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 • 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_400675 • The Mental Capacity Act (MCA) 2005 • The MCA Code of Practice

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 (2008, para 23.31)

4. 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.

5. 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.

6. 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.

7. 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.

8. 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?

9. 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

10. 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.

11. 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.

12. 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.

13. Human Rights Act and Consent • Article 3 No-one shall be subjected to torture or to inhuman and degrading treatment.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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).

19. 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).

20. 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.

21. 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.

22. 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)).

23. 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.

24. Mental Capacity Act 2005 • 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.

25. 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)).

26. 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.

27. 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.

28. 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.

29. 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

30. 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.

31. 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)

32. 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.

33. 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.

34. 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

35. 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

36. 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.

37. 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

38. 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

39. 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.

40. 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]."

41. 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.

42. 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.

43. 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

44. 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)

45. 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.

46. Sidaway v. Bethlem Royal Hospital [1985] 1 All ER 643 • if a body of medical opinion would not disclose 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.

47. 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.

48. 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

49. 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.

50. 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