Consent

Consent to Treatment

Sime Darby Medical Centre16th April 2009

Darryl S C Goon

“Informed Consent”

Does the term have any legal significance in Malaysia?

The Role of “Consent”

“There seems to be some confusion in the minds of some as to the purpose of seeking consent from a patient (whether adult or child) or from someone with authority to give that consent on behalf of the patient. It has two purposes, the one clinical and the other legal. The clinical purpose stems from the fact that in many instances the cooperation of the patient and the patient’s faith or at least confidence in the efficiency of the treatment is a major factor contributing to the treatment’s success… The legal purpose is quite different. It is to provide those concerned in the treatment with a defence to a criminal charge of assault or battery or a civil claim for damages for trespass to the person. It does not, however, provide them with any defence to a claim that they negligently advised a particular treatment or negligently carried it out.”

Per Lord Donaldson M.R. In re W (A Minor) (Medical Treatment: Court’s Jurisdiction) [1993] Fam 64 at pg 76

Consent

Relevance

of

Consent

X

Trespass Negligence

Battery

Tort of Trespassto the Person

Battery

“Battery is the intentional and direct application of force to another person”

“Any physical contact with the body of the plaintiff (or with his clothing) is sufficient to amount to ‘force’.”

Winfield & Jolowicz 15th Edn

NB: cf Assault

Tort of Battery and Medical Practice

“… as a general rule, the performance of a medical operation upon a person without his or her consent is unlawful, as constituting both the crime of battery and the tort of trespass to the person.”

Per Lord Goff in Re F (Mental Patient: Sterilisation) [1990] 2 AC 1 at page 71

How detailed must the explanation be for a valid consent?

“I am wholly satisfied that as a matter of English law a consent is not vitiated by a failure on the part of the doctor to give the patient sufficient information before the consent is given.”

Per Donaldson MR in Sidaway v Bethlem Royal Hospital Governors [1984] 1 All ER 1018, at 1026 and 1029

Informed Consent?

“The first argument was that unless the patient’s consent to the operation was a fully informed consent the performance of the operation would constitute a battery on the patient by the surgeon. This is not the law of England. If there is consent to the nature of the act, then there is no trespass to the person.”

Per Dunn LJ in Sidaway v Bethlem Royal Hospital Governors [1984] 1 All ER 1018, at pg 1029 [Decision upheld on appeal to the House of Lords]


“Anglo-Australian law has rightly taken the view that an allegation that the risks inherent in a medical procedure have not been disclosed to the patient can only found an action in negligence and not in trespass; the consent necessary to negative the offence of battery is satisfied by the patient being advised in broad terms of the nature of the procedure to be performed.”

Per Mason CJ, Brennan, Dawson, Toohey and McHugh JJ said in Rogers v Whitaker (1992) 175 CLR 479 at 490.


How much disclosure must there be for a “real” consent?

“In my judgment what the court has to do in each case is to look at all the circumstances and say, “Was there a real consent?’…

…

In my judgment once the patient is informed in broad terms of the nature of the procedure which is intended, 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.”

Per Bristow J in Chatterton v Gerson [1981] 1 All ER 257 at 265

Negligence & the Duty of Care

"The duty of a medical practitioner to exercise reasonable care and skill in the provision of professional advice and treatment is a single comprehensive duty. However, the factors according to which a court determines whether a medical practitioner is in breach of the requisite standard of care will vary according to whether it is a case involving diagnosis, treatment or the provision of information or advice; the different cases raise varying difficulties which require consideration of different factors."

Per Mason CJ, Brennan, Dawson, Toohey and McHugh JJ in Rogers v Whitaker :(1992) 175 CLR 479, at 489.

Doctors’ Duty of CareIn the United Kingdom

Sidaway v Bethlem Royal Hospital Governors and others [1985] 1 All ER 643

“Held: (1) (Per Lord Diplock, Lord Keith and Lord Bridge, Lord Scarman dissenting) The test of liability in respect The test of liability in respect of a doctor’s duty to warn his patient of risks inherent in of a doctor’s duty to warn his patient of risks inherent in treatment recommended by him was thetreatment recommended by him was the same as the test applicable to diagnosis and treatment, namely that the doctor was required to act in accordance with a practice accepted at the time as proper by a responsible body of medical opinion. Accordingly, English law did not recognise the doctrine of informed consent.”

Doctors’ Duty of CareIn the United Kingdom

The Single Comprehensive Duty is embodied in the Bolam Test:

“A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.

… Putting it the other way round, a doctor is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion which takes a contrary view.”

per Justice McNair inBolam v Friern Management Committee [1957] 2 All ER 118

Doctors’ Duty of CareIn Malaysia

In Malaysia the “single comprehensive duty” of care has 2 parts:

(i) The Bolam test for diagnosis and treatment (supra)

(ii) The test in Rogers v Whitaker for advice and disclosure of risks

Doctors’ Duty of CareIn Malaysia

“(1) The Bolam Test has no relevance to the duty and standard of care of a medical practitioner in providing advice to a patient on the inherent and material risks of the proposed treatment…”

“(2) … On this basis the Rogers v Whitaker test would be more appropriate and a viable test of this millennium than the Bolam Test.”

Foo Fio Na v Dr Soo Fook Mun & Anor [2007]1 MLJ 593, Federal Court

What is the rule in Rogers v Whitaker?

“Except in the case of an emergency or where disclosure would prove damaging to the patient, a medical practitioner has a duty to warn the patient of a material risk inherent in proposed treatment.”

per Mason CJ, Brennan, Dawson, Toohey and McHugh JJ.,

in Rogers v Whitaker [1992] 175 CLR 479

What is the Rogers v Whitaker test for materiality?

“A risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it.”

per Mason CJ, Brennan, Dawson, Toohey and McHugh JJ.,

in Rogers v Whitaker [1992] 175 CLR 479

The Test in Rogers v Whitaker

Translates into:

(1) Except in the case of an emergency or where disclosure would prove damaging to the patient (therapeutic privilege), a medical practitioner has a duty to warn the patient of a material risk inherent in a proposed treatment.

The Test in Rogers v Whitaker

(2) A risk is “material” if:

in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or

if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it.

The Logic

“Whether a medical practitioner carries out a particular form of treatment in accordance with the appropriate standard of care is a question in the resolution of which responsible professional opinion will have an influential, often a decisive, role to play; whether the patient has been given all the relevant information to choose between undergoing and not undergoing the treatment is a question of a different order. Generally speaking, it is not a question the answer to which depends upon medical standards or practices.” [Emphasis added]

per Mason CJ, Brennan, Dawson, Toohey and McHugh JJ., in Rogers v Whitaker [1992] 175 CLR 479 at 489

The Rationale

‘…it is for the courts to adjudicate on what is the appropriate standard of care after giving weight to “the paramount consideration that a person is entitled to make his own decisions about his life”.’

per Mason CJ, Brennan, Dawson, Toohey and McHugh JJ., in Rogers v Whitaker [1992] 175 CLR 479 at 487 F. v. R.

(1983), 33 SASR at p 193

Consent & Duty of Care

Tort of Battery Tort of Negligence

Consent Duty of Care (Suffice to inform of intended procedure (i) Duty to Advisein broad terms) (Test in Rogers v Whitaker)

(ii) Duty in relation to Diagnosis

& Treatment(Bolam test)

“Valid Consent”

Private Healthcare Facilities & Services

(Private Hospitals and Other Private Healthcare Facilities) Regulations 2006

Regulation 47

A written “valid consent” must be obtained “…before any procedure or surgery is carried out on the patient.”

For patients under 18 and unmarried, consent must be obtained from the parent or guardian

Contravention of Regulation 47 is an offence punishable by a maximum fine of RM10K and/or a maximum of 3 months imprisonment.

Note: No similar provision is found in the Private Healthcare Facilities & Services (Private Medical Clinics or

Private Dental Clinics) Regulations 2006

Regulation 48A Regulation 48 “valid consent” may be dispensed with:

- If a surgeon believes that any delay caused by trying to obtain a valid consent would endanger the life of the patient and

- Provided, “…a consensus of the surgeon and another registered medical practitioner is obtained and the surgeon signs a statement stating that the delay would endanger the life of the patient”.

Contravention of Regulation 48 is an offence punishable by a maximum fine of RM10k and/or a maximum of 3 months imprisonment.

The Extent of the Right to Consent

“First, 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 interest to do so …To this extent, the principle of the sanctity of human life must yield to the principle of self-determination…and, for present purposes perhaps more important, the doctor’s duty to act in the best interests of his patient must likewise be qualified”

Per Lord Goff in Airedale NHS Trust v Bland [1993] AC 789 at pg 864

NB: Euthanasia calls for a positive act to bring about the death of a patient. An omission is not euthanasia.

Is age a criterion for consent to treatment?

• In relation to any “procedure” or “surgery” written consent of a parent must be obtained if the patient is below 18 and unmarried: [Regulation 47 of the Private Healthcare Facilities & Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006]

• No provision exists for consent in clinics, from married 17 year olds or, for example, for medical prescriptions.

Common law?

Is age a criterion for consent to treatment – common law?

Gillick v West Norfolk A.H.A v Department of Health and Social Security [1986] 1 AC 112

“Held: …(1)…; that a girl under the age of 16 years had the legal capacity to consent to medical examination and treatment, including contraceptive treatment, if she had sufficient maturity and intelligence to understand the nature and implications of the proposed treatment.

(2) That the parental right to control a minor child deriving from parental duty was a dwindling right which existed only in so far as it was required for the child’s benefit and protection; that the extent and duration of that right could not be ascertained by reference to a fixed age, but depended on the degree of intelligence and understanding of that particular child; that the parents’ right to determine whether a child under 16 should have medical treatment terminated when the child achieved sufficient intelligence and understanding to make that decision itself...”

Malaysia

Will the Gillick test of the competent patient be applied in Malaysia?

Minors - consent from whom?

Age of Majority Act, 1971

Age of majority of all males and females is upon attainment of 18yrs of age.

Minors - consent from whom?

Guardianship of Infants Act 1961

• Age of majority for Muslims is 18 yrs and for other persons 21 years.

• The “guardian” (cf parent) of the person of an infant shall have the custody of the infant, and shall be responsible for his support, health and education: Section 3

Minors - consent from whom?Child Act 2001

• A child (under 18 yrs of age) who is in need of care may be taken into custody by a Protector or police officer (Section 18)

• A Protector or police officer may authorise the medical treatment of a child taken into custody by a “medical officer” (Section 20).

• “Medical Officer” is defined as a registered medical practitioner in the service of the Government and includes a registered medical practitioner in any teaching hospital of a University.

Parents’ Rights – Common Law?

“Nobody doubts, certainly I do not doubt, that in the overwhelming majority of cases the best judges of a child’s welfare are his or her parents. Nor do I doubt, that any important medical treatment of a child under 16 would normally only be carried out with the parents’ approval.”

Per Lord Fraser, in Gillick v West Norfolk A.H.A. [1986] AC 112 at pg 172

Parental Duty to Provide Medical Care

“It is not surprising that the common law imposed no general duty on parents to provide medical treatment for their children.”

Per McHugh J, in Secretary, Dept of Health and Community Services v JWB and SMB (1992) 175 CLR 218 at pg 313

Can the Court override a minor’s refusal to treatment?

In Re W. (A Minor) [1993] Fam. 65, CA

Held: …”that, although a minor of any age who had sufficient maturity might consent to treatment, his refusal to give consent could not overrule consent given by the court; that in exercising its inherent jurisdiction the court would take particular account of the minor’s wishes, the importance of which increased with his age and maturity, but would override them where his best interests so required;”

Nature of Consent

Express Consent

Implied Consent

Evidence of Consent – in writing and witnessed

Especial Consent Forms/Acknowledgement of Risks Forms

Simplicity of Language

Corroborating Records

Validity of Consent

Form of Consent

“I should add that getting the patient to sign a pro forma expressing consent to undergo the operation ‘the effect and nature of which have been explained to me’, as was done here in each case, should be a valuable reminder to everyone of the need for explanation and consent. But it would be no defence to an action based on trespass to the person if no explanation had in fact been given. The consent would have been expressed in form only, not in reality.”

Per Bristow J in Chatterton v Gerson [1981] 1 All ER 257 at 265

THANK YOU

Consent

Health & Medicine

Transcript of Consent