The applicable legal test to be applied in determining whether an alternative treatment is reasonable and requires to be discussed with the patient is the professional practice test
August 23, 2023
McCulloch and others v Forth Valley Health Board
2023 UKSC 26
Supreme Court of the UK
Lord Reed, P & SCJ; Lord Hodge, DP & SCJ; Lord Kitchin, Lord Hamblen & Lord Burrows, SCJJ
July 12, 2023
Reported by Faith Wanjiku and Betty Nkirote
Health Law-medical negligence-duty to inform a patient of reasonable alternative treatments-legal test for establishing negligence by a doctor in diagnosis-where the appellants claimed that the death of the patient was caused by negligence of the doctor -where the appellants alleged that the doctor had a duty to discuss the option of using non-steroidal anti-inflammatory drugs with the deceased patient-which legal test was to be applied to the assessment as to whether an alternative treatment was reasonable and required to be discussed with a patient-whether the assessment by the doctor in the instant case fell below the required standard of reasonable care in failing to make the deceased patient aware of an alternative treatment where the doctor’s opinion was that the alternative treatment was not reasonable and that opinion was supported by a responsible body of medical opinion.
The appellants brought a claim for damages against the respondent for negligently causing the death of Mr McCulloch on April 7, 2012. They alleged that the death of Mr McCulloch (deceased patient) was caused by the negligence of Dr Labinjoh (doctor), a consultant cardiologist employed by the respondent.
It was the appellants’ contention that the doctor had a duty to discuss the option of using non-steroidal anti-inflammatory drugs (NSAIDs) with the deceased patient. They argued that had such advice been given, he would have taken the NSAIDs and would not have died.
The appellants’ claim failed in both the Outer House and the Inner House of the Court of Session. In dismissing the appellants’ claim, both courts held that a doctor did not have a duty to discuss a course of treatment with their patient if the doctor had concluded, applying their professional skill and judgment, that it was not a reasonable option in the circumstances of the case and the doctor’s view was supported by a responsible body of medical opinion. Further, both courts established that even if negligence had been established, the claim would still have failed because the appellants had not proven on the balance of probabilities that it caused the patient’s death.
- Which legal test was to be applied to the assessment as to whether an alternative treatment was reasonable and required to be discussed with a patient?
- Whether the assessment by the doctor in the instant case fell below the required standard of reasonable care in failing to make the deceased patient aware of an alternative treatment where the doctor’s opinion was that the alternative treatment was not reasonable and that opinion was supported by a responsible body of medical opinion.
- The applicable legal test to be applied to the question of what constituted a reasonable alternative treatment was the professional practice test. On the facts of the instant case, as the doctor took the view that prescribing NSAIDs was not a reasonable alternative treatment because Mr McCulloch had no relevant pain and there was no clear diagnosis of pericarditis. That view was supported by a responsible body of medical opinion and there was no breach of the duty of care to inform. There was no error of law made by the lower courts and there was no basis for going behind their decision reached on the evidence that the doctor was not negligent.
- It was important to stress that it was not being suggested that the doctor could simply inform the patient about the treatment option or options that the doctor himself or herself preferred. Rather, the doctor’s duty of care was to inform the patient of all reasonable treatment options applying the professional practice test.
- In line with the distinction drawn between the exercise of professional skill and judgment and the court imposed duty of care to inform, the determination of what were reasonable alternative treatments clearly fell within the former and ought not to be undermined by a legal test that overrode professional judgment. In other words, deciding what the reasonable alternative treatments were was an exercise of professional skill and judgment. That was why it was appropriate to refer synonymously to reasonable alternative treatments or to clinically appropriate or to clinically suitable alternative treatments.
- The identification of which treatments were reasonable alternatives was as much a matter falling within medical expertise and professional judgment and hence governed by the professional practice test, as the identification of risks associated with any treatment. They were closely linked as the risk of any given treatment would be a significant part of any analysis of alternative treatment options. The identification of reasonable alternative treatments ought to be treated in the same way as the identification of risks associated with any treatment. It was only once the reasonable alternative treatments had been identified that the second stage of the advisory role arose. The doctor was required at the second stage to inform the patient of the reasonable alternative treatments and of the material risks of such alternative treatments.
- If the court was to reject the professional practice test in determining reasonable alternative treatments, one consequence would be an unfortunate conflict in the exercise of a doctor’s role. That was because the law would be requiring a doctor to inform a patient about an alternative medical treatment which the doctor exercising professional skill and judgment, and supported by responsible body of medical opinion, would not consider to be a reasonable medical option.
- The doctor’s duty was not fulfilled by bombarding the patient with every possible potential treatment for every potential diagnosis, however mainstream or fringe, however simple the case could be and however likely treatment might be to bear fruit. If it obstructed the patient’s understanding, providing too much information could be as unhelpful as providing too little. To require a doctor to outline the risks of all possible alternative treatments, even those considered not to be reasonable was unlikely to be in the patient’s best interest and could impair good decision making.
- It was important for doctors to be readily able to understand when they had an advisory role and what that role required of them. Extending the advisory role in the way contended for by the appellants would introduce considerable uncertainty to both those questions.
- On the appellants’ case, what constituted reasonable alternative treatment options was to be determined by the court having regard to a range of factors which included:
- Alternative treatments that in the circumstances of a particular case, a reasonable person in the patient’s position would be likely to attach significance to in the context of making his or her decision and could reasonably consent to;
- Alternative treatment that the particular patient would be likely to attach significance to in the context of making such a decision and/or could reasonably consent to; and
- Alternative treatment that the doctor appreciated or ought to appreciate would be considered reasonable within the medical profession even though the doctor reasonably elected to recommend a different course of action.
- If those were the factors by which the court was to judge the conduct of the doctors, it followed that those were factors to which the doctor was also to have regard. That would render the doctor’s task inappropriately complex and confusing. Further, for that to be a matter to be determined after the event by the court would create real practical difficulties for a doctor. A doctor could not foresee what a court could thereafter make of the matter in the light of bodies of expert evidence viewed through a retrospectoscope. The consequence of that would be defensive medicine with the doctor advising on all possible alternative treatment options however numerous or clinically inappropriate they could be.
- There were two possible qualifications of the application of the professional practice test in the context of reasonable alternative treatments. The first possible qualification was whether there ought to be an additional filter turning on whether it was reasonable for a doctor to inform a patient of all reasonable alternative treatments. It could be argued, for example, that the disinterest of the patient could make it reasonable to inform that patient of fewer of the reasonable alternative treatments than if the patient was very interested in the reasonable alternatives. Having discussions with the patient, so that one had a complete picture of the patient and of his or her medical history, could lead to an expansion or restriction of the reasonable alternative treatments. However, once the doctor, applying the professional practice test had a range of reasonable alternative treatments, the patient ought to be informed of all of them. It would cause uncertainty if the doctor had to qualify which reasonable alternative treatments the patient ought to be informed about by asking which of the reasonable alternatives it was reasonable for that particular patient to be informed about. Of course, a patient could specifically request greater or lesser information about reasonable alternative treatments.
- The second possible qualification was whether the doctor was under a duty of care to inform a patient of a possible alternative treatment that, applying the professional practice test, he or she did not regard as a reasonable alternative treatment but where the doctor was aware or perhaps ought to be aware, that there was a responsible body of medical opinion that did regard that treatment as reasonable. That qualification was to be rejected. Not only would it render the law more difficult for a doctor to apply but it would also lead to the unfortunate conflict in the doctor’s role. Provided the doctor’s assessment of what was and what was not a reasonable alternative treatment was supported by a responsible body of medical opinion, the doctor would not be liable for failure to inform a patient of other possible alternative treatments.
Relevance to Kenyan jurisprudence
In Kenya, the primary legislation on health matters is the Health Act, No. 21 of 2017 (Health Act). The Health Act provides for the right of every person to health information which includes the right to be informed of all the risks involved in a certain treatment, the possible consequences and the range of reasonable alternative treatments available.
Section 8 of the Health Act provides as follows:
Section 8-Health information
(1) Every health care provider shall inform a user or, where the user of the information is a minor or incapacitated, inform the guardian of the
(b) range of promotive, preventive and diagnostic procedures and treatment options generally available to the user;
(c) benefits, risks, costs and consequences generally associated with each option
Further, the Kenya National Patients’ Rights Charter, 2013 emphasizes on the need for a doctor to inform a patient of alternative treatments available before undertaking any medical procedure. It provides in this regard thus:
8-Right to informed consent to treatment
Every person’s, patient or client, has a right to be given full and accurate information in a language one understands about the nature of one’s illness, diagnostic procedures, proposed treatment, alternative treatment and the cost involved for one to make and decision except in emergency cases
The decision shall be made willingly and free from duress.
Thus, it is evident from the above provisions that the law in Kenya recognizes the duty of health care providers to inform patients of reasonable alternative treatment. Also, health care providers are under an obligation to ensure that such information is communicated to the patient in a language that the patient understands.
In L A W & 2 others v Marura Maternity & Nursing Home & 3 others  eKLR, the court held thus:
In addition, the healthcare provider had a legal duty as required under sections 8 and 9 of the Health Act to explain to her the available alternatives of family planning. By juxtaposing the 1st petitioner’s position and the legal requirements in obtaining informed consent side by side, it is apparent that the 1st respondent did not obtain any such informed consent from the 1st petitioner. There is no evidence that the 1st respondent undertook any meaningful due diligence on the 1st petitioner in the quest to obtain the requisite consent.
Consequently, it follows that health care providers in Kenya have an advisory role towards their patients on the available forms of treatment. They have a duty of ensuring that patients understand their diagnosis, the risk involved in a proposed treatment and any reasonable alternative treatment available. This ensures that patients are in a position to make an informed decision.
This case is therefore relevant to Kenyan legal system as it expands Kenyan jurisprudence on the duty of health care providers to discuss reasonable alternative treatments with a patient and the extent of their liability regarding that discussion. The case also extends Kenyan jurisprudence on the legal test to be applied in determining whether an alternative treatment is reasonable and requires to be discussed with the patient.