Using Private Law to Combat Influencers’ Health Misinformation

Jan 10, 2025 Wendy EpsteinAdd a Comment

Wendy Epstein

The spread of disinformation is one of the most pressing problems facing society today. Lawmakers, policymakers, and researchers have focused on how disinformation disrupts political discourse and undermines democratic processes, threatens global security by contributing to the spread of extremist ideologies, furthers social and political polarization, and more. But as Leah Fowler, Max Helveston, and Zoë Robinson describe in their forthcoming article, Influencer Speech-Torts, it can also harm people’s health. (See also the Surgeon General’s Report, Confronting Health Misinformation.) They take on the specific problem of social media influencers providing health advice that causes their followers injury or even death.

Many of us might be thinking of COVID-19 examples, like how people may have ingested bleach and other disinfectants recommended by influencers and faced serious health consequences. But as Fowler, Helveston, and Robinson point out, the problem is pervasive, even outside the pandemic context. Consider, for instance, people with cancer who avoid evidence-based treatments because they become convinced that a particular diet or detox will cure their cancer, or influencers who promote extreme weight loss methods that, when followed, cause serious health harms.

In a world where content moderation, consumer protection laws, and other solutions have not solved the problem, the authors turn to private law. They argue that influencers should be held liable in negligence when they spread health misinformation to their followers that could foreseeably result in injury.

The article is well-written and convincing. Part I describes the influencer economy and how influencers make money from disseminating medical misinformation. The authors define influencers as “content creators who share information for commercial gain.” (P. 37.) They explain why influencing is different from advertising and describe the intense“parasocial relationship” that some individuals form with influencers, making them particularly susceptible to influencers’ advice. Indeed, the authors make the important point that influencer health misinformation exacerbates health inequity, as it is more likely to negatively impact those with limited access to healthcare professionals who could combat misinformation. Part I also explores why existing mechanisms are insufficient to compensate for influencer-driven physical harms.

Part II lays out the authors’ proposed solution. It argues that influencers should owe a duty of care to their followers and that public policy supports the imposition of a duty. Fowler, Helveston, and Robinson wrestle with an issue of first impression, as courts have not yet imposed a duty on influencers to avoid sharing health misinformation. But they argue that under traditional doctrinal approaches, an influencer should owe a duty to their followers. The nature of the influencer-follower relationship, being “fiduciary-like,” further strengthens the claim. Followers rely on the advice of influencers and assume they have followers’ best interests at heart, while the influencer maximizes commercial gain. The authors also offer three convincing policy rationales to support the imposition of a duty: “the social inutility of health misinformation, the potential for influencer duties to prevent disproportionate harms against marginalized populations, and the reduction in negative externalities that result from influencer duties.” (P. 36.)

The final part takes on the First Amendment and argues that free speech rights should not bar tort recovery for physical harm. The authors argue that influencer health misinformation should not be considered “covered speech” under the First Amendment because it is misleading commercial speech or because it should be deemed a new category of uncovered speech. In the alternative, regardless of how it is categorized, they argue that where the speech causes physical harm, the interest in remedying that harm should always outweigh speech rights for constitutional purposes. (Notably, the authors cabin their arguments to physical harm, and do not include economic and reputational harms.)

In sum, followers who suffer physical harm, because they took harmful health advice from an influencer, should be able to sue that influencer under the law of negligence and recover for their injury.

Followers, of course, face additional hurdles in bringing a successful claim beyond those that are the primary focus of the paper, including difficulty accessing the court system at all, proving that advice is indeed “misinformation,” establishing causation, and proving damages. But it might not take a flood of successful claims for the deterrence value of these negligence claims to still be impactful, which is part of the appeal of this solution.

Further, I see Influencer Speech-Torts as an important contribution to a larger problem in our field—namely, how to address areas where the market does not provide patients and consumers reliable signals of safety and efficacy, and where regulatory oversight is also non-existent or insufficient. This category arguably includes surgical techniques and medical procedures, dietary supplements, off-label use of drugs, complementary and alternative medicine, and more. Getting the balance right between patient autonomy, fostering innovation, and protecting people from harm is a perpetual challenge, making the approach in this paper even more provocative.

Building Trust: Reforming Fraud Laws for a Changing Healthcare System

Nov 21, 2024 Jessica Lind MantelAdd a Comment

Jessica Lind Mantel

Trust between patients and providers, and in the healthcare system at large, is essential for effective care delivery and positive health outcomes. Yet today’s complex healthcare landscape poses significant challenges to cultivating and maintaining this trust. In her thought-provoking essay Building Trust in Health Care Through Regulation and Payment Systems, Professor Katrice Bridges Copeland offers an insightful examination of the government’s crucial role in building and maintaining trust through its dual roles of regulator-enforcer and participant-payer.

Copeland explores the intricate interplay between trust and regulation, enforcement, and payment policies, demonstrating how government actions profoundly shape trust in healthcare. For instance, the ongoing shift towards value-based payment (VBP) models promises to revolutionize healthcare delivery and could be a tool to increase trust as it moves providers away from being rewarded for quantity over quality. But it also introduces new complexities in maintaining trust, particularly as it might incentivize providers to do things like improperly manipulate quality data to maximize compensation. Copeland makes a persuasive case for modernizing the healthcare fraud and abuse laws to address the unique risks posed by VBP and ensure patient trust in the new healthcare landscape.

Copeland’s article is structured in three parts, each addressing a crucial aspect of trust in healthcare. In Part I, she elucidates the two dimensions of this trust: interpersonal trust between patients and providers, and institutional trust in the health care system as a whole. Interpersonal trust is essential for effective diagnosis and treatment, as patients need to feel confident in disclosing intimate health details to their providers. This trust relies on the belief that providers act in patients’ best interests, free from undue financial incentives. Copeland emphasizes that patients often trust their providers implicitly, unaware of when their provider has conflicting financial incentives. Unfortunately, this can lead to patients overtrusting providers and assuming that they act solely in patients’ best interest. Moreover, as Copeland observes, overtrusting patients are ineffective monitors of providers, which increases the risk of fraud.

Institutional trust, on the other hand, relates to the broader healthcare system, encompassing hospitals, insurance companies, and pharmaceutical firms. This trust is crucial for ensuring that patients engage with, and adhere to, medical advice and treatments. Unlike interpersonal trust, institutional trust is built over time and is easily damaged if patients believe institutions are driven by profit considerations rather than patients’ welfare. Unfortunately, Gallup surveys show a significant decline in public confidence in the medical system, from 80% in 1975 to just 38% in 2019.

The combination of patients’ overtrust in their providers and declining institutional trust underscores the critical role that government must play in promoting and safeguarding trust within the healthcare system. In Parts II and III, Copeland explores how the government can effectively address these concerns by combating fraud and reforming payment systems.

Part II delves into the government’s role as regulator-enforcer, examining how healthcare fraud enforcement impacts trust. Copeland provides a comprehensive overview of key laws such as the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) that target financial incentives that may corrupt medical decision-making. She argues that while these laws can promote trustworthy conditions, their enforcement has been inconsistent. Copeland further explains that their enforcement under the False Claims Act (FCA) shifts the focus from policing conflicts that undermine trust to recovering federal funds.  In particular, the substitution of civil penalties under the FCA for criminal sanctions under the AKS and the Stark Law dilutes the deterrent effect of these laws and does little to address trust erosion.

In Part III, Copeland turns her attention to the government’s role as participant-payer, exploring how different payment systems under Medicare and Medicaid affect trust in healthcare. The discussion begins with a nuanced exploration of how the government’s reliance on fee-for-service reimbursement models incentivizes providers to exploit patients’ belief in their fidelity and increase the volume and cost of services. Moreover, fee-for-service creates opportunities for unscrupulous doctors and institutions to fraudulently bill the government for items and services never received by patients. These fraudulent billing schemes contribute to declining institutional trust by exposing a lack of fidelity on the part of providers. Copeland then shows how the structure and financial constraints of managed care can cast suspicion on providers’ fidelity to patients and damage institutional trust by limiting patients’ choices and subjecting their providers to payer oversight.

Part III concludes with a forward-looking examination of value-based care, a discussion I consider the Article’s most important contribution.  Copeland rightly contends that the government’s shift to value-based payment models has tremendous potential to enhance trust by balancing financial incentives for cost-conscious care with incentives that reward high-quality care and improved patient outcomes.  Yet Copeland also cautions that VBP introduces new fraud risks that could harm trust, such as providers falsifying data on quality measures. She therefore calls for the government, in its role as regulator-enforcer, to proactively develop and rigorously enforce criminal fraud and abuse laws specifically tailored to the VBP context.

In sum, Copeland’s article makes a significant contribution to the field of health law with its nuanced analysis of trust in healthcare. In particular, her examination of how the government’s dual role as regulator-enforcer and participant-payer impacts trust provides crucial insights for policymakers. Particularly valuable is her examination of VBP models and both their potential to enhance trust and the new fraud risks they create. These insights offer critical guidance for government regulators navigating the transition to VBP, emphasizing the need to strengthen patients’ trust in their providers and the larger healthcare system. Failure to address these issues, Copeland warns, could undermine the potential benefits of VBP and further erode patient’s trust.

Centering Disability Rights in Challenges to Abortion Bans

Oct 28, 2024 Maya ManianAdd a Comment

Maya Manian

In the U.S. Supreme Court’s recent decision in Moyle v. United States, the Court punted (until after the November 2024 election) on the question whether EMTALA (the Emergency Medical Treatment and Active Labor Act) preempts state abortion bans that fail to include an exception for emergency abortion care necessary to protect a pregnant patient’s health. EMTALA is a federal law mandating that hospitals receiving federal Medicare funds provide stabilizing treatment to protect a patient’s health for any individual arriving at an ER with an emergency medical condition. The ongoing litigation in Idaho, and other well-publicized cases in Texas, have spotlighted the public health crisis caused by post-Dobbs abortion restrictions especially with regard to health exceptions. Moyle leaves in place, at least for now, total bans on abortion without EMTALA’s protections in Texas and other states.

In her draft article, Disabling Abortion Bans, Robyn Powell focuses on the impact of stringent abortion bans on people with disabilities. She examines the adverse health effects of narrowly defined health exceptions, particularly on patients with chronic illnesses, including mental health conditions—serious health concerns that have been largely overlooked in litigation over health exceptions. While media attention has been primarily focused on women with urgent pregnancy complications unable to obtain emergency abortion care, less attention has been paid to individuals with chronic conditions or mental health issues who need abortion care but might not qualify for “emergency” abortion care under EMTALA or narrowly crafted health exceptions.

Since the Dobbs decision ushered in a slew of abortion bans across the country, legal scholars have critiqued the unworkablity of these so-called health exceptions—so-called because health exceptions to abortion bans are rarely applied in reality. Scholars have pointed out that these exceptions do not work in practice because they are designed to be vague and to have a chilling effect on health care providers’ willingness to offer abortion care except in the most dire circumstances. Disabling Abortion Bans is a significant contribution to the ongoing debate about health exceptions to abortion bans. In particular, the article shows how bringing disability rights into view could help shape an incrementalist strategy to challenge abortion bans and build a broader coalition between disability rights and reproductive justice advocates. By centering people with disabilities, Powell also underscores the public health harms of abortion bans beyond emergency care, especially emphasizing their disproportionate impact on individuals with chronic physical and mental health illnesses.

The first section of the article sets the stage by describing the public health crisis generated by the post-Dobbs policy landscape. Powell explains how health exceptions that are deliberately circumscribed and ambiguous have created a chilling effect on physicians’ ability to provide standard medical treatment for pregnancy-related health concerns. With this background, the second section argues that these narrow health exceptions disproportionately harm people with disabilities. Powell describes how systemic health disparities lead to higher maternal mortality and morbidity rates among people with disabilities (data shows an eleven times higher maternal mortality rate). Additionally, the chilling effect of vague health exceptions erodes trust in the physician-patient relationship, particularly harmful to disabled individuals who already distrust the medical establishment due to its history of abuse and discrimination against disabled patients.

One important contribution of the article is how it shines a light on the impact of abortion bans on individuals with chronic conditions, extending the discussion beyond emergency medical situations highlighted in the EMTALA litigation. Powell elucidates how women with common chronic conditions such as autoimmune disorders, heart disease, and kidney disease, face substantially increased pregnancy risks and are especially vulnerable to suffering health harms from abortion bans.

Powell also highlights how chronic mental health issues have been overlooked in discussions about the impact of abortion bans on access to health care. In Moyle, several concurring opinions emphasized the Biden administration’s concession that EMTALA does not apply to abortion in cases of mental health emergencies, further segregating and stigmatizing mental health concerns. Throughout the article, Powell carefully marshals public health evidence showing the prevalence of mental health disabilities during the perinatal period. Pregnancy can exacerbate existing mental health conditions and trigger new mental health problems.

To illustrate this point, in the article’s introduction, Powell discusses a case involving a patient with bipolar disorder and postpartum psychosis facing an unexpected pregnancy. This situation would not constitute an “emergency” under EMTALA, but the patient and her doctor believed terminating the pregnancy was necessary for her health. Yet, most health exceptions in abortion bans exclude mental health indications entirely. Powell argues that this “divergence reveals a troubling inconsistency between growing efforts to achieve mental health parity and the unbalanced approach being taken in abortion policy.” (P. 22.) The lack of mental health exceptions in most abortion bans is particularly troubling given the public health evidence Powell recounts, including that at least one in five pregnant people experience mental health issues during or immediately after pregnancy and that mental health conditions are a leading cause of pregnancy-related deaths in the United States. Powell also provides a historical account of the push to exclude mental health as a ground for health exceptions, originating from proposed Congressional bills seeking to ban adults from assisting adolescents traveling for out-of-state abortion care.

In the final sections, Powell analyzes potential legal and advocacy strategies to chip away at draconian abortion bans. First, Powell proposes that narrowly defined health exceptions should fail even under the rational basis standard set by Dobbs. Although this legal theory may not succeed with the current U.S. Supreme Court, developing arguments using the rational basis test is crucial for making incremental changes and laying the groundwork for a longer-term effort to overturn Dobbs. Powell suggests challenges could also be brought under state constitutions, arguing that health exceptions that are too vague and narrow are irrational.

Second, in addition to potential constitutional challenges under rational basis review, Powell also proposes a range of strategies that are both pragmatically incremental and call for a longer term vision to protect both disability rights and reproductive justice. In the short term, she explores expanding and clarifying health exceptions and protecting providers’ good faith medical judgment through statutory reforms. Powell suggests using the Americans with Disabilities Act (ADA) as a framework for a broader understanding of protecting health in the law. She argues that by “integrating [the ADA’s] expansive understanding of disability into abortion exceptions, pregnant people with disabilities would receive more comprehensive protection.” (P. 65.) Powell acknowledges the limits of proposals to broaden and clarify health exceptions—particularly because overmedicalized framings can perpetuate ableism—as well as the need to move beyond a focus on these exceptional abortion cases. Nevertheless, incremental strategies focusing on health exceptions, disability rights, and medically indicated abortions may be necessary steps to provide limited access to abortion care in the short term.

For the long term, Powell emphasizes building coalitions between the disability rights and reproductive justice movements. These movements have historically been in tension regarding abortion, particularly around prenatal genetic testing and disability-selective abortion bans. Powell’s focus on amplifying the voices of people with disabilities in the abortion law health exception debate is an excellent starting point for building coalitions across these two movements. The article’s arguments on the intersection between disability rights and reproductive justice also build nicely on Powell’s earlier work on Disability Reproductive Justice. Powell convincingly argues that “the disability community is uniquely positioned to lead the way” in challenges to abortion bans, and that by “centering the experiences and needs of people with disabilities, advocates can catalyze incremental changes that pave the way for broader systemic reforms.” (P. 69.)

Disabling Abortion Bans is essential reading for scholars and advocates seeking to understand the full public health impacts of post-Dobbs abortion bans beyond the emergency room context. As litigation and scholarly commentary continue to focus on the problems with health exceptions, Powell makes a persuasive case that centering the disability rights framework is a productive way to advance these challenges.

A Postmortem on the ACA

Sep 26, 2024 Amy MonahanAdd a Comment

Amy Monahan

The Affordable Care Act (the “ACA”) has had a somewhat tortured existence since its enactment in 2010. In The Ghosts of the Affordable Care Act, Professor Gabriel Scheffler tells the compelling story of the various ways in which this massive piece of social legislation has been scaled back or repealed by either Congress or the courts, and begins to offer an explanation of why the legislation was vulnerable to such attacks. More specifically, the article takes on the conventional wisdom that social programs, once enacted, are incredibly difficult to dismantle—a phenomenon commonly referred to as entrenchment. In place of this traditional story, the article makes the case for “enactment-entrenchment tradeoffs.” Professor Scheffler argues that, at least in the case of the ACA, lawmakers were forced to make the law more vulnerable to future amendment or repeal in order to ensure its passage. The article not only produces a compelling historical account of the ACA’s travails, but also offers important lessons for anyone interested in social policy change through the federal legislative process.

The article begins by cataloging the various post-enactment repeals and retrenchments of the ACA’s original terms. Some of these are well known, such as the Supreme Court decision in NFIB v. Sebelius, which made the Medicaid expansion optional for states. But others have received much less attention outside of health policy circles—such as the repeal of the Cadillac Tax and the Independent Payment Advisory Board. Some lived such a short and inconsequential life that even health policy scholars are likely to have forgotten they were ever included in the first place (I am looking at you, CLASS Act). Seeing these changes catalogued in a single place presents a compelling picture of just how much the ACA has changed between 2010 and the present day.

Professor Scheffler then turns to the primary contribution of the article—exploring why it is that the ACA was so vulnerable to post-enactment attacks. In seeking to answer this question, the article synthesizes the social science and public policy literature along with the author’s original contributions. The primary argument advanced in The Ghosts of the ACA is that it was political compromises that were necessary to ensure enactment of the ACA that directly led to its post-enactment vulnerability.

It is difficult to do justice to the depth of the analysis in The Ghosts of the ACA in this short review, but in my view, one of the most intriguing parts of the article is its consideration of the various ways our political and legal climate have changed, rendering entrenchment of social legislation is no longer automatic. Some of the factors identified are unique to health care reform, such as the fact that most Americans already have health insurance coverage and like that coverage, thereby making truly innovative and disruptive health care reform difficult to achieve. Others are unique to the time—such as hostility toward the country’s first Black president. But others have broader applicability. Among these are fiscal constraints and budgeting rules that make it difficult to pass legislation with significant costs, and asymmetric political polarization of both Congress and the judiciary, which make it nearly impossible to pass reforms with bipartisan support, therefore increasing the likelihood of legislative and judicial retrenchment. The growing power of interest groups and the rise of the so-called “submerged state” (in this case referring to the provision of social benefits through the tax code or through private organizations), are also identified as important contributors to post-enactment vulnerability of the ACA.

Each of these factors, Scheffler argues, contributed to the ACA being “under-entrenched” when enacted. While there are many aspects of the ACA that contributed to its under-entrenchment, there are two that receive significant attention—the Act’s complexity and its delayed effective date for key reforms. Together, these factors made the reforms difficult for the average voter to understand, and prevented many benefits from being felt until four or more years after enactment, with the result that legislators likely felt little political pressure to protect the Act’s reforms.

The article concludes by reexamining the conventional wisdom that social legislation becomes quickly entrenched, using the ACA as a case study of sorts, and by highlighting other recent examples of social legislation either enacted on a temporary basis or otherwise repealed. For those interested in enduring social legislation, the article acknowledges that the very things that make legislation harder to retrench also make it harder to enact in the first place. The article, however, does offer some suggestions for reforms that might affect this enactment-entrenchment trade-off. Examples include changing CBO scoring rules and reducing vetogates in the federal legislative process.

But the strength of Professor Scheffler’s contribution in this article lies not in producing a neat and tidy solution to the possible unwinding of social programs, but rather in drawing attention to the fact that various contemporary legal and political factors make retrenchment of such programs a realistic outcome, particularly in the first few years following enactment. It provides a very stark reminder that today’s polarized and fractious political and legal landscape has a real impact on what Congress can accomplish.

Regulating Skin Lightening Products: A Case Study of Structural Forces Shaping Inequities in Health

Aug 16, 2024 Medha MakhloufAdd a Comment

Medha Makhlouf

When I was growing up, every two years or so, my family would spend the summer in India, from where my parents immigrated to the United States. For many hours on those long, hot days, when our cousins were at school or work, my bookish siblings and I read whatever we could find around the house that was printed in English: musty paperbacks of The Famous Five and The Hardy Boys, women’s magazines like Femina, and every page of any English-language newspaper – including the matrimonial ads. We were children raised in the United States, so we cackled over the frequent use of the word “homely” to describe women who were purportedly good at domestic labor and at ads that described suitors as having “no vices.” However, among the bewildering array of “biodata” listed in these ads were descriptors of skin tone: “very fair,” “fair” or “wheatish” (never “toffee,” “chestnut,” or “dark”). The Matrimonial section is where I first encountered the idea of skin color as social capital. My understanding of the societal conflation of light skin tone with beauty was reinforced in the ubiquitous ads (in magazines, on television and billboards) for Fair & Lovely, a skin-lightening cream. These ads featured the biggest Bollywood stars who, in the “after” images, had skin so light it would meet Victorian beauty ideals.

I recalled these experiences as I read Collen Campbell’s recently published article, which uses, as a case study, the under-regulation of skin-lightening creams to illustrate the need for intersectionality analyses in U.S. food and drug law. Safety concerns about cosmetics have been trivialized in food and drug law because of its “characterization as a superficial beautifying agent and its feminization, since women are its primary consumers.” Beauty products whose primary consumers are women of color are even more neglected, leaving these consumers more vulnerable to toxic exposures and compounding existing health disparities.

The Article begins with an explanation for how we got here, drawing on the existing feminist and intersectional critiques of food and drug law. As Professor Campbell states, “An intersectional lens uncovers the various underlying forces that produce a disparate health impact for women of color: systemic racism in health, racially targeted marketing, and hegemonic beauty norms shaped by race and skin color constructs.” The Article places in context the lax regulation of cosmetics marketed to women of color – and Black women in particular – by describing how these groups have disproportionately borne the risks of novel reproductive technologies, such as intrauterine devices like the Dalkon Shield and injectable contraceptives like Norplant.

The Article includes a nuanced and valuable discussion of motivations for skin lightening. Professor Campbell first defines systemic colorism as “[a]n idealization of phenotypic proximity to Whiteness and the social valuation of those features.” She explains that although colorism and racism are “systems of discrimination [that] emanate from specific sociocultural, institutional, and historical processes, including the institutions of slavery and colonialism,” they are distinct. Here, Professor Campbell makes an important contribution to public health discourses on the risks of skin lightening by pointing to the overemphasis on individualized interventions—issuing consumer warnings about skin-lightening products, “educating” women that dark skin is beautiful—while neglecting structural forces such as “systemic racism and colorism, hegemonic beauty norms, transnational capitalism, and racial marketing.”

Troublingly, Professor Campbell notes, individualizing the public health problem of skin lightening “reproduce[s] problematic stereotypes that invariably pathologize women.” It also erases the perspectives of women of color who may, in the context of systemic colorism, make rational choices to lighten their skin in order to acquire social capital or even escape harm.

In the end, Professor Campbell takes a characteristically nuanced position, calling for more regulatory attention to toxic chemicals in skin-lightening products, but not for a general ban on skin-lightening products. She links the issue of “greater regulatory attention to feminized products” to the perennial challenges women face in exercising their bodily autonomy. Professor Campbell acknowledges that some readers may still perceive her proposal as paternalistic but justifies it as an acceptable response to the public health threat of toxic exposure to cosmetics and their contribution to health disparities.

I encourage health law scholars to read this article in part because its case study focuses on a topic that, not so long ago, might have been considered so marginal as to be unsuitable for scholarly inquiry. And this precisely illustrates Professor Campbell’s point: The need to mainstream intersectionality analyses in food and drug law—and health law generally—in order to identify the structural forces shaping health inequities and the scale of interventions needed to eliminate them.

Implementing Age-Related Triage Protocols

Jul 18, 2024 Zack BuckAdd a Comment

Zack Buck

Legal scholarship frequently deals with the theoretical: a scholar identifies an interesting legal problem or inconsistency, and by applying an incisive legal analysis, attempts to solve it. This is the typical process of the legal academic. This endeavor and type of legal scholarship and focus is important, and may even be prescient, but—to echo a well-worn critique—it may often lack real-world and immediate practical effect.

This is not the case for Professor Jessica Mantel, who, colleagues know, is an important voice within health law scholarship, and is well-known for her clarifying work on health care finance topics in an era of dynamic change. Her work is grounded in practical import. Professor Mantel shows her range through her recent work, exemplified by Age is More Than Just a Number: A Legal and Ethical Defense of Age-Based Triage Protocols. This work is particularly important in a world and a field that has been pressure-tested and scrambled following the COVID-19 pandemic.

In this piece, Mantel spends time analyzing the legality of age-related protocols, a gap existing scholarship had failed to fill. She then addresses the ethical arguments around the triaging and tiering of scarce medical resources during a period of limited resources (like the COVID-19 pandemic). This part of her article is an impressive tour through utilitarian and egalitarian theories, procedural justice concerns, and liberty interest analysis. By canvasing the literature, she grounds her suggestions among the well-respected company of bioethics scholars.

After surveying and categorizing the ethics-related literature, Mantel then evaluates the three main types of justifications for including age-based criteria and concludes that none of them provides a convincing ethical defense for prioritizing the treatment of younger patients over older ones. These justifications include using age as a proxy for patients’ likelihood of survival (which raises major ethical concerns based on the failure to conduct individualized assessments), using age as a proxy for patients’ life expectancy and quality of life (which devalues the lives of elderly), and using age-based rationing in an effort to give younger patients the opportunity to reach a natural lifespan (which fails to account for egalitarian and democratic concerns).

Instead, Mantel defends age-based triage protocols under a theory of prudential prioritization—arguing that it is appropriate for protocols to give preference to younger patients in times of scarce resources because doing so shows regard for all individuals by working to lessen everyone’s risk of dying young. This approach uses a veil of ignorance to push protocols to ensure that patients “experience as much of their life plans as possible,” and to design protocols that lessen the risk “of dying young by giving preference to [patients’] future younger selves over their future older selves” (P. 426). Because this approach gives all people an equal opportunity—“no one knows whether they will experience medical scarcity during a public health crisis” in their lives (P. 427)—Mantel argues that it expresses equal respect and dignity for individuals of all ages. Indeed, as Mantel notes, every starting position is equal, and “whether prudent prioritization benefits or burdens any one individual is purely a matter of chance or luck” (P. 427).

But what about the law? Mantel argues that, although the Age Discrimination Act of 1975 does not ban age-based protocols, such proposals would likely violate the statute’s implementing regulations as currently interpreted. After identifying the relevant regulations adopted by the U.S. Department of Health and Human Services and explaining how they are narrower than what the statute requires, she calls for existing regulations to be amended to allow the policies for which she advocates.

Like her other scholarship, Mantel takes on a relevant problem, provides an interesting analysis of the problem, and leaves the reader with a roadmap of implementable and practical solutions—in this case, a regulatory reinterpretation. This type of work—always important within health law scholarship—is made all the more important on the heels of the devastating COVID-19 pandemic. And as she describes in the article, she presents “a more nuanced justification … that protects an individual’s interest in reducing the risk of dying young while promoting equality in the opportunity to live a long life” (P. 440). Keeping with the theme of implementable and practical solutions, she challenges the regulators’ reading of the Age Discrimination Act of 1975. Her persuasive and well-argued thesis convinces the reader, too.

A Principled Approach to Damages in Pregnancy Loss and Beyond

Jun 24, 2024 Nadia SawickiAdd a Comment

Nadia Sawicki

Dov Fox and Jill Wieber Lens’ 2023 prescient article, Valuing Reproductive Loss, could not have arrived at a more important time. In February 2024, the Alabama Supreme Court held that a state law permitting parents to recover for the wrongful death of a minor child also protects cryopreserved in vitro embryos. The case sparked vigorous nationwide debate about its implications for access to medical services like assisted reproductive technology and abortion. Broader debates like these are absolutely essential, but according to Fox and Lens, they risk crowding out the core question posed in the Alabama lawsuit and many others: What legal remedies should be available to intended parents when a defendant’s wrongful conduct results in the loss of their desired child before birth? Fox and Lens tackle this challenging issue head-on, and directly counter the narrative that rights to abortion will inevitably be jeopardized by legal recognition of reproductive loss.

This article reports on the results of the authors’ empirical study of jury verdicts in cases brought by intended parents who have suffered losses as a result of mishandled embryos, mismanaged pregnancies, or general negligence (for example, a car accident that causes a miscarriage). They find “wildly erratic outcomes” that do not correlate with the factors one might think are most likely to impact damages awards–such as the plaintiff’s age at the time of loss, the gestational age of the fetus, the type of legal action brought, or the nature of the defendant’s wrongdoing. Instead, they suggest that the outcomes in these reproductive loss cases may be driven by jurors’ unconscious biases about race and class, about who qualifies as a “deserving parent,” and about whether a child is truly “wanted.” To counter these biases and the resulting disparities in damage awards, the authors present a novel and more principled framework for valuing reproductive loss in civil litigation.

Fox and Lens’ findings about the biases that impact outcomes in reproductive loss cases are a valuable addition to the literature on racial and class biases in both economic and non-economic damage awards. They highlight striking language from verdicts in cases where damage awards were limited–comments that a plaintiff did not exhibit “the conduct of a mother who wanted her baby,” that plaintiffs were unmarried, that a plaintiff “had had two previous voluntary abortions,” or that a plaintiff returned to work shortly after the pregnancy loss. (P. 72.) Fox and Lens note that jurors’ concerns about whether intended parents are “responsible” and whether a child is “wanted” often come down to the plaintiffs’ socioeconomic status. For example, they highlight the dramatic racial and wealth disparities in access to in vitro fertilization, which can cost tens of thousands of dollars. If jurors consider a parent’s investment in fertility treatment as evidence of the child’s “wantedness,” then “almost all the eye-popping emotional distress damage awards in embryo-destruction cases end up going to plaintiffs who are wealthy and white, not poor people of color.” (P. 74.) The authors offer several other examples of how systemic and individual biases lead to disparate outcomes in pregnancy loss cases, and forcefully argue that a more principled approach is needed.

The model Fox and Lens offer looks to three factors for assessing the severity of a plaintiff’s injury and the extent of their non-economic damages. First, they advocate for an individualized assessment of the plaintiff’s subjective experience, untainted by biases and focused instead on the plaintiff’s own lived experience and understanding of the loss. Importantly, they highlight that a focus on subjective loss in this context may help support abortion rights advocacy, because deference to a pregnant person’s subjective beliefs about the loss of an embryo or fetus is “fundamentally irreconcilable with the antiabortion premise that legal personhood objectively begins at conception.” (P. 107.)

Second, they would consider the objective chance of reproductive success in the absence of negligence. For example, because success rates of in vitro fertilization drop significantly by age, there would be good reason to award reduced damages to a forty-five year old woman whose cryopreserved embryo is negligently destroyed as compared to a twenty-five year old woman. Here, too, however, the authors caution that efforts need to be made to ensure that biases don’t creep into these calculations. In analogy to cases like GMM v. Kimpson (E.D.N.Y. 205) rejecting race-based wage statistics in civil damage awards, the statistical fact that Black women are 43% more likely than white women to miscarry reflects widely racial documented disparities in medical care during pregnancy that should not be reinforced through damage awards.

Finally, they would recognize that the significant traumas that may accompany a reproductive loss deserve special compensation. People who have no experience with stillbirth may not realize that when a fetus dies in the womb after 20 weeks of pregnancy, the gestating parent must still give birth to them. The “physical, emotional, and cognitive trauma” accompanying this experience has not, to date, been adequately recognized. (P. 98.) Other examples of distinct traumas may be when parent chooses to terminate a desired pregnancy based on negligent medical advice, or where a plaintiff suffers reproductive loss and is incapable of producing future offspring.

Taking these factors into account, the authors argue, will result in more just and principled outcomes in these difficult cases. Ultimately, Fox and Lens describe the goal of their project as “promot[ing] reproductive justice and recover[ing] principle in how the law treats prenatal death across the landscape of civil awards and criminal restrictions.” (P. 61.) This finely written article moves us closer to that goal.

Editor’s Note: For a previous review of Valuing Reproductive Loss in the Family Law section, see Philomila Tsoukala, How Much Is The Lost Chance To Reproduce Worth? (May 23, 2024).

A Comparative Law Analysis of Professional Disciplinary Systems: What Can Tennessee Learn from the U.K.?

May 24, 2024 Carl ColemanAdd a Comment

Carl Coleman

In Doctors Playing Lawyers, Rebecca Haw Allensworth and Cathal T. Gallagher argue that professional disciplinary systems are “in a state of crisis” (P. 7.) Clear evidence of misconduct is often “ignored or tolerated.” (P. 3.) Despite their ostensible mission to protect the public from incompetent and unethical behavior, boards “systematically fail to identify and stop dangerous professional practice.” (P. 7.)

A key reason for this problem, they argue, is that disciplinary boards are made up primarily of members of the regulated professions. This results in two problems. First, by nature, “self-disciplinarians” are likely to over-identify with the accused (P. 7). Second, except in the system of lawyer discipline, professionals serving on disciplinary boards typically lack any expertise or training in investigation or adjudication. Instead, they are “peers who take a few days out of their busy professional lives to moonlight as self-regulators,” usually with “very little in the way of standards or law to apply, other than to do discipline in the name of the ‘health, safety and welfare’ of the people of their state.” (P. 5.) What results is a haphazard process of “casual, collegial decisions,” rather than a rigorous application of the rules to the facts of the case. (P. 7.) It is therefore not surprising that disciplinary boards exhibit a “high level of variability and inconsistency” in the way they react to allegations misconduct, even within the same profession in the same state. (P. 38.)

The American system of professional discipline stands in sharp contrast to the system in the United Kingdom, which was reformed about twenty years ago to make oversight by the General Medical Council (GMC) “more balanced, structured, and unbiased.” (P. 47.) Today, disciplinary cases against physicians are decided by a tribunal that is separate from the authority that sets entry and practice standards for the profession. Cases are heard by panels of three people drawn from a pool of fully trained and financially compensated hearing officers, at least one of whom must be a layperson. In contrast to the American system, the GMC publishes guidance detailing the standards and procedures for handling complaints and assessing penalties.

To compare the two systems, Allensworth and Gallagher coded five years of disciplinary data from Tennessee and two years of data from the GMC. In Tennessee, they found numerous examples of board decisions that seemed inexplicably lenient. In some cases, “boards use education to rehabilitate providers whose transgressions go beyond a lack of knowledge.” (P. 42.) In others, they impose practice restrictions that “may prevent the precise conduct from recurring in the exact same way, but they ignore the more general danger presented by a provider who has abandoned an ethos of patient or client care to engage in graft or abuse.” (P. 43.) They found that boards had a tendency to minimize misconduct in cases where there was evidence of substance abuse, “persist[ing] in the view that substance abuse is the root cause of misconduct in the face of clear evidence of other factors not as susceptible to treatment: sexual predation, mendacity, narcissism, and gross professional incompetence.” (P. 44.)

In contrast, this tendency toward leniency was not apparent in their review of the U.K data. Of physicians who had been found by a tribunal to have engaged in serious misconduct, the U.K. system imposed serious sanctions at a far higher rate than in Tennessee: 88 percent in the U.K., compared to only 39 percent in Tennessee. Although the percentage of all licensed physicians subject to “serious public action” was higher in Tennessee (about 0.02%) than the in the U.K. (about 0.008%), the authors suggest that this may be because misconduct is simply more prevalent in the U.S.’s profit-driven healthcare system.

Allensworth and Gallagher conclude that the U.K.’s approach offers a model that U.S. states should emulate. Specifically, they call on state legislatures to create a tribunal system to review professional disciplinary cases that would be structurally independent from the entities in charge of setting licensing standards. The tribunal would hear cases from all the licensed professionals, with cases decided by panels of three: one member of the profession in question, one lawyer who works for the tribunal, and one layperson. Unlike the current system, negotiated settlements would not be permitted; all cases in which serious allegations have been brought would result in hearings before the panel.

In addition to improving the quality of the decision-making process, they argue that giving the authority to enforce licensing standards to an independent entity would create an incentive for licensing boards to be more thoughtful when standards are initially developed. Now, boards have the option “to sound tough at rulemaking stage and then refuse to bring the hammer down in individual cases.” (P. 64.) If they a separate entity were empowered to apply the rules, however, the licensing board’s influence over final decisions would depend entirely on how the rules are written. As a result, “boards would likely feel obligated to promulgate, after public input, theories and specifics about when and how a professional should be disciplined.” (P. 64.)

Doctors Playing Lawyers makes a persuasive case for reducing professional dominance over the disciplinary system and systematizing the decision-making process. More broadly, the article stands as a model of the effective use of comparative law to address a contemporary problem in health law. It is a testament to an effective collaboration between scholars on both sides of the Atlantic.

Gillick Competence

Apr 23, 2024 Emma CaveAdd a Comment

Emma Cave

In Gillick v West Norfolk and Wisbech Area Health Authority (1986) the UK House of Lords held that minors under the age of 16 could access contraceptive advice and treatment in their own right provided they satisfied a test which became known as “Gillick competence.” Lord Fraser said:

Provided the patient … is capable of understanding what is proposed, and of expressing his or her own wishes, I see no good reason for holding that he or she lacks the capacity to express them validly and effectively and to authorise the medical man to make the examination or give the treatment which he advises. (P. 409.)

As a result, Gillick competent minors were able to consent to treatment and medical examination, and while they might be encouraged to involve their parents, they were entitled to keep the matter confidential.

In Life without Gillick, Adolescent sexual and reproductive healthcare in Ireland, published in Clinical Ethics, Barry Lyons and Mary Donnelly remind us of Gillick’s value. They articulate clearly and compellingly what is lost when a jurisdiction declines to endorse Gillick’s central premise.

Widely considered a landmark case, Gillick has since been applied in new non-medical contexts such as adoption. The United Nations Convention on the Rights of the Child’s emphasis on the rights of the child and the primacy of best interests was in tune with Gillick and several other common law jurisdictions adopted the decision or a version of it. Ireland ratified the Convention in 1992, but as Lyons and Donnelly describe, the historical emphasis on children as objects of parental rights and duties has resulted in a lacuna in the law.

Mrs. Gillick was a Roman Catholic mother of ten children. She sought assurance that guidance recognising that minors could seek confidential advice on contraception or abortion would not apply to her five daughters until they turned 16. Not only did she lose her claim, but the test applied to uphold the child’s right bears her name. The enactment of the UK Human Rights Act 1998 led to a subsequent unsuccessful challenge by Mrs. Axon in 2006. Though some parents lament the diminution of control and authority Gillick heralds, in England and Wales the Children Act 1989 is clear that parental responsibility includes not only rights and powers but also duties and responsibilities and that in matters relating to the upbringing of the child, the child’s welfare is the paramount consideration.

Ireland is Britain’s closest neighbour, but it is not part of the United Kingdom which comprises Scotland, Wales, Northern Ireland and England. It has been a free state since 1922 and as such is not bound by the UK Supreme Court (previously House of Lords) decisions, including Gillick.  While several other common law countries set out mature minor laws, for Ireland the matter of child competence proved too hot a potato to pick up.

The absence of relevant legal provisions is partially addressed through Irish Medical Council guidance requiring that parental consent be obtained as a “general rule” but allowing that parents can be excluded in “unusual” circumstances. Alas, guidance does not have the status of law and as such provides only limited reassurance for minors who seek confidential sexual or reproductive advice or treatment, as well as for the health professionals who provide it.

Lyons and Donnelly point to some of the consequences of legal uncertainty in Ireland. The most compelling is the public health impact of minors being driven away from health support if they wish to keep their sexually active status from their parents or carers. Since 2018, abortion has been lawful in Ireland (including) in circumstances where the pregnancy is under 12 weeks gestation. But an impediment to the effective operation of the Act is that it does not address access by minors. For health professionals who support those minors who seek their confidential assistance in sexual and reproductive healthcare, Lyons and Donnelly point to occupational distress around potential medico-legal implications.

They make a compelling case for reform. The lacuna should be filled by recognising minors’ rights to reproductive healthcare. Failures to do so, they point out, will likely “fall most heavily on the most vulnerable individuals who, for whatever reason, cannot rely on family support to help them negotiate the complex world of adolescent sexuality.”

Taking the Lid Off Canada’s MAID Law and Practice

Mar 20, 2024 Trudo Lemmens2 comments

Trudo Lemmens

Canada’s euthanasia law and practice—which the federal parliament termed “medical assistance in dying,” resulting in the awkward acronym MAiD—continues to be a dominant theme in Canadian and international health law and bioethics scholarship. If MAiD had remained the “exceptional practice” the Canadian Supreme Court originally envisaged, the attention it receives would be perplexing. But ongoing legal expansion—mental health was scheduled to become a basis for MAiD in March 2024 but Parliament suspended this introduction at the last minute until at least 2027—and the staggering increase in the number of people who have died with a health care providers’ lethal injection, explain this attention. In less than 7 years, about 45,000 Canadians—13,241 in 2022 alone—have died by MAiD, more than 4% of all deaths. Quebec, the second largest province, has become the jurisdiction with the highest euthanasia practice in the world, with around 7% of people dying by MAID.

International parliamentary committees, policy makers, and commentators are increasingly paying attention. A new interdisciplinary volume in Springer’s International Library of Bioethics Series, Medical Assistance in Dying (MAiD) in Canada: Key Multidisciplinary Perspectives, edited by Jaro Kotalik and David W. Shannon, should help inform any jurisdiction contemplating some form of legalization. With 31 chapters by experts in law, medicine, social science, philosophy, and bioethics, as well as practitioners and community advocates, the book provides unique, explicitly critical perspectives on various aspects of Canadian MAiD law, policy, and practice.

In a first legal and regulatory part, the book sets out the legal framework and the unique legislative history of the Canadian law. The chapters in this section critically examine the assumptions underlying the Supreme Court’s decision in Carter v. Canada (Attorney General) and subsequent legislative action, and the reasons why the first law, focused on a broad end-of-life context, was subsequently expanded to include disabled persons not approaching their natural death. International readers will find sufficient details here to understand the legal context: the ruling of the Supreme Court, subsequent parliamentary initiatives and court cases, and the intersection between federal and provincial laws and regulations.

A second part documents in five chapters operational challenges of Canada’s MAiD practice. The chapters reveal some remarkable deficiencies in the federal and provincial monitoring and reporting of MAiD. International readers will be surprised, for example, to read how some professional regulations instruct health care providers to state on death certificates the disease that underlies the MAiD request as the cause of death, rather than MAiD itself, even though there is still an obligation to report MAiD separately. With current MAiD law allowing the ending of life of persons who are not even remotely approaching their death, say a person with paraplegia, the absurdity and arguably fraudulent nature of such official policies stand out. In another chapter, a practitioner reflects in an interview on what MAiD may mean for medical practice in remote communities. A last chapter discusses organ donation following euthanasia, for which Canada has become the world leader—unsurprisingly so, considering the emphasis in Canadian MAiD law and policy on facilitating access to, not protection against, death.

Separate sections, each consisting of four to five chapters, are devoted to MAiD and palliative care, MAiD and mental health care, and disability perspectives on MAiD. There are chapters by health care providers, persons involved in community-based suicide prevention, disability scholars, and legal scholars and practitioners. From a health law perspective, a chapter by disability advocates Kerri Joffe and Roberto Lattanzio stands out for its persuasive argument that Canada’s law violates international human rights law, particularly the International Convention on the Rights of Persons with Disabilities. This chapter joins other recent legal publications that put forward detailed legal arguments about the discriminatory nature of Canada’s MAiD law. Other interesting legal analyses are also provided in this book by scholars Jonas Beaudry and Mary Shariff, and by two legal practitioners.

A fourth section contains divergent topics, ranging from the impact of MAiD on trust in the doctor-patient relationship and the right to conscientious objection to perspectives from Indigenous communities and various religious and spiritual groups. The inclusion of reflections by Indigenous, Muslim, Jewish, Roman Catholic, and Protestant religious leaders is a welcome exception in the recent Canadian literature on MAiD, which generally excludes, and sometimes even explicitly rejects, the relevance of religious and spiritual perspectives on MAiD. This is somewhat surprising, considering that 68% of Canadians have a religious affiliation. It likely reflects how religious views are much less part of public and political discourse in Canada than, for example, in the United States.

Notwithstanding growing emphasis in Canada on the need to engage meaningfully with Indigenous communities as part of a Truth and Reconciliation process, MAiD was legalized and subsequently expanded without significant consultation with and involvement of Indigenous people. Two chapters on Indigenous perspectives merit therefore special attention. As one of the chapters points out, while there are different perspectives within Indigenous communities, there is clearly a very serious concern about what the promotion of medical access to death may mean for some Indigenous communities confronted with high suicide rates, as well as about the clash between the medicalized practice of MAiD and Indigenous worldviews.

The book concludes with broader reflections by two prominent participants in Canada’s MAiD debate. Tom Koch, a medical ethicist, warns that public support may be shifting in the wake of several controversies, and that legal challenges may lead to a judicial review of components of the practice. Harvey Schipper, an emeritus professor of medicine, reflects on how the legalization and subsequent rapid expansion of MAiD in Canada has been driven by ideology, not by cautious step-by-step evidence-informed evaluation and adjustment. As he reminds the reader, he speaks from experience when it comes to witnessing polarized politization of the debate in Canada. In 2018, he was appointed to chair a working group on Advance Requests for MAiD of the Council of Canadian Academies (equivalent to the National Academy of Sciences). But a strategically placed national media article, “Doctor who compared assisted dying to Nazi genocide to chair review of advance requests,” came out the day before the first meeting. It undermined his position and he had no choice but to resign. The article referred to a 2014 op-ed in which he simply observed that, as a Jewish physician, he was particularly wary of what can happen when physicians are legally permitted to cross a clear moral line in the sand when it comes to death. While he accepts that MAiD has found “a place in our society,” Schipper lauds the other authors for raising key questions about Canada’s law and practice, which demand answers and political and legal responses, not political posturing.

Readers should not expect a carefully balanced academic dialogue for and against the legalization of euthanasia and assisted suicide, or a comparative review with discussions of the advantages and disadvantages of various legislative models. What they will find instead is a broad spectrum of critical reflections, some more academic in nature, others more practice oriented, and further information about the law and practice in the jurisdiction with arguably the most open-ended system of medically-administered death. Some authors are more explicitly opposed, while others recommend significant adjustment and improvement of specific aspects of Canada’s law and practice. Overall, the book should make it clear why a growing number of people have legitimate concerns about at least some components of Canada’s MAiD law and practice and why, in my view, it is a model to be avoided.