Jonathan specialises almost exclusively in clinical negligence work and his expertise covers the whole area, including orthopaedic injury, cancer misdiagnosis, cerebral palsy birth injury, surgical mishap and wrongful treatment and consent. He has worked with SpecialistInfo for over five years training expert witnesses in this area of law.
It is now 6 years since the Supreme Court seemingly changed the legal landscape in respect of informed consent in its judgment in Montgomery v Lanarkshire Health Board  UKSC 11. The test of materiality was born. A doctor was now “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 treatments“. The test of materiality was described as “whether in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should be aware that the particular patient would be likely to attach significance to it“. Patient choice had found its way to the fore in informed consent, replacing the previous incarnation of medical paternalism.
Has there been any change in the legal (and also medical) landscape following the Montgomery decision? In particular:
i. How have the courts implemented the materiality test from a practical perspective?
ii. Has Montgomery had any noticeable impact on the number of cases brought before the courts? and;
iii. Has there been any change in focus from the medical profession in terms of informed consent following the decision?
In assessing materiality, the Supreme Court gave the following guidance:
i. The assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors in addition to its magnitude: the nature of the risk, its effect on the patient’s life, the importance to the patient of the benefits sought by the treatment, the alternatives available, and the risks involved in the alternatives; and
ii. The doctor’s advisory role involves dialogue, the aim of which is to ensure that the patient understands all the matters involved. The information provided is to be comprehensible and is not fulfilled by bombarding with technical information.
In Duce v Worcestershire Acute Hospitals NHS Trust  EWCA Civ 1307, the Court of Appeal, in the judgment of Hamblem LJ, gave practical guidance regarding the nature of the duty that was involved in informed consent. It is a twofold test and is described by Hamblem LJ, at paragraph 33 of the judgment as:
i. “what risks associated with an operation were or should have been known to the medical professional in question. This is a matter falling within the expertise of the medical professionals; and
ii. Whether the patient should have been told about such risks by reference to whether they were material. This is a matter for the Court to determine. The issue is not therefore the subject of the Bolam test and not something that can be determined by reference to expert evidence alone“. Accordingly, on a case-by-case basis, the medical experts instructed are to deal with the risks that that should have been known or ought to have been known by the medical professional in question (and in so doing this limb retains homage to Bolam). In relation to the Duce case, Hamblem LJ, specified at Paragraph 42 of the judgment that whether gynaecologists were or should have been aware of the relevant risks at issue “is a matter for expert evidence”. Thereafter, whether those risks should have been communicated to the patient by reference to whether they were material is a question for the court to determine. The test is replicated at Paragraph 12 of the judgment of Yip J, in the subsequent case of Hazel Kennedy v Dr Jonathan Frankel  EWHC 106 (QB). This is an unfortunate case in that the Defendant doctor had provided his diagnosis and treatment gratuitously, but it did not absolve him from his duties in respect of informed consent. Hamblem LJ, repeated at Paragraph 35 of the Duce judgment, those factors relevant to determining materiality that were previously elucidated by the Supreme Court in Montgomery.
Determination of materiality brings with it a need to inform not only of the risk involved in the treatment but also “any reasonable or variant treatments”.
In Bailey v George Elliott Hospital  EWHC 3398 , HHJ Worster, sitting as a Deputy High Court Judge, considered what test should be applied as to whether an alternative treatment was “reasonable”. HHJ Worster determined that the matter was to be judged by what was known, or ought to have been known, about the alternative treatment at the relevant time. The question of reasonableness had to be approached by reference to all the circumstances, including the particular patient concerned, their condition and their prognosis.
The case of Mills v Oxford University Hospitals NHS Trust  EWHC 936 (QB) highlights the need to advise as to alternative treatments in addition to the risk involved in the treatment proposed.
A failure to provide informed consent still brings with it the need to establish that the failure was causative. It is not a presumptive sequitur. This is best exemplified in the case of Diamond v Royal Devon and Exeter NHS Foundation Trust  EWCA Civ 585. The Claimant had had an abdominal hernia repaired using surgical mesh, but was not advised of the alternative of a suture repair. At first instance, HHJ Freedman held that the Claimant had not been given the appropriate information required for informed consent, but that had she been so informed she would have proceeded with the mesh repair, which in fact took place. The Court of Appeal approved the trial judge’s approach adopted to the question of factual causation. The court re-iterated that the but for test applies to causation in informed consent cases.
A recent exposition of the consideration given by a trial judge as to the facts to establish causation (which was established) is usefully illustrated in the judgment of Stacey J in Betty Plant (by her son and Litigation Friend, Rodney Winchester) v Mr Ahmed El-Amir and London Eye Hospital Limited  EWHC 2902 (QB).
A study conducted at Queen Mary University of London: “the effect of the Montgomery judgment on settled claims against the NHS due to failure to inform before giving consent to treatment“ published in March, 2020 (by DS Wald, JP Bestwick, P Kelly in the Quarterly Journal of Medicine, DOI: HCAA082), gives a fascinating insight into the practical effect of the Montgomery decision in so far as claims initiated as against the NHS concerning a failure to provide informed consent.
The research established that while the rate of increase of other clinical negligence claims has remained steady, cases relating to consent have risen four times as fast since the Montgomery decision in March, 2015, and where failure to inform was added as a contributory claim, the rise was nearly ten-fold.
Data established that as between 2005 and 2019 the NHS settled 70,000 cases, of which 2,300 were linked to a failure to inform (either primary or secondary) with a total value of nearly £400 million. Between 2011 and 2015, costs for settling informed consent cases rose from £25 million to £28 million per annum. Thereafter, from 2015 (post Montgomery) to 2019, costs rose to £62 million per annum. The rise was purely due to the increase in the numbers of claims, as the cost per claim remained steady. The study found that lawyers’ fees accounted for about 40% (£155 million) of costs paid by the NHS in settled claims due to a failure to inform.
Professor Wald remarked that “claims involving failure to inform are normally invisible in the overall numbers of negligence claims, but the rise we have identified is striking and shows no signs of stopping. The data support concerns that lawyers are adding consent-related claims to other allegations, which on their own may not be successful in court. The Montgomery ruling now makes these cases much easier to win, and the NHS is paying the bill“. Professor Wald’s study is symbolic evidence of the growth in informed cases being brought post Montgomery.
From the medical perspective, some 5 ½ years post the Montgomery decision, the GMC issued new guidance to doctors entitled “Decision Making and Consent” on 30th September, 2020, and which came into practical effect on 9th November, 2020. It replaces its guidance on consent last issued in 2008. It focuses on “the importance of meaningful dialogue, personalised communication and potential benefits and harms, and how doctors can support patients to make decisions with them about treatment and care”. At its core are “the seven principles of decision making and consent”. The seven principles find their genesis and meaning in the Montgomery judgment. At the heart of the new guidance is the concept of meaningful dialogue. The new guidance translates the Montgomery decision into practical guidance for medical professionals.
It is clear as per the research by Professor Wald and his co-authors, that the Montgomery decision has seen a rise in informed consent cases per se, or in unison with substantive allegations. It will be interesting to see whether the upward trend continues.
From a personal perspective, in presenting the medico-legal clinical negligence course for SpecialistInfo, it is apparent in discussions with medical professionals that in the main they have taken on board the ratio of the Montgomery decision. Meaningful discussion now forms the mainstay of their informed consent discussions moving forward. Another very apparent insight is that there appears to be the commended adoption of ensuring that the contemporaneous medical notes and correspondence properly detail the informed consent process undertaken.
In the light of the new guidance on consent from the GMC, together with the informed consent process that I have had outlined reported to me by medical professionals, it will be interesting to see whether there is a levelling off or decline in informed consent cases being brought. Whether we have reached the ultimate destination in so far as informed consent cases are concerned, or whether the journey continues with vigour remains to be seen.