Legal aspects of consent

Transcription

1 BJU International (2000), 86, 275±279 Legal aspects of consent B. JONES Our Lady of Lourdes Hospital, Drogheda, Louth, Ireland Introduction Consent, as developed through the common law over the last 3±4 decades, has become a central component of medical jurisprudence. The advice of Hippocrates: `perform these duties calmly and adroitly, concealing most things from the patient while you are attending to him. Give necessary orders with cheerfulness and sincerity, turning his attention away from what is being done to him; sometimes ¼¼ sharply and emphatically, and sometimes comfort with solicitude and attention revealing nothing of the patients future or present condition hold no legal status. Rather this has been replaced by the concept espoused by Judge Cardozo: `every human being of adult years and sound mind has a right to determine what shall be done with his own body; when a Surgeon performs an operation without his patients consent, he commits an assault for which he is liable in damages [1]. This concept has been approved in the House of Lords [2]. The Canadian Courts have also approved this [3], where Judge Robins stated that `a competent adult is generally entitled to reject a speci c treatment or all treatment or to select an alternate form of treatment even if the decision may entail risks as serious as death and may appear mistaken in the eyes of the medical profession or the community. Battery vs negligence Traditionally, the importance of consent was to protect the doctor against an allegation of battery. Battery is de ned by Fleming [4] as: `intentionally bringing about a harmful or offensive contact with the person or another. This suggests that for a battery to be committed there must be hostile or harmful intent on the part of the actor. In most medical cases the intent would not be hostile or harmful. It is generally recommended by the judiciary that cases involving consent or the lack of it should go to negligence rather than battery. `Unless there has been misrepresentation or fraud to secure consent to the treatment, a failure to disclose the attendant risks, however serious, should go to negligence rather than battery [5]. This has been approved in the English courts [6]; Judge Hirst said `I should respectfully add that I agree with Bristow J. in deploring reliance on these torts of (assault and battery) in medical cases of this kind; the proper cause of action, if any, is in negligence. There are several advantages from the plaintiffs perspective in pursuing the issue of consent through the tort of battery. First, unlike negligence it is not necessary to prove damage. To succeed through negligence it is necessary for the plaintiff to prove duty of care, standard of care, causation and damage. To succeed through the tort of battery it is simply necessary to show that contact or touching occurred without proper authorization. Another advantage lies in the level of disclosure required for the consent to be valid. The Bolam test (see Corcoran, page 280) has been applied to the level of disclosure necessary for consent to be valid [2], albeit with some reservations. In other words, the level of disclosure required would be that approved of by a body of reasonable like-quali ed doctors. Consequently, where the issue of consent is pursued through negligence, it is necessary for the plaintiff to adduce expert opinion supporting their case. Where the case is pursued as a battery this is not necessary. Nevertheless, it is generally believed that in the absence of hostile intent or fraudulent representation, the issue of consent in general should be restricted to the area of negligence. However, fraud could apply to a situation where a surgeon incorrectly represents an operation to a patient as being essential and necessary, where the surgeon gains nancially by performing that operation. The Crown Indemnity Scheme is expressly restricted to claims in negligence. Although it possibly could be interpreted to also cover a technical battery, it certainly does not extend to either a crime or tort of battery where hostile or fraudulent intent was demonstrated. Ironically, this fact is a signi cant incentive to plaintiffs to pursue the issue through negligence when seeking damages in tort; it is normal for the plaintiff to pursue the defendants with the `deepest purse. In general the purse of the medical insurance companies is deeper than that of most urologists. Indeed, actions for battery against doctors are relatively rare in the UK and Ireland, and are usually con ned to fairly obvious situations such as tubal ligation without consent during a Caesarean section [7]. Elements of consent There are three key elements of consent, i.e. competence, that it is voluntary and that the patient is informed. The # 2000 BJU International 275

2 276 B. JONES court has to be satis ed that these three elements are present for a consent to be valid. Both express and implied consent are a frequent source of confusion. Consent is similar to a contract; the latter may be oral or written, as may consent. That a patient has signed a consent form, regardless of how explicit or detailed it may be, does not guarantee consent. The consent form is merely documentary evidence which can be rebutted in a court of law. The actuality of consent is based on the understanding present between the doctor and the patient at the time. There is no requirement in law for consent to be presented in written form. Equally there is no xed format to which a consent form must adhere. `I should add that getting the patient to sign a pro-forma expressing consent to undergo the operation, "the effect and nature of which has been explained to me" was done here in each case, should be a valuable reminder to everyone of the need for explanation and consent. It would be no defence to an action based on trespass to the person if no explanation had in fact been given. Consent would have been expressed in form only and not in reality. Judge Bristow, in [8] It was held in Bruchett v Cowan [9] on appeal that the trial judge had erred on looking exclusively to the signed consent form, having no regard to all other factors in deciding whether consent was present or not. Even though consent may be held valid in the absence of a consent form, in normal hospital practice, simple logistics dictate that a consent form be preserved as documentary evidence that the issue of consent was discussed. The precise legal status of implied consent is not entirely clear. There is a point of view that subscribes to the idea that consent can be implied from a patients actions and conduct. This is probably true to a point. Certainly, the logistics of normal clinical activity dictate that in certain areas consent can be implied. For instance, consent to a standard abdominal examination can be implied when a patient presents himself/herself to a doctor complaining of abdominal pain. However, the opinion of Fleming [4] that `actions often speak louder than words; holding ones bare arm to a doctor at a vaccination point is as clear an assent as if it were expressed in words, would not win universal approval; this view is overstating the situation, speci cally in the case of vaccination, where there are possible rare complications, which would require express consent, although not necessarily in written form. Fleming compares the situation to that of Volente, i.e. the voluntary assumption of risk that occurs where people participate in violent sports [4]. Again, this is inaccurate because in most situations where Volente applies, the participants are aware of the risks. One clear situation where implied consent would be valid is also covered by the Doctrine of Necessity, e.g. where an unexpected serious or life-threatening complication arises in the course of an operation. Disclosure A common concern among doctors is how much need be disclosed to the patient for the consent to be informed and therefore valid. In Sidaway v Bethlem Royal Hospital Governors [2] the Bolam test was applied to the duty of disclosure. Lord Scarman stated that the duty of disclosure should be con ned to material risk but that failure to disclose material risk will not necessarily render the doctor liable if he/she was of the opinion that disclosure of such risks would be detrimental to the patients health. The Bolam test as applied to Sidaway means that a doctor who fails to disclose certain material risks will not be found negligent if it can be shown that a responsible body of similarly quali ed specialists would have acted likewise in similar circumstances. However, this was modi ed somewhat in Bolitho v City and Hackney Health Authority [10], where Judge Brown Wilkinson held that `in a rare case it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible¼¼ it would very seldom be right for a Judge to reach the conclusion that views genuinely held by a competent medical expert are unreasonable¼.it is only where a Judge can be satis ed that the body of expert opinion can not be logically supported at all, that such opinion will not provide the benchmark by reference to which the defendants conduct falls to be assessed. In an Irish case [11] it was held that the extent of disclosure must `as a matter of common sense vary with what might be described as the elective nature of the surgery concerned. In the same case, Judge OFlaherty stated `where there is a question of elective surgery which is not essential to health or bodily well-being, if there is a risk - however exceptional or remote - of grave consequences involving severe pain stretching for an appreciable time into the future and involving the possibility of further operative procedure, the exercise of the duty of care owed by the defendants requires that such possible consequences be explained in the clearest language to the plaintiff. The document formulated by the Australian Law Reform Commission [12] examines this area lucidly. The factors they recommend be taken into account include: the personality of the patient their intelligence, the temperament of the patient whether the patient wants the information; refusing information is on one hand an exercise of the patients

3 CONSENT 277 autonomy, nevertheless a doctor still has a duty in this type of situation to disclose basic information with reasonable care and judgement. whether the patient asks questions; clearly these questions should be answered. the patients level of understanding; it is not the duty of the doctor to cross-examine the patient, to ensure that each and every point is fully understood, rather in the doctors judgement a reasonable understanding has been achieved. the nature of the treatment; the more drastic the treatment, the more information is required. However, the degree of urgency reduces the extent of disclosure required. Clearly nonessential cosmetic surgery requires a higher degree of disclosure than potentially life-saving cancer surgery. the magnitude of possible harm; this applies particularly to serious and speci c adverse effects. the likelihood of the risk; there is a greater obligation to discuss more frequent adverse effects than rare ones. In predicting risk an honest estimation from experience should be given rather than quoting the results of a world authority from the literature. It is probably unnecessary to discuss adverse effects that can only occur through negligent practice. For instance, for TURP in a standard benign setting, it is probably not necessary to advise the patient of the risk of external sphincter damage. An inevitable part of disclosure is that the patient requires some understanding of the natural history of the condition being treated, i.e. what is likely to happen if no treatment is instigated. Equally well the patient should be aware of legitimate alternative treatments to the one being proposed. The doctor need only be aware of reasonable mainstream alternatives. There is no duty on the doctor to be conversant with unusual `alternative treatments. Again, the Bolam test of reasonableness applies here; in the Canadian case of Haughian v Paine [13] it was held that the failure to advise a patient that a more conservative treatment option was available was a breach of the doctors duty. In Truman v Thomas [14] it was held that explaining the natural history of the disease if left untreated was part of the disclosure process. Capacity For consent to be valid the patient must have capacity to consent. Capacity comprises status, which normally refers to age, and understanding or mental competence. Status The Family Law Reform Act of 1969, which changed the age of majority in the UK from 21 to 18 years, also stated that the age of majority was not relevant when determining capacity to consent to medical treatment. Section 8 (1) of this act states that, `the consent of a minor, who has attained the age of 16 years, to any surgical, medical or dental treatment which in the absence of consent would constitute a trespass to his person which will be as effective, as it would be if he were of full age; and where a minor has by virtue of this section given an effective consent to any treatment, it shall not be necessary to obtain any consent for it from his parent or guardian. Section 8 (2) of the same act expands the terms surgical, medical or dental treatment to include procedures undertaken for the purpose of diagnosis, i.e. nontherapeutic procedures. However, this does not necessarily include nontherapeutic procedures that have no bene t to the health and well-being of the person. It would not for instance include organ donation. The law in Scotland is covered by The Age of Legal Capacity (Scotland) Act This differs signi cantly in its wording. Section 2(4) states `that children under 16 years may consent to any surgical, medical or dental procedure or treatment. In the Republic of Ireland the law is covered by The Non-fatal Offences Against a Person Act 1997, Section 23 which states, `the consent of a minor who has attained the age of 16 years to any surgical, medical or dental treatment which in the absence of consent would constitute a trespass to his/her person shall be as effective as it would be if he/she were of full age; and where the minor has by virtue of this section given an effective consent to any treatment, it shall not be necessary to obtain any consent from his/her parent or guardian. The status of persons under the age of 16 is not provided for by statute. The leading case on the matter is Gillick v West Norfolk & Wisbech AHA [15]. It is regrettable that both the Scottish and Irish Statutes which postdated this case failed to address this situation. Gillick is considered good law in the UK but has not been considered in signi cant detail by the Irish courts. In this case, Mrs. Gillick sought a declaration that the giving of contraceptive advice and treatment to a girl under the age of 16 years without parental consent was unlawful. The Court of Appeal agreed with Mrs. Gillick stating, `that as a matter of law, a girl under the age of 16 years can give no valid consent to anything in the areas under consideration which apart from consent would constitute an assault, whether civil or criminal, and can impose no valid prohibition on a doctor against seeking parental consent. I conclude further that any doctor who advises a girl under 16 years as to contraceptive steps to be taken or affords contraceptive or

4 278 B. JONES abortion treatment to such a girl without the knowledge and consent of her parent, save in an emergency, which would render consent in any event unnecessary, infringes the legal rights of the parent or guardian. Save in an emergency, it is proper course to seek parental consent or apply to the courts. Judge Fox [15]. This case was then taken to the House of Lords, which reversed the opinion of the Court of Appeal. Lord Frazer stated `providing the patient, whether a boy or a girl, is capable of understanding what is proposed and of expressing his/her own wishes, I can see no good reason for holding that he/she lacks the capacity to express them validly and effectively and to authorize the medical man/woman to make the examination or give the treatment which he advises. Lord Scarman, concurring, stated, `in the light of the foregoing I would hold that as a matter of law the parental right to determine whether a minor child below the age of 16 years will have medical treatment terminates if and when the child achieves a suf cient understanding and intelligence to enable him/her to understand fully what is proposed. It will be a question of fact whether a child seeking advice has suf cient understanding of what is involved to give a consent valid in law¼. Emergency, parental neglect, abandonment of the child or enability to nd the parent are examples of exceptional situations justifying the doctor proceeding to treat the child without parental knowledge and consent. Speci cally, the age group considered in Gillick is 14±16 years. Mentally disordered patients It is incorrect to assume that patients with psychotic illness are incompetent to give a valid consent. Skegg [16] stated, `the fact that a person is suffering from a mental disorder, as de ned in the Mental Health Act 1983, does not of itself preclude that person from giving a legally effective consent, whether the person is capable of doing so depends on whether the person can understand and come to a decision upon what is involved. Section 57(2) of the Mental Health Act 1983 states, `that a patient shall not be given any form of treatment ¼. unless he has consented to it and a Registered Medical Practitioner appointed for this purpose of this part of this act by the Secretary of State ¼. and two other persons appointed for the purpose of this paragraph¼¼. have certi ed in writing that the patient is capable of understanding the nature, purpose and likely effects of the treatment in question and has consented to it. Even patients who have been `sectioned under the Mental Health Act for the purposes of involuntary detention in a psychiatric hospital, plus involuntary treatment for the psychiatric illness, may still be deemed competent to consent or withhold consent to treatment for other conditions. In the case of Re C [17] a chronic schizophrenic detained in Broadmoor Prison refused consent to have a gangrenous right foot amputated. In addition, he sought an injunction to restrain doctors from amputating the leg without his expressed consent in the future. The court held that the patient C. comprehended and retained the relevant information and that he was able to understand the information and arrive at a choice. Consequently he was held to be competent to withhold his consent to this particular treatment. There are some psychiatric disorders where refusal of treatment is a speci c part of the condition. This applies particularly to anorexia nervosa and the refusal of nasogastric feeding. This was held in Re R. (a minor) [18]. Volition The third vital component of consent is that it must be given voluntarily. There should be no duress either on the part of the doctor or third parties, i.e. parents, etc. In the case of Re: T [19] a single mother in her 34th week of pregnancy was injured in a road traf c accident. Her mother was a Jehovahs Witness and the patient had lived with her mother until the age of 17 years. The medical opinion was that a Caesarian section was necessary and the likelihood of requiring a blood transfusion was high. Ms. T. made no comment on this possibility until after a visit from her mother. Directly after her mother left, Ms. T. announced that she would not accept a blood transfusion. Her father and boyfriend sought a declaration from the High Court to make blood transfusion lawful. This was granted and was subsequently upheld by the Court of Appeal. The rationale behind this was the fact that the overall condition of Ms. T. undermined her capacity to give valid consent. Furthermore, the situation was an emergency. Third, it was felt that the proximity of Ms. T.s refusal of blood transfusion to the visit of her mother suggested that undue in uence was brought about by her mother. Consequently, the withholding of consent was not voluntary. Third party consent Situations arise in clinical practice where patients cannot of themselves give valid consent. It should be clearly stated that where a genuine emergency exists and there is a danger to life or limb, that treatment ought to be administered in the absence of expressed consent. This applies to unconscious adults and to minors. It is governed by statute and by the doctrine of necessity. In the case of children, consent may be given by a parent or proxy. A parent who has parental responsi-

5 CONSENT 279 bility, as de ned by the Children Act 1989, may consent to medical treatment on behalf of the child where that child is considered incompetent. Also covered by this act are others who may acquire parental responsibility; consequently they can validly give consent. This includes local authorities such as health authorities, or under Section 3(5) `a person who does not have parental responsibility for a particular child but has care of the child, may subject to provisions of this Act do what is reasonable in all circumstances of the case for the purpose of safe-guarding or promoting the childs welfare. This would include teachers or child-minders. The principle remedies available where consent is not available for situation that is not an emergency or where consent is being withheld by a parent contrary to a clear medical imperative are threefold: To apply to the High Court to have the child made a ward of court. However, if the wardship of the court is granted, it is important to note that `no important step in the life of the child can be taken without the consent of the court [20] until such time that the wardship is revoked. To apply to the parens partriae inherent jurisdiction of the courts. Unlike wardship, the court will only apply this jurisdiction speci cally to the area in question, i.e. medical care. It will not apply to other important decisions in the childs life. A third option is to apply for a care order under the Children Act 1989, or in the Republic of Ireland the Child Care Act In this situation the local Health Authority will assume responsibility for the decision making about the childs health. This responsibility will persist until such time as the child attains competence or if it is demonstrated that the childs parents have become competent to act on behalf of the child. Conclusion The area of consent is one of the most important aspects of the law from the perspective of the medical practitioner [21]. Clearly over the years there has been a change in emphasis. Rather than complicating clinical practice, a properly developed understanding of consent can become a great facilitator. Lord Donaldson compared consent to `a legal ak jacket. It protects from claims by the litigious, and consequently will reduce the level of litigation. The concept of consent should move away from permission given by a patient to carry out a procedure (`they want to take out my kidney), towards a consensus or contract type situation (`having my kidney removed seems to give the best chance of being cured, will you do the operation?). The paternalistic approach to the doctor-patient relationship as espoused by Hippocrates, and which is still practised today, is now largely obsolete. It is not the duty of the doctor to protect his/her patient from worrying information. Rather the patient should be informed as clearly as possible of the facts that pertain to the patients condition, including the probable natural history of the disease if left untreated and the legitimate treatment alternatives that are available. This is the standard of care expected by Judges and increasingly so by patients. References 1 Schloenhoff v Society of New York Hospital. 211 NY125, Sidaway v Governors of Royal Bethlem Hospital. AC Malette v Shulman. 67DLR321 (Ont. CA) Fleming JG. Law of Torts. 8th edn. London: LBC Publishing, Reibl v Hughes. 114DLR(3d)1(CAN sup. CT) Hills v Potter. AER Hamilton v Birmingham RHB. 2BMJ Chatterton v Gerson. 1AER Bruchett v Cowan. 2MEDLR Bolitho v City and Hackney Health Authority. 4AER Walsh v Family Planning Services Ltd and others. IR Australian Law Reform Commission. Informed Decisions about Medical Procedures. Canberra: ALRC Haughian v Paine. 37DLR Truman v Thomas. 611P2D902 (Californian Supreme Court) Gillick v West Norfolk & Wisbech AHA. (1986) AC112 and (1985) 3AER Skegg PDG. Law, Ethics and Medicine. Oxford: Clarendon Press, Re C. NLJR Re R. (a minor) (Wardship: Medical Treatment). FAM11 [1991] 4AER Re: T. (an adult) (Refusal of Treatment. AER Re: D. (a minor) (Wardship: Sterilization). FAM Kennedy I, Grubb A. Medical Law: Text with Materials. 2nd edn. London: Butterworths, 1994 Author B. Jones, MCh, FRCSI, DipL, Consultant Urologist, Our Lady of Lourdes Hospital, Drogheda, Louth, Ireland.