Montgomery and informed consent: where are we now?
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2224 (Published 12 May 2017) Cite this as: BMJ 2017;357:j2224
All rapid responses
The Montgomery v Lanarkshire case [1] discussed by Chan and colleagues [2] (one of whom was directly involved in the case) has focused the attention of the medical profession on consent, but it does not represent a seismic shift in the landscape. As Lords Kerr and Reed commented in Montgomery, English courts had already largely stopped using the Bolam test to decide on consent cases. Instead the standard for the duty to disclose was generally taken to be that “if there is a significant risk that would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk”, as set out by Lord Woolf in the Court of Appeal in 1998 - almost twenty years ago, and before the events in Lanarkshire. [3]
This was reformulated by the Supreme Court in Montgomery to state that a doctor must make a patient aware of any material risks, and the test of materiality is whether “a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.” [1] The two main difficulties for doctors (and ultimately the courts) are knowing which risks “a reasonable person in the patient’s position” would consider significant, and when a doctor should “reasonably be aware” of their particular patient’s priorities. With regards the first of these, a reasonable approach would seem to be to discuss those risks that might affect the decision of a reasonable patient, as advocated by Lord Woolf. As for the second, this can seem like an impossibly high bar for doctors who cannot know exactly which details the particular patient in front of them may or may not consider significant. There is however, unlikely to be too much cause for alarm. When discussing this part of the test, Lords Kerr and Reed referred to and borrowed heavily from Rogers v Whitaker from the High Court in Australia [4] in which a patient, who was already blind in the eye scheduled for surgery, was not warned of the risk of sympathetic ophthalmia (thought to be the cause of Louis Braille’s blindness) [5] that could (and ultimately did) result in blindness in their good eye. It is very reasonable to presume that being blind in one eye would affect someone’s attitude to the risk of blindness in their other eye, and the surgeon clearly knew about it. What remains to be seen is how our courts interpret this and also how they decide when a doctor “should be reasonably aware” of a particular patient’s priorities, but judges are generally sensible and, if anything, could be accused of having been too lenient on doctors in the past.
Ultimately, if you follow GMC guidance and keep in mind that our role is to give patients the information they need to be able to decide what is right for them, then you should still be very unlikely to fall foul of the law.
1. Montgomery v Lanarkshire Health Board [2015] UKSC 11
2. Chan S, Tulloch E, Cooper ES et al. Montgomery and informed consent; where are we now? BMJ 2017:357:j2224
3. Tina Marie Pearce and Another v United Bristol Healthcare NHS Trust [1999] ECC 167
4. Rogers v Whitaker [1993] 4 Med LR 79; [1992] ALMD 6993
5. Bullock J, Galst J. The story of Louis Braille. JAMA Ophthalmology 2009;127:1532-3. Available at: http://jamanetwork.com/journals/jamaophthalmology/fullarticle/424447 (accessed 26.5.2017)
Competing interests: No competing interests
Interesting judgment and discussion about the ethics of not informing pregnant patients about facts that are relevant to them. Here in the Netherlands, I am hoping women (or their descendants) will start a few court cases about this, in particular because they were not informed antenatally about the option of a tubal ligation (TL) in case their deliveries became a caesarean section (CS), as FIGO advises to discuss long before term (1), and a study in the Netherlands shows most women with ≥1 children would desire (2). This can have serious consequences because without the TL there is of course much more risk of an unintended/ unwanted pregnancy (such women are regularly seen in abortion clinics, and are often particularly upset (2)). Risks related to pregnancy are larger for these if-given-the-option-would-have-chosen-a-TL-women compared to the risks in average pregnancies because of the uterine scar, because of possible recurrent complications related to the CS indication (e.g. diabetes, hypertension, >BMI) and because these women are on average older(3). On top of that, there are the costs and side effects (e.g. thrombosis on the pill especially in smokers when they get older) and anxieties related to contraception for the next 10-15 years. With leftover sutures from the uterine closure, the TL is gratis, unlike with clips or with hysteroscopic sterilisations later on: and at least as reliable (3). Moreover, a very likely benefit of TL, i.e. a significant reduction in subsequent ovarian carcinoma risk, is withheld ― bilateral total salpingectomy is probably most effective for this effect, and easily performed during a CS. These malignancies apparently often originate in the tubes and there is no good method (like with breast and cervix carcinoma) to detect with screening these neoplasms when still relatively harmless (3). Conversely, serious TL regret is of course a risk, but many gynaecologists, or their mentors, were trained at a time when regret was more likely: women were more easily coerced; under five mortality was higher; serious congenital abnormalities were easier missed antenatally; IVF was not so mainstream; and women were on average much younger when they delivered their ≥2 child. Indeed, regret is not so much related to parity but very significantly to age (3). One can’t help but wonder if one woman with regret who is offered free IVF is worse: ethically; from a medical-complications perspective; and in light of financial considerations, than say 10 unintended pregnancies.
In the Commonwealth countries, Brazil, Spain, Switzerland (reputed to have the lowest induced abortion rate in the world), and the USA, most women know very well that a TL during a CS for a soon-expected-to-be-complete family is a popular option. This TO option is more or less understood to be on the table antenatally. Many doctors in the Netherlands, France, Germany, Eastern Europe and Belgium think it is unwise, unethical or even financially disadvantageous for them to offer the TO option under the above circumstances and most women are not well-informed enough to demand it or to insist. There is also very subtle TO counter-propaganda by cat food producers, where it hurts most, see photo (3). Not giving the TO option also has serious consequences for, for example, Africa where the medical norms are often related to those in Europe, where there is often no guaranteed access to a repeat CSs let alone NIPT and where millions of women have an unmet need for contraception and save abortion. A few court cases in Europe might help. In sub-Saharan Africa uterine scars can carry a similar risk to landmines: they can “explode” even 10 years after the last CS (3). Who knows whether the medical services will be in that particular region adequate then?
(1) Dickens B. Female contraceptive sterilisation: International Federation of Gynecology and Obstetrics (FIGO) Committee for the Ethical Aspects of Human Reproduction and Women's Health. Int J Gynaecol Obstet 2011;115:88–9.
(2) Verkuyl DA, van Goor GM, Hanssen MJ, Miedema MT, Koppe M. The right to informed choice. A study and opinion poll of women who were or were not given the option of a sterilisation with their Caesarean Section. PLoS ONE 2011;6:e14776. doi:10.1371/journal.pone.0014776. PMID: 21445338 http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0014776
(3) Verkuyl DA. Recent developments have made female permanent contraception an increasingly attractive option, and pregnant women in particular ought to be counselled about it. Contraception and Reproductive Medicine (2016) 1:23 DOI 10.1186/s40834-016-0034-1 (open access)
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Society has to compensate patients harmed by medical procedures without the added burden of proving negligence. Compensation should not be limited to the tenacious few who can navigate the legal maze and win the litigation lottery. Naturally, the legal profession has a conflict of interest in opposing such “no fault “schemes.[1].
But to frame the recent change of law on informed consent, following the Montgomery case, as a clash of patient autonomy versus medical paternalism is disingenuous.[2]. If anything, it is legal paternalism masquerading as patient autonomy. The judges, based on one single case, have decided what the new legal standard is for millions of other future patients without canvassing anyone else’s views. Furthermore, this new standard applies to everyone except the legal profession. The legal profession will not automatically and retrospectively apply this new standard to past cases where “ the bolam” standard has been applied.
Natural justice demands that a professional knows in advance what is legally compliant and an assurance that their actions are not judged retrospectively by a particular patient outcome and future “case law” standards.
To avoid NHS being overwhelmed, directly and indirectly, by “malpractice” claims, the society and parliament need act urgently and enact a statutory law on medical negligence. [3].
References
1 Capstick B. The future of clinical negligence litigation? BMJ 2004;328:457–9. doi:10.1136/bmj.328.7437.457
2 Chan SW, Tulloch E, Cooper ES, et al. Montgomery and informed consent: where are we now? BMJ 2017;357:j2224. doi:10.1136/bmj.j2224
3 Jena AB, Schoemaker L, Bhattacharya J, et al. Physician spending and subsequent risk of malpractice claims: observational study. BMJ 2015;351:h5516.
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I find it strange that David A. Stephenson, Q.C., asks (12 May):
‘First, the decision in Montgomery purports to accord with the current (2008) GMC guidance on consent. If this is so, one might then wonder why change to the GMC’s guidance would be required in the light of Montgomery.’
Well, the Mental Capacity Act’s section 3 enshrined Informed Consent in English and Welsh law just before 2008: although the MCA does not use the term, it clearly did that [even if many people failed to notice].
Montgomery has more recently made it clear that Informed Consent is in fact the law for the whole of the UK (and has been since before the year 2000).
The GMC writes guidance which covers all of the UK.
Did I misunderstand why the question was posed [and I could not read the full article] ?
PS Although the above analysis is I think correct, I would point out that I consider the GMC's '2008 interpretation' of parts of the MCA - in particular how the Act applies to family carers - to be flawed, and therefore that it does need alteration.
Mike Stone mhsatstokelib@yahoo.co.uk @MikeStone_EoL
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Lady Hale gives what appears to be ‘a short lecture’ at the end of the Montgomery ruling. Lady Hale concludes with:
117. These additional observations, dealing with the specific example of pregnancy and childbirth, are merely a footnote to the comprehensive judgment of Lord Kerr and Lord Reed, with which I entirely agree. Were anyone to be able to detect a difference between us, I would instantly defer to their way of putting it. I would allow this appeal.
It seems to me, that any interpretation other than ‘my fellow judges have perhaps used different words to express our ruling, but we are in fact all in agreement’ would be perverse: the importance resides in the reasons why rulings were arrived at, and although those reasons can only be expressed by words, the actual words used are merely the tool to try and get across the ‘thinking’.
Sometimes 'the thinking' is clear, and can be clearly expressed: Lady Hale's explanation that 'Bolam' does not apply to consent, is such a situation. She makes it very clear, that 'consensus medical opinion' (my phrase) is not the test of whether a patient was given sufficient clinical information before consenting: so there are few options left, logically, apart from a test which 'looks from the patient-side, as to whether sufficient information was supplied'.
Sometimes 'the thinking' either has not been fully-worked-through, or is inherently so complex as to defy clear expression: exactly how much 'clinical detail' must be divulged within a given consultation, in order that the patient has been sufficiently informed to 'give properly-informed consent' is not something you will be able to 'dig out' [for 'the general case'] from court rulings, because that falls into this category.
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We can all 'nit pick the wording' of court rulings for ever.
But it seems very clear to me, that the 'ethos' of the Montgomery ruling [and also the ethos of sections 1-3 of the Mental Capacity Act] is clear:
Patients should normally be provided with all of the clinical information, which might affect the patient's decision to consent or decline an offered intervention: and this applies at the level of individual patients, not at the level of 'the average patient'.
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Re: Montgomery and informed consent: where are we now?; inaccurate and potentially misleading remark
With reference to Montgomery[1], authors say that "a patient should be told whatever they want to know, not what the doctor thinks they should be told"[2]; such statement is inaccurate and potentially misleading. Rather than telling "whatever they want to know"[2], the doctor is "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" (para.87[1]). Further at para.88, the Supreme Court expressly states, "The doctor is however entitled to withhold from the patient information as to a risk if he reasonably considers that its disclosure would be seriously detrimental to the patient's health.The doctor is also excused from conferring with the patient in circumstances of necessity, as for example where the patient requires treatment urgently but is unconscious or otherwise unable to make a decision"[1]. Of course, such therapeutic exceptions "should not be abused"(para.91[1]).
References
[1]http://www.bailii.org/uk/cases/UKSC/2015/11.html
[2]BMJ 2017;357:j2224
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Informed consent is a redundancy, because being properly informed is a precondition of consent. Without being properly informed, a patient or client cannot give any legitimate, binding consent. Therefore, it is imperative that all professionals withhold any request for agreement or signatures, until after all information and questions have been addressed.
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The authors are correct when they state that the General Medical Council has yet to update its guidance on consent post-Montgomery. However two additional points are worth making.
First, the decision in Montgomery purports to accord with the current (2008) GMC guidance on consent. If this is so, one might then wonder why change to the GMC’s guidance would be required in the light of Montgomery.
Second, despite this observation, the GMC is embarked upon a general review of its position on consent. The initial public consultation period has ended. Draft revised guidelines are promised later this year when it is anticipated that there will be further consultation. Doctors (and others) will then have an opportunity to respond to the draft guidelines and seek to shape their final form. See http://www.gmc-uk.org/guidance/news_consultation/30001.asp
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The 'reformulation' is significant Re: Montgomery and informed consent: where are we now?
As Hugo Wellesley (response 26 May) has commented, Montgomery is in line with other recent court rulings, in placing the emphasis on the situation as viewed from the perspective of the specific patient:
'a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.;
As Wellesley points out, the 'the particular patient would be likely to attach significance to it' wording is interesting 'logically' - 'this can seem like an impossibly high bar for doctors who cannot know exactly which details the particular patient in front of them may or may not consider significant'.
This 'doctors cannot know' is even more relevant when instead of Informed Consent the MCA's best-interests process is thought about, because recent rulings are making it increasingly clear that this same 'patient individuality' principle should guide best-interests decisions-making: logically therefore the people 'close to the patient' [the patient's close family and close friends], who do understand the patient's individuality far better than the patient's clinicians understand that individuality, should in fact be able to make better-considered best-interests decisions than the clinicians who are involved.
Professionals are resistant to that implication, which is one of many 'inconvenient conclusions' which follow if one reads the Mental Capacity Act in the context of its ethos of patient autonomy and 'patient individuality'. As I have pointed out previously, this change from an emphasis on clinical situations, to 'the autonomous decision of a mentally-capable patient [and for best-interests we have a similar if more complex situation, but still requiring an understanding of 'patient individuality'] within a clinical and wider-life situation' is something very challenging for working clinicians. In particular, one 'inconvenient conclusion' is that the MCA is a very hard read, if you are trying to fit it into a context of 'safeguarding'.
There is one fundamental difference between the application of 'individuality' within Informed Consent, or within best-interests decision-making. If the consultation had no time restriction and the patient is capacitous, then in theory an unlimited number of 'if you decide that, then '...' will be the result - do you understand that?' explanations/questions from the doctor, satisfy informed consent by eventually 'covering everything the patient needs to be aware of, in order to make an informed decision'. But this is not true, during best-interests decision-making: because during informed consent the patient only needs to express yes/no answers (consent or not) and the patient does not need to explain 'why I'm deciding as I am'. Whereas best-interests does require 'an understanding of the patient's mind' (that phrase is inexact - I can think of no precise and short phrase!) because the decision-maker has to incorporate that understanding into his own decision-making: during best-interests you cannot simply 'keep throwing in more clinical information, and finding out if the new information alters the patient's decision by simply asking the patient and seeing if his/her decision changes'
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