New Rules of Consent: the Patient Decides
I have stolen the title from the title of a piece in the BMJ by Fiona Godlee (BMJ 2015;350:h1534):
http://www.bmj.com/content/350/bmj.h1534
Fiona's piece is about the Montgomery court ruling:
https://www.supremecourt.uk/decided-cases/docs/UKSC_2013_0136_Judgment.pdf
I have discovered, after reading all through the ruling, that I have no need to comment on its conclusions about either the specific case, or about certain wider legal issues it mentions - it turns out, that the court's 'arguments and thinking' are almost identical to my own.
However, I THINK THERE ARE ARGUABLY SOME WIDER - and VERY SIGNIFICANT - IMPLICATIONS OF THIS COURT RULING: those are what I intend to begin discussing here.
INTRODUCTION
The immediate impact of the Montgomery ruling (I will normally just use 'the ruling' from now on, or just 'Montgomery') is to make it clear that consenting to, or refusing, an offered medical treatment, is definitely a decision the patient makes. The role of the doctor, is to adequately inform the patient of everything clinical which might affect the patient's decision. The ruling supported this earlier legal position (and I would like to point out, that some judges have now started to stop presenting their points in long-winded 'legal jargon' and have taken to explaining the point in clear English - these judges do that, in 44):
43. At the other end of the spectrum was the speech of Lord Scarman, who took as his starting point "the patient's right to make his own decision, which may be seen as a basic human right protected by the common law". From that starting point, he inferred:
"If, therefore, the failure to warn a patient of the risks inherent in the operation which is recommended does constitute a failure to respect the patient's right to make his own decision, I can see no reason in principle why, if the risk materialises and injury or damage is caused, the law should not recognise and enforce a right in the patient to compensation by way of damages."
44. In other words, if (1) the patient suffers damage, (2) as a result of an undisclosed risk, (3) which would have been disclosed by a doctor exercising reasonable care to respect her patient's right to decide whether to incur the risk, and (4) the patient would have avoided the injury if the risk had been disclosed, then the patient will in principle have a cause of action based on negligence.
45. Lord Scarman pointed out that the decision whether to consent to the treatment proposed did not depend solely on medical considerations:
"The doctor's concern is with health and the relief of pain. These are the medical objectives. But a patient may well have in mind circumstances, objectives, and values which he may reasonably not make known to the doctor but which may lead him to a different decision from that suggested by a purely medical opinion."
Montgomery has consigned to the legal dustbin, this rather patronising counter-argument, which was once the accepted legal position:
Lord Eassie stated that "communication of general anxieties or concerns, in a manner which does not clearly call for the full and honest disclosure of factual information in reply, falls short of qualifying under Lord Bridge's observation". Mrs Montgomery's concerns had been of a general nature only. Unlike specific questioning, general concerns set no obvious parameters for a required response. "Too much in the way of information ... may only serve to confuse or alarm the patient, and it is therefore very much a question for the experienced practitioner to decide, in accordance with normal and proper practice, where the line should be drawn in a given case".
Sections 58 and 59 of the ruling, run through some of the [obvious !] logical arguments, which I would have written up, if the court had not already done it for me. There is a particularly powerful piece of logic, which I could not have expressed any better, at the end of section 59:
'Why should the patient's asking a question make any difference in negligence, if medical opinion determines whether the duty of care requires that the risk should be disclosed? The patient's desire for the information, even if made known to the doctor, does not alter medical opinion. The exception, in other words, is logically destructive of the supposed rule.'
Section 71 points out:
"Whether a medical practitioner carries out a particular form of treatment in accordance with the appropriate standard of care is a question in the resolution of which responsible professional opinion will have an influential, often a decisive, role to play; whether the patient has been given all the relevant information to choose between undergoing and not undergoing the treatment is a question of a different order. Generally speaking, it is not a question the answer to which depends upon medical standards or practices. Except in those cases where there is a particular danger that the provision of all relevant information will harm an unusually nervous, disturbed or volatile patient, no special medical skill is involved in disclosing the information, including the risks attending the proposed treatment."
This is the point I was making in my piece at:
http://www.bmj.com/content/350/bmj.h841/rr-2
'The logical consequence of the Mental Capacity Act, if we set aside the real-world complexity of any involvement of 'mental illness' and restrict ourselves to situations where it seems clear that a patient is either definitely mentally capable, or definitely lacking in mental capacity, is that it is no longer helpful to state that 'doctors have a duty of care towards their patients'. For mentally-capable patients, the duty seems to be to adequately inform the patient so that the patient can make an informed decision, and then to exhibit clinical competence in the administration of any treatment which the patient has accepted.
The duty - and in my view section 4 of the MCA, and section 4(9) in particular, describe a legal duty and not a legal power - for mentally-incapable patients, then becomes 'to satisfy section 4(9) of the MCA' [which could be phrased as 'to act in the patient's best interests', provided we understand that 'best interests' means compliance with section 4 of the MCA].'
We are now approaching, something I see as a fundamental - only a little more 'background' is necessary.
When I have 'argued about the law' [usually about the meaning of the Mental Capacity Act] with clinicians, usually doctors, during the past few years, I have often been annoyed that they tend to point at 'concepts in medical ethics' whereas I reply with 'no - we should be arguing from the law'. The Montgomery ruling, has made it clear that my position is legally correct. Their position was arguably correct in the middle of the last century - but, their position was ALWAYS 'logically muddled', even when the courts supported it.
This is a fundamental 'difference of mindset', which I mentioned in my report about hospital DNACPR forms, where I started the introduction with:
'It seems to me, that there is a significant difference between the way I look at the Mental Capacity Act, and the [apparent] way that many clinicians look at it. In essence, to me the Act is about the definition of, and duties and powers of, decision-makers, and about the principles these decision-makers must follow: it is clear that the Act is not describing clinical things, such as the best way to apply a treatment, or how best to arrive at a prognosis - the Act is about a wider, less well-defined and much more complex, question of should
an intervention take place at all. I also see what I consider to be a lack of terminological clarity, around the phrase 'best interests': I reserve 'best interests' for decisions which involve the decision-maker being able to claim to have legitimately complied with section 4(9) of the MCA - effectively, this places the non-offer of a medical intervention because it could not be clinically successful, and any decision made by a person who does not understand at least a substantial portion of the things described in section 4 of the MCA, as 'not best interests decisions' (although, that does not automatically equate to not legitimate decisions).
By contrast, many clinical authors devote much more time to descriptions of the clinical situations in which decisions are made, with much less discussion of the origin of the 'legal authority or legal justification' of the person making a decision.
Very bluntly, and somewhat over-simplified, I analyse the 'rules' by defining the decision-making process and this leads to less involvement of precise clinical situations in my analyses: most clinical authors are much more precise in their categorisations of clinical situations, but then they tend to make unproven assertions about who can legitimately be a decision-maker.
In its most concise form, this difference comes down to sentences which I often see, such as 'ultimately DNACPR is a clinical decision': unless 'a clinical decision' need not be a decision which requires a clinician to make it, that sentence is clearly wrong, because of sections 6(6) and 6(7) of the MCA, taken in logical combination with the absence of any requirement that welfare attorneys and court deputies need to be clinically qualified.'
This section of the ruling, 'covers all of the bases':
87. The correct position, in relation to the risks of injury involved in treatment, can now be seen to be substantially that adopted in Sidaway by Lord Scarman, and by Lord Woolf MR in Pearce, subject to the refinement made by the High Court of Australia in Rogers v Whitaker, which we have discussed at paras 77-73. An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. 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. The test of materiality is 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 reasonably be aware that the particular patient would be likely to attach significance to it.
THE TEST FOR THE APPLICATION OF AN OFFERED TREATMENT - in other words, the test for consent - IS 'THE JUDGEMENT OF A REASONABLE PERSON IN THE PATIENT'S POSITION'.
So for 'consent' the rule is that 'a normal, reasonable person (who is similar to the patient in question), would see the behaviour of the clinical professional(s) as acceptable', using my phrase.
I used this 'reasonable layman' test, in a piece I wrote about cardiopulmonary resuscitation (CPR) a couple of years ago:
'1. If it is believed before a CPR attempt, that CPR would fail to re-start the heart and breathing, it should not normally be attempted.
2. If it is believed that CPR might restore life, then if the quality of that restored life might be deemed acceptable by some patients - even a very small minority - the usual ethical principles apply. In such a situation, it is for the patient himself to have judged whether the outcome of CPR would be acceptable, and for the patient to indicate his decision: which clearly must have been done, in advance of the CPA itself. This is usually described as patient autonomy, and a mentally capable patient, once informed of the clinical consequences of accepting or refusing an offered treatment, instructs the clinician whether or not to proceed with the treatment.
For CPR, the rule is that if a clinician is aware of information which would persuade a reasonable person, that the patient would have refused CPR for the CPA in question, had the patient somehow been able to consider the issues relevant to his CPR decision during a CPA and also to indicate his refusal, then the clinician must not attempt CPR. If a clinician attempts CPR, and a third party believes the clinician should have concluded that the patient would have refused resuscitation had the patient been capable of doing so during the CPA, the clinician is running a risk of prosecution for assault.
If the clinician is not reasonably persuaded that the patient would have refused CPR, then CPR should be attempted.'
This is my GENERAL [logical] EXTENSION of the Montgomery ruling (this is only subject to minor caveats - this is the 'fundamental rule'):
In EVERY situation where 'the question is whether an available treatment should be applied', the test is 'would PUBLIC opinion support the decision made' - it is NOT 'would PROFESSIONAL opinion support the decision made'.
I will attempt to suggest some applications of that 'General Rule' in a later post here !
The court ruling from the Montgomery case can be downloaded at:
https://www.supremecourt.uk/decided-cases/docs/UKSC_2013_0136_Judgment.pdf
Sections 75 and 76 of the ruling are good descriptions of modern mindsets:
75. Since Sidaway (added note: Sidaway was a 1985 court case - see my footnote), however, it has become increasingly clear that the paradigm of the doctor-patient relationship implicit in the speeches in that case has ceased to reflect the reality and complexity of the way in which healthcare services are provided, or the way in which the providers and recipients of such services view their relationship. One development which is particularly significant in the present context is that patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising choices: a viewpoint which has underpinned some of the developments in the provision of healthcare services. In addition, a wider range of healthcare professionals now provide treatment and advice of one kind or another to members of the public, either as individuals, or as members of a team drawn from different professional backgrounds (with the consequence that, although this judgment is concerned particularly with doctors, it is also relevant, mutatis mutandis, to other healthcare providers). The treatment which they can offer is now understood to depend not only upon their clinical judgment, but upon bureaucratic decisions as to such matters as resource allocation, cost-containment and hospital administration: decisions which are taken by non-medical professionals. Such decisions are generally understood within a framework of institutional rather than personal responsibilities, and are in principle susceptible to challenge under public law rather than, or in addition to, the law of delict or tort.
76. Other changes in society, and in the provision of healthcare services, should also be borne in mind. One which is particularly relevant in the present context is that it has become far easier, and far more common, for members of the public to obtain information about symptoms, investigations, treatment options, risks and side-effects via such media as the internet (where, although the information available is of variable quality, reliable sources of information can readily be found), patient support groups, and leaflets issued by healthcare institutions. The labelling of pharmaceutical products and the provision of information sheets is a further example, which is of particular significance because it is required by laws premised on the ability of the citizen to comprehend the information provided. It would therefore be a mistake to view patients as uninformed, incapable of understanding medical matters, or wholly dependent upon a flow of information from doctors. The idea that patients were medically uninformed and incapable of understanding medical matters was always a questionable generalisation, as Lord Diplock implicitly acknowledged by making an exception for highly educated men of experience. To make it the default assumption on which the law is to be based is now manifestly untenable.
I believe that the Montgomery ruling has firmly established these 3 ideas in law:
a) The patient is the judge of his/her own life. It is no longer the somewhat ambiguous 'No decision without me' and it is instead 'The decision is mine to make'.
b) Doctors and nurses are now expected to be clinically competent, but that only means things such as 'performed the operation properly'.
c)The law recognises that individual patients, even in the same clinical situation, make their own individual decisions: it is not for clinicians, to 'challenge these decisions'.
There is still an issue with a), in connection with the approach a clinician must adopt when explaining the risks of an offered treatment to a patient, and I have been 'locking horns with' a doctor in Australia over it, in a series of BMJ rapid responses at:
http://www.bmj.com/content/350/bmj.h1481/rapid-responses
I wrote a piece at March 24 (Montgomery separates Consent from Competent Treatment) and then we were 'exchanging pieces'.
The problem, is whether it is enough for the doctor to 'try and put herself in the patient's shoes' - both of us accept that in reality, that is what doctors are likely to try to do. But beyond that, we were disagreeing.
The Montgomery ruling explains point c):
46. This is an important point. The relative importance attached by patients to quality as against length of life, or to physical appearance or bodily integrity as against the relief of pain, will vary from one patient to another. Countless other examples could be given of the ways in which the views or circumstances of an individual patient may affect their attitude towards a proposed form of treatment and the reasonable alternatives. The doctor cannot form an objective, "medical" view of these matters, and is therefore not in a position to take the "right" decision as a matter of clinical judgment.
It also clearly emerges in this, which was told to me by a doctor in an e-mail:
'There was a man in his fifties, who came in for investigations of suspected cancer of the lung, possibly inoperable, but who would have needed his chest opened to find out.
Well. He asked the evening before the operation, whether there was a possibility that he would die. Perhaps he saw the hesitancy on my face. He said he did not mind dying but he did not want to die without ensuring that his wife, who had been having an affair, did not inherit his possessions. On being told of the possibility of dying, he asked to be allowed out for a few hours. He came back with a calm demeanour.'
The qualification to a), is that doctors are not obliged to offer a treatment which would be of no clinical benefit, and must not apply a treatment which is known to be 'clinically harmful', and as 'a system' the NHS can legitimately not offer treatments which are too costly. So it is really 'Once a treatment has been offered, the decision is mine to make'.
The patient, decides whether the risks of accepting an offered treatment, are acceptable - the doctors and nurses must explain the risks, but the patient decides if something is too risky or not. SHOULD THIS 'THE PATIENT DECIDES WHICH RISKS TO TAKE' principle BE MORE GENERAL ?
There are currently serious problems with end-of-life in the patient's own home, because the professionals are not confining themselves to 'clinical expertise', and are projecting their perspectives onto other things. For example, there was a recent report by the House of Commons Health Select Committee:
http://www.publications.parliament.uk/pa/cm201415/cmselect/cmhealth/805/805.pdf
Disturbingly, even the Chief Executives of Ambulance Services, are aware that their 999 Paramedics are attempting cardiopulmonary resuscitation when they should be leaving patients to die in peace:
'106. The Association of Ambulance Chief Executives in their written evidence state that a unified approach to DNACPR documentation is crucial for paramedics and other ambulance clinicians when a swift and difficult decision needs to be taken to allow a person to have a dignified death. They comment:
Without a DNACPR form or information that establishes that a person is at the end of life, resuscitation may be the course of action decided upon by the clinician that may be later seen as unethical, inappropriate and most importantly not what the patient would have wished for.'
The problem, is that THE PARAMEDICS CONSIDER THAT THE DECISION ABOUT CPR IS THEIRS TO MAKE - they think that 'the risk of not attempting CPR rests with us'.
It shouldn't - THE RISK SHOULD REST WITH THE PATIENT.
So, if a patient tells his GP or nurse "I want my daughter to be believed and trusted", the 999 Services should default to believing the daughter if she says 'If my dad has arrested, you should let him die, because he HAS EXPLAINED TO ME that is what he wants'.
If a written Advance Decision meets the criteria for validity (is witnessed, clear in its instruction, etc) paramedics SHOULD FOLLOW ITS INSTRUCTION (currently they do not - when shown a 'new ADRT', they argue that 'we can't be sure this isn't forged' etc) - the patient would not have created an ADRT unless he wanted it to be followed, so THE RISK OF CREATING AN ADRT, AND OF READERS FOLLOWING IT, RESTS WITH THE PATIENT.
WE SHOULD ALL - FAMILY and PROFESSIONALS - BE HELPING THE PATIENT.
HELPING THE PATIENT, CANNOT INCLUDE 'GOING AGAINST THE PATIENT'S OWN CHOICES'.
HELPING THE PATIENT, CANNOT INCLUDE 'THWARTING THE PATIENT'S DECISIONS BY IMPOSING IMPOSSIBLE-TO-SATISFY 'SAFEGUARDING HURDLES'.
With a lot of luck, Montgomery will force clinicians, patients and relatives, to work better together - with clinicians sticking to expertise about diseases, treatments, etc, and keeping out of 'quality of life' decisions: and family and friends, being accepted as 'the experts on how a patient thinks, and what he would decide if he cannot make the decision himself' (for example if the patient has become unconscious).
FOOTNOTE.
Montgomery, said that 'Since Sidaway however, it has become increasingly clear that the paradigm of the doctor-patient relationship implicit in the speeches in that case has ceased to reflect the reality and complexity of the way in which healthcare services are provided, or the way in which the providers and recipients of such services view their relationship.'
Sidway was a court case in 1985, so 30 years ago - but most judges quote earlier cases, so Sidway was almost certainly quoting from court rulings made 40, 50 or 60 years ago !
At the end of Montgomery, one of the 7 judges who ruled on the case but who did not write the ruling (only 2 of the judges wrote the ruling), Lady Hale, added a ' foot-section'. Lady Hale started by stating:
107. In the third (2010) edition of their leading work on Principles of Medical Law, Andrew Grubb, Judith Laing and Jean McHale confidently announced that a detailed analysis of the different speeches of the House of Lords in Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] AC 871 was no longer necessary. A combination of the 2008 Guidance provided by the General Medical Council, the decision of the Court of Appeal in Pearce v United Bristol Healthcare NHS Trust [1999] PIQR P 53 and the decision of the House of Lords in Chester v Afshar [2005] 1 AC 134 meant that it could now be stated "with a reasonable degree of confidence" that the need for informed consent was firmly part of English law (para 8.70). This case has provided us with the opportunity, not only to confirm that confident statement, but also to make it clear that the same principles apply in Scotland.
One of the judges, is confirming that English law is as a book (2010) suggested it was, and also saying that the same law applies in Scotland (logically, applied in Scotland in 1999).
It is in my opinion possible to arrive at the same conclusion as the 2010 book - 'it could now be stated "with a reasonable degree of confidence" that the need for informed consent was firmly part of English law' - by reading sections 3 and sections 25(4)(c) of the Mental Capacity Act, and 'digging out the necessary internal logic'.
And as Lady Hale says, the law is usually THE PRINCIPLES - it isn't a case of 'nit-picking over the words used': you need to get back, from the words the judges use, to 'their internal mental concept of the law they describe by their words'.
As Lady Hale goes on to say:
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.