Philip Fennell Professor of Law Cardiff Law School Consent to treatment Philip Fennell Professor of Law Cardiff Law School

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

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)

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.

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.

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.

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.

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?

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

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.

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.

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.

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

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.

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.

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.

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.

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).

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).

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.

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.

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)).

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.

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.

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)).

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.

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.

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.

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

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.

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)

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.

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.

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

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

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.

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

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

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.

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]."

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.

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.

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

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)

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.

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.

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.

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

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.

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

Developments since Pearce Birch v University College Hospital NHS Foundation Trust [2008] EWHC 2237 Cranston J my view is that in the special circumstances of Mrs Birch’s case the hospital should have discussed with her the different imaging methods catheter angiography and MRI and the comparative risks. Had it done so Mrs Birch would have declined cerebral catheter angiogram and thus avoided her stroke. Given that Mrs Birch was known to be a diabetic, and this more likely to develop complications and that the chances of an aneurism were low, catheter angiography had risks outweighing the benefits

Developments since Pearce Para 74 In my judgment there will be circumstances where consistently with Lord Woolf’s statement in Pearce, the duty to inform the patient of significant risks will not be discharged unless she is made aware that fewer or no risks, are associated with another procedure. In other words, unless the patient is informed of the comparative risks of different procedures she will not be in a position to give her fully informed consent to one procedure rather than another. In my judgment, in the special circumstances of Mrs Birch’s case, that duty arose

The Doctor’s 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...

The Doctor’s 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 patient’s 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.

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.

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

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.

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.

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.

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 (1% - 2%) Patient suffered paralysis. The Court of Appeal held that the 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.

Chester v Afshar House of Lords The House of Lords held by a 3-2 majority that the defendant had been negligent in informing the patient of the risk of paralysis, and that the claimant was entitled to damages even though that failure to inform had not, on a strict application of the but for test resulted in the injuries suffered by the patient. Doctrine of informed consent given priority over the rules of causation.

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.

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.

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

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

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

12 Key points on Consent 9. Consent can be written, oral or non-verbal 10. Competent adult patients entitled to refuse treatment even where it would clearly benefit their health

12 Key points on Consent 11. No-one can give consent on behalf of an incompetent adult – the decision for doctor acting in patient’s best interests. Unless the power to consent has been conferred under the MCA 2005 on a donee under a Lasting Power of Attorney, a deputy appointed by the Court of Protection, or the Court of Protection consents

12 Key points on Consent 12. Advance decision by a competent patient is valid and applicable if it was made by the patient when capable, is clear and specific about which treatments are being refused, and is sufficient in scope to cover the situation which has currently arisen. If life sustaining treatment is to be refused by advance decision the decision must be in writing.