Informed Consent: What is the test for reasonable alternative or variant treatments?

Articles
07 Jul 2023

The Supreme Court in Montgomery imposed (or perhaps clarified) a duty to ensure that any patient is aware of the material risks involved in any recommended treatment.  They also extended the duty to obtain informed consent to informing the patient of “any reasonable alternative or variant treatments.”

In Bilal v St George’s University Hospitals NHS Trust [2023] EWCA Civ 605, a question was raised over the meaning of ‘reasonable alternative or variant treatments’.  Specifically, is ‘reasonable’ in this context to be judged in the same way as other aspects of medical negligence i.e., the Bolam test?  Or is it to be judged from the patient’s perspective?

In practical terms, what does a claimant need to prove in order to succeed in a claim based on a reasonable alternative treatment allegation:

  • Is it; ‘that no responsible body of doctors would fail to have offered that treatment to the patient?’
  • Is it effectively the inverse; ‘that at least a responsible body of doctors would not regard it as improper to have offered the treatment to the patient’.
  • Or is it somewhere in between, with reasonable in the consent context being different from the standard of treatment context?

The Facts and First Instance Decision

Bilal was a complex case concerning a poor outcome from 2 spinal surgeries.  It involved both traditional clinical negligence allegations concerning the diagnosis of the nature of post-operative pain, and informed consent allegations which included a failure to discuss or recommend alternative treatments to surgery, such as pain management or injections.

The Claimant lost on all aspects of the claim at trial.  HHJ Blair KC (sitting as a Deputy High Court Judge) made clear that much of the case turned on a factual dispute over the nature of post-operative pain.  In dismissing the alternative treatment allegation, he said:

“I consider that a responsible and respectable body of skilled spinal surgeons would have reasonably concluded that there were no reasonable alternative treatments available” on the basis of the patient’s reported symptoms.

As to causation, he found that the patient would have proceeded to surgery even if he had been advised of other treatment options.

The Appeal

The Claimant appealed on 3 grounds.  It was contended that HHJ Blair KC was wrong:

  • To have held that it was reasonable to have offered revision surgery when the surgeon was unaware of the duration of pain.
  • To have held that the patient was aware of reasonable alternative treatments.
  • To have held that causation had not been proved.

Ground (2) included a discussion of the applicable test, although the precise framing of the test was not the central aspect of the ground.  The Court of Appeal’s reasons for dismissing Ground (2) occupied only 4 paragraphs of the 70 paragraphs judgment.  The leading judgment was given by Nicola Davies LJ, with whom both Coulson LJ and King LJ agreed.  It was said that the Defendant’s neurosurgery expert had expressed the view that all other treatment options had been exhausted such that it was reasonable to have offered surgery and not other treatments.

The Court of Appeal held that Montgomery drew a distinction between (i) assessing treatment options, for which the Bolam test would apply, and (ii) “an assessment of what risks and treatment should be explained to the patient because they are material”, for which the Montgomery test would apply.  It was held that “reasonable in respect of the assessment of alternative or variant treatments encapsulates the Bolam approach”.

In what many will see as a significant departure from the anti-paternalistic and patient centric theme of Montgomery, Nicola Davies LJ concluded:

“In my judgment it is for the doctor to assess what the reasonable alternatives are; it is for the court to judge the materiality of the risk inherent in any proposed treatment, applying the test of whether a reasonable person in the patient’s position would be likely to attach significance to the risk. Thus the Judge at [93] was correct to apply Bolam and to conclude that his assessment reflected the guidance set out in para 87 of Montgomery.”

Analysis

It was necessary for the Court of Appeal to revisit Montgomery, in which the Supreme Court held:

  • The counterpart to the doctor’s duty of care to avoid exposing a patient to risk is the patient’s entitlement to decide whether or not to incur that risk. That entitlement “does not depend exclusively on medical considerations” (paragraph 82).
  • There is a distinction between on one hand the doctor’s role when considering possible investigatory or treatment options, and on the other hand the doctor’s role “in discussing with the patient any recommended treatment and possible alternatives, and the risks of injury” (paragraph 82).
  • It is ‘a non sequitur’ to conclude that the question of whether a risk of injury, or the availability of an alternative form of treatment, ought to be discussed with the patient, is also a matter of purely professional judgment (paragraph 83).
  • The doctor’s advisory role cannot be regarded as solely an exercise of medical skill without leaving out of account the patient’s entitlement to decide on the risks to her health which she is willing to run (a decision which may be influenced by non-medical considerations) (paragraph 83).
  • “An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo………….The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments……..” (paragraph 87).

The decision in Bilal feels paternalistic – a doctor judging what is best for the patient and taking it upon themselves to exclude possible alternative treatments that would not have been unreasonable to offer.  In that respect, it is the antithesis of Montgomery.  The Court of Appeal in Bilal suggested that the movement away from paternalism was confined only to the disclosure of risks element of Montgomery, where materiality includes what the individual patient would consider significant, and not to be determined by what the doctor regarded as significant.

The Court of Appeal have seemingly split the duty surrounding informed consent.  It remains the case that it is the Court that determines the question of materiality of a risk of treatment with reference to the subjective interests of the particular patient.  However, in relation to offering possible alternative treatments, the interests of the patient are effectively determined by the doctor.

Paragraphs 82 and 83 of Montgomery group together the concepts of informing as to risks and informing as to alternative treatments.  Paragraph 83 expressly rejects the notion that the decision on whether to offer an alternative treatment is ‘purely’ a matter of professional judgement.

The practical effect of Bilal is now that if 95% of responsible doctors would offer a patient an alternative treatment, but 5% of responsible doctors would not, there is no breach of duty for a failure to offer a reasonable alternative treatment.  Even though, if 95% of responsible doctors would have offered it to the patient, it must in reality be reasonable.

Whilst it seems unlikely that Bilal will be taken to the Supreme Court given the dismissal of other parts of the appeal, including the factual finding on causation, in May 2023 the Supreme Court heard an appeal on similar issues in the Scottish case of McCulloch v Forth Valley Health Board.  Judgment is anticipated to be handed down later this year.


Article by Aneurin Moloney

Author

Aneurin Moloney

Call: 2013

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