Health Law and Policy Commons^™

The Fda’S Power Over Non-Therapeutic Uses Of Drugs And Devices, Patricia J. Zettler

Washington and Lee Law Review

Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the …

Public Health Originalism And The First Amendment, Claudia E. Haupt, Wendy E. Parmet

Washington and Lee Law Review

Current First Amendment doctrine has set public health regulation and protections for commercial speech on a collision course. This Article examines the permissibility of compelled public health and safety warnings after the Supreme Court’s decision in National Institute of Family & Life Advocates v. Becerra (NIFLA) through the lens of a concurrence to the Ninth Circuit’s en banc decision in American Beverage Ass’n v. City & County of San Francisco (American Beverage II) suggesting that only health and safety warnings dating back to 1791 are presumptively constitutional under the First Amendment.

Rejecting this form of “public health originalism,” this Article …

“Waiving” Goodbye To Medicaid As We Know It: Modern State Attempts To Transform Medicaid Programs Through Section 1115 Waivers, Chandler Gray

Washington and Lee Law Review Online

This Note explores recent state efforts to reshape their respective Medicaid programs through Section 1115 waivers. Specifically, this Note looks at states that wish to convert their Medicaid program to a block grant through Section 1115 waivers. Examining the lawfulness of these waivers requires analyzing the language and application of both the Medicaid Act and the Administrative Procedure Act. This Note argues that any use of Section 1115 waivers to implement a block grant program would be a violation of the Medicaid Act and thus unlawful. Further, federal approval of such programs would be deemed arbitrary and capricious. To justify …

Habeas Corpus, Conditions Of Confinement, And Covid-19, Allison Wexler Weiss

Washington and Lee Journal of Civil Rights and Social Justice

Incarcerated individuals, worried about contracting the disease in prison without adequate healthcare and often serious health risks, have filed lawsuits challenging their incarceration in the age of COVID-19. Overall, very few have been successful. This virus has changed our world and the reality for those in prison. The traditional legal avenues available to incarcerated individuals to challenge their continued confinement are often ill-equipped to allow for comprehensive and expedited review. The author argues that during these unprecedented times, courts should recognize that the “duty to defend the Constitution” requires them to grant motions for habeas corpus by the most vulnerable …

The Pandemic Juror, Melanie D. Wilson

Washington and Lee Law Review Online

While the deadly and highly contagious COVID-19 virus lingers and spreads across the country, courts are resuming criminal jury trials. In moving forward, judges reference case backlogs, speedy trial rights, and other concerns for the rights of the accused. Overlooked in this calculus is the importance of jurors and their safety. The Sixth Amendment guarantees “the right to a speedy and public trial, by an impartial jury.” Without jurors, there is no justice.

Even before the COVID-19 pandemic, the justice system sometimes took advantage of juror vulnerability, treating jurors callously, if not rudely, during voir dire by asking them intensely …

Profiteering Off Public Health Crises: The Viable Cure For Congressional Insider Trading, Charles L. Slamowitz

Washington and Lee Law Review Online

This article takes an approachable, forward-thinking, and academic dive into congressional insider trading in the wake of the coronavirus (COVID-19) pandemic. After a confidential briefing by the Senate Health Committee warned of COVID-19, massive stock sell-offs by members of Congress and their spouses suddenly ensued. Some senators even publicly disparaged COVID-19’s viral effects while their own shares were being offloaded. By the time the American people were made aware of its dangers, vast investment holdings by congressional insiders had already been sold. Shockingly, it is unclear if congressional insiders trading on confidential coronavirus information are actually breaking the law. Congress …

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.

Covid-19 And The Conundrum Of Mask Requirements, Robert Gatter, Seema Mohapatra

Washington and Lee Law Review Online

As states begin to loosen their COVID-19 restrictions, public debate is underway about what public health measures are appropriate. Many states have some form of mask-wearing orders to prevent the spread of COVID-19 infection. Public health guidance from the Centers for Disease Control and Prevention and the World Health Organization has conflicted. From a public health point of view, it is not clear what the right answer is. In the absence of directives, individuals are also making their own choices about mask use. At a time when public health measures, like shelter-in-place orders and social distancing, are being used to …

The Right To A Public Trial In The Time Of Covid-19, Stephen E. Smith

Washington and Lee Law Review Online

Maintaining social distance in the time of COVID-19 is a public health priority. A crowded courtroom is an environment at odds with public health needs. Accordingly, until science determines otherwise, it will be necessary for judges to manage courtroom attendance and exclude the public from trials, wholly or in part. Courtrooms may be closed to the public, despite the Sixth Amendment’s right to a public trial, when the closure is justified by a strong government interest and is narrowly tailored to further that interest. Typically, this heightened scrutiny is applied on a case-by-case basis and turns on a case’s specific …

Personhood: Law, Common Sense, And Humane Opportunities, Helen M. Alvaré

Washington and Lee Law Review Online

It is pointless to approach Professor Chatman’s argument on its own terms (to wit, “tak[ing] our laws seriously,” or equal application across myriad legal categories of “full personhood” rights) because these terms are neither seriously intended nor legally comprehensible. Instead, her essay is intended to create the impression that legally protecting unborn human lives against abortion opens up a Pandora’s box of legal complications so “ridiculous” and “far-fetched” that we should rather just leave things where they are under the federal Constitution post-Roe v. Wade and Planned Parenthood v. Casey. This impression, in turn, is a tool to …

Under Ten Eyes, Anthony Michael Kreis

Washington and Lee Law Review Online

Carliss Chatman’s If a Fetus Is a Person, It Should Get Child Support, Due Process and Citizenship brilliantly captures the moment America is in, where abortion rights hang in the balance as state legislators, like those in Alabama, Georgia, Ohio, and elsewhere clamor to embrace fetal personhood. But, as Professor Chatman illustrates, legislators have expressed no interest in the full logical extent of this policy or the rights that should attach to a fetus if their measures ultimately become effective. The article incisively demonstrates how fetal personhood is singularly focused on ending abortion in the United States and is gaining …

If A Fetus Is A Person, It Should Get Child Support, Due Process, And Citizenship, Carliss N. Chatman

Washington and Lee Law Review Online

This Article was originally published in The Washington Post on May 17, 2019. It has been edited and updated prior to its publication in the Washington and Lee Law Review.

Alabama has joined the growing number of states determined to overturn Roe v. Wade by banning abortion from conception forward. The Alabama Human Life Protection Act subjects a doctor who performs an abortion to as many as ninety-nine years in prison. The law has no exceptions for rape or incest. It redefines an “unborn child, child or person” as “[a] human being, specifically including an unborn child in utero …

Covid-19 And The Provisional Licensing Of Qualified Medical School Graduates As Physicians, Paul J. Larkin Jr.

Washington and Lee Law Review Online

Each level of government has its own peculiar responsibilities to address the COVID-19 pandemic. The states are responsible for licensing physicians who can treat the affected people. Each year, a large number of American and foreign medical school graduates do not find a residency position in the United States. Medical school graduates who have passed the qualifying examination have acquired a considerable amount of education and training during their medical studies, far more than physician assistants, nurses, military corpsmen and medics, and civilian paramedics or emergency medical technicians. They comprise a pool of talent that could be immensely useful in …

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 …

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Washington and Lee Law Review

This Article explores four beliefs about supposed pharma-benevolence that appear to be shared by more than the industry, reaching the level almost of conventional wisdom. These figurative pillars help support one-sided results in court. However, each of the pillars on examination turns out at least a bit shaky. This Article puts them forward for review to start a necessary discussion.

The locus of this Article is products liability, where a court concludes that a manufactured object is defective or could be called defective by a factfinder following a trial. Drug manufacturers enjoy near-immunity from this consequence. Modern products liability identifies …

Fighting America’S Best-Selling Product: An Analysis Of And Solution To The Opioid Crisis, Ashley Duckworth

Washington and Lee Journal of Civil Rights and Social Justice

Deaths from drug overdoses have doubled over the last ten years and are now the leading cause of accidental death in the United States. Although some overdoses may have involved more than one drug, prescription and/or illicit opioids were involved in many of these drug overdose fatalities. The Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC), and Congress have enacted a string of regulations, statutes, and programs since the early 1990s, but nothing has seriously improved the opioid epidemic as it stands. If anything, the use of opioids has persisted. Many people want pharmaceutical companies to …

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. …

Fetal Equality, Shaakirrah R. Sanders

Washington and Lee Law Review Online

I join Carliss Chatman’s call to fully consider the equal protection implications of the conception theory and raise an additional right to which a fetus may be entitled as a matter of equal protection: health care, which implicates state laws that provide civil and criminal exemptions to parents who choose religious healing instead of medical care for their children and minor dependents. The evidence of harm to children from religious healing is well documented. Yet, currently, approximately forty-three U.S. states and the District of Columbia have some type of exemption to protect religious healing parents in civil and criminal cases. …

The Future Of Physicians’ First Amendment Freedom: Professional Speech In An Era Of Radically Expanded Prenatal Genetic Testing, Wynter K. Miller, Benjamin E. Berkman

Washington and Lee Law Review

This Article explores the First Amendment questions prenatal whole genome sequencing (PWGS) is likely to raise. It argues that most of the foreseeable options for state intervention in conversations between physicians and prospective parents about genetic sequencing should trigger at least heightened scrutiny. Part I provides an overview of the most recent advances in genetic testing. It assesses the ongoing impact of non-invasive prenatal testing (NIPT) for providers and patients and charts the course from NIPT to PWGS. Part II establishes a foundational background for evaluating First Amendment claims. Part II.A describes the development of First Amendment jurisprudence, focusing on …

Healthtech: How Blockchain Can Simplify Healthcare Compliance, Kathryn M. Bennett

Washington and Lee Journal of Civil Rights and Social Justice

This Note broadly explores solutions to modern-day accessibility and security problems latent in electronic health records. Specifically, this Note discusses HIPAA and HITECH, the current law in place, and how blockchain technology can be used to fix the accessibility and security problems of current electronic health records. This Note proposes that blockchain technology can help a healthcare industry struggling to adhere to the current rule of law in an era of Big Data. Further, Blockchain technology can help individual consumers, particularly those with significant health issues, obtain the best possible medical care while simultaneously keeping their private and sensitive information …

The Burden Of A Good Idea: Examining The Impact Of Unfunded Federal Regulatory Mandates On Medicare Participating Hospitals, Rachel J. Suddarth

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

Contraception Matters: Rights, Class, And Context, Naomi Cahn

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

Zika, Feminism, And The Failures Of Health Policy, Johanna Bond

Washington and Lee Law Review Online

The Zika epidemic caused serious concerns about fetal health throughout Latin America and some southern states in the United States. The prevailing governmental response throughout the region continues to emphasize two disease control factors: pregnancy delay and mosquito abatement. This essay argues that the current health policy approach of the World Health Organization, the Centers for Disease Control, and various national governments fails in three primary ways. First, the approach does not adequately consider the intersection of gender and poverty; thus, the current policy fails to respond to the needs of women living in poverty. Second, the health policy response …

On Health, Law, And Religion, Stacey A. Tovino

Washington and Lee Law Review

The Supreme Court recently decided a number of cases involving health, law, and religion, including Whole Woman’s Health v. Hellerstedt, Zubik v. Burwell, and Burwell v. Hobby Lobby Stores, Inc. These cases were important for understanding constitutional undue burden limitations and the boundaries of religious exercise during the Obama Administration. Unfortunately, the Supreme Court’s recent opinions addressing health, law, and religion have little value for many health law professors and most practicing health care attorneys. These individuals, tasked with teaching and applying the thousands of federal and state statutes, regulations, and government guidance documents that address a …

Classification Standards For Health Information: Ethical And Practical Approaches, Craig Konnoth

Washington and Lee Law Review Online

Secondary health information research requires vast quantities of data in order to make clinical and health delivery breakthroughs. Restrictive policies that limit the use of such information threaten to stymie this research. While the Notice of Proposed Rulemaking (NPRM) for the new Common Rule permits patients to provide broad consent for the use of their information for research, that policy offers insufficient flexibility. This Article suggests a flexible consenting system that allows patients to consent to a range of privacy risks. The details of the system will be fleshed out in future work.

Selected Issues Concerning The Ethical Use Of Big Data Health Analytics, Lieke Jetten, Stephen Sharon

Washington and Lee Law Review Online

No abstract provided.

A Failure To Rehabilitate: Leaving Disability Insurance Out Of The Mental Health Parity Debate, Christopher R. Wilson

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

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 …