It is increasingly common for noncitizens living in the United States to avoid seeing a doctor or enrolling in publicly funded health programs because they fear surveillance by immigration authorities. This is the consequence of a decades-long shift in the locus of immigration enforcement activities from the border to the interior, as well as a recent period of heightened immigration enforcement. These fears persist because the law incompletely constrains immigration surveillance in health care.This Article argues that immigration surveillance in health care is a poor choice of resource allocation for immigration enforcement because it has severe consequences for health and the health care system; additionally, it compromises the legitimacy of the state vis-à-vis its noncitizen residents. The consequences include public health threats, health care system inefficiency, ethical dilemmas, and increased vulnerability in immigrant communities. Laws permitting immigration surveillance in health care also create legitimacy harms by obstructing noncitizens’ access to health care and undermining their privacy and rights to public benefits. The COVID-19 pandemic starkly illustrates these dangers, but they exist even in the absence of a novel disease outbreak.Health care access for noncitizens has largely been left to the vagaries of immigration policy. Immigration surveillance in health care should prompt us to consider the scope and limits of health law and the role of discretion in immigration law. Health care sanctuaries — durable legal protections against immigration surveillance in health care — recover some of the lost equilibrium between immigration enforcement and other goals and values of public policy.
Public health emergency statutes should give executive-branch officials clear authority to respond swiftly in a crisis while setting forth principles to guide executive discretion. Statutes already provide specific authorizations and statutory guardrails for individually targeted measures like isolation and quarantine. New legislation is needed to provide similarly specific authorizations and guardrails for compulsory social distancing and face mask orders. Reforms should facilitate democratic accountability for executive-branch decisions in addition to protecting individual rights. This article offers five key principles to guide legislation. First, statutes should mandate transparency, which is critical to secure the public’s trust. To ensure compulsory orders are conditioned on a demonstrated threat of significant risk and a suitable fit between the means and clearly stated ends, mandated disclosures should include statements of the strategic purpose orders are intended to serve, the scientific understanding on which they are based, and the criteria for when they can be lifted. Second, statutes should provide officials with a graded range of alternatives to ensure a sustainable emergency response that can be tailored to evolving conditions and understanding. To facilitate a scaled response that balances the risk of contributing to community transmission against other public priorities, classifications of services, businesses, and activities as essential or high-priority should be developed in advance. Third, statutes should provide substantive standards to ensure orders are neutral laws of general applicability that do not discriminate on the basis of religion. Fourth, to enable widespread voluntary compliance and minimize unjust distribution of the benefits and burdens of public health intervention, statutes should mandate that restrictions must be accompanied by financial and other material supports, legal protections, and accommodations for safer alternatives to restricted activities to the greatest extent possible within available resources. Finally, statutes should authorize criminal enforcement against individuals who violate social distancing orders only if executive-branch officials establish that it is the least restrictive alternative available to achieve the government’s purpose. These principles should also guide executive officials as they exercise the discretion granted to them under existing statutes. This article proceeds in four parts. In Part I, I describe the evolution of public health emergency law through the turn of the twenty-first century, which determined the governmental powers available at the start of the coronavirus pandemic. In the Part II, I describe the community mitigation strategy implemented to slow the spread of the 2020 coronavirus pandemic in the United States after containment efforts failed. In Part III, I map the legal challenges to coronavirus emergency orders adjudicated in state and federal courts and describe their key themes. Finally, I propose statutory guardrails for state legislatures to guide the use of compulsory social distancing and PPE for the general public.
Despite over a century of evidence that lead is a neurotoxin that causes irreparable harm, today, lead continues to pervade children’s environments and remains a constant threat to health and wellbeing. One in three homes across the United States housing children under the age of six has significant lead-based paint hazards that place occupants at risk of permanent neurological harm and lifelong poor health risks. During the COVID-19 pandemic, the potential for lead exposure and lead poisoning increased due to a reduction in well child visits, strained public health departments, the move to remote learning and strategies to contain the COVID-19 pandemic that required shelter in place. As the United States works to contain the virus, it must also prioritize the control of lead hazards to prevent permanent harm to children. Federal, state, and local governments must use a range of primary prevention strategies in order to fully eradicate the risks and protect children from lead poisoning. This Article provides a comprehensive examination of best practices for addressing lead poisoning and proposes urgent reform measures at the local and state levels. Successful interventions ultimately prioritize health justice strategies and rely on community ownership and cross-sector participation; dedicate significant resources and funding to completely eliminate lead in the environment; and prioritize primary prevention practices that identify lead-based paint hazards before children are exposed.
Artificial intelligence (AI) holds great promise for improved health-care outcomes. It has been used to analyze tumor images, to help doctors choose among different treatment options, and to combat the COVID-19 pandemic. But AI also poses new hazards. This Article focuses on a particular type of health-care harm that has thus far evaded significant legal scrutiny. The harm is algorithmic discrimination. Algorithmic discrimination in healthcare occurs with surprising frequency. A well-known example is an algorithm used to identify candidates for “high risk care management” programs that routinely failed to refer racial minorities for these beneficial services. Some algorithms deliberately adjust for race in ways that hurt minority patients. For example, such algorithms have regularly underestimated African Americans’ risks of kidney stones, death from heart failure, and other medical problems. The Article argues that algorithmic discrimination in medicine can violate civil rights laws such as Title VI and Section 1557 of the Affordable Care Act when it exacerbates health disparities or perpetuates inequities. It urges that algorithmic fairness constitute a key element in designing, validating, and implementing AI and that both legal and technical tools be deployed to promote fairness. To that end, we call for the reintroduction of the disparate impact theory as a robust litigation tool in the health-care arena and for the passage of an algorithmic accountability act. We also detail technical measures that AI developers and users should implement.
Patterns of population health are keen reflections of structural inequities in societies, yet they are rarely subject to the requirements of democratic justification that other systemic inequalities provoke. Nor are health systems generally subject to societal scrutiny regarding fidelity to normative commitments of dignity and equality. Increased recognition of social determinants of health has challenged the narrow biomedical view of health as a stochastic phenomenon. More recently the sweeping devastation of the COVID-19 pandemic has laid bare structural injustices across many democracies, which contributed to widely disparate rates of infection and mortality. However, a lack of clarity remains regarding the conceptual linkages between the right to health and the institutional arrangements required for diverse people to live flourishing lives in a plural democracy. Here we attempt to contribute to a deeper understanding of the right to health by examining the implications of three related claims: (1) the content of a right to health (public health preconditions and care) reflects the arrangement of social institutions and the negotiation of difference in a plural democracy; (2) health systems are democratic institutions that should be organized around showing diverse persons equal moral consideration; and (3) democratic accountability can enhance health protections across borders. We argue that understanding the connections between health and democracy has profound implications for health system financing, priority-setting, and the organization and delivery of health goods and services, as well as oversight. Further, underscoring the connections between health and democracy inexorably calls upon us to enlarge our conception of the way legal determinants of health function and health rights are theorized.
In 2018, President Trump signed a federal “right to try” law, claiming that it would give desperately ill patients earlier access to unapproved medicines, by allowing the patient, doctor, and drug company to arrange for access without federal oversight. Critics of the law argued that it would not meaningfully increase access to experimental medicines, because federal oversight was not the obstacle in the first place. And they were correct. U.S. law already permitted companies to provide terminally ill patients with early access to unapproved medicines. The problem was instead that companies did not take advantage of this option. This Article offers new insights into U.S. law on early access, as well as the new rightto-try law, by offering a comparative perspective using French law. We explore the historical, legal, and cultural differences between France and the United States that may explain differences in their early access systems and why the right-to-try law emerged in one country but not the other. The differing approaches reflect in part differing reactions to arguments grounded in personal autonomy and patients’ rights, when held up against utilitarian arguments for premarket approval and traditions of medical paternalism. Using the French experience, this Article also considers the possibility that the key to increasing use of expanded access in the United States might be financial: making it worthwhile for companies, by allowing them to profit from sales, and making the medicines and associated healthcare services free for patients through insurance coverage. * Erika Lietzan is an Associate Professor at the University of Missouri School of Law. She is grateful to Alec Larsen (University of Missouri School of Law Class of 2019) and Henry Adams (2020) for research assistance. Her work on this project was also supported by an Armstrong Teasdale Schlafy & Davis Faculty Research Fellowship, a John W. Cowden Faculty Research Fellowship, and a Lewis A. & Verne H. Snyder Faculty Research Fellowship. Isabelle Moine-Dupuis is an Associate Professor at the University of Burgundy and member of the Center for Research in International Trade and Investment Law (Credimi), the French Health Law Association (AFDS), and Norms, Science and Technics (NoST, CNRS). The authors are grateful to Christine Coughlin, Jeanne Fabre, Aaron Kesselheim, Paul Litton, Lyrissa Lidsky, Eveline Van Keymeulen, Tom Watson, Patricia Zettler, and three anonymous reviewers for comments and suggestions. 1 Lietzan and Moine-Dupuis: Early Access to Unapproved Medicines in the United States and Fra Published by Yale Law School Legal Scholarship Repository, 2020 YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS 19:2 (2020)
Past infectious disease epidemics in the United States and governmental responses to them made it highly predictable that people living in poverty, people of color, and people with disabilities would bear the brunt of the coronavirus pandemic due to discrimination that limits equal access to resources, such as health care, housing, and employment. The COVID-19 pandemic magnified and accelerated the impact of longstanding discrimination and health inequity among historically marginalized groups and low-income populations. Black and Latinx populations have a higher COVID-19 contraction and mortality rate, higher rates of unemployment, less access to health care, and are at higher risk of eviction during the pandemic, among other significant inequities. Without robust and swift government interventions, the impacts of the pandemic will be wide and deep. This article analyzes mechanisms of discrimination and barriers to health in the pandemic setting using the health justice framework to address discrimination and poverty. The health justice framework offers four overarching principles to prevent and eliminate health disparities during and after the COVID-19 pandemic. First, legal and policy responses must address the impacts of discrimination and poverty on the social determinants of health, which in turn threaten to exacerbate the health, financial, and social impacts of a public health emergency on low-income communities, communities of color, and other marginalized communities. Second, interventions mandating healthy behaviors—such as staying at home from work when sick, mask wearing, and minimizing close contacts outside the home—must be accompanied by legal protections, accommodations, and social supports to enable those behaviors while minimizing economic, social, and cultural harms. Third, because emergencies typically exacerbate long-standing and interconnected crises in low-income communities and communities of color, legal and policy responses must address root problems in addition to immediate needs. Fourth, historically marginalized communities must be engaged as leaders in the development of any interventions and the attainment of health justice. To demonstrate the application of the health justice framework and principles, this article focuses upon three pillars that support resilience and equip marginalized communities to withstand the immediate and long-term impacts of the pandemic: health care, housing, and employment. This article explains how health care discrimination is a social determinant of health, how lack of access to health care operated as a barrier to health justice during the COVID-19 pandemic, and applies the health justice framework to address health inequity. Then this article explains how housing and eviction are social determinants of health, how housing discrimination is a barrier to health justice during the COVID-19 pandemic, and suggests way to achieve health justice in housing. Finally, this article discusses how poverty and employment inequity are social determinants of health, how structural discrimination is an accelerator of employment inequity during the COVID-19 pandemic, and suggests how health justice principles can help achieve equity in employment. Ultimately, the framework can be adopted across numerous social determinants of health and structures to ensure the elimination of discrimination, poverty, and poor health among marginalized people during and after the pandemic.
Scientific evidence indisputably demonstrates that lead poisoning causes permanent neurological damage and numerous co-morbidities for children and adults. Exposure to lead hazards irreversibly harms individuals and, left unchecked, can devastate communities into the future. In recognition of these threats, the President’s Task Force on Environmental Health Risks and Safety Risks to Children (Task Force) was established by Executive Order in 1997. The original Task Force created the first coordinated federal response to eliminate childhood lead poisoning in the United States and set an ambitious ten-year timeline to achieve its goals of prevention, treatment, research, and progress management. However, the most recent Task Force retreated from these bold goals. Rather than eliminating lead poisoning, in 2018 the Task Force sought merely to reduce it. This Article provides a comprehensive overview of the dangers of lead exposure, details the federal government’s evolving response to lead poisoning, and, for the first time, disseminates previously unpublished comments on “Drafting a New Federal Strategy to Reduce Childhood Lead Exposures and Impacts,” submitted to the Task Force in 2017, ahead of its most recent report. By providing these comments publicly, this Article creates a record of critical recommendations to the Task Force, provides best practices for the federal government's response to lead poisoning, and encourages federal policymakers to take the necessary steps to meet the original goal of eradicating lead hazards and protecting children from lead poisoning.
Legislatures have increasingly turned to education-based strategies to address significant public health challenges, despite unclear efficacy of statutory mandated education. In this Article, we examine the recent and rapid adoption of youth sports concussion laws as a lens to explore the limits of educationbased legislative intervention models. In less than 10 years, all 50 states adopted a youth sports concussion statute—and each law mandates concussion education for coaches and/or studentathletes. This expansive, expensive intervention was designed to reduce concussion incidence and improve concussion care. But based on a review of 54 peer-reviewed studies, we argue that concussion education has not, and likely will not, produce the desired public health outcomes. The data largely demonstrate that, at most, concussion education can produce short-term changes in knowledge, but that these gains are unlikely to translate into measurable behavior changes that reduce the incidence and risk of concussion in sport. The Article uses public health perspectives to explore the reasons why top-down education interventions from legislatures may fail to have their * Sydney Diekmann, B.S. Neuroscience, University of Minnesota. Christine Egan, B.S. Neuroscience, University of Minnesota. Carly Rasmussen, B.S. Neuroscience & B.A. Psychology, University of Minnesota. Francis X. Shen, Professor of Law & McKnight Presidential Fellow, University of Minnesota; Director, Shen Neurolaw Lab; Executive Director, Massachusetts General Hospital Center for Law, Brain, and Behavior; Instructor in Psychology, Harvard Medical School MGH Dept. of Psychiatry; Executive Director of Education & Outreach, MacArthur Foundation Research Network on Law and Neuroscience. Contact: Walter F. Mondale Hall, 229-19th Avenue South, Minneapolis, MN 55455, 612-625-5328, fxshen@umn.edu. Acknowledgements: Preparation of this article was supported in part by the University of Minnesota Law School, a University of Minnesota Grand Challenges Grant. For helpful feedback and advice, we thank members of the Grand Challenges Grant team and the Big Ten/Ivy League Traumatic Brain Injury Research Collaboration. For excellent research assistance, we thank Micaela Yarosh. 1 Diekmann et al.: The Failure of Youth Sports Concussion Laws and the Limits of Leg Published by Yale Law School Legal Scholarship Repository, YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS 19:1 (2019) 2 intended effect. Given these limitations, the Article argues for a new type of concussion education intervention that better aligns with incentives to win, focuses on primary prevention, and promotes culture change in concussion reporting. 2 Yale Journal of Health Policy, Law, and Ethics, Vol. 19 [], Iss. 1, Art. 1 https://digitalcommons.law.yale.edu/yjhple/vol19/iss1/1
Drug injury advertising, which solicits consumers for lawsuits against drug and medical device manufacturers, is a $114 million business. Yet little is known about how consumers respond to the medical information contained in those ads. This research applies insights from the field of marketing to the drug injury advertising context and further tests those insights through two experiments. Results suggest that some consumers are deceived by drug injury ads and that some types of advertising are more deceptive than others. We also find that deceptive drug injury ads have a stronger influence on consumer risk perceptions and behavioral intentions. These effects can be mitigated through educational interventions or competing advertisements promoting the drug. Additionally, we find some evidence of a “spillover effect,” where unaffected groups nevertheless perceive increased risk. We situate this research within the factual and legal background for drug injury advertising, as well as the extant scientific literature. We conclude with a discussion of the regulatory implications of the study.
A career as a doctor was long considered to be among the best professional paths that one could pursue. But medicine may no longer be the sought-after career that it once was. All too often, doctors, struggling with the demands of electronic health record systems and a myriad of administrative and regulatory responsibilities, find that they fail to derive much joy from their work and become victims of burnout. Physician burnout is an acute concern in the medical community, with over half of doctors reporting that they suffer from it. Physician burnout is a public health threat. Doctors who are profoundly distressed cannot provide their patients with the highest quality of care. Thus far, physician burnout has received little if any notice in the legal literature. This Article argues that the problem deserves and requires legal attention. First, health care regulations relating to health information technology, insurance, and many other matters are partly responsible for physician burnout and must be streamlined. As a prime example, electronic health record systems are now heavily regulated, but rather than improving the quality and usability of products, the regulations needlessly overburden clinicians. Second, the government traditionally oversees and protects the health and well-being of the American workforce. This is especially true for safety-critical jobs, such as those in the transportation industry. Likewise, physicians should be understood to be doing safety-critical work because patients put their lives in clinicians’ hands. This Article, therefore, aims to fill a void in the literature by analyzing physician burnout through a legal lens and by developing recommendations for legal interventions to address the problem.
Advocates, activists, and academics have criticized pharmaceutical intellectual property (pharma IP) rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, that do not rely on IP; and wealthy private individuals. Their resources could be used to aid patients by providing direct medical assistance, funding prizes or biomedical research, or purchasing pharmaceutical patents and granting rights to the disadvantaged. After identifying this exceptionalism, this Article evaluates several arguments in its defense. These are that pharma IP holders are unique in (1) owning what poor patients need, (2) being in special proximity to these patients, (3) being able to assist at low cost to themselves, (4) having a professional duty to help these patients, or (5) being implicated by their past conduct in these patients' plight. It concludes that none of these arguments are compelling: while IP holders have a duty to help, this duty is not fundamentally different from the duties others owe. Even though this project criticizes exceptionalism, it does not absolve pharma IP holders of duties to help the sick. Rather, it argues that spreading the costs of aiding patients in need across a greater number of market actors, via publicly funded pull programs like prizes and patent buyouts or push programs like grants, would be preferable. So would allowing pharmaceutical firms to seek contribution from others who are able to help. However, if others cannot be held to account, imposing burdens on pharma IP holders can be justified in order to promote global health: treating wealthy firms arbitrarily is preferable to ignoring the urgent needs of the global poor.
“Externalities”, or harms to others, provide a standard justification for government intervention in the private market. There is less agreement over whether government is justified in correcting “internalities,” or harms to self the self is largely powerless to avoid. While some of the internality dispute is philosophical, some is practical. Critics suggest government lacks information to regulate internalities, and that any intervention would inefficiently distort a private market for self-help. In this Article, I show that these critiques of regulation overlook well-established tools of externality regulation, as well as a burgeoning literature on the measurement of internalities.
Tens of millions of people enroll in research studies in the United States every year, making research a multi-billion-dollar industry in the U.S. alone. Research carries risks: although many harms are inevitable, some also arise from errors or mistreatment by researchers, and the history of research ethics is in many ways a history of scandal. Despite regulatory efforts to remedy these abuses, injured subjects nonetheless have little recourse to U.S. courts. In the absence of tort remedies for research-related injuries, the only venue for resolving such disputes is through alternative dispute resolution (ADR)—or more commonly, internal dispute resolution (IDR) through a process offered by the research institution. The federal regulations on human subjects are silent on resolving subject grievances, and to date, little is known about how institutions handle these disputes. This Article is the first empirical study of how U.S. universities and hospitals resolve subjects’ claims of physical injury, dignitary harm, non-compensation, deviations from research protocols, and maltreatment by research staff. I have conducted in-depth interviews with personnel from 30 hospitals and universities to understand how institutions respond to grievances involving research subjects. These interviews reveal highly flexible dispute resolution processes managed by institutional review boards (IRBs), the institutional authorities mandated by federal law to protect human subjects. Although many interviewees spoke intuitively of procedural justice—including elements such as voice, neutrality, and courtesy—these interviews also indicated problems with neutrality, expertise, representation of participants, one-sided appeals, and access to the dispute resolution process itself. This Article takes a close look at current practices, and then suggests strategies for improvement, addressing both the federal regulations and options for institution-led reforms.
Incentive-based pay is rational, intuitive, and popular. Agency theory tells usthat a principal seeking to align its incentives with an agent's should be able tosimply pay the agent to achieve the principal's desired results. Indeed, thisstrategy has long been used across diverse industries-from executivecompensation to education, professional sports to public service-but with mixedresults. Now a new convert to incentive compensation has appeared on the scene:the United States' behemoth health-care industry. In many ways, the incentivemismatch story is the same. Insurance companies and employers are concernedabout constraining the cost of care, and patients are concerned about quality ofcare. Physicians lack an adequate financial incentive to pay attention to either.Health care's recent move away from the traditional fee-for-servicecompensation model to incentive pay is perhaps unsurprising.But there is a problem: mixed preliminary evidence and potential mal-effectson vulnerable third-party patients. This Article employs a new lens-the legaland behavioral literature on optimal contract specificity-to suggest whyincentive pay is problematic and why the health-care experience will be nodifferent than other industries. The use of incentive pay is a change in contractdraftingstrategy, a decision to write a more detailed, control-based contractrather than one that relies on discretion. The contracts literature suggests that thisstrategy will only work well where simple compliance is the goal rather thancreativity or innovation. The health industry will not succeed in implementingincentive pay better than other industries have. What it needs is to recognize thelimits of incentive pay and implement it sparingly. The new TrumpAdministration may be particularly primed to heed this call.
