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Medical Law Consent, Battery: Information and

Voluntariness

• Prof Orla Sheils

Department of Histopathology

TCD

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Principal Issues

• Importance of consent –morally and legally

• Elements of battery• Elements of consent• Distinction between battery and

negligence• Nature and purpose• Relevance of fraud

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Purpose of the law of consent• To protect the ethical principle that

each person has a right to self-determination and is entitled to have their autonomy protected.

• Breach of this amounts to the tort of battery and may constitute a criminal offence.

– Trespass to the body

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Issues of consent

• Crime of battery

• Tort of battery

• Tort of negligence

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INFORMED CONSENT-Definition

• Informed consent means the knowing consent of an individual or their legally authorised representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or any form of restraint or coercion.

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Issues of Consent• A person gives informed consent when, with substantial

understanding and in the substantial absence of control by others, they intentionally authorise a professional to do something.

• Range of ethical concepts used to justify informed consent:

• self-determination,

• dignity,

• autonomy,

• freedom,

• privacy.

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Issues of Consent

• Most influential concept in writing on consent: autonomy.

• Self-determining moral agent

• Moral claim that it is wrong to treat others in such a way that prevents them from shaping their own lives in accordance with their own intentions, plans and values.

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• Consent in medical procedures can usually be obtained by presenting the patient with a consent form to sign.

• The consent form exists to demonstrate that a process of communication has taken place during which the patient has learned about his/her illness and treatment options and reached a point where they can decide, on an informed basis to proceed with, restrict, or decline the proposed intervention.

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• The doctrine of consent operates to reflect the self-autonomy of the patient.

• In many jurisdictions it is now regarded as a fundamental human right.

• In Ireland, this fact is well established. The Supreme Court has stated that:– "The requirement of consent to medical treatment is an

aspect of a person's right to bodily integrity under Article 40, s. 3 of the Constitution" (In re a Ward of Court [1996] 2 IR 79 at 156, Denham J.).

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• The Supreme Court in the same case made it clear that:– "If medical treatment is given without consent it may

trespass against the person in civil law, a battery in criminal law and a breach of the individual's constitutional rights" (ibid).

• Thus, before undertaking medical treatment of any sort whatsoever, a healthcare professional must obtain the consent of the patient.

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• Legal requirements: focus on disclosure and comprehension. Influenced by risk management, litigation fears, avoidance of harm, protection of rights.

• Moral elements: •From the moral viewpoint informed consent is more

concerned with the choices of the patient and maintaining trust in the doctor-patient relationship. Legal consent is concerned with protecting bodily integrity, avoiding injury and risk.

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• For consent to be valid a patient must have – capacity– it must be voluntarily given, – there should be no duress – Information regarding risks, benefits, side-effects

and alternatives must be given so that the patient is able to make an informed decision as to whether or not to proceed with treatment.

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• Five elements are crucial in the concept of informed consent:– Disclosure– Comprehension– Voluntariness– Competence– Agreement.

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Central issues for consent

• Is the person competent

• Is the consent voluntary

• Is it adequately informed

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Capacity

• Patient must be able to communicate their choice.

• Capacity is decision-specific.– A patient should not be regarded as

lacking capacity merely because they do not take their doctors advice or make a decision that would ordinarily be regarded as imprudent

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Consent and Law• ECHR

– Forced treatment against wishes would breach a person’s rights under article 3 not to be subjected inter alia to ‘inhuman and degrading treatment’

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Constitution

Article 40.3.2 of the Irish Constitution states: -

“The State shall, in particular, by its laws protect as best it may from unjust attack and, in the case of injustice done, vindicate the life, person, good name and property rights of every citizen”.

THIS MEANS THAT Each of us has a right to have our bodily integrity protected against invasion by others.

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Schloendorff v Society of New York Hospital (1914) – Justice Cardozo

• “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 patient’s consent commits an assault for which he is liable in damages.”

• Right to self determination includes right to refuse treatment or select an alternative.

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The consequences of an unauthorised and unjustified invasion of bodily integrity include: -

• Civil claims for compensation

• Criminal liability for battery (unlikely except in cases of non consensual touching by a clinician)

• Investigation for alleged misconduct by professional regulatory body

Consequences

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The Law Reform Commission in its report into Vulnerable Adults and the Law (2006) states that the informed consent requires the following elements to be satisfied: -

• Prior disclosure of sufficient relevant information by the medical practitioner to the patient to enable an

informed decision to be made about the treatment

• Given by a person with the necessary capacity at the time to decide whether or not to consent to the

proposed treatment

• In a context which allows the patient to voluntarily make a decision as to whether to consent or decline the proposed treatment

Valid Consent

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Types of consent

• Express– Patient explicitly agrees to what is proposed by

doctor

– Brushett v Cowan (Newfoundland CA)• Muscle and Bone bx• Alleged no consent for bone bx• Held-bone bx was part of the ongoing investigation –

fell within express consent given.

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– Pridham v Nash • Exploratory laparoscopic procedure• Adhesions lysed• Consent to investigative procedure• Lysis found to be necessary, additional,

curative procedure

– Person must be informed in broad terms of the nature of the intended procedure.

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Types of consent

• Implied– Implied consent becomes a form of estoppel

whereby a patient, although he did not actually agree to an intervention, is estopped from denying he did so.

– Actions speak louder than words• If a person opens their mouth and sticks out their

tongue, they can’t complain if a doctor depresses tongue with a spatula.

• O’Brien v Cunard SS Co (1891)– Small pox vaccination

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Implied Consent

• While implied consent is one possible justification for an intervention it is not necessarily the most appropriate.

• Doctor’s justification for treating an unconscious patient must rest in the doctrine of necessity recognised by HoL in Re F (1990)

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INFORMED CONSENT –Express or Implied

• Patients must be allowed to decide whether they agree to a proposed treatment even if a refusal will lead to their harm. Similarly, patients must be allowed to withdraw consent to treatment at any time.

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INFORMED CONSENT –Exceptions to the Rule

• It is generally acknowledged that there are two exceptions to the common law rule:– Therapeutic Privilege - this arises where the failure of the

doctor to disclose is justified in the interest of the psychological wellbeing of the patient. This limited disclosure should be a very rare event and that the reasons not to disclose should be recorded in the patient's notes.

• The mere fact that the patient might become upset by hearing the information, or might refuse treatment, is not sufficient to act as a justification for nondisclosure of information.

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– Emergency - in an emergency life-threatening situation where the patient is unable to consent or to appreciate what is required a healthcare professional, acting in the best interests of the patient, may administer the necessary medical treatment to save the life or preserve the health of the patient without formal consent.

– However, the treatment given should be only that which is immediately necessary for the patient's well being. If some coincidental and non-urgent problem is encountered during an emergency procedure it should not be dealt with until consent can be obtained at a later time.

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Imposing medical treatment without consent may be permissible in exceptional circumstances, such as: -

• To save life in an emergency, where the patient’s wishes are not known.

• Where the patient is in an irrational state because of impaired consciousness.

• Where the patient has a highly infectious and dangerous disease and treatment is the only means of avoiding spread of the disease.

EXCEPTIONS

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Medical treatment should not be given without the informed consent of the patient or patient’s proxy.

Acting from necessity may legitimise an otherwise wrongful act. The court will examine whether the benefit anticipated by the clinical intervention outweighed the consequences of adhering strictly to the law.

Treatment permissible in such circumstance is limited to that necessary for the immediate survival and well-being of the patient.

Defence of Necessity

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Marshall v Curry (1933) 3 DLR 260

The plaintiff claimed damages when a surgeon removed a testicle during agreed surgery for a hernia repair. The surgeon argued that the testicle was diseased and its removal was necessary to safeguard the plaintiff’s health. The Court found that removal was necessary and it would have been unreasonable to put off the surgery.

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The plaintiff consented to the removal and replacement of a leaking breast implant. During surgery a more serious condition was diagnosed and the surgeon performed a subcutaneous mastectomy.

The Court found: -

• The plaintiff had not consented to the second procedure

• If asked to do so, she would not have given her consent

She was awarded compensation notwithstanding the court found she would have needed to undergo the surgery at some stage.

Williamson v East London & City Health Authority (1998) 41 BMLR 85

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An adult (age 18 and over) of sound mind has the absolute right to give or refuse consent to medical treatment even if it may result in death.

R v Ward of Court (Witholding Medical Treatment)

(No 2) (1996) 2 IR 79

“Medical treatment may not be given to an adult of full capacity without his or her consent”

Consent to Treatment

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Having mental capacity means that a person is able to make their own decisions, namely: -

• Understand the information given to him or her

• Retain that information long enough to be able to make a decision

• Weigh up the information available to make the decision

• Communicate his or her decision

Mental Capacity

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In Re a Ward of Court (witholding consent to treatment) (No. 2) (1996) 2 IR 79

Denham J

“The loss by an individual of his or her mental capacity does not result in any diminution of his or her personal rights recognised by the Constitution, including the right to life, the right to bodily integrity, the right to privacy, including self-determination and the right to refuse care or treatment”.

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Everyone aged 18 and over is presumed to be competent to give consent for themselves unless the opposite is demonstrated.

Medical treatment may not be given to an adult of full capacity without his or her consent. No one can consent or refuse consent on behalf of a competent adult patient.

A competent adult, in anticipation of future incapacity may give another competent adult an enduring power of attorney to include the making of decisions with regard to healthcare.

Legal Capacity: Adults

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In practice, the views of next-of-kin/family members are often taken into account by clinicians, but their overriding guiding principle is to act in the best interests of their patient.

Where conflict or doubt arises an application to make the patient a ward of court should be made. If the patient is made a ward of court, all decisions about medical treatment are made by the President of the High Court.

The one exception is emergency treatment to preserve life.

Legal Capacity: Adults

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Legal Capacity: Adults

In Re a Ward of Court (witholding consent to treatment) (No. 2) (1996) 2 IR 79

Denham J

“The family’s view as to the care and welfare of its members carries a special weight. A court should be slow to disagree with a family decision as to the care of one of its number if that decision has been reached bona fides…it is a factor to which the court should give considerable weight”.

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Adults with Intellectual Disability• The Law Reform Commission has

recommended the enactment of capacity legislation, which would make provision for substitute and assisted decision-making structures in the event an adult is deemed to lack capacity.

• The position in Ireland with regard to consent to treatment of adults who lack capacity is grey and undecided.

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Adults with Intellectual Disability• However, the following practices have evolved over

the years:– If the person's mental condition or disability is such that it

does not impair his/her ability to understand the nature, purpose and effect of the proposed treatment/procedure, then he/she can consent (or decline) to it.

– If a patient lacks capacity consideration needs to be given as to whether they are likely to regain capacity in the near future (e.g. regain consciousness). If this is likely then treatment can be delayed until that time, provided it is safe to do so.

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• If the person's mental condition is such that he/she is unable to comprehend the proposed treatment/procedure and every effort has been pursued to make that information accessible to that person, then the practice in this country has been to obtain the consent of the next of kin.

• While it may be the practice, there is, in fact, no legal or common law basis.

• Common law has made It clear that no one can express consent on behalf of the adult patient.

• The relatives should be included in the decision making process.• The ideal situation is for the decision to reflect a consensus view

between the healthcare professional and those closest to the patient.• It is only the best interests of the patient that are relevant and not the

interests of other parties.

Adults with Intellectual DisabilityAdults with Intellectual Disability

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Patients with Mental Disorders

• There is no legislation in Ireland governing consent to treatment of adults with mental disorders.*

• Accordingly, Common Law principles apply.– To treat such adults for their mental disorder without

obtaining their consent is unlawful unless it is an emergency and/or life-threatening situation.

• When dealing with such a category of vulnerable persons and with all persons, doctors must always act reasonably in the best interests of the patient.

• This should include a consideration of alternatives (if any) and/or less invasive procedures to the one proposed.

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The courts distinguish between giving and failing or refusing to give consent.

In re R (a minor) (Wardship: Consent to Treatment) (1991) 4 All E.R. 177

Lord Donaldson MR held that the failure or refusal of a Gillick competent child to consent is a very important factor in the doctor’s decision whether or not to treat, but does not prevent the necessary consent being obtained from another competent source.

The minor’s refusal could be disregarded if a parent gave consent.

Legal Capacity: Minors

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Children - Ireland

• Doctors must be familiar with the recent legislation covering the treatment of children.

• Section 23 of the Non-Fatal Offences against the Person Act, 1997 provides that a minor who has attained the age of 16 years can consent to surgical, medical or dental treatment.

• Under Subsection 3 of Section 23, practitioners can still proceed as formerly on the parents' consent.

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Who can obtain Consent from Patients or Guardians?

• Permitting junior doctors to obtain informed consent can lead to problems.

• Junior doctors may not have the necessary knowledge or experience to be in a position to explain the options available for treating the condition in question, the likely outcome and the risks attached to each one.

• Someone suitably qualified or experienced to understand the proposed treatment and risks involved should secure consent.

• Healthcare professionals have an obligation not to delegate responsibility for securing consent to someone they know or suspect to be under-qualified for the task.

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CommunicationIssues a Prudent Doctor might Address – in Simple Language – when taking Consent to Treatment: -

• Explain the diagnosis

• Identify the main treatment options

• What are the benefits of each option?

• What are the risks associated with each option?

• Success rates – both personal and nationally

• Why is a particular option being recommended

• What is likely to happen if the patient chooses to do nothing?

• How will the treatment affect the patient and for how long?

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Communciation - Consent Issues

WHEN?

Give the patient as much time as possible to consider all options and ask questions.

Taking consent to an elective procedure on the morning of same is frowned upon by the courts.

WHERE?

Somewhere private where the patient will not be anxious about other patients overhearing the conversation.

BY WHOM?

Let the seniority of the clinician performing the procedure act as a guideline.

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• Prepare explanatory leaflets about the procedure

• Record in the chart all communications about the proposed treatment and advices given

• Pay particular attention to the consent form and elaborate on advices given

Document All Communications

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Information

Chester v Afshar (2005) AC 134 (HL) 143

Lord Steyn stated: -

“A rule requiring a doctor to abstain from performing an operation without the informed consent of the patient serves two purposes. It tends to avoid the occurrence of the particular physical injury the risk of which a patient is not prepared to accept. It also ensures that due respect is given to the autonomy and dignity of each patient”.

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Withholding information• A patient may wish not to participate in the

decision making process concerning their treatment or care.

• If such a situation occurs the patient, if willing, should be asked to sign a waiver stating that he/she does not wish to discuss the matter following advice being offered.

• If the patient does not sign a waiver then their request not to be given additional information should be recorded in the patient's record.

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What Patients should be told• Information which the patient needs to know

before deciding whether or not to consent to treatment:– Details of the diagnosis and prognosis, and the

likely prognosis if the condition is left untreated.– Uncertainties about the diagnosis including

options for further investigation prior to treatment.

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• The purpose of a proposed investigation or treatment;• details of the procedures or therapies involved, including

subsidiary treatment such as methods of pain relief, and how the patient should prepare for the procedure.

• Explanations of the likely benefits and the probabilities of success and a discussion of any serious or frequently occurring risks* and of any lifestyle changes which may be caused by, or necessitated by, the treatment.

• Advice about whether a proposed treatment is experimental.

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• How and when the patient's condition and any side effects will be monitored or re-assessed.

• A reminder that patients can change their minds about a decision at any time and that they always have the right to a second opinion.

• Give the name of the doctor who will have the overall responsibility for the patient and explain, where appropriate, that no guarantee about who will carry out the procedure can be given.

• Where applicable, details of costs or charges which the patient may have to meet.

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• Be aware of the distinction, which the Courts have made in recent years in elective and non-elective surgery.

• In the case of elective surgery the duty to disclose information to the patient is much more onerous, particularly where there may be serious or material risks associated with the proposed procedure.

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Irish Case Law on Disclosure

– Test case: Dunne v National Maternity Hospital [1989] Finding of negligence. (Woman with twins. One died, other developed cerebral palsy.)

– Supreme Court held that to establish negligence the plaintiff would have to prove that the defendant doctor had been…

• “guilty of such failure as no medical practitioner of equal specialist or general status and skill would be guilty of if acting with ordinary care.”

• Endorsing the ‘professional practice’ standard. But court did not accept Bolam test completely: also held that the doctor would not be protected if there were defects in the practice that would be obvious to anyone giving it due consideration.

• Walsh v Family Planning Services [1992] Disclosing the risks inherent in a vasectomy.

• Unanimous view of all the judges: elective as opposed to therapeutic procedures should be subject to more rigorous disclosure standards. Patients should be warned of even remote risks.

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Geoghegan v Harris [2000] – negligence in carrying out dental implant.• Patient said he would not have had procedure even if there

was only a 0.1% chance of nerve damage. But judge adopted the reasonable patient standard – since he was keen to have the procedure it seems reasonable to conclude that given the very small risk and the great benefit a reasonable person would have consented.

• Importance of this case: the doctor must give warning of material risk. For elective surgery this means even remote risk (statistics are irrelevant). Moving in direction of greater legal recognition of patient autonomy (at least in elective area).

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Fitzpatrick vs White [2007] Informed ConsentThe Reasonable Patient Test

• Facts of the case:– Mr. Fitzpatrick was appealing an earlier High

Court decision by White J. – The plaintiff in the instant case suffered eye

muscle slippage and subsequent double vision following a cosmetic operation to relieve a long-standing convergent squint in the Royal Victoria Eye and Ear Hospital in 1994.

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Kearns J:

• In his judgement Kearns J elaborated on three legal principles;

• a) the obligation to warn, • b) the content of the warning and • c) the timing of the warning.

– Only the final principle was actually applicable to the appeal decision, but Kearns J clarified the Irish legal situation in relation to the standard of care to be exercised by doctors in giving warnings of proposed treatments.

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Kearns J

…the patient has the right to know and the practitioner a duty to advise of all material risks associated with a proposed form of treatment…Materiality includes consideration of both (a) severity of the consequence and (b) statistical frequency of the risk…The reasonable man, entitled as he must be to full information of material risks, does not have impossible expectations nor does he seek to impose impossible standards.

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Mr. Justice Kearns found that the plaintiff should have been informed of the risk of neuropathic pain. Accordingly, he had not given his informed consent to the surgery.

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He then went on to decide whether, as argued by the plaintiff, he would not have undergone the surgery had he been made aware of this risk. Two tests were applied: -

(1)Objective

He found that a reasonable patient, looking objectively at all the circumstances of the plaintiff, on the balance of probabilities, would have undergone the surgery.

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(2) Subjective

When he examined the particular features of this case, he found that the plaintiff had long been embarrassed by the state of his teeth and would have assumed the less than 1% risk of developing neuropathic pain, for the benefit of having much improved teeth.

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Battery

• Person need not suffer harm to recover damages in battery

• Harm is assumed – as the tort protects from symbolic harm as well as that which results in injury

• Battery may be committed even if doctor acts in patient’s best interests

• Elements required:– Intentional, unlawful touching

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Examples

• Mohr v Williams (Minnesota) – [ear surgery]

• Re. F(mental patient: sterilisation) – Lord Goff– Principle of necessity

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Necessity• Where no one is capable of giving

consent for an adult patient who does not have the capacity to give consent himself for whatever reason, Lord Goff in Re F. seized upon the fact that:-

• "There exists in the common law a principle of necessity which may justify action which

would otherwise be unlawful ..." p. 74 A.

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Necessity• The basic requirements,

applicable to such a case of necessity, are that to fall within the principle:-

• "... not only – must there be a necessity to act when it

is not practicable to communicate with the assisted person, but also

– the action taken must be such as a reasonable person would in all the circumstances take, acting in the best interests of the assisted person", p. 75H.

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• Battery does not require proof of causation.

• Burden of proof rests on the defendant to prove consent was valid.

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3 broad categories where patient can be misled:

• What is being done

• Who is doing it

• Risks and consequences of the conduct

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Appleton v Garrett (1995)34 BMLR 23(QBD)What is being done…

• Dentist struck off for gross over treatment

• Withheld information in bad faith• Altered charts

– Recording fillings where he previously noted caries free teeth

• Held: none of the claimants consented• They agreed to therapeutic intervention but got

something quite different

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R v Maurantonio (1967) 65 DLR 2d672 (Ontario CA) Who is doing it…

• If deception causes misunderstanding as to the nature of the act –consent is vitiated

• Maurantonio was not medically qualified, so the nature of consent was altered

• R v Tabassum (2000)2Cr App R 328– Where the identity of the person affects the

understanding of what is being done the patient who misunderstands does not validly consent.

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R v Richardson (1998) 42 BMLR 21 (CA)

• Dentist suspended from practicing• Treated patients without complaint from them• Her failure to inform could lead to a civil claim for

damages but is not the basis for criminal liability

• Patients agreed to dental work and that is precisely what they got – consent valid.

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Voluntariness

• Forced treatment

– Compulsory vaccination

– Removing bullets needed for evidence

– Sedating inmates of hospital to protect other patients/staff

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Re T [1992] 4 All ER 649 [1992] 9 BMLR 46 (CA)

• 34yo female – pregnant, pneumonia

• Mother JW

• Refusal of blood transfusion

• Held: overturned refusal of consent due to undue pressure from mother

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Advance Care Directives

• An "advance directive" or "living will" involves a patient specifying in advance how they would like to be treated in the case of future incapacity.

• Now recognised in the English courts there is no legislation or case law in Ireland, which has considered advanced care directives and therefore no indication of the extent, if any, to which they would be legally recognised. – Give valuable evidence of the patient's prior wishes and could be

taken into consideration, together with any evidence available from other sources, such as close relatives, when deciding on treatment.

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Provision for Patients of Differing Cultures and Language

• These patients must receive the appropriate written and oral information they need in order to make a rational decision.

• Provision must also be made for staff to communicate appropriately with patients.

• Interpreters must be informed of the obligation of confidentiality and if deemed necessary and desirable be asked to sign a confidentiality agreement.

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Suggested Reading

• Medical Law– Ian Kennedy and Andrew Grubb

• Law and Medical Ethics– Mason, McCall Smith, Laurie

• Medicine Ethics and the Law – Deirdre Madden