Law Commons^™

Immunity Through Bankruptcy For The Sackler Family, Daniel G. Aaron, Michael S. Sinha

All Faculty Scholarship

In August 2023, the U.S. Supreme Court temporarily blocked one of the largest public health settlements in history: that of Purdue Pharma, L.P., reached in bankruptcy court. The negotiated bankruptcy settlement approved by the court would give a golden parachute to the very people thought to have ignited the opioid crisis: the Sackler family. As the Supreme Court considers the propriety of immunity through bankruptcy, the case has raised fundamental questions about whether bankruptcy is a proper refuge from tort liability and whether law checks power or law serves power.

Of course, bankruptcy courts often limit liability against a distressed …

Abortion Disorientation, Greer Donley, Caroline M. Kelly

Articles

The word “abortion” pervades public discourse in the wake of Dobbs v. Jackson Women’s Health Organization. But do we know what it means? Not only do law and medicine define it differently; state legislatures have codified wildly different definitions of abortion across jurisdictions. Our analysis exposes inherent ambiguities at the boundaries of the term, particularly as abortion intersects with other categories that we often think of as distinct: pregnancy loss, ectopic pregnancy, and other forms of medically necessary care. By juxtaposing statutory text next to real people’s experiences of being denied care in states with abortion bans, we reveal …

Ella P. Stewart And The Benefits Of Owning A Neighborhood Pharmacy, Randall K. Johnson

Faculty Works

This Essay is the first to explain how and why Ella P. Stewart, who was among the first Black women to earn a doctoral degree in Pharmacy, used her status as a small business owner to protect the limited set of legal rights that were available to African-Americans in the twentieth century. It also describes how Stewart’s early personal and professional experiences informed her subsequent public service career. Additionally, this Essay highlights the various ways that Stewart expanded the real freedoms that Black Americans enjoyed by guaranteeing they received a fair share of public goods or services. It concludes by …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

The Promise Of Telehealth For Abortion, Greer Donley, Rachel Rebouché

Book Chapters

The COVID-19 pandemic catalyzed a transformation of abortion care. For most of the last half century, abortion was provided in clinics outside of the traditional healthcare setting. Though a medication regimen was approved in 2000 that would terminate a pregnancy without a surgical procedure, the Food & Drug Administration required, among other things, that the drug be dispensed in person. This requirement dramatically limited the medication’s promise to revolutionize abortion because it subjected medication abortion to the same physical barriers of procedural care.

Over the course of the COVID-19 pandemic, however, that changed. The pandemic’s early days exposed how the …

Medicaid Expansion Expectations, Deborah Farringer

Law Faculty Scholarship

Although financial stability in rural hospitals has been a relatively long-standing national problem, in the last decade, hospital closures and the incidence of highly distressed hospitals in rural areas have disproportionately impacted certain states. States that have not expanded their Medicaid programs under the Affordable Care Act, which implemented a program to extend additional federal support to cover adults living below 138% of the federal poverty line (referred to herein as “Medicaid Expansion”), are bearing the brunt of this crisis. Although the reason for hospital closures is multi-faceted and complex, health policy experts have consistently identified the lack of Medicaid …

Life After The Covid-19 Pandemic, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

After 2 years of a seemingly relentless pandemic that has upended work, education, and social interactions, the questions many are asking are when will we get back to normal and what will life be like after the COVID-19 pandemic? In truth, science cannot fully predict what SARS-CoV-2 variants will arise and the trajectory of the pandemic. Yet, history and informed scientific observations provide a guide to how—and when—society will return to pre-pandemic patterns of behavior. There will not be a single moment when social life suddenly goes back to normal. Instead, gradually, over time, most people will view COVID-19 as …

Medication Abortion Exceptionalism, Greer Donley

Articles

Restrictive state abortion laws garner a large amount of attention in the national conversation and legal scholarship, but less known is a federal abortion policy that significantly curtails access to early abortion in all fifty states. The policy limits the distribution of mifepristone, the only drug approved to terminate a pregnancy so long as it is within the first ten weeks. Unlike most drugs, which can be prescribed by licensed healthcare providers and picked up at most pharmacies, the Food and Drug Administration only allows certified providers to prescribe mifepristone, and only allows those providers to distribute the drug to …

Righting Health Policy: Bioethics, Political Philosophy, And The Normative Justification Of Health Law And Policy, D. Robert Macdougall

Publications and Research

In Righting Health Policy, D. Robert MacDougall argues that bioethics needs but does not have adequate tools for justifying law and policy. Bioethics’ tools are mostly theories about what we owe each other. But justifying laws and policies requires more; at a minimum, it requires tools for explaining the legitimacy of actions intended to control or influence others. It consequently requires political, rather than moral, philosophy. After showing how bioethicists have consistently failed to use tools suitable for achieving their political aims, MacDougall develops an interpretation of Kant’s political philosophy. On this account the legitimacy of health laws does …

The Role Of State Attorneys General In Improving Prescription Drug Affordability, Michelle M. Mello, Trish Riley, Rachel Sachs

Scholarship@WashULaw

Impact litigation initiated by state attorneys general has played an important role in advancing public health goals in contexts as diverse as tobacco control, opioids, and healthcare antitrust. State attorneys general also play a critical role in helping governors and legislatures advance health policies by giving input into their drafting and defending them against legal challenges. State attorneys general have entered the prescription drug affordability arena in both these ways—for example, by initiating lawsuits relating to price fixing by generic drug manufacturers and defending state laws requiring disclosures of pharmaceutical prices. Yet the scope of their collective efforts is not …

Health Care Civil Rights Under Medicare For All, Valarie K. Blake

Law Faculty Scholarship

The passage of Medicare for All would go a long way toward curing the inequality that plagues our health care system along racial, sex, age, health status, disability, and socioeconomic lines. Yet, while laudably creating a universal right to access to health care, Medicare for All may inadvertently dampen civil rights protections that are necessary to ensure equality in health care delivery, an outcome its creators and supporters surely would not intend.

Federal money is typically requisite for civil rights enforcement. Title VI, Title IX, and the Age Discrimination Act of 1975 all apply to recipients of federal financial assistance. …

Commentary On Burton V. State, Greer Donley

Book Chapters

In March of 2009, Samantha Burton went into labor only 25 weeks into her pregnancy. This is a very serious pregnancy complication that not only risks the pregnant woman’s health, but also greatly reduces her potential child’s chance of survival despite the most aggressive care. Ms. Burton’s doctor prescribed, among other things, inpatient bed rest for the duration of her pregnancy, which would have required her to be separated from her two minor children at home. Ms. Burton found that recommendation unacceptable, and as a competent adult, asked to be discharged or to obtain a second opinion from another hospital. …

The Italian Model To Fight Covid-19: Regional Cooperation, Regulatory Inflation, And The Cost Of One-Size-Fits-All Lockdown Measures, Fernanda Giorgia Nicola Dr.

Articles in Law Reviews & Other Academic Journals

What has come to be known worldwide as the Italian model to fight COVID-19 was a series of governmental measures undertaken in early 2020 to reduce the contagion of a deadly virus ravaging the northern regions of Italy—especially Lombardy, Veneto, and Piedmont. These measures included quarantine or lockdown throughout the Italian territory, together with the revamping of hospitals, followed by economic recovery packages to address the standstill of the national economy. This Article focuses on the strengths and weaknesses of the Italian model. By highlighting the initial missteps, we can understand how this turned into a productive national and regional …

Territorial Exceptionalism And The American Welfare State, Andrew Hammond

UF Law Faculty Publications

Federal law excludes millions of American citizens from crucial public benefits simply because they live in the United States territories. If the Social Security Administration determines a low-income individual has a disability, that person can move to another state and continue to receive benefits. But if that person moves to, say, Guam or the U.S. Virgin Islands, that person loses their right to federal aid. Similarly with SNAP (food stamps), federal spending rises with increased demand—whether because of a recession, a pandemic, or a climate disaster. But unlike the rest of the United States, Puerto Rico, the Northern Mariana Islands, …

Encouraging Interagency Collaboration: Learning From Covid-19, Rachel Sachs

Scholarship@WashULaw

In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and other agencies all share responsibilities in the development and dissemination of new healthcare technologies. Scholars have previously written about the importance of interagency collaboration both in the healthcare area and more generally, and about strategies for encouraging collaborative efforts to promote various policy goals. Under these accounts, a failure to collaborate between federal agencies may be unfortunate, but it does not typically result in or exacerbate a crisis. In the …

Drivers Of Health Policy Adoption: A Political Economy Of Hiv Treatment Policy, Matthew M. Kavanagh, Kalind Parish, Somya Gupta

Georgetown Law Faculty Publications and Other Works

Why do some countries rapidly adopt policies suggested by scientific consensus while others are slow to do so? Through a mixed methods study, we show that the institutional political economy of countries is a stronger and more robust predictor of health policy adoption than either disease burden or national wealth. Our findings challenge expectations in scholarship and among many international actors that policy divergence is best addressed through greater evidence and dissemination channels. Our study of HIV treatment policies shows that factors such as the formal structures of government and the degree of racial and ethnic stratification in society predict …

Introduction A Bold Agenda For The Next Steps In Health Reform, Lindsay Wiley

Articles in Law Reviews & Other Academic Journals

Introduction: In the aftermath of the largely failed Clinton-era health reform push and the build-up to Obamaera reforms, experts worried that another failed effort could cast a ten-year shadow. The tenth anniversary of the Affordable Care Act offered an opportunity for participants in the 2019 Next Steps in Health Reform conference to reflect. If the ACA proves resilient, what paths will it have paved for the next decade of reforms?

The Drug (Pricing) Wars: States, Preemption, And Unsustainable Prices, Isaac ("Zack") D. Buck

Scholarly Works

It is no secret: the prices of prescription drugs in the United States are unsustainable. A piercing example of the limits of America’s incomplete and disordered health care non-system, the crisis has only worsened in recent years. And not only do drug prices exact a toll on America’s consumers, they impact Americans’ access to life-enhancing (and sometimes life-saving) drugs. They constitute a real and present threat to the quality of health care in the United States in 2020.

Recognizing this harm, states are increasingly operating in this space, seeking diverse regulatory solutions to better protect their citizens — from gouging …

Parental Autonomy Over Prenatal End-Of-Life Decisions, Greer Donley

Articles

When parents learn that their potential child has a life-limiting, often devastating, prenatal diagnosis, they are faced with the first (and perhaps, only) healthcare decisions they will make for their child. Many choose to terminate the pregnancy because they believe it is in their potential child’s best interest to avoid a short and painful life. I argue that these decisions should be protected in the same way that parental healthcare decisions are constitutionally protected after birth—including a parent’s refusal or withdrawal of life-saving treatment for an infant or child who is very sick or dying. Parental autonomy ensures that parents …

The Legal And Medical Necessity Of Abortion Care Amid The Covid-19 Pandemic, Greer Donley, Beatrice Chen, Sonya Borrero

Articles

In response to the COVID-19 pandemic, states have ordered the cessation of non-essential healthcare. Unfortunately, many conservative states have sought to capitalize on those orders to halt abortion care. In this short paper, we argue that abortion should not fall under any state’s non-essential healthcare order. Major medical organizations recognize that abortion is essential healthcare that must be provided even in a pandemic, and the law recognizes abortion as a time-sensitive constitutional right. Finally, we examine the constitutional arguments as to why enforcing these orders against abortion providers should not stand constitutional scrutiny. We conclude that no public health purpose …

Is Medicare For All The Answer? Assessing The Health Reform Gestalt As The Aca Turns 10, Nicole Huberfeld

Faculty Scholarship

As presidential candidates debate health reform, the expression “Medicare for All” (“M4A”) is on repeat, yet few appear to understand precisely what Medicare is or what M4A would mean. Even more striking is that Americans are vigorously debating health reform when the ACA – President Obama’s signature legislation and a health reform effort on a scale not seen in decades – turns 10 on March 23.

The ACA pioneered universal coverage, but it also ratcheted up health care complexity by building new scaffolding around an old foundation. This fragmented landscape has been exacerbated by a crazy quilt of implementation crafted …

Manufactured Emergencies, Robert Tsai

Articles in Law Reviews & Other Academic Journals

Emergencies are presumed to be unusual affairs, but the United States has been in one state of emergency or another for the last forty years. That is a problem. The erosion of democratic norms has led to not simply the collapse of the traditional conceptual boundary between ordinary rule and emergency governance, but also the emergence of an even graver problem: the manufactured crisis. In an age characterized by extreme partisanship, institutional gridlock, and technological manipulation of information, it has become exceedingly easy and far more tempting for a President to invoke extraordinary power by ginning up exigencies. To reduce …

Regulation Of Encapsulated Placenta, Greer Donley

Articles

The practice of placenta encapsulation is rapidly growing. It typically involves post-partum mothers consuming their placentas as pills in the months after childbirth. The perceived benefits include improved mood and energy, reduced bleeding and pain, and greater milk supply. But these effects are unproven, and consumption comes with health risks. The rise of this trend has sparked a vigorous debate in the recent medical literature, but this Article is the first to consider the legal implications of placenta encapsulation. This Article examines whether FDA should regulate encapsulated placenta, and if so, whether it should be regulated as a drug, supplement, …

What Is Federalism In Health Care For?, Nicole Huberfeld

Faculty Scholarship

The Affordable Care Act offers a window on modern American federalism—and modern American nationalism—in action. The ACA’s federalism is defined not by separation between state and federal, but rather by a national structure that invites state-led implementation. As it turns out, that structure was only a starting point for a remarkably dynamic and adaptive implementation process that has generated new state-federal arrangements. States move back and forth between different structural models vis-à-vis the federal government; internal state politics produce different state choices; states copy, compete, and cooperate with each other; and negotiation with federal counterparts is a near-constant. These characteristics …

Zika And The Failure To Act Under The Police Power, Jacqueline Fox

Faculty Publications

Zika is a mosquito-borne and sexually transmitted disease that is a dangerous threat to pregnant women, causing catastrophic birth defects in a large percentage of fetuses when their mothers become infected while pregnant. It raises numerous issues related to abortion, birth control, poverty, and women’s control over their procreative choices. While the United States received ample warning from January 2016 onward that it was at risk of local transmission of this virus and public health officials at all levels generally behaved properly, the state and federal legislative responses in the summer of 2016 were entirely inadequate. For example, no state …

Teaching Health Law From A Social-Ecological Perspective, Lindsay Wiley

Articles in Law Reviews & Other Academic Journals

I started teaching health law relatively recently-in the fall of 2010, just after the Affordable Care Act ("ACA") was enacted, but before much of it had been implemented. This timing has been a blessing because I started with a fresh slate rather than adding the ACA on top of a previously developed course. It has also been a curse, but ultimately I appreciate that I started teaching the course at a time when the ACA was under constant threat. The ever-evolving nature of health law means that health law teachers must always bear in mind a goal that applies to …

Remedying Stigma-Driven Health Disparities In Sexual Minorities, Valarie K. Blake

Law Faculty Scholarship

No abstract provided.

From The Technical To The Personal: Teaching And Learning Health Insurance Regulation And Reform, Allison K. Hoffman, Whitney A. Brown, Lindsay Cutler

All Faculty Scholarship

In the Fall of 2016, I taught Health Law and Policy for the fourth consecutive semester. Over time, one thing has become increasingly clear: the aspect of this course that I work with most closely as a scholar—the regulation of health care financing and insurance, including the Patient Protection and Affordable Care Act (ACA)—is also the material that I find the most challenging to teach. Every time I reflect on teaching this material, and hear from students about how they learn this material, the thing that stands out is how critical it is that my students understand the profound impact …

Liability For Mobile Health And Wearable Technologies, Lindsay Wiley, Nicolas Terry

Articles in Law Reviews & Other Academic Journals

Most of the legal commentary regarding mobile health has focused on direct regulation leveraging existing laws and regulators such as HIPAA privacy through HHS-OCR or device regulation by the FDA. However, much of the mobile health revolution likely will play out in lightly regulated spaces bereft of most of the privacy, security, and safety rules associated with traditional health care. This article examines the potential for common law liability models to bridge these gaps (even on a temporary basis). Part II of this paper provides an introduction to the terminology used, and presents a brief typology of the apps appearing …

Everything Old Is New Again: Will Narrow Networks Succeed Where Hmos Failed?, Deborah R. Farringer

Law Faculty Scholarship

As health insurers try to navigate the new limitations set forth under the ACA, including prohibitions on denying individuals with pre-existing conditions and limitations on the rating of patients, insurers are looking towards models that will enable them to control costs without access to their usual tools. What they have developed is not so much a new insurance model, but actually a concept that first arose during the rise of managed care; that is, limited provider networks utilized within health maintenance organizations (“HMOs”). These “new” insurance products, often referred to as narrow networks or high-performance networks, offer beneficiaries a more …