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(1987) Brazier - Patient Autonomy and Consent To Treatment - The Role of The Law?
(1987) Brazier - Patient Autonomy and Consent To Treatment - The Role of The Law?
Citation:
Margaret Brazier, Patient Autonomy and Consent to
Treatment: The Role of the Law, 7 Legal Stud. 169
(1987)
Copyright Information
Introduction
Until recently claims for damages by patients against their doctors were
rare in England. Patients who did pursue such claims often found scant
sympathy from Her Majesty's judges. The clinical judgment of the
medical practitioner was accorded something very like immunity from
suit.' Since 1980 the pace of medical litigation has quickened dramati-
cally. Patients seem less and less willing to accept without complaint the
results of unsuccessful or injurious treatment. They are more and more
inclined to question their doctor's judgment.2 Medical litigation and
scrutiny of medical decision making is highly newsworthy in 1987. The
practice of medical litigati6n looks set to become profitable for lawyers.
To the cynical oberver all this might look like good news for lawyers and
bad news for doctors.
This article examines just one of the issues among the plethora of
.medico-legal matters now hotly debated by doctors, lawyers and
ethicists, the question of 'informed consent'. It is an issue which has
troubled the courts a number of times in the past seven years 3 and was
considered by the House of Lords in Sidaway v Bethlem Royal Hospital
Governors.4 The Sidaway decision, I shall suggest, in no way concludes the
debate on the role of the law in determining how much information
* While it has been possible for some amendments to be made to this article in the light of
the Court of Appeal'sjudgment in Goldv Haringey AMA (see (1987) Times, 15 April, CA),
it should be noted that the article was written beforejudgment on appeal was given in this
case.
1. For vivid illustration ofjudicial deference to medical judgment from ajudge not noted
for deference to anyone or any institution, see the judgments of Lord Denning in Hatcherv
Black (1954) Times, July 2 and Whitehouse vJordan [1980] 2 All ER 650, CA.
2. The action for negligence is a far from ideal vehicle for investigating a complaint or
discovering what went wrongin treatment. But in the absence ofcomplaints procedures in
the private sector, and in the light of inadequacies in NHS complaints procedures, a
negligence claim may be seen as the patient's only means of venting his grievance; see
Kralj v McGrath [1986] 1 All ER 54 and note the comments of Mrs McGrath after the
judgment in The Times, 28June 1985; and see Lee v South West Thames RHA [1985] 2 All ER
385. The General Medical Council has expressed concern about public dissatisfaction with
complaints procedures and has recently initiated a review of its own procedures with
especial references to problems and grievances in the private sector.
3. Chattertonv Gerson [1981] QB 432; Hills v Potter[1984]I WLR 641; PottsvNorth West RHA
(judgment in trespass) reported only as a news item The Guardian 23 July 1983; Blyth v
BloomsbugyAHA (1985) Times 24 May and (1987) Times 11 February, CA; GoldvHaringy
AHA (1986) Times, 17June and (1987) 15 April, CA. 'Informed consent' was also in issue
in Thake v Maurice [1986] 1 All ER 497 and Eyre v Measday [1986] 1 All ER 488.
4. [1985] 1 All ER 634.
170 Legal Studies
5. Gold v HaringyAHA (1986) Times 17June. But see the judgment of the Court of Appeal
(1987) Times, 15 April.
6. Lord Edmund-Davies in Whitehouse vJordan castigated as unacceptable any 'defence' of
error of clinical judgment. He put it thus: 'To say that a surgeon committed an error of
clinical judgment is wholly ambiguous for, while some such errors may be completely
consistent with the due exercise ofprofessional skill, other acts or omissions in the course of
exercising 'clinical judgment' may be so glaringly below proper standards as to make a
finding of negligence inevitable' [1981] 1 All ER 267 at p 276, HL.
7. For a forceful account of lack of accountability in a campaigning work for greater
patient participation in decision-making see Carolyn Faulder, Whose Body Is It - The
Troubling Issue of Informed Consent (Virago, 1985).
Patient autonomy and consent to treatment 171
(1) It is one issue which affects all doctors equally. Until disaster
strikes no-one expects to be the subject of an action for negligence in
diagnosis or carrying out treatment. 'Outside' interference in the advice
8. In particular the contingency-fee system for funding personal injuries actions, and the
'fee-for-service form' of medical care; see Ian Kennedy's note on the Court of Appeal
judgment in Sidaway (1984) 47 MLR 454; and see Harvey Teff 'Consent to Medical
Procedures, Paternalism, Self-Determination or Therapeutic Alliance' (1985) 101 LQR
432 at pp 433-436.
9. See Making Health Care Decisions (President's Commission for the Study of Ethical
Problems in Medicine. US Govt Printing Ofice 1982), p 21 at note 22. Survey in 1975-76
revealed that only 3% of cases concerned 'informed consent'.
172 Legal Studies
one gives patients, in laying down rules as to what should and should not
be said, affects all doctors in their everyday practice. It may appear to be
an unwarranted intrusion into the conduct of professional practice, and
an unjustifiable aspersion on doctors' skill and their concern for their
patients.
(2) Doctors genuinely fear that rules on 'informed consent' may damage
the doctor-patient relationship. They fear that they could be compelled
to force information on unwilling or unready patients. To protect them-
selves from litigation they may be pressured, as has happened in the
USA, to resort more and more to detailed written consent forms at the
expense of genuine communication with patients.' °
(3) Some medical practitioners fear that the development of 'informed
consent' may be simply a device for introducing strict liability for
medical accidents by the back door." All these reasons for medical
practitioners' suspicion of the doctrine of 'informed consent' and enforc-
ing such a doctrine in the courts merit careful consideration.
10. See Making Health Care Decisions. President's Commission (op cit) at p 153fTwhere the
danger of legal rules leading to a proliferation of pro forma and meaningless consent forms
is fully discussed.
11. See A. Meisel 'The Expansion of Liability for Medical Accidents: From Negligence to
Strict Liability by Way of Informed Consent' (1977) 56 Nebraska Law Review 51; and see
G. Robertson 'Informed Consent to Medical Treatment' (1981) 97 LQR 102 at
pp 109-112.
12. See 'Failure of Medical Advice: Trespass or Negligence' above at p 149.
13. See the model for 'informed consent' formulated by A. Meisel, L. H. Roth and C. W.
Lidz 'Towards a model of the legal doctrine of informed consent' (1977) Vol 134 Am J
Psychiatry at p 285 '... . when information is disclosed by a physician to a competent person
that person will understand the information and voluntarily make a decision to accept or
refuse the recommended medical procedure.' The model is examined and further discussed
by Meisel and Roth in 'What We Do and Do Not Know About Informed Consent' (1981)
Vol 246 Journal of the American Medical Association at p 2473.
Patient autonomy and consent to treatment 173
14. The classic and basic statement of patient autonomy remains that of Cardozo J. in
Schloendorffv Sodefy of New York Hospital (1914) 211 NY 125 'Every human being of adult
years and sound mind has a right to determine what shall be done with his own body: and a
surgeon who performs an operation without his consent commits an assault.. .'. See the
commentary on Schloendorffin Making Health CareDecisionsPresident's Commission op cit at
pp 20-21.
15. See J. L. Dixon and M. G. Smalley 'Jehovah's Witnesses - The Surgical/Ethical
Challenge' (1981) Vol 246Journalof the American Medical Association at p 2471.
16. For strongly worded criticism of any 'outside' interference with medical judgment on
how much to tell patients see 'What should the doctor tell?' (1984) 289 BMJ 235. For a
wider perspective on the debate within the medical profession see G. R. Dunstan and M.J.
Seller (eds);'Consentin Medicine: convergenceanddivergence in tradition,King Edward's Hospital
Fund of London (OUP, 1983) andJ. F. Childress, Who Should Decide? Paternalismin Health
Care (OUP, 1982).
17. The classic example is not disclosing to a patient that he has cancer or some chronic
and degenerative disease. It remains untested whether in English law a patient who agreed
to surgery on the basis of a misleading diagnosis ie told that he has a stomach ulcer and not
that the diagnosis is certainly or very nearly certainly cancer has any claim against the
surgeon. He may well be aware of the 'broad general nature of the procedure' and even of
the risks attendant on surgery. For pertinent criticism on ethical and medical grounds of
doctors' unwillingness to communicate unfavourable diagnosis see Institute of Medical
Ethics Bulletin No 13 (1985) reviewing several articles from nursing journals.
174 Legal Studies
18. See Carson Strong, 'Informed consent: theory and policy' (1979) 5Journal of Medical
Ethics at p 196: M. D. Kirby 'Informed consent: what does it mean?' (1983) 9Journal of
Medical Ethics at p 69.
19. Making Health CareDecisions (op cit).
20. Consent to Medical Care Law Reform Commission of Canada 1980.
21. See Making Health CareDecisions(op cit) at p 153, and the literature referred to in note 5
in particular H. K. Beecher 'Consent to Clinical Experimentation - Myth and Reality'
(1966) Vol 195 Journal of the American Medical Association at p 39.
22. See the empirical surveys commissioned by the President's Commission and reported
in Making Health CareDecisions.And see the seminal studies by Alfidi: R.J. Alfidi 'Informed
consent: a study of patient reactions' (1971) Vol 216 Journal of the American Medical
Patient autonomy and consent to treatment 175
thwarted from pursuing what one's skill and experience indicate is the
best option should not be underestimated - particularly as the doctor has
probably got to continue to treat the patient. The risk that the doctor,
having respected the patient's initial decision, may fear that he could
face legal action later by that patient or his relatives for failing to pursue
27
or press further what the doctor saw as the medically superior option
must be taken into account in formulating legal rules. The undesirable
result that doctors will simply resort more and more to meaninglessly
detailed written consent forms countersigned by patients and witnesses
to protect medical staff from legal action must be avoided.
Before giving detailed consideration to these practical problems of
'informed consent', its application and enforcement, the contention that
more information offered to patients will damage their health care must
be challenged further. Accepting that there may be cases where an
individual patient rejects the better option for cure and/or palliation of
his condition on grounds considered irrational by the doctor, it is being
widely argued now that in many cases fuller information to patients
actually enhances their health care as well as re-inforcing individual
autonomy. 9 The informed patient is better equipped to participate in
treatment. A frequent complaint by doctors is of a lack of self-help and
co-operation by patients. Drugs are not taken in the correct dosage:
courses of antibiotics are not finished. The time of hospital staff and
general practitioners is wasted when patients, who have not been fully
counselled, became anxious about normal if unpleasant side-effects.
Patients' health is put at risk if they fail to recognise serious symptoms.
The informed patient aware of how he may feel after surgery or during
drug therapy will be more able to cope, more able to give his doctors an
intelligent assessment ofhis progress. The patient who has to be told that
his prognosis is hopeless has the time to reconcile himself to death, to
spend his last weeks as he wishes, and to seek what palliation of his pain
and distress as may be available. The debate on 'informed consent' is not
simply about the philosophical concept of autonomy but offers an oppor-
tunity to develop co-operative health care.
48. (1980) 165 Cal Rept 308; 27 Cal (3d) 285, 611; P (2d) 902.
49. [1985] 1All ER 643 at p 633. And see SirJohn Donaldson MR [1984] 1All ER 1018 at
p 1028 and in Lee v South West Thames AHA [1985] 2 All ER 385 at pp 389-390.
50. (1986) Times, 17June.
Patient autonomy and consent to treatment 183
51. The Court of Appeal's decision in Byth vBloonmsbuyAHA (1987) Times, 11 February
raises doubts about what degree of disclosure is required in relation to contraceptive treat-
ment. The Court said that even when expressly questioned by the patient the doctor had no
obligation to reveal all the information available to him about the controversial drug
Depo-Provera. in determining how much to tell Mrs Blyth the issue of what would be the
proper answer in the light of responsible medical opinion was relevant but not apparently
conclusive.
52. (1987) Times, 15 April, CA.
184 Legal Studies
supporters of the Sidaway 'rule'. But had it been based on a case by case
development of a distinction between therapeutic and non-therapeutic
research its practical implications could pose considerable difficulties.
Where will the line be drawn between the doctor doing his best for the
patient utilising perhaps experimental procedures, and the researcher
having as his dominant purpose an interest in the operation of the
experiment and its potential benefit to others? Doctor and researcher
will often be one and the same individual. Motive may determine
whether in the event the procedure falls into the therapeutic or non-
therapeutic category. The reversal of Schiemann J's judgment by the
Court of Appeal now poses the question of how, if at all, the law will
protect the autonomy of research subjects in clinical trials.
Third, even Lord Diplock considered that if a particular patient
specifically questioned the doctor as to the risks and side-effects of the
treatment proposed, or presumably inquired as to the advantages and
disadvantages of alternative therapies, the doctor's obligation was to
answer him truthfully and fully. The judgment in Sidaway setting the
'professional standard' for disclosure is limited to what degree of
information the doctor must volunteer. The inquisitive patient has a
right to know. The therapeutic 'lie' once sanctioned by Lord Denning
appears to be outlawed.53 But this distinction between the questioning
and the apparently acquiescent patient is another distinction more
apparent than real. No guidance is given in Sidaway as to what degree of
disclosure is triggered by questioning. The Court of Appeal in Blyth v
Bloomsbuiy AHAM held that a patient inquiring as to the likely risks and
side-effects of the injectable long-acting contraceptive Depo-Provera
was not entitled to all the information the doctor had on the drug.
Evidence of proper practice in answering such questions was relevant
but not conclusive. Doctors and patients get the worst of all worlds. The
doctor is again left 'second-guessing' the courts as to when the courts will
judge proper practice as inadequate. The patient is denied a right to
information before deciding whether to accept one of a range of con-
traceptive options. 55 Nor is the event which triggers any higher duty of
disclosure, albeit at present such a vague and undefined duty, in any
sense as definite as their Lordships suggest. It would no doubt be made
crystal clear to a Harley Street surgeon when a Law Lord required
further and better particulars of proposed treatment. In a busy NHS
clinic doubts and questions may be less well articulated. 'I haven't got
cancer, have I, doctor?' may well be a plea for reassurance not a request
for further information. How should the doctor attempting to apply the
Sidaway rules interpret such a plea?
Fourth, from the perspective of the medical profession the 'profes-
sional standard' may be regarded by some doctors as inhibiting greater
development of patient autonomy and partnership in health-care. To
(1) The proposition that pati ents in general do not want comprehensive
information on treatment proposals, and may react capriciously to such
information, is not founded on any hard evidence. Indeed as we have
seen what evidence there is from the USA is to the contrary.59
(2) The Law Lords (as we have seen) held unanimously that the patient
who requests further information must be answered truthfully and
comprehensively. They contended patients' rights were thereby suffi-
ciently protected as the patient who expressly sought to exercise his
autonomy was empowered so to do. The practical problems for doctors
of applying this 'want to know' test were considered in the previous
section. And it has to be doubted whether in any real sense a test which
requires the patient to take the initiative can even genuinely promote
patient autonomy. The articulate middle-class patient, 60 whether receiv-
ing private or NHS treatment, may well be in a position to initiate
discussion of risks and benefits. The less articulate, the apprehensive,
those who feel socially ill at ease with the consultant, or whose doctors
are hard-pressed in inner city clinics, will be hesitant to initiate dis-
cussions. Not 'bothering' the doctor is a deeply entrenched tradition in
many parts of Britain. It implies that the patient doubts the doctor's
skill, raises fears of offending those who are going to care for you, and
mayjust seem plain rude. It does not follow though that the tradition of
patient silence implies lack of interest or desire to participate in decision-
making if that opportunity is offered by the doctor.6' All that is required
is a carefully communicated inquiry by the physician as to what (if
anything) the patient wishes to be told. And now of course the Court of
Appeal's decision in Blyth v Bloomsbury AHA' 2 has thrown the status of
even the inquisitive patient's 'right to know' into confusion. Ms Blyth
57. At p 653.
58. At p 660. Note once again the emphasis placed on disclosure in relation to surgery and
the consequent dismissal of its importance in relation to drug therapy. Only Lord Diplock
in Sidaway expressly recognises the importance of warnings and consent in relation to
drugs, at p 658.
59. See above at pp 174-175.
60. See Lord Diplock's bland assumption that what the highly trained barrister wants to
know from his doctor he will 'elicit' by 'cross-examination' and the masses will not want or
be able to deal with such information; at pp 658-659.
61. What is desperately needed is empirical research in England on patients' attitude to
information and health-care decisions on the lines of that already extensively published in
the USA.
62. (1987) Times, 11 February.
Patient autonomy and consent to treatment 187
68. At p 653.
69. See Making Health Care Decisions op cit at pp 23, 101; and see A. Meisel and L. D.
Kabrick 'Informed Consent to Medical Treatment: An Analysis of Recent Legislation' 41
U Pitt LR 407.
70. See Halushka v University of Saskatchewan (1965) 53 DLR (2d) 436.
Patient autonomy and consent to treatment 189
judge, but of the very individual before him. Would such a test then not
lead to patients who do suffer injury in the course of treatment mis-
remembering or even lying about what was said, what questions the
doctor asked them? The danger of self-serving testimony in such cases is
real.7" But it exists whichever test is applied to some extent, and the
veracity of witnesses and the reliability of their memory under stress is
tested in courts thoughout the land every day.
The most fundamental problem with seeking to give legal force to an
ethical optimum for disclosure based on respect for the autonomy of the
particular patient is rather different in nature. If,as I have suggested, the
function ofcomprehensive disclosure is not simply to uphold the individ-
ual's autonomy but also to promote co-operation and better health care,
disclosure will very often not be a 'one-off process, or even a task
undertaken by one health professional alone. Communication with a
patient is more likely to be effective if attempted by someone known to
the patient. So a consultant may wish to have initial discussions with the
patient he has met perhaps once or twice only, and then to rely on the
family GP to take matters further in the familiar setting of the local
surgery. Minutes after a man is told that he has cancer of the prostrate is
not the time for him to make an intelligent choice between castration and
endrocine therapy. Nursing staff are vital to communication with seri-
ously ill patients in hospital. Good communication is teamwork but it is
the consultant who carries out surgery or prescribes drug therapy who is
likely to be sued. His head is on the block. If the law enforces a 'particular
patient' standard, will consultants feel free to involve all medical staff
treating the patient within and without the hospital in communication
with the patient? Or will the medical profession put up a barricade of
detailed forms for patients to sign at all stages of treatment at the expense
of genuine communication and better health care?
Finally alongside the issue of whether a 'particular patient' standard
would and could be operated so as to enhance the substance of commu-
nication between professionals and patients, as opposed to imposing
possibly unhelpful formulae, there is the question of by what legal means
can a 'particular patient' standard be enforced? It may be open to
question as to whether the tort of negligence can readily extend to
embrace a standard of care which rejects the general for the particular.
And indeed it may be stretching the very concept of a duty of care to
snapping point once it is divorced from the issue of negligence, or error
advertent or inadvertent in any real sense. Trespass having been rejected
as a device in normal circumstances for the protection of patient auton-
omy, two options remain. Lord Scarman in Sidaway74 rejected the propo-
sition that the doctor's duty to his patient might be categorised as a
fiduciary duty imposing thereby a duty offull disclosure and frankness in
his dealings with the patient. Fiduciary duty was said to be limited to
duties in respect of another's property entrusted to the duty bearer. The
case law so far of course supports that proposition. Yet in a sense the
73. The problems of self-serving testimony are fully discussed in Making Health Care
Decisiansat p 26.
74. At p 651.
Patient autonomy and consent to treatment 191
patient does entrust his most precious property, his body and his health
to the doctor. Is equity too rigid in 1987 in England to expand to fill the
inflexibility of tort within the common law? In relation to breach of
confidence the recent case law has shown a potential for growth is still
inherent in equity. The second option, of course, if the conceptual
difficulties of finding a vehicle for 'informed consent' within the common
law are too great, is for statutory intervention creating a specific and
tailormade form of legal redress.
single standard for disclosure in all cases but a statute or statutory code
of practice resulting from the Commission's deliberations would specify
with clarity the criteria governing the doctor's decisions.
tions are unfounded on evidence. And for the doctor the 'rules' governing
his advice and counsel to patients are so bedevilled by fine distinctions
and 'nice' points of law that he needs a law degree to understand his
obligation of disclosure.
A Commission investigating 'informed consent' would start afresh
with a clear aim in sight to produce clear and comprehensible standards
and agreed procedures for enforcement. Any necessary reform of the law
including creation of a specific form of legal redress could be enacted
subsequent to the Commission's report. With luck agreement on
common ethical standards, reflected as far as this is feasible in the legal
rules, would make recourse to law largely unnecessary.75
75. The prime method of enforcement once standards were agreed could be left to the
General Medical Council disciplining doctors for misconduct who failed in their duties of
disclosure.
In 1986 two doctors were suspended from the Medical Register for failing to disclose to
the parents ofa small boy the inherent risks ofsurgery to remove a blemish from his lip. The
boy died. Recognition by the GMC that failure to inform patients adequately ofhazards of
treatment is misconduct is a significant advance for the development ofpatient autonomy.