Health Law and Policy Commons^™

Competency To Decide For Another, Elyn R. Saks

Health Matrix: The Journal of Law-Medicine

Our topic is competency of a Substitute Decisionmaker (SubDM) to make a decision about medical treatment for another who is incompetent himself (the “ward”). While there is Competency to Decide for Another considerable literature on competency to decide for oneself, there is very little on competency to decide for another. Some studies look at a range of things that a SubDM needs to do —for example, seek information on what the ward has said—but there is none on how well a person must understand the relevant issues to be a competent SubDM.

The Paradoxes Of Defensive Medicine, Michael J. Saks, Stephan Landsman

Health Matrix: The Journal of Law-Medicine

For decades, “defensive medicine” has been the leading argument driving reforms of medical malpractice laws throughout the United States. Defensive medicine is the presumed practice of administering excessive tests and treatments as a stratagem for reducing healthcare providers’ risk of malpractice liability, despite the absence of any expected benefit for the patient. The practice is widely believed to exist throughout American healthcare as a response to fears of malpractice litigation, and thought to be enormously wasteful of healthcare dollars. In consequence, it has become a justification for law reforms insulating the healthcare industry from tort liability. These claims are promoted …

The Promise And Failures Of Children's Medicaid And The Role Of Medical-Legal Partnerships As Monitors And Advocates, L. Kate Mitchell

Health Matrix: The Journal of Law-Medicine

For decades we have known that access to early and preventive diagnosis and treatment can dramatically alter the course of a child’s life. Because of this knowledge, immediately after Congress enacted Medicaid, it created the Early and Periodic Screening, Diagnostic and Treatment, or EPSDT, program. EPSDT requires broad, holistic, and preventive care to correct or ameliorate health defects identified in Medicaid-eligible children. This coverage currently extends to 2 out of 5 children in the United States, and 47 percent of children with special health care needs. Because of the broad parameters of coverage mandated by EPSDT, Medicaid-eligible children should receive …

The Off-Label Loophole In The Psychopharmacologic Setting: Prescription Of Antipsychotic Drugs In The Nonpsychotic Patient Population, Lisa E. Smilan

Health Matrix: The Journal of Law-Medicine

U.S. physicians have wide discretion in treating patients with off-label medications. Many consider off-label prescription essential in our country’s health care system, and it is wholly supported by FDA and federal courts. Assumptions about physicians’ expertise, judgments, and commitments to beneficence and nonmaleficence undergird laissez-faire policies that allow and support physicians’ novel and innovate uses of FDA-approved drugs for purposes and populations not studied in original, strictly regulated clinical trials. Though sometimes beneficial, off-label prescribing, which flourishes in privatepractice psychiatry, often harms scores of psychiatric patients. Frequently, potential harms are insufficiently disclosed to patients. In the public health sector, officials …

Why The United States Is Failing New Mothers And How It Can Counteract Its Rapidly Climbing Maternal Mortality Rate, Khouloude Abboud

Health Matrix: The Journal of Law-Medicine

No abstract provided.

The Survival Of Critical Infrastructure: How Do We Stop Ransomware Attacks On Hospitals?, Helena Roland

Catholic University Journal of Law and Technology

Our nation’s infrastructure is under an emerging new threat: ransomware attacks. These attacks can cause anything from individual laptops, to entire cities to shut down for a period of time until the victim pays a ransom to the attacker. Unfortunately, these attacks are on the rise and the attackers have a new target: hospitals. Ransomware attacks on hospitals can temporarily shut down operating room technology and limit physician access to patient files, ultimately threatening the safety of hospital patients and the surrounding community. This paper examines how the threat of ransomware attacks on hospitals is on the rise and what …

Assumed Compliance, Stacey A. Tovino

Faculty Articles

No abstract provided.

The Full Swede: Revising Rhode Island’S Prostitution Law To Decriminalize The Selling Of Sex While Still Criminalizing The Buying Of Sex, Amanda Larocca

Roger Williams University Law Review

No abstract provided.

Consumer Protections In The Context Of Holistic Healthcare, Rachel Pauerstein

SMU Science and Technology Law Review

No abstract provided.

In Re Zhu: Implied Consent To Posthumous Sperm Retrieval, Mary Kathryn Sapp

SMU Science and Technology Law Review

No abstract provided.

Crispr And The Future Of Fertility Innovation, June R. Carbone

SMU Science and Technology Law Review

No abstract provided.

The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman

All Faculty Scholarship

Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.

Structural Discrimination In Covid-19 Workplace Protections, Ruqaiijah Yearby, Seema Mohapatra

All Faculty Scholarship

Workers, who are being asked to risk their health by working outside their homes during the COVID-19 pandemic, need adequate hazard compensation, safe workplace conditions, and personal protective equipment (PPE). Sadly, this is not happening for many essential workers, such as those working in home health care and in the meat processing industry. These workers are not only being unnecessarily exposed to the virus, but they are also not receiving paid sick leave, unemployment benefits, and affordable health care and childcare. The lack of these protections is due to structural discrimination and has disproportionately disadvantaged women of color and low-wage …

The Problem With Relying On Profit-Driven Models To Produce Pandemic Drugs, Ana Santos Rutschman

All Faculty Scholarship

The longstanding problems of relying on a market response to a pandemic are becoming readily apparent in the United States, which has quickly become the epicenter of the COVID-19 outbreak. The problems are particularly pronounced in pharmaceutical markets, where we are pinning our hopes for both cures and vaccines. In previous work we have shown how characteristics of healthcare markets in the United States create a divergence between the private incentives of for-profit companies and public health needs, leading to sub-optimal health outcomes in what is a uniquely market-driven healthcare system. In this Essay, written as the COVID-19 pandemic unfolds, …

The Reemergence Of Vaccine Nationalism, Ana Santos Rutschman

All Faculty Scholarship

This short essay explores the reemergence of vaccine nationalism during the COVID-19 pandemic. The essay traces the pre-COVID origins of vaccine nationalism and explains how it can have detrimental effects on equitable access to newly developed vaccines.

PortugalʼS Response To Covid-19, Ana Santos Rutschman

All Faculty Scholarship

This essay for the Regulatory Review's special series on Comparing Nations’ Responses to COVID-19 examines the early response to the pandemic in Portugal. The essay focuses on measures adopted in connection with the declarations of state of emergency and state of calamity, as well as the treatment of migrant populations throughout the pandemic.

Mapping Misinformation In The Coronavirus Outbreak, Ana Santos Rutschman

All Faculty Scholarship

The coronavirus outbreak has sent ripples of fear and confusion across the world. These sentiments—and our collective responses to the outbreak—are made worse by rampant misinformation surrounding the new strain of the virus, COVID-2019. In this post, I survey some of the most pervasive areas of tentacular coronavirus-related misinformation that has proliferated online -- as well as the responses of social media companies like YouTube, Facebook, Pinterest and TikTok that may ultimately prove inadequate given the magnitude of the problem.

Substance Use Disorder, Discrimination, And The Cares Act: Using Disability Law To Strengthen New Protections, Kelly K. Dineen, Elizabeth Pendo

All Faculty Scholarship

The COVID-19 pandemic is having devastating consequences for people with substance use disorders (SUD). SUD is a chronic health condition—like people with other chronic health conditions, people with SUD experience periods of remission and periods of exacerbation and relapse. Unlike people with most other chronic conditions, people with SUD who experience a relapse may face criminal charges and incarceration. They are chronically disadvantaged by pervasive social stigma, discrimination, and structural inequities. People with SUD are also at higher risk for both contracting the SARS-CoV-19 virus and experiencing poorer outcomes. Meanwhile, there are early indications that pandemic conditions have led to …

The Case For Face Shields: Improving The Covid-19 Public Health Policy Toolkit, Timothy L. Wiemken, Ana Santos Rutschman, Robert Gatter

All Faculty Scholarship

As the United States battles the later stages of the first wave of COVID-19 and faces the prospect of future waves, it is time to consider the practical utility of face shields as an alternative or complement to face masks in the policy guidance. Without face shields specifically noted in national guidance, many areas may be reluctant to allow their use as an alternative to cloth face masks, even with sufficient modification.

In this piece, we discuss the benefits of face shields as a substitute to face masks in the context of public health policy. We further discuss the implications …

Reviving Focused Scrutiny In The Constitutional Review Of Public Health Measures, Robert Gatter

All Faculty Scholarship

This article re-examines the "focused scrutiny" standard proposed by Prof. Scott Burris in 1989 and argues for its application particularly during an infectious disease emergency such as the COVID-19 pandemic. Focused scrutiny seeks to tie judicial review of the constitutionality of public health measures closely to the facts of the particular disease and to evidence of the efficacy of each governmental action to prevent the spread of that disease, even when courts adopt rational basis testing.

Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman

All Faculty Scholarship

As several pharmaceutical companies approach the Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19. This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is likely to remain …

Protecting The Rights Of People With Disabilities, Elizabeth Pendo

All Faculty Scholarship

One in four Americans — a diverse group of 61 million people — experience some form of disability (Okoro, 2018). On average, people with disabilities experience significant disparities in education, employment, poverty, access to health care, food security, housing, transportation, and exposure to crime and domestic violence (Pendo & Iezzoni, 2019). Intersections with demographic characteristics such as race, ethnicity, gender, and LGBT status, may intensify certain inequities. For example, women with disability experience greater disparities in income, education, and employment (Nosek, 2016), and members of under-served racial and ethnic groups with disabilities experience greater disparities in health status and access …

Medicaid's Vital Role In Addressing Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

All Faculty Scholarship

Medicaid plays an essential role in helping states respond to crises. Medicaid guarantees federal matching funds to states, which helps with unanticipated costs associated with public health emergencies, like COVID-19, and increases in enrollment that inevitably occur during times of economic downturn. Medicaid’s joint federal/state structure, called cooperative federalism, gives states significant flexibility within federal rules that allows states to streamline eligibility and expand benefits, which is especially important during emergencies. Federal emergency declarations give the secretary of Health and Human Services temporary authority to exercise regulatory flexibility to ensure that sufficient health care is available to meet the needs …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

All Faculty Scholarship

This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

All Faculty Scholarship

Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …

Vaccine Hesitancy: Experimentalism As Regulatory Opportunity, Ana Santos Rutschman, Timothy L. Wiemken

All Faculty Scholarship

This symposium on patient innovation has prompted us to explore problems related to departures from official vaccination schedules. At a time in which vaccine confidence has been plummeting across the world, we argue that a more granular understanding—and ultimately a more finely tuned regulatory framework—is needed to reflect the current behavioral heterogeneity among indicated patients who choose to forego or delay administration of recommended vaccines. In particular, we focus on a phenomenon we term “vaccine staggering:” a departure from vaccination schedules in the form of delays in receiving one or more vaccines, which is motivated by the desire to boost …

Center For Progressive Reform Report: Protecting Workers In A Pandemic--What The Federal Government Should Be Doing, Thomas Mcgarity, Michael C. Duff, Sidney A. Shapiro

All Faculty Scholarship

The "re-opening" of the American economy while the coronavirus that causes COVID-19 is still circulating puts workers at heightened risk of contracting the deadly virus. In some blue-collar industries, the risk is particularly acute because of the inherent nature of the work itself and of the workplaces in which it is conducted. And the risk, for a variety of reasons, falls disproportionately on people of color and low-income workers. With governors stay-at-home orders and other pandemic safety restrictions, Center for Progressive Reform Member Scholars Thomas McGarity, Michael Duff, and Sidney Shapiro examine the federal government's many missed opportunities to stem …

Smoke Screens: An Initial Analysis Of The Coronavirus Lawsuits In The United States Against China And The World Health Organization, Ana Santos Rutschman, Robert Gatter

All Faculty Scholarship

In this short essay we provide a preliminary analysis of the lawsuits filed by Missouri against China, and New York against the World Health Organization over the COVID-19 pandemic. We also situate the lawsuits against the expanding coronavirus-related misinformation “epidemic.”

Public Health Law Tools: A Brief Guide, Kristen Underhill

Faculty Scholarship

The COVID-19 pandemic offers a threat with few precedents in modern times and tests the tools of modern surveillance and public health law. The goal of this chapter is to provide a brief overview of the types of measures that state and federal governments can invoke to treat and prevent the spread of infectious disease. The following sections will provide an orientation to domestic public health law followed by the types of measures available to state and federal public health authorities.

Although this chapter does not consider international institutions, treaties, or norms that affect public health, these are also essential …

Who’S Afraid Of Section 1498? A Case For Government Patent Use In Pandemics And Other National Crises, Christopher J. Morten, Charles Duan

Faculty Scholarship

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict – indeed, have already begun to conflict – with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government-paid compensation under 28 U.S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today a conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point …