Equality of Autonomy? Physician Aid in Dying and Supported Decision Making

The legalization of physician aid in dying (“PAID”) has been spreading across the United States and is currently legal in ten jurisdictions. Meant to respect autonomy at the end of life, PAID legislation is modeled after the Oregon Death with Dignity Act, which permits only terminally ill adults with contemporaneous decisional capacity to choose to hasten death with PAID. Right-to-die advocates and legal scholars have critiqued the strict eligibility requirements, which although meant to function as safeguards against mistakes and abuse, can be autonomy thwarting. Advocates and scholars have thus proposed using advance directives for PAID to expand access to this end-of-life option. Such a reform would permit terminally ill persons with moderate dementia or other types of decisional impairments to access PAID.To date, scholars have neglected another possibility for respecting autonomy at the end of life by expanding access to PAID for terminally ill persons with decisional impairments: supported decision-making. Supported decision-making legislation is also spreading across the United States as an alternative to guardianship and surrogate decision-making for persons with cognitive disabilities and is an option in nine jurisdictions. With this model of decision-making, a person with a cognitive disability receives decision-making assistance from supporters to facilitate the exercise of autonomy and retain legal capacity.This Article is the first to address whether terminally ill persons with cognitive impairments should be able to access PAID through supported decision-making. If provided with decision-making support, terminally ill persons with cognitive impairments may be able to elect PAID intentionally, voluntarily, and with understanding; that is, despite their impairments, such persons may be capable of autonomous end-of-life decision-making. This Article thus argues that the principle of equality demands that the law not exclude terminally ill supported persons with decisional impairments from PAID. This Article also argues that supported decision-making is a superior means for terminally ill persons with decisional impairments to access this end-of-life option compared to advance directives, which have numerous and well-documented problems.This Article also considers how PAID and supported decision-making laws interact in the one jurisdiction that currently has both laws, the District of Columbia, and concludes that it may be permissible for a terminally ill person with a decisional impairment, which would otherwise preclude them from accessing PAID, to elect this end-of-life option with assistance from a supporter. The Article ends with considerations for policymakers about building additional safeguards into these laws to ensure that persons with cognitive disabilities do not mistakenly, without understanding, or after the application of undue pressure hasten death through PAID

Dementia, Autonomy, and Supported Healthcare Decisionmaking

Healthcare providers often rely on surrogates to decide on behalf of their patients with dementia who are deemed incapable of exercising autonomy. There is a longstanding debate about the appropriate standard of surrogate healthcare decisionmaking for these patients. Many influential scholars argue that the precedent autonomy of the person with dementia should be respected, and healthcare decision-making laws generally reflect this principle. These laws direct surrogate decisionmakers to follow instructions in living wills or to decide on the basis of the wishes and values of the person before the onset of dementia.But other prominent scholars have questioned whether surrogates should instead use the best interests standard, which accounts for the current interests of the person with dementia. This debate about decision-making standards ignores an arguably more important issue: who should be deciding? Empirical research demonstrates that persons with mild dementia retain the ability to make or participate in decisions despite their acquired cognitive impairments, and that they prefer to be actively involved in healthcare decisionmaking. However, persons with dementia are routinely marginalized in the decision-making process, which leads to a decline in their psychological wellbeing. Based on studies of their decision-making abilities, preferences, and experiences, this Article will argue that persons with dementia should not be prevented from making their own healthcare decisions. Stated differently, persons with dementia should have the legal right to make their own healthcare decisions at the time when the decisions need to be made. Ensuring this right will require looking beyond surrogate-based healthcare decision-making law, which facilitates the exclusion of persons with dementia from decisionmaking. Disability law in six U.S. jurisdictions provides an alternative decision-making model, known as supported decisionmaking, which empowers persons with cognitive impairments to make their own decisions and could be usefully applied to dementia. In supported decisionmaking, an adult with a disability (the “principal”) voluntarily chooses people to assist them in decisionmaking (a “supporter”) and formalizes this arrangement in a written agreement. The supporter’s role is to help the principal gather relevant information, think through the decision, and convey the decision to other people. Supported decisionmaking preserves the legal decision-making authority of a person with a disability rather than transferring such authority to a surrogate. Because supported decisionmaking accords with the preferences and interests of persons with dementia, supported decision-making laws should be widely adopted. This novel application of supported decisionmaking to dementia also provides insight into the nature of autonomy in the larger context of late-life healthcare decisionmaking. My past research has demonstrated that autonomous decisionmaking in this context is relational, which is consistent with supported decisionmaking. This Article will further build upon this conceptualization and advance a new understanding of autonomy in healthcare decisionmaking as more closely approximating relational agency. With this revised understanding of autonomy and the adoption of supported decisionmaking, persons with dementia can remain autonomous for longer in the progression of their disease

A Case for Randomized, Double-Blinded, Sham-Controlled Class III Medical Device Trials

In this paper, I evaluate the ethical implications of the FDA’s move to en-courage randomized, double-blinded, sham-controlled trials for Class III devices when such studies are possible. In Part I, I describe the placebo effect and how researchers control for it. In Part II, I describe the results of studies of medical procedures and devices that have used a sham control. In Part III, I de-scribe the ethical concerns surrounding the use of sham surgeries to study medical devices. In Part IV, I argue for the use of randomized, double-blinded, sham-controlled device trials, and propose an ethical framework for these studies

End of Life and Autonomy: The Case for Relational Nudges in End-of-Life Decision-Making Law and Policy

Autonomy is a central principle in many areas of health law. In the case of end-of-life decision-making law and policy, however, the principle of autonomy requires revision. On the whole, law conceptualizes autonomy at the end of life as an individual making private, personal decisions based solely on their interests and values, and independent of others. But ordinary people understand autonomous decisionmaking at the end of life differently, in a way that acknowledges the importance of their interpersonal relationships. Social science research has documented that strengthening relationships with others, sharing responsibility in the decision-making process with healthcare providers, and taking care to not burden loved ones become important when confronting death and making decisions at the end of life. The divergence in how law and most people conceptualize autonomy becomes particularly consequential when people do not have decision-making capacity when an end-of-life decision must be made, and have not adequately planned in advance for loss of capacity. Failures of rationality explain this all too common situation: a fear and avoidance of death makes people less likely to plan for it, and even when they do plan, they are unable to anticipate every possible end-of-life scenario and their preferences for each scenario. In such cases, the law provides default processes and standards for end-of-life decisionmaking, which constitute a best guess of a surrogate decision-making process that will effectuate the principle of autonomy. However, in this default decision scheme, relational concerns are often accorded a different weight or valence than most people would prefer as evidenced in empirical studies. For example, state statutes may direct an incapacitated person’s surrogate to make end-of-life decisions in the context of the patient’s religious or moral beliefs but not explicitly instruct surrogates to consider the patient’s relationality. Thus, decisions made at the end of life may not accord with people’s values, preferences, and interests. Paradoxically, therefore, the current defaults in end-of-life law may impede, rather than promote, autonomy. In order to address this unintended consequence and make consistent the purpose and intended outcome of end-of-life decision-making law and policy, which is respect for autonomy, this Article argues for changes to accommodate the relational nature of autonomy at the end of life. Drawing on the law and behavioral economics literature about choice architecture, I argue that relational “nudges” should be built into end-of-life decision-making law and policy. The proposed nudges are meant to combat failures of rationality, promote a relational autonomy, and reduce negative externalities in end-of-life decisionmaking. These nudges would be designed to affect an individual’s end-of-life decisions prior to loss of capacity; a surrogate’s healthcare decisions in the absence of advance directives; and healthcare providers’ shared decisions with the patient or surrogate. While this necessitates changing some defaults, more consequentially, the nudges at the policy level would also change the way information and choices are presented to decisionmakers, such as patients and physicians, to prime the decisionmaker to decide, in part, based on relationality. These changes may increase the likelihood that end-of-life decisions are made in accordance with most persons’ stated preferences—namely that these decisions are shared with and made in consideration of others

Resuscitating Consent

The scholarly focus on autonomy in healthcare decision making largely has been on information about, rather than consent to, medical treatment. There is an assumption that if a patient has complete information and understanding about a proposed medical intervention, then they will choose the treatment their physician thinks is best. True respect for patient autonomy means that treatment refusal, whether informed or not, should always be an option. But there is evidence that healthcare providers sometimes ignore treatment refusals and resort to force to treat patients over their contemporaneous objection, which may be facilitated by the incapacity exception to informed consent requirements. This Article uses the case of treatment over objection to resuscitate analysis of consent. This Article asserts that the nature of autonomy in medical decision making is misunderstood, which can lead to wrongful use of the incapacity exception and subsequent harm. Autonomy has become erroneously conflated with an individual’s capacity for rational decision making, obscuring the reality that the exercise of autonomy is mediated by the body. That is, autonomy is not solely cognitive, but also corporeal. Indeed, bodily integrity is a necessary component of autonomy, and so violating bodily integrity by treating patients over their objection is inconsistent with respect for autonomy. Further, when healthcare providers violate patients’ bodily integrity, there can be significant harms to wellbeing. Moreover, if providers misuse the incapacity exception in order to treat patients over their objection, this nullifies informed consent law. This Article argues that patients should not be treated over their objection even when providers do not perceive refusals to be rational because such treatment is inconsistent with respect for patient autonomy and bodily integrity, promotion of wellbeing, and maintenance of the rule of law. In order to prevent or remedy treatment over objection, this Article argues that states should adopt laws that provide adults with absolute legal capacity to refuse medical treatment unless a court overrides their decision. The proposed law thus would prevent healthcare providers from disqualifying their patients from refusing treatment even when there are questions about the patient’s decisional capacity

Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the absence of medical devices in clinical practice. We conclude with recommendations to foster more widespread development of generic medical devices

Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the absence of medical devices in clinical practice. We conclude with recommendations to foster more widespread development of generic medical devices

Severe Brain Injury, Disability, and the Law: Achieving Justice for a Marginalized Population

Thousands of persons with severe brain injury who are minimally conscious or locked in are wrongly treated as if they are unconscious. Such individuals are unable to advocate for themselves and are typically segregated from society in hospitals or nursing homes. As a result, they constitute a class of persons who often lack access to adequate medical care, rehabilitation, and assistive devices that could aid them in communication and recovery. While this problem is often approached from a medical or scientific point of view, here we frame it as a legal issue amenable to legal remedies. This Article comprehensively explores and analyzes sources of federal, state, and international human rights law that can be leveraged- both in traditional and novel ways-to improve the lives and protect the rights of persons with severe brain injury. We argue that state laws may be the most promising basis for legal action to ameliorate the clinical marginalization and societal neglect faced by persons with severe brain injury, and to promote their recovery and reintegration into their communities

Severe Brain Injury, Disability, and the Law: Achieving Justice for a Marginalized Population

Thousands of persons with severe brain injury who are minimally conscious or locked in are wrongly treated as if they are unconscious. Such individuals are unable to advocate for themselves and are typically segregated from society in hospitals or nursing homes. As a result, they constitute a class of persons who often lack access to adequate medical care, rehabilitation, and assistive devices that could aid them in communication and recovery. While this problem is often approached from a medical or scientific point of view, here we frame it as a legal issue amenable to legal remedies. This Article comprehensively explores and analyzes sources of federal, state, and international human rights law that can be leveraged- both in traditional and novel ways-to improve the lives and protect the rights of persons with severe brain injury. We argue that state laws may be the most promising basis for legal action to ameliorate the clinical marginalization and societal neglect faced by persons with severe brain injury, and to promote their recovery and reintegration into their communities