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Medicine Law Consent to Medical Treatment PPQa. “The current law does not guarantee children under the age of 18 the right to refuse medical treatment yet it allows mature minors to consent to treatment without their parents’ knowledge.” Consider the current law. Is it fit for purpose? (finalist 201...

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Medicine Law 1. Consent to Medical Treatment PPQ a. “The current law does not guarantee children under the age of 18 the right to refuse medical treatment yet it allows mature minors to consent to treatment without their parents’ knowledge.” Consider the current law. Is it fit for purpose? (finalist 2018) b. Does English law pay sufficient regard to patients’ refusals of treatment, and to the needs of patients who seek further information about proposed treatment in order to decide whether or not to consent to it? (Formative)(also a ppq) c. Does the current law on consent do enough to protect a patient’s right to make an informed choice that will be respected by medical professionals? Explain your reasoning. - Demonstrated an understanding of the law of consent as it operates in medical practice. This would mean explaining when consent is required, why and what this looks like (capable patient, voluntary and informed) and the consequences of not having given good consent (for doctor: assault – both civil and criminal; for patient – possible loss of sense of autonomy and self-determination). - Unpick the arguments surrounding informed consent in particular and some of the challenges experienced in this area. To be considered good consent to avoid an action for trespass/assault, the consent needs to be informed in broad terms (Chatterton v Gerson) but this is a low standard. Any arguments that the medical professional has failed to disclose sufficient information beyond this low level are dealt with as issues of negligence (good students would unpick this policy decision as diverting informed consent decisions to matters of negligence rather than trespass is a pro-medical profession move which protects doctors from possible criminality in all but the most extreme cases and also means damage has to be established by the claimant – trespass actions are actionable per se without proof of loss). - Some areas would repay detailed consideration: for example, therapeutic privilege; the recent changes in judicial opinion since Sidaway which have led to a positioning of the patient in a central position, protecting their right to make an informed decision (Chester, Montgomery); the growing distrust of medical opinion; the growth of Dr Google and how this is managed. - Give an opinion whether the law is sufficiently robust or whether improvements could be made. - If the level of detail was very strong and the arguments very well-made, students could expect to achieve a mid- to high first class mark. If there were inaccuracies or omissions, the mark with fall. d. ‘The English law of consent to medical treatment clings to the belief that ‘doctor knows best’ and is designed to enable patients to be lawfully treated in accordance with medical advice, often against the express wishes of the patient.’ Discuss.

e. Has the law gone too far in imposing medical treatment on children against their wishes and in the face of objections from the parents? - Requires candidates to examine the existing law relating to the overriding of refusals of treatment by children and their parents, and the underlying principles of autonomy and paternalism. - It was also necessary to make a judgement about whether the law was justified or had gone too far, which by implication also required candidates to consider what alternative stances the law might take. - Good answers considered these issues in the light of medical ethics, philosophical principles and the right to private and family life f. If gender reassignment surgery is legal, should it also be lawful and if so in what circumstances, for medical professionals to perform amputations of healthy limbs where requests are made by fully informed, competent adults? (2015/2016nf) - a discussion of the principles of autonomy and informed consent which underpin the assumed legality of gender reassignment surgery or other requested operations. - The question is designed to test to what extent the law should respect consent or whether there should be limits in the interests of public policy or paternalism g. h. Notes -

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A decision made by a patient with capacity must be respected, even if it appears unwise or irrational (this is discussed in more detail in part two of this series). Although hospitals and other healthcare providers have a legal obligation to provide adequate care for their patients (Cassidy v Ministry of Health, 1951), patients do not generally have to accept any offer of treatment. Health professionals sometimes find it difficult to respect their patients’ rights to autonomy, and may feel frustrated by what they see as a foolish or reckless decision. They may also feel uncomfortable knowing that a failure to provide care may lead to liability in civil law (negligence) or a criminal charge of gross negligence manslaughter if the patient dies as a result. In the cases above, people’s right to choose whether and how their bodies are touched was considered. Lord Goff made the position clear in the case of Collins v Wilcock (1984) when he said: “The fundamental principle, plain and incontestable, is that every person’s body is inviolate.” This means that any unwanted touching, or putting someone in fear of unwanted touch, is usually unlawful. The giving of consent simply means that a person has communicated their agreement to something For health and mental healthcare professionals, assessing an individual's capacity to consent to treatment is a necessary, if generally implicit, part of every encounter. That is, treatment cannot be provided unless the patient or a legally authorized representative has given his/her valid informed consent. Although precise data on common practice are not available, formal assessment of healthcare decisional capacity probably arises most frequently when a person refuses recommended treatment. In other words, we suspect that in actual application, the issue of consent capacity tends to be discussed explicitly not so much in terms of capacity to consent but

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capacity to dissent/refuse treatment. But the absence of active consideration of consent capacity among those who are assenting to treatment is ethically problematic too. The latter is of particular concern in situations involving options about which reasonable people might disagree depending on their specific values or preferences . For example, none of the existing treatments for prostate cancer is risk or side-effect free, but the risk:benefit considerations vary among options, and the values individuals place on these risks and benefits may differ widely (O'Callaghan et al., 2014). Although decisional capacity is most frequently thought of in reference to patients with serious mental illness or dementia, the problem in other contexts may be more widespread than generally appreciated. For example, in a comprehensive review of studies of rates of healthcare decisional capacity across different settings and populations, Sessums, Zembrzuska and Jackson (2011) found 26% of medical inpatients lacked decisional capacity1. Gillick Competence o Health professionals must be confident in assessing a child's Gillick competence in order to ensure that the child's rights are respected, this requires the health professional to evaluate the child's maturity and intelligence when seeking consent to immunization. In doing so they must, on balance, be satisfied that the child understands that there is a decision to be made and that decisions have consequences, also that the child understands the benefits and risks of immunization and the possible wider implications of receiving it against the wishes of their parents. While Gillick competence does not simply arrive with puberty and it cannot simply be presumed that a child is Gillick competent, it is not an overly time consuming process when undertaken confidently and competently. o The Gillick Ruling and Competence to Consent to Medical Treatment o The law in the US and in the UK concerning consent to medical treatment differs in various respects. Nonetheless there are commonalities in approaches, notably here in the approach to capacity to consent, which is the focus of our concern. o The legal concept of consent has three main elements: that it is given voluntarily; that it is given by a person competent to consent; and that it is adequately informed. o At a minimum, the law imposes a duty that information must be disclosed in order to avoid a charge of battery or unlawful touching. In English law, this information only needs concern the “broad nature and purpose of the procedure” (Re C 1994). Obviously, good medical treatment requires more than this, and a better view is that the law of consent requires a more extensive duty to disclose information beyond this minimal level. The intent of the law in this area is expressed in the case of Re W, where Lord Donaldson considered that consent has a clinical purpose, deriving from the fact that very often the patient’s confidence in the treatment contributes significantly to its success (Re W 1992). o We are less concerned with how the law on consent might relate to possible criminal charges and civil action than with how it relates to the fostering of good medical practice, and how a close examination of case law might form

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5007079/

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the framework for a discussion of such good practice. We consider that in the case of genetic carrier testing, its clinical purpose requires a consent that fully comprehends the implications for later use. That is, the patient must be able to retain the information and see its significance, when it becomes relevant to reproductive decision making. There are different approaches possible to making judgments of competence to consent. A “status” approach to judgments of competence is one based upon some attribute of the person such as age. The Gillick ruling replaces a status approach to capacity to consent with a functional approach, which makes “ability to understand” the basis for capacity or competence to make a decision. Following Gillick, the General Medical Council guidelines emphasise that the judgment of whether patients are capable of giving or withholding consent to treatment or disclosure must be based on an assessment of their ability to appreciate what the treatment or advice sought may involve and not solely on their age (General Medical Council 1998, p. 23). The Law Commission also adopted the functional test in its report Mental Capacity (Law Commission 1995) which is now incorporated into the Mental Capacity Act 2005. Likewise, in the US, a President’s Commission favored the functional approach (President’s Commission 1983). The Gillick ruling thus made clear that there should not be a blanket rule about capacity to consent based upon age or any other criterion, but each case considered individually based upon a judgment of “sufficient understanding.” This will depend upon differences between individual persons, and also differences between procedures should be considered. Different presumptions with regard to consent operate depending on age. The Mental Capacity Act 2005 s 1 provides a rebuttable presumption that from the age of 18, every adult has the capacity to consent to medical treatment. Over the age of 16, children have the right to give consent to medical and surgical treatment equivalent to those of an adult by virtue of the Family Law Reform Act 1969 s 8 (1). The Children’s Act 1989 allows that a child’s views on genetic testing be sought and a child under 16 may give valid consent provided the implications of the test are understood. Under 16, the child is presumed incompetent, although this is rebuttable as Gillick establishes. As maturity develops, and especially for less major procedures, it will become easier to claim or to demonstrate that a child is in fact competent to consent. The average intelligent older child can often demonstrate competence to consent to a simple medical procedure. UK law allows children under 16 greater powers to consent to medical treatment than to refuse. A person with parental authority, or a medical professional, can overrule a child’s refusal of treatment (Re R 1992). A person with parental authority can also consent to treatment on behalf of a child under 16. Our discussion below will consider the significance of whose consent is obtained in the case of carrier testing. It is necessary to consider these matters in more detail. What is taken into account in considering whether a child (or other) is competent to consent? The notion of “Gillick competence” quite clearly considers the staged development of a normal child. The idea of a fixed capacity to consent at a given age was specifically rejected in Gillick by Lord Scarman in his judgment: “If the law should impose upon the process of growing up fixed limits where nature knew only a continuous process, the price would be

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artificiality and a lack of realism in an area where the law must be sensitive to human development and social change” (p. 186). o The common law of England uses a three-stage approach for establishing capacity to decide:  the ability to comprehend and retain the necessary information;  the ability to believe it;  the ability to weigh the information, balancing risks and needs, to arrive at a choice (Re C 1992). o It would seem that the ability to understand, as required by Gillick, requires all three of these elements. We will be considering these later in relation to carrier testing, especially the ability to retain the necessary information, as well as what is involved in comprehending the information. o So, how would this approach to capacity testing apply to genetic carrier testing? McHale (1997, p. 6) considers that “given that the implications of such a test may be considerable, it is likely that a high level of maturity would be required before the child will be held to be competent to testing/screening without the knowledge of his parents or against their express wishes.” We are not here concerned per se with cases of child/parent conflict, but with what level of maturity is needed for truly adequate consent, which this opinion would set as high. As well as theoretical reasons for requiring such a high level of maturity, we have evidence from considering our interview data that tends to confirm this view. o The majority decision in Gillick was formed bearing in mind the relative urgency and weightiness of possible unwanted teenage pregnancy and abortion. Despite relatively high numbers of teenage pregnancies in the UK and the US, the reality is that most teenage girls avoid this outcome, and carrier testing at these ages provides information for future use only. It may easily be 10 years or more before a teenager decides to start a family. We further discuss issues of adolescent risk-taking in sexual relationships below. Some limits of informed consent o

The right to consent: is it absolute? -

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Four main principles of medical ethics are justice, non-malificence, autonomy and beneficence. Autonomy is the main ethical consideration underlying informed consent Debate whether a right or a principle is absolute not only involves ethical and legal aspects Freedom as an example cant exist as an absolute principle because granting one individual absolute freedom will infirnge the freedom ofa second individual considerably Total autonomy of one individual has a negative effect on autonomy of other indivs. the modern democratic society has designed rules and laws to create a fair way of living. On the one hand this restricts autonomy, while on the other hand this same restricted autonomy guarantees the same amount of it to all members of this society Requirements of informed consent

Informed consent requires the patient to understand the diagnosis and uncertainties about it as well as the different treatment options (incl doing nothing) and their advantages, disadvatnages and achievable outcomes. o Amt of info required to make consent informed may vary depending on complexity and risks of treatment as well as the patient’s wishes o Patients have different levels of intellectual capabilities and understanding of their illness. Thus, mandatory to tailor information provided to an individual patient and the current situation o Principal of an absolute right to consent could easily be undermined by partial information Legal requirements While no one can consent for a competent adult UK laws are regulating consent for minors, patients with acutely or permanent incapacity and patients suffering from severe mental illness. o Minors. (Gillick competent child – the controversies here) when a competent child refuses treatment persons with parental responsibility may authorise this or a court may overrule the child’s decision. o Acute and permanent incapacity. o

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UK law on consent embraces the prudent patient standard -

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Montgomery o Montgomery’s obstetrician had not warned her of the risk of shoulder dystocia during vaginal delivery or discussed alternatives such as caesarean section. The court held that the doctor should have done both: doctors have a duty to ensure that each patient is aware of any material risks of any recommended treatment and of any reasonable alternative treatments. The test of materiality is whether a reasonable person in that particular patient’s position would be likely to attach importance to the risk, or whether the doctor is—or should reasonably be—aware that that particular patient would be likely to attach importance to it. The message for clinicians is: know your patient and provide tailored information Doctrine of informed consent o Requirement for full disclosure of material risks to the patient, with the standard of disclosure being determined not by the medical profession but by the court, is known as the legal doctrine of informed consent. o Prior to the Montgomery test, this doctrine was established in the case of Sidaway. The court ruled that the doctrine of informed consent did not apply in the UK and endorsed the postion articulated in the case of Bolam that: “a doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men.” Departure from the professional standard o The courts do, however, move with the times, and there has been a gradual but steady shift away from the professional standard. o The case of Bolitho established that if professional opinion does not withstand logical analysis the judge is entitled to hold that the body of opinion is not reasonable or responsible.

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In the case of Pearce the Court of Appeal stated that “a doctor’s decision not to disclose risks will now have to be subjected to logical analysis,” and if he has withheld information without good reason “he will be liable even though his decision may have been consonant with ordinary professional practice.” More recently, in the Chester case the House of Lords side stepped the traditional requirement to prove causation (that is, had the claimant been warned of the undisclosed risk, she would not have had the treatment) in order to protect the patient’s right to self-determination. And in the case of Birch, the High Court stated that the duty to disclose significant risks included information about alternative treatments The Montgomery case thus marks the final stage of the UK courts’ transition from the professional standard to the prudent patient standard.

Implications? 2 The Supreme Court has rejected a clinician-centred and paternalistic approach to consent. The test is no longer what a responsible body of clinicians would advise, a test whose yardstick is the current practice of the medical profession. That test has been replaced with one that treats patients as adults capable of making their own decisions based on medical information but also on non-medical considerations. The recognition that non-medical factors may be important to a patient is imp...