Clinical Ethics and Law

NOTE: The UW Dept. of Bioethics & Humanities is in the process of updating all Ethics in Medicine articles for attentiveness to the issues of equity, diversity, and inclusion.  Please check back soon for updates!

Authors:

Lisa V. Brock, J.D., M.A.

Anna Mastroianni, J.D., M.P.H., Professor, University of Washington School of Law.

Core Clerkship: General Curriculum

Topics addressed:

  • Understanding relationships: clinical ethics, law & risk management
  • Orientation to law for non-lawyers
  • Common clinical ethics issues: medical decision-making and provider-patient communication
  • Case studies highlighting the interplay between clinical ethics, legal & risk management issues

Disclaimers:  

  • This information reflects the opinions of its author, Lisa V. Brock, J.D., M.A. (Bioethics), Assistant Attorney General/Senior Counsel, and Anna Mastroianni, J.D., M.P.H., Professor, University of Washington School of Law. It is not a formal opinion of the Washington State Attorney General's Office. These materials are for educational purposes only and are not intended to substitute for advice of legal counsel on any specific situation.
  • The information contained in this site is for general guidance only. The application and impact of laws, institutional risk management, and clinical ethics can vary widely based on the specific facts involved, institutional policies, and legal jurisdiction. In addition, law is not static in application and change can be expected as technology evolves and new issues emerge. The information on this site is provided with the understanding that the authors and publishers are not rendering legal, risk management, clinical ethics, or other professional advice and services. As such, the information in this article should not be used as a substitute for consultation with your own professional advisors.

Introduction

Clinical ethics and law are disciplines with overlapping concepts, yet each discipline has unique parameters and a distinct focus. For example, the ethics concept of respect for autonomy is expressed in law as individual liberty.  Each of these disciplines has its forums and authority; however law may ultimately “resolve” a clinical ethics dilemma with a court order. 

To better understand the relationship between ethics, law and risk management, these materials will briefly review:

  1. Introduction
  2. Understanding relationships: clinical ethics, law & risk management
    1. Definitions and  sources of authority
    2.  Conceptual models
  3.      Orientation to law for non-lawyers
    1. Potential legal actions against health care providers
    2. The litigation process: a brief summary
    3.  How and where to find the law on a particular topic
  4. Common clinical ethics issues
    1. Surrogate decision-making
    2. Advance directives
    3. Provider-Patient communications
  5. Case studies highlighting the interplay between clinical ethics, legal & risk management issues

    Case 1: Disagreement among surrogate decision-makers/patient with advance directive/end of life/futility
    Case 2: Surrogate decision-maker with potential conflict of interest
    Case 3: Minor patient/Jehovah’s Witness/non-treatment against medical advice

 

Understanding relationships: clinical ethics, law & risk management

Definitions and sources of authority.  In the course of practicing medicine, a range of issues may arise that lead to consultation with a medical ethicist, a lawyer, and/or a risk manager. The following discussion will outline key distinctions between these roles.

  • Clinical ethics may be defined as:  a discipline or methodology for considering the ethical implications of medical technologies, policies, and treatments, with special attention to determining what ought to be done (or not done) in the delivery of health care.  
  • Law may be defined as: established and enforceable social rules for conduct or non-conduct; a violation of a legal standard may create criminal or civil liability.
  • Risk Management may be defined as: a method of reducing risk of liability through institutional policies/practices.

Many health care facilities have in-house or on-call trained ethicists to assist health care practitioners, caregivers and patients with difficult issues arising in medical care, and some facilities have formally constituted institutional ethics committees. In the hospital setting, this ethics consultation or review process dates back to at least 1992 with the formulation of accreditation requirements that mandated that hospitals establish a “mechanism” to consider clinical ethics issues.1

Ethics has been described as beginning where the law ends. The moral conscience is a precursor to the development of legal rules for social order.  Ethics and law thus share the goal of creating and maintaining social good and have a symbiotic relationship as expressed in this quote:

  • [C]onscience is the guardian in the individual of the rules which the community has evolved for its own preservation.  

          ~ William Somerset Maugham2

The role of lawyers and risk managers are closely linked in many health care facilities. Indeed, in some hospitals, the administrator with the title of Risk Manager is an attorney with a clinical background. There are, however, important distinctions between law and risk management. Risk management is guided by legal parameters but has a broader institution-specific mission to reduce liability risks. It is not uncommon for a hospital policy to go beyond the minimum requirements set by a legal standard. When legal and risk management issues arise in the delivery of health care, ethics issues may also exist. Similarly, an issue originally identified as falling within the clinical ethics domain may also raise legal and risk management concerns.

To better understand the significant overlap among these disciplines in the health care setting, consider the sources of authority and expression for each.

Ethical norms may be derived from:

  • Law
  • Institutional policies/practices
  • Policies of professional organizations
  • Professional standards of care, fiduciary obligations

Note: If a health care facility is also a religious facility, it may adhere to religious tenets. In general, however, clinical ethics is predominantly a secular professional analytic approach to clinical issues and choices.

Law may be derived from:

  • Federal and state constitutions (fundamental laws of a nation or state establishing the role of government in relation to the governed)
  • Federal and state statutes (laws written or enacted by elected officials in legislative bodies, and in some states, such as Washington and California, laws created by a majority of voters through an initiative process)  
  • Federal and state regulations (written by government agencies as permitted by statutory delegation, having the force and effect of law consistent with the enabling legislation)
  • Federal and state case law (written published opinions of appellate-level courts regarding decisions in individual lawsuits)
  • City or town ordinances, when relevant

Risk Management may be derived from law, professional standards and individual institution’s mission and public relations strategies and is expressed through institutional policies and practices.

Conceptual Models:

  • Linear
  • Distinctions
  • Interconnectedness

Orientation to law for non-lawyers

Potential legal actions against health care providers.  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.3

  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.4

           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. 5

           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.” 6

​​​​​​​The litigation process: a brief summary.  There are essentially three distinct phases to the litigation process: (1) initiation, (2) pre-trial, and (3) trial and post-trial. The possibility that the parties will reach an agreement about the legal claims before or during trial, known as a settlement, means that the vast majority of initiated claims do not go through all three phases.  An understanding of the litigation process and its accompanying vocabulary can be helpful in providing a fuller understanding of the intersection of law, clinical ethics, and risk management. 

  1. Initiation phase: A lawsuit will begin when the plaintiff (an allegedly injured patient) files a complaint (claim) with the court. The plaintiff is obligated to legally notify (serve) the defendant(s) (e.g., the health care provider) with a summons and the complaint on the defendant. Medical malpractice lawsuits frequently include more than one defendant and may be made against more than one provider, institution, and manufacturer of medical equipment and/or pharmaceutical companies.  In the complaint, the plaintiff presents the facts that are the basis for the lawsuit. The defendant is required to file an answer (written response) with the court, and to also provide the plaintiff with a copy within a specified period of time.  
  2. Pre-trial phase: After filing a lawsuit and before trial, both sides (plaintiff and defendant) gather information using various methods known as discovery. Discovery methods used may include interrogatories, which are written questions that the opposing side must answer under oath. Requests for production require the opposing side to provide documents to the other side. Requests for admissions require the opposing side to state that some facts are true before trial. Witnesses can be required to answer questions in person under oath, known as a deposition, and may also be required to bring documents to the deposition. Although the information collected during discovery prepares the parties for trial, it also can be used as a basis for settlement. Indeed, most civil lawsuits, including actions against health care providers, are settled and never go to trial before a judge or jury. 7 Some cases are resolved by summary judgment, in which the court decides in favor of one party based on information derived during the discovery process. To encourage the parties to find a resolution to a health care dispute before trial, a few states require the parties to submit to mediation. 8
  3. Trial and post-trial phase. Cases involving injuries in health care are typically decided by a jury. However, cases involving federal health care facilities (and their employees), such as the Veterans Health Administration, are decided by a judge. 9  A trial in front of a jury will involve the following, in this order: jury selection; opening statements by both parties; plaintiff’s trial testimony; defendant’s trial testimony; closing arguments; jury instructions (argued by legal counsel to the judge, determined by the judge, and designed to guide the jury in decision-making); jury deliberation; and, verdict. Even after a jury verdict, there may be post-trial motions to the judge which could alter the outcome of the case.

​​​​​​​How and where to find the law on a particular topic. 10  Law is dynamic—it is constantly evolving and changing, and this is particularly true in health law.  Courts and legislatures respond to new issues and technologies by creating new laws or applying and interpreting existing laws. The changing nature of the law prompts a caveat to legal researchers: material obtained through general legal searches may not be current and the state of the law should be confirmed with a practicing lawyer before relying upon it.  The internet offers many helpful resources to orient non-lawyers to locating relevant law, several of which are described below.

In addition, a number of useful resources are available in hard-copy, book format, two of which are mentioned below.

  •  Law 101: Everything You Need to Know About the American Legal System, 3d ed. (Oxford University Press, 2010). Available at the University of Washington School of Law Library (KF387.F45 2010 at Classified Stacks).
  •  American Law: An Introduction (W.W. Norton, 1998). Available at the University of Washington School of Law Library (KF387.F74 1998 at Classified Stacks).

Reference librarians at law schools, particularly at public institutions, may be helpful in locating specific documents or orienting an interested person to the law. Specific statutes, regulations or case law may also be available on official government websites.  In addition, medical journals (available on the internet or in medical school libraries) frequently have articles on clinical ethics or policy issues in health care which often address relevant legal authority.

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.

Surrogate decision-making.  The determination as to whether a patient has the capacity to provide informed consent is generally a professional judgment made and documented by the treating health care provider. The provider can make a determination of temporary or permanent incapacity, and that determination should be linked to a specific decision. The legal term competency (or incompetency) may be used to describe a judicial determination of decision-making capacity. The designation of a specific surrogate decision-maker may either be authorized by court order or is specified in state statutes.

If a court has determined that a patient is incompetent, a health care provider must obtain informed consent from the court-appointed decision-maker. For example, where a guardian has been appointed by the court in a guardianship action, a health care provider would seek the informed consent of the guardian, provided that the relevant court order covers personal or health care decision-making.

If, however, a physician determines that a patient lacks the capacity to provide informed consent, for example, due to dementia or lack of consciousness, or because the patient is a minor and the minor is legally proscribed from consenting, then a legally authorized surrogate decision-maker may be able to provide consent on the patient’s behalf.  Most states have specific laws that delineate, in order of priority, who can be a legally authorized surrogate decision-maker for another person. While these laws may vary, they generally assume that legal relatives are the most appropriate surrogate decision-makers. If, however, a patient has previously, while capable of consenting, selected a person to act as her decision-maker and executed a legal document known as a durable power of attorney for health care or health care proxy, then that designated individual should provide informed consent.

In Washington State, a statute specifies the order of priority of authorized decision-makers as follows: guardian, holder of durable power of attorney; spouse or state registered partner; adult children; parents; and adult brothers and sisters. If the patient is a minor, other consent provisions may apply, such as: court authorization for a person with whom the child is in out-of-home placement; the person(s) that the child’s parent(s) have given a signed authorization to provide consent; or, a competent adult who represents that s/he is a relative responsible for the child’s care and signs a sworn declaration stating so.11   Health care providers are required to make reasonable efforts to locate a person in the highest possible category to provide informed consent. If there are two or more persons in the same category, e.g., adult children, then the medical treatment decision must be unanimous among those persons.12  A surrogate decision-maker is required to make the choice she believes the patient would have wanted, which may not be the choice the decision-maker would have chosen for herself in the same circumstance. This decision-making standard is known as substituted judgment. 13 If the surrogate is unable to ascertain what the patient would have wanted, then the surrogate may consent to medical treatment or non-treatment based on what is in the patient's best interest. 14

Laws on surrogate decision-making are slowly catching up with social changes. Non-married couples (whether heterosexual or same sex) have not traditionally been recognized in state law as legally authorized surrogate decision-makers. This lack of recognition has left providers in a difficult legal position, encouraging them to defer to the decision-making of a distant relative over a spouse-equivalent unless the relative concurs. Washington law, for example, now recognizes spouses and domestic partners registered with the state as having the same priority status. 15

Parental decision-making and minor children. A parent may not be permitted in certain situations to consent to non-treatment of his or her minor child, particularly where the decision would significantly impact and perhaps result in death if the minor child did not receive treatment. Examples include parents who refuse medical treatment on behalf of their minor children because of the parents’ social or religious views, such as Jehovah’s Witnesses and Christian Scientists.  The decision-making standard that generally applies to minor patients in such cases is known as the best interest standard.  The substituted judgment standard may not apply because the minor patient never had decision-making capacity and therefore substituted judgment based on the minor’s informed choices is not able to be determined. It is important to note that minors may have greater authority to direct their own care depending on their age, maturity, nature of medical treatment or non-treatment, and may have authority to consent to specific types of treatment. For example, in Washington State, a minor may provide his or her own informed consent for treatment of mental health conditions, sexually transmitted diseases, and birth control, among others. Depending on the specific facts, a health care provider working with the provider’s institutional representatives could potentially legally provide treatment of a minor under implied consent for emergency with documentation of that determination, 16 assume temporary protective custody of

Advance directives.  The term advance directive refers to several different types of legal documents that may be used by a patient while competent to record future wishes in the event the patient lacks decision-making capacity.   The choice and meaning of specific advance directive terminology is dependent on state law. Generally, a living will expresses a person’s desires concerning medical treatment in the event of incapacity due to terminal illness or permanent unconsciousness. A durable power of attorney for health care or health care proxy appoints a legal decision-maker for health care decisions in the event of incapacity. An advance health care directive or health care directive may combine the functions of a living will and durable power of attorney for health care into one document in one state, but may be equivalent to a living will in another state. The Physician Orders for Life Sustaining Treatment (POLST) form is a document that is signed by a physician and patient which summarizes the patient’s wishes concerning medical treatment at the end of life, such as resuscitation, antibiotics, other medical interventions and artificial feeding, and translates them into medical orders that follow patients regardless of care setting. It is especially helpful in effectuating a patient’s wishes outside the hospital setting, for example, in a nursing care facility or emergency medical response context.  This relatively new approach is available in about a dozen states, although the programs may operate under different names: POST (Physician Orders for Scope of Treatment), MOST (Medical Orders for Scope of Treatment), MOLST (Medical Orders for Life-Sustaining Treatment), and COLST (Clinician Orders for Life-Sustaining Treatment).  The simple one page treatment orders follow patients regardless of care setting. Thus it differs from an advance directive because it is written up by the clinician in consultation with the patient and is a portable, actionable medical order.  The POLST form is intended to complement other forms of advance directives. For example, Washington State recognizes the following types of advance directives: the health care directive (living will), the durable power of attorney for health care, and the POLST form. 17 Washington also recognizes another legal document known as a mental health advance directive, which can be prepared by individuals with mental illness who fluctuate between capacity and incapacity for use during times when they are incapacitated. 18

State laws may also differ on the conditions that can be covered by an individual in an advance directive, the procedural requirements to ensure that the document is effective (such as the number of required witnesses) and the conditions under which it can be implemented (such as invalidity during pregnancy).

Advance directives can be very helpful in choosing appropriate treatment based upon the patient’s expressed wishes. There are situations, however, in which the advance directive’s veracity is questioned or in which a legally authorized surrogate believes the advance directive does not apply to the particular care decision at issue. Such conflicts implicate clinical ethics, law and risk management.

Provider-patient communications: disclosing medical error.  Honest communication to patients by health care providers is an ethical imperative. Excellent communication eliminates or reduces the likelihood of misunderstandings and conflict in the health care setting, and also may affect the likelihood that a patient will sue.

One of the more contentious issues that has arisen in the context of communication is whether providers should disclose medical errors to patients, and if so, how and when to do so. Disclosure of medical error creates a potential conflict among clinical ethics, law and risk management. Despite a professional ethical commitment to honest communication, providers cite a fear of litigation as a reason for non-disclosure. Specifically, the fear is that those statements will stimulate malpractice lawsuits or otherwise be used in support of a claim against the provider.  An increase in malpractice claims could then negatively affect the provider’s claims history and malpractice insurance coverage.  

There is some evidence in closed systems (one institution, one state with one malpractice insurer) that an apology coupled with disclosure and prompt payment may decrease either the likelihood or amount of legal claim.  In addition, a number of state legislatures have recently acted to protect provider apologies, or provider apologies coupled with disclosures, from being used by a patient as evidence of a provider’s liability in any ensuing malpractice litigation.19 It is currently too early to know whether these legal protections will have any impact on the size or frequency of medical malpractice claims.20For this reason and others, it is advisable to involve risk management and legal counsel in decision-making regarding error disclosure.

Case studies highlighting the interplay between clinical ethics, legal & risk management issues

The three cases below are examples of fact patterns that may arise in practice. The facts are derived from actual cases which have been modified to allow further exploration of the intersection of the law with clinical ethics and risk management.  Each situation is unique and the cases are not intended to be authority for any specific application.

  • Case 1: Disagreement among surrogate decision-makers/patient with advance directive/end of life/futility 
  • Case 2: Surrogate decision-maker with potential conflict of interest
  • Case 3: Minor patient/Jehovah’s Witness/non-treatment against medical advice
Bioethics Topics: 
Clinical Ethics and Law