Ethics Learning Resources

Discipline of Medical Ethics, Law and Professional Practice MEDI7131 EPP1

LEARNING RESOURCE: INTRODUCTION TO MEDICAL LAW

INTRODUCTION TO MEDICAL LAW SUMMARY Author Malcolm Parker (SOM) Contact [email protected] Revised January 2015 Learning Objectives 1. Understand the broad connections between ethics and

law, and the uncertain nature of both. 2. Understand the broad principles, structures and categories of the Australian legal system. 3. Describe the categories of Australian law relevant to medical practice, and the range of legal processes to which doctors and health institutions can be subject.

Resource Summary Medical practice has traditionally proceeded in ignorance of the law, although the law has always been one of medicine's crucial contexts. In this resource session, the origin, purposes and fundamental structures of Australian law are enunciated, together with the areas of law of major relevance to medicine. The distinctions between statute and common law, and civil, criminal, disciplinary and other areas of law, are discussed, as well as introductory medico-legal concepts, and a precis of the legal duties of doctors. The distinctions and relationships between ethics and law are examined, and its uncertainty, frequently a surprising feature of law to the uninitiated, is emphasised.

Key Words common, criminal, tort, negligence, trespass, registration, professional behaviour, abortion, uncertainty, competence, duty of care

References Kerridge et al. Ethics & Law for the Health Professions. (4th Ed) Ch 4. Stewart et al. The Australian Medico-Legal H’book. Ch 3.

NOTE This LR was originally prepared for students in year 1 in 2011, due to the Brisbane floods preventing the face to face presentation of the lecture. It is simply an explanatory guide to the lecture slides, rather than a detailed expansion of the lecture, but it may prove useful for clarification purposes. Chapter 4 of the recommended text is a good source of information and explanation. INTRODUCTION Slides 4-6: Dr Baddoc’s misdemeanours are summarised, followed by the legal processes that each misdemeanour resulted in, and then a summary of these. Quite a day! Of course, this is a device to convey the wide range of areas of the law in which doctors may find themselves involved. It is NOT meant to convey the idea that doctors are a bad lot! LAW Slides 7-8: Summary comments on law and ethics. Slides 9-10: The nature of law in democratic states like ours, where it is one of the three main arms of governance, with power separated amongst them in order to ensure that each arm is checked and balanced by the others, as originally proposed by Montesquieu.

mailto:[email protected]

Discipline of Medical Ethics, Law and Professional Practice EPP 1


Slide 11: Types of law. The Kerridge and Stewart chapters give some good explanations for these. Essentially, Australian law is positivist, with some human rights elements (deriving from the natural law tradition) entering via human rights statutes, although these exist only in the ACT and Victoria as yet. These statutes require, at least in a prima facie way, that subsequent new laws observe basic human rights. Review the lecture “Introduction to Law and Human Rights” here. Slide 12: Sources of Australian law. (Not to be confused with the two broad kinds of law as natural and positivist). The sources discussed here are the immediate sources of our explicit and particular laws. Connections with the English common law system are explained. Slide 13: the core principles of the common law. Slide 14-15: types of courts, tribunals and commissions. Slide 16: World map showing different types of law. Note that Australia is pink, ie a common law country, and that the pink areas on the map roughly correspond to the old British empire, to which the English common law was exported. Because the province of Quebec is French-speaking and derived from French migration, but is in Canada, which was an English dominion, it has a mixture of common law and European civil law. Slide 17-18: the words “common” and civil” have a number of confusing usages. See below. LEGAL DUTIES AFFECTING DOCTORS Slide 19: From this point on we look at specific legal duties affecting doctors. Slide 20: The broad legal categories that are important in medicine. Slide 21-22: Criminal law Some examples are given here which share some features but are also distinct. Shipman was a British GP who murdered over 200 patients. The fact that he was a doctor was, in a sense, incidental, although it did give him great access to the people he killed without being detected for a long time. But he was essentially a psychopath who happened also to be a doctor. He was jailed for life as for any gross murderer (and subsequently committed suicide in jail). But he was also permanently deregistered from medical practice. Michaux was a Brisbane doctor who drugged his female patients on house calls and raped them. So this was more in the way of a “medical” crime. He was jailed, but has since been released, but his medical registration was permanently erased. Pearce is another Qld doctor who mistakenly gave a burnt infant ten times the appropriate dose of morphine. So, according to the court, she caused the baby’s death, but not intentionally. So she was found guilty of criminal negligence – negligence because it was not intentional, but criminal because the mistake was so clearly of gross proportions. Her medical registration was suspended but not erased, and following re-registration, she continued to practise for some years. By now you will be getting a feel for two things: the difference between intentional and negligent criminal acts, and the fact that these different categories have different consequences for registration status. The Patel case is interesting as it, like Pearce was one of manslaughter, or unlawful killing, where the doctor did not intend to kill his patients, but where gross incompetence resulted in death or serious harm. S288 of the criminal code requires the exercise of reasonable skill, and Pearce and Patel clearly failed this test. But in Patel’s case, it was

Discipline of Medical Ethics, Law and Professional Practice EPP 1


argued successfully that his failure was not in the execution of the surgery, but in his diagnostic and advisory roles, since he advised people to have surgery which was beyond him, or he had previously been barred from performing, or which ought not have been carried out in Bundaberg. Note that the consent of the patients to the surgery did not extinguish his responsibilities. Slide 23: There are various kinds of actions which doctors must avoid on pain of transgressing the criminal law. Note that altruistic surrogacy was, but no longer is a crime in Qld. Note also that defrauding Medicare is a crime. Unlawful abortion is a crime, and in next semester’s course, we will discuss the complex ethics and law concerning abortion. Slide 24: Actions in criminal law are brought by the state, not individuals, and the standard of proof is beyond reasonable doubt. Both these elements reflect the seriousness of crimes, and the seriousness of their punishments. Slide 25-27: Regulatory or Disciplinary law These essentially summarise material covered in the forthcoming Professionalism and Accountability lecture. You can see, again, how different categories of law intersect. Slide 28-29: Public law and Human rights / Administrative law These are crucial areas, but involve institutions more than individuals; we do not look at them in detail now. Slide 30-35: Civil law Recall that civil law was contrasted with common law in terms of worldwide systems, with the European civil law contrasting with the English common law. But we also refer to a broad area of law, within our common law system, as civil law, as distinct especially from the criminal law. So whereas criminal law actions are brought by the state in response to serious, harmful events, the civil law is an area that addresses grievances between individuals - civilians (This can include institutions, corporations, and governments, which are regarded as legal individuals. For example, I may sue the government for negligence; when I do, I and the government are acting as legal individuals). For medicine, the primary areas of concern are the laws of contract and tort. In the Kerridge chapter, there is considerable discussion of contract, but because there are very few contracts written between doctors and patients, and even though there is an implied contract between doctor and patient in every interaction, it does not figure frequently in law suits involving doctors. Nor do fiduciary duties which are applied by the law of equity; indeed there have been no cases brought and decided on primarily in terms of doctors’ fiduciary duties to patients. The legal suit of major interest is that of negligence, which, as you will see from the subsequent Duty of Care lecture, is the one that is brought by patients who believe they have been harmed by a failure of the doctor to observe the required standard of care in any one of the various categories where is a legal duty of care exists. Another tort (civil wrong) is trespass. This is a far less frequent action, and we look at the difference between negligence and trespass more closely later. Slide 36: Uncertainty. These examples demonstrate that the law, which attempts to prescribe action in relation to all of them, cannot give explicit instruction for every case that arises, just as a code of ethics is constrained to providing general guidance. The prescriptions in both areas are subject to interpretation, deliberation, negotiation and judgment. Slide 37: With apologies to the lawyers!

Discipline of Medical Ethics, Law and Professional Practice MEDI7131 EPP 1

LEARNING RESOURCE: AUTONOMY, PATERNALISM, COMPETENCE, INTERVENTION, REGULATION

AUTONOMY, PATERNALISM, COMPETENCE, INTERVENTION, REGULATION SUMMARY Author Malcolm Parker (School of Medicine) Contact [email protected] Revised February 2015 Learning Objectives

1. Discuss the relationships between psychological and moral autonomy 2. Define the related concepts of autonomy, competence, best interests and paternalism 3. Outline the ethical and legal limitations and obligations of practitioners in dealing with mental illness and self-harm (introduction only) a) What is the law regarding involuntary admission of patients (both adults and minors)? (introduction only) b) What are the ethical issues associated with interventions to prevent self-harming behaviour?

Resource Summary

This resource illustrates how ethical and psychological issues are deeply intertwined. It introduces conceptual and applied aspects of autonomy, competence, consent, refusal, paternalism, medical interventions and limitations, and mental health regulation (introduction only). Do we have the ethical and legal right to force treatment upon someone, even if the patient has an apparently false belief, which may lead to her death? The case introduces many aspects of the doctor-patient relationship which may conflict in difficult cases as well as the more everyday ones. The lecture uses case examples to explore these issues, connecting them to the cognitive, psychological and ethical concepts & principles involved. The lecture and the LR should allow you to reflect about the issues and generalise to a broad range of situations. There are also obvious links to the L on assessing competence.

Key Words autonomy paternalism competence doctor-patient relationship diagnosis consent refusal mental illness involuntary treatment

References 1. Kerridge et al (recommended text) Chapters 7, 16 (4th ed). NB You do not need to read all the following references !!! They provide a range of further reading which those interested can follow up. 2. Quill T & Brody H, Physician Recommendations and Patient Autonomy: Finding a Balance between Physician Power and Patient Choice, Annals of Internal Medicine, 1996; 125: 763-769. (Critiques the deficiencies of absolute views of the doctor-patient relationship, and describes the recent history of change in the relationship). 3. Hawkins J & Emanuel E. Clarifying Confusions about Coercion. Hastings Center Report, 2005; 35(5): 16-19. (Very clear explanation of the concept of coercion, and the differences between coercion and other influences). 4. Barilan Y & Weintraub M. Persuasion as Respect for Persons: An Alternative View of Autonomy and of the Limits of Discourse. J of Med & Philosophy, 2001; 26: 13-33. (A longer and somewhat more philosophical argument for a duty to persuade patients to accept medical advice).




NOTE This LR was originally based on a PBL case of anorexia. It retains some references to and material concerning anorexia, as a clinical illustration of the concepts under discussion this week, and also because we introduce some aspects of legal intervention/mental health. INTRODUCTION This quotation from the twentieth century British philosopher Isaiah Berlin, nicely captures the core idea of personal autonomy: “I wish my life and decisions to depend on myself, not on external forces of whatever kind. I wish to be the instrument of my own, not of other men’s acts of will. I wish to be a subject, not an object; to be moved by reasons, by conscious purposes, which are my own, not by causes which affect me, as it were, from outside. I wish to be somebody, not nobody, a doer – deciding, not being decided for, self-directed and not acted on by external nature or by other men as if I were a thing, or an animal, or a slave incapable of playing a human role, that is, of conceiving goals and policies of my own and realizing them….I wish, above all, to be conscious of myself as a thinking, active being, bearing responsibility for my choices and able to explain them by reference to my own ideas and purposes.” [From Jeremy Holmes and Richard Lindley. The Values of Psychotherapy] This resource should help you to consider and debate some aspects of the doctor-patient relationship, how that relationship has developed historically, and how it fits within social frameworks including the law and the codes which inform the practice of the profession. The resource is an opportunity to reflect on some of the concepts and issues covered in the lecture and the lecture on assessing competence, and to begin to generalise these. The recommended text reference can help you to familiarise yourself with the relevant concepts. The other references are certainly not “required reading” but provide further exploration of the area. The aspects of legal intervention in the mental health area covered here are introductory only. Later in this semester, the concepts of autonomy, respect and paternalism discussed here will be built upon in considering issues of consent to and refusal of medical treatment, and more detailed attention will be paid to mental illness and the ethical and legal aspects of psychiatric diagnosis and involuntary treatment in year 2. With the help of this resource & references, in conjunction with the lecture, you should be able to 1. explain the relationships between psychological autonomy or competence, and

moral autonomy; 2. understand the concepts of, and connections between, rationality, competence,

autonomy and paternalism; 3. appreciate the ways in which the duty to benefit patients (the principle of

beneficence) can sometimes conflict with the duty to respect their autonomy and values, but also why persuading patients to accept medical advice is not



necessarily paternalistic, but depends on patient autonomy and can be seen to respect it;

4. understand, in broad outline, the principles of lawful involuntary treatment of patients afflicted by mental illness;

5. begin to critically appraise recent historical changes in the doctor-patient relationship, in the context of broader social changes.

DONT PANIC !! These are all introductory objectives, and the sorts of accounts you are able to give now will be built upon through this year, throughout the EPP courses and throughout the program, as you revisit the doctor-patient relationship and related topics on a number of occasions. NB the objective now is NOT to know the details of the Mental Health Act !! Note also that the questions below are intended to prompt your thinking. Some students ask “Well what are the answers to all these questions you are asking?” but at present they are designed simply to encourage you to make some links between your own experiences (eg as ordinary citizens, as patients etc) and how you currently understand medical practice. MEDICAL POWER Ethics has a lot to do with the exercise of power, and with how we treat other beings (human and animal) and things (the environment). Think of the many ways in which we exercise power in our dealings with other

human beings and other animals. What are the different meanings of power? Think of different verbs which are ways of influencing others, like suggest, persuade, authorise, coerce, compel, dominate, force. What do these each mean, and how do they differ? Are they examples of the application of power? Or does this seem too strong in

some cases or too weak in others? What feelings, and what ethical connotations, do each of these words raise for

you? Now try and recall some of the ways in which power was exercised by different individuals in your previous courses (including staff and other students), or in other settings, eg school, church, clubs, social relationships etc. Can you recall both legitimate and illegitimate uses of power in these

experiences? What was it about them which made them seem legitimate or illegitimate?

What ethical observations can you make about these uses, or abuses, or power? (You might here consider concepts and issues of justification, harm and virtue).



Now consider medical practice 1. In what ways do you think power can be exercised in medicine? Can you think of

some legitimate and some illegitimate ways yet? 2. What is it for a doctor to make a diagnosis? Try and think of the different

processes that are happening, and try and describe the process of diagnosing from the point of view of different people or groups. Is the making of a diagnosis an exercise of power in any sense?

3. Are there differences between psychiatric and other kinds of diagnosis, and if so, what do they consist of? Are there any ethical implications of these differences?

AUTONOMY Now think of the potential dilemma for those attempting to help patients in cases where there is some disagreement. There can be conflict in perceptions concerning the patients’ best interests, between doctor and patient at times. Whose perception is right, and why? We have already looked at autonomy as a crucial, some would say overrated, principle of biomedical ethics in previous lectures. In our society, self-determination or personal autonomy is strongly valued and protected. We think of people as being self-determining, if they can comprehend situations, deliberate about action in terms of their desires and beliefs, choose a course of action, and then act accordingly and account for their choices. We commonly say that such people are competent, sometimes that they are rational decision-makers, or that they are responsible, or that they are autonomous. Sometimes we might also say that they are free, in the sense that with freedom goes responsibility and vice versa. If a person is not in some important sense free to make her own decisions, then we do not hold her responsible for them. We cannot be held responsible for decisions that affect us but that we had no choice about. The eighteenth century German philosopher Immanuel Kant was a great champion of the idea and importance of autonomy. For Kant, human beings had the capacity, not only to act in order to achieve their goals and desires, but to impose upon themselves rules or laws of morality, which he considered must be based in reason. According to Kant, these abilities were amongst the defining properties of human beings, and he thought that it followed that each person should be treated as an “end in itself” (ie himself or herself), rather than as an object (see also Berlin quote above). Kant implored us to always act so that we could simultaneously “will” that the principle of our action could become a universal law - this is a rather complicated way of saying that Kant thought we should treat others as we would want ourselves to be treated – the golden rule. Kant has come in for a lot of criticism from subsequent philosophers, but his ideas capture some central themes concerning the self and self-determination with which we remain familiar, and of course, as we have seen, with ethics. [As it happens, that thought – that each person should be treated as an end in himself or herself, rather than as an object - is a nice way to capture one of the central features about medical practice and the philosophy of medicine: on the one hand, we apply our knowledge of bodies (and minds) as objects, in order to help



people, who are somehow more than objects; they are persons, or ends in themselves, with freedom (eg to refuse treatment) and responsibility. Think of what this makes medicine, in contrast to veterinary science, at least in direct regard to the animals that veterinarians treat]. Do the highlighted terms three paragraphs above all mean exactly the same thing? If not, what are the relations between these terms? For example, is a competent person always free? Perhaps this depends on the meaning we give to the idea of freedom – freedom from or freedom to. Is a competent person always responsible? Perhaps not, but maybe someone we think of as responsible must be competent. And so on. Think about what the terms share in meaning, but also what makes them distinct. A patient may be competent in some technical sense, but what if her aims go against what others strongly consider is in her best interests? Maybe at times some psychological mechanisms produce conflict amongst a person's beliefs and desires, so as to threaten his/her autonomy. In some cases it is a matter of a difference of opinion about best interests, based on differences in certain facts, or on differences in fundamental values. Is it still possible for an individual, even in a society which strongly values individuality, to somehow be mistaken about his or her values? If it were possible to be mistaken, this would depend on our values somehow being able to be objectively judged, and many people would think this is impossible, by rejecting the idea of there being any source of objective values. This is consistent with the democratic idea of maximising freedom in order that people may live the lives of their choosing. Of course, others will identify a source of values which they will claim to be objective, ie true for everybody. Recall from earlier lectures the different claimed sources of values. What do you think of these claims? Are some better grounded than others? Perhaps we sometimes express preferences which conflict with our deeper values, without being aware of the inconsistency. For example, I might refuse to have a vaccination because I am afraid of fainting from the needle, but I also continue to want to protect myself from disease when I travel. I have to somehow reconcile and make a decision concerning these two conflicting positions. Think about the following questions. 1. Do different kinds of illnesses affect autonomy in different ways or to different

degrees? (See Anorexia, Autonomy & Control, below) 2. Is autonomy less important in the context of some kinds of illnesses? 3. Can we sometimes over-value autonomy, to the detriment of patients? 4. How might patient autonomy conflict with a doctor's legal duty of care? 5. What is the difference between (1) a patient's best medical / health interests, and

(2) her best interests, all things considered? NB Again, these are not questions to which you need to have answers now. They are simply aimed at helping you to think about the concepts being discussed, and encouraging you to discuss them with your colleagues.



PATERNALISM, COERCION AND PERSUASION It is crucial to be clear about exactly what it is we are discussing when we use these terms. Consider paternalism, frequently encountered when we discuss autonomy. It is good to remember that, while the term paternalism is derived from the parent-child relation (check the dictionary), the parent-child relation is not the same as the idea of a paternalistic relationship in medicine. Paternalism, particularly in medical contexts, is about

imposing my conception of what I think is in your interests, based on my genuine belief that you will benefit, even though you are competent to choose, ie autonomous (unlike the child in

the parent-child relation). Interventions in the interests of those who are not competent, on this definition, are therefore not instances of paternalism, although some describe such interventions as cases of "weak paternalism". (Think of providing seat belts for small children, in contrast to requiring competent adults to use them: these are respectively weak and strong, or soft and hard, types of paternalism). Although the word is derived from the parent-child relationship, we are not being paternalistic when we put a seat-belt on a child, because the child is not autonomous. But we would be being paternalistic if we insisted that a competent adult, who does not wish to wear a seat-belt, did so, out of genuine concern for his safety. But be careful! If wearing a seat-belt while driving was shown to reduce accidents, then enforcing drivers to wear belts would, at least in part, then be justified by the interests of others in the car and others on the road, so this part of the justification would not be a paternalistic one. What makes things difficult for any health practitioner wanting to help the patient who resists what the health practitioner thinks is in his/her best interests, is the question of competence. If someone is competent, shouldn’t they remain at liberty to determine what they do? Consider, in the context of anorexia nervosa - which is described medically as an eating disorder characterized by food restriction, considerable weight loss, unusual eating habits or rituals, obsession with weight and figure control and a distorted body self-perception - 1. Does an anorexic patient’s beliefs and apparent denials of having any kind of

illness constitute a mental illness which calls for intervention in the service of a medical duty of care, or is her situation more of a lifestyle choice, which should be respected on grounds of individualism, liberty and autonomy? (Note here the connections with the previous concerns regarding diagnosis and power).

2. Just what is the scope of mental illness?

3. Does having a mental illness automatically mean the person is not competent? 4. Are there ethical and legal rights to refuse medical treatment? If so, what

conditions need to be satisfied, in order to respect the refusal?



5. What principles and requirements should underpin a medical obligation to intervene in someone's interests? For example, is the judgement that someone is mentally ill by itself sufficient to ethically and legally justify intervention, including involuntary admission to hospital?

(Again, these are questions aimed at stimulating your thoughts, to encourage you to become familiar with the concepts being used, and to encourage you to try and get your thoughts into a roughly coherent order. They are expanded on at later points in the program). Think again of those different terms for how we can influence others: suggest, persuade, authorise, coerce, compel, dominate, force. Is it legitimate to try to persuade someone to take a particular course of action, which I think they should, because it is in their interests, or is this an example of unjustified paternalism? The increasing dominance of autonomy as a principle of medical ethics and practice arose as part of the general assertion of individual rights through the second half of the twentieth century, and more specifically as a result of unethical clinical research practices dating from before World War 2, coming to a peak during the war, and also subsequently. This ascendancy of autonomy, especially in its contractual form, has tended to suggest that the doctor patient relationship is analogous to a commercial one, defined essentially by patients having a choice from options made available by the doctor. However, this tends to leave the duty to do good for patients (the medical principle of beneficence) somewhat out of the picture. We generally accept that the doctor-patient relationship is different from a purely commercial transaction, eg the shopkeeper does not have a duty to benefit the consumer, beyond the normal commercial expectations. Some people will contest this, of course, or argue that the doctor-patient relationship ought to approximate the commercial model (more on this in year 2). While it is generally agreed to be wrong to coerce a patient into a particular treatment, or to dominate the process by which medical decisions are made, some people might believe that persuading a patient to a particular course of action is also ethically wrong. However, to persuade somebody, or to be persuaded, requires competence and autonomy, since it is the result of a rational dialogue between two people, and this is a process which recognises and respects each one as autonomous. Rationally persuading somebody to believe or to do something, assuming that we observe the proper boundaries and rules of the process, therefore does not amount to paternalism, either strong or weak. Legitimate persuasion implies respect for autonomy, and is a proper aspect of medical professionalism. Remember that because persuasion is an autonomy-respecting process, no sanctions can be applied if the competent patient does not agree or refuses to accept the view which the doctor is supporting (as long as all relevant information is conveyed). Once sanctions are applied or even threatened, we have moved from persuasion to coercion or compulsion. But note also that, on this account of how persons can be respected, the conflict between the principles of autonomy and beneficence is reduced, because we are trying to persuade the patient to autonomously come round to our view of what is in their best interests. Clearly, the limits to these processes of “rational persuasion”



must be clearly in view and strictly observed; moreover, many patients are more vulnerable than usual due to their illness state, even though from a technical point of view, they remain competent, and the boundary of rational persuasion becomes more fragile, requiring continuing vigilance and self-awareness on the part of the doctor. (See refs 3 & 4) COMPETENCE / CAPACITY We suggested above that people are considered to be self-determining, or autonomous, if they can comprehend situations, deliberate about action in terms of their desires and beliefs, choose a course of action, and then act and account for their choices. We say that such people are competent. In clinical practice, we usually do not consciously ask ourselves whether the patient is competent, because usually there is nothing which raises the question in our minds; we assume that everyone is competent, unless there is a feature about them or their decisions which puts their competence in question. This situation is reflected in the law, which obliges us to presume that patients are competent, and places the onus on the doctor to show that a patient is not competent, rather than on the patient to show that s/he is competent. We will apply ideas of competence later in the program, in relation to refusal of treatment, substitute decision-making, advance care planning etc. Here, we will conceptualise competence (or decision-making capacity) as the ability to a. receive, comprehend, retain and recall relevant information; b. integrate the information received; c. evaluate the benefits and risks of acting or not acting in the context of one’s own values and goals; d. select an option and give reasons for the choice; e. communicate their choice to others (somehow); f. persevere with that choice, at least, until the decision is acted upon. Using these elements as constituting the conceptual core of capacity, a helpful practical capacity assessment process is the Six Step Process of Prof Peteris Darvins & colleagues of Monash University: SIX STEP CAPACITY ASSESSMENT Step 1 – ensure a valid trigger is present

An event that puts either the person being assessed or others at risk, and also, on the face of it, calls the person’s capacity into question.

Must cross a high threshold before embarking on a capacity assessment - remember the presumption of capacity.

Step 2 – engage those being assessed

Inform them of the capacity assessment process, obtain their assent if possible.



Step 3 – information gathering From person being assessed. Collateral information (from the person(s) alleging incapacity and from other

key informants). Need to know:

o the trigger (“the problem”); o the relevant choices; o the reasonably foreseeable consequences of particular choices; o any evidence of delusions that are related to the “trigger”; o the evidence of cognitive impairment.

Step 4 – education

Provide opportunity to learn the needed information. Step 5 – capacity assessment

Look for evidence of incapacity o does not know the problem / “trigger” o does not know the choices o does not appreciate the reasonably foreseeable consequences of

choices o decision-making based on a delusional construct.

If fail to find evidence of incapacity let the presumption of capacity stand. If find positive evidence of capacity this strongly refutes possibility of

incapacity. Record the evidence you observe.

Step 6 – act on results of assessment

If found to lack capacity, find a valid surrogate decision-maker. If capacity confirmed, consider the need for help with problem solving for the

trigger to the assessment and emotional support for the trauma of the assessment.

(From Darzins P, Molloy DW & Strang D. (Eds) Who Can Decide? – the six step capacity assessment process. p150). [These steps are considered further in the L on Assessing Competence]. ANOREXIA, AUTONOMY AND CONTROL The previous version of this week’s PBL case involved a young female patient with a possible diagnosis of anorexia nervosa. The patient’s mother is worried that her daughter will develop this problem as a result of crash-dieting. The problem of anorexia is useful for further discussion of the issues of autonomy, competence and paternalism as they are linked with the management of mental disorders. While the aetiology of the eating disorders is unresolved and extremely complex, including genetic factors, family environments etc, sufferers frequently exhibit traits including those mentioned above, and in addition -



Disturbance of body image, perfectionism, obsessionalism, self-consciousness;

Withholding of feelings, social withdrawal, avoidance of risks, fear of failure; and

Sensitivity to rejection, low self-esteem, requirement for approval. Many sufferers are thought to behave as they do in order to establish a measure of control in their lives. Control of their eating and body habitus may allay anxieties related to lack of control of a more general kind. The fact that anorexia occurs predominantly in the adolescent/young adult age group suggests that it might be a strategy for coping with some of the developmental milestones of this period, including the development of independence, separation from the family, and establishing individual identity. The desire to take on more responsibility is normal and expected, but these achievements are never won without fear and anxiety. It makes sense that this will be more difficult for people from families where the interpersonal environment has been controlling, over-protective, devoid of emotional expression, negative towards children’s individual needs etc, because there will have been little or no graduated individuation which has prepared them for a world of interpersonal connection and its attendant risks and losses. (These factors occur to a variable extent in the families of sufferers, and should not be understood as agreed causes). Consider again the meaning of autonomy. My dictionary states “right of self-rule”. This was originally a right conferred on smaller cities in the ancient world by national administrations, and while retaining its political connotation, it also has a derived personal application with which you should by now have become familiar. Now look at the traits listed above as characterising anorexia. Many bear a relationship to the self. We have suggested that the eating disorders are characterised by an attempt to establish control. Self-rule and self-control mean much the same thing. Are there degrees of control? Are there pathological degrees of control? Perhaps you know someone or have heard of someone described as a “control freak”. Think about the extent to which their controlling patterns are a matter of choice. Perhaps you know someone who is obsessional. A measure of control is good, but very obsessional people seem to be “controlled by control”;; they have no freedom or carefree moment to balance that unremitting control. As stated previously, freedom and choice imply the notion of responsibility. What emerges is the paradox that people with an eating disorder appear to utilise various controlling strategies compulsively to allay anxieties and maintain self-esteem, but such strategies also prevent them from establishing normal social relationships. Adult autonomy is characterised in part by a balance between independence / responsibility and the inter-dependence that characterises social relations. Those with eating disorders are compelled to maintain a severe, unbalanced independence, and so cannot progress to that mature, balanced position. They are arguably lacking in personal autonomy of the mature type, despite appearances (and their own beliefs) to the contrary. This of course is a matter of degree.



FROM PERSUASION TO INTERVENTION These considerations suggest that making a diagnosis in these areas that seem to involve control mechanisms appears to be about diagnosing a disorder of autonomy, or a disorder of the self. This is clearly quite different from making a diagnosis of heart failure or arthritis; these are diagnoses of conditions that happen to the self or person. And it is surely puzzling, especially when the patient appears to be so in control. But rigid control resists encouragement and persuasion towards help, and as problems escalate, denial and resistance on the part of the patient can increase. More clearly “physical” and more directly threatening symptoms and signs may develop, at which point ethical and legal considerations of necessity may arise, especially when physical effects interfere with cognition, and finally when clinical (life-threatening) emergencies arise, such as severe electrolyte imbalances, in advanced cases of anorexia. In these more extreme contexts, the ethical and legal questions become somewhat more straightforward – there is general agreement that in the emergency situation we should treat the patient, without consent if necessary. Prior to reaching this stage, however, the difficult issue is whether one is dealing with a patient with a mental illness, and whether one can enforce treatment, in the best interests of the patient, according to the provisions of the Mental Health Act, if they are not rationally persuaded to obtain treatment voluntarily. This is an extremely difficult and controversial issue. On the one hand, most people with apparent eating disorders are technically competent, ie they understand the nature of proposed treatment, its risks and so on, and so should arguably be respected as self-determining citizens, capable of deciding for themselves, and deserving to have their decisions, including refusal of treatment, respected. On the other hand, they appear to be in need of medical assistance to prevent deterioration and to enable them to develop their lives to the full. These observations and attributions clearly pull in opposite directions. There appears to be a continuum along which it becomes more reasonable to diagnose a mental illness with greater severity of symptoms or threat of deterioration, but prior to which help will be more effective. But at the earlier stage, offered help may appear to the patient as a controlling authoritarianism on the part of the doctor, risking the re-enactment of previous family dynamics, resulting in further withdrawal from the helping process. The details concerning the assessment and treatment criteria under the Mental Health Act 2000 (Qld), which go some way to helping in these decisions, will be dealt with in year 2, but are summarised in the lecture. Anorexia and other eating disorders are certainly classified as mental disorders, which can come under the provisions of this legislation, such that in certain cases, patients may be involuntarily treated.



LINKS The lectures and this resource describe some basic concepts and relationships which you will find applied in many resources within the EPP courses, including the following: Year 1 Consent to and refusal of treatment Informed decision-making Concepts of disease Self-induced disease Confidentiality Consent for minors Advance care planning End-of-life decision-making Year 2 Substitute decision-making and advance health directives Psychiatric diagnosis Psychosis & Involuntary Treatment You should also begin to observe how important these concepts are in clinical settings, and how frequently they become factors in medical decision-making, as you become increasingly involved in clinical work.


LEARNING RESOURCE: THE DUTY OF CARE

THE DUTY OF CARE SUMMARY Author Malcolm Parker (SOM) Contact [email protected] Revised February 2015 Learning Objectives

Explain how basic ethical concepts including sympathy, compassion, care, need, harm, autonomy, beneficence, consent & necessity form the basis of the medical duty of care. Explain the fundamental legal concepts of the duty of care, the standard of care & negligence. Explain the changing scope of the duty of care, using examples such as the duty of care in emergencies.

Resource Summary

This session introduces the duty of care concept as it applies to medical practice. While medicine is motivated to respond to basic human needs from sympathy and compassion, (the motivations of the biblical figure of the Good Samaritan), its activities are also formalised in professional and legal conceptions of duty. Concepts such as medical necessity and beneficence, autonomy and consent, duty of care, standards of care and, in an introductory way, negligence, liability and litigation are discussed. The basic law concerning medical emergencies is examined. The obligations of students qua students is discussed and contrasted with their future obligations as practitioners, to illustrate (a) their assuming the responsibilities of a new role, and (b) the variation in legally expected standards of care. The emergency situation serves as an illustration of the ever-changing scope of the legal duty of care.

Key Words duty of care, emergency, proximity, foreseeability, standard of care, torts, negligence, litigation

References 1. Kerridge et al, Ethics & Law for the Health Professions, 4th ed 2013, Federation Press, Ch 10 (185-205).

2. Stewart et al. The Australian Medico-Legal Handbook. 2008. Elsevier. Ch 4.

3. Civil Liability Act 2003 (Qld) at http://www.legislation.qld.gov.au/Acts_SLs/Acts_SL_C.htm

4. Medical Board of Australia. Good Medical Practice: A Code of Conduct for Doctors in Australia. Available at

http://www.medicalboard.gov.au/Codes-Guidelines-Policies.aspx 5. Law Reform Act 1995 (Qld) s16. Available at

http://www.legislation.qld.gov.au/Acts_SLs/Acts_SL_L.htm 6. Mitchell EW. The ethics of passer-by diagnosis. (2008) 371

Lancet 85-87.


http://www.legislation.qld.gov.au/Acts_SLs/Acts_SL_C.htm

http://www.medicalboard.gov.au/Codes-Guidelines-Policies.aspx

http://www.legislation.qld.gov.au/Acts_SLs/Acts_SL_L.htm



INTRODUCTION This resource supports the lecture on the duty of care. It covers quite a wide territory, and may appear to be a lot to digest at this early stage of the course. But it is designed to introduce some concepts which you will revisit a number of times throughout the program. The material covered in the lecture is expanded and explained in this resource. If you have questions about this resource or any of the subsequent ones, do not hesitate to contact your lecturers. As outlined at Orientation and in the Introduction to Courses, one of your tasks is to make links between the different occasions on which you strike a particular issue, within the CBL cases where this occurs, and in the context of practice situations. This resource and the lecture also introduce you to a second model which we use for EPP issues, and that is to consider the ethical aspects of an issue, and its legal aspects, and try to see the relationships between these two aspects, the extent to which they are similar or different, and why. Recall that we have indicated that the recommended text (Kerridge) follows this pattern in most chapters, where ethical and legal aspects are considered for each topic. When you read these chapters, try and remain critically aware of the overlaps between the ethical and legal treatments, and why for some areas the law may appear to be more comprehensive and/or dogmatic than what the section on ethics says. A final recommendation: always keep a hard copy dictionary or a web-link (eg Meriam Webster on-line dictionary: http://www.merriam-webster.com/) handy. If there is a word you are not sure or clear about – look it up. In many cases, the dictionary definition will provide the clarity you are seeking. “BLOOD ON THE ROAD” The CBL case “The ABCs of Medicine” was previously titled “Blood on the Road”. It deliberately presents a dramatic scene which confronts you with a number of challenges and questions. In response to a fellow human being apparently suffering from an acute, life-threatening problem, most people will feel the urge to do something to help, since not helping could mean the death of the person in trouble. On this basis there is at least a prima facie ethical obligation to do something. In other words, most people feel that they ought to stop and help, out of human sympathy, fellow-feeling, or perhaps the idea of the Golden Rule: “What if it were me – wouldn’t it be good if someone tried to help me, so shouldn’t I do something here?” Many people, of course, would feel that this is not really a moral matter at all, in the sense that because they would feel that they want to help, or feel automatically motivated, even inwardly compelled, to help, the idea that there is some duty or moral obligation to help could seem somewhat excessive. Why would any sort of obligation need to be imposed in relation to something that I am going to do anyway? This is an example of the age-old contest between different theories about ethics, which we encountered briefly in the introductory lecture. Duty-based theories would say that there is an ethical duty or obligation to help the injured person, and that this has nothing to do whatsoever with wanting to do so. Indeed, the Kantian ethicist would say that if you really desire to help, then it is not a matter of ethics at all. By contrast, the naturalistic ethicist will deride this position as so much rigid nonsense, and say “Of course we want to help, but we are also morally obliged to do so”. On this theory, moral obligation and what we desire to do are not mutually exclusive.

http://www.merriam-webster.com/



But you must also consider the fact that now you are a medical student. Does this change things at all? Would the community expect you to be better able than someone else to help the person in trouble? Is that a reasonable expectation, or is it just because you are a medical student, which doesn’t necessarily mean much, at least at week 4, year 1?! And how would any obligation on your part compare with that of a qualified doctor? A second consideration is whether these apparent ethical obligations also translate to legal obligations. Are all ethical obligations legal ones, or at least are all medical ethical obligations also legal ones? Is there a difference between the legal obligations in this setting between doctors and medical students? And would a doctor be legally required to assist, even if s/he has never seen the person before, ie if the person is not a patient of the doctor? The lecture and this resource explore these questions. The focus here is on the duty of care, ie on the questions “Who has a medical duty of care, and when will it exist?” “What factors or circumstances establish that there is a duty of care?” “What are the limits to the legal duty of care?” We will also touch on related issues such as the legal standard of care by introducing the legal notion of negligence, but this is taken up in greater detail in subsequent weeks. DUTY, CARE AND THE DUTY OF CARE The two words duty and care conjure up different kinds of associations. Look up your dictionary, which you now have a mouse-click away, or possibly in hard copy to hand. Duty brings to mind ideas like rules, laws, obligations, requirements, even possibly ideas like being contrary to what I want or desire to do, (eg I really want to go clubbing, but I have a duty to look after my little sister because my mother is sick. In this example, you can see that duties and certain desires can certainly conflict, and the naturalistic ethicist would agree. But s/he would add that the duty to look after your sister is not divorced from desire, since we also desire the welfare of our loved ones). By contrast, care suggests things such as compassion, human feeling, love, concern etc. There is a spontaneous feeling about caring, whereas there is a more rigid, regimented feel to the notion of duty. Is it not therefore somewhat odd to combine these two words in the phrase, the duty of care? As we said earlier, why should there be any rules about doing things which are spontaneous, things that we are going to do anyway? The answer lies in what it is that professional ethics and the law aim to do, and also in the relationship between ethics and law. These are large areas of intellectual and practical interest, but you should start becoming familiar here with these relationships and their underpinnings. First, there are many things which could be considered to be unethical but which are not subject to any legal restriction. And there are laws which do not appear to relate to issues of morality. Can you think of any examples? Think here of the difference between private life and public life, and some examples may suggest themselves. Here is a recent example related by a friend:

My friend signed a lease contract with the owner of a business property, which included an agreement by the signatories that at any time, with a certain period of notice, the landlord could terminate the lease, if he decided to demolish the building and rebuild on the site. At the time of signing the contract, he had already submitted an application to the local authority for such a demolition and rebuilding. My friend signed the lease, and has



subsequently been informed that the demolition will go ahead. Hence he needs to find alternative premises to run his business. He was not told at the time of signing the contract that an application had been made, nor was it made verbally explicit that this was likely to happen. He feels cheated by the landlord. One could argue that the landlord has treated him unethically, but he certainly has not treated him unlawfully, since the possibility which he now faces was included on the contract which he signed.

If we return to the scene of the car accident, should the law require anyone present to assist? Think about the consequences if it did. If there were a general legal requirement, might there be a chaotic situation with everyone at the scene pitching in to help, for fear of being found at fault for not doing so, with the possible result that the injured person is not helped at all? So, if not just anyone is legally required to assist, where should the line be drawn? And how serious would the injury need to be for there to be a legal obligation imposed on at least some classes of people to assist? These considerations result in the fact that there is, in the Australian common law system, no general duty to rescue. This means, for example, that if an ordinary citizen is walking past a pond, and sees someone struggling in the water, they would not be held legally responsible for the struggling person’s death, as a result of failing to help. This may sound harsh, but it is a practical position for the law to take, as it is considered that it would impose too high a level of obligation on ordinary citizens. We may well feel that the person who passed by and failed to be a Good Samaritan acted immorally or unethically, but there is no legal requirement to help (there is one exception to this in the Northern Territory, discussed later). One of the consequences of this is that a passer-by who failed to help the drowning person would not be punished by the law, although he may well attract moral/social censure for the omission to act. Now if we consider just the moral sphere, we may still want to draw a line here, for example between a fit, young life-saver who happens to be strolling past the pond, and a frail elderly lady on her morning walk. We will be more likely to criticise the life-saver for failing to save the life of the drowning person than the elderly lady, due to the relative ease with which the life-saver could save the person’s life, and the danger that the elderly lady would put herself in, were she to try and assist, and the likely futility of her attempt. Both ethics and law take into account the various circumstances which are relevant to our judgments. But we can also imagine that it would be highly impractical if the law tried to make these sorts of distinctions in individual cases, so - as in many other areas - it establishes a rule which is quite black and white, and to which some of us might morally object on the basis that the failure to act by the life-saver was a culpable omission, because to act and save the person’s life would be something of little or no cost to the life-saver. But if the law tried to specify who was obliged to help and who was not, and also specify the kind of situations in which certain categories of people were or were not obliged, our laws would become voluminous, cumbersome and impractical. The law is often described as a blunt instrument, but this is inevitable. As we will see later, there may be a legal requirement for a doctor to help in the circumstances of our CBL case. Sometimes the law will single out an identifiable category of person, in certain defined circumstances, and impose a generally agreed ethical obligation as a legal one. So in summary, there can be a legal duty to do something which we take, from the human and ethical point of view, to be caring: a duty of care, within circumscribed



conditions. The law shapes and formalises what it understands as a moral consensus in the community: for example, that doctors have a higher level of obligation than other people, in certain defined circumstances. Recall from the lecture on law and human rights how our positivist system attempts to respond to changing social consensus. THE LEGAL DUTY OF CARE AND NEGLIGENCE Now recall, from the introductory lecture on medical law, that the legal category that most frequently involves doctors is that of torts, or civil wrongs, and the most frequently encountered tort is negligence. The law imposes a duty on doctors to act with reasonable skill and care; failure to do that amounts to being medically negligent. But first we need to determine what it means to be, and when, we are under that legal duty. What does it mean for someone to be under a legal duty? In general terms, it means that if the duty is not discharged (or not discharged at the required standard), the law can impose some sanction against the person placed under the duty, in favour of the person to whom the duty was owed. This might be a fine or imprisonment in criminal cases (eg where the “duty” is the duty not to assault or murder someone else). Or it might be financial compensation paid by someone who unintentionally harms someone else or their property (where the relevant duty is the duty to take reasonable care). Here we are interested in the duty to take reasonable care, as both an ethical and professional duty, but also as a legal duty, ie a duty which is considered of such importance that the community places us under the legal obligation, and if we are thought to have failed to adequately discharge that obligation, we may be considered to have been legally negligent (dictionary!). If someone considers that someone else has been legally negligent, they must demonstrate all of a number of important things (see Fundamentals of medical negligence, below), but the first of these is that the person considered negligent was, at the outset, under a duty of care to the person who claims to have been injured. So establishing that a duty of care existed is the first step in the process of demonstrating negligence: if I was not under a legal duty of care, then I cannot be held legally responsible for not acting in the way that the duty requires. Think of the pond example again: if no citizen is subject to a legal duty to rescue, then no one could be found legally negligent for failing to rescue the drowning person; however, if the pond was inadequately fenced and/or sign-posted by the local council, then the council could well be sued for negligently failing to take reasonable care to make the pond safe. Now, for doctors, it is uncontroversial that they are under both a professional and a legal duty of care to diagnose and treat their patients (and to do other things, but diagnosis and treatment are primary examples of the duty). In this resource, we are interested in both the foundations of that duty, and the boundaries of the duty. By examining some situations that are different from the ordinary case of the doctor and his/her patient in the surgery or the hospital, you will gain an appreciation of the shifting boundaries, and some of the uncertainty, in how the law governs medical practice. This uncertainty results from the fact that, unlike other areas of the law, where penalties are established for defined misdemeanours, “the types of action for which a negligence action can be brought are limitless and undefined: they cover the



full spectrum of human behaviour”.1 You can see that the law will be concerned with establishing a reasonable balance between compensating injured people on the one hand, and on the other hand, not stifling enterprise and initiative that create risk, since if there were no limits to negligence at all, no one would be willing to participate in anything for fear of continually being sued! Establishing the duty of care So it is important to establish the scope or boundaries of the duty of care, in our case, for doctors. This has tested the minds of the judges, politicians and others for a long time, and recently further significant changes have occurred, which will be introduced here, but elaborated in later lectures. Doctors will have all the duties to take reasonable care that any citizen has. For example, you could be sued for damaging your neighbour’s house if you fail to ensure that, while trimming your tree, a limb does not fall on his roof. The fact that you are a doctor makes no difference in cases like this. But we are interested here in doctors’ medical duties of care. While the scope and content of the medical duty will obviously be relevant to medical practice, the general requirements are the same across all activities. The first of these requirements that are crucial to the existence of a legal duty of care, including the medical duty, is the general idea of the neighbour. In very general terms, a legal duty of care arises between people who are “legal neighbours”, ie people who have the relevant relationship in the eyes of the law. This relationship is based on two central principles, although they have undergone some modifications more recently (see below). These are the principles of reasonable foreseeability and the relationship of proximity. If you think of neighbours and relationships, it makes sense that no duty of care can exist if there is no such relationship. The extreme case is easy: if you and I are both driving to town, I cannot be held responsible for your accident if I am on a different road – there is no relationship which connects us in terms of responsibility for the accident. The other extreme is also easy: if I am following you to town, and I fail to brake and consequently run into your car, then there is clearly a prima facie case that I negligently caused harm to you and/or your car – I failed to take reasonable care to avoid causing you harm, by failing to apply the brakes. I was your legal neighbour because I was behind you on the road. The modern era of negligence law began with a famous English case Donoghue v Stevenson,2 where Lord Atkin framed the test of the relevant relationship in these terms: “You must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour. Who, then, in law is my neighbour? The answer seems to be - persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts or omissions which are called in question.” (my emphases)

Here you can see the principles of foreseeability and proximity at work. But they are not easy to pin down. What is reasonable foreseeability? Who defines what is

1 J McIlwraith and B Madden. Health Care and the Law. Lawbook Co, Sydney, 2006, at 177. 2 [1932] AC 562.



reasonable? How closely and directly affected by my action must someone be in order that I should have them in contemplation? Just anyone who is affected, or a more limited number? You can see that even when the law tries to define things in terms of guiding principles, it is impossible to be so specific that all uncertainty is removed. The general idea is that not just anything that is foreseeable can be the subject of a legal duty of care, and it cannot be just any kind of relationship. Again, this would impose too high a level of duty, and be impractical in operation, so there must be some limits. The proximity of the relationship limits the foreseeable cases which are subject to the duty. The High Court of Australia, as well as lower courts, have wrestled with how these limits should be drawn, over a number of years. In recent times, the limits put on foreseeability by proximity have included different kinds of proximity: there could be physical proximity (eg of road users), causal proximity (a clear link between the action/omission and the injury sustained) and circumstantial proximity (eg a defined relationship such as the doctor/patient relationship, and further specifications of this). These types will often overlap. It is up to the courts to determine whether a defendant has a duty of care, based on the reasonable foreseeability of harm occurring within a relationship of sufficient proximity. The test of reasonable foreseeability established in an Australian case in 1980 was that a risk be “not far-fetched or fanciful”. A third element was subsequently added to foreseeability and proximity, which was a test of what was fair, just and reasonable. You can see that with this kind of test, judges had to interpret what the community would consider was a fair, just and reasonable imposition of a duty of care. So-called public policy considerations are important. These three tests were subsequently rejected in favour of a test of what is “reasonable in the circumstances according to community standards”, and a determination of what risks it was reasonable to take care about, including considerations of the social utility of the activity in question. Again, you can see here an attempt to balance (1) the necessity of all kinds of social and economic activity (including professional activities like medicine) and the difficulty of guarding against risks of harm, against (2) the need to compensate people for significant harms sustained as a result of what the community would agree as being substandard or negligent action. Note that the evaluative word “reasonable”, which appeared in Lord Atkin’s famous ratio, occurs again in this more recent Australian test. A brief history of negligence law Such was the situation in the early 2000s. It will be helpful to briefly digress in time and consider some historical facts which will put these and subsequent developments in perspective, and bring us up to date. In the English common law world, compensation for injury was once a matter of strict liability, ie compensation was paid by the person whose action or omission caused harm, not because s/he was at fault, but because the person was harmed as a result of a (usually dangerous) undertaking from which the first person benefited (eg a worker injured by an employer’s machinery would be compensated by the employer). In these cases, the defence that reasonable care had been taken did not operate, because even if the defendant had taken all the care that was possible, he would still be found liable if harm resulted, ie he was strictly liable. As the industrial revolution developed rapidly during the nineteenth century, it became apparent that strict liability would put unreasonable limits on enterprise, and



the law was changed to require a finding of fault, in order for compensation to be paid. The fault is the negligent failure to take reasonable care. This change effectively limited liability, and the history of this area of law has been, in part, a succession of strategies to limit liability in response to the expansion in the scope of negligence claims (remember the idea of the limitless types of action for which a negligence action might be brought, covering the full spectrum of human behaviour). In the area of medical negligence, the demonstration of fault is not easy, and many commentators have said that particularly in the medical arena, obtaining compensation is therefore often a matter of luck. Nevertheless, in recent years, particularly the 1990s, there was an apparent increase in the number of medical negligence claims in Australia (reflecting a world-wide trend), together with an increase in the damages (compensation) awarded to patients. This helped to bring about the perception of a “medical indemnity crisis”, with increasing indemnity premiums and a loss of doctors from some of the higher risk areas of practice, eg rural obstetrics, where the major load was shouldered by rural GPs. This in turn prompted the Commonwealth government to initiate a Review of the Law of Negligence in 2002, and this informed new legislation in all states, known as Civil Liability legislation, which again was designed to limit liability and damages through a number of measures. (The Review of the Law of Negligence which led to the Civil Liability legislation, was not confined to the medical arena, but was a general review, and the Civil Liability legislation is also general, although there are some sections which are specifically designed for professionals, and some even more specifically for doctors). (It should also be noted that many commentators consider that the “crisis” was deliberately contrived to favour doctors and their insurers, and that patients’ probability of being compensated for medical harm has been significantly eroded as a result of these changes). One of the measures was to provide a statutory definition of the duty of care, ie to try to give a more exacting definition the duty of care for professionals, including doctors. The relevant section in the Civil Liability Act 2003 (Qld) is: (1) A person does not breach a duty to take precautions against a risk of harm unless— (a) the risk was foreseeable (that is, it is a risk of which the person knew or ought reasonably to have known); and (b) the risk was not insignificant; and (c) in the circumstances, a reasonable person in the position of the person would have taken the precautions. (2) In deciding whether a reasonable person would have taken precautions against a risk of harm, the court is to consider the following (among other relevant things)— (a) the probability that the harm would occur if care were not taken; (b) the likely seriousness of the harm; (c) the burden of taking precautions to avoid the risk of harm; (d) the social utility of the activity that creates the risk of harm

(Reference 3) You can see here again the use of troublesome words like “reasonable” and “not insignificant”, but also that there is a need to take into account probability and seriousness of risk, the difficulty of avoiding the risk, and the social utility of the activity. In other words, this has been a natural progression from where the High Court arrived prior to the Review, and is an attempt to balance compensation for



injury with necessary social and professional activity. There is no doubt, however, that the aims of the Review and the legislation were to impose further limits on liability, ie to make it harder for injured people to obtain compensation, and consequently to drive down indemnity premiums and encourage doctors back into higher risk practice. As such, it has been criticised for favouring doctors more than patients. However, it needs to be said that requirements (1) & (2) above will be easily satisfied in the majority of ordinary doctor-patient interactions, and it will remain the case that the existence of a duty of care is usually not the subject of legal dispute between doctors and patients. It was the subject of debate in the emergency case described below, which shows how the boundaries of the duty of care are not fixed, and how they remain controversial and contested. Torts and negligence To further orient you in relation to the duty of care and negligence, it is helpful to understand negligence as one of a number of torts. Tort is originally a French word meaning civil wrong (tort means wrong, or twisted – consider our word “tortuous”). Torts are civil wrongs which give rise to legal actions between people, in order to provide compensation for harm. Recall the example of my tree limb falling on my neighbour’s roof. Here, I did not intend the damage to his roof to happen; nevertheless, I may be held to have been careless, ie to have not exercised sufficient (reasonable) care to prevent it falling and damaging the roof. You can see that negligence does not require that someone’s action be intentional, as it must be in the case of most crimes. There is a continuum of seriousness of motivation in relation to torts: intentional (more serious) wreckless negligent innocent (less serious) and also a continuum of seriousness of the interests which tort law protects: bodily security (more serious) property / reputation / feelings economic status (less serious) Negligence is not intentional, but it is also not innocent, because some fault is considered to be involved. It is a matter of not taking sufficient care. Imagine I am a Himalayan tour guide. It is one thing to push one of my clients off the mountain to their death. It is another thing to fail to ensure that my party is given instructions about safe walking. If someone falls to their death as a result of my failure to issue safety instructions, I have been negligent – not as seriously at fault as if I had intentionally pushed them off the edge, but at fault nonetheless. An example of an intentional tort is trespass against land or person eg if I assault someone, I may be criminally responsible, but I may also be sued for the tort of assault in a civil court. So there are intentional torts and unintentional torts. The unintentional tort of negligence is the one which, much more frequently than other torts, involves medical practitioners.



Fundamentals of medical negligence We are now in a position to make some sense of the central requirements of negligence, including medical negligence. There are three fundamental requirements, all of which must be demonstrated in order for the doctor to be found negligent, and to have to provide compensation to the patient. 1. A DUTY OF CARE WAS OWED (eg by the doctor to the patient)

• foreseeable risk qualified by factors described above 2. THERE WAS A BREACH OF THE STANDARD OF CARE

• reasonable care = that of ordinary skilled person professing skill • defined currently as care widely accepted by peer professional opinion, ie by a

significant number of respected practitioners in the field, as competent professional practice.

3. THE BREACH CAUSED THE DAMAGE OR HARM SUSTAINED

• factual causation (breach is a necessary condition of harm) • normative causation (it is appropriate for scope of liability to extend to harm) • remoteness of damage (~ = foreseeability)

(These three elements are now part of the Civil Liability Act 2003 (Qld), whereas previously they were accepted as part of the case law. You can see here that a statute has “taken over” from the case law, although the case law remains relevant, and negligence cases are still decided in the courts. The courts must now look to the legislation for guidance, in addition to earlier cases).

Don’t worry at this stage about the details of requirements 2 & 3. The focus at present is on establishing the existence of a duty of care, and the scope of the duty of care (element 1 above). It will suffice at present to give a simple example of how the three requirements are applied. Imagine that a young female patient consults a doctor concerning a breast lump. The doctor examines the patient and considers that she has a benign lump, and reassures her. Twelve months later she is found to have breast cancer. She sues the doctor for failure to diagnose her breast lump adequately, with resulting harm. In order to be successful, she must persuade the court that 1. A DUTY OF CARE WAS OWED This is clearly the case, as she is one of the doctor’s patients (relationship of circumstantial proximity; reasonable forseeability that failure to diagnose a cancerous lump could lead to damage, of a not insignificant kind; other requirements of Civil Liability Act satisfied). 2. THERE WAS A BREACH OF THE STANDARD OF CARE Reasonable care in the circumstances would require more than a physical examination. It would in many if not most instances also require imaging; this would be widely accepted by peer professional opinion by a significant number of respected practitioners in the field as competent professional practice, and failure to arrange it would be a failure to practice at a reasonable standard. 3. THE BREACH CAUSED THE DAMAGE The failure to order imaging is likely to be seen as having brought about the harmful result, because the court would be likely to accept expert evidence that imaging



would have probably revealed the lump to be a cancer, facilitating earlier treatment. So the breach is a necessary condition of harm (factual causation); it was appropriate for the scope of liability to extend to harm in this case (normative causation); and the damage was not too remote. Note that establishing causation would depend on clinical expert evidence to the effect that it was more likely than not that the lump found on initial examination in fact developed into the cancerous lump. If this is not accepted, the patient cannot win the case, and obtain compensation, even if it is established that the doctor breached the standard of care. Why? Because all three elements must be satisfied. More about causation and the standard of care in later resources. MEDICAL NEGLIGENCE AND EMERGENCY ATTENDANCE TO STRANGERS We are now in a position to examine the case of an emergency, and to think about how we would answer some of the questions posed at the beginning. Remember that the object is not to become expert about this particular kind of case – you will see that no one is an expert concerning emergency cases for reasons that will emerge, and that uncertainty remains – but about the general principles of the duty of care and the shifting scope of the duty. In considering the issues, you should get a good general feel of how the law in this area operates as one of the primary social contexts of medical practice. We have already seen, and illustrated this with the pond example, that there is no general duty to rescue in the Australian common law system. There is, in fact, one exception. Section 155 of the Criminal Code of the Northern Territory states:

"Any person, who, being able to provide rescue, resuscitation, medical treatment, first aid or succour of any kind to a person urgently in need of it and whose life may be endangered if it is not provided, callously fails to do so is guilty of a crime and is liable to imprisonment for 7 years.“

The phrase “any person” appears to impose the duty on the average citizen, but note the use of “being able to provide …” and “callously”. Our elderly lady passing the pond would not be considered “able to provide …”, and her failure to help would not be regarded as callous. “Callous” was interpreted in a 1994 NT case as meaning a deliberate and conscious choice not to help, and so, to some extent, restricts the scope of the duty. It is clear from the breast cancer example that in the normal situation of doctors and patients, a duty of care exists, but apart from the NT exception, there is no general duty to rescue, and this was confidently thought to extend to medical practitioners in relation to people who were not their patients, ie in situations like that in the CBL case. This confidence was upset by a well known NSW case in 1996.3 The sister of an epileptic child was sent to summon help from a local doctor, when the boy was found severely fitting one day, during a holiday. The doctor advised her to bring him to the surgery, and when she said this was impossible, he told her to summon the ambulance, which she said had already been done by another family member. Despite her insistence, the doctor refused to attend the child himself. The court considered that had he gone, he would have been able to treat the child with

3 Lowns v Woods [1996] Aust Torts Reports 81 – 376 (CA NSW)



intravenous valium, which could have aborted the fit and probably prevented some or all of the serious brain damage which subsequently occurred. The doctor was found to have negligently failed to attend the child. The case was controversial as the child was not his patient, and therefore the situation was one of “rescuing a stranger”, for which there was no legal precedent, even in the case of a doctor. So the initial and crucial question for the court was “Was there a duty of care?” Remember that all three elements (duty, breach of standard of care, causation) are required to establish negligence, and a little thought will reveal, on the story given, that the other elements would have been probably satisfied. So in this case, the question of the existence of a duty was the crucial concern that the court had to decide. As previously noted, the existence of the duty of care will usually be in no doubt, and it will be the breach or the causation element which will be in dispute – think of our breast cancer case above. At the NSW Court of Appeal, it was found that physical proximity was satisfied (it was a short distance from the doctor’s surgery to the boy’s accommodation); circumstantial proximity was satisfied (there were no barriers preventing the doctor from attending, such as dealing with another patient); causal proximity was satisfied (treatment could have prevented harm). But it was also considered, in view of a statement in the existing Medical Practitioners’ Act 1958 (NSW) concerning emergency attendance, as expected professional conduct, and that the medical profession has a generally higher duty than the public, that the duty element was satisfied. Not surprisingly, the decision was criticised heavily from some quarters, notably the medical profession, which saw its duties being expanded beyond existing precedent, and considered that this would set an unduly onerous standard for doctors – the implication being that they would always have to regard themselves as being “on duty”. It was felt that such a decision was not for the courts to make, and that the court was making new law on the run, rather than this kind of development requiring legislation. The court was seen as usurping the role of the parliament, by transforming a moral and professional obligation (in the Medical Practice Act) into a legal one, in the absence of a clear legal precedent. Remember that the case reached the NSW Court of Appeal, not the High Court of Australia. This means that the case forms a precedent for NSW, not for the rest of Australia. Remember, too, that the case was heard under the common law regime which existed then, and which has now been superseded by the Civil Liability statutes. And finally, remember that this is just one case, with its particular circumstances. Any future case, say in Queensland, would be tested under the Civil Liability Act 2003 (Qld), and in terms of its particular details. So prediction about future emergency cases is not an easy matter. Having said all this, it is also the case that the NSW decision would be studied closely in any state in any case that bore a fundamental similarity to it. GOOD SAMARITANS Failure to render aid in an emergency may be regarded as unprofessional conduct. “Good Medical Practice: A Code of Conduct for Doctors in Australia”, which is recognised by the Medical Board of Australia as setting professional standards for all doctors, states at 2.5 Treatment in Emergencies:



Treating patients in emergencies requires doctors to consider a range of issues, in addition to the patient’s best care. Good medical practice involves offering assistance in an emergency that takes account of your own safety, your skills, the availability of other options and the impact on any other patients under your care; and continuing to provide that assistance until your services are no longer required. (Reference 4) Note that this is a professional guideline, not a duty under negligence law as established in NSW for doctors (Lowns v Woods) or a statutory duty as in the Criminal Code in the NT. Recently in WA, the professional guideline was subject to examination in a case involving an off-duty radiologist who had been in an incident involving another car at night, and had driven to a nearby police station to summon help, rather than stay at the scene and render direct assistance. The trip to the police station took only a minute, but a person in the other car subsequently died at the scene. The WA Administrative Tribunal found that the doctor should have stayed at the scene and rendered assistance, even though she was shocked and shaking, and that her failure to do so amounted to improper conduct for a doctor. This decision was overturned by the Court of Appeal of the Supreme Court of WA, based primarily on finding that the Tribunal had failed to establish that there was a specific professional duty that the doctor failed to uphold, that would have been supported by her professional peers. This was a hotly disputed case, pitting the general principle that doctors should try and assist in emergencies against the particular, distressing circumstances at the time. Clearly, while the doctor in this case finally (after 12 years!) had the initial decision overturned, it remains the case that doctors could be found to have practised improperly in relation to the Medical Board of Australia’s Code of Conduct for Doctors in Australia, in certain circumstances where they fail to render “Good Samaritan” assistance. But what happens when a medical “Good Samaritan” does go to someone’s aid? For example, had Dr Lowns gone to the aid of the fitting child, what standard would his treatment have been held to, given that he would have been out of his usual surgery environment? What standard would an off-duty doctor be held to, in a “Blood on the Road” situation? Queensland and all other states and territories have enacted protective legislation which encourages health professionals to step forward and help, with an assurance that they will not be sued if something goes wrong. Under this legislation, there is no liability for the health professionals if the action is performed in good faith, without gross negligence, and without a fee or expectation of a fee. It is important to note that this legislation does not require attendance at emergencies, but provides protection against legal liability in the event that a health professional attends and treats. Note also that there have been no Australian cases of negligence against Good Samaritans, including doctors. Once a doctor moves to a conventional situation, however, the normal rules of negligence apply. For example, if a doctor provided assistance at the scene of an accident, accompanied the person to a recognised treating facility, and continued to provide treatment, say in a hospital or emergency centre, the circumstances have changed, with any concessions made for the difficulties of treating at the roadside no longer applying. (Reference 5)



CATEGORIES OF THE LEGAL DUTY OF CARE We have examined the difficulties of establishing the scope of the duty of care, mainly in relation to the example of the emergency attendance on a stranger, but this is an unusual case, and with the normal doctor/patient relationship there is no such difficulty. But just what are the activities within this normal relationship, which are governed by the legal duty of care and the required standard? That is to say, what are the routine categories of activities of doctors that are subject to the legal duty of care? They include

the duty to diagnose and treat (straightforward - the most common duties); the duty to attend when required (eg house-calls) or at least to arrange for

medical attendance / attention (including at least some emergencies in NSW, and possibly elsewhere, but note the uncertainties for other places and for all places depending on the circumstances of the case);

the duty to disclose adequate information for decision-making (detailed attention is given to this topic in year 2);

the duty to follow-up patients (some uncertainty exists here as to the level of follow-up, but cases of negligent follow-up have been decided against doctors in Australia);

the duty to keep patients’ confidences (detailed attention is given to this topic in year 2).

The following duties are somewhat less certain, ie they illustrate the uncertain scope of the medical duty of care:

the duty to passers-by (see below); the duty to protect third parties (two cases in NSW); the duty to potential patients (non-emergency cases; one case in NSW).

There is also a duty of care which, although it is certain, is somewhat unusual:

the duty to the unborn (more detailed attention will be given to this topic in year 2; it is mentioned in the Kerridge text).

There is an additional duty that might not be seen as a direct duty of patient care, but can be thought of as helping to fulfil the general concern to benefit and not harm patients. This is

the duty to disclose medical error (see below). And a new duty is rearing its head, although it is too early to be clear about it:

The duty to review test results generated by Nurse Practitioners (NP), even if there is no established collaborative arrangement between the NP and the GP to whom the NP has sent the results.

Finally, the question arises as to whether there is a duty to continue to see a patient, once a doctor-patient relationship has been established. Or can a doctor end a doctor-patient relationship? The answer to this second question is - yes. There will inevitably be instances of communication breakdowns, loss of trust, instances of extremely poor compliance, doctor-shopping, coercive or otherwise unacceptable behaviour on the part of a patient despite attempts to medically manage this, and so on. In such cases, it is legally permissible for a doctor to indicate to the patient that s/he can no longer be their doctor. The primary consideration should be that continuing the doctor-patient relationship is judged to be not in the best interests of



the patient, even though the motivating factor for the doctor might be something the patient has said or done. This requires adequate advice regarding the decision, advice re outstanding clinical issues that need to be addressed, and a request for the patient to notify the doctor of any new arrangement so that clinical information can be forwarded. Duty to disclose medical error In these days of quality assurance, demands for quality and transparency from more educated/demanding patients, and the erosion of professional autonomy and protection, the duty to disclose error has become a cutting edge issue for ethics and law. On the one hand, error itself is complex and not always attributable (or at least solely attributable) to individuals; it may imply an admission of legal liability and vulnerability to sanctions; and it may harm vulnerable people. On the other hand, admission of error is one way of dealing honestly with patients; it satisfies requirements for justice; and it supports a more open system which can use it to improve medical treatment, prevent recurrences and provide patients with reassurance that something has been done. There has been a trend in recent years to move from a professional ethical discretionary model (ie where doctors are encouraged to disclose individual error) to a more systematic model, where disclosure of error will often be from a team or institution. There is greater support for both patients and health care workers within the healthcare environment, but there is also a trend towards imposing a more explicit legal duty. An Australian Open Disclosure Framework has been developed by the Australian Commission on Safety and Quality in Health Care: (http://www.safetyandquality.gov.au/our-work/open-disclosure/), in association with other safety and quality assurance measures. Queensland Health has an Open Disclosure program which follows the principles of the Australian Open Disclosure Framework. The Medical Board of Australia, in “Good Medical Practice: A Code of Conduct for Doctors in Australia”, includes disclosure guidelines at 3.10.

(Reference 4) But is there a strict legal duty to disclose medical error? The short answer is YES – at least to the extent that there has been a case in NSW, where the judge stated that the doctor, who had severed the patient’s accessory nerve during an operation to remove a shoulder lump, and where the patient lost the opportunity to have the nerve repaired because she was not told, ought to have determined that the nerve had been damaged and ought to have informed her.4 And there have been cases in overseas common law jurisdictions, notably in the UK - Naylor v Preston Area Health Authority (1987) 2 All ER 353 - where the judge stated that there is a duty of candour which arises out of the general duty of care of the doctor to the patient. Like the Lowns v Woods emergency attendance case, these cases do not provide a certain precedent for Queensland; nevertheless, it is likely that a similar case here would have the same result. More will be said about medical error, patient safety and open disclosure in year 2.

4 Wighton v Arnott [2005] NSWSC 637.

http://www.safetyandquality.gov.au/our-work/open-disclosure/



Duty to passers-by Consider the following cases: 1. A doctor passing through the airport notices that the security officer checking his bags is sweating, has a tremor, a distinct anterior neck welling and very prominent eyes. The doctor suspects that the officer may have hyperthyroidism, and wonders whether to say anything to her. 2. A doctor notices a very dark, craggy skin lesion on the foot of a forty year old friend of her daughter. She wonders whether to advise him to seek medical advice. These cases are like the Lowns V Woods case in one respect – there is a possible obligation on the doctor towards someone who is not their patient – but unlike the Lowns v Woods case in another - they are not of the same urgency (although both are potentially serious). Such cases have not arisen within the case law, so there is no direct legal guidance to be had. You should think about them from the ethical and professional point of view. Try and formulate a case where there is a strong ethical (and a likely legal) duty to act, and another where the ethical duty would not be so strong, and where it would be unlikely that there was a legal duty. (Reference 6) FINAL WORD OF ADVICE You should regard this resource and the accompanying lecture as a broad basis for much of what follows in phase 1 in the areas of the professional and legal duty of care, and related issues to do with the standard of care and causation. Refer back to this resource when you reach these other topics, and it should assist you in obtaining a coherent picture of some of the most important professional and legal requirements imposed on individual doctors. The detail of cases is not the focus, but the principles to which they point, and the reasons for changes in the law governing these areas.


LEARNING RESOURCE: CONSENT TO MEDICAL TREATMENT

CONSENT TO MEDICAL TREATMENT ETHICAL BASES, ELEMENTS AND LEGAL REQUIREMENTS SUMMARY Author Malcolm Parker (School of Medicine) Contact [email protected] Revised February 2015 Learning Objectives

Explain the ethical bases of consent to medical treatment the ethical and legal requirements for valid consent the legal implications of failure to obtain consent the contribution of proper consent to patient safety

Resource Summary

The series on consent issues comprises Consent to Medical Treatment, Informed Decision-Making / Negligence and Refusal of Treatment. This lecture examines the ethical bases of consent to medical treatment, the necessary elements of consent including competence, voluntariness, and disclosure, additional legal requirements for legally valid consent, and the legal processes which may be pursued when valid consent is not obtained.

Key Words consent, competence, informed decision-making, disclosure, trespass, negligence, advance directives, research

References 1. Kerridge I et al, Ethics and Law for the Health Professions, Ch15 (4th Ed). 2. Stewart C et al. Australian Medico-legal Handbook. Ch 6 (pp 65-72). 3. QHealth Informed Consent website: http://www.health.qld.gov.au/consent/ At this site, see examples of individual procedure consent forms. See QHealth Guide to Informed Decision-Making in Healthcare at http://www.health.qld.gov.au/consent/documents/ic-guide.pdf 4. Australian Health Ethics Committee of the NHMRC: National Statement on Ethical Conduct in Research Involving Humans (2007), at http://www.nhmrc.gov.au/guidelines/publications/e72 5. A Akkad et al. Patients' perceptions of written consent: questionnaire study. (2006) 333 BMJ 528. 6. S Seiden & P Barach. Wrong-Side/Wrong Site, Wrong-procedure and Wrong-Patient Adverse Events. (2006) 141 Archives of Surgery 931-93.


http://www.health.qld.gov.au/consent/

http://www.health.qld.gov.au/consent/documents/ic-guide.pdf

http://www.nhmrc.gov.au/guidelines/publications/e72



Purpose The lecture and this LR examine the ethical and legal elements of consent to medical treatment. In addition, they attempt to clarify some important variations in terminology. In discussions about consent, some terms have different meanings, depending on the country or jurisdiction in which they are used. (eg consent, valid consent, informed consent, informed decision-making). These differences will also be considered in the materials concerning information disclosure for decision-making. The three resources covering consent, informed decision-making and refusal of treatment, should be considered as a suite of interrelated materials. Ethical bases of consent The idea of consent goes beyond mere agreement. Think of the sorts of things we might agree to, and the sorts of things we might consent to. Are they the same? Agreement is often (though not always) concerned with factual or moral belief - "I agree with what you say";; “I believe the same thing you do”. With consent, there is more of a sense of acting: giving consent means the authorisation, by a competent, and hence autonomous person, of someone else to perform some act in relation to the authorising person. Failure to obtain proper consent prior to acting therefore amounts to interfering with the person without his/her authorisation. Whether this causes damage or not, it is an infringement of their freedom, but if there is damage, it is also an infringement of their bodily integrity and inviolability. Consent to medical treatment is ethically and legally required because what would otherwise, in many cases, be an assault of a serious nature, must be authorised! Patients may consent to many different things, such as the release of confidential information (where increased obligations have been applied to health care practitioners through amendments to the Commonwealth Privacy Act). The paradigm case of consent, of course, is the performance of a medical procedure or investigation, which often involves some risk to the person. This is an example of consenting to a direct intervention affecting the patient. More “indirect” interventions, such as prescribing drugs, must also be consented to, although this is often achieved by an implied consent, rather than an explicitly stated or written consent (see below). Elements of consent Not surprisingly, all of the following requirements relate to the patient's autonomy: 1. The authorisation must be free and voluntary. Think of the kinds of influence which a doctor might bring to bear on a patient which might coerce his decision, and the things which, while still having some bearing on patient decisions, leave the patient to freely decide. Is there a difference? What are some examples of these different types of influence? 2. The patient must be competent. The patient must comprehend, believe, and understand the information provided.



Recall earlier discussions of the requirements for competence, including the situations in which competence may be compromised. Could a person be incompetent in some respects yet competent to authorise a certain treatment? Remember too that a person may be permanently incompetent, while someone else may be temporarily incompetent, eg due to the effect of drugs, alcohol or a medical condition eg an infection. 3. The patient must be adequately informed. Authorising a treatment without adequate knowledge might turn out to be authorising something which we do not want to happen. In regard to this, some patients will have language difficulties, and may require interpreters to help them understand the proposed treatment. Note that being competent and being informed are different things. Some people see being informed as an element of competence, believing that you can’t make a competent decision unless you are adequately informed. Well, you certainly can make a competent decision, even if you are inadequately informed, but you may well have made a different decision, had you been better informed. Think clearly about this statement. In both cases, you make a competent decision in the light of whatever information was made available to you. Competence is a characteristic of the person making the decision, not of the information made available. Legally valid consent The three ethical principles covered above are also included in Australia's requirements for legally valid consent. But it is important to note in relation to being informed, that for legally valid consent, this must be in the form of being given a broad, general understanding of what is proposed. We will see in the lecture on informed decision-making that more detailed, patient centred information must also be provided, but this is in relation to satisfying the requirements for non-negligent disclosure for decision-making. This may sound like splitting hairs, but in Australia the law has certainly split this particular hair). In addition to these three fundamental requirements, there are some additional legal requirements: 1. The patient's consent must cover the actual procedure to be performed, and not a different one. If I consent only to an appendicectomy but I am also sterilised during the procedure, then I have not consented to everything that occurred; my consent was not legally valid in relation to the sterilisation. (Are there any exceptions to this? Think of life-threatening situations). 2. The procedure must be legal in itself. (What examples of illegal medical procedures can you think of, to which a patient may still be willing to consent, even desperately keen to have happen?) 3. The consent given to a doctor to perform a procedure refers to only that doctor. (In what situations might this rule be waived? Why? Think of public hospitals and the nature of the care provided therein).



Consent and trespass Failure to satisfy these requirements may indicate that consent was invalid, and result in legal proceedings against doctors. Consider a case where the left arm was operated on instead of the right: what was done was not what was consented to. Or consider a case where the person was deceived into providing consent to a procedure which he did not really want. In these cases, something has occurred without the patient's voluntary authorisation - an invasion of the person's body to which he did not properly consent – legally, this amounts to a trespass on that patient's person. You should review the material concerning the duty of care, where the idea of tort was introduced. Trespass is a tort (a civil wrong) involving a wrongful, direct interference with another person, or with his/her land or property. Trespass can be of two kinds, when it concerns interference with the person: assault or battery. An assault is an intentional or reckless act causing someone to be put in fear of harm. A battery is an intentional or reckless application of physical force to someone without his consent. (The terminology is a little confusing, since in day to day conversation, we often use the term “assault” to indicate physical contact and harm, but the legal terminology distinguishes assault and battery as described). The criminal law punishes common batteries. Medical assaults/batteries resulting from, say, fraud, deception, or physical force may also be punished as crimes (consider a doctor who sedates patients in order to indulge in sexual acts with them – if found guilty he will be sent to prison, for criminal assault and for rape). But more usually, medical assault/battery will be dealt with under the civil law tort of trespass, because most cases will be unintentional, and because the primary aim of the legal suit is to recover compensation for the patient. Think again of the mistaken operation on the left arm instead of the right. The doctor who committed this mistake arguably should not be put in jail, as s/he did not intend to operate on the wrong arm. However, s/he did make a serious error. (Here we are interested primarily in the legal matter of consent and trespass, but in such a case, of course, related issues of patient safety, medical error, apology etc also arise: see last section of this LR). Trespass is said to be actionable per se, ie the patient does not have to prove that any actual damage occurred, in order to be successful in the legal suit. Indeed, a patient whose life has been saved may still sue in trespass, if s/he did not provide consent to the life-saving procedure. This occurred in a well known Canadian case where a life-saving blood transfusion was given to a patient who had rejected in advance any treatment with blood products. Damages were awarded, despite the opinion of the appeal court that the treatment in itself was competent, the results were favourable (ie favourable in the eyes of most people because life was saved), and the doctor's overall conduct was exemplary. Nevertheless, the Jehovah’s Witness patient suffered mentally and emotionally as a result of an unconsented blood transfusion. In view of the tensions between the patient’s advance refusal of the treatment that was given and the doctor’s understandable perceptions of his professional obligation to save the patient’s life, the damages awarded were only small - $C20000).



Trespass and negligence Recall the other, medically more frequent kind of tort, introduced in the Duty of Care lecture - negligence. The distinctions between trespass and negligence are important in Australian medical law. 1. Consider the saving of the Canadian patient's life by way of a blood transfusion, despite her carrying an informal advance directive, refusing consent to any such transfusion: here, there is an intentional action (a battery), and the patient may sue the doctor in trespass (a technical battery). 2. Consider another case, where a patient consents to an operation on her left arm, but the doctor mistakenly operates on her right. Since she did not consent to the procedure that occurrred, the patient again may sue the doctor in trespass. The fact that the doctor did not intend the damage resulting from operating on the wrong arm does not prevent the patient from taking such action, as we have seen. (See reference 6 for further consideration of errors of the wrong side, wrong site, wrong procedure and wrong patient types). 3. Finally, consider the case where the patient consents to an operation on her left arm, having a general idea of the kind of operation which will be performed. The operation is performed on her left arm, but complications follow, about which she was not fully appraised. Because she had an adequate broad, general understanding of the proposed surgery (one of the requirements of legally valid consent, above), and because the doctor did nothing which she didn't authorise, she would not be able to successfully sue the doctor in trespass, since she validly consented to the operation performed, on the basis of that general understanding. It is only actions where no consent to the procedure done has been given (eg 1 & 2 above) which can be pursued in trespass. In case 3, the doctor has not failed to obtain the patient's consent, nor acted without her consent, and not overridden her refusal. But in failing to disclose to her certain materially relevant risks, the doctor has reduced the "quality" of the consent she has given, by making it less informed from her particular point of view. Had the patient been more adequately informed of the risks, she may not have had the procedure. In this case, she could sue the doctor in negligence, based on the claim that she was inadequately, or negligently, informed, in terms of what was significant to her. In summary, a valid consent requires the features listed above, just one of which is a generally adequate disclosure. If valid consent is not obtained, a patient may sue the doctor in trespass. Informed decision-making is governed by more stringent disclosure requirements, and failure to disclose risks under these requirements may result in a suit in negligence. This will be discussed fully under Informed Decision-Making / Negligence, in the next lecture.



Because of this distinction, the term informed consent, which combines the consent element and the disclosure element, is somewhat misleading in Australia. Interestingly, Queensland Health has developed a framework for consent and a collection of specific consent forms for a range of procedures, which go some way towards combining the requirements for both consent to treatment and informed decision-making, which have been distinguished above. We will examine these more closely under Informed Decision-Making / Negligence. QH has also recently developed a comprehensive Guide to Informed Decision-making in Healthcare, which similarly combines the requirements in relation to both consent, and informed decision-making. (Ref 3) Queensland statutory provisions concerning consent by incompetent persons Patient competence was stated above to be one of the primary requirements for an ethically and legally valid consent. Does this mean that when a patient is not competent to consent to treatment, consent is not required?

No, it means that consent must be sought from another person or body, in almost all cases.

Queensland (and other states) have enacted a number of laws which provide for substitute decision-making, following extensive community and professional consultation. Generally speaking, these provisions have shifted decision-making power in the direction of patients and families, and away from health care professionals. The relevant Queensland legislation is the Powers of Attorney Act Qld (1998) and Guardianship and Administration Act Qld (2000). These Acts and their provisions will be examined in greater detail later this year, when there is a focus on advance health directives and substitute decision-making for people who have been competent but have lost that competence (or decision-making capacity). At this stage, it is important to be generally aware that they extend the decision-making powers of citizens by way of processes allowing advance planning for a time when the person will be incompetent, for example, by writing an advance health directive, or appointing an attorney (usually a family member) who can give or refuse consent for

a number of (but not all), health care matters, or in the absence of the appointment of an attorney, having a default attorney, known

as a “statutory” attorney, given the same powers (usually a spouse, unpaid carer or close friend).

What is consented to by a competent person, or through an advance directive, carries most weight. There are some matters, such as tissue donation, research, ECT, psychosurgery, and sterilisation, to which consent may be given by competent persons, either directly or through an advance directive, but not by attorneys acting for incompetent people. In Queensland, these matters are referred to as Special Health



Care. Consent to such matters on behalf of an incompetent person, who has not previously authorised them via an advance directive, is given by the Queensland Civil and Administration Tribunal, or in the case of ECT and psychosurgery, under the provisions of the Mental Health Act. The withdrawal of life-sustaining treatment, which a competent person may authorise directly or via an advance directive, was initially a Special Health Care matter, and was excluded from those things to which attorneys could give consent. However, an amendment to the Powers of Attorney Act 1998 now allows this to occur, under certain conditions. Most people who write advance health directives do so to indicate what treatments they do not want, and under what circumstances, in order to prevent receiving unwanted treatment. But advance health care planning, including advance health directives, includes the possibility of consenting to treatment in advance, as well as refusing treatment in advance. When might it be important to think about making an advance consent to treatment? (Clue: think of the mental health setting). A current controversial issue concerning consent on behalf of incompetent people relates to treatment that is considered clinically futile by the treating doctor/team. The Queensland legislation currently requires that the substitute decision-maker must consent to the withholding of treatment that is considered futile, because (1) medical treatment must be consented to and (2) withholding treatment is included in the definition of medical treatment in the relevant legislation (Guardianship Act). This means that doctors must inform substitute decision-makers about treatment that they are not considering commencing, and obtain consent for not commencing it. This is not a requirement in other states, based on the common law rule that doctors are not obliged to provide futile treatment. This situation was considered by the Qld Law Reform Commission in its recent inquiry into Queensland’s Guardianship regime, with some submissions stating that Queensland should remove this requirement so that doctors are not required to obtain consent to not provide treatment that they believe is futile, whereas others argued for the requirement to be retained, on the basis that it is an extra safeguard against unilateral decision-making by doctors. We will revisit this particular feature of Queensland law when we discuss advance care planning and substitute decision-making in more detail later in the year and also in year 2. Ways of giving consent Three axes exist: consent may be given currently or in advance (see above); it may be explicit or implied, and it may be verbal or written. You should be able to distinguish explicit and implied consent, and provide examples of each. In which clinical situations would an implied consent be sufficient, and when would it be insufficient? An example of a situation where both explicit and implied consent are utilised is that of bone marrow transplantation. Here, consent will be provided at the outset, after the patient is appraised of the broad nature of the process. During the process, which often



involves a number of separate events, consent may be implied for the less significant interventions, while for the more invasive ones, a separate consent form may be completed. The crucial aspect is the continuing communication between health professionals and patients for the duration of the process. You should also be able to explain the relations between verbal and written consent, and the limitations of written consents (eg consent forms) in terms of consent being a process, rather than an event. Exercise See if you can obtain a consent form from a hospital ward, and critically assess it. Determine the extent to which a hospital consent form satisfies the requirements for

ethically and legally valid consent, as discussed above. Is the consent form the same as that provided at the QH Informed Consent website

for the procedures offered in that particular clinical setting, or is a different/”local” form in use?

Consent mistakes, checklists, hierarchies and patient safety The clinician responsible for the patient’s care is responsible for obtaining consent for interventions. This responsibility is still sometimes delegated to junior staff, and has often been performed poorly, through no fault of those staff, but often as a result of time constraints, procedural inadequacies and inexperience. Inadequate consent procedures can have serious consequences, mainly for patients but also for doctors and health facilities. For example, in 2002, a 78 year old woman’s healthy right breast was removed instead of her cancerous left breast, due to an error in a written consent form completed during a busy morning session at Campbelltown Hospital (NSW) as a result of a failure to check the medical records. In 2004, an English surgeon removed a transplanted kidney instead of the diseased polycystic kidney from a female patient, who subsequently required dialysis, as a result of inadequate time spent obtaining consent and confusion on the theatre list. Recognition of the problems, better consent forms, awareness of legal risk involved in poor consenting practices, and changes to procedures (such as obtaining consent at preadmission clinics) are helping to improve things. If junior staff obtain consent from patients, they must be aware of all the requirements of this task. Senior staff must be aware of their responsibilities to both patients and their junior colleagues in the matter of consent. Mistakes can also be minimised by the use of checklists. Recent research (2009) by the UK National Patient Safety Agency showed that using checklists can reduce surgery-related mortality by 40%. Another contributor to patient harm can be the hierarchical nature of medical culture, whereby junior staff members are prevented from speaking up in response to perceived failures in processes and procedures. Deliberate strategies, eg including on surgical checklists the requirement for all members of the surgical team to introduce themselves at the commencement of the procedure, can change the likelihood that staff will speak up when they have concerns.



Check the Surgical Safety Program page at p56 of the Fifth QH Report on Clinical Incidents and Sentinel Events in the Qld Public Health System 2009-2011, at http://www.health.qld.gov.au/psu/reports/docs/lta5.pdf. While this LR has focused on the ethical and legal aspects of consent in relation to individuals, you will see that a proper consent procedure is one of a large number of patient safety programs undertaken by modern health systems – check the program list under Section 5 at the contents pages. Also check the WHO Surgical Safety Checklist at http://whqlibdoc.who.int/publications/2009/9789241598590_eng_Checklist.pdf. Consent in clinical practice & research Consent to medical procedures is parallelled by issues of consent in research involving human subjects. Indeed, developments in the ethical and legal requirements of research preceded and stimulated changes in clinical requirements. Why do you think this was the case? (See ref 4 regarding consent requirements in research involving humans, but note that there is also a separate lecture concerning Research Ethics which covers this).

http://www.health.qld.gov.au/psu/reports/docs/lta5.pdf

http://whqlibdoc.who.int/publications/2009/9789241598590_eng_Checklist.pdf


LEARNING RESOURCE: INFORMED DECISION-MAKING

INFORMED DECISION-MAKING: STANDARDS OF DISCLOSURE, LEGAL REQUIREMENTS, NEGLIGENCE SUMMARY Author Malcolm Parker (School of Medicine) Contact [email protected] Revised January 2015 Learning Objectives

Distinguish between consent & informed decision making. Critically appraise the contested ethical standards of information and risk disclosure in relation to informed decision-making for medical procedures. Describe current legal standards for disclosure, and the history of change in the standard in Australia. Explain how failure to warn or disclose, as a breach of the duty of care, can constitute medical negligence.

Resource Summary

The lecture elaborates different perspectives on informed decision-making: ethical, clinical and legal. This associated LR notes allow students to reflectively explore issues raised: contested standards of risk disclosure, recent changes in legal requirements and their interpretation, and related legal procedures in medical negligence against doctors who inadequately inform patients.

References 1. Kerridge I et al, Ethics & Law for the Health Professions, 2013 4th Ed. (recommended text). Ch 15: Disclosure is discussed within the context of ethics & law of consent generally, but pay attention to pp356-365 in the legal section. See also Ch 13, pp277-278 & pp284-286 on therapeutic privilege. 2. Kirby M, Patients' Rights - why the Australian courts have rejected 'Bolam', Journal of Medical Ethics, 1995, 21:5-8. (an account of developments in negligence law concerning disclosure in Australia, with contrasts to other jurisdictions) 3. NHMRC. General guidelines for medical practitioners on providing information to patients. 2004. http://www.nhmrc.gov.au/publications/synopses/e57syn.htm 4. NHMRC. Communicating with Patients: Advice for Medical Practitioners. http://www.nhmrc.gov.au/publications/synopses/e58syn.htm 5. NHMRC. Making decisions about tests and treatments: principles for better communication. http://www.nhmrc.gov.au/publications/synopses/hpr25syn.htm 6. AMA. Informed Financial Consent 2006. https://ama.com.au/position-statement/informed-financial-consent-2006 7. QHealth Informed Consent Site: http://www.health.qld.gov.au/consent 8. Civil Liability Act 2003 (Qld) http://www.legislation.qld.gov.au/LEGISLTN/CURRENT/C/CivilLiabA03.pdf 9. Joint Commission. What Did the Doctor Say? Health Literacy and Patient Safety. http://www.jointcommission.org/assets/1/18/improving_health_literacy.pdf


http://www.nhmrc.gov.au/publications/synopses/e57syn.htm

http://www.nhmrc.gov.au/publications/synopses/e58syn.htm

http://www.nhmrc.gov.au/publications/synopses/hpr25syn.htm

https://ama.com.au/position-statement/informed-financial-consent-2006

https://ama.com.au/position-statement/informed-financial-consent-2006

http://www.health.qld.gov.au/consent

http://www.legislation.qld.gov.au/LEGISLTN/CURRENT/C/CivilLiabA03.pdf

http://www.jointcommission.org/assets/1/18/improving_health_literacy.pdf



PURPOSE This resource supports the lecture on informed decision-making, and is the second in the trio of lectures and LRs on consent, informed decision-making and refusal of treatment. These resources should help you to place the duty of disclosure in the context of the broad area of consent, and to understand the standard of care for disclosure of information and how that contrasts with the standard for other medical duties such as diagnosis and treatment, which will be discussed in a subsequent lecture. The previous lecture and the LR on consent to medical treatment contrasted valid consent/trespass with information disclosure/negligence, and explained why the phrase “informed consent” is somewhat confusing in the Australian legal context, as it combines these two distinct, though related, legal notions. Information provision or disclosure is discussed in more detail here. As one of the areas concerned with the standard of care, disclosure is the subject of recent legislative developments (civil liability legislation) which was part of the response, beginning in the early 2000s, to the medical negligence “crisis” of the 1990s. INTRODUCTION Recall that ethically and legally valid consent has a number of requirements. One of these is that the patient must be adequately informed about treatment, risks etc. Recall also that, in Australia, a patient's general understanding of a proposed treatment is sufficient to negate a doctor's liability in trespass, because with a broad or general understanding of the proposed procedure, the patient is able to authorise treatment (assuming all other consent requirements are satisfied). The phrase “informed consent” arose in the US, where failure to disclose risks and alternatives counted as negating proper consent. But for Australia, (and in the US too, more recently), the phrase is misleading, as it rolls two concepts, and two legal processes, into one (consent/trespass and disclosure/negligence). Does an authorisation based on a general understanding sufficiently reflect a particular patient's true wishes? To avoid legal suits for battery, doctors need to advise patients of the nature, benefits & risks of procedures in broad terms only; however, to avoid suits in negligence, they need to advise patients in greater detail, because risks of a specific nature may persuade a particular patient not to undergo a procedure. Failure to advise the patient of certain specific risks may result in the patient making a decision, which is not fully informed in terms of how that individual evaluates the risks. Just what needs to be disclosed and who determines this have changed over time, in both ethical and legal senses, to reflect changes in patient requirements and social mores. This raises issues for practice. Bear in mind the indication, given in the LR on Consent, that Queensland Health’s framework for consent and its surgical consent forms tend to blur the contrast between consent/trespass and disclosure/negligence, to some extent. You should revisit the QH consent website while considering the lecture and this LR, and think about the adequacy of the consent forms to



satisfy the requirements for both consent and informed decision-making. (Ref 8) INFORMATION DISCLOSURE AND NEGLIGENCE Recall previous discussions concerning the duty of care of doctors, in “normal” situations, emergency situations and others. Establishing that a duty of care existed is the first of a number of requirements in pursuing a negligence action, which is the pertinent action in relation to a claim of inadequate information disclosure. 1. Duty of Care In the vast majority of actions under consideration, there will be no dispute concerning the existence of a duty of care. 2. Standard of Care for disclosure: material risk Negligence implies that there was an alleged failure to observe the required standard of care. Very generally speaking, the legally required standard of care (for any pursuit, but including medicine) is the exercise of reasonable care to avoid foreseeable risks, where reasonable care provided by a person in a specific area is that of the ordinary skilled person exercising and professing to have that special skill. For any given group such as doctors, the difficult question is "What is reasonable?" and it has been answered differently in different jurisdictions and historical periods. That is to say, there have been changes in how the question is answered, but also in terms of who has the authority to answer it. Australia has tended to follow English rather than US legal trends until relatively recently. While in the US, a so-called reasonable person standard of information disclosure came into effect more than 40 years ago, English and Australian courts for a long time accepted that current professional practice should determine the legal standard of care. This became known as the "Bolam principle" (after a UK case), which states that doctors cannot be found negligent if they act in accordance with what a responsible body of medical opinion deems proper at the time. This applied to all areas of practice, including diagnosis, treatment, and disclosure of risks, and is also known as the professional practice standard. The profession determined the standard, and the courts accepted this. From the early 1980s, courts in Australia began to move away from the Bolam principle, this shift being a specific instance of the general rejection of medical paternalism. The famous Australian High Court case of Rogers v Whitaker (1992) crystallised as law for all of Australia, what some state courts had already been developing as more patient-centred requirements for information disclosure, based on the idea that medical expertise is not relevant to the question of what should be disclosed to a patient to facilitate his or her



decision-making, since medical expertise per se does not extend to knowing what is significant to each and every individual. In other words, medical knowledge does not give the answer – you have to ask the patient. From Rogers v Whitaker (RvW): "... a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. This duty is subject to the therapeutic privilege." So, in relation to disclosure, there are three possible standards:

1. Professional standard (Bolam: derived from UK)

2. Reasonable person standard (US) (Australia, following RvW)

3. Particular person standard Prior to RvW, state courts had moved only to the reasonable person standard, whereby doctors needed only to indicate serious or frequent risks, or risks specifically asked about by the patient. Note how the statement from RvW combines the notion of a reasonable person standard with the additional one of a subjective or particular person standard (ie what the particular patient deems relevant or material). Note also that this standard is quite high, since it requires the doctor to be aware of what his/her individual patients would be likely to attach significance to, not simply what they happen to ask about. They may not ask about things that they would still attach significance to, due to often not knowing the appropriate question to ask. You can see that this places a significant onus on the doctor to ensure that s/he becomes aware of this. Interestingly, the Bolam principle has now lost its influence in the disclosure cases even in the UK, through some recent cases which have moved closer to a reasonable person requirement for disclosure. Think about the three standards so far described, including the particular person standard, in relation to disclosure. How do they compare? Is there a best one, and if so, why? 3. Causation in relation to disclosure Recall that as well as the existence of (a) a duty of care, and (b) a breach of the standard of care, a successful negligence action requires (c) the demonstration that the patient was harmed by the breach of the standard of care, ie that the breach of the standard of care legally caused the harm.



Now, just as material risk can be understood in objective ways (reasonable patient) and subjective ways (particular patient), so too can the causation requirement. In the US, an objective (reasonable patient) standard for causation is used; this means that for procedures which are generally agreed to be necessary and important for patient welfare, negligence actions based on claims of inadequate disclosure seldom succeed, since the patient will find it very difficult to persuade the court that they would not have had the procedure, even if they been better informed. This is because they would have to demonstrate that a reasonable person would not have had the procedure. They need to do this in order to demonstrate the causal link between the harm sustained and the failure by the doctor to adequately inform them. If it is considered that the patient would have proceeded with treatment anyway, even in the absence of a warning, the patient cannot then claim that the damage would not have occurred. The court will usually think that a reasonable person would have had the treatment in most cases. By contrast, the High Court of Australia applied the subjective standard to both materiality of risk (above) and causation. This means that when a patient sued a doctor for inadequate disclosure of information leading to harm which could have been avoided, it was open to the patient to show that s/he would not have gone ahead, rather than having to demonstrate that any reasonable person would not have proceeded. Now while this appears to be easier to show - some critics have said the subjective standard "puts a premium on hindsight” and hence favours patients - it still had to be demonstrated in some way, not just claimed. A number of Australian disclosure/negligence cases following RvW failed because patients were not able to persuade the court of the causal link. The court believed that even if the particular patient in question had been more specifically warned, they would still have gone ahead with the treatment. This contrasts with RvW where the patient was able to persuade the court that she would not have gone ahead. ETHICS, LAW AND PRACTICE Despite the importance of the decision in RvW, (and as a consequence of the judgement), some commentators and doctors claimed that abiding by the law on disclosure became difficult and uncertain. The formal legal criteria concerning material risk still left it somewhat uncertain as to how much to disclose in individual cases. How are the various factors in each case, including the nature of the medical problem, the patient's desire for information (or sometimes the desire not to be informed), the nature of the treatment or test, the health status of the patient and the patient’s level of understanding etc, to be weighed? Can too much information be provided? There have been cases where patients have sued doctors for diligently disclosing information about risks or side effects, which the patient has then claimed persuaded him/her not to



undertake treatment, with resulting harm! You may be relieved to know that in these cases the defendant doctors have not been successfully sued ! Furthermore, how do doctors’ experiences, biases and preferences about investigations and treatments distort the provision of materially relevant information to patients? And did the High Court’s judgement, by placing greater impositions on doctors, lead to the practice of disclosing information being more of an event rather than an evolving process of interaction between doctor and patient, as some have suggested? This may have resulted from the understandable but mistaken interpretation of RvW by doctors that everything down to the remotest and most trivial risks must be disclosed, with time-poor doctors “solving” the problem by providing exhaustive lists of risks to patients (look again at the QH consent forms – are these excessively detailed? not detailed enough?) The NHMRC also produced guidelines for medical practitioners on information provision in 1993, yet uncertainty remained, and the requirements continued to be seen by some doctors as too demanding, especially considering the time usually available to discuss risks with patients. [It should be noted that these guidelines were in preparation well before the High Court made its judgement in RvW. They were based on a combined report of the Australian, NSW & Victorian Law Reform Commissions in 1989, that reflected developing community attitudes towards information disclosure]. The 1993 guidelines were recently reviewed, but they have remained in their original format (ref 3), supported by an additional statement on good communication practices with patients (ref 4), and a further publication “Making decisions about tests and treatments: principles for better communication” (ref 5). Therapeutic Privilege In RvW, the High Court stated that the duty of disclosure was subject to a “therapeutic privilege”. The court included the medical profession's right not to disclose information, in circumstances where the doctor considers that the disclosure itself would lead to significant patient harm. Generally speaking, the privilege demands a high threshold probability of significant harm, given current views on patient autonomy, and also considering empirical evidence suggesting that patients usually benefit from knowledge and participation in decision-making. It is generally agreed that, even if it is thought that the provision of information for decision-making will provoke anxiety and stress, this is insufficient to invoke the therapeutic privilege. (ref 1) Disclosure contrasted with diagnosis & treatment Clearly, the Australian trend during these years was towards a court-determined standard for information disclosure, reflecting the courts' recognition of the rights of patients to make decisions based on their own values and deliberations, rather than a profession-derived one. However, it is important to note that although the High Court defined the duty of medical



care as a “single comprehensive duty”, it also distinguished between negligent failure to diagnose & treat, on the one hand, and negligent failure to disclose risks, on the other hand, in terms of establishing an adequate standard of care. Although the High Court recognised that, in cases concerning diagnosis and treatment, the Bolam principle had not always been applied in Australia, it went much further in cases of disclosure of information for decision-making, by making it clear that the Bolam principle was well and truly “dead in the water”. Thus the court was recognising a logical and common sense distinction between areas where current professional practice must strongly influence legal judgments concerning the standard of care (diagnosis & treatment), and the area where medical expertise cannot be informative (the extent to which a particular patient desires information). This distinction will be explored further when we deal with the standard of care in diagnosis and treatment. THE MEDICAL INDEMNITY CRISIS AND RECENT REFORMS TO MEDICAL NEGLIGENCE, INCLUDING DISCLOSURE You will recall when we examined the duty of care, our brief coverage of how medical indemnity underwent significant changes from the late 1990s, in response to perceptions of excessive premiums, excessive medical litigation, and over-generous damages awards to patients. The medical profession had become increasingly critical of changes in how the standard of care was determined, whereby the knowledge and authority of doctors, even in diagnosis and treatment cases, had been apparently diluted as a result of a series of High Court judgements, including and following RvW. Due to community and medical pressure, the Commonwealth and state governments became active in this area from 2001. NSW passed legislation which restricted damages awards in personal injury cases. Queensland followed suit in 2002, with legislation which capped large claims, streamlined legal procedures, and encouraged structured settlements in preference to lump sums, amongst other reforms. The AMA amongst other groups pressured the Commonwealth government to reform the medical indemnity system, aiming for capped damages awards, a national scheme for financing catastrophic injury claims, and the redefinition of medical negligence, according to the perceptions of unfairness to the profession, mentioned above.

In early 2002, the Commonwealth initiated the Commonwealth Review of the Law of Negligence (Ipp Review), whose primary reference was to propose law reform aimed at limiting liability and the level of damages arising from personal injury and death (generally, not just in relation to medical practice). The Review made numerous recommendations concerning personal injury in general, but important ones concerning the duty of care, standard of care, causation and damages elements of negligence, including medical negligence. Some of these recommendations have been incorporated into



recent legislation, including Queensland’s Civil Liability Act 2003 (ref 8). We therefore now have the situation where different parliaments have responded to a perception of the inability of the common law to manage personal liability in a balanced way, particularly in the medical negligence arena. Consider this section of the Civil Liability Act 2003 (Qld) concerning the standard of care for professionals:

Standard of care for professionals (1) A professional does not breach a duty arising from the provision of a professional service if it is established that the professional acted in a way that (at the time the service was provided) was widely accepted by peer professional opinion by a significant number of respected practitioners in the field as competent professional practice. (2) However, peer professional opinion can not be relied on for the purposes of this section if the court considers that the opinion is irrational or contrary to a written law. (3) The fact that there are differing peer professional opinions widely accepted by a significant number of respected practitioners in the field concerning a matter does not prevent any 1 or more (or all) of the opinions being relied on for the purposes of this section. (4) Peer professional opinion does not have to be universally accepted to be considered widely accepted.

This is a return towards the Bolam principle of determining the standard of care, although it does include an “irrationality” condition (clause 2) which means that the court can still override professional opinion in rare circumstances. We will examine this “modified Bolam” standard when we look at the standard of care for diagnosis and treatment. BUT - importantly for the area of disclosure, there is a final paragraph to the section:

(5) This section does not apply to liability arising in connection with the giving of (or the failure to give) a warning, advice or other information, in relation to the risk of harm to a person, that is associated with the provision by a professional of a professional service.

So disclosure was quarantined from the return to the “modified Bolam” test for the standard of care. For disclosure, the Civil Liability Act implemented the recommendations of the Ipp Review:

Proactive and reactive duty of doctor to warn of risk (1) A doctor does not breach a duty owed to a patient to warn of risk, before the patient undergoes any medical treatment (or at the time of being given medical advice) that will involve a risk of personal injury to the patient, unless the doctor at that time fails to give or arrange to be given to the patient the information about the risk –



(a) that a reasonable person in the patient’s position would, in the circumstances, require to enable the person to make a reasonably informed decision about whether to undergo the treatment or follow the advice; and (b) that the doctor knows or ought reasonably to know the patient wants to be given before making the decision about whether to undergo the treatment or follow the advice.

Clause (a) is the proactive duty, while clause (b) is the reactive duty. Now, recall the requirements for disclosure laid down in RvW:

"... a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. This duty is subject to the therapeutic privilege."

The proactive and reactive duties concerning disclosure of risk in the new legislation more or less restate the RvW requirements. However, some commentators consider that the test is not as tough on doctors as the RvW test, since being aware of what the particular patient would be likely to attach significance to (RvW), is arguably more onerous than being aware of what information the particular patient actually wants to be given (Civil Liability Act) (see comments above at p4 para 4). Other commentators consider that the difference will prove to be insignificant. In any event, the standard for disclosure has remained more or less equivalent to the RvW standard, and this makes the distinction between the legal standards for diagnosis/treatment and disclosure much clearer. Regarding the element of causation as it applies to disclosure, the Civil Liability Act 2003 (Qld) states, inter alia, that

if it is relevant to deciding factual causation to decide what the person who suffered harm would have done if the person who was in breach of the duty had not been so in breach - (a) the matter is to be decided subjectively in the light of all relevant

circumstances, subject to paragraph (b); and (b) any statement made by the person after suffering the harm about what

he or she would have done is inadmissible except to the extent (if any) that the statement is against his or her interest.

This appears to (a) affirm the subjective standard for the causation element, as described above, but (b) excludes statements from the patient concerning what s/he would have done had s/he been adequately warned. You can see that, whereas the post - RvW courts had to be careful to avoid being



persuaded by injured patients’ hindsight bias, the new legislation seems to rule out the possibility of hindsight bias arising. Note that while a case-based common law approach to negligence has now been displaced by a statutory regime, judges must still interpret all the terms and clauses contained in the new legislation, when cases arise, and the previous important cases (particularly those from the High Court) will continue to be referred to. INFORMED FINANCIAL CONSENT A recent sub-species of informed decision-making has arisen for discussion and action. This is so-called informed financial consent. The AMA and the Commonwealth government have cooperated to increase the provision of information regarding fees in relation to procedures and prostheses etc, in order to reduce the incidence of patients discovering after the event that they may be considerably more out of pocket than they anticipated.

(ref 6) COACHING “Health coaching” has evolved in recent years to provide assistance to patients who lack confidence and/or skills to actively engage in doctor-patient consultations. Coaching occurs most commonly in settings of chronic illness, and is available through some call centres and through management programs and patient support groups. There are also a number of patient decision-aids being developed, increasingly on-line. Decision-aids and coaching provide information and explanations, help clarify values and wishes, and support deliberation and communication. There are many operational barriers to developing these methods of assisting patients, but there is some evidence that they can improve knowledge and communication, and sometimes improve health outcomes. Concepts and practices concerning health literacy, adult learning, coaching, better interpreter services, and so on will be increasingly seen in Australia. For example, see http://www.bupa.com.au/health-and-wellness/Programs-and-Support/Member-Support-Programs/bupa-health-dialog. (also see ref 9) LOSS OF A CHANCE Until recently, some negligence suits, including some involving failure to disclose adequate information, were decided in favour of the patient-plaintiff on the basis of the loss of a chance of a better medical outcome than what occurred. This means that the case is decided, not on the balance of probabilities that the doctor’s action or omission caused the harm, but by proving that the chance of a better outcome was a possibility, even at a less than 50% level of probability. However, in a recent High Court case, Tabet v Gett, the court ruled that the common law in Australia does not allow a plaintiff to obtain compensation on the basis of a loss of chance action, although some commentators believe that there may remain some exceptions.

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