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Compounding Vulnerability: Hospital Emergency Rooms as Sites Of Race- And Class-Based Police Surveillance

Ji Seon Song, Policing the Emergency Room, 134 Harv. L. Rev. 2646 (2021).

At the time of this writing, there is widespread public consciousness of both racial health disparities, owing to the COVID-19 pandemic, and the problems of racialized policing in the United States, owing to a wave of protests of police killings of Black people. In a timely new article, Professor Ji Seon Song masterfully explores the relationship between inequitable access to health care and policing by analyzing whether and how criminal procedure doctrine protects patients in hospital emergency rooms (ERs) from harmful police practices.

Professor Song’s primary field of interest is criminal law, not health law—but that, I suggest, is one of the reasons why health law scholars and others interested in health policy should give it a read. This, an article primarily analyzing a criminal law issue, provides new and valuable insights about primary interests and status relationships in health care. Though debates about the coherency and scope of health law as a field are ongoing, most health law scholars are concerned with a fairly discrete set of primary interests and status relationships. Among these are the unique vulnerability of patients during a therapeutic transition, the duty of care that medical professionals owe to vulnerable patients, and the persistence of inequities in access to health care by race and class. Professor Song touches on each of these interests in her analysis of the criminal procedure doctrine governing police investigations. As someone who seeks to provide valuable insights about the intersection of health and immigration laws to the community of health law scholars, this type of scholarship is of particular interest to me, and I appreciated the opportunity to review this piece and provide feedback to Professor Song before it was published.

In the article, Professor Song explains how the current doctrine of criminal procedure does not account for the medical vulnerability of patients in the ER; rather, it views ERs as “an extension of the street.” She also explores the ways in which medical professionals become enlisted in policing-related tasks and explains how this involvement both enhances policing and may contradict medical professional norms and responsibilities. Finally, she describes how ERs serve as safety net providers for disproportionately poor and minority (not to mention, immigrant) populations. Therefore, policing the ER “can have a net-widening effect” on police surveillance of historically marginalized groups. Professor Song’s analysis of criminal procedure doctrine reveals that far from accounting for the multiple vulnerabilities of ER patients, the doctrine intensifies them. She outlines a new doctrinal approach rooted in the concept of immigration sanctuary, proposing a revision of the Fourth Amendment reasonable expectation of privacy standard based on medical privacy. She also proposes hospital-based institutional practices and local policies to safeguard ER patients’ privacy and dignity based on harm reduction principles.

The article’s major descriptive contribution is its analysis of how criminal procedure doctrine has failed to protect the privacy rights and dignity of patients in the ER, and how this relates to primary interests in health law such as ethical considerations of medical vulnerability, medical professional duties to patients, and the eradication of health care access inequities. Its normative contribution is its proposal to conceptualize ERs as patient sanctuaries through constitutional doctrine, local policymaking, and institutional practices.

As police reform proposals are actively debated, Professor Song offers valuable insight into their salience for health law and policy. Social and political pressure may soon reach a tipping point for doctrinal, legislative, and institutional shifts that would provide some measure of privacy and dignity to patients in the ER, restore patients’ trust in medical professionals in the ER, and eliminate a discrete barrier to health care access based in criminal law.

Cite as: Medha Makhlouf, Compounding Vulnerability: Hospital Emergency Rooms as Sites Of Race- And Class-Based Police Surveillance, JOTWELL (November 10, 2021) (reviewing Ji Seon Song, Policing the Emergency Room, 134 Harv. L. Rev. 2646 (2021)),

Coming Out of the Drug-Use Closet

Dr. Carl Hart’s Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear opens with a controversial admission. The Columbia University Ziff Professor of Psychology declares that he is “an unapologetic drug user” and, consequently, “a happier and better person.” Dr. Hart urges “responsible” adults to “come out of the closet” about their recreational drug use and its myriad beneficial impacts.

Two important contentions animate Drug Use for Grown-Ups. The first is the widely accepted notion among experts that America’s long-standing criminalization of certain drugs, grounded in their anti-scientific demonization and racialization, is the crux of our problem. Simply stated, our never-ending war on drugs, which has resulted in our country’s unenviable distinction as global mass incarcerator, is an expensive and racist failure. Dr. Hart aptly characterizes American drug policy as a “monstrous, incoherent mess.” Few drug policy experts would disagree.

In fact, critiques of the U.S. drug regime tend to revolve around this theme. Scholars often implore policymakers to end the racist drug war by pointing out that it exacerbates widespread and inequitable harms. They argue that individuals who suffer from problematic drug use deserve compassion and evidence-based treatment instead of stigmatization and incarceration. Drug Use for Grown-Ups, however, not only refuses to loiter in these basic premises, it rejects them as a viable entry points to a productive conversation about American drug prohibition.

As such, the book’s significant contribution to the drug reform canon is located in its dominant and more contentious claim. That is, that responsible, recreational adult drug use enhances pleasure and happiness and that the Declaration of Independence endows all Americans with the unalienable right to such pursuits. Dr. Hart is not a legal academic and, to his credit, he makes no effort to engage with scholarly debates about the founders’ meaning of the Declaration’s “pursuit of happiness” clause. Instead, he deploys the clause to point out that government prohibition undermines our fundamental right to use drugs to enhance happiness so long as that use does not inflict collateral, societal harms. In this connection, Congress enacted a federal right to try law in 2018, which permits individuals with life-threatening health care conditions to take investigational drugs that have not yet obtained Food and Drug Administration (FDA) approval so long as they satisfy enumerated, stringent criteria. The overwhelming majority of the states have also enacted their own right to try laws. The federal courts, on the other hand, have repeatedly rejected the claim that Americans have a fundamental, constitutional right to use illicit substances.

Drug Use for Grown-Ups’s straightforward proposition that adults who do not suffer from serious or terminal illness ought to be able to use drugs to live more empathetic, enjoyable, and meaningful lives has been met with predictably vigorous resistance. Such opposition, of course, has much to do with the power and pervasiveness of American anti-drug propaganda, which teaches that the use of illicit drugs to achieve an altered consciousness is a moral failing that will inevitably lead to problematic outcomes, such as bad parenting, unemployment, substance use disorder, and premature death. Our “what doesn’t kill you makes you stronger” culture is defined by anti-pleasure principles, such as the timeless notion that euphoria is the devil’s work.

American sprinter Sha’Carri Richardson’s recent disqualification from the 2021 Summer Olympic Games due to a positive marijuana test brilliantly illustrates the tension between our cultural anti-drug programming and science. It makes no sense that Richardson was forced out of the Olympics on such grounds because there is no support for the claim that marijuana improves athletic prowess. Banning Richardson from running in the Summer Games due to marijuana use is indistinguishable from—and just as ridiculous as—banning her for taking a Tylenol.

More telling was Richardson’s explanation for her marijuana use and the public’s reception to that rationale. Richardson reported that she had legally used marijuana to cope with the unexpected death of her mother and the public response was predominantly sympathetic and supportive. One wonders how the American public would have responded if Richardson—a Black American woman and athletic superstar—had simply used marijuana to experience pleasure and happiness.

There is, of course, nothing remarkable about Richardson’s drug use. Most Americans take drugs. Some use prescription drugs to mitigate or treat health care conditions; they do so even when such use runs the risk of serious side effects, such as heart attack, seizure, or paralysis. Others routinely use legal, over-the-counter drugs—such as caffeine and alcohol—to achieve a more desirable consciousness, such as heightened alertness or reduced anxiety. Dr. Hart challenges us to examine these phenomena against our otherwise deeply held belief that there is something sinister about using drugs responsibly to enhance our happiness and well-being.

This review is in no manner intended to undermine the seriousness of substance use disorder and other forms of addiction. As already noted, however, the criminalization of drugs enhances drug use-related harms; exacerbates poor public health outcomes; fuels unsafe, illicit underground drug markets; and disparately targets minority populations and other socially and economically disenfranchised groups. Our criminal legal system both ignores the root causes of substance use disorder and devours significant resources that could be devoted to addressing the social and structural determinants of health that drive drug overdose epidemics. The pervasive criminal surveillance of certain drugs, such as opioids, coupled with concerns about substance use disorder also has led to the undertreatment of individuals with chronic pain conditions who may benefit from opioid therapeutics.

Dr. Hart intentionally unmoors his argument that responsible adults have a fundamental right to use drugs to enhance happiness from conventional advocacy for substance use disorder prevention and treatment, on the theory that most recreational drug use is for pleasure and not problematic. He dedicates a chapter of Drug Use for Grown-Ups to critique the term “harm reduction” due to its negative connotations with drug use outcomes. That stated, the evidence strongly suggests that drug decriminalization or legalization would both permit drug use for pleasure and improve the public health outcomes associated with problematic drug use. In the throes of a significant heroin drug crisis two decades ago, Portugal decriminalized simple drug possession and replaced its criminal justice approach with evidence-based public health treatment interventions. Twenty years later, Portugal’s drug overdose rate is five times lower than the European Union average and one-fiftieth of that of the United States. Equally impressive is that fact that Portugal’s drug use rate has declined among 15-to-24-year-olds, which is the population most at risk of initiating drug use.

It is important to close by noting the significant risks that Dr. Hart undertook by coming out in Drug Use for Grown-Ups. Individuals who admit to illicit drug use in the United States face a panoply of potential punitive repercussions including arrest and imprisonment, loss of custody of a child, professional licensure discipline, and even research funding exclusion. As a prolific neuropsychopharmacology expert and tenured drug researcher at a prestigious Ivy League university, Dr. Hart may be viewed as imbued with the privilege necessary to withstand the professional and legal blowback he is likely to receive in response to his candor. Because Dr. Hart is a Black man with dreadlocks living in America, it strikes me as more appropriate under the circumstances that we characterize him as a profile in courage rather than one in privilege.

Cite as: Jennifer Oliva, Coming Out of the Drug-Use Closet, JOTWELL (October 12, 2021) (reviewing Carl L. Hart, Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear (2021)),

How the Mantra of Informed Consent in the Canadian Assisted Dying Debate Obscures Somatic Oppression

Jonas-Sébastien Beaudry, Somatic Oppression and Relational Autonomy: Revisiting Medical Aid in Dying through a Feminist Lens, 52 U.B.C. L. Rev. 241 (2020), available at SSRN.

In 2015, Canada’s Supreme Court ruled that an absolute prohibition on physician assisted suicide and euthanasia violated the right to life, liberty and security of the person. It did not endorse a full-fledged constitutional right to what has since been termed in Canada ‘medical assistance in dying’ [hereafter MAID], explicitly limiting its ruling to the circumstances of the plaintiff, a person approaching her natural death due to a fatal neurological disease (Amyotrophic lateral sclerosis). It also suspended its declaration of invalidity for one year, inviting Canada’s parliament to develop a ‘stringent regulatory regime’ and made other statements that left room for lawmakers to design specific access criteria. Yet, the constitutional rights basis of its ruling and parameters it set out in its ratio dedicendi fuelled a seemingly irresistable rhetoric around the existence of a broad constitutional right to MAID.

This rhetoric found its culmination in a recent bill, which expanded MAID outside an already flexible end of life context. During parliamentary hearings on the new law, about all major disability rights organizations, and three United Nations Special Rapporteurs, warned that the new law, which creates, exclusively for people with disabilities, access to MAID outside the end-of-life context, was stigmatizing and discriminatory. Some academic commentators expressed dismay about how Canadian feminist scholars jumped on the bandwagon of atomistic autonomy-based rhetoric and failed to account for the complexity of end-of-life decision-making in the context of a seriously constrained health care and social support system. Daryl Pullman, invoking Carol Gilligan, argued for the need to hear from a “different voice of care”. McGill University’s professor Jonas Beaudry recently provided such a different voice in Canadian legal scholarship with a sophisticated analysis of the country’s MAID debate through a relational theory and disability rights focused lens.

In Somatic Oppression and Relational Autonomy, Beaudry puts forward that most Canadian arguments around Medical Assistance in Dying ignore how ableist, ageist and ‘diseasist’ attitudes can lead to an internalized form of oppression that undermines the autonomy of people with disabilities in their decision making with respect to requests for termination of their life. The paper follows an earlier MAID-focused publication in which Beaudry urged the Canadian Supreme Court, which has in recent years increasingly interpreted even socio-economic rights from a more individualistic angle, to embrace a concept of autonomy that takes stock of our embededness in a larger social, cultural and economic context.

With extensive references to relational, feminist, and disability theory, Beaudry puts forward a concept of autonomy that goes beyond the mantra of choice as expressed through “informed consent”; a mantra that dominates Canadian health law and bioethics discourse around MAID and has been strikingly present in Canadian case-law that undergirds the country’s legal expansion of MAID. He particularly builds on Diana Meyers’ procedural concept of autonomy to explore how factors of oppression can compromise the relational competency to construct one’s authentic self, and how that concretely plays out for people with disabilities in the context of MAID. Beaudry adds to Meyers’ key components of autonomy–the ability to self-discover, self-define, and self-direct–the notion that autonomy as relational competency requires a sufficient range of options.

After laying out this theoretical basis, the paper analyzes in detail how societal attitudes towards disability, ageing and struggling with illness concretely interfere with people’s ability to make autonomous decisions, and particularly so in the context of a seriously constrained health care context. Beaudry’s rich tapestry of how somatic oppression interferes with autonomy finds inspiration in disability literature, but he also discusses evidence of MAID practices in other liberal MAID regimes. Having followed closely the media reporting and having participated actively in Canadian parliamentary hearings on MAID legalization, I find his discussion of how internalizations of shame, disgust, and fear of becoming a dependent self and a burden to others, can contribute to somatic oppression and may fuel demand for MAID particularly compelling. During recent parliamentary hearings, for example, one parliamentarian called for a broadening of MAID with vivid descriptions of what she termed the ‘indignity’ of incontinency, loss of self-control and pain. Such declarations happened in sessions where other (disabled) Canadians were testifying about the stigmatizing, ableist nature of references to ‘loss of dignity’ in discourses about what for many is an inevitable component of their daily life. The first official report of Canada’s 5 year of MAID practice, which came out after Beaudry’s article was published, also confirms explicitly that many people who died by MAID in Canada experienced some of the factors he discusses, such as fear of being a burden to others, loneliness, and an inability to participate in meaningful activities, as key components of their ‘unbearable suffering.’ Beaudry’s analysis should inspire others to concretely document how these concerns are already playing out in practice.

Beaudry concludes his analysis with an agenda for further research and policy work, which should focus in his view on promoting ‘social aid in living’ and ‘dignity in life’ for persons with disability. He acknowledges that convincing courts, legislators, and legal scholars to embrace the complexity of how people make health care decisions in the face of oppression, cultural harms, and social inequality, will be an uphill battle. The bright line offered by an atomistic informed consent model, supposedly protected by procedural rituals of health care professionals, offers seemingly easy and pragmatic solutions, which policy makers find uniquely appealing and which dominates our legal discourse. But he puts forward that his approach, which calls for shifting from discourses about safeguards to developing substantive support measures to counter oppression, should be broadly acceptable as it “need not be interpreted as a justification for banning MAiD or directly negating individual preferences in a way that would raise a charge of paternalism.”

With this last point, Beaudry may in my view be looking too much for a reconciliation of a disability and feminist critique of MAID with the dogmatic embracing in Canada of open-ended life-termination by choice. Beaudry’s analysis should, so it seems to me, also inspire a questioning of the expressivist impact of a legislative endorsement of the medical profession’s role in actively ending the lives of people with disabilities who are otherwise not close to death, based on inherently complex concepts of autonomy and suffering. Canadian law now explicitly endorses in legislation the perception (a self-perception but one which clearly—as convincingly argued by Beaudry—is influenced by context and other-perception) that a life with disability is more likely unbearable, lacking in dignity, and without further purpose, than the lives of others.

Beaudry’s argument that ‘informed consent’ procedures and current safeguards in Canadian MAID law do not address the much more fundamental issue of somatic oppression and its impact on autonomy is spot on. But particularly those reading his insightful analysis from outside the Canadian context should ask whether the legalization of the practice of state-supported, medical profession organized ending of life of people with disabilities isn’t in and of itself a form of state-supported oppression which risks fundamentally undermining their autonomy, and above all, constitutes an immediate threat to their lives.

Cite as: Trudo Lemmens, How the Mantra of Informed Consent in the Canadian Assisted Dying Debate Obscures Somatic Oppression, JOTWELL (September 8, 2021) (reviewing Jonas-Sébastien Beaudry, Somatic Oppression and Relational Autonomy: Revisiting Medical Aid in Dying through a Feminist Lens, 52 U.B.C. L. Rev. 241 (2020), available at SSRN),

How Research Ethics Committees Act as a “Witness” to Research

Rachel Douglas-Jones, Committee as Witness, 39 Cambridge J. of Anth. 55 (2021), available at Berghahn Journals.

In her recently published article in the Cambridge Journal of Anthropology, Dr. Rachel Douglas-Jones, an Associate Professor at the IT University of Copenhagen, investigates how research ethics committees (RECs, or IRBs as they are known in the United States and some other countries) witness research that has yet to occur. For those of us in law, “to witness” holds particular meaning. According the free Legal Dictionary (to take a relatively trite form of research at my desk), a witness is one who, being sworn or affirmed, according to law, deposes as to their knowledge of facts in issue between the parties in a cause. For those who remember their law school lectures in civil and criminal procedure, there are a variety of rules and tests to determine competence to give evidence qua witness, and compellability of witnesses. To witness, and to be a witness, holds particular power in law.

But to witness also holds other forms of meaning, and can be a powerful concept in extra-legal circumstances, too. Douglas-Jones, as an anthropologist, is less interested in the legal meaning of “witness” (though, as an aside, it would make for an interesting area of investigation in legal anthropology). She is instead keen to better understand how RECs, particularly those in the Asia-Pacific region where she spent a number of years conducting research, rely on “visual cultures”–“spatial and temporal forms that underpin [their] capacity to speak”–to render a collective decision on the ethical acceptability of a research project even before the research itself happens. Her article is an excellent one that is deserving of a wide readership.

Applying this to regulatory studies, we would say that RECs provide a kind of “regulatory event license” to researchers. RECs all over the world, like other forms of administrative bodies (particularly those designed to review applications and then grant, or not, or revoke or suspend, licenses–think of “Gambling Control Boards” or “Alcoholic Beverage Control boards”), have taken more or less the same form since their creation in the 1960s and 1970s. Indeed, were we to relabel RECs/IRBs, we might be more inclined to label them Research Control Boards, as this more accurately captures the regulatory design. After all, their approach is similar to other control boards. Specifically, they comprise a body of experts (and sometimes “lay” community members) who receive applications from researchers, who in turn seek to conduct a project that involves human participants in some way. These research applicants ask the committee for an ethical “green light” to begin their project. Phrased another way, researchers apply to a REC and essentially request: “here is the project I propose to do, and all the ethical issues I think are associated with it, and how those issues have been adequately addressed; can you give me a permission to begin it?”

Legal scholars such as Professor Carl Schneider have been highly critical of this approach in the context of research ethics, arguing that the regulatory design of RECs is so fundamentally misconceived that it inevitably does more harm than good. Taking a blue skies approach, we can think of other ways in which research projects might be (better) assessed for ethical acceptability, and to ensure that researchers conduct themselves ethically. We could, for instance, establish a regulatory regime where research is only reviewed after the fact to see if any wrongs were committed (a kind of audit regime), and if so, sanction those researchers for their transgressions. We could rely solely on tort law as a kind of private ordering regime, enabling research participants to sue researchers and institutions for legal wrongs committed (e.g., battery, negligent conduct). Or, as another example, we could design a more trust-based system that instils in researchers values of virtuous conduct, whereby they promise to behave ethically and with integrity (adhering to a kind of honor code that would lead to institutional or professional sanction if breached).

In any event, countries, and institutions within them, around the globe continue to operate the regulatory design enacted more than 50 years ago for research involving human participants. In other words, the regulatory event-license regime continues to operate without having undergone any fundamental reform. Maybe that means the system is working, or maybe it is more a case of inertia and inability to consider alternative, better (read: more effective and more efficient) ways of assessing the ethics of research projects. The system remains: RECs receive documents, and as part of this may invite researchers to present their project at a committee meeting; they read, listen, and deliberate; and they render an opinion in the form of a regulatory event-license (the approval letter). In her article, Douglas-Jones focuses on the power behind this form of witnessing. She does not criticize this regulatory design per se; rather, she encourages us to consider how witnessing is not just a legal concept, but in fact, in this context, an “ethical moment” and a bureaucratic instantiation of ethics.

Through ethnographic examples of her fieldwork of RECs in Asia, Douglas-Jones’s article deftly points to instances in the process of ethics committee work where there is a “translation of ideals of vision into the bureaucracies of ethics committee practice,” such as the witnessing of the scientific validity of the protocols on their table (which is not bearing witness to the making of a fact but to what can be sought as knowledge) and the committee’s approval level as the (final) product of their assessment, and which can be seen as a form of attestation. More specifically, Douglas-Jones elucidates how a visual logic of seeing from “all sides” (the participants’, the researchers’, each REC member’s, the sides from society more generally, etc.) underpins the committee’s imagined vision, and thereby its legitimacy. And the visual is what predominates at the form of witnessing: neither individual REC members, nor the REC as a whole, are generally constituted to leave their conference table and go out into the “field” to actually witness in all senses how research is being performed, and how ethical a given research project is. Instead, they view documents, and as a possible addition, they may ask the applicant to present at the committee meeting and observe their responses to questions as a means of establishing rapport and gauging trustworthiness. The form of witnessing for a REC, then, is a witness to the attendant documents, the visual culture, that comprise committee work generally, and ethics committee work especially. So, to witness in this context is not merely to “see” the proposal and attendant documents; it is to see it in a certain way, and to produce – through the social technology of the committee – a document with a decision. And, as noted above, RECs “witness” research at the ex ante and ab initio stages: they not only “see” the proposal as a kind of (anticipatory) witness to it, but they also witness it in a certain way, and produce a document with a decision – all situated in a space of anticipation – and we might add, in a black boxed space where one cannot easily witness the witnessers in action.

Ultimately, Douglas-Jones invites us in her article to reflect on how REC members across the world participate in a “global regime of knowledge making” (a finding Prof. Laura Stark has also noted in her work on IRBs in the USA) through their ethical consideration of prospective research and approval of project designs, and that this is best understood through the lens of witnessing. The knowledge making “is anticipatory, it depends on ideals of disinterested yet motivated vision, and it has the power to generate a collective voice through which to speak.” It also depends on partial obscurity, of course, where individual REC members’ voices are obscured and reflected in “concealed expertise,” with the REC approval (or rejection) letter reflecting an ostensibly consensus view of the committee. Through their positioning the research lifecycle, that is, at the beginning stage, the REC’s approval letter enables the research project to move forward, onto the next stage – which is the implementation of the project (subject, of course, to any other regulatory approvals that might be needed). The concept of “witnessing”, as Douglas-Jones describes it, adds to our understanding of RECs because it helps us see how they fit within the longer traditions of scientific witnessing. Douglas-Jones urges us to take stock of the importance of this bureaucratic work, and how this work performs a kind of witnessing of what “good” science will be, both scientifically and ethically. As she writes, “research futures – as they pass over the tables of ethics committees – emerge through the ideal that committee work will indeed be witnessing work; that it will be ethical work, for ethical ends.”

For those of us in law, and with an interest in the regulatory design and performance of these committees, the question is: is that “ideal” actually being realized, and is this an appropriate ideal at all? And if not, how might the realization of ethical research be better accomplished? This is an area where anthropologists and lawyers can bring their work together fruitfully to consider how, if at all, the system of research ethics review might be done better.

Cite as: Edward Dove, How Research Ethics Committees Act as a “Witness” to Research, JOTWELL (August 13, 2021) (reviewing Rachel Douglas-Jones, Committee as Witness, 39 Cambridge J. of Anth. 55 (2021), available at Berghahn Journals),

Stopping the Sale of Cigarettes

Micah Berman, Tobacco Litigation, E-Cigarettes, and the Cigarette Endgame, 13 Ne. U. L. Rev. 219 (2021).

If tort litigation could help drive asbestos and other dangerous products from the market, might it also do so for cigarettes? For several decades, that has been the hope of scholars such as Richard Daynard and other advocates. In Tobacco Litigation, E-Cigarettes, and the Cigarette Endgame, Micah Berman provides a blueprint for the elimination of cigarette sales in the United States.

As Berman observes, “under general principles of tort law, if a less harmful ‘reasonable alternative design’ of a product is available, then the more harmful version is deemed to be defectively designed and cannot be sold without liability for the harm it causes.” E-cigarettes would seem to be a less harmful, reasonable alternative design to traditional cigarettes.

To be sure, as Berman writes, tobacco litigation has failed as a strategy before, and it has done so in three distinct waves. In the first wave, which ran from the 1950s to the 1980s, cases were brought by lung cancer victims or their families. Cigarette manufacturers were able to fend off such cases through either aggressive “scorched earth” pre-trial tactics or, for the few cases that went to trial, by arguing that the connection between smoking and lung cancer had not been conclusively established. In wave two, from the 1980s to the 1990s, manufacturers had to acknowledge the connection between smoking and cancer, and they successfully argued that the risks of smoking were common knowledge and that smokers voluntarily assumed the risks to their health from smoking.

But the wall began to crumble in the early 1990s after the disclosure in second-wave litigation of internal documents revealing that manufacturers had hidden their knowledge of smoking’s health risks and suppressed efforts to develop a less harmful cigarette. In some states, individual plaintiffs prevailed, costing the industry hundreds of millions of dollars in payments overall. In addition, suits brought by state attorneys general resulted in the 1998 Master Settlement Agreement (MSA) and its $200 billion in payments by industry. Still, cigarette manufacturers could shift much of their litigation costs to smokers by raising prices, and the MSA protected industry from suits by states for future-smoking-related costs.

Here is where e-cigarettes come in. As with traditional cigarettes, they serve as a delivery system for nicotine, which satisfies the smoker. But e-cigarettes supply their nicotine by using heat to vaporize a nicotine-containing liquid rather than through the burning of tobacco. Hence, the nicotine is delivered without the tar and other toxic substances that come in the smoke of a traditional cigarette. This is not to say that e-cigarettes are harmless—they are not—but even while we do not know exactly how harmful they are, they are certainly safer than traditional cigarettes. On their websites, cigarette manufacturers explicitly cite the reduced harm to smokers from e-cigarettes. This raises the question whether e-cigarettes represent a “reasonable alternative design” for traditional cigarettes and therefore expose cigarette manufacturers to serious tort liability for marketing a product that is unreasonably dangerous to the health of users.

As Berman discusses, a few obstacles exist to a theory of reasonable alternative design. For example, e-cigarettes have only been marketed recently, and it takes decades of smoking for someone to suffer the kind of harm to health that would support a viable case. In addition, plaintiffs would have to establish that smokers would consider e-cigarettes to be “as satisfying as regular cigarettes.” Relatedly, are e-cigarettes an alternative design for traditional cigarettes, or are they a different product? Are cigarettes essentially nicotine-delivery systems, in which case e-cigarettes would be a reasonable alternative, or do traditional cigarettes provide benefits beyond nicotine that e-cigarettes do not deliver?

Still, none of these obstacles are insurmountable. For example, even though e-cigarettes have not been available for purchase very long, major cigarette manufacturers had developed and patented the technologies used for e-cigarettes starting in the 1960s. The companies decided against bringing e-cigarettes to market not because of technical challenges, but because they did not want to cannibalize sales from their traditional cigarettes or undermine their public claims that nicotine was not addictive and that they were not manipulating nicotine levels in traditional cigarettes. Tort liability has the potential to doom sales of traditional cigarettes.

In addition, the effort to remove traditional cigarettes from the market can proceed on more than one front. Besides using the threat of tort liability, tobacco control advocates can encourage legislators to ban the sale of traditional cigarettes. As Berman observes, we might have finally reached a time in which the long-held goal of eliminating traditional cigarettes is an achievable goal.

Cite as: David Orentlicher, Stopping the Sale of Cigarettes, JOTWELL (July 28, 2021) (reviewing Micah Berman, Tobacco Litigation, E-Cigarettes, and the Cigarette Endgame, 13 Ne. U. L. Rev. 219 (2021)),

Health Equity Governance

Wendy Netter Epstein, A Legal Paradigm for the Health Inequity Crisis (Feb. 17, 2021), available on SSRN.

“It Shouldn’t Take a Pandemic,” read the title of an essay published several months into the COVID-19 pandemic. The bioethicist authors argued that, by focusing on moral issues relating to patient care, bioethics had “gone too small” and should be paying more attention to broader moral issues of injustice. Of course, anyone paying the slightest attention to the news over the past fifteen months has witnessed to how the pandemic has laid bare the greater suffering and death endured by people who are Black, Brown, Indigenous, poor, or disabled. The essayists point out that the inequity of poorer health and unevenly borne suffering is not new. Avoidable, and thus unjust, disparities in health, health care, and social determinants of health have been part of the health landscape in the U.S. seemingly forever, and efforts over the past decades have largely failed to dent them. Wendy Netter Epstein’s new article, A Legal Paradigm for the Health Inequity Crisis, argues that governance challenges offer one explanation for the lack of meaningful progress and suggests an approach to addressing those challenges. And she turns to an improbable chapter in health law’s history for her model: HIPAA Administrative Simplification.

By squarely focusing on how challenges in addressing health inequity are partly a governance problem, Epstein’s article makes a valuable contribution. It helps explain why health inequity has proven so intractable—it is embedded in a fragmented system where no single actor has “both adequate incentive and adequate wherewithal to create progress.” Problems of churn among various payers, the compartmentalization of government actors, and siloed funding for health and other issues are all part of this fragmentation. Currently, nothing supports, much less compels, these fragmented entities to undertake collective planning and action in pursuit of health equity.

After making the case that a lack of effective governance hampers progress towards health equity, the article makes its second key contribution. Epstein draws a parallel to how the health care industry met “a different, seemingly impossible problem” several decades ago in developing the Administrative Simplification provisions of HIPAA. Those provisions of the 1996 legislation addressed a technical challenge—the need to standardize communications between health care providers and payers in health data sharing and payment technologies. When HIPAA was enacted, severe fragmentation typified data technology in the health care industry. And, despite much industry wailing and gnashing of teeth on HIPAA’s enactment, Epstein asserts that “the desired standardization was ultimately achieved.” I’m guessing that these provisions have fallen off many health law teachers’ and scholars’ radar screens, but Epstein describes how challenges posed by administrative simplification resembled those health equity advocates face today.

To start, industry fragmentation creates a collective action problem for private actors who might be motivated to pursue greater equity. Federalism and fragmentation of government agencies silo health agencies and budgets from agencies responsible for social spending. It’s unclear exactly what steps will best move the needle toward health equity. And, even if achieving the goal will produce enormous savings in the long run, it requires substantial front-end investments. This part of Epstein’s paper persuaded me that, even though the moral stakes in addressing health inequity are distinctively high, many of the characteristics making it so difficult to address are not unique.

Epstein proceeds to make the case for using HIPAA’s approach as a template for addressing health equity’s governance challenges. That template would entail several elements. At the federal level, hard-law mandates of milestones towards achieving health equity goals would carry deadlines and penalties for noncompliance, creating a sense of urgency and forcing involvement of industry actors who might otherwise be recalcitrant. Those mandates could also force the collection of data critical to understanding and addressing disparities and prompt the development of non-binding soft-law solutions and mechanisms. Epstein forecasts that collaboratives of public and private entities at local, regional, and state levels will test out strategies and share knowledge about what works (and doesn’t).

The article acknowledges several challenges to the proposed approach. To start, it’s not clear what the substance of a health equity mandates should be: what is the measurable outcome that the federal government should order, and who should be subject to that order? Moreover, given the important roles of environmental and social factors in producing health inequity, health systems actors cannot achieve health equity goals alone. Any mandate will need to spur action and cooperation by state and local governments and a broad range of private entities. True health equity will require tackling housing policies, discriminatory policing and mass incarceration, environmental racism, and unjust school funding, to name just several incredibly thorny problems. And effective interventions to address the upstream and proximate causes of health injustice won’t be cheap. Epstein argues that the federal government must make a serious financial investment if the proposed hard law-plus-soft law approach is to produce results.

Despite these challenges, I think that Epstein is onto something in focusing on governance, an under-examined aspect of the health equity puzzle. Her article is in the tradition of legal scholarship that considers how the law might most effectively play a role in solving a difficult societal problem. Like the best of that scholarship, Epstein’s article is creative: She identifies a model for making health equity progress in an unlikely place – a decidedly unsexy law regarding technology administrative simplification from a quarter-century ago. And, to her credit, Epstein doesn’t overclaim. She acknowledges that addressing structural racism in the U.S. is a necessary component of true health equity. But the article implicitly heeds the warning (often attributed to Voltaire) about not letting the perfect be the enemy of the good. A governance model will never be “the” answer to health injustice in the U.S. But a model that addresses collective action, knowledge-sharing, and funding problems could help us make sorely needed headway toward health equity.

Cite as: Mary Crossley, Health Equity Governance, JOTWELL (June 30, 2021) (reviewing Wendy Netter Epstein, A Legal Paradigm for the Health Inequity Crisis (Feb. 17, 2021), available on SSRN),

Update of Jotwell Mailing Lists

Many Jotwell readers choose to subscribe to Jotwell either by RSS or by email.

For a long time Jotwell has run two parallel sets of email mailing lists, one of which serves only long-time subscribers. The provider of that legacy service is closing its email portal next week, so we are going to merge the lists. We hope and intend that this will be a seamless process, but if you find you are not receiving the Jotwell email updates you expect from the Health Law section, then you may need to resubscribe via the subscribe to Jotwell portal. This change to email delivery should not affect subscribers to the RSS feed.

The links at the subscription portal already point to the new email delivery system. It is open to all readers whether or not they previously subscribed for email delivery. From there you can choose to subscribe to all Jotwell content, or only the sections that most interest you.

Understanding the Competitive Effects of a Public Option

Brendan S. Maher, The Private Option, 2020 Mich. St. L. Rev. 1043 (2021).

Proposals to allow individuals to buy into a public health insurance program such as Medicare have been circulating for over a decade and have been the subject of much academic work. In The Private Option, Professor Brendan Maher offers an important addition to that literature by exploring how the competition between public and private payors that is inherent in public option proposals is likely to play out with respect to three key functions of health insurance: risk bearing, cost control, and ensuring quality care. It is a careful, highly readable, and non-ideological piece of scholarship that should be helpful to a range of stakeholders – from students trying to understand how health insurance markets function to policymakers trying to weigh the benefits of current health reform proposals. While not Pollyanna-ish, the article is ultimately hopeful, making an underappreciated case for the public option by explaining how competitive pressure from a public payor might result in better private health insurance options.

The article begins by explaining the various roles that health insurers play in the United States, focusing on three primary functions: risk-bearing, cost control, and encouraging quality care. The remainder of the article is devoted to evaluating how private payors might behave in a world in which they must compete against a public option. This evaluation is accomplished by assessing the comparative advantages of public and private payors with respect to the three primary functions of insurers previously identified. With respect to risk-bearing, the article unsurprisingly concludes that public payors have an enormous advantage over private payors. Indeed, Maher admits, if insurers were solely serving a risk-bearing function, no private payor could effectively compete with the government. As a result, it is unlikely that a public option would create genuine competition with respect to the risk-bearing function of insurance.

The next two functions, controlling cost and ensuring quality, are more likely to respond to competitive pressures in the face of a public option. The article explores a wide variety of tools that can be used to control cost and improve quality, and concludes that some of these tools favor public payors, while others favor private payors. For example, the government has a distinct advantage in the ability to control cost through rate setting. However, that advantage is somewhat bounded, in that providers will exit the system if reimbursement rates are set too low.

When it comes to ensuring quality care, however, Maher does not believe public payors hold an advantage. Indeed, he thinks it more likely that competitive pressures will result in private payors innovating in this space, and will perhaps result in private payors offering higher-quality products for higher prices when faced with a public option competitor. For example, if provider reimbursement rates in the public option are low, superior providers might elect not to participate in the public option. If so, private insurers might be able to capture such providers and sell a higher priced product tied to superior provider quality. An added benefit of this type of competition is that having multiple payors using different incentive and payment structures should continue to encourage a wide variety of providers to enter and remain in the market.

The article also explores the critical intersection of cost and quality – what is commonly referred to as high-value health insurance. As Maher explains, most health insurance policies, whether public or private, generally cover medical treatments that are clinically beneficial, but avoid differentiating between treatments based on their relative effectiveness or cost-effectiveness. As the article acknowledges, this has been a long-standing and difficult issue to solve, despite the repeated urging of health policy scholars. Americans are unenthusiastic about payors overruling the judgment of treating physicians, and have rejected rationing efforts along these lines. In my view, one of the most important arguments this article makes is that public/private competition in health insurance markets may create the dynamic that finally results in acceptance of health insurance coverage terms that are premised on cost-effectiveness of treatments and services. Maher’s argument is multi-faceted, but is based in part on the likelihood of private insurers being nimble enough and having enough relevant data to offer a product distinct from what a public payor is likely to offer. For example, although the public option is likely to enjoy lower reimbursement rates than private payors, private payors may be able to offer a competitive product by offering some combination of evidence-based coverage terms (or perhaps even coverage terms that embrace personalized medicine), coverage terms based on minimum levels of cost-effectiveness, and high-quality providers. Maher is careful not to suggest that a public payor couldn’t accomplish the same result, but realistically explains that it may be politically more difficult to enact such distinctions in a public program.

In the end, The Private Option argues that government has an overwhelming advantage on risk bearing, a meaningful advantage on cost, no advantage on quality, and a seeming disadvantage on cost-effectiveness – a dynamic that is likely to lead to real competition among insurers. Private payors, Maher argues, may take bold steps in response to a competitive public option. The resulting experimentation could be immensely valuable, and would be lost if health reform eliminates private payors. While I might be more skeptical of the likely behavior of private insurers when faced with competitive pressure, Maher makes a compelling case that a competitive health insurance market with both public and private payors is well worth pursuing.

Cite as: Amy Monahan, Understanding the Competitive Effects of a Public Option, JOTWELL (June 1, 2021) (reviewing Brendan S. Maher, The Private Option, 2020 Mich. St. L. Rev. 1043 (2021)),

Using Public Health Law to Minimize the Racially Disparate Impact of COVID-19

Govind Persad, Allocating Medicine Fairly in an Unfair Pandemic, __ Illinois L. Rev. __ (forthcoming 2021), available at SSRN.

Since the start of the COVID-19 pandemic, there has been significant public debate about how to fairly allocate scarce medical resources. Questions about resource allocation have become even more pressing now that vaccines are finally being distributed. This has resulted in important body of scholarly work arguing that the allocation of scarce resources for the prevention and treatment of COVID-19 should prioritize groups that have been hardest-hit by the pandemic as a result of structural disadvantages like systemic racism.

Govind Persad’s article, Allocating Medicine Fairly in an Unfair Pandemic (forthcoming in the University of Illinois Law Review) is a welcome addition to these conversations. Persad’s article focuses on issues of racial justice in resource allocation, and applies a much-needed legal lens to the practicalities of distribution systems that are often addressed from a more theoretical perspective. Many commentators in the fields of medicine, medical ethics, and public health have proposed that racial disparities be taken into account in the criteria for resource distribution, but not all have the legal background to understand whether and how such criteria could actually be implemented. Persad’s work offers valuable suggestions for how allocation priorities that minimize the disproportionate effects of COVID-19 on racial minorities might be implemented without being struck down on constitutional grounds.

This article echoes the recommendations of a September 2020 JAMA article in which Persad and colleagues Monica Peek and Ezekiel Emanuel argued that because distribution policies not only have a direct impact in preventing death and disability, but also “indirectly alleviate socioeconomic harms like unemployment, poverty and educational deprivation,” these policies should be guided by ethical values. In his new article, Persad directly tackles the legal implications of these ethical recommendations.

Persad presents evidence of COVID-19’s dramatically disproportionate impact on Black, Hispanic, and Native American populations, as well as the unequal distribution of scarce resources like testing, equipment, and personnel. Challenging what he calls an “imagined trade-off between preventing deaths and reducing disparities,” Persad makes a compelling argument that random allocation of scarce resources is likely to exacerbate race-based disparities, resulting in more deaths overall as compared to alternative distribution models. Persad recognizes, however, that explicitly race-based allocation policies (except in the narrow context of Native American tribes) are not a viable solution to this problem given current Supreme Court jurisprudence on the Equal Protection clause and Title VI of the Civil Rights Act.

Instead, Persad proposes alternative mechanisms for crafting resource distribution policies that might serve to alleviate the racially disproportionate impact of COVID-19. He describes his approach as using “facially race-neutral criteria or aggregate neighborhood-level racial data” that have the goal of addressing racial disparities and, in turn, are likely to result in significant public health benefits. While recognizing that any sort of race-conscious classification would be subject to criticism, he argues that facially neutral policies are more likely to survive legal challenges under the current composition of the Supreme Court. Persad suggests that “policies could be designed with the explicit goal of prioritizing locations or occupations that have been hard-hit by COVID-19, not as a proxy for race but as a form of justice that matters in itself.” Such policies, according to Persad, “would be effectively insulated from equal protection concerns, even if they confer disparate benefits on racial minorities[.]”

Persad identifies two policies that might achieve these goals. First, what he calls “disparity-sensitive policies” similar to those used by school districts to address educational disparities. This approach would “prioritize individuals who live in disadvantaged geographic areas or work in occupations hard-hit by COVID-19, potentially alongside explicitly race-sensitive aggregate metrics like neighborhood segregation.” Persad cites Castillo v. Whitmer, a recent Sixth Circuit case, to support his claim that race-neutral public health policies aimed at reducing disparities are likely to be upheld if challenged on Equal Protection grounds. In Castillo, the Sixth Circuit denied a motion for preliminary injunction against a state order that imposed testing protocols in some agricultural settings, which would have had a disparate impact on Latinos. The plaintiffs, agricultural workers and employees, argued that the order was motivated by discriminatory intent because the state had referenced the “the disproportionate impact COVID-19 has had on communities of color and the desire to improve racial equity in healthcare.” The court rejected this argument, however, concluding that “considering the effects of government action on various racial groups is not evidence of improper purpose.” Persad further supports the constitutionality of race-neutral but disparity-sensitive public health policies by citing several federal agencies and policies focused on addressing racial health disparities, including the Office of Minority Health and the United Network for Organ Sharing Minority Affairs Committee.

Persad’s second suggestion is that resource distribution policies focus on the “distinctive and disparately suffered harm of death early in life from COVID-19.” Persad presents dramatic evidence that those who die young as a result of COVID-19 are disproportionately more likely to be Black, Hispanic, Native American, and Asian/Pacific Islander. For example, he cites research demonstrating that the mortality rates of Black patients ages 25-54 are up to seven times higher than those of white patients. This evidence leads Persad to conclude that prioritizing vaccines for elderly patients based on “one-size-fits-all age cutoffs,” as recommended by the WHO and CDC, “would inequitably assign higher-risk minority patients less priority than lower-risk non-minority patients,” worsening racial disparities. Instead, Persad proposes that age be used as one of multiple factors to be taken into consideration – for example, by prioritizing elderly people living in multi-generational households, or those in geographic regions hardest hit by COVID-19.

Persad recognizes that his approach may meet resistance from critics who believe it doesn’t go far enough. He rightfully acknowledges that the policies he proposes are less likely to be effective at reducing racial disparities as compared to explicitly race-based policies; but, he argues, the legal vulnerability of race-based alternatives is simply too great. Scholars across all disciplines who believe that public health law has a role to play in reducing racial disparities ought to consider Persad’s argument.

Cite as: Nadia Sawicki, Using Public Health Law to Minimize the Racially Disparate Impact of COVID-19, JOTWELL (March 29, 2021) (reviewing Govind Persad, Allocating Medicine Fairly in an Unfair Pandemic, __ Illinois L. Rev. __ (forthcoming 2021), available at SSRN),

Democratizing, Protecting, and Supporting Communities: Improving the Government’s Pandemic Response

Lindsay F. Wiley, Democratizing the Law of Social Distancing, 20 Yale J. of Health Policy, L. & Ethics __ (2020), available at SSRN.

Prior to the COVID-19 pandemic, U.S. emergency preparedness laws and plans to prevent, detect, manage, and contain the spread of communicable disease targeted individual actions, rather than community mitigation efforts. For example, the Model State Emergency Health Powers Act and state emergency preparedness laws concentrated on detecting, managing, and containing the spread of an infectious disease, in part, through the medical examination, testing, isolation, and quarantine of individuals. This began to change when Congress amended the Public Health Service Act in 2002 to provide states with financial support and strategies to prepare for and respond to public health emergencies. By 2004, the Centers for Disease Control and Prevention began to use the term social distancing as a way to describe a strategy to stop the community spread of disease.

Yet, as Professor Lindsay Wiley discusses in Democratizing the Law of Social Distancing, social distancing was not widely implemented as a community containment strategy until the COVID-19 pandemic. Many states have begun to incorporate community mitigation efforts, such as stay-at-home/lockdown, mask, and social distancing orders, into emergency preparedness laws and plans to contain the community spread of COVID-19. These efforts have resulted in slowing the spread of COVID-19 in most communities. However, not only have the laws met with resistance from the public and the courts, but also these community mitigation efforts have not been effective in slowing the spread of COIVD-19 in racial and ethnic minority communities.

Because these efforts were adopted during the pandemic, Professor Wiley argues that many of the measures lacked transparency and democratic accountability. Additionally, the efforts have also exacerbated health inequities. State government officials have broad powers to address public health emergencies with community mitigation strategies, especially during a crisis. Nevertheless, to be effective in controlling the spread of disease while balancing the democratic ideals of individual freedoms, there is a need for accountability and support. Wiley’s article is significant because it provides a thorough review of the history of public health laws addressing emergencies, from Jacobson v. Massachusetts through the COVID-19 pandemic; discusses the legal support for public health powers; integrates some of the principles from the health justice framework; and provides solutions and a model for a range of community mitigation efforts.

Professor Wiley provides five key principles that should be used when adopting community mitigation laws, such as stay-at-home orders, to provide transparency, accountability, and supports. First, orders implementing community mitigation measures must provide clear and transparent reasoning for the measures. This can increase the public’s trust in government action, and help ensure that orders are conditioned on a demonstrated threat of significant risk and a suitable fit between the means and clearly stated ends. Many of the current stay at home orders do not include an end date or information regarding evaluative measures for ending the orders. Thus, citizens challenging the orders have argued that the government’s powers have no limit. To address this problem, Professor Wiley proposes that the orders include statements of the strategic purpose they 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. Professor Wiley provides a figure that links the three levels of community transmission (minimal, moderate, and substantial) to the type of intervention (surveillance, altered operation of public facilities, restrictions on business, and restrictions on individuals). Linking the response to the level of transmission allows for a balance between prevention and individual rights, which allows for transparency. Third, statutes should provide substantive standards to ensure orders are neutral laws of general applicability that do not discriminate on the basis of religion. This builds on decisions by many courts, including the Supreme Court, that orders specifically focused on religious activities violate the First Amendment.

Fourth, to enable widespread voluntary compliance and minimize unjust distribution of the benefits and burdens of public health interventions, 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. One of the most significant failures of current community mitigation efforts is the lack of long-term supports for individuals who are required to stay at home during lockdown orders. The need for supports is one of the key principles in the health justice framework, which provides a mechanism for systems-level transformation of governmental responses to health disparities to achieve health equity, in which “everyone has the opportunity to attain full health potential and no one is disadvantaged from achieving this potential because of social position or any other socially defined circumstance.”

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. This will address the current problem where in some cities police officers have handed out free masks and advised, but not required, people gathering outdoors in predominately White affluent neighborhoods to wear the masks, but have arrested and cracked down on Black and Latino people for gathering and not wearing masks.

With these five principles, Professor Wiley offers readers a new framework for implementing community mitigation orders to address public health emergencies that provides accountability, financial supports, and community involvement. Most valuably, this article proposes a more democratic way to stop the spread of disease so that the entire population of the United States can achieve health and well-being.

Cite as: Ruqaiijah Yearby, Democratizing, Protecting, and Supporting Communities: Improving the Government’s Pandemic Response, JOTWELL (March 1, 2021) (reviewing Lindsay F. Wiley, Democratizing the Law of Social Distancing, 20 Yale J. of Health Policy, L. & Ethics __ (2020), available at SSRN),