Allocation of very scarce medical interventions such as organs and vaccines is a persistent ethical challenge. We evaluate eight simple allocation principles that can be classified into four categories: treating people equally, favouring the worst-off, maximising total benefits, and promoting and rewarding social usefulness. No single principle is sufficient to incorporate all morally relevant considerations and therefore individual principles must be combined into multiprinciple allocation systems. We evaluate three systems: the United Network for Organ Sharing points systems, quality-adjusted life-years, and (...) disability-adjusted life-years. We recommend an alternative system—the complete lives system—which prioritises younger people who have not yet lived a complete life, and also incorporates prognosis, save the most lives, lottery, and instrumental value principles. (shrink)

In this article, we propose the Fair Priority Model for COVID-19 vaccine distribution, and emphasize three fundamental values we believe should be considered when distributing a COVID-19 vaccine among countries: Benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern for all individuals. The Priority Model addresses these values by focusing on mitigating three types of harms caused by COVID-19: death and permanent organ damage, indirect health consequences, such as health care system strain and stress, as well as (...) economic destruction. It proposes proceeding in three phases: the first addresses premature death, the second long-term health issues and economic harms, and the third aims to contain viral transmission fully and restore pre-pandemic activity. -/- To those who may deem an ethical framework irrelevant because of the belief that many countries will pursue "vaccine nationalism," we argue such a framework still has broad relevance. Reasonable national partiality would permit countries to focus on vaccine distribution within their borders up until the rate of transmission is below 1, at which point there would not be sufficient vaccine-preventable harm to justify retaining a vaccine. When a government reaches the limit of national partiality, it should release vaccines for other countries. -/- We also argue against two other recent proposals. Distributing a vaccine proportional to a country's population mistakenly assumes that equality requires treating differently situated countries identically. Prioritizing countries according to the number of front-line health care workers, the proportion of the population over 65, and the number of people with comorbidities within each country may exacerbate disadvantage and end up giving the vaccine in large part to wealthy nations. (shrink)

Health policy is only one part of social policy. Although spending administered by the health sector constitutes a sizeable fraction of total state spending in most countries, other sectors such as education and transportation also represent major portions of national budgets. Additionally, though health is one important aspect of economic and social activity, people pursue many other goals in their social and economic lives. Similarly, direct benefits—those that are immediate results of health policy choices—are only a small portion of the (...) overall impact of health policy. This chapter considers what weight health policy should give to its “spill-over effects,” namely non-health and indirect benefits. (shrink)

We argue that the ethical case for instituting vaccine benefit programs is justified by 2 widely recognized values: (1) reducing overall harm from COVID-19 and (2) protecting disadvantaged individuals. We then explain why they do not coerce, exploit, wrongfully distort decision-making, corrupt vaccination's moral significance, wrong those who have already been vaccinated, or destroy willingness to become vaccinated. However, their cost impacts and their effects on public perception of vaccines should be evaluated.

This article proposes a novel strategy, one that draws on insights from antidiscrimination law, for addressing a persistent challenge in medical ethics and the philosophy of disability: whether health systems can consider quality of life without unjustly discriminating against individuals with disabilities. It argues that rather than uniformly considering or ignoring quality of life, health systems should take a more nuanced approach. Under the article's proposal, health systems should treat cases where quality of life suffers because of disability-focused exclusion or (...) injustice differently from cases where lower quality of life results from laws of nature, resource scarcity, or appropriate tradeoffs. Decisionmakers should ignore quality-of-life losses that result from injustice or exclusion when ignoring them would improve the prospects of individuals with disabilities; in contrast, they should consider quality-of-life losses that are unavoidable or stem from resource scarcity or permissible tradeoffs. On this proposal, while health systems should not amplify existing injustice against individuals with disabilities, they are not required to altogether ignore the potential effects of disability on quality of life. (shrink)

This paper takes a novel approach to the active bioethical debate over whether advance medical directives have moral authority in dementia cases. Many have assumed that advance directives would lack moral authority if dementia truly produced a complete discontinuity in personal identity, such that the predementia individual is a separate individual from the postdementia individual. I argue that even if dementia were to undermine personal identity, the continuity of the body and the predementia individual’s rights over that body can support (...) the moral authority of advance directives. I propose that the predementia individual retains posthumous rights over her body that she acquired through historical embodiment in that body, and further argue that claims grounded in historical embodiment can sometimes override or exclude moral claims grounded in current embodiment. I close by considering how advance directives grounded in historical embodiment might be employed in practice and what they would and would not justify. (shrink)

Current challenges in medical practice, research, and administration demand physicians who are familiar with bioethics, health law, and health economics. Curriculum directors at American Association of Medical Colleges-affiliated medical schools were sent confidential surveys requesting the number of required hours of the above subjects and the years in which they were taught, as well as instructor names. The number of relevant publications since 1990 for each named instructor was assessed by a PubMed search.In sum, teaching in all three subjects combined (...) comprises less than two percent of the total hours in the American medical curriculum, and most instructors have not recently published articles in the fields they teach. This suggests that medical schools should reevaluate their curricula and instructors in bioethics, health law, and health economics. (shrink)

Several quantitative surveys have been conducted internationally to gather empirical information about physicians’ general attitudes towards health care rationing. Are physicians ready to accept and implement rationing, or are they rather reluctant? Do they prefer implicit bedside rationing that allows the physician–patient relationship broad leeway in individual decisions? Or do physicians prefer strategies that apply explicit criteria and rules?

All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including development, testing, and manufacturing; fair distribution; sustainability; and accountability. All parties' obligations should be coordinated and mutually consistent. For (...) instance, companies should not be obligated to provide host countries with additional booster shots at the expense of fulfilling bilateral contracts with countries in which there are surges. Finally, any satisfactory approach should include mechanisms for assurance that all parties are honouring their obligations. This assurance enables countries, pharmaceutical companies, global organisations, and others to verify compliance with the chosen approach and protect ethically compliant stakeholders from being unfairly exploited by unethical behaviour of others. (shrink)

This chapter discusses how justice applies to public health. It begins by outlining three different metrics employed in discussions of justice: resources, capabilities, and welfare. It then discusses different accounts of justice in distribution, reviewing utilitarianism, egalitarianism, prioritarianism, and sufficientarianism, as well as desert-based theories, and applies these distributive approaches to public health examples. Next, it examines the interplay between distributive justice and individual rights, such as religious rights, property rights, and rights against discrimination, by discussing examples such as mandatory (...) treatment and screening. The chapter also examines the nexus between public health and debates concerning whose interests matter to justice (the “scope of justice”), including global justice, intergenerational justice, and environmental justice, as well as debates concerning whether justice applies to individual choices or only to institutional structures (the “site of justice”). The chapter closes with a discussion of strategies, including deliberative and aggregative democracy, for adjudicating disagreements about justice. (shrink)

Household debt has been widely discussed among social scientists, policy makers, and activists. Many have questioned the levels of debt households are required to take on, and have made various proposals for assisting households in debt. Yet theorists of distributive justice have left household debt underexamined. This article offers a normative examination of the distributive justice issues presented by proposals to relieve household debt or protect households from overindebtedness. I examine two goals at which debt relief proposals aim: remedying disadvantage (...) and stabilizing expectations. I then examine strategies for relieving existing debts such as debt abolition, forgiveness, bankruptcy, and mitigation, as well as strategies that aim to prevent future indebtedness, such as public provision or financing of costly goods and credit or interest rate regulations. (shrink)

We consider an ethical dilemma in global health: is it ethically acceptable to provide some patients cheaper treatments that are less effective or more toxic than the treatments other patients receive? We argue that it is ethical to consider local resource constraints when deciding what interventions to provide. The provision of cheaper, less effective health care is frequently the most effective way of promoting health and realizing the ethical values of utility, equality, and priority to the worst off.

Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.

The coronavirus disease 2019 (COVID-19) pandemic has motivated medical ethicists and several task forces to revisit or issue new guidelines on allocating scarce medical resources. Such guidelines are relevant for the allocation of scarce therapeutics and vaccines and for allocation of ICU beds, ventilators, and other life-sustaining treatments or potentially scarce interventions. Principles underlying these guidelines, like saving the most lives, mitigating disparities, reciprocity to those who assume additional risk (eg, essential workers and clinical trial participants), and equal access may (...) compete with one another. We propose the use of a “categorized priority system” (also known as a “reserve system”) as an improvement over existing allocation methods, particularly because it may be able to achieve disparity mitigation better than other methods. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

In this commentary, I critique three aspects of Emily Walsh's proposal to reduce the moral and legal weight of advance directives: (1) the ambiguity of its initial thesis, (2) its views about the ethics and legality of clinical practice, and (3) its interpretation and application of Ronald Dworkin’s account of advance directives and L.A. Paul's view on transformative experience. I also consider what Walsh’s proposal would mean for people facing the prospect of dementia. I conclude that our reasons to honor (...) many advance directives survive the move to a transformative experience framework. (shrink)

By 20 October 2021, the U.S. Food and Drug Administration (FDA) had amended its Emergency Use Authorizations for immunocompetent adults who previously received the Pfizer-BioNTech, Moderna, or Johnson & Johnson COVID-19 vaccines. For the 2-dose Pfizer-BioNTech and Moderna vaccines, the FDA permitted a single booster dose for adults aged 65 years or older and adults aged 18 to 64 years at high-risk for severe COVID-19 or at high risk for occupational or institutional COVID-19 exposure. For the single-dose Johnson & Johnson (...) vaccine, the FDA permitted a single booster dose for all adults aged 18 or older. These eligibility schemes were endorsed by the Centers for Disease Control and Prevention shortly after FDA approval. (shrink)

Technological and societal changes have made downward social and economic mobility a pressing issue in real-world politics. This article argues that a Rawlsian society would not provide any special protection against downward mobility, and would act rightly in declining to provide such protection. Special treatment for the downwardly mobile can be grounded neither in Rawls’s core principles—the basic liberties, fair equality of opportunity, and the difference principle—nor in other aspects of Rawls’s theory. Instead, a Rawlsian society is willing to sacrifice (...) particular individuals’ ambitions and plans for the achievement of justice, and offers those who lose out from justified change no special solicitude over and above the general solicitude extended to all. Rather than guaranteeing the maintenance of any particular individual or group’s economic position, it provides all of its members—the upwardly mobile, the downwardly mobile, and the immobile—a form of security that is at once more generous and more limited: that they will receive the liberties, opportunities, and resources promised by the principles of justice. (shrink)

In the United States, the Presidential Commission for the Study of Bioethical Issues has proposed deliberative democracy as an approach for dealing with ethical issues surrounding synthetic biology. Deliberative democracy might similarly help us as we update the regulation of human subjects research. This paper considers how the values that deliberative democratic engagement aims to realize can be realized in a human subjects research context. Deliberative democracy is characterized by an ongoing exchange of ideas between participants, and an effort to (...) justify decisions that bind participants by appeal to reasons that the participants can understand and share. Even when unanimous agreement is not reached, the active participation of everyone along with the requirement that reasons be made accessible enhances the legitimacy of the ultimate outcome. Importantly, deliberative democratic structures avoid strict hierarchies and place participants, as much as possible, in the position of equals. Human subjects research has some features that may make deliberative democratic principles seem initially unappealing. For one, there are asymmetries in knowledge between expert researchers conducting the research and participants in the research process. For another, statistical validity is made easiest by research paradigms that produce standardized, quantitative data, which can be difficult to achieve if research participants are given the power to deliberatively reshape the research design as it progresses. These and other problems have tended to produce a human subjects research process where subjects do not actively participate in shaping research, but rather consent to a predefined set of interventions designed by expert researchers and vetted by Institutional Review Boards (IRBs). In this paper, I suggest some ways in which human subjects research could do more to realize deliberative democratic values, and, in particular, how a revised Common Rule might help to realize these values. First, research participants could be treated not as passive subjects but instead involved in research design, ethical review, and the ongoing conduct and dissemination of research. Such participation might involve, for instance, including people who have served as research subjects on IRBs, or replacing IRB oversight for certain forms of research exempted from IRB oversight under a revised Common Rule with oversight by a body of community members or research subjects. It might also involve having the oversight of research that uses more participatory models be more participatory and less hierarchical in nature. I also raise questions about the exemption of research on public benefit programs from any research-level oversight and from consent requirements. While IRBs are likely not the correct overseers, there may be good reason to view such research with a critical eye, because of its potential for long-range impacts on the lives of participants. By giving research subjects a greater voice in research that aims at fine-tuning public benefit programs on which subjects rely, a deliberative oversight process has the potential to recast research participation as a form of active democratic participation and to address a “democratic deficit” in public health. Numerous proposals regarding health care have called for greater participation by laypeople and a more nonhierarchical approach to setting health priorities. Involving lay research subjects in the conduct of public benefits research and other forms of public health research may help to further these goals. (shrink)

In this short response to Kerstein and Bognar, we clarify three aspects of the complete lives system, which we propose as a system of allocating scarce medical interventions. We argue that the complete lives system provides meaningful guidance even though it does not provide an algorithm. We also defend the investment modification to the complete lives system, which prioritizes adolescents and older children over younger children; argue that sickest-first allocation remains flawed when scarcity is absolute and ongoing; and argue that (...) Kerstein and Bognar are mistaken to base their allocation principles on differences in personhood. (shrink)

When hospitals face surges of patients with COVID-19, fair allocation of scarce medical resources remains a challenge. Scarcity has at times encompassed not only hospital and intensive care unit beds—often reflecting staffing shortages—but also therapies and intensive treatments. Safe, highly effective COVID-19 vaccines have been free and widely available since mid-2021, yet many Americans remain unvaccinated by choice. Should their decision to forgo vaccination be considered when allocating scarce resources? Some have suggested it should, while others disagree. We offer a (...) framework for evaluating when it is ethical and briefly discuss its legality in American law. (shrink)

Recent events have revived questions about the circumstances that ought to trigger therapists' duty to warn or protect. There is extensive interstate variation in duty to warn or protect statutes enacted and rulings made in the wake of the California Tarasoff ruling. These duties may be codified in legislative statutes, established in common law through court rulings, or remain unspecified. Furthermore, the duty to warn or protect is not only variable between states but also has been dynamic across time. In (...) this article, we review the implications of this variability and dynamism, focusing on three sets of questions: first, what legal and ethics-related challenges do therapists in each of the three broad categories of states (states that mandate therapists to warn or protect, states that permit therapists to breach confidentiality for warnings but have no mandate, and states that give no guidance) face in handling threats of violence? Second, what training do therapists and other professionals involved in handling violent threats receive, and is this training adequate for the task that these professionals are charged with? Third, how have recent court cases changed the scope of the duty? We conclude by pointing to gaps in the empirical and conceptual scholarship surrounding the duty to warn or protect. (shrink)

In this open peer commentary, we categorize the possible “neuroscience in national security” definitions of misuse of science and identify which, if any, are uniquely presented by advances in neuroscience. To define misuse, we first define what we would consider appropriate use: the application of reasonably safe and effective technology, based on valid and reliable scientific research, to serve a legitimate end. This definition presents distinct opportunities for assessing misuse: misuse is the application of invalid or unreliable science, or is (...) the use of reliable scientific methods to serve illegitimate ends. Ultimately, we conclude that while national security is often a politicized issue, assessing the state of scientific progress should not be. (shrink)

Our Viewpoint argues that expanding access to less effective or more toxic treatments is supported not only by utilitarian ethical reasoning but also by two other ethical frameworks: those that emphasise equality and those that emphasise giving priority to the patients who are worst off. The inadequate resources available for global health reflect not only natural constraints but also unwise social and political choices. However, pitting efforts to reduce inequality and better fund global health against efforts to put available resources (...) to their best use mistakes complementary objectives for conflicting ones. (shrink)

This article examines a fundamental question of justice in global health. Is it ethically preferable to provide a larger number of people with cheaper treatments that are less effective (or more toxic), or to restrict treatments to a smaller group to provide a more expensive but more effective or less toxic alternative? We argue that choosing to provide less effective or more toxic interventions to a larger number of people is favored by the principles of utility, equality, and priority for (...) those worst-off. Advocates are mistaken to demand that medical care provided in low-income and middle-income countries should be the same as in high-income countries. (shrink)

In this commentary, I suggest expanding the deliberative aspects of critical care policy development in two ways. First, critical-care policy development should expand the scope of deliberation by leaving fewer issues up to expertise or private choice. For instance. it should allow deliberation about the relevance of age, disability, social position, and psychological well-being to allocation decisions. Second, it should broaden both the set of costs considered and the set of stakeholders represented in the deliberative process. In particular, it should (...) consider efforts to reduce the cost of end-of-life care and to redirect resources away from the provision of costly interventions, and should expand the set of individuals included in deliberation to include stakeholders outside the health-care system. (shrink)

Recent work in the behavioral sciences asserts that we are subject to a variety of cognitive biases. For example, we mourn losses more than we prize equivalently sized gains; we are more inclined to believe something if it matches our previous beliefs; and we even relate more warmly or coldly to others depending on whether the coffee cup we are holding is warm or cold. Drawing on this work, case law and legal scholarship have asserted that we have reason to (...) select legal norms, or revise existing norms, so as to eliminate the influence of these and other cognitive biases. -/- In this Article, I critically evaluate whether and when this reaction is warranted. I begin by contrasting predominantly descriptive definitions of bias, on which bias is merely deviation from a predictive model, with prescriptive definition of bias, on which biased conduct is conduct that actors ought not do. I then similarly contrast the behavioral-scientific concepts of statistical significance and effect size with the concept of significance required to justify legal conclusions. -/- With this apparatus in place, I go on to consider a variety of examples where legal commentators and decisionmakers have worried about the effects of cognitive bias on law. I argue that many of these cognitive biases (for example, our aversion to losses), while reflecting deviations from behavioral scientists’ models of human behavior, are not normatively objectionable and so give us no reason to revise our legal norms to eliminate their effect. Others (e.g., the effect of judges’ hunger on their decisionmaking), however, constitute biases under both descriptive and prescriptive definitions and therefore give us good reason to revise our legal norms. -/- I conclude by contrasting my conclusion — that evaluation of cognitive biases’ legal significance must explicitly evaluate the normative arguments for and against the model of decisionmaking in question on a case-by-case basis — with the arguments of influential scientists and legal commentators like Daniel Kahneman and John Mikhail, who treat cognitive heuristics and biases as more broadly desirable or objectionable. (shrink)

The Affordable Care Act (ACA) may be the most important health law statute in American history, yet much of the most prominent legal scholarship examining it has focused on the merits of the court challenges it has faced rather than delving into the details of its priority-setting provisions. In addition to providing an overview of the ACA’s provisions concerning priority setting and their developing interpretations, this Article attempts to defend three substantive propositions. First, I argue that the ACA is neither (...) uniformly hostile nor uniformly friendly to efforts to set priorities in ways that promote cost and quality. Second, I argue that the ACA does not take a single, unified approach to priority setting; rather, its guidance varies depending on the aspect of the health care system at issue (Patient Centered Outcomes Research Institute, Medicare, essential health benefits) and the factors being excluded from priority setting (age, disability, life expectancy). Third, I argue that cost-effectiveness can be achieved within the ACA's constraints, but that doing so will require adopting new approaches to cost-effectiveness and priority setting. By limiting the use of standard cost-effectiveness analysis, the ACA makes the need for workable rivals to cost-effectiveness analysis a pressing practical concern rather than a mere theoretical worry. (shrink)

The assumption that procuring more organs will save more lives has inspired increasingly forceful calls to increase organ procurement. This project, in contrast, directly questions the premise that more organ transplantation means more lives saved. Its argument begins with the fact that resources are limited and medical procedures have opportunity costs. Because many other lifesaving interventions are more cost‐effective than transplantation and compete with transplantation for a limited budget, spending on organ transplantation consumes resources that could have been used to (...) save a greater number of other lives. This argument has not yet been advanced in debates over expanded procurement and could buttress existing concerns about expanded procurement. To support this argument, I review existing empirical data on the cost‐effectiveness of transplantation and compare them to data on interventions for other illnesses. These data should motivate utilitarians and others whose primary goal is maximizing population‐wide health benefits to doubt the merits of expanding organ procurement. I then consider two major objections: one makes the case that transplant candidates have a special claim to medical resources, and the other challenges the use of cost‐effectiveness to set priorities. I argue that there is no reason to conclude that transplant candidates’ medical interests should receive special priority, and that giving some consideration to cost‐effectiveness in priority setting requires neither sweeping changes to overall health priorities nor the adoption of any specific, controversial metric for assessing cost‐effectiveness. Before searching for more organs, we should first ensure the provision of cost‐effective care. (shrink)

This chapter examines how social- scientific research on public preferences bears on the ethical question of how those resources should in fact be allocated, and explain how social-scientific researchers might find an understanding of work in ethics useful as they design mechanisms for data collection and analysis. I proceed by first distinguishing the methodologies of social science and ethics. I then provide an overview of different approaches to the ethics of allocating scarce medical interventions, including an approach—the complete lives system—which (...) I have previously defended, and a brief recap of social-scientific research on the allocation of scarce medical resources. Following these overviews, I examine different ways in which public preferences could matter to the ethics of allocation. Last, I suggest some ways in which social scientists could learn from ethics as they conduct research into public preferences regarding the allocation of scarce medical resources. (shrink)

When life-saving medical resources are scarce and not everyone can be saved, is the only relevant goal saving the most lives? Or can other factors be considered, at least as tiebreakers, such as how early in life the people we don't save will die or how much future life they are likely to lose? This commentary defends a multiprinciple allocation approach that considers objectives in addition to saving more lives, including preventing early death and preventing harm in the form of (...) lost future life. Particularly compared to an arbitrary, coin-flip tiebreaker, this multiprinciple approach more effectively prevents harm, prioritizes the worst-off, mitigates socioeconomic and racial health disparities, and tracks public values regarding allocation under scarcity—and is legally sound. -/- . (shrink)

Through engagement with key informants and review of ethical theories applicable to refugee policy, this paper examines the ethical and policy considerations that policy-level stakeholders believe should factor into setting the refugee resettlement ceiling. We find that the ceiling traditionally has been influenced by policy goals, underlying values, and practical considerations. These factors map onto several ethical approaches to resettlement. There is significant alignment between U.S. policy interests and ethical obligations toward refugees. We argue that the refugee ceiling should be (...) restored to historical norms, and that there exists a corresponding obligation to counter negative public perceptions about refugees and the costs of resettlement. (shrink)

-/- This chapter evaluates the ethical issues that using cost-effectiveness considerations to set animal health priorities might present, and its conclusions are cautiously optimistic. While using cost-effectiveness calculations in animal health is not without ethical pitfalls, these calculations offer a pathway toward more rigorous priority-setting efforts that allow money spent on animal well-being to do more good. Although assessing quality of life for animals may be more challenging than in humans, implementing prioritization based on cost-effectiveness is less ethically fraught.

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that scarce resources such as tissue (...) samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, (...) first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; and (vi) the need to avoid quality-of-life judgments. In the second part, we lay out some positions on which reasonable people can and do differ. These include (i) conflicts between maximizing benefits and priority to the worst off; (ii) role-based priority; and (iii) whether patients’ existing lifesaving resources should be subject to redistribution. (shrink)

The U.S. FDA has issued emergency use authorizations for monoclonal antibodies for non-hospitalized patients with mild or moderate COVID-19 disease and for individuals exposed to COVID-19 as post-exposure prophylaxis. One EUA for an oral antiviral drug, molnupiravir, has also been recommended by FDA’s Antimicrobial Drugs Advisory Committee, and others appear likely in the near future. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (...) with increased infectivity and/or severity emerge, further rationing may be required. We identify relevant ethical principles and priority groups for access to therapies based on an integrated approach to population health and medical factors. Using priority categories to allocate scarce therapies effectively operationalizes important ethical values. This strategy is preferable to the current approach of categorical rules based on vaccination, immunocompromise status, or older age, or the ad hoc consideration of clinical risk factors. (shrink)

This chapter argues that rather than viewing transparency as a right, we should regard it as a finite resource whose allocation involves tradeoffs. It then argues that those tradeoffs should be resolved by using a multi-principle approach to distributive justice. The relevant principles include maximizing welfare, maximizing autonomy, and giving priority to the worst off. Finally, it examines some of the implications for law of recognizing the tradeoffs presented by transparency proposals.

Since the Supreme Court upheld the partial birth abortion ban in 2007, more U.S. abortion providers have begun performing intraamniotic digoxin injections prior to uterine dilation and evacuations. These injections can cause medical harm to abortion patients. Our objective is to perform an in-depth bioethical analysis of this procedure, which is performed mainly for the provider’s legal benefit despite potential medical consequences for the patient.

Cass Sunstein and Richard Thaler's proposal that social and legal institutions should steer individuals toward some options and away from others-a stance they dub "libertarian paternalism"-has provoked much high-level discussion in both academic and policy settings. Sunstein and Thaler believe that steering, or "nudging," individuals is easier to justify than the bans or mandates that traditional paternalism involves. -/- This Article considers the connection between libertarian paternalism and the regulation of reproductive choice. I first discuss the use of nudges to (...) discourage women from exercising their right to choose an abortion, or from becoming or remaining pregnant. I then argue that reproductive choice cases illustrate the limitations of libertarian paternalism. Where choices are politicized or intimate, as reproductive choices often are, nudges become not much easier to justify than traditional mandates or prohibitions. Even beyond the context of reproductive choice, it is not obvious how much easier nudges are to justify than bans or mandates. -/- Part I of this Article briefly introduces Sunstein and Thaler's libertarian paternalism. Part II then turns to the context of reproductive choice. Part II.A reviews restrictions on the right to choose an abortion-particularly post-Casey regulations such as waiting periods, requirements that women receive certain types of information, and requirements that women undergo ultrasound-that pitch themselves as steering choice without entirely closing off the right to choose an abortion. This distinction between nudges and prohibitions echoes Sunstein and Thaler's proposals, but works to subordinate women's choices to the judgment of (often male) experts and administrators-hence my term "libertarian patriarchalism." Part II.B reviews efforts to nudge women-particularly teenagers, HIV-positive women, and others thought to be unsuitable mothers-to avoid pregnancy. -/- Part III considers the normative implications of nudging reproductive decisions. In Part III.A, I argue that the political nature of reproductive choices presents a problem for nudges. I do so by considering a parallel with voting rights. Empirical research shows that voters are more likely to choose the candidate listed first on the ballot. Yet we do not empower the administrator in charge of ballot design to choose a default rule that nudges individuals toward the candidate he sincerely believes would promote choosers' welfare. Given the political nature of reproductive choices, a policymaker's attempting to nudge reproductive decisionmaking in the direction he prefers-or indeed in any direction-fails to show adequate respect for the chooser's agency. In Part III.B, I offer an argument that targets the use of nudges in the context of pregnancy. Finally, in Part III.C, I argue that nudges do not merely add choices to an existing menu, but change the substantive choices available to individuals and thereby impose more-than-trivial costs on them. I conclude by exploring the implications of my arguments for nudges more generally. (shrink)

This Note offers a normative critique of cost-benefit analysis, one informed by deontological moral theory, in the context of the debate over whether tort litigation or a non-tort approach is the appropriate response to mass harm. The first Part argues that the difference between lay and expert intuitions about risk and harm often reflects a difference in normative judgments about the existing facts, rather than a difference in belief about what facts exist, which makes the lay intuitions more defensible. The (...) second Part considers how tort has dealt with this divergence between lay and expert perspectives. It also evaluates how tort's approach has differed from that of public law approaches to accident law, such as legislative compensation and risk regulation by administrative agencies. Ultimately, tort's ability to recognize the value of lay intuitions supports retaining the tort perspective as part of our societal arsenal of responses to risk and harm. This ability can also support a pro-tort perspective in two practical debates in the arena of tort law: that over preemption of tort law by administrative agency judgments, and that over access to tort recovery as part of a no-fault system. (shrink)

This chapter explores two questions in detail: How should we determine the threshold for costs that individuals are asked to bear through insurance premiums or care-related out-of-pocket costs, including user fees and copayments? and What is an adequate relationship between costs and benefits? This chapter argues that preventing impoverishment is a morally more urgent priority than protecting households against income fluctuations, and that many health insurance plans may not adequately protect individuals from health care costs that threaten to drop their (...) financial status below a decent minimum. A design that places greater emphasis on preventing impoverishment and finances the achievement of that goal by reducing unnecessary subsidies to better-off households would better accord with a sufficientarian approach to health care. -/- . (shrink)

Citizenship and marriage are legal statuses that generate numerous privileges and responsibilities. Legal doctrine and argument have analogized these statuses in passing: consider, for example, Ted Olson’s statement in the Hollingsworth v. Perry oral argument that denying the label “marriage” to gay unions “is like you were to say you can vote, you can travel, but you may not be a citizen.” However, the parallel between citizenship and marriage has rarely been investigated in depth. This paper investigates the marriage-citizenship parallel (...) with a particular focus on three questions prompted by recent developments in law and policy: -/- 1) Should we provide second-best statuses? Some couples — in particular gay and lesbian couples — have been offered permanent statuses, like civil unions, that bear legal privileges but fall short of full marriage equality. In contrast, similar differentiations within citizenship are generally resisted. The history of citizenship may presage the increasing unacceptability of differentiations within status in the gay marriage context. Meanwhile, the history of marriage equality efforts may help present-day citizenship advocates choose legal strategies. -/- 2) Should statuses be a gateway to rights? Some early gay rights advocates unsuccessfully argued that advocates should challenge the primacy of marriage, rather than seek access to the institution. Advocates attempting to expand the rights of current noncitizens face similar choices: should they seek to give current noncitizens greater access to citizenship, or challenge the reservation of important rights to citizens? -/- 3) Can status relationships be plural? Many critics of dual and multiple citizenship argued that allegiance to multiple states was immoral, unadministrable, or both. More recently, polygamous marriage has become a topic of legal and political discourse, first as a foil in anti-gay marriage arguments and later as a political possibility in its own right. I consider whether polygamous marriage advocates can profitably draw on arguments for multiple citizenship, and how multiple-citizenship advocates should responsibly respond to the analogy with polygamy. (shrink)

In this retrospective for Ethics, I discuss H.M. Oliver’s “Established Expectations and American Economic Policies.” This article, by a then-modestly-famous economist, has been ignored (no citations) since its 1940 publication. Yet it bears directly on a normative problem at the intersection of ethics and economics that challenges today’s policymakers but has received comparatively little philosophical attention: how should we balance potentially desirable institutional change against the disruption of established expectations? -/- Oliver details how the principle of fulfilling established expectations cuts (...) across political lines. Conservatives, he observes, criticized inflation for disrupting expectations, and demanded the protection of established corporations. New Deal progressives achieved “the safeguarding of the economic positions of certain important sections of the American people” (104) via statutes designed to protect income and homeownership status. And labor leaders lobbied for the preservation of occupational status. Oliver criticizes these demands on two grounds. First, they are noncompossible: they can’t simultaneously be fulfilled. Second, they are economically inefficient. He concludes that “in a modern dynamic economy, the preservation of status is not and cannot be a feasible criterion of economic justice” (107). -/- I argue that Oliver accurately recognizes both the wide endorsement and the moral ill-foundedness of fulfilling expectations. However, I criticize Oliver’s belief in the noncompossibility of expectations. The established expectations of the wealthy, middle-class homeowners and retirees, and current workers can all be maintained, but at the price of constricting the opportunities of new graduates, immigrants, and the poor—all groups yet to develop settled expectations. This insight renders the protection of expectations not merely inefficient but also unjust. (shrink)