Jul 18, 2024 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.
Jun 24, 2024 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).
May 24, 2024 Carl Coleman
Rebecca Haw Allensworth & Cathal T. Gallagher,
Doctors Playing Lawyers, Vand. L. Rsch. Paper No. 23-42, available at
SSRN (Aug. 9, 2023).
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.
Apr 23, 2024 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.”
Cite as: Emma Cave,
Gillick Competence, JOTWELL
(April 23, 2024) (reviewing Barry Lyons & Mary Donnelly,
Life without Gillick
: Adolescent sexual and reproductive healthcare in Ireland, available at Sage Journal of Clinical Ethics (Dec. 25, 2023)),
https://health.jotwell.com/gillick-competence/.
Mar 20, 2024 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.
Feb 26, 2024 Myrisha Lewis
The first two sentences of the abstract for Leah R. Fowler’s & Michael R. Ulrich’s Femtechnodystopia are stunning but accurate: “Reproductive rights, as we have long understood them, are dead. But while history seems to be moving backward, technology moves relentlessly forward.” (P. 1233.)
The law often trails behind technology, especially reproductive technology. Femtechnodystopia focuses on fertility awareness-based contraception and proception apps and how these apps, which can enable users to take control over their reproductive lives, can, in a post-Dobbs world, be (legally) dangerous to users. After discussing the many benefits and perils of Femtech, Professors Fowler and Ulrich argue that there are three key criteria that Femtech must satisfy in order to avoid a potential dystopian future: “apps must be accurate, the data they contain must be kept private and secure, and the consumer must be aware of their risks and limitations.” (P. 1240.)
Part I of the article is divided into two sections. Part I.A discusses the lead-up to the Supreme Court’s decision in Dobbs v. Jackson Women’s Health. This section includes a discussion and analysis of cases related to many longstanding bioethical issues, including the reduced autonomy of pregnant people, fetal personhood, and reproductive rights more broadly. In addition to addressing the leadup to Dobbs, the article discusses potential future areas of litigation that have received attention lately, including the Comstock Act of 1873 and the Supreme Court’s increasing deference to religiously-based objections to the provision of healthcare. The authors write that “If Hobby Lobby walked so Zubik and Little Sisters of the Poor could run, Dobbs is sprinting to usher in an even more aggressive era of restrictions.” (P. 1247.)
Part I.B discusses the potential benefits of Femtech like fertility and period trackers, including their ability to enhance reproductive autonomy. The authors note that more individuals may turn to Femtech to meet menstrual and reproductive health needs as access to reproductive care declines in the U.S. This section also explains the U.S. Food and Drug Administration (FDA) regulatory scheme that applies to the apps. Notably, proceptive apps that “identify fertile days, so long as they do not claim the user can rely on this information from contraceptive purposes,” benefit from FDA enforcement discretion. (P. 1238.)
Part II, “Femtech’s Dystopia,” turns to the many perils of Femtech, including the possibility that the apps may be insecure or that the information shared with or generated by them may be introduced against users in civil and criminal legal proceedings. Moreover, Femtech apps, like many other apps, generate data that may be sold to other companies. One of the studies cited by the authors includes a 2014 estimate that “a pregnant person’s data are worth fifteen times that of the average person.” (Pp. 1265-66.
Beyond legal dangers, the apps themselves can be ineffective and lack extensive privacy protections. Additionally, many mobile health apps do not permit individuals to delete their data.
The authors note that individuals often find these apps through various sources, including magazine lists of the “best” tracker apps. While some of these sources discuss the apps’ limited effectiveness, they are far less likely to mention the privacy risks.
Ultimately, the authors do not recommend that users abandon these applications. Instead, Part III of the article provides many creative solutions to the issues facing period and fertility tracking apps after Dobbs. The authors acknowledge the limitations of their proposed solutions, including the practical difficulties Congress or administrative agencies like the FDA or the Federal Trade Commission would face in mandating changes. Rather than relying only on top-down changes, the authors identify options that app developers could implement themselves, along with an explanation as to why these changes would be helpful to users. They also alert readers to alternative apps, some of which were created abroad and have stronger privacy protections than some of the more well-known Femtech apps.
As technology permeates our lives, it is worth continually revisiting the authors’ caution: “Technology in a world with an anemic right to privacy endangers everyone.” (P. 1313.)
Jan 23, 2024 André den Exter
Leonard Fleck is a well-known philosopher and ethicist who has written extensively on various ethical issues in health care, including healthcare rationing. Although he writes from a moral perspective, the topic is also relevant to health lawyers. Healthcare rationing, interpreted as the denial or delay of necessary medical care for non-medical reasons, raises serious issues of equal access to health care as a human right, informed consent and shared decision-making (SDM), well-known concepts in contemporary legal doctrine. Long waiting times and delays in medical treatment, substantial co-payments, or restrictions in health insurance access can be considered a form of de facto rationing, challenging the right to health care as a human right.
Fleck’s Precision Medicine and Distributive Justice: Wicked Problems for Democratic Deliberation discusses healthcare rationing in the context of new pharmaceutical innovations, including precision medicine, targeted cancer therapies and immunotherapies. These are highly promising but costly drugs (ranging from $100,000 to $475,000 in total costs per treatment) mainly used with metastatic cancer, a terminal illness. Most patients with access to these drugs will gain only a few extra weeks or months of life (P. 11.) Is society willing to pay for each patient’s life-prolonging targeted therapy with marginal gains at general public expense?
Although Fleck focuses on health ethics and policy (distributive justice), the central question of who will decide what treatment should be provided/reimbursed and based on what criteria also has legal implications. The law may set not only the decision-making procedures but also the substantive (medical, economic, ethical) criteria for selecting healthcare services for which we are willing to pay.
The book includes nine chapters, starting with a review of the medical literature regarding metastatic cancers and cutting-edge therapeutic interventions. From an economic perspective, none of these treatment options appear reasonably cost effective. This raises the notion of what Fleck calls wicked or “ragged edge” problems (P. 22). These are situations for which no ethical theory can provide a satisfactory answer and every proposed solution seems as problematic as the issues it is intended to solve.
Fleck argues that, because rationing is unavoidable, a respectful process of democratic deliberation is the only way to solve these problems of “rough justice” (P. 23.) From a legal perspective, notions like equal access to healthcare, non-discrimination, right to life, informed consent, shared decision-making, transparency and participation, and the need for legal remedies provide a valuable framework for thinking about the rationing issues generated by targeted therapies. A public debate addressing the abovementioned concepts would enable society to make more just choices on life-extending targeted therapies. A shared understanding of rationing or selection criteria at the policy level (severity of disease, clinical and cost-effectiveness, equal access, etc.) will help to formulate socially agreed-upon ideas about a threshold of basic healthcare and its limits. Ultimately, this will help physicians make more reasonable decisions on targeted therapies in individual cases.
Dec 8, 2023 Jessica Lind Mantel
Erin C. Fuse Brown & Mark A. Hall,
Private Equity and the Corporatization of Health Care, 76
Stan. L. Rev. __ (forthcoming, 2024); GSU L. Studies Rsch. Paper, available at
SSRN.
The corporatization of medicine is not new. As Paul Starr masterfully documented in his historical account of American medicine, throughout the 20th Century various private organizations pursued bureaucratic control over the delivery of healthcare. Initially, the medical profession was largely successful in resisting efforts to corporatize healthcare. Several decades of mergers, acquisitions and corporate alliances, however, have firmly entrenched corporate ownership in American healthcare. In their article Private Equity and the Corporatization of Health Care, Erin Fuse Brown and Mark Hall explore the latest chapter of this trend—the acquisition of physician practices by private equity (PE) firms.
An aging population, advancements in medical technology and drug therapies, and other factors have fueled tremendous growth in the health care sector, which today comprises one-sixth of the U.S. economy. As the healthcare sector has expanded, private equity (PE) investors have recognized health care organizations as potential sources for profit-making. In Part I of their article, Fuse Brown and Hall explain that this PE incursion into health care is a particularly aggressive form of corporate investment. When PE firms target physician practices, they assume control over practices’ business strategies and downgrade physician ownership to minority status. This leaves acquired physician practices no longer governed by health professionals with ethical obligations that put patients’ medical needs before profits. Moreover, PE’s goal of boosting profitability leads to a focus on quick fixes and practices designed to maximize revenue rather than long-term operational changes that would enhance the quality and efficiency of care.
The authors identify several risks posed by the PE model. First, incremental acquisitions can result in horizontal market consolidation, which can increase prices, reduce the quality of medical care, and limit access. Second, astute PE investors have capitalized on various market inefficiencies for profit, such as exploiting billing loopholes, engaging in aggressive risk-coding, and steering patients to unnecessary or inefficient care. These practices in turn risk increasing overall healthcare spending without any corresponding improvements in quality. Third, PE control of physician practices threatens physicians’ clinical independence and can result in reduced staffing levels, potentially compromising the quality of patient care and physician morale. The authors also highlight several studies of PE in health care that support these concerns.
Fuse Brown and Hall convincingly argue that mitigating these risks requires an immediate and comprehensive policy response. The good news, as thoroughly covered in Part II of their article, is that existing legal tools under federal and state law can address many of the risks posed by PE investment in physician practices. These include antitrust laws that can target horizontal consolidation and fraud and abuse laws that police improper medical billing and self-referral. The authors also call for the revival of two policies that have fallen into disfavor, the corporate practice of medicine doctrine and state fee-splitting laws. In addition, employment laws can target PE practices that curtail physicians’ clinical and professional autonomy, such as non-compete, anti-disparagement, and non-disclosure provisions in physician employment contracts.
The article’s examination of existing legal tools provides a timely and indispensable roadmap for policymakers and legal practitioners seeking to safeguard the healthcare system from the adverse consequences of PE investment in physician practices. For example, regulators and qui tam litigators looking to curb PE-owned practices’ inappropriate billing and referral practices will benefit greatly from the authors’ in-depth analysis of fraud and abuse case law and regulations. Fuse Brown and Hall also discuss specific steps regulators can take to strengthen existing enforcement tools. For instance, antitrust regulators can increase their scrutiny of PE firms’ incremental acquisitions by lowering the mandatory reporting thresholds for pre-merger review and updating federal antitrust merger guidelines to address serial add-on acquisitions across broader geographic markets.
The authors’ meticulous analysis of existing laws, however, reveals a regulatory landscape that in many respects is ill-equipped to address the risks posed by PE investment in health care. To close these gaps, the authors propose various legislative actions designed to strengthen existing laws. For instance, states can amend their medical practice laws to eliminate loopholes that have allowed PE investors to circumvent the corporate practice of medicine prohibition. The authors also advocate for new legislation that would create additional policy tools for mitigating the risks of PE in healthcare, including closing Medicare billing loopholes, enhancing transparency in PE ownership and financial structures, and eliminating the tax advantages enjoyed by PE investors. Finally, in a nod to federalism, the authors stress the essential role played by states in responding to PE’s incursion into health care, both as co-enforcers of applicable federal law and overseers of medical practice laws that have no federal counterpart.
In sum, this provocative article is a must-read for anyone concerned with the continued march toward the corporatization of health care. While corporatization can support the shift to value-based care by providing needed capital, economies of scale, and innovation, its underlying profit motive also threatens medicine’s traditional professional values. Fuse Brown and Hall argue that with PE’s incursion into health care, the pendulum has swung too far in the direction of profiteering. Their article issues an urgent call to utilize existing policy levers to protect the healthcare system from the potential risks posed by PE. But Fuse Brown and Hall also caution that our existing legal tools are outdated and that legislative and regulatory action is needed to if we are to fully address the potential harms of PE investment in health care.
Nov 8, 2023 Christina S. Ho
Wendy Parmet has a new book out, called Constitutional Contagion: COVID, the Courts, and Public Health. It is a long-awaited sequel of sorts to one of her earlier books, Populations, Public Health and the Law (2009). I mention this because, while COVID is the occasion for her argument, i.e., the circumstance that brings her point to the sharpest focus, the account is actually one she has been building for a long time, and its implications transcend the current crisis. At the most general level, Parmet argues for the health of the polity as not just one of but perhaps even the most central value that our laws exist to serve. In this newest volume, she surveys our Constitutional jurisprudence, re-centering our understanding of America’s foundational law in relation to its most fundamental material stakes.
Parmet’s argument proceeds with the sound, measured consideration that we know and trust from her body of work. Thus, she is perfectly within rights to distinguish her position from my maximalist gloss. But as an intemperate enthusiast of the Parmet project, I view her work as teeing up the claim that population health is part of the inner morality of law. Just as Lon Fuller found reciprocity, human agency, and a certain formal integrity to inhere in law, Parmet finds an additional substantive morality at the ground level of law’s project. As she says in her first book, “[P]ublic health is not simply a norm, but also a legal norm that should be embraced by and incorporated into the legal system.” (P. 52.)
This understanding did not used to shock. It was a familiar feature of an older wisdom, the residue of which remains in common law and in the Latin phrase, salus populi suprema lex (“the health of the public is the supreme law.”). Only lately have we in our public law banished basic Hobbesian and Aristotelian insights, suppressing the recognition that bodily security and human flourishing—values inseparable from health—are the reasons for the constitution of the polity to begin with.
Chapters two and three of Parmet’s book reveal that it was not so long ago that our constitutional analysis reflected this basic health-centered wisdom through its police power jurisprudence. Parmet’s excavation of historical caselaw reveals that, in the 1800’s, “if a law appeared to be a health regulation, then the Court . . . would usually accept that it was an exercise of the police power and hence within the states’ prerogative.” (P. 34.) From the 19th century antebellum period into the early 20th century, before many of the Constitution’s individual rights were incorporated to apply to the states, individual rights-based reasoning played far less of a role in cabining the constitutional range of health protections we could pursue as a polity, which at that time consisted mostly of state efforts. Even when individual rights were invoked during that period, the prevailing view was that they “[E]xisted only in relation to the police power and the common good. Because individuals had no ‘right’ to endanger public health or safety, laws that aimed to protect those interests could not violate individual rights.” (P. 35.)
It was surprisingly late, not until after the New Deal, that courts “came to hold that even public health laws were only within the police power if they were reasonable or necessary to achieve their public health goal.” That phrase has since transmogrified into a turbocharged constitutional scrutiny to protect individualism and elevate a lopsided handful of health-harming negative rights, like religious liberty, commercial speech and gun possession. But Parmet cautions us not to naturalize this state of affairs and to remember the older wisdom of a more capacious liberty: “In this bygone world, the liberty that enabled people to stay healthy was recognized as one of the reasons we have governments.” (P. 29.)
Reading Parmet’s book all at once as I did (while recovering from COVID no less) is not for the fainthearted. The various doctrinal trendlines that constitute our unhealthy environment have closed in on us over time. She traces such strands as First Amendment speech and religious liberty rights insofar as they have diminished the scope of federal action; she recounts our anemic, retrogressive equality jurisprudence, and the role of qualified immunity as handmaiden to police violence; the sad recent histories of campaign finance law and receding protection for voting rights. She connects each of these developments to specific health-harming conditions. It was stomach-turning to see gathered in one place all the fronts of regressive Constitutional law converging to train harm on the targets of right-wing ire—including racial minorities and immigrants, women and gender minorities, and persons with pre-existing disabilities or health risks.
And here Parmet’s salus populi account links up with the bald truth of Ruth Wilson’s Gilmore’s famous definition of racism. Racism, Gilmore says in The Golden Gulag, is the “production and exploitation of group-differentiated vulnerability to premature death.” Our constitutional politics is functioning in precisely that manner—shaping, distributing, and patterning mortality, a necropolitics that is, as ever, cleft along old lines. Parmet’s book serves overwhelming evidence of how we have contorted our constitutive laws to thwart the common good. Can it truly be that we would forsake the good rather than hold it in common?
But her message is fundamentally a hopeful one insofar as she is pointing out the contingency of our current constitutional condition, the shallowness of the recent health-hostile stance of the courts, and the more deeply-rooted, pro-public health orientation that we could recuperate.
One final note about the resonance Parmet’s book has in our times: to the extent that Adrian Vermeule and others promote a substantive turn for law, they have typically proffered right wing theocratic candidates for the substantive good at stake. Their projects stall for many reasons, not least of which is the failure to counter Parmet’s case for health as an equally if not more plausible candidate. Her most recent book calls us to consider anew the deflection and distortion of purpose that has come to afflict the constitution of our corpus populi.
Oct 13, 2023 Amy Monahan
Valarie Blake,
The Freedom Premium,
WVU Coll. of L. Rsch. Paper, No. 2023-010 (forthcoming), available at
SSRN (Mar. 13, 2023).
In the United States, universal health care is frequently derided as anti-American and liberty-infringing. In The Freedom Premium, Professor Valarie Blake turns this argument on its head by systematically exploring the ways in which our fragmented system of health care coverage influences the fundamental life choices of Americans – where and how much they work, when or if they marry or divorce, and where and with whom they live. Our current approach to health care coverage, she argues, unduly constrains these personal choices and, if freedom is a primary consideration, universal coverage is the answer.
To make this provocative argument, Professor Blake begins by establishing what she terms the “freedom premium” imposed by our system of health care finance, for both means-tested public programs and employer-sponsored insurance (ESI). The freedom premium refers to the incentives embedded in the eligibility provisions and coverage terms of a particular source of health care coverage that influence core social choices. Rather than relying solely on statutory terms to establish the relevant freedom premia, Blake interviews nearly two dozen individuals who have directly grappled with these and other trade-offs inherent in obtaining health coverage. Professor Blake finds, perhaps not surprisingly, that public programs tend to impose the most significant freedom premia on participants, primarily in the areas of work and marriage.
For example, an individual with a disability might decline employment opportunities because, even if their job came with ESI, that coverage would be unlikely to provide coverage for the types of services an individual with a disability requires. To maintain eligibility for Medicaid, the only type of coverage specifically designed to meet the needs of individuals with disabilities, the individual must limit their income and asset levels—for example, by self-employing and paying themselves below-market compensation, or by forgoing work altogether. For those considered categorically needy under Medicaid, income and asset thresholds are lower per person for a married couple than a single individual, creating a disincentive to marry for those who must rely on Medicaid to access health care. Unlike in many other areas of the law, Medicaid (by piggybacking on SSI provisions) actually allows the government to go a step further and treat individuals as married if they hold themselves out as married, creating an incentive not only to forgo legal marriage, but to forgo a committed relationship altogether.
While public programs most obviously impose freedom premia, so too does ESI. Professor Blake catalogs the well-known phenomenon of job lock (where individuals either pick jobs or stay at jobs for purposes of obtaining or retaining specific health insurance benefits), but also highlights less appreciated aspects of ESI’s impact on life choices. For example, as Americans increasingly delay childbearing into their thirties and forties, many workers have children who rely on them for health coverage well past normal retirement age. It is not uncommon, then, for workers otherwise eligible for Medicare to continue working in order to provide coverage for young adult children who can remain on the worker’s ESI through age twenty-five. While this incentive might not strike many as particularly problematic, it not only impacts a worker’s fundamental economic choice, but it also impacts the broader economy and labor market as individuals continue working past expected retirement age.
The solution, Professor Blake argues, is to uncouple eligibility for health benefits from “socially salient categories of work, poverty, and dependency and instead tie benefits to universal criteria like residency or citizenship.” (P. 9.) She works through some of the basic components of a universal system of coverage without getting too far into the weeds of system design. But the power of her argument does not depend on the particulars of a system of universal coverage. Rather, her argument’s power is in plainly stating the truth that the way we finance health care has a significant impact on how people structure their lives.
“Freedom” and “choice” are common buzzwords in debates about health care reform, but they are nearly always used in reference to the freedom to choose one’s own health plan or freedom to see the doctor of one’s choice. What Professor Blake argues is that we need to consider more fundamental personal freedoms—the freedom to marry or not and the freedom to structure one’s working life according to one’s personal and economic preferences—when we contemplate how health coverage should be arranged and financed. Not everyone will be swayed by the position put forward in The Freedom Premium, but the article caused me to think about our fragmented system of health finance in a new way, and I look forward to seeing where Professor Blake takes this line of inquiry in future work.
Cite as: Amy Monahan,
Freedom and Health Care, JOTWELL
(October 13, 2023) (reviewing Valarie Blake,
The Freedom Premium,
WVU Coll. of L. Rsch. Paper, No. 2023-010 (forthcoming), available at SSRN (Mar. 13, 2023)),
https://health.jotwell.com/freedom-and-health-care/.
