Medical Law Consent, Battery: Information and Voluntariness

1. Medical Law Consent, Battery: Information and Voluntariness • Prof Orla Sheils • Department of Histopathology • TCD

2. 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

3. 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

4. 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.

5. 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’

6. Issues of consent • Crime of battery • Tort of battery • Tort of negligence

7. 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.

8. 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. • 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.

9. 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.

10. 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.).

11. 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.

12. 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.

13. 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.

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

15. Central issues for consent • Is the person competent • Is the consent voluntary • Is it adequately informed

16. 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

17. 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.

18. 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.

19. 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

20. 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)

21. 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.

22. 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.

23. 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 welt 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.

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

29. 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.

30. 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.

31. 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).

32. Fitzpatrick vs White [2007] • 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.

33. 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.

34. 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. • He does not invoke only the wisdom of hindsight if things go wrong. • He must be taken as needing medical practitioners to deliver on their medical expertise without excessive restraint or gross limitation on their ability to do so.

35. Children • 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.

36. 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.

37. 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.

38. Adults with Intellectual Disability • 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.

39. 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.

40. 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.

41. 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.

42. 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

43. Examples • Mohr v Williams (Minnesota) • [ear surgery] • Re. F(mental patient: sterilisation) – Lord Goff • Principle of necessity

44. 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.

45. 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.

46. Battery does not require proof of causation. • Burden of proof rests on the defendant to prove consent was valid.

47. 3 broad categories where patient can be misled: • What is being done • Who is doing it • Risks and consequences of the conduct

48. 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

49. 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.

50. 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.