Through the Louisiana Purchase in 1803, the United States expanded its size by over 800,000 square miles. But neither President Thomas Jefferson nor Congress knew exactly what they had bought until 1806, when Meriwether Lewis and William Clark returned from their famous expedition. One of the most significant contributions of the Expedition was a better perception of the geography of the Northwest. Lewis and Clark prepared approximately 140 maps and filled in the main outlines of the previously blank map of (...) the northwestern United States. Robert I. Field has done much the same for the vast territory of U.S. health care regulation.On the front cover of Fields new book, Health Care Regulation in America: Complexity, Confrontation, and Compromise, is a picture of a giant three-dimensional labyrinth. Rarely is cover art so perfectly appropriate. (shrink)

When people lose capacity to make a medical decision, the standard is to assess what their preferences would have been and try to honor their wishes. Dementia raises a special case in such situations, given its long, progressive trajectory during which others must make substituted judgments. The question of how to help surrogates make better‐informed decisions has led to the development of dementia‐specific advance directives, in which people are given tools to help them communicate what their preferences are while they (...) are still able. Such directives allow the perspective of the person to play a clearer role in guiding decisions about their care. Dementia directives can never serve as rigid algorithms. Rather, they can be used to help inform conversations, to help surrogates make decisions that are better aligned with the preferences the person would have had. This essay lays out the proposed utility of dementia‐specific directives and addresses some of the criticisms raised about them. (shrink)

The overwhelming weight of legal authority in the USA and Canada holds that consent is not required for brain death testing. The situation in England and Wales is similar but different. While clinicians in England and Wales may have a prima facie duty to obtain consent, lack of consent has not barred testing. In three recent cases where consent for brain death testing was formally presented to the court, lack of consent was not determinative, and in one case the court (...) questioned whether the clinicians were even required to seek consent from the parents of a child at all. (shrink)

The legal doctrine of informed consent has overwhelmingly failed to assure that the medical treatment patients get is the treatment patients want. This Article describes and defends an ongoing shift toward shared decision making processes incorporating the use of certified patient decision aids.

Ariane Lewis offers a comprehensive and expert review of ethical issues raised by brain death in the United Kingdom and how they compare to management of those issues in the United States (Lewis 20...

In this issue of JCE, Douglas Diekema argues that the best interest standard (BIS) has been misemployed to serve two materially different functions. On the one hand, clinicians and parents use the BIS to recommend and to make treatment decisions on behalf of children. On the other hand, clinicians and state authorities use the BIS to determine when the government should interfere with parental decision-making authority. Diekema concedes that the BIS is appropriately used to “guide” parents in making medical treatment (...) decisions for their children. But he argues that the BIS is inappropriately used as a “limiting” standard to determine when to override those decisions. Specifically, Diekema contends that the BIS “does not represent the best means for determining when one must turn to the state to limit parental action.” He argues that this limiting function should be served by the harm principle instead of by the BIS.I contend that we should not reassign the BIS’s limiting function to the harm principle. In this article I make two arguments to support my position. First, the BIS has effectively served, and can serve, both guiding and limiting functions. Second, the harm principle would be an inadequate substitute. It cannot serve the limiting function as well as the more robust BIS. (shrink)

Bester offers powerful arguments for why the harm principle cannot replace the best interest standard (BIS) as a guide for, and limit on, surrogate healthcare decision making (Bester 2018). Since B...

Pullman argues that when it comes to medical aid in dying (MAID), “Canada … has much to learn from California” (Pullman 2023). Canada and California have similar populations: each about 40 million...

Patients in the United States have been subject to an evergrowing “avalanche” of unwanted medical treatment. This is economically, ethically, and legally wrong. As one advocacy campaign puts it: “Patients should receive the medical treatments they want. Nothing less. Nothing more.” First, unwanted medical treatment constitutes waste (and often fraud or abuse) of scarce healthcare resources. Second, it is a serious violation of patients’ autonomy and self-determination. Third, but for a few rare exceptions, administering unwanted medical treatment contravenes settled legal (...) rules and principles. This “Legal Briefing” describes a central and growing role for the law. Specifically, courts and agencies have increasingly imposed penalties on healthcare providers who deliberately or negligently disregard advance directives and DNR (donot-resuscitate) orders. I group these legal developments into the following five categories: 1. Five Types of Unwanted Medical Treatment2. State and Federal Duties to Follow Advance Directives3. Doctors Hospital of Augusta v. Alicea4. Other Lawsuits for Ignoring Advance Directives5. Administrative Penalties for Ignoring Advance Directives. (shrink)

This issue’s “Legal Briefing” column covers legal developments pertaining to organ donation and allocation. This topic has been the subject of recent articles in JCE. Organ donation and allocation have also recently been the subjects of significant public policy attention. In the past several months, legislatures and regulatory agencies across the United States and across the world have changed, or considered changing, the methods for procuring and distributing human organs for transplantation.Currently, in the U.S., more than 100,000 persons are waiting (...) for organ transplantation. In China, more than 1.5 million people are waiting. Given the chronic shortage of available organs (especially kidneys and livers) relative to demand, the primary focus of most legal developments has been on increasing the rate of donation. These and related developments are usefully divided into the following 12 topical categories: 1. Revised Uniform Anatomical Gift Act2. Presumed Consent and Opt-Out3. Mandated Choice4. Donation after Cardiac Death5. Payment and Compensation6. Donation by Prisoners7. Donor Registries8. Public Education9. Other Procurement Initiatives10. Lawsuits and Liability11. Trafficking and Tourism12. Allocation and Distribution. (shrink)

Like the authors of some of the other responses to Schneiderman, Jecker, and Jonsen, I too was one of the group that produced “An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to Requests for Futile and Potentially Inappropriate Treatments in Intensive Care Units”. Furthermore, ethical and legal issues surrounding futile and potentially inappropriate medical treatment have been a primary focus of my scholarship for more than a decade. Schneiderman, Jecker, and Jonsen offer a strong critique of the Multiorganization Statement, but they do (...) not describe it with sufficient precision. There are points of true normative disagreement between the... (shrink)

Syltern and colleagues argue that we should give parents more time to make difficult decisions about life-sustaining treatment at the margins of viability (Syltern et al. 2022). This thesis is appe...

This issue’s “Legal Briefing” column covers legal developments pertaining to conscience clauses and conscientious refusal. Not only has this topic been the subject of recent articles in this journal, but it has also been the subject of numerous public and professional discussions. Over the past several months, conscientious refusal disputes have had an unusually high profile not only in courthouses, but also in legislative and regulatory halls across the United States.Healthcare providers’ own moral beliefs have been obstructing and are expected (...) to increasingly obstruct patients’ access to medical services. For example, some providers, on ethical or moral grounds, have denied: (1) sterilization procedures to pregnant patients, (2) pain medications in end-of-life situations, and (3) information about emergency contraception to rape victims. On the other hand, many healthcare providers have been forced to provide medical treatment that is inconsistent with their moral beliefs.There are two fundamental types of conscientious objection laws. First, there are laws that permit healthcare workers to refuse providing — on ethical, moral, or religious grounds — healthcare services that they might otherwise have a legal or employer-mandated obligation to provide. Second, there are laws directed at forcing healthcare workers to provide services to which they might have ethical, moral, or religious objections. Both types of laws are rarely comprehensive, but instead target: (1) certain types of healthcare providers, (2) specific categories of healthcare services, (3) specific patient circumstances, and (4) certain conditions under which a right or obligation is triggered. For the sake of clarity, I have grouped recent legal developments concerning conscientious refusal into eight categories: 1. Abortion: right to refuse2. Abortion: duty to provide3. Contraception: right to refuse4. Contraception: duty to provide5. Sterilization: right to refuse6. Fertility, HIV, vaccines, counseling7. End-of-life measures: right to refuse8. Comprehensive laws: right to refuse. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving institutional healthcare ethics committees. This topic has been the subject of recent articles in JCE. Healthcare ethics committees have also recently been the subject of significant public policy attention. Disturbingly, Bobby Schindler and others have described ethics committees as “death panels.” But most of the recent attention has been positive. Over the past several months, legislatures and courts have expanded the use of ethics committees and clarified their roles concerning both (...) end-of-life treatment and other issues. These developments are usefully grouped into the following eight categories: 1. Existence and availability2. Membership and composition3. Operating procedures4. Advisory roles5. Decision-making and gate-keeping roles6. Confidentiality7. Immunity8. Litigation and court cases. (shrink)

Volume 19, Issue 5, May 2019, Page 27-28.

This issue’s “Legal Briefing” column covers recent legal developments involving POLST (physician orders for lifesustaining treatment.) POLST has been the subject of recent articles in JCE. It has been the subject of major policy reports and a recent New York Times editorial. And POLST has been the subject of significant legislative, regulatory, and policy attention over the past several months. These developments and a survey of the current landscape are usefully grouped into the following 14 categories: 1. Terminology2. Purpose, function, (...) and success3. Status in the states4. Four legal routes of implementation5. Which professionals can authorize POLST?6. Is the patient’s signature required?7. Can surrogates consent to for incapacitated patients?8. If a POLST conflicts with an advance directive, which prevails?9. Is offering POLST mandatory?10. What are the duties of healthcare providers?11. What is the role of electronic registries?12. What is the role of the federal government?13. International adoption14. Court cases. (shrink)

Volume 20, Issue 6, June 2020, Page 1-3.

This issue’s “Legal Briefing” column covers recent legal developments involving total brain failure. Death determined by neurological criteria (DDNC) or “brain death” has been legally established for decades in the United States. But recent conflicts between families and hospitals have created some uncertainty. Clinicians are increasingly unsure about the scope of their legal and ethical treatment duties when families object to the withdrawal of physiological support after DDNC. This issue of JCE includes a thorough analysis of one institution’s ethics consults (...) illustrating this uncertainty. This experience is not unique. Hospitals across the country are seeing more DDNC disputes. Because of the similarity to medical futility disputes, some court cases on this topic were reviewed in a prior “Legal Briefing” column. But a more systematic review is now warranted. I categorize recent legal developments into the following nine categories: 1. History of Determining Death by Neurological Criteria2. Legal Status of Determining Death by Neurological Criteria3. Legal Duties to Accommodate Family Objections4. Protocols for Determining Death by Neurological Criteria5. Court Cases Seeking Physiological Support after DDNC6. Court Cases Seeking Damages for Intentionally Premature DDNC7. Court Cases Seeking Damages for Negligently Premature DDNC8. Court Cases Seeking Damages for Emotional Distress9. Pregnancy Limitations on DDNC. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving the Patient Self-Determination Act . Enacted in the wake of the U.S. Supreme Court’s Cruzan decision in 1990, the PSDA remains a seminal event in the development of U.S. bioethics public policy, but the PSDA has long been criticized as inadequate and ineffective. Finally, recent legislative and regulatory changes promise to revitalize and rejuvenate it. The PSDA has been the subject of recent articles in The Journal of Clinical Ethics.I categorize (...) new legal developments concerning the PSDA into the following eight sections:1. Background and History2. Rules and Requirements3. Criticism and Challenges4. Failed Efforts to Amend the PSDA5. Personalize Your Care Act of 20136. New Regulations7. New Regulatory Guidance8. Expanded Enforcement. (shrink)

The American Journal of Bioethics, Volume 12, Issue 10, Page 43-45, October 2012.

British courts have adjudicated dozens of medical futility disputes over the past 10 years. Many of these cases have involved pediatric patients. All these judgements are publicly available in searchable legal reporters. And most were covered by the print or broadcast media.1 Yet, as noted by Dressler, none of these earlier cases received even a fraction of the public or scholarly attention that Charlie Gard has received. One might assess the Gard case from two different perspectives. At one level, the (...) Gard case is not unique. It is merely the n+1 medical futility dispute decided by the British courts. Admittedly, the Gard case has a much higher profile than earlier cases. But it announced no new rules or principles. It merely focused a spotlight on an already well-established process for resolving medical futility disputes. However, from another perspective, the Gard case is distinctive in at least five ways from other medical futility cases decided by the British courts. Because these unique features illustrate the limits or weaknesses of current rules and principles, they allude to potential improvements in the dispute resolution process. The papers in this special issue offer many valuable suggestions. After identifying the five unique features of the Gard case, I focus on the most prevalent two questions. Are courts the best forum for resolving these disputes? Is the best interest standard the right test for determining the limits of surrogate decision-making authority? Because the British courts have so many publicly available judgements in medical futility cases, it is possible to identify five distinctive features in the Gard case. First, Charlie’s parents were not asking GOSH clinicians to continue treating Charlie against either their professional judgement or against their personal beliefs. Instead, Charlie’s parents wanted to transfer him to another hospital that was willing …. (shrink)

A capacitated pregnant woman has a nearly unqualified right to refuse a cesarean section. Her right to say “no” takes precedence over clinicians’ preferences and even over clinicians’ concerns about fetal health. Leading medical societies, human rights organizations, and appellate courts have all endorsed this principle. Nevertheless, clinicians continue to limit reproductive liberty by forcing and coercing women to have unwanted cesareans. This “Legal Briefing” reviews recent court cases involving this type of obstetric violence. I have organized these court cases (...) into the following six categories: 1. Epidemic of Unwanted Cesareans2. Court-Ordered Cesareans3. Physician-Coerced Cesareans4. Physician-Ordered Cesareans5. Cesareans for Incapacitated Patients6. Cesareans for Patients in a Vegetative State or Who Are Brain Dead. (shrink)

A major appellate court decision from the United States seriously questions the legal sufficiency of prevailing medical criteria for the determination of death by neurological criteria. There may be a mismatch between legal and medical standards for brain death, requiring the amendment of either or both. In South Australia, a Bill seeks to establish a legal right for a defined category of persons suffering unbearably to request voluntary euthanasia. However, an essential criterion of a voluntary decision is that it is (...) not tainted by undue influence, and this Bill falls short of providing adequate guidance to assess for undue influence. (shrink)

Cook and Hoas (2008) have identified and illustrated serious shortcomings in rural bioethics and healthcare decision-making. Some of the problems that the authors discuss are unique to the rural co...

This issue’s “Legal Briefing” column covers the recent decision by the Centers for Medicare and Medicaid Services (CMS) to expand Medicare coverage of advance care planning, beginning 1 January 2016. Since 2009, most “Legal Briefings” in this journal have covered a wide gamut of judicial, legislative, and regulatory developments concerning a particular topic in clinical ethics. In contrast, this “Legal Briefing” is more narrowly focused on one single legal development. This concentration on Medicare coverage of advance care planning seems warranted. (...) Advance care planning is a frequent subject of articles in JCE. After all, it has long been seen as an important, albeit only partial, solution to a significant range of big problems in clinical ethics. These problems range from medical futility disputes to decision making for incapacitated patients who have no available legally authorized surrogate. Consequently, expanded Medicare coverage of advance care planning is a potentially seismic development. It may materially reduce both the frequency and severity of key problems in clinical ethics. Since the sociological, medical, and ethical literature on advance care planning is voluminous, I will not even summarize it here. Instead, I focus on Medicare coverage. I proceed, chronologically, in six stages: 1. Prior Medicare Coverage of Advance Care Planning 2. Proposed Expanded Medicare Coverage in 2015 3. Proposed Expanded Medicare Coverage in 2016 The Final Rule Expanding Medicare Coverage in 2016 4. Remaining Issues for CMS to Address in 2017 5. Pending Federal Legislation. (shrink)

The dispute resolution mechanism in the Texas Advance Directives Act (TADA) fails to comply with core ethical and legal notions of fundamental fairness. Kapottos and Youngner (2015) acknowledge the...

This issue’s “Legal Briefing” column covers recent legal developments involving coerced treatment and involuntary confinement for contagious disease. Recent high profile court cases involving measles, tuberculosis, human immunodeficiency virus, and especially Ebola, have thrust this topic back into the bioethics and public spotlights. This has reignited debates over how best to balance individual liberty and public health. For example, the Presidential Commission for the Study of Bioethical Issues has officially requested public comments, held open hearings, and published a 90-page report (...) on “ethical considerations and implications” raised by “U.S. public policies that restrict association or movement (such as quarantine).” Broadly related articles have been published in previous issues of JCE. We categorize recent legal developments on coerced treatment and involuntary confinement into the following six categories: 1. Most Public Health Confinement Is Voluntary 2. Legal Requirements for Involuntary Confinement 3. New State Laws Authorizing Involuntary Confinement 4. Quarantine Must Be as Least Restrictive as Necessary 5. Isolation Is Justified Only as a Last Resort 6. Coerced Treatment after Persistent Noncompliance. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving medical decision making for incapacitated patients who have no available legally authorized surrogate decision maker. These individuals are frequently referred to either as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. The challenges involved in obtaining consent for medical treatment on behalf of these individuals have been the subject of major policy reports. Indeed, caring for the unbefriended has even been described as the “single greatest category of problems” encountered (...) in bioethics consultation. In 2012, JCE published a comprehensive review of the available mechanisms by which to make medical decisions for the unbefriended. The purpose of this “Legal Briefing” is to update the 2012 study. Accordingly, this “Legal Briefing” collects and describes significant legal developments from only the past three years. My basic assessment has not changed. “Existing mechanisms to address the issue of decision making for the unbefriended are scant and not uniform.” Most facilities are “muddling through on an ad hoc basis.” But the situation is not wholly negative. There have been a number of promising new initiatives. I group these developments into the following seven categories: 1. Increased Attention and Discussion 2. Prevention through Better Advance Care Planning 3. Prevention through Expanded Default Surrogate Lists 4. Statutorily Authorized Intramural Mechanisms 5. California Litigation Challenging the Team Approach 6. Public Guardianship 7. Improving Existing Guardianship Processes. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving home birth and midwifery in the United States. Specifically, we focus on new legislative, regulatory, and judicial acts that impact women’s access to direct entry (non-nurse) midwives. We categorize these legal developments into the following 12 categories. 1. Background and History2. Certified Nurse-Midwives3. Direct Entry Midwives4. Prohibition of Direct Entry Midwives5. Enforcement of Prohibition6. Challenges to Prohibition7. Forbearance without License8. Voluntary Licensure9. Unclear and Uncertain Status10. Growth of DEM Licensure11. Licensure (...) Restrictions12. Medicaid Coverage. (shrink)

This issue’s “Legal Briefing” column covers legal developments pertaining to informed consent. Not only has this topic been the subject of recent articles in this journal, but it also been the subject of numerous public and professional discussions over the past several months.Legal developments concerning informed consent can be usefully grouped into nine categories: 1. General disclosure standards in the clinical context2. Shared decision making3. Staturorily mandated abortion disclosures4. Staturorily mandated end-of-life counseling5. Other staturorily mandated subject-specific disclosures6. U.S. Food and (...) Drug Administration (FDA) labeling and federal pre-emption of state informed consent law7. Relaxed informed consent for HIV testing8. General disclosure standards in the research context9. Issues on the horizon. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving futile or non-beneficial medical treatment. This topic has been the subject of recent articles in JCE. Indeed, it was the subject of a “Legal Briefing” in fall 2009. Accordingly, this column focuses on legal developments from the past two years. These developments are usefully grouped into the following 11 categories: 1. Texas Advance Directives Act2. Ontario Consent and Capacity Board3. Surrogate selection4. Ex post cases for damages5. Ex ante cases for (...) injunctions6. Coercion and duress7. Assent and transparency8. Brain-death cases9. Criminal and administrative sanctions10. Conscientious objection11. Penalties for providing futile treatment. (shrink)

This issue’s “Legal Briefing” column, one product of a Greenwall Foundation grant, reviews recent developments concerning compulsory reporting duties.1 Most licensed clinicians in the United States are “mandated reporters.” When these clinicians discover certain threats to the safety of patients or the public, they are legally required to report that information to specified government officials. Over the past year, several states have legislatively expanded the scope of these reporting duties. In other states, new court cases illustrate the vigorous enforcement of (...) already existing duties. I have organized all these legal developments into the following eight categories: 1. Overview of Mandatory Reporting Duties 2. Controversy over the Benefits of Mandatory Reporting 3. New and Expanded Duties to Report 4. Criminal Penalties for Failing to Report 5. Civil Liability for Failing to Report 6. Disciplinary Penalties for Failing to Report 7. Legal Immunity for Good-Faith Reporting 8. Protection against Employers’ Retaliation. (shrink)

This column concisely reviews: significant legal developments concerning medical futility and assisted suicide; three late-2009, early 2010 court cases involving neonatal medical futility disputes; and a number of cases involving the criminal enforcement of assisted suicide laws, as well as recent court cases and legislation aimed to legalize assisted suicide.

(2010). Restricting CPR to Patients Who Provide Informed Consent Will Not Permit Physicians to Unilaterally Refuse Requested CPR. The American Journal of Bioethics: Vol. 10, No. 1, pp. 82-83.

This issue’s “Legal Briefing” column covers recent legal developments involving informed consent. We covered this topic in previous articles in The Journal of Clinical Ethics. But an updated discussion is warranted. First, informed consent remains a central and critically important issue in clinical ethics. Second, there have been numerous significant legal changes over the past year. We categorize recent legal developments into the following 13 categories: 1. Medical Malpractice Liability2. Medical Malpractice Liability in Wisconsin3. Medical Malpractice Liability in Novel Situations4. (...) Enforcement by Criminal Prosecutors5. Enforcement by State Medical Boards6. Enforcement through Anti-Discrimination Laws7. Statutorily Mandated Disclosures Related to End-of-Life Counseling8. Statutorily Mandated Disclosures Related to Aid in Dying9. Statutorily Mandated Disclosures Related to Abortion10. Statutorily Mandated Disclosures Related to Telemedicine11. Statutorily Mandated Disclosures Related to Other Interventions12. Statutorily Mandated Gag and Censorship Laws13. Informed Consent in the Research Context. (shrink)

In the United States, authoritative legal guidance remains sparse on whether or when clinicians may stop life-sustaining treatment without consent. Fortunately, several significant legislative and judicial developments over the past two years offer some clarity. We group these legal developments into the following seven categories: 1. Lawsuits for Damages 2. Amendments to the Texas Advance Directives Act 3. Constitutional Attack on TADA 4. Legislation Prohibiting Clinicians 5. Legislation Authorizing Clinicians 6. Cases from Canada 7. Cases from the United Kingdom.

Some individuals facing dementia contemplate hastening their own death: weighing the possibility of living longer with dementia against the alternative of dying sooner but avoiding the later stages of cognitive and functional impairment. This weighing resonates with an ethical and legal consensus in the United States that individuals can voluntarily choose to forgo life‐sustaining interventions and also that medical professionals can support these choices even when they will result in an earlier death. For these reasons, whether and how a terminally (...) ill individual can choose to control the timing of their death is a topic that cannot be avoided when considering the dementia trajectory. With a focus on the U.S. context, this landscape review considers the status of provisions that would legally permit people facing dementia to hasten death with appropriate support from medical professionals. This review can be used to plan and guide clinical and legal practitioner discussion and policy development concerning evolving questions not fully covered by existing medical decision‐making provisions. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 49-51, January 2012.