Law Commons^™

Diploma Privilege And The Constitution, Claudia Angelos, Sara Berman, Mary Lu Bilek, Carol L. Chomsky, Andrea Anne Curcio, Marsha Griggs, Joan W. Howarth, Eileen R. Kaufman, Deborah Jones Merritt, Patricia Salkin, Judith W. Wegner

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The COVID-19 pandemic and resulting shutdowns are affecting every aspect of society. The legal profession and the justice system have been profoundly disrupted at precisely the time when there is an unprecedented need for legal services to deal with a host of legal issues generated by the pandemic, including disaster relief, health law, insurance, labor law, criminal justice, domestic violence, and civil rights. The need for lawyers to address these issues is great but the prospect of licensing new lawyers is challenging due to the serious health consequences of administering the bar examination during the pandemic.

State Supreme Courts are …

An Epic Fail, Marsha Griggs

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All at once, the U.S. found itself embattled with the threat of COVID-19, the new normal of social distancing, and the perennial scourge of racial injustice. While simultaneously battling those ills, the class of 2020 law graduates found themselves also contending with inflexible bar licensing policies that placed at risk their health, safety, and careers. During a global health pandemic, bar licensing authorities made the bar exam a moving target riddled with uncertainty and last-minute cancellations. This costly and unsettling uncertainty surrounding the bar exam administration was unnecessary because multiple alternatives were available to safely license new attorneys. A ball …

Vaccines And Ip Preparedness In The Coronavirus Outbreak, Ana Santos Rutschman

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The COVID-19 pandemic has shed renewed light on the importance of research and development (R&D) on biopharmaceutical products needed to prevent or lessen the burden posed by outbreaks of infectious diseases. Among these, the need for new vaccines has become of paramount importance. While a race to develop different types of vaccines unfolds at unusual speed, there are still significant shortcomings in the ecosystem that leads to the production and dissemination of vaccines targeting infectious diseases like COVID-19.

Law, Structural Racism, And The Covid-19 Pandemic, Ruqaiijah Yearby, Seema Mohapatra

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Racial and ethnic minorities have always been the most impacted by pandemics because of: disparities in exposure to the virus; disparities in susceptibility to contracting the virus; and disparities in treatment. This article explains how structural racism, the ways in which laws are used to advantage the majority and disadvantage racial and ethnic minorities, has caused these disparities. Specifically, this article focuses on how employment, housing, health care, and COVID-19 relief laws have been manipulated to disadvantage racial and ethnic minorities, making minorities more susceptible to COVID-19 infection and death. This article uses Blumenshine’s 2008 framework to outline how structural …

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

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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, …

PortugalʼS Response To Covid-19, Ana Santos Rutschman

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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.

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

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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.

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

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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

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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

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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 …

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

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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 …

'Terroristic Threats' And Covid-19: A Guide For The Perplexed, Chad Flanders, Courtney Federico, Eric Harmon, Lucas Klein

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The first few months of the COVID-19 outbreak in the United States saw the rise of a troubling sort of behavior: people would cough or spit on people or otherwise threaten to spread the COVID-19 virus, resulting in panic and sometimes thousands of dollars’ worth of damages to businesses. Those who have been caught doing this — or have filmed themselves doing it — have been charged under so-called “terroristic threat” statutes. But what is a terroristic threat, and is it an appropriate charge in these cases? Surprisingly little has been written about these statutes given their long history and …

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

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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.

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

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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 …

Missing The 'Target': Preventing The Unjust Inclusion Of Vulnerable Children For Medical Research Studies, Ruqaiijah Yearby

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The central purpose of medical research on children is to generate new knowledge that can improve children’s health, subject to ethical standards that promote justice. Incorporated in U.S. law, international law, and European Union law, the Justice Principle prohibits targeting in medical research, which is the selection of research subjects because of their manipulability and compromised position, rather than for reasons directly related to the problem being studied. Unfortunately, medical research studies involving children have too often violated the Justice Principle, by targeting children in a compromised position due to their health status and vulnerable to manipulability because of their …

The Health Exception, Monica E. Eppinger

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The abortion doctrine laid out in Roe v. Wade permits a procedure necessary to preserve the life or the health of the pregnant woman, setting out what has come to be called the “life exception” and the “health exception.” This Article investigates the background and antecedents of the health exception, identifying three periods of formation and change up to the drafting of the Model Penal Code in 1959. It argues that theories of health lie at the heart of legal doctrine, shaping common-law treatment of abortion and persisting in nineteenth- and twentieth-century statutes. This account reveals origins of a health …

The Injustice Of Inclusion And Fair Opportunity: Exploiting Children In Medical Research For The Benefit Of An Unworthy Society, Ruqaiijah Yearby

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The history of pediatric medical research has been characterized as a history of child abuse. Usually, the debate regarding the use of children in medical research has centered on questions of Autonomy (informed consent) and Beneficence (the best interest of the child based on a benefit risk analysis). The debate has rarely focused on the question of which children should participate in medical research by discussing the legal principle of Justice (prohibits use of vulnerable populations for medical research who are already overly burdened for medical research unrelated to health issues affecting them and requires that populations who participate in …

Regulators As Market-Makers: Accountable Care Organizations And Competition Policy, Thomas L. Greaney

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Of the many elements animating structural change under health reform, Accountable Care Organizations (ACOs) have drawn the greatest attention. The ACO strategy entails regulatory interventions that at once aim to reshape the health care delivery system, improve outcomes, promote adoption of evidence based medicine and supportive technology, and create a platform for controlling costs under payment system reform. Ambitious aims to be sure. Implementation, however, has proved a wrenching process. This article looks at the intersection of markets and regulation under the Affordable Care Act. Specifically, it analyzes regulatory interventions under the MSSP designed to foster commercial market competition. Assessing …

Review Of Jonathan Baron, Against Bioethics, Chad Flanders

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This is a short review of a recent book by Jonathan Baron, entitled "Against Bioethics."

Polluting Medical Judgment? False Assumptions In The Pursuit Of False Claims Regarding Off-Label Prescribing, Sandra H. Johnson

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Over half of the FDA-approved prescription medications taken by patients are prescribed for a different purpose, in a higher or lower dose, for a discrete population, or over a longer period of time than that for which the drug was approved. Safety and efficacy concerns attract the most attention; but critical benefits in fostering innovation and providing patients with medications that may be uniquely effective for them are often overlooked.

The current dominant public policy response to off-label prescribing addresses this practice as a particular breed of financial conflicts of interest in which pharmaceutical firms pollute medical judgment by appealing …

Ending The Exploitation Of The Vulnerable: The Promise Of The Intersection Of American Bioethics, Human Rights, And Health Law, Ruqaiijah Yearby

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Traditionally, American bioethics has served as a safety net for the rich and powerful, for they are not forced to act as research subjects to obtain access to general health care for themselves or their children. However, American bioethics has failed to protect the vulnerable, i.e. indigent minorities. The vulnerable are not treated the same as the rich. They do not have access to health care. They are exploited in clinical trials that promise monetary gain or access to health care and their autonomy rights are often ignored. Some of the vulnerable most affected by these disparities are African-Americans. African-Americans …

Dealing With Conflicts Of Interest In Biomedical Research: Irb Oversight As The Next Best Solution To The Abolitionist Approach, Jesse Goldner

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The author details the conflicts of interest facing individual investigators and research institutions and describes the current mechanisms, primarily focused at the relationship between the investigator and the research institution, to regulate these conflicts. The author finds these mechanisms insufficient and believes that the best approach is not to regulate conflicts, but to abolish them. The author acknowledges, however, that there is a lack of political will in an abolitionist approach. He proposes, therefore, institutional review board oversight at the level of the relationship between researcher and individual subjects as the next best solution.

Managed Care And Mental Health: Clinical Perspectives And Legal Realities, Jesse Goldner

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Managed care is beginning to dominate the delivery of mental health services. The Article reviews limitations on managed care's ability to deal adequately with mental illness. It discusses empirical and other research examining the use of primary care providers as gatekeepers and it explores utilization review mechanisms, focusing particularly on providers' responses to UR. The impact on quality, access and continuity of care on discrete populations is analyzed. The article then surveys a variety of legal issues in the regulation of managed care, particularly as they apply to the provision of mental health services. These include ERISA, parity and liability …

Managed Competition, Integrated Delivery Systems And Antitrust, Thomas L. Greaney

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A central question confronting proponents of managed competition during the health reform debate in 1994 was whether competitive networks or integrated delivery systems would emerge. Under reformers’ vision, controlling costs depended on the emergence of a sufficient number of efficient and viable integrated delivery systems. Conversely, if one or a few integrated networks dominate the market for physician or hospital services, rivalry on the main issues of health care cost control would likely dissipate. This article argues that vigilant and sensible antitrust enforcement was also a prerequisite for the success of the managed competition model. Despite the considerable emphasis on …

The Changing Nature Of The Bioethics Movement, Sandra H. Johnson

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Commemorating the thirtieth anniversary of the field of bioethics, this article analyzes the future of bioethics by identifying its role in intellectual history and classifying stages of its development.

Part I considers the formative role of Quinlan, where the New Jersey Supreme Court held that the withdrawal of medical treatment is legally permissible under some circumstances. Quinlan and its progeny established a legal framework for life-sustaining treatment decisionmaking, affirming the use of substituted judgment or best interests standards.

In Part II the article documents the framework shift brought by Cruzan, a high-profile case challenging a family’s authority to make medical …