Employer legal responsibility
A hospital employing surgeons has an obligation to maintain and monitor their competence, to protect patients. This duty is recognised by statute and the common law.
Section 11(3) of the Health and Disability Services Act 1993 provided that it was an objective of every hospital and health service to exhibit a sense of social responsibility by having regard to the interests of the community in which it operates (section 11(3)(a)), and to uphold the ethical and quality standards generally expected of providers of health or disability services (section 11(3)(b)). The Health and Disability Services Act 1993 was repealed from 1 January 2001, and replaced by the New Zealand Public Health and Disability Act 2000 (the NZPHDA), which established District Health Boards. Section 23(1)(i) of the NZPHDA provides that for the purpose of pursuing its objectives, each District Health Board must, as one of its functions, monitor the delivery and performance of services by it and by persons engaged by it to provide or arrange for the provision of services. The NZPHDA also provides that it is an objective of every District Health Board to improve, promote, and protect the health of people and communities (section 22(1)(a)), to exhibit a sense of social responsibility by having regard to the interests of the people to whom it provides, or for whom it arranges the provision of, services (section 22(1)(g)), and to uphold the ethical and quality standards commonly expected of providers of services and of public sector organisations (section 22(1)(i)).
Criminal liability or culpability
Employers are vicariously liable under Section 72(2) of the Health and Disability Commissioner Act 1994 (the Act) for any breach of the Code by an employee. Under Section 72(5) of the Act it is a defence for an employing authority to prove that it took such steps as were reasonably practicable to prevent the act or omission of employees that breached the Code.
Both public and private hospitals are also subject to the duties imposed on health care providers by the Code of Health and Disability Services Consumers’ Rights, in particular, the duty to provide services with “reasonable care and skill” (Right 4(1)). The organisational duty of care and skill of a public hospital has been considered in several major Health and Disability Commissioner reports
Informed Consent
Informed consent is legally required before a doctor can even touch a patient This is the very reason why the HDC was established, to protect the health consumers, not the health providers.
Key note: The HDC breached the patients’ rights by covering up the easily provable facts about Laparoscopic Cholecystectomy, Health consumers were not being advised of:
- Alternative treatment options
- Side effects risks affecting long term quality of life
- The direct risks of the surgery.
1] From an HDC perspective
‘My work as Commissioner over the past three years has been characterised by an emphasis on patients’ rights and responsibilities. A patient has a responsibility to share information that he or she knows to be relevant to the particular clinical decision. But I do not consider that a patient’s right to adequate information should be qualified by any duty or responsibility in using the information imparted. Many patients will prefer to leave decision making to their doctor
And goes on to conclude;
and Right 6(3)(b) of the Code recognises that patients are entitled to ask their doctor for a recommendation. Patients have a responsibility to make a decision, but how they do so is ultimately their business.
Keynote: This is the directive given to all doctors, their right to practice with clinical freedom is protected.
2] From a New Zealand Medical Association perspective
Key points made in ruling referenced by HDC “Director of Proceedings vs. Frizelle. Medical Practitioners Disciplinary Tribunal: Decision No. 219/02/94D; 3 December 2002. URL” [2]
- The current Code of Ethics of the New Zealand Medical Association records: “Doctors should ensure that patients are involved within the limits of their capacities, in understanding the nature of their problems, the range of possible solutions, as well as the likely benefits, risks, and costs, and shall assist them in making informed choices”.
- The approach taken by the High Court of Australia was strikingly similar to the standards, which the New Zealand Medical Council had enunciated.
“….that 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, warned of the risk, would be likely to attach significance to it.”
- The High Court of New Zealand B v The Medical Council of New Zealand
“In my view, the provision of inadequate information in a situation where the patient needs that information for his or her decisions affecting treatment or investigation, will almost always be professional misconduct or conduct unbecoming”.
3] From a legal perspective – What the law says
No one has the right to even touch, let alone treat another person. Any such act, done without permission (as a result of making informed consent), is classified as “battery” – physical assault and is punishable. The issue: Non-disclosure for the risks associated post removal of gallbladder and function and the false information provided about putting the patient’s safety at risk.
UK Law:
” The legal position regarding the provision of information needed to make an informed consent derives from the 1985 case of Sidaway v Board of Governors Bethlem Royal Hospital (Sidaway v Board of Governors Bethlem Royal and the Maudsley Hospital [1985] 2 WLR 480), where the House of Lords held that the legal standard to be used in deciding whether adequate information had been given to a patient would be the same as that in judging whether a doctor had been negligent in their care”
Australian Law:
Roger vs. Whitaker. In this case the patient was already blind in one eye when the decision to operate on the other eye was made. The patient was not informed about the 1:14,000 chance of blindness as a possible result of the operation. The doctor was found to have breached his duty of care for not disclosing a risk of 1:14,000 because the patient’s circumstances (already blind in the other eye)
US Law:
What constitutes a material risk surrounding the informed consent doctrine? Generally, the patient should be informed of all serious risks, even if unusual or rare. In one court case, a 1% risk of hearing loss required disclosure (Scott v. Wilson, 396 S.W.2d 532 [Tex. Civ. App. 1965]) In Canterbury, a young man was advised by his physician to undergo a laminectomy in an effort to alleviate back pain. The physician, aware that 1 per cent of laminectomies resulted in paralysis, did not advise the patient of the risk because he believed this might cause the patient to reject the useful treatment. Following the procedure, the patient fell from his hospital bed and was paralyzed. It remained uncertain whether the laminectomy procedure or the patient’s fall caused the paralysis. The patient sued, alleging that the physician failed to inform him of the risks associated with the procedure. The court held that “the standard measuring [physician] performance…is conduct which is reasonable under the circumstances”. In other words,the court held that, instead of adhering to the community disclosure standard, physicians are now required to disclose information if it is reasonable to do so. Essentially, to establish true informed consent, a physician is now required to disclose all risks that might affect a patient’s treatment decisions. In Canterbury, the decision outlined key pieces of information that a physician must disclose:
- condition being treated;
- nature and character of the proposed treatment or surgical procedure;
- anticipated results;
- recognized possible alternative forms of treatment; and
- recognized serious possible risks, complications, and anticipated benefits involved in the treatment or surgical procedure, as well as the recognized possible alternative forms of treatment, including non-treatment.
4] From a doctor’s ethical perspective
The ethical principle of autonomy which protects patient self-determination goes hand in hand with truth telling. Lying to and deceiving patients breach the autonomy of individuals and interferes with the doctrine of informed consent… Withholding information from patients impairs their decision-making capacity. Even when treatment options are limited, and prognosis is grave, knowing what to expect allows patients to prepare for what lies ahead instead of being overtaken by events.
Edwin, A. (2008). Don’t Lie but Don’t Tell the Whole Truth: The Therapeutic Privilege – Is it Ever Justified? Ghana Medical Journal, 42(4), 156–161. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2673833/
The Nuremberg Code that guide Doctors ethics regarding medical interventions,
- Thevoluntary consent of the human subject is absolutely essential
- Exercise freepower of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion…
- Should have sufficient knowledge and comprehension of the elementsof the subject matter involved as to enable him/her to make an understanding and enlightened decision.
Carlson, Robert V, Kenneth M Boyd, and David J Webb. “The Revision of the Declaration of Helsinki: Past, Present and Future.” British Journal of Clinical Pharmacology 57.6 (2004): 695–713. PMC. Web. 4 Apr. 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1884510/
Note: Ethical principles around consent:
The four main principles of medical ethics are 1] justice, 2] non-malificence, 3] autonomy and 4] beneficence. Autonomy is the main ethical consideration underlying informed consent. The patients’ right to determine what investigations and treatment to undergo must be respected by all doctors. For consent to be informed patients rely on the information provided by their doctor. Honesty and truthfulness are required to make the process of consent valid. The ethical principle of justice needs to be applied when deciding what treatments are offered to or withheld from patients. This touches the process of informed consent and is further explored when the right to demand certain treatments is discussed.
Note: Patient Autonomy (cornerstone of medical law, legal and ethical practice): The right of patients to make decisions about their medical care without their health care provider trying to influence the decision. Patient autonomy does allow for health care providers to educate the patient but does not allow the health care provider to make the decision for the patient.
Definition of Patient autonomy – MedicineNet: https://www.medicinenet.com/script/main/art.asp?articlekey=13551
5] From a Patients perspective
Department of Surgery, Christchurch Hospital Study: A questionnaire was developed from the Disability Commissioner’s Regulations (1996) and was administered to patients and doctors at Christchurch Hospital.
Results: According to patients the five most important aspects of informed consent were: (1) the major risks, (2) quality of life, (3) outcome, (4) consequences of not undergoing the procedure and (5) quantity of life.
Conclusion: “Both patients and doctors consider the explanations of risks and complications important, especially if the complication is serious and risk is greater than 1 in 1000. (0.01%) Patients consider aspects of outcome, quantity and quality of life important”
Newton-Howes PA1, Bedford ND, Dobbs BR, Frizelle FA. Informed consent: what do patients want to know Department of Surgery, Christchurch Hospital. https://www.ncbi.nlm.nih.gov/pubmed/9785548