Health Law and Policy Commons^™

Immortal Justice: Why The Henrietta Lacks Family Merits Restitution Today, Suzette Malveaux

Scholarly Articles

Almost three quarters of a century have passed since Henrietta Lacks had her cells biopsied from her cervix without her knowledge or consent. Upon discovering that Henrietta’s cells were immortal, scientists have been able to solve the most vexing medical problems of modern times and save countless lives worldwide. Aware of the cells’ scandalous origins, big pharma has nonetheless commercialized and wildly profited from the HeLa cell line without sharing the benefit with Henrietta’s family, who has been left traumatized and destitute by the initial theft.

Despite the passage of time, Henrietta’s family is seeking restitution today from pharmaceutical companies …

Transformative Experiences, Anticipatory Regret, And Informed Consent, Elizabeth Lanphier, Shannon Fyfe

Scholarly Articles

Regret risk is not consistently part of information sharing within informed consent. Yet two kinds of decisions that often invoke concerns about future regret, abortion and sterilization, raise considerations for the role of regret in clinical decision-making and informed consent, particularly regarding decisions about potentially transformative experiences. We distinguish between first-personal and second-personal anticipatory regret and argue that first-personal anticipatory regret can play a productive role, but second-personal anticipatory regret can function in ways that are pernicious. Introducing second-personal anticipatory regret into medical informed consent processes is, we argue, not only not required for informed medical decision-making, but impermissible within …

The Supreme Court During Covid-19: Keeping Its Head When Those About It Were Losing Theirs, Timothy C. Macdonnell

Scholarly Articles

Alexander Hamilton's Federalist No. 78 suggests that one of the reasons for a life-tenured judiciary whose pay cannot be altered is because "judges may be an essential safeguard against the effects of occasional ill humours in the society." Our Nation's history is replete with instances of ill humor leading to violations of constitutional rights. Wars, epidemics, natural disasters, civil unrest, and economic crises all demand governments to act and act swiftly. But courts, and particularly the United States Supreme Court, are necessary to check governments when they go too far in contending with an emergency.

Historically the country's courts have …

Pandemic As Transboundary Harm: Lessons From The Trail Smelter Arbitration, Russell A. Miller

Scholarly Articles

The COVID-19 pandemic has caused incalculable harm around the world. The fact that this immense harm can be traced back to a localized outbreak in or near Wuhan, China, raises questions about the responsibility China might bear for the pandemic under public international law. Famously applied in the seminal Trail Smelter Arbitration (1938/1941), the Transboundary Harm Principle provides that no state can use or allow the use of its territory in a manner that causes significant harm in the territory of other states. This article does not intend to tap into the unseemly, xenophobic spirit that animates much of the …

Disciplining Doctors: A Call For Caution When Responding To Physicians' Counter-Consensus Speech In The Time Of Covid-19, Timothy Macdonnell

Scholarly Articles

The COVID-19 pandemic affected nearly every aspect of life in the United States, including most notably, work-life, home-life, and community-life. During the pandemic, the government took extraordinary steps to try and reduce the spread of the disease by closing businesses, mandating the wearing of masks, and requiring vaccines. Government officials repeatedly justified their actions by stating that they were "following the science." However not all members of the scientific/medical community agreed with these actions. Some of these counter-consensus opinions were labeled mis/dis/mal/information.

As the COVID-19 pandemic dragged on, calls to punish doctors for COVID-19 misinformation increased. Some doctors who claimed …

We Shouldn't Need Roe, Carliss Chatman

Scholarly Articles

In the face of state-by-state attacks on the right to choose, which result in regular challenges to Roe v. Wade in the U.S. Supreme Court, this essay asks whether Roe is needed at all. Decades of state law encroachments have caused Roe to fail to properly protect the right to choose. Building on prior works that challenge the premise of fetal personhood and highlighting the status of Roe-based rights after decades of challenges, this essay proposes an alternative solution to Roe. Federal legislative and executive efforts, including the Women’s Health Protection Act, are necessary to ensure the right …

Making An Offer That Can't Be Refused: The Need For Reform In The Rules Governing Informed Consent And Doctor-Patient Agreements, Timothy C. Macdonnell

Scholarly Articles

On a daily basis, throughout the country, patients are required to sign informed consent forms regarding the care they receive from their doctors. Informed consent forms are an important part of ensuring patients are making an intelligent, autonomous decision regarding their healthcare based on the facts related to their particular situation. However, frequently these consent forms contain what amount to contract-like terms that require patients to permit doctors to substitute other healthcare providers to care for the patient under the doctor’s supervision (substituted caregiver terms). Often these terms are presented to patients on the eve of surgery and on a …

Neurorights For Incarcerated Persons: Should We Curb Inflation?, Shannon Fyfe, Elizabeth Lanphier, Andrew Peterson

Scholarly Articles

We support protecting privacy and freedom, both generally and in carceral settings. Yet we remain skeptical that expanding so-called “neurorights” achieves these aims (cf. Bublitz 2022). Instead, it may inflate human rights in ways that diminish the ability to enforce them, overlook the ways in which incarceration is at odds with other human rights, and raise questions of whether neurotechnologies can violate such rights in the ways Ligthart et al. imply.

Age—Not Sex Or Gender—Makes The Case Of Ellie Anderson Complex, Elizabeth Lanphier, Shannon Fyfe

Scholarly Articles

In ’The Complex Case of Ellie Anderson’, Joona Rasanen and Anna Smajdor raise several ethical questions about the case. One question asks, but does not answer, whether Ellie faced discrimination for being transgender when her mother was not allowed access to Ellie’s sperm following her death. In raising the question, the authors imply anti-trans bias may have influenced this determination. However, this inference is not supported by current ethical and legal guidance for posthumous use of gametes, with which Ellie’s case is consistent. We consider the authors’ responses to their other ethical queries, and how their suggestions for what options …

Pursuing A Right To Genetic Happiness, George P. Smith Ii

Scholarly Articles

With the continued expansion of assisted reproductive technology (ART), and society's inability to regulate it, complex medico-legal issues and ethical and social dilemmas are arising. Although the desire to prevent or limit genetic disease by, for example, gene editing and mitochondrial transfer is noble, what has been termed the "customization" of birth, raises the fundamental issue of procreative liberty, and, more specifically, the extent to which the state is obligated to assist in the use of ART which, in turn, validate the quest for genetic happiness. There is a current notion that reproductive freedom includes, within it, a right to …

Civil Disobedience In The Face Of Texas’S Abortion Ban, Alexi Pfeffer-Gillett

Scholarly Articles

This Article uses Texas’s abortion ban to demonstrate why civil disobedience is the best strategy against such private-enforcement schemes. It proceeds in three parts. Part I demonstrates that Texas’s private enforcement scheme in fact directly implicates state court officials and potentially state police forces. It then explains why bringing about the involvement of state courts and police through civil disobedience will put SB8 on constitutionally weaker ground. Part II details potential arguments against civil disobedience as a means of challenging private enforcement schemes. This Part also explains why relying on the federal government to challenge such laws will be insufficient. …

Pediatric Off-Label Use Of Covid-19 Vaccines: Ethical And Legal Considerations, Elizabeth Lanphier, Shannon Fyfe

Scholarly Articles

After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of the blanket prohibition against off-label pediatric Covid-19 vaccination in the VPA, as it blocks clinicians from providing the care they may determine to be clinically and ethically appropriate for their patient. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests.

Hearing On The Foreign Sovereign Immunities Act, Coronavirus, And Addressing China’S Culpability Before The Senate Committee On The Judiciary, Russell A. Miller

Scholarly Articles

There are a number of theories about the Chinese government’s acts or omissions concerning the emergence and world-wide spread of the coronavirus that may be the proximate cause of actionable transboundary harm. All of these theories start with the incontestable fact that the coronavirus outbreak originated in China. One theory is concerned with the conduct of the Chinese government after the health crisis emerged. This “ex post” theory alleges a broad range of acts and omissions that helped transform a local outbreak into a global pandemic. There is room for this theory under the Transboundary Harm Principle. But the “ex …

Emergency Parole Release For Older Parole-Eligible Doc Inmates, David I. Bruck

Scholarly Articles

Professor Bruck writes to Secretary Moran and Chairwoman Bennett to urge them to protect elderly Virginia prison inmates from the risk of death from COVID-19 by granting immediate parole release to as many over-60 parole-eligible prisoners as possible, upon a showing that they are at low risk to re-offend, and have a supportive home to go to once released.

State Prosecutors At The Center Of Mass Imprisonment And Criminal Justice Reform, Nora V. Demleitner

Scholarly Articles

State prosecutors around the country have played a crucial role in mass imprisonment. Little supervision and virtually unsurpassed decision making power have provided them with unrivaled influence over the size, growth, and composition of our criminal justice system. They decide which cases to prosecute, whether to divert a case, whether to offer a plea, and what sentence to recommend. Their impact does not stop at sentencing. They weigh in on alternative dockets, supervision violations, parole release, and even clemency requests. But they are also part of a larger system that constrains them. Funding, judicial limits on their power, and legislative …

The Moral Weight Of Preferences: Death, Sex, And Dementia, Shannon Fyfe, Elizabeth Lanphier

Scholarly Articles

In "Cognitive Transformation, Dementia, and the Moral Weight of Advance Directives," Emily Walsh raises pertinent questions regarding the stability of preferences, and interests, across time, particularly in the setting of dementia diagnosis (Walsh 2020). Advance directive policy and practice rely on an at least somewhat coherent account of personal identity, and we largely agree with Walsh that dementia raises complex issues for philosophical accounts of personal identity.

Brief Of Amicus Curiae The Washington And Lee University School Of Law Black Lung Clinic In Support Of Petitioners: California V. Texas, Timothy C. Macdonnell

Scholarly Articles

Section 1556 of the Patient Protection and Affordable Care Act (PPACA) makes two major changes to the Black Lung Benefits Act. These changes remove limiting language to make it simpler for disabled miners and their families to establish that they are entitled to federal benefits. First, § 1556(a) reinstates the fifteen-year rebuttable presumption, which presumptively entitles former coal miners to benefits if they have worked over fifteen years underground and have a totally disabling pulmonary disease. The second, § 1556(b), reinstates a continuation of benefits for surviving spouses whose coal-mining spouse was receiving benefits at the time of their death. …

The Limits Of Reading Law In The Affordable Care Act Cases, Kevin C. Walsh

Scholarly Articles

One of the most highly lauded legacies of Justice Scalia's decades-long tenure on the Supreme Court was his leadership of a movement to tether statutory interpretation more closely to statutory text. His dissents in the Affordable Care Act cases- National Federation of Independent Business v. Sebelius and King v. Burwell- demonstrate both the nature and the limits of his success in that effort.

These were two legal challenges, one constitutional and the other statutory, that threatened to bring down President Obama's signature legislative achievement, the Patient Protection and Affordable Care Act. Both times the Court swerved away from a direct …

Corporate Law After Hobby Lobby, Lyman P.Q. Johnson, David K. Millon

Scholarly Articles

We evaluate the U.S. Supreme Court’s controversial decision in the Hobby Lobby case from the perspective of state corporate law. We argue that the Court is correct in holding that corporate law does not mandate that business corporations limit themselves to pursuit of profit. Rather, state law allows incorporation for any lawful purpose. We elaborate on this important point and also explain what it means for a corporation to “exercise religion.” In addition, we address the larger implications of the Court’s analysis for an accurate understanding both of state law’s essentially agnostic stance on the question of corporate purpose and …

From The New Deal To The New Healthcare: A New Deal Perspective On King V. Burwell And The Crusade Against The Affordable Care Act, Sarah Helene Duggin

Scholarly Articles

Americans describe the new healthcare system established by the Patient Protection and Affordable Care Act (“ACA”) as both a blessing and a nightmare. For millions of low and middle income Americans, the ACA offers access to health insurance they could not otherwise afford. The ACA’s opponents, however, view the new healthcare system as a threat to economic prosperity, an intrusion on personal liberty and a violation of the principles of federalism at the heart of our system of government. These same kinds of arguments were made more than eighty years ago in response to President Franklin Delano Roosevelt’s New Deal. …

The Subsidy Question In King V. Burwell, Antonio F. Perez

Scholarly Articles

On the surface, King v. Burwell appears to be a simple case about statutory interpretation. In the Affordable Care Act (widely known as Obamacare), when Congress referred to the “State,” in the provision triggering federal subsidies to insurance consumers for purchases made from federally-authorized insurance providers selling federally-authorized insurance products, should the “State” be understood to refer to the federal market (i.e., exchanges) as well as “State” markets. Simple tools of statutory construction–namely, that Congress knew full well how to refer to a “federal” exchange and failed to do so–would seem to be sufficient to supply a result. It would …

Comment On The Proposed Definition Of “Eligible Organization” For Purposes Of Coverage Of Certain Preventative Services Under The Affordable Care Act, Lyman P.Q. Johnson, David K. Millon, Stephen M. Bainbridge, Ronald J. Colombo, Brett Mcdonnell, Alan J. Meese, Nathan B. Oman

Scholarly Articles

In late August 2014, after suffering a defeat in the Supreme Court Hobby Lobby decision when the Court held that business corporations are “persons” that can “exercise religion,” the Department of Health and Human Services (“HHS”) proposed new rules defining “eligible organizations.” Purportedly designed to accommodate the Hobby Lobby ruling, the proposed rules do not comport with the reasoning of that important decision and they unjustifiably seek to permit only a small group of business corporations to be exempt from providing contraceptive coverage on religious grounds. This comment letter to the HHS about its proposed rules makes several theoretical and …

Beyond Repeal—A Republican Proposal For Healthcare Reform, Timothy Stoltzfus Jost

Scholarly Articles

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Re-Negotiating A Theory Of Social Contract For Universal Health Care In America Or, Securing The Regulatory State?, George P. Smith Ii

Scholarly Articles

Political ideologies and evolving notions of social justice have shaped public health policies throughout American history in a quest to find a point of balance between the collective good and economic realities. In pursuit of this balance, Congress enacted the Affordable Care Act in 2010. This Article first examines the new law through the lens of the social contract as envisioned by Rousseau and adopted by the Framers of the Constitution. Using economic data, public opinion, and information from the medical community, Smith and Gallena proceed to offer a frank appraisal of the state of health care in America and …

Religious Freedom And Women's Health - Litigation On Contraception, Timothy Stoltzfus Jost

Scholarly Articles

Not available.

Self-Insurance For Small Employers Under The Affordable Care Act: Federal And State Regulatory Options, Timothy Stoltzfus Jost, Mark A. Hall

Scholarly Articles

As implementation of the Affordable Care Act reshapes the US health insurance market, state and federal policy makers should be prepared to revisit regulation of stop-loss coverage — a form of reinsurance — for small businesses. Aspects of the reform law could motivate small businesses to self-insure, rather than participate in state-regulated markets either inside or outside the new health insurance exchanges. If younger or healthier groups self-insure, premiums for insured plans will rise, perhaps to an extent that could seriously impair the regulated market. State or federal lawmakers can influence small businesses to participate in the regulated market by …

Gently Into The Good Night: Toward A Compassionate Response To End-Stage Illness, George P. Smith Ii

Scholarly Articles

End-of-life decision making by health care providers must respect individual patient values. Indeed, these values must always be viewed as the baseline for developing and pursuing patient-centered palliative care for those with terminal illness. Co-ordinate with this fundamental bioethics principle is that of beneficence or, in other words, respect for conduct which benefits the dying patient by alleviating end-stage suffering — be it physical or existential. Compassion, charity, agape and/or just common sense, should be a part of setting normative standards and of legislative and judicial responses to the task of managing death. Aided by the principles of medical futility, …

Applying Bioethics In The 21st Century: Principlism Or Situationism?, George P. Smith Ii

Scholarly Articles

After an examination of the four cardinal bioethical principles which define Principlism — autonomy, beneficence, non maleficence and justice — an explication of Joseph Fletcher’s theory of Situationism is undertaken.

The conclusion of this Article is that when an ethical dilemma arises and is “tested” as to its moral efficacy, rather than judge the acts in question in order to determine whether they are in conformance with one of the four bioethical principles, it is more humane and practical to determine the ethical propriety of questioned conduct by use of a situation ethic which in fact is more sensitive. This …

The Calculus Of Accommodation: Contraception, Abortion, Same-Sex Marriage, And Other Clashes Between Religion And The State, Robin F. Wilson

Scholarly Articles

This Article considers a burning issue in society today— whether, and under what circumstances, religious groups and individuals should be exempted from the dictates of civil law. The “political maelstrom” over the Obama administration’s sterilization and contraceptive coverage mandate is just one of many clashes between religion and the state. Religious groups and individuals have also sought religious exemptions to the duty to assist with abortions or facilitate samesex marriages. In all these contexts, religious objectors claim a special right of entitlement to follow their religious tenets, in the face of equally compelling claims that religious accommodations threaten access and …

The Supreme Court And The Future Of Medicaid, Timothy Stoltzfus Jost, Sara Rosenbaum

Scholarly Articles

Not available.