Informed Consent Post Montgomery – “More than a signature on a form”

Written by Jonathan Godfrey

Unbelievably, it is now almost seven years since the Supreme Court revolutionised the legal landscape in respect of informed consent with its seminal judgment in Montgomery v Lanarkshire Health Board [ 2015 ] 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 or variant 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 “.

It has been said that the decision encapsulated patient choice replacing the previous archaic approach of medical paternalism.

Seven Year post – A Gentle Reminder

In assessing materiality, the Supreme Court in Montgomery gave the following guidance :

1. 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. It is bespoke like a Saville Row suit ; and
2. 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 and/or copious brochures/literature

Practicalities and Realities

In Duce v Worcestershire Acute Hospitals NHS Trust [ 2018 ] EWCA Civ 1307, Hamblem LJ gave practical guidance from the Court of Appeal regarding the nature and extent of the duty that was involved in Montgomery informed consent. It is a twofold test and is succinctly set out by Hamblem LJ at paragraph 33 of the judgment as :

1. “ 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
2. 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 seemingly retains homage to Bolam ). In 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 [ 2019 ] EWHC 106 ( QB ). This is a sorry 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.

Alternative treatment

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 [ 2017 ] 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 “.  He set out the following guidance :

1. What is a reasonable treatment option must depend upon the patient, their treatment and their prognosis. In essence, all the circumstances ;
2. An alternative treatment option must be within the knowledge of a reasonably competent clinician as at the relevant time, and in so doing, satisfy Bolam ;
3. The alternative treatment must be an accepted practice at the relevant time ; and
4. The alternative treatment must be an “ appropriate “ treatment and not just a “ possible “ one.

The case of Mills v Oxford University Hospitals NHS Trust [ 2019 ] EWHC 936 ( QB ) highlights the need to advise as to alternative treatments in addition to the risk involved in the treatment proposed. The surgeon concerned failed to advise that the procedure to be followed was “ new “ and that there was an alternative available.

In the context of alternative treatment, the case of Mukhtar Malik v St George’s University Hospitals NHS Foundation Trust [ 2021 ] EWHC 1913 ( QB ) considered whether it was reasonable to not offer alternative treatment. In this matter, the clinician, a neurosurgeon offered further remedial spinal surgery and did not propose the alternatives of pain medication or nerve blocks. They had either not worked in the past, or would have had a very limited beneficial effect for a short duration of time. HHJ Blair QC approached the matter through the Bolam prism finding that  “ I consider that a responsible, competent, and respectable body of skilled spinal surgeons would have reasonably concluded that there were no reasonable alternative treatments available in the context of the parameters and discussion …. “.

Causation

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 [ 2019 ] 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 ( in which causation 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 [ 2020 ] EWHC 2902 ( QB ).

Before leaving causation, it is worth noting that at first instance in the Diamond case, those acting for the claimant sought a free standing right to damages to compensate for the invasion of the right to personal autonomy/choice. It failed. HHJ Freedman determined that a “ mere failure to warn of a risk , without more “  does not give rise to a free standing claim in damages. That aspect was not pursued before the Court of Appeal. The grounding of any claim in this respect is unlikely to find a renaissance.

Contemporaneous Evidence

Contemporaneous evidence is often the deal breaker in informed cases. Such cases generally tend to turn on a dispute of facts in respect of what was said in the consenting process. Accordingly, the contemporaneous medical notes are a must review in the evidential framework of consent, particularly given that the Montgomery decision recognises that each case is bespoke in its considerations. An absence of contemporaneous evidence to establish that informed consent was obtained is “ fraught with risks “. In the case of Malik v St George’s University Hospital NHS Foundation Trust [ 2021 ] EWHC 1913 ( QB ), the clinician concerned did not keep handwritten notes or typed notes of the consent consultation. HHJ Blair QC commented that:

“ I was taken aback by his practice of simply dictating a letter to his patient’s GP after an outpatient clinic appointment to relay the details of his patient’s current symptoms, recording his clinical assessment , giving his opinion as to appropriate treatment ( s ) but omitting to state what advice has been given about the risks and benefits of the avenue ( s ) open to the patient. This is a practice which it seems to me is fraught with risks of being unable confidently to answer important questions many years later without having the benefit of a contemporaneous set of detailed notes “.

A common and sensible approach often seen by clinicians nowadays following Montgomery, is to keep a detailed set of medical notes of the informed consent process, followed by a letter to the claimant and cc’d to the claimant’s GP setting out precisely what was discussed in the informed consent consultation, focusing on treatment options, risks and alternatives. Such an approach goes a long way evidentially to negate a finding of no valid consent having been obtained.

Montgomery Consequences

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 per cent ( £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 five and a half years post the Montgomery decision, the GMC issued new guidance to doctors entitled “ Decision Making and Consent “. It was dated 30^th September, 2020, and came into practical effect on 9^th November, 2020. It replaced the GMC guidance on consent last issued in 2008. The guidance 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 “ , and Lawrentian in their wisdom . 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. A central tenet is the keeping of contemporaneous medical notes.

The present vista

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 tandem with substantive allegations of negligence. It has had a profound effect on informed consent not only from a legal but also a medical viewpoint. The decision from the perceived ivory tower of the Supreme Court has resonated throughout the day to day decisions on consent made in hospitals and GP surgeries nationwide.

The crux of what represents informed consent post Montgomery is probably best summed up by the guidance given by the Royal College of Physicians and Surgeons of Glasgow, and which states the following:

“ Despite how it can often feel in the middle of a busy clinic, or at the start of a full theatre list, consent is more than obtaining a signature on a piece of paper. It is process that is part of patient-centred care and begins with finding out what matters to the patient, identifying what options are reasonable – including the option of no treatment – and helping the patient decide which option suits them best.

The decision the patient makes may not be the one you would have made but, if the patient has been kept at the centre of the process, it should be the right one for the individual patient at that time. When the moment comes to sign the consent form if a patient has been fully involved in the process and enabled to weigh up the different options and their benefits and risks – risks that must be transparently presented – then truly informed consent will have been given “.

The precis is simple, post Montgomery consent is “ a process not a signature on a form“.

Author

Jonathan Godfrey is a specialist clinical negligence barrister.