Another way to consider the relationship among the three disciplines is through conceptual models:
II. Orientation to law for non-lawyers
There are two primary types of potential civil actions against health care providers for injuries resulting from health care: (1) lack of informed consent, and (2) violation of the standard of care. Medical treatment and malpractice laws are specific to each state.
1. Informed Consent. Before a health care provider delivers care, ethical and legal standards require that the patient provide informed consent. If the patient cannot provide informed consent, then, for most treatments, a legally authorized surrogate decision-maker may do so. In an emergency situation when the patient is not legally competent to give informed consent and no surrogate decision-maker is readily available, the law implies consent on behalf of the patient, assuming that the patient would consent to treatment if he or she were capable of doing so.
Information that must be conveyed to and consented to by the patient includes: the treatment’s nature and character and anticipated results, alternative treatments (including non-treatment), and the potential risks and benefits of treatment and alternatives. The information must be presented in a form that the patient can comprehend (i.e., in a language and at a level which the patient can understand) and that the consent must be voluntary given. An injured patient may bring an informed consent action against a provider who fails to obtain the patient’s informed consent in accordance with state law.
From a clinical ethics perspective, informed consent is a communication process, and should not simply be treated as a required form for the patient’s signature. Similarly, the legal concept of informed consent refers to a state of mind, i.e., understanding the information provided to make an informed choice. Health care facilities and providers use consent forms to document the communication process. From a provider’s perspective, a signed consent form can be valuable evidence the communication occurred and legal protection in defending against a patient’s claim of a lack of informed consent. Initiatives at the federal level (i.e., the Affordable Care Act) and state level (e.g., Revised Code of Washington § 7.70.060) reflect approaches that support shared decision-making and the use of patient decision aids in order to ensure the provision of complete information for medical decision-making.
2. Failure to follow standard of care. A patient who is injured during medical treatment may also be able to bring a successful claim against a health care provider if the patient can prove that the injury resulted from the provider’s failure to follow the accepted standard of care. The duty of care generally requires that the provider use reasonably expected knowledge and judgment in the treatment of the patient, and typically would also require the adept use of the facilities at hand and options for treatment. The standard of care emerges from a variety of sources, including professional publications, interactions of professional leaders, presentations and exchanges at professional meetings, and among networks of colleagues. Experts are hired by the litigating parties to assist the court in determining the applicable standard of care.
Many states measure the provider’s actions against a national standard of care (rather than a local one) but with accommodation for practice limitations, such as the reasonable availability of medical facilities, services, equipment and the like. States may also apply different standards to specialists and to general practitioners. As an example of a statutory description of the standard of care, Washington State currently specifies that a health care provider must “exercise that degree of care, skill, and learning expected of a reasonably prudent health care provider at that time in the profession or class to which he belongs, in the State of Washington, acting in the same or similar circumstances.”
III. Common clinical ethics issues: medical decision-making and provider-patient communication
There are a number of common ethical issues that also implicate legal and risk management issues. Briefly discussed below are common issues that concern medical decision-making and provider-patient communication.
If a patient is capable of providing informed consent, then the patient’s choices about treatment, including non-treatment, should be followed. This is an established and enforceable legal standard and also consistent with the ethical principle of respecting the autonomy of the patient. The next two sections (Surrogate decision-making; Advance directives) discuss how this principle is respected from a legal perspective if a patient lacks capacity, temporarily or permanently, to make medical decisions. The third section briefly introduces the issue of provider-patient communication, and highlights a contemporary dilemma raised in decisions regarding the disclosure of medical error to patients.