Evaluating the Legal Implications Arising in the United Kingdom - Case Study Example

MEDICAL LAWS ABSTRACT This paper discusses the medico-legal aspects applicable in the United Kingdom, with a special emphasis on the subject of obtaining an ‘Informed Consent’ from a patient. The process of obtaining consent from a patient before any medical procedure is adopted, is not only a good practice on the part of a Health Professional but is also a legal requirement. This is mandatory, both in the case of an adult and a child, though the regulations differ according to the age of the child. The purpose of this paper is to identify and evaluate the legal implications arising in two specific cases. The first one is a case where a surgery performed after a valid consent has resulted in the partial paralysis of the patient, an inherent risk which was not informed to the patient before the operation. The second case is about a 15 years old child who refuses a necessary surgical procedure. The consequence of this refusal may lead to the death of the child and hence his parents are keen on accepting the treatment as per the doctor’s advice. The evaluation of both cases and the arguments presented are on the basis of various case examples as cited in authentic references. TABLE OF CONTENT: Seeking Patients’ Consent: The Ethical Considerations, GMC, paragraph 1, November 1998, Retrieved 11 December 2006, 3 Seeking Patients’ Consent: The Ethical Considerations, GMC, paragraph 28, November 1998, Retrieved 11 December 2006, 7 Seeking Patients’ Consent: The Ethical Considerations, GMC, paragraph 4, November 1998, Retrieved 11 December 2006, 9 Seeking Patients’ Consent: The Ethical Considerations, GMC, paragraph 10, 11, 12, November 1998, Retrieved 11 December 2006, 9  Bolam Test; Wikepedia, the free encyclopedia, paragraph 2, Retrieved 11 December 2006, 11 Bolam Test; Wikepedia, the free encyclopedia, paragraph 1, Retrieved 11 December 2006, 11 11 Bolam Test; Wikepedia, the free encyclopedia, paragraph 2, section 2.1, Retrieved 11 December 2006, 12 Seeking Patients’ Consent: The Ethical Considerations, GMC, Appendix A, November 1998, Retrieved 11 December 2006, 17 < http://www.gmc-uk.org/guidance/current/library/consent.asp#gmc_print> 17 INTRODUCTION The role of a health care professional has undergone radical changes in last few years. The rapid advances in medical science, growing number of diseases along with their changing patterns, increasing awareness among patients and their families, have raised their expectations from the medical practitioner. This has resulted in the growth of complexities in ethical considerations in their daily practice, thus making every act of a doctor very delicate. Amidst the ever-increasing pressure of duties and responsibilities, they find it extremely difficult to keep pace with the growing complexity of legal angles in their profession. The straightforward trust of patients in the medical advice, once experienced, is no longer accessible.1 The General Medical Council (GMC) gives rights and privileges to doctors and in return expects them to meet the standards of competence, care and conduct as set by the Council. One such expectation is to establish and maintain a level of trust and confidence of the patient. To achieve this, a doctor must respect the patient’s autonomy, defined by the GMC as ‘the right of the patient to accept or deny a particular medical intervention advised’. The doctor is required to provide detailed information to the patient regarding his disease condition, available treatment options and other relevant facts. The patient’s decision will be based on the information provided. Such a decision, protected by the law, is referred to as an ‘Informed Consent’.2 Before carrying out any medical procedure, whether for diagnosis or treatment, it is mandatory to obtain consent from every patient, an adult as well as a child. In case of children, the rules and regulations differ according to the age. To enable an identification and evaluation of the legal implications arising in cases based on ‘Informed Consent’, it is necessary to understand what are ‘Informed Consent’ and the related details as stated by various legal authorities. The explanation of such relevant guidelines will be presented in the next few chapters followed by a discussion of some relevant case studies. Chapter 1 AN ‘INFORMED CONSENT’ What is consent? A Patient’s approval of a medical procedure as advised by the doctors is termed as ‘consent’. To enable the patient give a valid consent, he should be informed of all the details related to the proposed medical procedure and he should be competent enough to understand the explanation provided. It is also essential to ensure that the consent is being given by the patient voluntarily and not under any pressure from anyone that includes medical staff, relatives, friends, police, prison authorities, employers and insurance companies.3 Such consent is considered as an ‘Informed Consent’. ‘Informed consent’ is a right that allows a capable patient to actively participate in the decision making process and does not leave him at the mercy of the doctors alone. Why is consent important? Obtaining consent from a patient for a medical procedure is not only considered a good practice on the part of the medical practitioner but it is also a legal requirement. The process of obtaining an ‘Informed Consent’ as guided by the GMC not only facilitates legal competence but also enables strengthen the doctor-patient relationship, based on trust and confidence.4 In the event of not obtaining such consent from the patient, a doctor may have to sometime face either a criminal proceeding, civil proceeding or GMC proceeding. As explained in the Medical Protection Society (MPS) guidelines5; - Touching a patient without consent may lead to Criminal Proceeding - If a patient proves that he was not warned of a particular after effect of the diagnostic/treatment procedure, the doctor may have to face Civil Proceeding under which a claim for damages may be made. - If the GMC receives a complaint regarding any violation of rules by the health professional as set by the council, he may have to face a GMC Proceeding. He may be suspended for such an act. How is consent obtained? The process of obtaining consent may differ from patient to patient. This is because of the varying individual needs and concerns. For obtaining a valid consent, a patient should be given complete details of his disease condition, the treatment options available, the preferred options and the reasons for the same. The benefits of the treatment and the consequences of not accepting the same should also be discussed. The doctor must ensure that the patient is clear about the probabilities of success via the chosen treatment option and also the associated risks and threats, if any. Excepting in the case of an emergency, the doctor is advised never to cross the boundaries as set by the patient in the process of obtaining the consent.6 The Department of Health has issued guidelines and sample consent forms for use in different situations. But there are no hard and fast rules regarding obtaining a written consent. It may be obtained verbally too. The GMC advices obtaining written consents under situations such as those involving significant risks, or when there may be considerable effect on the patients employment, social or personal life, where the procedure being adopted is for a non-therapeutic purpose and if the treatment is part of a research programme.7 Who can give consent? Law recognizes an individual aged 18 years and above as an adult and an adult is considered to be competent enough to give consent. Children in the age group 16-17 years are also treated as adults when it comes to obtaining a voluntary consent. The situation would differ in case the child refuses treatment. Under such circumstances, the person with ‘Parental responsibility’ plays a role in giving consent. In some cases, the court may be brought in for such a decision. Children under 16 may or may not be competent to give consent. For this age group, variations exist in laws throughout the UK. In Scotland, if a child under 16 possesses the capability to understand the nature of a treatment procedure and its consequences, then he is considered ‘competent’. In England, Wales and Northern Ireland children under 16 are categorized as ‘Gillick-competent’ and ‘Gillick-incompetent’. As per Department of Health (2001), a child who shows sufficient intelligence to understand what is proposed is recognized to be ‘Gillick-competent’. Such children are eligible to give consent. But in the case of refusal of treatment by a competent child, the decision can be overruled by the person holding ‘Parental responsibility’ and/or courts. Decisions are always made in the ‘best interest’ of the child, both clinically and psychologically.8 The person assuming ‘Parental responsibility’ (as per Children Act 1989) should have complete information about the diagnosis, treatment options available, reasons of choosing a particular option, consequences of the same, risks involved etc. Under a situation where the child refuses treatment and the consequences are serious, such as, death, the doctor should consider obtaining a decision from the court in addition to that given by the parents.9 Providing Information As per the GMC Guidelines, before deciding whether to consent to a treatment or an investigation, besides basic details such as the expenses involved, it is essential that a patient has complete information on other critical parameters as well. These include: - Details of disease condition, Consequences of refusal to treatment Treatment options available Benefits and probabilities of success, Risks involved in the treatment The possibility of any additional problems arising when the patient is in an unconscious state and in the midst of a treatment should also be discussed with the patient. The most likely intervention in such a situation should also be considered and consent for the same obtained in advance.10 Withholding Information Any information necessary for making a decision should not be withheld from the patient unless the doctor feels that disclosure of some information may cause serious harm to the patient. If any such information has been withheld by the doctor, he should record the details in patient’s files with a clear explanation and justification of the same11. Though the GMC guidelines, in exceptional cases, give an option of withholding some information with proper records, as per the Medical Protection Society, there is certainly a need to mention every side effect or complication associated with the treatment procedure even if the probability of such an incident is less than 1%. In a case reported from Australian court, an ophthalmic surgeon who failed to warn a woman of a minimal risk involved in the cosmetic surgery of her right eye was found negligent, after the woman lost sight in her left eye resulting in almost total blindness. The court passed a verdict in her favour. This case certainly sets precedence for the British courts to act on similar lines in certain cases.12 Chapter 2 CASE REVIEWS Part A: ‘Informed Consent’ case reviews (Adults) The increase in awareness among the laymen has led to a rise in expectations of the patients from the doctors. The gap between the patient’s perspective and that of the health professional has widened considerably. This has led to a rise in the number of medical cases presented before the court. The law finds it most difficult to strike a balance between the interests of the professionals and the appellants. It is therefore essential to analyze each case based on various principles set in the House of Lords in recent years. One such principle to be debated is the Bolam Principle. The Bolam Principle was developed through a series of English cases culminating in Bolam v Friern Hospital Management Committee (1957) 1 WLR 582. Since then, a number of revisions and advancements have come into practice after subsequent cases.13 The Bolam v Friern Hospital Management Committee (1957) 1 WLR 582 was a case filed for medical negligence. The claimant proved that the doctor had taken a decision which was not in line with the one that would have been taken by a responsible body of medical experts in a similar situation. The Court of Appeal held that “his actions were compatible with the general standards and practices of the profession, and the presence of conflicting views was not sufficient to establish a breach in the duty of care”.14 Since then, the Bolam test is one of the rules used to determine the issue of professional negligence. As per this principle, a doctor, nurse or other health professional is not termed ‘negligent’ if he or she has performed an act which is accepted as the most commonly resorted to by a responsible team of medical experts.15 As derived from this case, to prove an act of negligence, it is necessary to establish that the defendant owes a duty of care to the claimant and that the defendant is in the breach of duty. Once proven guilty in civil law, the defendant is liable to compensate the claimant for the loss and damage caused by him. In a civil case, “negligence is proved if there is greater than 50% chance that the claim as argued is correct, i.e. the duty was owed and the breach caused the injury.”16 Though Bolam test seems to strike a perfect balance between the rights of doctors, patients and general public, yet questions have been raised on its application after some subsequent cases like Bolithov City & Hackney Health Authority (1997) ALL ER 71. This case is considered as an exception to the Bolam test. Some recent Singapore cases are also an example of this exception. Most crucial argument raised is in the context of application of the Bolam test to the doctor’s explanation of treatment and the duty to warn patients. The way such cases are handled is different in the US, Singapore and UK. In some of these states, a patient’s consent is vitiated if he is given inadequate information concerning the proposed treatment. In England and Singapore, the Courts have instead applied the Bolam test to determine if a doctor has adequately explained the treatment or warned the patient, as is evident from the case cited below:17 Sidaway v Bethlem Royal Hospital Governors (1985) AC 871: This was a case filed by the claimant after she developed paraplegia following cervical cord decompression. The claimant proved that while obtaining consent for the procedure, she was not informed of this possibility by her neurosurgeon. On hearing the case, the court pronounced that it was not necessary to include an explanation of remote side effects while obtaining consent and hence rejected her claim for damages. In opposition to this verdict, Lord Scarman stated that the Bolam principle should not apply to the issue of informed consent. Also, a doctor should inform his patients about any inherent risk associated with the proposed treatment.18 Logically speaking, the benefits of the treatment procedure and the percentage probability of inherent risks should be weighed. Though the doctor is liable to discuss every possible risk, he may ignore the ones with a very remote possibility. If he is forced to discuss such complications/risks too, he may probably raise unwanted fears in the mind of the patient thus making it all the more difficult for him to take his decision. This may be more harmful to the patient than benefit able. Thus a Court in England has surely adopted a sensible approach by declaring that where the risks involved are relatively remote; there were obvious disadvantages in warning a patient of such risks: “On one hand you alarm unnecessarily, and on the other hand, you may put him in a position where he feels that he should take the decision, albeit the doctor is obviously much better qualified to weigh up the advantages and the desirability of the proposed operation as against the risks.” (O’Malley v Board of Governors of the National Hospital for Nervous Diseases).19 Yet another case to consider is from The Australian Court, as illustrated in Rogers v Whittaker (1992) 175 CLR 479. This court held that the matter of disclosure of information to the patient does not fall under the purview of Bolam test. As per the Australian court, there are a number of factors a doctor has to consider before deciding on disclosure of risk related information to the patient. Depending upon the physical and mental state of the patient, his reception to the information may be different.20 Arguments – Peter Smith case In Peter Smith v Borlotti case, Mr. Smith gave his consent for the operation after a discussion with his consultant surgeon, Mr. Borlotti. But Mr. Smith was not aware of any chances of an inherent risk of paralysis. Mr. Borlotti had not informed Mr. Peter Smith or his wife about the probability of such a risk though he is liable to do so as per the Medical Protection Society guidelines as well as those stated by the General Medical Council. Such consent related issues can lead to ethical dilemmas that may be brought to a Clinical Ethics Committee. Under such circumstances, Mr. Borlotti may be considered liable for an act of negligence. If Mr. Peter Smith decides to present this case to the Clinical Ethics Committee, it becomes necessary to determine whether there is a responsible body of clinicians who would warn about the relevant risks (the Bolam test). As revealed by some of the Recent judgments in legal cases, a patient should be informed of risks if: the incidence of the risk is sufficiently high - for example a 10% risk of stroke if the risk materialised, it would have serious consequences for the patient the patient specifically asks about a risk A case cited below gives a clear understanding of the consequences involved in Mr. Smith’s case: Chatterton v Gerson [1981] 1 ALL ER 257 In this case, Mrs. Chatterton suffered from permanent immobility of her right leg following an operation. Though she had been informed about the nature of the procedure and a valid consent obtained, Dr. Gerson, her pain specialist, had not discussed any possibility of a risk of paralysis. She, therefore, sued the doctor and claimed in battery. But the court decided that since she had been informed of the treatment procedure and her consent obtained, the doctor could not be sued for battery but any claim would have to be made in negligence.21 The case of Mr. Peter Smith is quite similar to the one above. He had all the information regarding the treatment procedure and had given his consent for the same, hence the doctor is not liable in battery. But Mr. Smith can sue the doctor for an act of negligence since he was not informed of the possibility of an inherent risk of paralysis. Moreover, Mr. Smith asserts that he would not have given consent to the operation had he been informed of this risk. In such a situation, the court may pass the verdict in his favour. Part B: ‘Informed Consent’ case reviews (Children) As per UK Clinical Ethics Network, the principle of beneficence highlights the moral importance of doing good to others. Though the doctors may wish to act in the best interests of a patient, they are liable to consider much more than just medical risks and benefits. Sometimes the religious and cultural interests of the patient may come in the way of doctor’s advice. It is the doctor’s duty to discover as far as possible, the patient’s interest in the situation or the most appropriate option for the patient. In the process of determining best interests, it is also essential that the doctor respects the patient’s autonomy. Most patients generally choose the treatment option that is considered to be in their best interests. Hence the chances of any conflict arising between beneficence and the principle of respect for autonomy are very remote.22 But a debatable situation may arise when the patients view opposes the medical opinion. Let us focus on the situation of refusal to treatment by children. The legal considerations for giving consent to treatment differ in the case of children, depending upon their age. As per The Family Reform Act 1969, the consent to treatment of a 16 or 17 year old is to be treated like the consent of an adult. For children under 16 there is precedent in case law governing consent to treatment. The law was set out in the case of Gillick (Gillick v West Norfolk and Wisbech AHA [1986] AC 112). As per this law, if a minor is intelligent enough to understand the treatment procedures and repercussions of the same, then he may be considered as ‘Gillick-competent’. Hence he has the right to consent to treatment23. In 1980, after Mrs. Gillick challenged the legality of a circular issued by the Department of Health, the House of Lords established two major principles, known as the Fraser Guidelines: - A parent’s right to consent to treatment on behalf of a child ends when the child has sufficient intelligence and understanding to consent to the treatment themselves (when the child becomes ‘Gillick competent’). - It is for the doctor to decide whether a child has reached this level. This principle only applies when giving consent to treatment. In cases where a child refuses treatment, his decision can be overruled by someone with parental responsibility or the courts.24 Thus when a doctor comes across a case of refusal to treatment by a child less than 16 years of age, he must assess the capacity of the child to take such a decision. This assessment must take into account the relevant laws or legal precedents in this area. The doctor may also consult the medical defence body or professional association for an up to date advice. Some of the relevant key legislations in this area (as per the GMC guidelines) are listed below: Children and Consent to Treatment and Testing: Some Key Legislations25 England & Wales Family Law Reform Act 1969 Gillick v West Norfolk and Wisbech AHA [1985], 3 AER 402 Children Act 1989 Scotland Age of Legal Capacity (Scotland) Act 1991 Children Act (Scotland) 1995, Section 6, Part 1. Northern Ireland Age of Majority Act 1969, Section 4. Arguments – Fred Case Since Fred is only 15 years old, as per The Family Reform Act 1969, considering him to be ‘Gillick-competent’, he has the right to consent to treatment. But as per the law, though a competent child can consent to treatment, a refusal of treatment may be overridden by a parent or the Court. This is especially true in cases where a refusal of treatment may result in death or permanent disability of the child. Though the doctors respect Fred’s religious concerns, it is in his best interests to give consent for the procedure. Since he is competent to make treatment decisions, it is imperative that he be counselled about the necessity of the operation. In spite of understanding the consequences of refusal, if he does not change his stand, his parents can take precedence over his decision and give consent to his treatment since failure to operate may result in his death. A similar case is cited below: Re M [1999] 2 FLR 1097 M was a competent 15 ½ year old who refused heart transplant following an acute heart failure. A decision was taken by the doctors to perform the transplant in spite of her refusal, as it was in her best interests. Such an act was declared lawful.26 Those with parental responsibility are under a legal obligation to act in the child’s best interests. Hence Fred’s parents can legally consent to his operation in spite of his refusal. CONCLUSION A doctor-patient relationship encompasses profound trust in each other. A patient therefore, follows his doctor’s advice in good faith. This makes it crucial for the doctor to disclose all the information related to the treatment and not keep his patient in the dark, thus ensuring a valid ‘Informed Consent’ from the patient. This process gives the patient opportunities to not only deny any medical procedure but also to request for alternatives, if any. A doctor should consider this process more as a matter of respecting human rather than just avoiding legal actions. A number of guidelines have been framed towards this effect. But the extent to which the government or the health authorities assume responsibilities for defining ethical standards of consent remains unclear. A 2001 publication by the UK Department of Health has stated that it is “a fundamental part of good practice for patients to be able to determine what happens to their own bodies.” Since 1998, the UK GMC has advised that “doctors should do their best to find out about patients individual needs and priorities when providing information about treatment options”. The Department of Health reference guide states that “in order to give valid consent patient needs to understand in broad terms the nature and the purpose of the procedure.” All the above guidelines do not clearly explain the extent of information to be given to the patient, especially when it comes to revealing the risks involved in a particular procedure.27 The extent of information provided may actually vary from one patient to the other. Sometimes lesser the information provided, better it may be. The physician has exercised his duty of care if he has revealed enough information to enable the patient to make a judicious decision. The extent of disclosure may correspond to that practiced most commonly by the medical fraternity. As per English case law “doctors should always inform the patients of a significant risk which would affect the judgement of a reasonable patient.” If the risk involved is up to a negligible percentage of probability, then the benefits due to be derived from the treatment procedure may outweigh the risk. But to avoid any legal implications, it is in the doctor’s best interests to discuss the risks with the immediate family members. As is in the case of Mr. Peter Smith, the probability of risk of paralysis following the surgery was only 2%. It certainly cannot be predicted for Mr. Smith to fall in such a small percentage of probable situations for paralysis. If he would have been a part of the 98% population, he would have undoubtedly reaped the benefits of surgery. Thus it was probably in the best interest of the patient that Mr. Borlotti did not discuss the remote possibility of paralysis so as to not create an unwanted fear in the patient’s mind. But he could have taken the opportunity to discuss the same with Mr. Smith’s wife to avoid any liability in future. It is also essential to follow the consent guidelines as set by the law when it comes to dealing with children. In the case of Fred, though the doctor’s respect his religious concerns, it is in the best interest of the child to involve the criteria of ‘parental responsibility’ and override his refusal. Since the refusal to treatment may result in death of the child, a court may also be involved if considered necessary. The positive decision of the doctor’s after the intervention of parents and the courts would be considered lawful. BIBLIOGRAPHY Bolam Test; Wikepedia, the free encyclopedia, Retrieved 11 December 2006, Bolam v Friern Hospital Management Committee (1957) 1 WLR 582, updated 23 February 2006, retrieved 20 December 2006, Brahams D., Doctor’s duty to inform patient of substantial or special risks when offering treatment, Lancet, 1985 Mar 2:1 (8427):528-30, retrieved 11 December, 2006, Case Studies, Retrieved 10 December 2006, Confidentiality and Disclosure of Health Information, Guidance from the BMA’s Medical Ethics Department, Retrieved 11 December 2006, Consent: A Complete Guide for Consultants, Medical Protection Society, 2003, Retrieved 13 December 2006, Consent to Medical treatment, Retrieved 13 December 2006, Consent, Policy and Guidance, Dept. Of Health, Retrieved 11 December 2006, Doctors’ Responsibilities in Child Protection Cases, Guidance from the BMA’s Medical Ethics Department, Retreived12 December 2006, Duty of Candour, Retrieved 11 December 2006, Dyer C, Failure to warn, Br Med J (Clin Res Ed) 1987 Apr 25:294(6579):1089-90, retrieved 11 December 2006, Ethical frameworks, Retrieved 10 December 2006, Ethics Resources Documents, Retrieved 10 December 2006, GMC advises doctors on seeking consent, BMJ, 1999 February 27; 318(7183): 553, Retrieved 11 December 2006, Good Medical Practice, Retrieved 11 December 2006, Harding AJ., “Informed consent” and disclosure of risks in medical treatment: some recent developments, Ann Acd Med Singapore, 1987 Apr: 16(2):375-9, retrieved 11 December 2006, Law and Ethics, Retrieved 9 December 2006, Legal Issues and Clinical Ethics Committee, Retrieved 9 December 2006, Medical Ethics and Law Teaching Materials, Consent, Retrieved 9 December 2006, Medical Ethics Committee, Retrieved 11 December 2006, Medical Law, Retrieved 9 December 2006, Negligence in failure to warn patient of slight inherent risk in surgery, Retrieved 11 December, 2006, Negligence in surgeon's failure to give warning of slight risk, Retrieved 11 December 2006, Parental responsibility, Guidance from the Ethics Department, June 2006, Retrieved 10 December 2006, Refusal of Treatment by a Competent Patient, Retrieved 13 December 2006, Refusal of Treatment by an Incompetent Patient, Retrieved 12 December 2006, Researching Case Law, Retrieved 9 December 2006, Seeking Consent: Working with Children, Dept. of Health, November 2001, Retrieved 11 December 2006, Seeking Patients’ Consent: The Ethical Considerations, GMC, November 1998, Retrieved 11 December 2006, < http://www.gmc-uk.org/guidance/current/library/consent.asp#gmc_print> Shanmugam K, Testing the Bolam Test: Consequences of Recent Developments, Singapore Med J 2002, Vol. 43 (1): 007-011, retrieved 11 December 2006, Sidaway v. Bethlem Royal Hospital, Great Britain. England. Court of appeal, Civil Division, All Engl Law Rep., 1984 Feb 23: [1984] 1:1018-36, retrieved 11 December 2006, Surgeon failing to warn claimant of inherent risk of paralysis in lumbar, Retrieved 11 December 2006, UK Clinical Ethics Network, Consent and Refusal of Treatment, retrieved 9 December 2006, UK Legislation, Retrieved 9 December 2006, Worthington R, Clinical Issues on Consent: Some Philosophical Concerns, J of Medical Ethics 2002; 28; 377-380, Retrieved 11 December 2006, Read More