Transcript Consent to treatment

Consent to treatment
Philip Fennell
Professor of Law
Cardiff Law School
Consent Guidance
• Health Service Circular HSC2001/023 Good Practice
in Consent
• NHS Plan commitment to patient-centred consent
practice
• Reference Guide to Consent Reference Guide to
Consent to Treatment (Second Edition) 2009
Department of Health Policy Guidance
http://www.dh.gov.uk/en/Publicationsandstatistics
/Publications/PublicationsPolicyAndGuidance/DH_4
00675
• The Mental Capacity Act (MCA) 2005
• The MCA Code of Practice
CONSENT
• The voluntary and continuing permission of
the patient to receive a particular treatment
based on an adequate knowledge of the
purpose, nature and likely risks of the
treatment including the likelihood of its
success and any alternatives to it.
Permission given under any unfair or undue
pressure is not consent. Mental Health Act
Code of Practice (2008, para 23.31)
Beatty v Cullingworth BMJ
(1896)
• Before doing an operation, surgeons
should be careful to explain what they
propose to do and get unequivocal
consent from the patient, or if the
patient is not in a condition to give
consent, from the patient’s nearest
friends. Such consent should either be
in writing or distinctly expressed
before witnesses.
Pratt v Davis (1906) 79 NE 562.
• Under a free government, at least, the free citizen's
first and greatest right, which underlies all others the right to inviolability of his person; in other
words, the right to himself - is the subject of
universal acquiescence, and this right necessarily
forbids a physician or surgeon, however skilful or
eminent, who has been asked to examine, diagnose,
advise and prescribe ..., to violate, without
permission, the bodily integrity of his patient by a
major or capital operation, placing him under
anaesthetic for that purpose and operating on him
without his consent or knowledge.
Kinkead on Torts 1905
• The contemporary edition of the American
commentary Kinkead on Torts placed based the
principle on natural law theory:
• The patient must be the final arbiter as to whether
he will take his chances with the operation, or take
his chances of living without it. Such is the natural
right of the individual, which the law recognises as
a legal one. Consent, therefore of an individual
must be expressly or impliedly given before a
surgeon has the right to operate.
Purpose of Consent
• Clinical purpose enlisting patient’s faith and
confidence in the efficacy of the treatment
is a major factor contributing to the
treatment's success.
• Legal purpose to provide those concerned in
the treatment with a defence
• Legal/Ethical purpose recognition of the
patient's right of self-determination.
The Elements of Consent
• Capacity - presumption of capacity for
all adults of sound mind - may be
rebutted by evidence of pain, fatigue,
drugs, etc.
• Voluntariness
• Information - How much is required?
• Decision - How is decision evidenced?
The right of selfdetermination
• Every human being of adult years and sound
mind has a right to determine what shall be
done with his own body… a surgeon who
performs an operation without his patient's
consent commits an assault, for which he is
liable in damages. Schloendorff v Society of
New York Hospitals (1914) 211 NY 125 at 128
The Right of Self-Determination (Re
T (1992)
• An adult patient who ... suffers from no mental
incapacity has an absolute right to choose whether
to consent to medical treatment, to refuse it, or to
chose one rather than another of the treatments
being offered... This right of choice is not limited to
decisions which others might regard as sensible. It
exists notwithstanding that the reasons for making
the choice are rational, irrational, unknown or even
non-existent.
The Right of Self-Determination (Re
T (1992)
• Prima facie, every adult has the right
and capacity to decide whether or not
he will accept medical treatment,
even if a refusal may risk permanent
injury to his health or even lead to
premature death.
Human Rights Act and
Consent
• Article 8 everyone has the right to
respect for his home, his privacy, and
his family life
• No interference unless necessary in a
democratic society, and in accordance
with law, to protect health or the
rights of others.
Human Rights Act and Consent
• Article 3 No-one shall be subjected to
torture or to inhuman and degrading
treatment.
The Medical and Ethical
Balance
• Self determination
• Sanctity of life
• balancing two aspects of respect for
persons - respect for their wishes and
respect for their welfare.
Airedale NHS Trust v Bland
[1993] 1 All ER 821 per Lord Goff
• It is established that the principle of selfdetermination requires that respect must be given
to the wishes of the patient, so that if an adult
patient of sound mind refuses, however
unreasonably, to consent to treatment or care by
which his life would or might be prolonged, the
doctors responsible for his care must give effect to
his wishes, even though they do not consider it to
be in his best interests to do so.
Adults Lacking Mental
Capacity
• If patient unconscious or incapable of
making a decision treatment may be
given if necessary in the patient’s best
interests. Mental Capacity Act 2005, s
5.
• Incapacity defined in ss 2 and 3 of the
MCA 2005, process for determining
best interests defined in s 4.
The Mental Capacity Act
2005: Principles
• (1) Capacity is presumed unless incapacity is
established by those alleging it.
• Section 3 Incapacity test inability by reason
of mental disability to
• understand and retain information relevant
to the decision,
• use or weigh the information as part of the
process of arriving at a decision (including
inability to believe the information), or
• communicate his decision by any means.
The Mental Capacity Act
2005: Principles
• (2) All reasonable steps must be taken
to help a person to make the relevant
decision (Re AK (Adult Patient: Medical
Treatment) [2001] 1 FLR 129).
The Mental Capacity Act
2005: Principles
• (3) A person is not to be treated as
unable to make a decision merely
because the decision is unwise (Re T
(Adult Refusal of Treatment) [1992] 3
WLR 782).
The Mental Capacity Act
2005: Principles
• (4) Acts done for people who lack
capacity must be in their best interests
(In Re F (Mental Patient : Sterilisation)
[1990] 2 AC 1). The balance sheet
approach.
Best interests
• Take into account person’s past and present wishes
and feelings, beliefs and values which might be
likely to influence decision, and any other factors
which s\he would be likely to consider if able to do
so. If practicable and appropriate, decision maker
must consider the views of anyone named by the
person to be consulted, any carer or person
interested in his welfare, any donee of a lasting
power of attorney granted by the person, and any
deputy appointed by the Court of Protection.
Best Interests
• Wishes and feelings of the patient
expressed when capable must be
considered by decision makers in
determining what is in the patient’s
best interests (Mental Capacity Act
2005, s 4(6)) as must the views of any
person nominated by the patient to be
consulted (s 4(7)).
The Mental Capacity Act
2005: Principles
• (5) Regard must be had before any act
is done, to whether it is the least
restrictive way of achieving its
necessary purpose, in other words, to
the European Convention principle of
proportionality.
Mental Capacity Act 2005
•
•
•
•
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Revamped Court of Protection ss 45-46.
Declarations s 15
Advance decisions ss 24-26.
Lasting Powers of Attorney ss 11-14 and ss 22-23.
Power of Court of Protection to make decisions and
appoint Deputies ss 16 – 20.
• Independent Mental Capacity Advocates ss 35-41.
Personal Welfare Decisions
• Both deputies and donees of lasting powers of
attorney can make decisions about personal
welfare, including consenting to treatment. A
decision refusing life sustaining treatment may only
be made by the donee of a lasting power of attorney
if it has been specifically granted by the donor of
the power (s 11(7)-(8)). Such a decision may not be
made by a court appointed deputy (s 20(5)).
Care and Treatment of Adults
Lacking Capacity
• Sections 5 and 6 of the 2005 Act
provide a general defence to acts of
care and treatment, which may involve
restraint and restriction of liberty of a
mentally incapacitated person.
The Section 5 Criteria
(1) D takes reasonable steps to establish
whether P lacks capacity in relation to
the matter;
(2) D reasonably believes that P lacks
capacity in relation to the matter
(3) D reasonably believes that it will be
in P’s best interests for the act to be
done.
Cases needing to go to Court
•
•
•
•
•
Treatments requiring court approval
Withholding or withdrawing ANH for patients in PVS
Organ or bone marrow donation
Non-therapeutic sterilisation
Some termination of pregnancy cases D v a NHS
Trust [2004] 1 FLR 1110
• Other cases where there is dispute about whether a
treatment is in a person’s best interests.
Restraint
• Restraint only permitted if the conditions in
s 6 are met.
• Defined in s 6 (4) as using or threatening to
use force to do an act which the person
resists
• Restricts the liberty of movement of a
person who lacks capacity whether or not
the person resists Code of Practice Paras
6.40-6.43
Restraint under section 6
• The first condition is that D reasonably believes that
the act is necessary to prevent harm to P.
• The second condition is that the act is a
proportionate response both to the likelihood of P’s
suffering harm, and the seriousness of that harm.
Restraint means the use or threat of force to secure
the doing of an act which P resists, or the placing of
any restriction of P’s liberty of movement, whether
or not P resists.
Valid Advance
Directive/Decision
Advance directive/decision refusing treatment for
mental disorder governed by the Part lV procedures
will not be binding if the patient is detained and
treatment is authorised under Part lV
Note however, a valid advance directive/decision in
relation to physical treatment will remain binding,
as Part lV only applies to treatment for mental
disorder. (See Code Para. 13.37)
Advance Decisions
• A distinction must be made between
advance directives (common law) and
advance decisions (Mental Capacity Act
2005, ss 24 - 26) where treatment is being
refused, and advance statements where a
specific treatment is being asked for. Valid
advance directives and decisions are binding,
but advance statements are not.
Advance Statements
• Made by a capable person asking for specific
treatment to be given in specified circumstances if
the person loses mental capacity. An example of
such a request is the case of R (Burke) v General
Medical Council [2004] EWHC 1879 (High Court)
[2005] EWCA Civ 1003 (Court of Appeal). Advance
statements not binding on doctors, who must
exercise their own clinical judgment about the best
interests of an incapacitated patient.
Section 37 Serious treatments
• If no-one other than paid carer to consult,
responsible body must appoint an Independent
Mental Capacity Advocate and submissions of
advocate must be taken into account in deciding
whether to provide the treatment.
• Section 37 decisions about providing, stopping or
withholding serious medical treatment
• IMCA may consider seeking a second opinion
Parental Consent
• Duty of those with parental responsibilities
to seek necessary medical for children. If
they don’t they risk prosecution for child
neglect.
• Parental
responsibilities
include
responsibility to consent to treatment on
child’s behalf.
• Child cardiac patients at Bristol Royal
Infirmary
Children and Consent
• Consent of child under 16 valid if child
Gillick competent (Gillick (1986))
• Children 16-18 Family Law Reform Act
1968, s 8.
Children and Refusal
• Refusal by competent child of any age
up to 18
• may be overridden by parent or court
if necessary in child’s best interests
The Law of Consent
• Liability in battery for touch
treatments where no consent
obtained, consent obtained by fraud or
duress, or capable patient has validly
refused treatment.
• Liability in negligence if consent
obtained but inadequate information
given by doctor about risks
Battery
• If adult capable patient is treated without
obtaining her or his consent, or in the face
of a refusal, the doctor is liable in the tort
of trespass to the person.
• Battery a form of trespass to the person
• Intentionally bringing about a harmful or
offensive contact with the person of
another.
Negligence: Chatterton v.
Gerson [1981] Q.B. 432
• ."...it would be very much against the
interests of justice if actions which are
really based upon a failure by the
doctor to perform his duty adequately
to inform were pleaded in trespass
[battery]."
Chatterton v. Gerson [1981]
Q.B. 432
• ...once patient is informed in broad terms of
the nature of the intended procedure, and
gives her consent, that consent is real, and
the cause of the action on which to base a
claim for failure to go into risks and
implications is negligence, not trespass. Of
course, if information is withheld in bad
faith, the consent will be vitiated by fraud.
Bad Faith and Fraud
• Appleton and others v Garrett [1997] 8 Med LR 75
dentist carried out unnecessary treatment. Withheld
information deliberately and in bad faith from
patients. Dentist liable in trespass and damages
awarded for pain suffering and loss of amenity, cost
of treatment from a top dentist to rectify
subsequent problems, and aggravated damages for
feelings of anger and indignation. Patients received
damages ranging from £15,000 to £28,000.
NEGLIGENCE AND DISCLOSURE OF
INFORMATION
• Elements in an action for negligence for
failure to give adequate treatment
information
• A duty to disclose the risk
• Breach of the duty to disclose
• Causation - the damage suffered must have
been caused by the breach of duty But see
now the House of Lords decision in Chester v
Afshar [2004] UKHL 41
The Standard of disclosure
• The risks which a responsible doctor
would disclose (UK Sidaway)
• The risks which a prudent patient
would want to know about (US,
Canada, Australia)
Sidaway v. Bethlem Royal
Hospital [1985] 1 All ER 643
• Operation for recurrent pain in the neck and arms.
Inherent risk of 1% - 2% of permanent damage to
spinal cord. Risk transpired. Actions in battery and
negligence alleging that had she been informed of
the risk, she would not have consented to the
operation. Action in battery ruled out. House of
Lords held that standard of care which should be
applied to disclosure is the same as that applicable
to other aspects of doctor's duty of care to patients,
i.e. Bolam. Standard had not been breached.
Sidaway v. Bethlem Royal
Hospital [1985] 1 All ER 643
• if a body of medical opinion would not
disclose Lord Bridge ..the issue whether nondisclosure a breach of the doctor's duty of
care an issue to be decided primarily on the
basis of expert medical evidence, applying
the Bolam test.
• However, disclosure of a particular risk of
grave adverse consequences could be so
obviously necessary that no prudent medical
man would fail to make it.
The Prudent Patient Test
• Adopted by the Canadian Supreme
Court (Reibl v. Hughes [1980] 114 DLR
3d 1) and by the High Court of
Australia in Rogers v. Whitaker [1993]
67 ALJR 47.
Pearce v. United Bristol Healthcare
N.H.S. Trust (1998) 48 BMLR 118
• In determining what information to provide a
patient, doctor must have regard to all relevant
circumstances, including the patient’s ability to
comprehend the information and the physical and
emotional state of the patient. Normally, it is a
doctor’s legal duty to advise a patient of any
significant risks which may affect the judgment of a
reasonable patient in making a treatment decision
Lord Woolf MR
Pearce v. United Bristol Healthcare
N.H.S. Trust (1998) 48 BMLR 118
• If a patient asks about a risk, it is the
doctor’s legal duty to give an honest
answer.
Developments since Pearce
• Birch v University College Hospital NHS Foundation
Trust [2008] EWHC 2237
• Clinical Negligence £621,000 stroke caused by a
cerebral catheter angiogram
• Patient had diabetes. Prof in charge of her
treatment referred her for a MRI scan angiogram
• Other doctors at Queen’s Square decided to carry
out there was a 1 per cent chance of stroke from
cerebral catheter angiogram
• In fact risk between 0.5 and 2% and higher for
patient’s with diabetes
Developments since Pearce
• Birch v University College Hospital NHS Foundation
Trust [2008] EWHC 2237 Cranston J my view is that
in the special circumstances of Mrs Birch’s case the
hospital should have discussed with her the
different imaging methods catheter angiography and
MRI and the comparative risks. Had it done so Mrs
Birch would have declined cerebral catheter
angiogram and thus avoided her stroke.
• Given that Mrs Birch was known to be a diabetic,
and this more likely to develop complications and
that the chances of an aneurism were low, catheter
angiography had risks outweighing the benefits
Developments since Pearce
• Para 74 In my judgment there will be circumstances
where consistently with Lord Woolf’s statement in
Pearce, the duty to inform the patient of significant
risks will not be discharged unless she is made
aware that fewer or no risks, are associated with
another procedure. In other words, unless the
patient is informed of the comparative risks of
different procedures she will not be in a position to
give her fully informed consent to one procedure
rather than another. In my judgment, in the special
circumstances of Mrs Birch’s case, that duty arose
The Doctor’s Duty
• To take into account all the relevant
considerations, which include the
ability of the patient to comprehend
what he has to say to his or her and
the state of the patient at the
particular time, both from the physical
point of view and the emotional point
of view...
The Doctor’s Duty: Which
risks to disclose
• It is important to notice that to be
‘significant’ a risk need not be one, which
would have altered the patient’s decision to
consent to the treatment. A lesser level of
importance may suffice. The risk must be
one that a “reasonable patient” would
consider
relevant
to,
rather
than
determinative of, his or her decision.
Causation
• Once the plaintiff has established
breach of duty he must then go on to
establish that the breach caused the
damage. That is to say he must show,
on the balance of probabilities, that if
he
had
been
given
adequate
information he would not have had the
operation.
Causation
• Smith v Barking, Havering and Brentwood Health
Authority [1994] 5 Med LR hydromyelia operation at
the age of nine. At age 18 she had a recurrence of
her condition. Second operation advised. Otherwise
tetraplegic within nine months. Operation regarded
as a very difficult one. Surgeon reluctant to
undertake. Despite his reluctance he decided that it
was an operation to be recommended, and did not
wish to undermine plaintiff’s confidence by giving
the impression that he did not want to do it.
Operation failed and patient rendered tetraplegic.
Causation
• Hutchinson J held that plaintiff could only
succeed for failure to warn if she could show
on the balance of probabilities that, if she
had received proper warning and advice, she
would not have had the operation. The onus
was not on the defendants to prove that she
would not have refused.
Causation
• Smith v Tunbridge Wells Health Authority [1994] 5
Med LR 334 Plaintiff succeeded in establishing on
balance of probabilities that surgeon had failed to
explain with sufficient clarity to be expected in
1988 of a colorectal surgeon the risk of impotence
from an ivalon sponge rectopexy (the Wells
operation). Moreover had also established on the
balance of probabilities that if risk had been
explained, he would not have had operation.
Causation
• In McAllister v Lewisham and North Southwark
Health Authority [1994] 5 Med LR 343 Operation to
remove ateriovascular malformation in head
resulting in problems with leg. Patient informed
that 20% chance of leg being made worse but risk in
fact much higher. Operation result complete
hemiplegia of her left side. Succeeded because
court satisfied on balance of probabilities that if
informed of full extent of risk, patient would have
postponed operation.
Chester v Afshar [2002] 3 All
ER 552
• Patient referred to eminent neurosurgeon
for operation for back pain removal of three
discs. Agreed to have operation but not
informed of small but known risk of paralysis
(1% - 2%) Patient suffered paralysis.
• The Court of Appeal held that the causal link
not broken by fact that claimant unable to
prove that she would not have had the
operation at some time in the future.
Chester v Afshar House of
Lords
• The House of Lords held by a 3-2 majority
that the defendant had been negligent in
informing the patient of the risk of paralysis,
and that the claimant was entitled to
damages even though that failure to inform
had not, on a strict application of the but for
test resulted in the injuries suffered by the
patient. Doctrine of informed consent given
priority over the rules of causation.
The Prudent Patient Test
• Based upon the information needs of
the patient, rather then on a clinical
assessment of best interests.
• Advocated by Lord Scarman in minority
speech in Sidaway, but failed to find
favour with his fellow judges.
The Prudent Patient Test
• US case Canterbury v. Spence 464 F. 2d 772
(D . C Cir. 1972) doctor must disclose all
material risks to his patient.
• a risk is material when a reasonable person,
in what the physician knows or should know
to be the patient's position, would be likely
to attach significance to the risk or cluster
of risks in deciding whether or not to forgo
the proposed therapy.
The Prudent Patient Test
• Rogers v Whitaker [1993] 4 Med LR 79 Patient almost blind in
one eye. She consulted an ophthalmic surgeon and asked about
possible complications if an operation was performed on it, but
did not ask specifically whether sympathetic ophthalmia
(damage to the other eye) could result. She made clear her
desire for information and to be informed of the possible
consequences. Expressed concern that no damage should befall
her good eye. One in 14,000 risk. Patient rendered blind in the
good eye as a result of the operation. Court rejected Bolam
approach
12 Key points on Consent
• 1. Consent necessary before examine
or treat competent patient.
• 2. Adults presumed to be competent
• 3. Patients may be competent to make
some health care decisions but not
others
• 4. Giving and obtaining consent a
process, not a one off event
12 Key points on Consent
• 5. Children can give consent for
themselves in certain circumstances
• 6. Always best for the person actually
treating to seek consent
• 7. Patients should be given sufficient
information about benefits and risks
• 8. Consent must be given voluntarily
not under duress
12 Key points on Consent
• 9. Consent can be written, oral or nonverbal
• 10. Competent adult patients entitled
to refuse treatment even where it
would clearly benefit their health
12 Key points on Consent
• 11. No-one can give consent on behalf
of an incompetent adult – the decision
for doctor acting in patient’s best
interests. Unless the power to consent
has been conferred under the MCA
2005 on a donee under a Lasting Power
of Attorney, a deputy appointed by the
Court of Protection, or the Court of
Protection consents
12 Key points on Consent
• 12. Advance decision by a competent patient
is valid and applicable if it was made by the
patient when capable, is clear and specific
about which treatments are being refused,
and is sufficient in scope to cover the
situation which has currently arisen. If life
sustaining treatment is to be refused by
advance decision the decision must be in
writing.