Consent to treatment

1
Consent to treatment

• Philip Fennell
• Professor of Law
• Cardiff Law School

2
Consent Guidance

• Health Service Circular HSC2001/023 Good Practice
  in Consent
• NHS Plan commitment to patient-centred consent
  practice
• www.doh.gov.uk/consent

3
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, (1999)

4
Purpose of Consent

• Clinical purpose enlisting patients 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.

5
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?

6
The right of self-determination

• 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

7
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.

8
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.

9
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 a legal
  procedure, to protect health or the rights of
  others.

10
Human Rights Act and Consent

• Article 3 No-one shall be subjected to torture or
  to inhuman and degrading treatment.

11
Elements of Consent

• Capacity - presumption of capacity for adult
  patients of sound mind - can be rebutted by
  evidence of effects of pain, fatigue, drugs, etc
• Voluntariness - consent must not be induced by
  coercion or fraud.
• Information - How much information is required?
• Decision - How is a decision communicated and
  evidenced?

12
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.

13
Airedale NHS Trust v Bland 1993 1 All ER 821
per Lord Goff .

• It is established that the principle of
  self-determination 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.

14
Mentally Incapacitated Adults

• If patient unconscious or incapable of making a
  decision treatment may be given if necessary in
  the patients best interests.
• Necessary in best interests if necessary to save
  life or to alleviate or prevent deterioration in
  physical or mental health (Re F 1990 AC 1).

15
Incapacity Presumption of capacity

• Patient incapable if
• (a) unable to understand and retain the relevant
  treatment information or
• (b) unable to believe it or
• (c) unable to weigh it in the balance to arrive
  at a decision (Re C (1994))

16
Incapacity

• A person lacks capacity if some impairment or
  disturbance of mental functioning renders them
  unable to make a decision whether to consent to
  or refuse treatment. Re MB (1997)

17
Incapacity (The Re MB Test)

• (a) unable to comprehend and retain information
  material to the decision, esp as to the likely
  consequences of having or not having the
  treatment in question or
• (b) unable to use the information and weigh it in
  the balance as part of the process of arriving at
  a decision. If compulsive disorder or phobia from
  which patient suffers stifles belief in the
  information presented, then decision may not be a
  true one.

18
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.

19
Children and Refusal

• Refusal by competent child of any age up to 18
• may be overridden by parent or court if necessary
  in childs best interests

20
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

21
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.

22
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."

23
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.

24
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.

25
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

26
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)

27
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.

28
Sidaway v. Bethlem Royal Hospital 1985 1 All ER
643

• Lord Bridge ..the issue whether non-disclosure 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, even if a body of medical opinion
  would not disclose the risk.

29
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 patients ability to
  comprehend the information and the physical and
  emotional state of the patient. Normally, it is a
  doctors 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

30
Pearce v. United Bristol Healthcare N.H.S. Trust
(1998) 48 BMLR 118

• If a patient asks about a risk, it is the
  doctors legal duty to give an honest answer.

31
The Doctors 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...

32
The Doctors 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 patients 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.

33
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.

34
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
  plaintiffs confidence by giving the impression
  that he did not want to do it. Operation failed
  and patient rendered tetraplegic.

35
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.

36
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.

37
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.

38
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.

39
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.

40
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.

41
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

42
Causation (Pearce)

• If the patient is to establish a causal link
  between the non-disclosure and her injury, the
  risk must be one which alone or in combination
  with other risks, would have led the patient to a
  different decision. Even if plaintiff had been
  advised of risk, the inference from the evidence
  was that she would still have agreed to natural
  delivery.

43
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. Patient
  suffered paralysis.
• 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.

44
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

45
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

46
12 Key points on Consent

• 9. Consent can be written, oral or non-verbal
• 10. Competnet adult patients entitled to refuse
  treatment even where it would clearly benefit
  their health
• 11. No-one can give consent on behalf of an
  incompetent adult - decision for doctor acting in
  patients best interests

47
12 Key points on Consent

• 12. Advance refusal by a competent patient valid
  if sufficient in scope to cover the situation
  which has currently arisen.