder dystocia was 0.2% for a brachial plexus injury and less than 0.1% for hypoxic injury. As the risk of serious consequence was felt to be so small, it was not discussed. It was also noted that the consultant stated that the risks would have been mentioned if specific questions had been asked. This practice refers back to the ruling of Lord Diplock in Sidaway who advised that if a specific question was asked, it should be answered. However, this could require a patient to have a level of knowledge that a non-medical professional cannot be expected to have.
This case was heard at the UK Supreme Court in July 2014 before seven Justices following failed appeals in the Court of Session and the Inner House. The involvement of seven justices in this final appeal is of particular importance as this is the number of justices required to change or overrule a previous House of Lords ruling; in this case, the ruling in Sidaway.
The argument in this appeal was that is not appropriate to use the accepted practice of a body of reasonable medical practitioners when consent is considered. It should be viewed differently from the process of diagnosis or treatment. The relevant guidance from the GMC was reviewed and this supported the argument that it was the doctor’s role to provide a patient with all the information to allow them to make a balanced judgement between different options.
All seven of the Justices supported the appeal.
This means that:
The law on consent has progressed from doctor focused to patient focused. The practice of medicine has moved significantly away from the idea of the paternalistic doctor who tells their patient what to do, even if this was thought to be in the patient’s best interests. A patient is autonomous and should be supported to make decisions about their own health and to take ownership of the fact that sometimes success is uncertain and complications can occur despite the best treatment.
As seen in clinical practice, it was acknowledged that some patients will express a wish to not be told of the risks of a treatment or procedure or to not make a decision. If these feelings are explored and the patient genuinely wishes no information or would prefer the doctor made the decision, then discussions should be documented and treatment proceeded with if that is felt to be appropriate. The concept of the therapeutic exception is also mentioned as a rare occurrence when a doctor may feel that discussion of risks will result in harm or detriment to the patient’s health and wellbeing. In these cases it is reasonable to not discuss risks but these circumstances are, as already said, rare.
This ruling supported the concept of material risk as previously described by Lord Scarman in his opposing view to the Sidaway ruling. Material risk is a risk that is deemed to be of significance by an individual patient rather than by a body of doctors. In order to discover what may concern a patient, it is imperative that a doctor endeavours to find out what matters to each patient; a concert pianist may have different concerns regarding a hand operation when compared with someone else whose livelihood does not rely on dexterity. There can be no ‘one fits all’ approach. Documentation of this discussion and the options offered is important and is required by the GMC guidance on the same.
The discussion and involvement of the patient in the planning of their care mirrors the approach of shared decision making. Involving a patient in their care and adopting a collaborative approach, as well as complying with the law and GMC guidance, can also result in a more positive, satisfying experience for patients and clinicians alike.
In conclusion, it is important to remember that this ruling involves both the exploration and discussion of risks and options, not just risks alone. As stated by Lady Hale in the ruling:
...it is not possible to consider a particular medical procedure in isolation from its alternatives. Most decisions about medical care are not simple yes/no answers. There are choices to be made, arguments for and against each of the options to be considered, and sufficient information must be given so that this can be done.
From the ‘body of medical opinion’ to the ‘reasonable patient’: the road from Bolitho to Montgomery
Hunter v Hanley1955 SC 200
Hanley took legal action after she suffered an injury during an injection being given by her doctor when the hypodermic needle broke. Her claim was that the accident, and her injury, were the result of Hunter not exercising the usual standard of care and competence that was his duty while performing the injection. It was specifically alleged that Hunter had used a type of needle that was not suitable for the type of injection given.
The case was found for the defence and the ruling introduced a legal test that a claimant would need to satisfy in order for medical negligence to be proved. This test has three parts which, as stated by Lord Clyde, must be met:
First of all it must be proved that there is a usual and normal practice; secondly it must be proved that the defender has not adopted that practice; and thirdly (and this is of crucial importance) it must be established that the course the doctor adopted is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care
Bolam v Friern Hospital Management Committee
This case involves a patient, Bolam, who sustained injuries during a course of electro-convulsive therapy being used as a treatment for depression. The patient had their ECT without the use of a muscle relaxant or physical restraints. ECT without the prior administration of a muscle relaxant results in muscle spasms and this has a known, although small, risk of bone fracture as a result. The doctor’s normal practice was to give ECT without a relaxant and without any physical restraints; the doctor would support the patient’s chin and shoulders while nurses stood at either side of the treatment couch to prevent the patient falling.
The patient alleged that the defendants were negligent in not administering a muscle relaxant, in not using restraints in the absence of a relaxant and in not informing him of the risks of injury as a result of the procedure.
Expert witnesses, representing either side, gave evidence that there are a number of different techniques used when administering ECT: some use muscle relaxants, some don’t; some use restraints, some don’t; some use manual control only, some don’t. All were in agreement that there was a body of medical opinion the supported the use of ECT without relaxants and without physical restraints as it was thought these could compromise the airway or increase the chance of injury.
With regards to the disclosure of the risk of fracture, it was the doctor’s practice not to discuss the risk unless directly asked, in which case he would say the risk was very slight.
The court found that a doctor’s actions are not necessarily negligent if they are found to conform to a practice that is accepted as reasonable and proper by other reasonable members of the profession. This stands even if other doctors may have acted in a different way. In this case, Bolam lost the case as the treatment he received was found to be in keeping with the practice of other doctors.
When the disclosure of the risk of injury was considered, the court took the view that in failing to warn of the ‘very slight’ risk, negligence would only be shown if Bolam could prove both that no other reasonable doctors would not have warned of the risk and that if he had been warned he would not have given consent to undergo the ECT.
This ruling took the view that practice in consent was to be regarded in the same was as diagnosis or treatment when considering if negligence had occurred and the test that was created was doctor, rather than patient, focussed.
Sidaway v Board of Governors of the Bethlem Royal Hospital
Mrs Sidaway was suffering from pain in her neck, right shoulder and arms and sought a treatment that might relieve this. She had previously had an elbow injury and spinal surgery and had been under the care of the neurosurgeon in question for many years. When the new pain developed, her surgeon suggested that a cervical cord decompression would alleviate her symptoms. Very unfortunately, Mrs Sidaway became paraplegic as a result of the surgery.
Mrs Sidaway alleged that, in the discussion of the decompression, she was not warned of the risk of paraplegia as a complication of the procedure. The risk for such surgery was held to be less than one per cent and Mrs Sidaway felt her surgeon had been negligent not to include this risk in the discussion. The competence of the surgery itself was never in doubt.
The Lord Justices found that, in this case, her surgeon had not been negligent in not informing her of the risk of paraplegia. In making this ruling, the Bolam test was applied which meant that as the usual practice of a body of reasonable doctors in the field of neurosurgery was to not have mentioned this less than one per cent risk. It was felt that, despite not being told of the risk of paraplegia, Mrs Sidaway had been given sufficient information to enable her to make a decision about proceeding with the treatment. A patient was to be informed of any common or serious potential consequences or complications and the determination of what was deemed common or serious was for the doctor to decide, not the patient.
In making their ruling, the different Lords had differing opinions of the case and what the duty of a doctor was in terms of discussion and consent.
Lord Diplock felt that the right amount of information to be disclosed was to be decided by the medical profession and that the right of the patient at that time was a right to be treated in the best way that a doctor thought they should be. He also added that if a patient asked a question then it should be answered. This would mean that a patient who asked specific questions would potentially be given more information than a patient that did not ask questions. Lords Bridge and Templeman applied the Bolam test with the addition that if there were risks that were so obviously frequent or serious, a doctor would be negligent not to mention them, no matter what the accepted practice was amongst the medical profession.
Lord Scarman, however, expressed a different and more patient-centred opinion but, as his was a minority view, it did not affect the overall rejection of the case. His opinions in this case are referred to in the Montgomery ruling. It is in fact Lord Scarman that introduced the concept of ‘material risk’, 30 years before the Montgomery ruling. He felt that the practice of gaining consent should be viewed differently from that of the skill of diagnosis or carrying out a treatment where the body of medical opinion does hold weight. He took the view that it was the patient’s right to make a decision about whether to proceed with a treatment or not, and the only way they could make that judgement was to have been presented with all the pertinent information. What was sufficient information to make a balanced decision could only be decided by the patient, not their doctor, and it should be presented along with information on reasonable alternative options. His comments also included the concept of the therapeutic exception where it would be acceptable for a doctor to withhold some information if it was felt that disclosure would harm the patient.
To the extent that I have indicated I think that English law must recognise a duty of the doctor to warn his patient of risk inherent in the treatment which he is proposing: and especially so, if the treatment be surgery. The critical limitation is that the duty is confined to material risk. The test of materiality is whether in the circumstances of the particular case the court is satisfied that a reasonable person in the patient’s position would be likely to attach a significance to the risk. Even if the risk be material, the doctor will not be liable if upon a reasonable assessment of his patient’s condition he takes the view that a warning would be detrimental to his patient’s health.
Bolitho v City and Hackney Health Authority
This case was brought by the mother of Patrick Bolitho, a young boy who died following a cardiac arrest in hospital that resulted in severe brain damage. Her two-year-old son had been admitted to hospital with croup under the care of two doctors, Dr Rodger and Dr Horn. Concerns for his condition were high and he was placed under specialist nursing care. He began to worsen and Dr Horn was called but did not attend. Patrick deteriorated and suffered a cardiac arrest from which he was resuscitated but he had sustained significant brain damage. He died seven years later.
It was argued by his mother that there had been negligence in his care as, had Dr Horn come to review her son and had he been intubated, then his brain damage and death could have been prevented. The defending Health Authority put forward the argument that even if Dr Horn had attended to Patrick, she would not have intubated him and this course of action would have been in keeping with a body of medical practice. This would have meant that although failing to see Patrick represented a breach in her duty of care, it was not a breach that resulted in his eventual death. By referring to the importance of the accepted practice of other doctors, the Trust used the Bolam test.
The House of Lords ruled for the Health Authority in this case and within the ruling they applied a further element to the Bolam test: that of logic of a medical opinion. The Lords felt that you could only accept a body of medical opinion if the action they supported was felt to be a logical one. If the action of a doctor was found to be an illogical course of action then they could be found to be negligent despite having a group of doctors who would have acted in the same way. In this case, the assertion that Dr Horn would not have intubated Patrick if she had been present was felt to be a logical one and, therefore, not negligent. The Lords proposed that the scenario where the action was thought to be illogical would be a rare one.
Pearce v United Bristol Healthcare NHS Trust
This case was brought by Mr and Mrs Pearce with regards to the obstetric advice she was given during her fifth pregnancy which ended with the stillbirth of her daughter, Jacqueline, in December 1991. She had seen her consultant at two week’s over her due date on 27th November to request induction or a Caesarean section. The advice from the consultant, following an examination and discussion of the risks of induction and Caesarean, was that Mrs Pearce should await the natural onset of labour. Although upset, Mrs Pearce accepted this advice. On 2nd December her daughter was found to have died in utero. Mrs Pearce had not been informed of the 0.1-02% risk of this happening as it was not felt to constitute a significant risk.
Mrs Pearce argued that had she been informed of this risk she would have opted for a Caesarean section as this would have posed least risk to her baby.
The Lords ruled in this case that if there was a significant risk that could affect the decision made by a reasonable patient about their options then it would be expected that a doctor would inform a patient of that risk. The ruling does not include any specific ‘percentage cut off’ for a risk as this cannot be relied upon to identify what risks could have such an impact on a reasonable patient’s judgement. They held that a patient cannot make a fully informed and proper decision if they have not been presented with all the facts that could influence that process.
Chester v Afshar
A patient, Miss Chester, was under the care of a neurosurgeon, Mr Afshar, for a 6-year history of back pain and she had been shown to have a vertebral disc protrusion on an MRI scan. The pain could be severe and she had experienced episodes of being unable to walk or control her bladder. Mr Afshar advised surgery on the protruding disc. The particular surgery was known to have a 1-2% risk of worsening her symptoms even if performed safely and competently. Mr Afshar had a duty of care to warn Miss Chester of this risk but he did not.
Miss Chester had the spinal surgery and suffered a worsening in her symptoms. She argued that had she been warned of the risk of this happening she would have taken longer to consider and reach her decision to have the surgery. This would have meant that she would have had her surgery at a later date rather than choosing not to have it at all.
The judge in the first case found on behalf of Miss Chester. It was felt that if she had proceeded with the surgery at a different time then it may have been successful. Mr Afshar appealed to the Court of Appeal which again found in favour of Miss Chester. He finally appealed to the House of Lords.
In his appeal to the House of Lords, Mr Afshar focused on the grounds of causation as Miss Chester was likely to have consented for the operation and that the operation would have carried the same risk, even if it had been performed at a later date.
The House of Lords dismissed the appeal and found, again, for Miss Chester. In his ruling, Lord Hope stated:
The injury was intimately involved with the duty to warn. The duty was owed by the doctor who performed the surgery that Miss Chester consented to. It was the product of the very risk that she should have been warned about when she gave her consent. So I would hold that it can be regarded as having been caused, in the legal sense, by the breach of that duty.