Health Law and Policy Commons^™

Addressing The Challenges Of Cognitive Decline In The Physician Workforce, Sharona Hoffman

Faculty Publications

This book chapter examines the growing challenge of cognitive decline among aging physicians and analyzes various approaches to addressing it. In 2024, twenty percent of working physicians were sixty-five or older, and evidence suggests that 12-14% of older clinicians have cognitive deficits that may affect job performance. The chapter evaluates two primary approaches to cognitive assessment: employer-initiated programs and programs operated by state medical boards. Employer "late career practitioner policies" (LCPP) that require older physicians to undergo testing are becoming increasingly popular among health care organizations. But they are vulnerable to challenge under disability and age discrimination laws, as evidenced …

Access To Primary Care And Health Care Fragmentation, Sharona Hoffman, Ishani Ganguli

Faculty Publications

This Article examines the growing crisis of long primary care wait times and the health care fragmentation that is associated with them. Patients who feel ill or are worried about new symptoms must often wait weeks or longer for appointments. In the wake of excessive wait times for primary care physician (PCP) appointments, patients increasingly turn to convenience care models such as urgent care centers, retail clinics, direct-to-consumer telemedicine, and at-home testing. While these alternatives offer prompt attention, they sacrifice other core functions of primary care and may exacerbate poor health outcomes and inequities. The Article argues that long wait …

Fda After Loper Bright, Erika Lietzan

Faculty Publications

Loper Bright, which overruled the Chevron decision from 1984, tells us that a court should determine the meaning of all statutory provisions for itself, rather than deferring to the views of the federal agencies that implement those provisions. But the overruling of Chevron may have less of an impact on the U.S. Food and Drug Administration than conventional wisdom supposes. Most challenges to FDA action do not concern its statutory interpretations. And the agency prevailed in most cases involving statutory interpretation, before the Chevron doctrine took hold. After 1984, when the doctrine did apply, the agency often lost cases at …

The Right To Seek Joy, Tyler Rose Clemons

Faculty Publications

Within the past three years, roughly half of American states have restricted access to gender-affirming medical treatment for children. In this article, I argue that these bans violate transgender children’s right to liberty guaranteed by the Fourteenth Amendment’s Due Process Clause. I do so by excavating the Framers’ understanding of liberty as the right to seek joy. Rooted in the philosophies of John Locke and Epicurus, the Framers understood liberty as the right to make important life decisions according to one’s subjective preferences without undue interference from the government. Based on this understanding, I develop a new framework for substantive …

Treatment Sentences, Evelyn Malavé

Faculty Publications

One of the most common mandates of a non-incarceratory sentence is to submit to treatment. Across the criminal legal system, from problem-solving courts to probation, millions of defendants sentenced to non-incarceratory sentences—including people not diagnosed with a substance abuse disorder—are required to attend drug treatment programs. After decades of policies that criminalized drug use, non-incarceratory sentences that match people with treatment may appear to be a step forward—or at least not the most pressing problem.

But criminal law scholarship has not fully reckoned with the harms of treatment sentences, including the harms of mandated treatment itself. Analysis of treatment sentences …

Impact Of The 23andme Bankruptcy On Preserving The Public Benefit Of Scientific Data, Jonathan E. Lotempio Jr., Chistopher R. Donohue, Jonatahan D. Moreno, Ana Santos Rutschman, Joshua Sarnoff, Michael S. Sinha, Thomas Stoeger, Jorge L. Contreras

Faculty Publications

The bankruptcy of 23andMe was an inflection point for the direct-to-consumer genetics market. Although the privacy of consumer data has been highlighted by many as a concern, we discuss another key tension in this case: the corporate enclosure of scientific data that has considerable potential value for biomedical research and public health.

Mapping Intellectual Property Abuses In The Pharmaceutical Field, S. Sean Tu, Ana Santos Rutschman

Faculty Publications

This Viewpoint details intellectual property abuses in the pharmaceutical industry involving patents, trademarks, copyrights, and trade secrets.

Patient Autonomy, Public Safety, And Drivers With Cognitive Decline, Sharona Hoffman, Cassandra Burke Robertson

Faculty Publications

With a growing elderly population, cognitive decline in drivers has become a significant public safety concern. Currently, over thirty-two million individuals who are seventy or older have driver’s licenses, and that number is growing quickly. In addition, almost ten percent of U.S. seniors (those sixty-five and older) have dementia, and an additional twenty-two percent have mild cognitive impairment. Between a quarter and a half of individuals with mild to moderate dementia still drive. As cognitive abilities such as memory, attention, and decision-making skills deteriorate, a driver's ability to operate a vehicle safely can be compromised. This not only puts the …

Reproductive Innovation And Reproductive Exceptionalism: How Private Health Insurance Coverage Of Fertility Treatment Complements Hostile Governmental Action And Expands Access To Assisted Reproduction In The United States, Myrisha S. Lewis

Faculty Publications

The use of fertility treatment and assisted reproductive technology (ART) in the United States and globally is increasing over time. As of April 2023, the World Health Organization estimates that approximately one in six individuals have faced infertility globally. Fertility treatment includes the use of drugs to stimulate egg production, in vitro fertilization (IVF), and, for some, the use of gestational surrogacy to aid in childbirth. Debates have abounded and continue to abound in federal legislatures, state legislatures, and society more broadly about the morality of abortion, contraception, and assisted reproduction, as well as whether governments, public insurers, and private …

From Myriad To Moderna: The Modern (Bio)Pharmaceutical Company, Ana Santos Rutschman

Faculty Publications

This Article examines the emergence of two modern pharmaceutical companies: Myriad and Moderna. After providing a brief background on each company, this Article contrasts them across the following areas: the technologies they have brought to market; their location; their start-up stages and the role that venture capital played in catalyzing their evolution from start-ups to large corporate structures; their relationships with other entities in the private sector, in academia and in the public sector; and their intellectual property and licensing strategies.

Personhood, Politics, Assisted Reproduction, And The Law Post-Dobbs, Myrisha S. Lewis

Faculty Publications

With the end of the federal constitutional right to abortion, state legislatures and state courts have become far more important in the sphere of reproductive rights. Before Dobbs, anti-abortion advocates had significant (albeit increasingly porous) ceilings on what they could prohibit in relation to reproductive health care. A significant check on those actions is now gone.

In the wake of Dobbs, societal debates about personhood have increased and expanded in terms of their practical implications. Before Dobbs, anti-abortion advocates admitted that Roe and subsequent cases limited the scope of their arguments, especially in relation to the legality …

"I Am Become Death, The Destroyer Of Worlds": Applying Strict Liability To Artificial Intelligence As An Abnormally Dangerous Activity, Renee Henson

Faculty Publications

Artificial intelligence (AI)-enabled tools have produced a myriad of injuries, up to and including death. This burgeoning technology has caused scholars to ask questions, such as, How do we create a legal framework for AI? Because AI creators have acknowledged that even they do not know the capacities of their technology for good or bad outcomes, this Article argues that an existing framework, strict liability, is an appropriate fit for harms arising from this new technology because a party need not prove negligence to prevail. Strict liability was uniquely developed to handle those activities that are “abnormally dangerous.” An abnormally …

Employers And The Privatization Of Public Health, Sharona Hoffman

Faculty Publications

This Article focuses on the role of employers in public health and argues that they constitute increasingly important actors in the U.S. public health arena. In the aftermath of the COVID-19 pandemic, a series of judicial decisions and newly enacted statutes enfeebled the public health powers of the federal and state governments. In a 2023 statement, Supreme Court Justice Neil Gorsuch clearly articulated his antagonism towards government-initiated COVID-19 interventions, describing them as “the greatest intrusions on civil liberties in the peacetime history of this country.” All too many share his views.

Employers may be highly motivated to safeguard their workers’ …

Gender Regrets: Banning Abortion And Gender-Affirming Care, Noa Ben-Asher, Margot J. Pollans

Faculty Publications

(Excerpt)

In the spring of 2023, the New York Times published a piece entitled “How a Few Stories of Regret Fuel the Push to Restrict Gender Transition Care.” It features Chloe Cole, who lived as a transgender boy for several years but now identifies as a cisgender woman. Cole has become a poster child for the idea that gender-affirming care (“GAC”) for minors may lead to later regret and should therefore be restricted by the state. Cole, who has been travelling the country as part of a conservative lawmaking effort to ban GAC, received a standing ovation after Florida Governor …

The Patient's Voice: Legal Implications Of Patient-Reported Outcome Measures, Sharona Hoffman, Andy Podgurski

Faculty Publications

In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This Article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field.

Patient-reported outcome measures (PROMs) are reports of patients’ symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic …

Ministerial Decision On The Trips Agreement (Wto), Ana Santos Rutschman

Faculty Publications

No abstract provided.

Segmented Innovation In The Legalization Of Mitochondrial Transfer: Lessons From Australia And The United Kingdom, Myrisha S. Lewis

Faculty Publications

The U.S. is often characterized as a leader in innovation—a home of Nobel Prize‐winning scientists, innovators, and abundant research funding. Yet, in the area of assisted reproduction combined with genetic modification or substitution, what I call “reproductive genetic innovation,” that characterization begins to wane. This Article focuses on the regulation of mitochondrial transfer, a subset of reproductive genetic innovation. While human clinical trials related to mitochondrial transfer go forward in the U.K., the clinical use of the technique remains illegal in the U.S. due to a system of subterranean regulation by the U.S. Food and Drug Administration and a now-recurring …

A Pill's Ransom: Healthcare Liability Litigation For Unnecessary Pelvic Examinations For Birth Control Pills, Bailey D. Barnes

Faculty Publications

Despite some of the modest advances made in reproductive rights and reproductive justice in the twentieth and early-twenty-first century in the United States, many vestiges of paternalism and overregulation of female bodies remain. This Article tackles the issue of the requirement of pelvic exams and Pap smear tests for the prescription of oral contraceptives, otherwise known as the birth control pill ("the Pill"). Though state legislators are somewhat to blame for this exercise of control over female bodies for women to receive access to contraceptives, it is the medical profession itself that is at the core of this ill. Owing …

The Perfect Storm: Substance Abuse, Mental Illness, And Rural America, Bailey D. Barnes

Faculty Publications

Across the United States in the late twentieth and early twenty-first century, substance abuse and mental illness have clashed with the criminal justice system to produce inequitable and tragic results. The War on Drugs especially affects rural communities, where resources for rehabilitative services, mental health treatment, and transitional housing are scarce. In these areas, the significant strain on the criminal justice system caused by the frequent intersection of substance abuse and mental illness has wrought overcrowded correctional facilities, congested criminal court dockets, exhausted public defenders, and devastated families. This Article is a case study of one such rural community's experience …

Healthcare Education Leaves The Hills: Frontier Nursing University’S Move From Appalachia, Hannah Haksgaard

Faculty Publications

Rural communities lack maternity and childbirth services, and access is getting worse. Despite the serious need for more rural-focused childbirth services, Frontier Nursing—the most famous rural-focused childbirth healthcare provider and educator—recently left the historic rural location it had called home since its inception nearly a century ago. Frontier Nursing, established in the Appalachian Mountains in 1925, initially provided nursing and midwifery care focused on the residents of Leslie County, Kentucky, and in 1939 established a school in Leslie County to train future rural nurse-midwives. Despite success over nearly 100 years deep in the remote and rural Appalachian foothills, Frontier Nursing …

Review: Wendy A. Bach, Prosecuting Poverty, Criminalizing Care, Anna Arons

Faculty Publications

(Excerpt)

“Lock ’em up, clean ’em up, and start over” (145). This is how a drug treatment coordinator in a court in East Tennessee sums up her approach to provisioning substance use services to poor Tennesseans. If someone needs treatment, the most expeditious route—often, the only route—is through the criminal legal system. First, the court administrator casts about for a criminal charge, hopefully a “little charge,” that the person can be arrested on. Then, once they are arrested, they can be brought to jail where they can detox, with no medical supervision and no medication to ease the detox. And …

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

A Dose Of Dignity : Equitable Vaccination Policies For Incarcerated People And Correctional Staff During The Covid-19 Pandemic, Itay Ravid, Jordan M. Hyatt, Steven L. Chanenson

Faculty Publications

Since its emergence in early 2020, the COVID-19 pandemic has altered the lives of millions of Americans. As it so often is during times of crisis, our most vulnerable communities have disproportionately suffered and were overlooked. Among these myriad communities, incarcerated people became a particularly potent symbol of our failure to handle the spread of the virus. In December 2020, a beacon of hope emerged with the introduction of new cutting-edge vaccines which promised to bring the world back to where it was just a year-and-a-half ago. Here again, however, policy and politics have led states to adopt different distribution …

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

So Many Have Died: Covid-19 In America's Nursing Homes, David M. English

Faculty Publications

As of the date of this writing in late September 2020, over 77,000 residents and staff of long-term care facilities have died of COVID-19 with more to come. This article will describe the reasons for this mass wave of death and provide practical suggestions for attorneys who represent a resident or family members of residents.

Co-Opting Coronavirus, Assailing Asylum, Ashley B. Armstrong

Faculty Publications

The Centers for Disease Control (CDC) issued an Order on March 26, 2020, under Title 42, Section 265 of the Public Health Service Act, in the name of combatting the spread of coronavirus. The Order has been called the “Asylum Ban” because it effectively has sealed the southern border to protection-seekers, resulting in the pushback of nearly 400,000 asylees and unaccompanied children. This Article argues that the Trump administration has contravened the rule of law by using the coronavirus pandemic as a convenient pretext to end asylum in the U.S., and by violating the rights of protection-seekers. In doing so, …

Difficulty Of Care: Alligning Tax And Health Care Policy For Family Caregiving, Christine S. Speidel

Faculty Publications

In the United States millions of people live with disabilities, many of whom require assistance with activities of daily life to remain in their homes and communities. However, financial support for this assistance is limited. Many caregivers forgo working outside the home in order to provide care to a family member. And while state and federal programs provide some compensation for caregiving, caregivers frequently face problems including poverty, lack of health insurance, lack of Social Security and Medicare credits, and lack of retirement savings. Our nation’s paltry support for caregiving threatens the practical ability of people with disabilities to choose …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

Covid-19 And Its Impact On America's Retirement System, David M. English

Faculty Publications

There is a long-standing debate over whether America's retirement system is in crisis. The COVID-19 pandemic has resolved the debate. Perhaps the system was merely challenged prior to March 2020, but it is certainly in crisis now. The pandemic has negatively impacted all four of the principal pillars of retirement: Social Security, employer-sponsored retirement programs, earnings from part-time work, and the worker's own savings. This short article will discuss the impact of the pandemic on the retirement system and discuss possible ways to restore the system to health or at least ameliorate the damage.

The Origins And Future Of Global Health Law: Regulation, Security, And Pluralism, Sam F. Halabi

Faculty Publications

The COVID-19 pandemic has presented a global health crisis unlike any seen in the seventy-five years since the United Nations and the World Health Organization were formed - one that is killing people, spreading human suffering, and upending people's lives. But this is much more than a health crisis. It is a human crisis. The coronavirus disease (COVID-19) is attacking societies at their core. It is therefore a crucial point around which to focus the capability of national and global institutions to address this essential threat to human health and life.

The purposes of this Article are to revisit and …