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Margaret Brazier, Patient Autonomy and Consent to
Treatment: The Role of the Law, 7 Legal Stud. 169
(1987)

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Patient autonomy and consent to treatment 169

Patient autonomy and consent to


treatment: the role of the law?*
Margaret Brazier
Senior Lecturer in Law, University of Manchester; Associate Director, Centre for Social
Ethics and Policy

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

patients must be provided with in order to give a considered consent to


medical treatment. Sidaway failed to take account of the complex nature
of the doctor/patient relationship and of much of the debate on the
development of effective health care in the United Kingdom. Their
Lordships were too readily convinced by arguments that enhancing
patient autonomy might damage patients' health. Barely a year after
Sidaway the process of attempting to narrow and distinguishing the
House of Lords' decision began.' It is likely to continue, generating only
uncertainty and distrust of the legal process among doctors and patients.
But at the end of the day while criticising the implications of the Sidaway
decision, it has to be as1.ed whether the process of adversarial litigation
alone can ever provide satisfactory answers to the difficult questions of
ethics and law raised in the debate on 'informed consent'.

The background to medical litigation today


Before attempting to examine the current debate on 'informed consent'
the background in which increased numbers of claims against doctors
take place should be examined. Many medical practitioners gaze in
horror across the Atlantic and tremble at the prospect of a 'malpractice
explosion' here. They may take temporary comfort in the knowledge
that, although the pace of litigation has stepped up, the tenor ofjudicial
decisions, at any rate at appellate levels, remains on a simplistic view
largely pro doctor. But judicial attitudes have still changed profoundly.
Judges are in the main now anxious to assert that the medical profession
alone is not the final arbiter of the scope of the doctor's obligation to his
patient. The near infallibility of clinical judgment once propounded by
Lord Denning is a thing of the past.' The final score in terms of cases
'won' by doctors, particularly 'informed consent' claims, favours the
doctors. Careful analysis of the judgments should dispel any compla-
cency in the medical profession's attitude to litigation. Medical litigation
and demands for medical accountability are not going to fade away.7
How will the controversy affect patients? The role of legal intervention
in health care should after all aim to protect patients' rights, and
facilitate effective health care. The patient at first sight might consider
that she is between the devil and the deep blue sea, that the law can only
damage her health! The earlier judicial stance in England that doctors
could do no wrong, that clinical judgment was not justiciable, denied
injured patients needed compensation. It actively encouraged medical

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

paternalism and paid scant regard to the right of competent adults to


make their own health care decisions. Once the decision to seek
treatment has been taken, the law recognised little in the way of any
further positive role for the patient. You were entitled to decide exactly
what should be done to your house or your car. Your body was for your
physician to dispose of, in your best interests, of course.
But is life any better for patients in those American states w'here
compensation for medical accident became more freely available, and
where doctrines of 'informed consent' first received legal sanction? Or
are their prospects differently but equally dire? Even if one does, as one
should, discount the worst of the horror stories from America about the
'malpractice explosion' as propaganda, and one makes allowance for
crucial distinctions in the practice of both law and medicine in the USA,'
the traumatic effect on the medical profession of legal interventions in
medicine in certain states cannot be denied and must not be overlooked.
Insurance premiums have reportedly risen to levels which force some
doctors out of practice. Others are tempted to 'go bare', to continue in
practice without adequate insurance cover. In high 'legal' risk speciali-
ties certain patients may be refused treatment altogether. Female law-
yers turned away from obstetricians' surgeries can testify to this evil.
Patients accepted for treatment complain of lengthy and unnecessary
series of tests designed not to benefit them but to safeguard doctors from
lawsuits. The spectre of defensive medicine is invoked to haunt anyone
who seeks to encourage the English courts to move from their earlier
reverential attitude to medicine and its practitioners.
It is in this emotionally charged atmosphere that the questions of
'informed consent' and the role of the law must be examined. In itself the
issue of the extent to which patients are entitled to full and comprehen-
sive information about treatment proposed in order to enable them to
give a considered and informed consent to that treatment is only one
smallish aspect of the much larger issue of medical accountability. Even
in the USA 'informed consent' claims form only a minute proportion of
the total number of claims against doctors and hospitals.9 But 'informed
consent' generates disproportionate concern in the medical profession
and creates a source of friction between doctors and those 'outsiders',
lawyers, ethicists and others who comment on medical practice. The
reasons for this disproportionate concern seem to me to be threefold:

(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.

The debate on 'informed consent'


The phrase 'informed consent' is much bandied about in medical, legal
and ethical seminars, but there is in England a lack of a clear and agreed
definition of the phrase.Judges in England dislike the phrase and seek to
avoid its use even when incorporating into English law some of the
underlying principles of 'informed consent' as developed in the USA. Dr
Tan Keng Feng pertinently criticises the phrase as a misnomer. 2 It
apparently defines the defence of consent when in reality, as developing
in England at present at least, it in fact relates to the doctor's duty to
warn and counsel patients in advance of treatment. But the phrase is too
well established to be dislodged now and, whatever its linguistic
shortcomings, it acts as useful shorthand to refer to the multi-faceted
debate of who ultimately takes the decision on an individual's medical
treatment, and how much information concerning that treatment
doctors should give to their patients. 3
What is the underlying concept at stake in the debate on 'informed
consent'? The basic concept is simple, self-evident and well-rehearsed. A

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

patient who is sufficiently mature and intellectually competent to under-


stand what is entailed in treatment is entitled to make up his or her own
mind as to whether to accept or reject proposed medical treatment. This
right is part and parcel of his or her autonomy, of sovereignty over one's
own body.' 4 With this basic proposition few would disagree. Coercion has
no part in normal health care. While surgeons still express concern as to
their potential liability in negligence if they operate on adult Jehovah's
Witnesses refusing blood transfusions, there is virtually no support for the
view that such an adult may be compelled to accept transfusion." The
medical profession's distaste for coercion and belief that it is counterpro-
ductive is well exemplified in the refusal by many leading practitioners to
countenance compulsory treatment of, or screening for, AIDS.
The controversy then surrounding 'informed consent' and patient
autonomy lies deeper than this. It centres on (1) what is entailed in patient
autonomy and what the function of patient autonomy is, and (2) the
practical problems in applying concepts of autonomy in health care
practice, and the extent to which the law intervenes to enforce autonomy.

Patient autonomy in health care decision-making


A still considerable body of medical opinion, albeit by no means all
medical practitioners today,' 6 consider that patient autonomy is suffi-
ciently respected once the patient, having taken an initial decision to seek
treatment, has had explained to him the broad general nature ofwhat his
doctors propose to do by way of treatment with perhaps some indication
given of any particularly significant risks inherent in treatment, at any
rate where the treatment is elective. The practitioner holding this view
may regard himself free, in addition, to withhold any information on the
nature oftreatment, the risks, or even the diagnosis,17where hejudges that
non-disclosure is in the patient's best interests. The practitioner's clinical

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

judgment is paramount in determining how much information patients


be given about their treatment. This perception of the patient's right to
autonomy contrasts sharply with the concept of patient autonomy as
defined by a number of commentators outside the medical profession.
Condemning the limited concept of the function of disclosure outlined
above as paternalist, and a derogation from patient autonomy, the view
is advanced' that a competent patient should be offered all the relevant
information about his condition, possible modes of treatment, their
benefits, risks and side-effects which that particularpatient requires to
make a truly autonomous and considered decision whether to consent to
the treatment proposed by the doctor. 8 This ethical optimum for
informed consent has been largely accepted by both the Presidential
Commission on Consent to Medical Procedures
20
in the USA, 9 and the
Law Reform Commission in Canada.
Both sides in the debate claim to be respecting patients' rights to
autonomy and self-determination. Proponents of a strictly limited duty
of disclosure rest their case on a number of contentions. Very many
patients, it is said, prefer to place themselves unreservedly in the hands
of their doctors. They do not want to know about risks and side-effects.
They are in general incapable of understanding a medical assessment of
risks and benefits. 'Informed consent', some doctors claim, is a myth. 2' A
layman, lacking years of medical training and experience, cannot pos-
sibly make a medicaljudgment. He entrusts suchjudgments to his doctor.
Furthermore there may well be cases where necessary treatment is
capriciously refused by patients frightened by information given to
them. Withholding information from patients therefore does not under-
mine their autonomy because, having decided in general terms to go
ahead with treatment, the patient has autonomously and voluntarily
conferred on the doctor the right to take decisions for him. And even
should patient autonomy in certain cases be derogated from, that dero-
gation is justified by the doctor's higher duty to provide what he judges
to be the best possible health care in the circumstances. The influence of
these contentions on the development of the law in relation to 'informed
consent' can be seen both in the setting of the standard of professional
custom and practice for advice and warnings in England, and in the
formulation of the defence of therapeutic privilege in the USA.
Let us examine the basis for those contentions. Empirical surveys in
the United States22 reveal that many patients do want much fuller

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

explanations of the risk/benefit ratio of proposed treatments, likely side-


effects and available alternative treatments. 3 The President's Commission
in the USA found little hard evidence ofhysterical rejection of treatment
after such explanations had been given, nor of consequent mental break-
down or suicide.2' There is however evidence that patients given compre-
hensive explanations about treatment fail to comprehend
or even accurately recall the information given to them.25 And itis also the
case that patients may elect to refuse treatment which the practitioner
honestly and reasonably believes to be the best available medical option.
Where does the empirical evidence available leave the debate on
patient autonomy? Primafacieto deny adult patients information which
those patients want and to deprive them of responsibility for decision-
making undermines autonomy. But is this a sterile and theoretical
assertion supporting an empty concept of autonomy if patients receiving
information may be unable to comprehend it, and so reach a conclusion
which is not 'in their best interests'? Two points must be made here. First
if patients fail to comprehend information is this because it is impossible
to explain risks, benefits and side-effects in language comprehensible to
the ordinary lay person? Or is it because medical training on communi-
cating with patients is inadequate? As to the possibility ofpatients taking
decisions conflicting with their doctor's advice, autonomy and the right
to self-determination includes the right to take decisions based on factors
other than pure reason, and embraces the right to take a wrong decision.
And on what criteria can or should a decision be judged to be wrong? A
pregnant woman refusing chemotherapy because of the risk to her
unborn child makes a 'wrong' decision in the context of her chances of
prolonging her own life. Yet she is likely to be commended for her
selflessness. A non-pregnantwoman declining chemotherapy because she
fears hair loss makes an unreasonable decision by my criteria of the
quality of life. But she must be the judge of that. Quality of life is
intensely personal. Surveys on the treatment of cancer of the throat show
that 20% of patients surveyed would elect for radiation therapy rather
than surgery albeit the survival rate for the latter is markedly better. But
surgery deprives the patient of normal speech. Who but the patient can
judge whether prolongation of life is worth that price?26
Such an analysis of the patient's rights creates considerable problems
for medical staff. The distress and frustration occasioned by being
Association at p 1325, and Alfidi 'Controversy, alternatives and decisions in complying
with the legal doctrine of informed consent' (1975) Vol 114 Radiology at p 231. The
statistical evidence and some apparent contradictions in Alfidi's work are reviewed by
Meisel and Roth in 'What We Do and Do Not Know about Informed Consent' (op cit).
23. See 'What Are My Chances Doctor?': A Review of Clinical Risks (Office of Health
Economics, 1986) for a full review of the US material in the context of health care practice
in Britain.
24. See Making Health Care Decisions (op cit) at pp 7-8 and 101-102. The Commission
indeed found more evidence to the effect that lack of information increases the likelihood of
treatment refusal.
25. For criticisms of the methodological shortcomings of some of these surveys see Making
Health Care Decisions (op cit) at p 90.
26. See 'What Are My ChancesDoctor?' (op cit) at p 39. As that report puts it 'Maximising
health-expectancy is not necessarily synonymous with maximising lzfre-expectancy.'
176 Legal Studies

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.

Autonomy and co-operative health care in practice


Belief that 'informed consent' can function as a positive aspect of co-
operative health care is growing in the medical profession itself, especi-
ally among younger practitioners. Putting this belief into everyday
practice still poses considerable difficulties, some of which I have men-
tioned earlier. Many of the difficulties are at least in part generated by a
fear of unpredictable legal intervention after the event.
27. See Truman v Thomas (1980) 165 Cal Repr 308; 27 Cal (3d) 285, 611; P (2d) 902 and see
G. B. Weiss, 'Paternalism Modernised' (1985) Vol 11 Journal of Medical Ethics 184.
28. The dangers of a proliferation of meaningless forms at the expense ofgenuine commu-
nication is addressed throughout the President's Commission Report Making Health Care
Decisions (op cit).
29. See in particular H. Teff 'Consent to Medical Procedures. Paternalism Self-
Determination or Therapeutic Alliance' (1985) 101 LQR 432 and What Are My Chances
Doctor? (op cit).
Patient autonomy and consent to treatment 177

First, the discussion so far of autonomy presupposes a patient


competent to make an autonomous decision. Certain patients are clearly
incompetent, for example, very small children, and severely mentally
handicapped patients. The law now provides principles governing the
medical treatment ofyoung children, and patients compulsorily detained
under the Mental Health Act. It is vague on the issue of the borderline
between competence and incompetence and guidance on the correct
procedure for authorising treatment of the incompetent is significantly
lacking. The proportion of confused and elderly patients, the mentally
frail, and those whose mental facilities have been diminished by alcohol
and drugs in, for example, any general surgical ward often exceeds their
proportion in the community at large. The temptation for the lawyer and
the ethicist is to say, in principle correctly,3" that the issue of whether X is
competent is irrelevant to the issue of what Y, who clearly is competent,
must be told to give his (Y's) 'informed consent' to treatment. Succumb-
ing to that temptation ignores the plight of the medical practitioner for
whom the question of competence often has to be addressed as a prior
question 3 before considering how much to disclose to his patient.
Much greater attention must be paid to the ethical and legal issues
inherent in the question of competence. The possibility of degrees of
competence must be explored. An elderly and frail person may be able if
carefully counselled to take a limited series ofdecisions for himself but lack
the capacity to exercise fruitfully the full concept of individual autonomy.
The role if any of proxy consents and advance directives on treatment
.should be investigated. The busy NHS surgeon cannot be left to take 99
out of 100 decisions on competence without guidance and then castigated
for getting the hundredth decision wrong.
Second, the application of 'informed consent' is by no means straight-
forward even in respect ofclearly competent patients. Reference has been
made to the surveys revealing that questioning of patients has demon-
strated poor recall of information given to them.32 The intrinsic difficulty
of communicating medical information to patients without medical
training has to be recognised. Further research into communication
between doctors and patients needs to be undertaken. It has been
suggested that even if in an ideal word comprehensible explanations of
treatment and risk/benefit ratios is feasible, it is just not possible in
England in busy NHS clinics.3 The resource implications for staffing and
30. As Teff does (op cit) at p 433.
31. Nearly a third of the President's Commission report on Making Health Care Decisions
addressed itself to the criteria determining competence and how individudl autonomy can
be enhanced either by provision for advance directives by the competent and how they are to
be treated if they later become incompetent or to provide for family participation in
decision-making via proxy directives.
32. See Meisel and Roth 'What We Do and Do Not Know about Informed Consent' (op
cit).
33. See chapter 6, 'Professional Behavior', Making Health CareDecisions,reviewing medical
education as it affects medical ethics and learning how to communicate with patients and
non-medical health care staff.
34. See R. Schwarz and A. Grubb, 'Why Britain Can't Afford Informed Consent' (Has-
tings Center Report, 1985). The report is critically reviewed in Bulletin No 16 of the
Institute of Medical Ethics (1986).
178 Legal Studies

use ofmedical time would have to be explored.35 Finally in relation to the


actual process of communication it is abundantly clear that effective
communication involves team effort. Nursing staff, the patient's general
practitioner and the whole 'firm' in hospitals and notjust the consultant
will be involved. The patient's family may be asked to participate. Yet at
the end of the day it is the consultant who on our present rules is likely to
be sued. He may consequently be unwilling to delegate and share the
process of consultation.36
Third, one relatively simple point has to be made crystal clear.
'Informed consent' is not mandatory forpatients. The doctor's obligation
would be to offer information not to forcefeed the patient. The patient
who elects to entrust all the necessary decisions to his doctor is entitled to
do so. Patient autonomy entails respect for patients' decisions and a
decision not to seek information merits the same respect as a decision to
take full responsibility for, and seek partnership in, the necessary health
care decisions. Legal rules must ensure that this right is respected and
that doctors are not penalised for acting on this basis.
These three practical problems contribute to the fourth and major
problem of applying notions of 'informed consent' in everyday practice.
Can legal rules be formulated, have the courts achieved such a result in
Sidaway, which promote the development of patient autonomy and
co-operative health care without exposing doctors to unfair and unpre-
dictable risks of legal action? What are these risks?
(1) There is the risk of self serving testimony. Patients who have indi-
cated that they entrust the entire process of decision-making to the
doctor may change their minds ifharm does materialise from an inherent
risk of treatment.
(2) Communication with patients may not be improved but damaged
because doctors will concentrate on ensuring they avoid legal liability
possibly forcing information on unwilling patients.
(3) The doctor genuinely attempting to share responsibility for
decision-making may be penalised for doing so. He may be sued in
negligence for failing to provide reasonable care.
(4) The law can only set broad general standards. It can never fully
assess an individual doctor/patient relationship.
(5) 'Informed consent' isjust a back-door means of introducing liability
without fault.

In the next two sections I attempt to examine these misgivings as to the


role of the law in the light of the law as it has developed in England, and
of potential further developments aimed at bringing the law more in line
35. Any additional cost cannot be built in on an item by item basis as is recommended in
the USA in Making Health Care Decisions. See also 'What Are My Chances Doctor? (op cit).
36. Chapter 7, 'Legal Reforms and Limitations', of Making Health CareDecisions, stresses
that the 'blunt instrument' of the law of battery and negligence can never alone deal with
the complexities and implication of shared decision-making and effective communication
with patients.
Patient autonomy and consent to treatment 179

with concepts of patient autonomy and co-operative health care earlier


outlined here.

The implications of Sidaway


The House of Lords' judgment in Sidaway v Bethlem Royal Hospital Gover-
nors37 may have been greeted with some relief in medical circles. Liability
in trespass for failure to disclose risks appeared to have been stamped on,
and Lord Scarman's attempt to set the standard for disclosure by
reference to the 'reasonable patient' was rejected by the majority in
favour of the standard of professional custom and practice. The per-
ceived 'benefits' of both those decisions must be examined, not only in
context of how they affect patient autonomy, but first as to whether in
reality they do protect doctors from legal action in the future. The
framework for 'informed consent' provided by Sidaway and earlier
English case-law may be seen to be fragile and unsatisfactory.

'Informed consent' - a question of trespass?


The case law relating to the classification of 'informed consent' as an
issue of trespass or negligence is fully dealt with earlier in this journal
by Dr Tan Ken Feng 8 He attacks the logic of the present distinction
drawn in England between failure to disclose the nature of treatment
actionable in trespass, and failure to disclose material risks actionable if
at all in negligence alone. And he propounds a test based rather on the
'degree' of information not disclosed as opposed to the 'type' of informa-
tion withheld. The demise of trespass as the appropriate form ofaction to
litigate issues of patient autonomy may be regretted on a number of
grounds 39 and Dr Tan Keng Feng's attempt to highlight a 'middle way'
has much to recommend it to lawyers. The primary advantage of tres-
pass if available lies in the type of harm protected by that tort. It is not
necessary, as in negligence, to establish either that physical injury has in
fact resulted from the unauthorised conduct, or that, had the patient
been adequately informed, he would have rejected the proposed
treatment. Compensation should be available for dignitary harm
alone.' The function of trespass can be clearly perceived as enforcing the
individual's right to self-determination. A trespass-based definition of
patient autonomy can thus be seen as less likely to result in 'informed
consent' developing into an attempt to impose liability without fault for
medical accident because the emphasis lies on the unauthorised act not
the harm suffered.
Nevertheless there seem to me to be two factors fatal to any develop-
ment of medical trespass even along the eminently logical lines proposed

37. [1985] 1 All ER 643.


38. 'Failure of Medical Advice: Trespass or Negligence' (above) at p 149.
39. See Teff (op ct) for a clear and forceful account ofthe advantages oftrespass as a means
of vindicating patient autonomy.
40. However even in the USA there appears to be no reportedjudgment in which a patient
recovered for dignitary harm alone in a claim based solely on inadequate disclosure; see
Making Health Care Decisions (op cit) at p 25, note 35.
180 Legal Studies

by Dr Tan Keng Feng. First, the historical function of trespass as a


means of enforcing the individual's right to autonomy, a person's right to
choice, appears to be on the wane in England. The courts increasingly
regard the tort of trespass as somewhat anomalous. Its function is
limited to protection from deliberately inflicted injury, albeit the injury
need only be slight and may be largely affront to dignity. And the injury,
the Court of Appeal has said, must flow from some 'hostile' act.4 Save in
the area of police powers, trespass as a means for the vindication of civil
liberties seem sadly to be regarded with suspicion by our courts. The
result of a limitation on trespass in the majority of cases to what are
literally assaults and batteries aggravates medical reaction to liability in
trespass in such cases. A judgment in trespass for a failure in communi-
cation, an over-zealous desire to make the right decision for a patient,
may be seen as putting the doctor on a par with a police officer who beats
up a suspect. And this is not simply an emotional response. The overlap
between the tort of battery and the crime of assault cannot be ignored.
Should surgery be performed without adequate disclosure of risks,
would proponents of an extensive doctrine of 'informed consent' as an
ethical optimum wish to see the surgeon subject to criminal liability?
The second reason for rejecting trespass as the main vehicle for
promoting patient autonomy is that it would be severely limited both as
a means of enhancing autonomy and of promoting co-operative health
care. Trespass requires physical contact and thus would lie only where
the patient has undergone surgery, or some other form of invasive
treatment. It offers no remedy to the patient prescribed and accepting
drugs without an adequate opportunity to assess the risks and benefits
for himself.42 A vital and controversial area of medical practice is left
untouched. And it is an area where patient choice and patient co-
operation are crucial. The dangers ofdrugs are becoming more and more
evident. Patient co-operation in taking drugs in the correct dosage,
avoiding alcohol with certain drugs, and reporting side-effects is of the
highest importance.43 Statistics from the USA show that formal consent
for drug therapy is rarely sought even by litigation-conscious US
doctors.' Belief in an absence of legal redress in these cases does not on
its own explain this discrepancy between consent and counselling pro-
cedures for surgery and drug therapy. But as long as the legal spotlight
directs itself almost exclusively to surgical interventions physicians may
to some extent lack the impetus to consider fully the implications of drug
therapy and consent.

41. Wilson v Pringle [1986] 2 All ER 440.


42. It was held in Malloy v Shanahan (1980) 421 A 2d 803; A 2d 803 that failure to disclose
the risks inherent in drug therapy could not in the absence ofphysical contact (eg injecting
drugs) constitute a battery.
43. Disclosure of risks in relation to prescription drugs and the role ofpatient participa-
tions in prescription monitoring in central to the report What Are My ChancesDoctor? (op cit)
from the Office of Health Economics.
44. See Making Health Care Decisions (op cit) at p 108.
Patient autonomy and consent to treatment 181

'Informed consent': The scope of negligence


'Today, most states view failure to secure informed consent as a variety
of medical malpractice, subject to norms governing negligence law'.
Thus the President's Commission in the USA described the transition
from medical trespass to negligence based liability.45 Can a framework of
liability based in negligence adequately protect patient autonomy and
define the doctor's obligation of disclosure? Negligence-based liability
may be linguistically less obnoxious to doctors but the flexibility of
negligence means it is by no means more favourable to them regardless of
whether the professional judgment or the reasonable patient test is
adopted to define the scope of the duty owed to the patient.

(1) Drug therapy as well as surgery is readily embraced in a negligence


framework.' Thus a wider group of the profession must become aware of
the issues of patient consent. General practitioners prescribing powerful
tranquillisers and anti-arthritic drugs must all now have due regard to
the issue of patients' right to know.
(2) Negligence more easily extends to a wider range of matters which
the doctor should canvass with his patient. In trespass the focus neces-
sarily centres on what the patient is told of what is to be done to him, its
risks and side-effects. In negligence a duty to canvass alternative
treatments with the patient in order to give him overall reasonable and
careful advice is sustainable. In Goldv HaringeyArea HealthAuthority47 the
defendants were at first instance held liable in negligence for failing to
explain to a female patient the merits of and higher success rate for
vasectomy on her husband as an alternative to her agreeing to sterili-
sation. While the decision of SchiemannJ. was reversed by the Court of
Appeal, the availability of negligence for such a claim was not challenged
by the Appeal Court. I find it difficult to see such a decision being arrived
at in trespass. Nothing was done to the plaintiff which she did not fully
understand and consent to.
(3) Once liability rests in negligence the doctor is potentially exposed to
'heads I win, tails you lose' scenario. The issue of whether the doctor
afforded to his patient adequate information on the basis of which the
patient can make an autonomous decision whether to consent to that
treatment may be seen asjust one facet of the larger question of whether
the doctor discharged his obligation to treat the patient with reasonable
care and skill. At any rate if the view is taken that the duty of disclosure is
nothing more than part and parcel of the general duty of care, no
particular premium can be placed on, or priority given to fulfilling, the
duty of disclosure. A doctor having faithfully given due respect to his
patient's right of self-determination may find himself liable for failing to
45. (Op dt) atp21.
46. See Hamilton v Hardy (1976) 549 P 2d 1099 (Colo App 1976); Sharpe v Pugh (1967) 270
NC 598; 155 SE 2d 108; Marsh v Arnold (1969) 446 SW 2d 949 (Texas Ct App) and note
recent litigation leading to a settlement in which British women received substantial
compensation for undisclosed risks inherent in the contraceptive 'Pill'.
47. (1986) Times, 17 June and see (1987) Times, 15 April, CA.
182 Legal Studies

press the patient harder to accept treatment, or even for disclosing


details of treatment which promoted that rejection of treatment. In
Truman v Thomas' a gynaecologist was found liable for the death of a
woman who had refused to agree to a cervical smear which would have
revealed her cancer at a treatable stage. To the medical profession,
rightly or wrongly, the law may appear to demand that they empower
patients with the responsibility to take their own autonomous decisions,
and yet condemn the doctor if that decision proves harmful to the
patient. Fear ofself-serving testimony by patients or relatives and the use
of legal action to secure compensation for medical accident without fault
by one means or another are exacerbated.

The 'professional' standard and the professionals


In England the House of Lords in Sidaway set the standard by which the
adequacy of disclosure would be judged by reference to professional
custom and practice. Does that decision answer the uncertainties just
expressed? Providing that the defendant practitioner complied with
accepted practice on disclosure he will not be liable for failure to give a
patient adequate information. Providing he complied with accepted
practice in the degree ofdisclosure and the emphasis which he placed on
the desirability of treatment, he presumably should not be found liable
for a failure in overall care if the patient suffered harm because he
rejected treatment. Such a result would follow if the logic of the greater
part of Lord Diplock's judgment were followed. But four areas of
uncertainty bedevil this logic.
First, Lord Bridge asserted that the medical profession and medical
practice were not the sole arbiters ofadequate disclosure. Primafaciewhat
constitutes adequate disclosure is governed by accepted practice but the
courts could intervene even in the absence of expert opinion condemning
lack of disclosure where '. . . disclosure of a particular risk was so
obviously necessary to an informed choice that no reasonably prudent
medical man would fail to make it." 9 The doctor is left to 'second-guess'
the courts. In attempting to assess what level or nature of risk he must
disclose in contravention of accepted practice of non-disclosure, he has
to judge the materiality of that risk by reference not to the patient before
him, the patient he knows, but to the unknown judicial standard.
Second, barely a year after Sidaway the process of attempting to
distinguish and narrow the scope of that judgment began. In Gold v
Haringey Health Authority5° a woman conceived again after nature had
reversed her surgical sterilisation. The surgeon had failed to advise her of
alternative methods of permanent contraception. In particular he never
discussed with her the option of vasectomy for her husband. The failure
rate for vasectomy is much lower than that for female sterilisation.
Schiemann J held himself to be free to judge what the surgeon should

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

have volunteered by way of information to his patient by the standard of


what degree of information that patient would have needed to make a
considered decision. The Sidaway test of the 'professional standard' did
not extend to non-therapeutic interventions. It did not apply to con-
traceptive counselling.
The distinction drawn between therapeutic and non-therapeutic
interventions, while well-intentioned and designed to promote patient
autonomy, is fraught with difficulty and uncertainty. Female sterilisation
is itself a prime example of where drawing the line will be nigh on
impossible in many cases. If a woman of 37 requests sterilisation after
giving birth without complications to two healthy babies, will surgery on
her be classified as therapeutic because of the increasing risk to mother
and baby of pregnancy at that age? Or will it be regarded as simply a
convenient means of contraception and so non-therapeutic? Will the test
be whether the intiative comes from the woman wanting no more
children or the doctor judging that she should have no more children?
Will sterilisation of mentally handicapped women because they may be
considered unfit to bring up a child be therapeutic or non-therapeutic?
Other examples can be listed endlessly where the doctor will be placed
in the awkward dilemma of first having to pigeon-hole his treatment into
therapeutic or non-therapeutic before knowing what degree ofdisclosure
is demanded of him. Contraceptive counselling and treatment is presu-
mably normally non-therapeutic. 5 Into which category does infertility
treatment fall? What about abortions, other than those rare operations
carried out to safeguard the mother's health? And the classification of
vasectomy, the option the surgeon should have discussed with Mrs Gold,
raises a fascinating conundrum. Vasectomy can rarely if ever be
designed to benefit the patient's health. It may be vital to his wife's. Will
that render vasectomy a therapeutic intervention?
The Court ofAppeal52 reversed SchiemannJ's judgment holding that
no distinction should be drawn between therapeutic and non-
therapeutic intervention. That judgment apparently eliminates some of
the problems of classification earlier discussed. However, in terms of
principle, the judgment can only be dubiously acceptable. What justifi-
cation can there be for undermining individual autonomy in respect of a
procedure which has no or very minimal implication for the patient's
health care?
Finally, Schiemann J's attempt to create a non-therapeutic 'excep-
tion' to the 'rule' in Sidaway would have opened the way for judges to
require a higher degree of disclosure in respect of research procedures.
General agreement that this ought to be the case exists even among

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

53. Hatcher v Black, (1954) Times, 2 July.


54. Supra, n 51.
55. In The Times report the relevance of Gold v HaringeyAHA (above) setting a higher
standard of disclosure for non-therapeutic interventions does not appear to have been
canvassed.
Patient autonomy and consent to treatment 185

conform to the 'professional standard' does not mean of course that


innovation is outlawed. There may well be more than one body of
respected opinion on a medical issue and conformity with either body of
opinion would satisfy the test ofreasonable care. But the test particularly
as it relates to the duty of disclosure to patients may make doctors wary
of attempts to practise disclosure of information equating to the needs of
particular patients even if they accept that as the ethical optimum. Once
again the reason for this lies in the risk of legal action if the patient having
made a decision regrets it and sues the doctor for failure to conform to the
more paternalist tradition. Nor is it only a lawsuit by the patient that the
doctor may fear. Even if his patients are content with the decision they
made, if the outcome is seen as medically 'bad', if harm results, the
doctor may face disciplinary action. At the heart of the Wendy Savage
inquiry lay the extent to which she was justified, to which it was good
professional practice, for her to allow her patients significant and
autonomous choices in the management of childbirth. Her alleged
departure from the 'professional standard' was one of the causes of her
ordeal. Her acquittal vindicated her practice and her patients' right to
autonomy. Two questions affecting the application of the 'professional
standard' in future negligence claims are posed by the events surround-
ing Mrs Savage's case and the inquiry into her practice as an obstetri-
cian. The evidence given at the inquiry illustrated just how difficult it
may be to ascertain any 'professional standard' in relation to childbirth
today. 6 Clear and bitter divisions on the patient's rights and the feasibi-
lity of natural childbirth were displayed. And the interesting question
may be raised ofwhether medical assistance in childbirth and ante-natal
care should be classified as therapeutic or non-therapeutic intervention.
Feminists who argue that childbirth is a natural process, not an illness,
might seek, with support from practitioners like Wendy Savage, to argue
that the context of obstetric practice, and consequently the role of the
doctor, is sharply differentiated from the context of normal health care.
Interventions in childbirth could thus be regarded as non-therapeutic?
All in all the application of the 'professional standard' for disclosure
and 'informed consent' set in Sidaway seems to offer the professionals
rather less than certain guidance as to the legal framework governing
communications with patients.

The 'professional standard' and patients


If the perceived benefit to the professionals of the 'professional standard'
is more apparent than real the effect on patients of the standard selected
in Sidaway has to be examined once again. The 'professional standard'
clearly falls short of the ethical optimum of patient autonomy outlined
earlier in this article. And yet four out of the five Law Lords paid at least
lipservice to patient autonomy and self-determination. The right of the
competent adult to self-determination lay at the core of Lord Scarman's
dissent from the 'professional standard' test. But we shall need to see
whether his 'reasonable patient' test allied to a widely drawn defence of
56. See Mrs Savage's own account in The Savage Inquiy (Virago, 1986).
186 Legal Studies

therapeutic privilege57 in practice comes much closer to the ethical


optimum of patient autonomy than the 'professional standard' opted for
by his brethren. Lord Bridge for the majority expressly recognised the
patient's right '. . . to decide for himself whether or not he will submit to
a particular course of treatment proposed 58
by the doctor most signifi-
cantly surgery with general anaesthesia.'
For their Lordships in the majority, reconciliation of patient auton-
omy with the 'professional standard' appears to be dependent on three
basic assumptions, two of which are of dubious validity.

(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

was not entitled to all available information on Depo-Provera. Profes-


sional practice in answering queries such as hers was to be taken into
account. The ultimate effect of this decision, the extent to which it may
negate any right to greater information for those who expressly seek to
share in their health care decisions remains to be assessed.
(3) Finally the majority in Sidaway regarded any test of disclosure other
than the 'professional standard' as impracticable, expressly rejecting
Lord Scarman's adoption of the 'reasonable patient' standard. The
ethical optimum outlined earlier in this article went further than Lord
Scarman, focussing the test of disclosure on the needs of the 'particular
patient'. Can this ethical optimum even be reflected in legal rules? Is the
'reasonable patient in the plaintiffs particular position' a tolerable
compromise? Both questions are inherently difficult to answer. Taking
the second question, of the acceptability and applicability of a 'reason-
able patient' test, consideration ofhow it would work in practice suggests
there may be less material difference between the 'reasonable patient'
standard and the 'professional standard' than at first seems likely. The
courts in applying the 'reasonable patient' standard in the USA and in
Canada' have tended to operate a strictly objective test paying little
regard to the idiosyncracies of individual patients. In particular the rules
applied relating to causation have diminished the utility of the 'reason-
able patient' test in upholding individual autonomy. The plaintiff must
establish, not only that he would have refused treatment if fully informed,
but that the 'reasonable patient' would also have rejected the treatment
proposed. 5 The right to be wrong, to act on individual preferences, to act
against one's best interests as perceived by others, is unprotected even by
a 'reasonable patient' test.
Examination of an admittedly eclectic group of decisions purporting
to apply the 'reasonable patient' standard suggests that very often the
'reasonable patient' will be found to want to know exactly what 'profes-
sional standard' might well have offered to tell him.66 The benefits in
terms of upholding patient autonomy of the 'reasonable patient' test
however remain these. Firstly the courts signal unequivocally to the
medical profession that '... . the right to know.., is no longer to be
limited by what the medical profession customarily tells them; . . . the
patient's right to be able to make an intelligent choice about any pro-
posed surgery transcends the interest of the medical profession in setting
its own autonomous standards of disclosure. 7 In fact, as we have seen,
63. See Making Health Care Decisions at p 27.
64. Reibl v Hughes (1981) 114 DLR (3d) 1; Hopp v Lepp (1981) 112 DLR 67; Ferguson v
Hamilton Civic Hospitals (1983) 144 DLR (3d) 219.
65. Ferguson v Hamilton Civic Hospitals (op cit); White v Turner (1981) 120 DLR (3d) 269.
66. Eg in requiring much more detailed information re cosmetic surgery than 'health-
promoting' procedure. White v Turner (op cit), where the court held that the 'reasonable
patient' would have refused cosmetic breast surgery if fully informed of the risks raises a
nice point. The reasonable patient (as defined by an elderly malejudge) may place a much
lower premium on attaining the perfect bust than any particular young woman. The doctor
via the reasonable patient test may thus be penalised for complying with his patient's
express wishes.
67. White v Turner (op cit) at pp 283-284.
188 Legal Studies

the Lords in Sidaway also signalled the death-knell of untrammelled


medical autonomy but their signal was muffled by their adoption of the
'professional standard'. Secondly the onus is placed on the doctor to
consider at least what in general a patient in the plaintiff's circumstances
would want to know. The onus is placed on the doctor to initiate an
exploration of the extent to which his patient wishes actively to partici-
pate in his treatment decisions. The discrimination inherent in Sidaway
between the articulate and the less articulate is thereby avoided.
But the extent to which these two 'benefits' to patients operate in
practice depends almost entirely on how widely the courts extend any
complementary defence of therapeutic privilege. Lord Scarman in Sida-
way setting the 'reasonable patient' standard as the prima facie test of
disclosure defined therapeutic privilege thus:
'This [defence] enables a doctor to withhold from his patient informa-
tion as to risk if it can be shown that a reasonable medical assessment (my
italics) of the patient would have indicated to the doctor that disclosure
would have posed a serious threat of psychological detriment to the
patient'. 68

The effect of such a defence dependent once again on professional


judgment suggests at first sight that all a 'reasonable patient' test does is
reverse the burden of proof. Doctors may still rely on custom and
practice to withhold information but they must prove the custom and
practice. It does a little more than this; the medical judgment relied on to
invoke therapeutic privilege must be specific to that patient. It at least
requires that the doctor explore his relationship with that individual and
probe to discover the potential effect on him of disclosure. It is not
dependent on a general assumption that disclosure equals harm to the
patient.
Examining the 'reasonable patient' standard as it may be perceived
by, and affect, the professionals, the reaction in America to judicial
imposition of the patient-centred standard cannot be overlooked. So
extreme was the outcry in certain states that state legislatures acted to
re-impose the 'professional standard'. 9 What lies at the core of such
opposition to the 'reasonable patient' test? After all one 'benefit' to the
profession might at first sight be the elimination ofsome of the uncertain-
ties inherent in the application of the 'professional standard' notably
that one test of disclosure could govern all intervention removing the
possibility of any difficult distinction between therapeutic and non-
therapeutic interventions. But this 'benefit' would of course disappear if
in general a wide defence of therapeutic privilege were first permitted in
normal health-care contexts and then excluded for non-therapeutic inter-
0
ventions as has happened elsewhere.

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

The basic problem with a 'reasonable patient' standard lies in ascer-


taining the nature and reactions of the mythical reasonable patient.
Professional practice may be disputed, medical opinion may be divided
on disclosure, but some hard evidence will be to hand. Lord Bridge
condemned the 'unpredictability' of the 'reasonable patient' test." One
has to ask, though, why the 'reasonable patient' is so much more of a
difficult and unpredictable concept than the 'reasonable man' utilised to
set general standards of care and to establish contributory negligence.
Nevertheless the different and idiosyncratic reactions of individuals to
doctors, hospitals, illness and ultimately to the prospect of death do add
unknown and unknowable factors to the equation. The trouble perhaps
is that there is no standard patient only particular patients. Should that
conclusion logically lead to application by the law then of the ethical
optimum of a 'particular patient' test? Christopher Newdick" put it
bluntly'... there is no half-way house between the "reasonable doctor"
and "informed consent" tests of a patient's willingness to undertake
risks.' The latter test he ruled out as 'over-optimistic or artificial' and
opted for the 'professional standard' because it could provide a coherent
body of principles based on medical standards sensitive to the com-
munity's expectations.

The 'particular patient' and the limitations of the law


If there is no half-way house, and it does look an uninviting residence,
must one follow Newdick and opt, however reluctantly, for the 'profes-
sional standard'? After all the debate on 'informed consent' is only
marginally about legal rules. If the ethical debate gains ground in the
profession, and doctors themselves come to consider that their profes-
sionalobligation is to make their patients full partners in decision-making
then in years to come the 'particular patient' test could in theory become
the legal standard dictated by professional practice. Such a process
would however take decades and could only be achieved on the unlikely
assumption that one day no respectable body of medical opinion will still
cling to more limited standards of disclosure. Waiting for a change in
practice denies any active role to the law. The force of legal rules in
reflecting and enforcing the expectations of the community as a whole is
abrogated altogether. And moreover the 'professional standard' set as
the legal norm may, as we have seen with the Wendy Savage affair, serve
to inhibit less courageous doctors than her from seeking to move to
involve their patients as partners in health care.
Fundamental opposition to a 'particular patient' test like opposition
to the 'reasonable patient' test rests once again at least in part on the
assertion of its unpredictability and impracticability. Yet the 'particular
patient' test when carefully considered in fact provides a more certain
framework for doctor/patient consultations than either of the alterna-
tives. The doctor's decision as to what to disclose would turn not on his
assessment of the hypothetical 'reasonable patient', or of an unknown
71. At p 662.
72. See 'The Doctor's Duties of Care under Sidaway' [1985] NILQ 243 at p 250.
190 Legal Studies

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.

Why Parliament should intervene


The case for the adoption of the 'professional standard' accepted by the
Lords in Sidaway is seriously flawed. Patient autonomy is seriously
undermined and the alleged benefits to doctors of the judgment are
largely illusory. Yet the opposite case for legal enforcement of a 'particu-
lar patient' test is far from totally convincing as yet. No radical change in
the law should be essayed without caution. The debate on 'informed
consent' is still to some extent in its infancy in Britain. Much of the
literature and virtually all the relevant statistics on what patients want to
know and how doctors respond come from across the Atlantic. American
materials enable us to question and doubt the majority consensus among
doctors and lawyers in England that only the 'professional standard' is
fair and practicable. Differences in national temperament, the absence
in general of a consumerist approach to medicine, the effect of changed
practices on the financing of the NHS are just some of the reasons why
American evidence alone cannot be relied on to urge a change in the legal
rules in this country.
What is needed is order to work towards a practicable and acceptable
legal framework for 'informed consent' in Britain is for the DHSS to
initiate an examination of the many issues ofhealth care practice, ethics,
economics and law which relate to patient consents to therapy. There is
increasing support for the creation of a Standing Commission on Medi-
cine, Law and Ethics which would as its first task investigate the
problem of 'informed consent'. A blueprint for its research methods and
deliberations is there waiting for it in the form of the President's Com-
mission Report from the USA on Making Health Care Decisions.
The advantages of setting the legal framework for 'informed consent'
in this manner and abandoning the case by case approach has self-
evident advantages:

(1) The Commission can, as no court could, examine the fundamental


assumptions made in Sidaway about patients' requirements in relation to
disclosure.
(2) The composition of the commission would reflect medical and legal
expertise and doctors' and patients' interests. A solution to the problem
could be worked through via co-operation not confrontation.
(3) The thorny issues of competence to consent and the particular
problems of consent to research procedures would obviously be
thoroughly investigated. It might well prove impossible to arrive at a
192 Legal Studies

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.

(4) The legal standard could be considered in the wider context of


health care procedures generally. It might well be that the Commission
would focus on processes of consultation providing for greater involve-
ment of all health care professionals in communication with patients.
Codes of practice and NHS guidelines could supplement the stark legal
rules.
The issue of 'informed consent' may, abstracted from problems of
health care generally, be perceived as relatively minor. That is right of
course if it is judged in proportion to the litigation turning solely on the
question of how much information the doctor chose to disclose. But it
looms largely in the minds of the doctors generating too often a defensive
suspicion of the law. And 'informed consent' most importantly lies at the
heart of many other difficult problems of medicine law and ethics. Let us
look at just a few examples. Whether and when a doctor may lawfully
desist from attempts to prolong life depends to a large extent on to what
extent our society will permit patients to decide for themselves when life
ceases to have value, and what provision the law makes to allow patients
to define in advance of a loss of competence, what they wish to be done to
them and for them at the end of life. External regulation of research
procedures acquires greater importance the less the premium we place
on individual autonomy. Clearly if individuals can be used as research
subjects with less than full disclosure of the risks to them, some other
body must protect their interests. The safety of drugs is now subject to
detailed external controls albeit drug 'disasters' have not been elimi-
nated. Again the question of patient choice rears its head. After the
withdrawal of the anti-arthritic drug, Opren, several patients declared
that for them the risk of kidney or liver damage was more thanjustified
by the relief of the appalling pain of acute arthritis. Was this a choice
society via the law should deny them?
These and other implications of the extent to which in 1987 we permit
adults to make and take responsibility for their own health-care deci-
sions can be examined by a Commission as they never could be in a
contested action before the courts. How health care professionals can be
trained to involve patients in decision-making could be investigated.
The limitations of legal rules can be clearly defined. The legal norm can
be set by a Commission in the context of the ethical and professional
standards agreed on.
The law should reflect the expectations of the community, should act
as an incentive to effective and co-operative health care, should safe-
guard the patient's autonomy and provide a clear and certain framework
for the discharge of professional obligations. Too many grey areas afflict
thejudge-made rules. The prior issue of competence to consent is largely
untouched by the law at present. The legal origins of 'informed consent'
in battery still distort lawyers' perceptions focussing the debate too
exclusively on surgery. Judicial assumptions on community expecta-
Patient autonomy and consent to treatment 193

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.

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