Consent: Selecting reasonable alternatives for your patient

An update from a regular series written by Mr Robert Wheeler, director, department of clinical law, where he considers various aspects of clinical law that our nursing and medical staff rely on when caring for patients.

Mr McCulloch was thirty-nine when he was admitted to hospital with pleuritic pains, a pericardial effusion, nausea and vomiting. Pericarditis was diagnosed, but his presentation, with several months of weight loss and then abdominal symptoms, was considered atypical. Following antibiotics the pain resolved and he was discharged, only to be readmitted 48 hours later.

On this occasion there were no objective signs of pericardial constriction, despite a small amount of pericardial fluid. Pericardiocentesis was considered for diagnosis, but unnecessary for treatment. Since Mr McCulloch was not now in pain, and there was no diagnosis of pericarditis, the cardiologist did not prescribe (or discuss with the patient) the use of non-steroidal anti-inflammatory drugs (NSAIDs), since she did not regard their prescription as appropriate in the circumstances. Discharged once more from hospital because of his improved condition, 4 days later he suffered cardiac arrest at home. His cause of death was recorded as idiopathic pericarditis; and that he died of cardiac tamponade, as a result of pericardial effusion. His family alleged that had he been given NSAIDs, he would not have died.

The court had heard that it was standard practice to treat pericarditis with NSAIDs, although there was disagreement as to whether these drugs were appropriate in the absence of pain. Some experts in cardiology regarded it as usual practice to give NSAIDs in the absence of pain, to reduce the inflammation (and hence the volume of pericardial fluid). Whilst others noted that the effusion got better spontaneously, and that the risk of the drugs (Mr McCulloch had pre-existing gastric pathology) was a reason to avoid NSAIDs in this case. A third expert witness concluded that there were variations in practice in the use of NSAIDs where no pain was reported. No evidence was adduced from clinical trials to demonstrate that NSAIDs alter the natural history of pericardial effusions.

The Supreme Court case of Montgomery was discussed, noting that the doctor's duty of care is to inform the patient of all reasonable treatment options. Whilst expert witnesses are required to report on whether a doctor in exercising his or her judgement is supported by a responsible body of medical opinion (the ‘professional practice test’), this is inapplicable to setting the standard for disclosure prior to consent. The final stage of the disclosure process is confirmed in Montgomery; that patients must be made aware ‘…of all reasonable treatments…’ The choice of which of these alternatives to disclose is not a matter for professional judgement. For these reasons, courts do not seek expert evidence to guide them as to whether reasonable alternatives should have been disclosed to the claimant patient.

The question for the Supreme Court in McCulloch focussed on an earlier, preliminary evaluation by the clinician; as to whether the alternative treatments that may be available were all reasonable for this particular patient? Is that a matter for professional judgement? The court found as a fact that the cardiologist did not consider prescribing NSAIDs to Mr McCulloch as reasonable, because there was no pain and no clear diagnosis of pericarditis. Her view was supported by a responsible body of medical opinion. The court thereby held that the identification of reasonable alternative treatments is an exercise of professional skill and judgement.

The British Medical Association intervened in the hearing, proposing that it might be reasonable for a doctor to inform the patient of alternatives based upon his or her engagement; '… for example, that the disinterest of the patient may make it reasonable to inform…of fewer of the reasonable alternative treatments than if the patient was very interested...'

Unsurprisingly, the Supreme Court found that once the doctor, having applied the professional practice test, has identified a range of reasonable alternative treatments, the patient should be informed of them all. The Court concluded that the selection of what is a reasonable alternative for the patient in front of you is a matter for responsible professional judgement. In Mr McCulloch’s case, a reasonable body of cardiologists supported the notion that NSAIDs were not indicated, so the claim was dismissed. The principle established in this case is applicable to every clinical speciality.

Robert Wheeler
Department of clinical law