Law Commons^™

The Great American Health Care System And The Dire Need For Change: Stark Law Reform As A Path To A Vital Future Of Value-Based Care, Marilyn Uzdavines

Faculty Scholarship

No abstract provided.

Today’S Crusades: A Therapeutic Jurisprudential Critique Of Faith-Based Civil Rights In Health Care, Kathy Cerminara

Faculty Scholarship

No abstract provided.

The Pandemic Paradox In International Law, Peter G. Danchin, Jeremy Farrall, Shruti Rana, Imogen Saunders

Faculty Scholarship

No abstract provided.

Kidney Donation And The Consent Of The Poor, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

In "Consentability," Nancy Kim tackles an important and current topic—in an age of increasing options about how to live, die, and procreate, what limits, if any, should the law place on those choices? "Consentability" is a valuable resource for scholars and policymakers alike, summarizing the arguments for and against government intrusion on the choices of consenting adults with encyclopedic thoroughness. After weighing the arguments, Kim proposes that “bodily integrity exchanges” be permitted, subject to limitations. Although we agree with the general conclusion that bodily integrity exchanges should be permitted, we disagree with the specific limitations that treat the decisions of …

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 …

A Public Health Law Path For Second Amendment Jurisprudence, Michael Ulrich

Faculty Scholarship

The two landmark gun rights cases, District of Columbia v. Heller and McDonald v. City of Chicago, came down in 2008 and 2010, respectively. In the decade that has followed, two things have become abundantly clear. First, these cases provide little clarity about the nature and scope of Second Amendment rights, resulting in chaos and circuit splits in the lower courts. Second, growing empirical evidence has revealed that, in the background of the debate on individual constitutional rights, a serious gun violence epidemic is intensifying around the country. In one corner, gun rights advocates worry that increased firearm regulation will …

Pedagogy And Policy: A Tribute To Karen Rothenberg’S Contributions To Health Law, Michael Ulrich

Faculty Scholarship

Professor Karen Rothenberg has had a significant influence on my life, impacting my education, my career, and the way I think. Professor Rothenberg has been a pillar in the health law community, but perhaps her most lasting impact for myself was creating the health law program at the University of Maryland, Francis King Carey School of Law. This nationally recognized program grew from her passion, expertise, and recognition of the importance of health, and is the reason I chose to attend the University of Maryland. The curriculum, faculty, and experience made it one of the best decisions of my life …

The New "Essential": Rethinking Social Goods In The Age Of Covid-19, Olatunde C.A. Johnson

Faculty Scholarship

The Covid-19 crisis has laid bare the fragility of social insurance systems in the United States and the lack of income security and basic benefits for many workers and residents. The United States has long had weaker protections for workers compared to other liberal democracies racial and economic disparities among those most affected by these dislocations (analyses are hampered by a paucity of demographic data). Those who were socially and economically vulnerable before the pandemic (for example due to homelessness, immigration status, or incarceration) are likely to suffer the most harm. Changes in workplace conditions as a result of the …

Linked Fate: Justice And The Criminal Legal System During The Covid-19 Pandemic, Susan P. Sturm, Faiz Pirani, Hyun Kim, Natalie Behr, Zachary D. Hardwick

Faculty Scholarship

The concept of “linked fate” has taken on new meaning in the face of the COVID-19 pandemic. People all over the world – from every walk of life, spanning class, race, gender, and nationality – face a potentially deadly threat requiring cooperation and sacrifice. The plight of the most vulnerable among us affects the capacity of the larger community to cope with, recover, and learn from COVID-19’s devastating impact. COVID-19 makes visible and urgent the need to embrace our linked fate, “develop a sense of commonality and shared circumstances,” and unstick dysfunctional and inequitable political and legal systems.

Nowhere is …

Covid-19 And The Law: Elections, Richard Briffault

Faculty Scholarship

With one Supreme Court decision, lower federal and state court decisions, pending litigation, and proposals around the country for major changes in how elections are conducted, COVID-19 has already had and likely will continue to have a significant impact on election law.

The discussion that follows proceeds in two parts. The first addresses the initial consequences of COVID-19 as an electoral emergency. Voters were due to go to the polls in states around the country just as the pandemic was gathering force and governors and mayors were calling on people to stay at home and avoid large gatherings – which, …

Evaluating For-Profit Public Benefit Corporations As An Additional Structure For Antibiotic Development And Commercialization, Kevin Outterson, John H. Rex

Faculty Scholarship

While antibiotics are a key infrastructure underpinning modern medicine, evolution will continue to undermine their effectiveness, requiring continuous investment to sustain antibiotic effectiveness. The antibiotic R&D ecosystem is in peril, moving towards collapse. Key stakeholders have identified pull incentives such as Market Entry Rewards or subscription models as the key long-term solution. If substantial Market Entry Rewards or other pull incentives become possible, there is every reason to expect that for-profit companies will return to the antibiotic field. However, the political and financial will to develop such Market Entry Rewards or other similar incentives may be difficult to muster in …

First Man And Second Woman: Reflections On The Anniversaries Of Apollo 11 And Cruzan, George J. Annas

Faculty Scholarship

THE United States Supreme Court's decision in Cruzan v. Director, Missouri Department of Health marks its thirtieth anniversary in 2020.' This follows closely after the fiftieth anniversary of the Apollo 11 moon landing.² Anniversaries provide an opportunity for reflection and to gain perspective. We can, I suggest, gain deeper insights regarding human life and death by considering these two anniversaries together. Apollo 11 may seem far from Nancy Cruzan-but the discovery of disturbing details about the death of Neil Armstrong, the first man on the moon, is a productive introduction to the topic of death in a modern American …

Is Tort Law The Tool For Fixing Reproductive Wrongs?, Christopher Robertson

Faculty Scholarship

In his 2019 book, Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law, Dov Fox offers a compelling argument for new torts allowing recovery for wrongful reproduction. These torts would include three sorts of cases, those where wrongdoing (whether negligent, reckless, or intentional) caused undesired reproduction; stymied desired reproduction; or confounded reproduction, causing birth of a child different than that intended by the parents. The likely defendants in these torts are gynecologists, urologists, sperm banks, and IVF clinics.

Federalism Complicates The Response To The Covid-19 Health And Economic Crisis: What Can Be Done?, Nicole Huberfeld, Sarah Gordon, David K. Jones

Faculty Scholarship

Federalism has complicated the US response to the novel coronavirus. States’ actions to address the pandemic have varied widely, and federal and state officials have provided conflicting messages. This fragmented approach has cost time and lives. Federalism will shape the long-term health and economic impacts of COVID-19, including plans for the future, for at least two reasons: First, federalism exacerbates inequities, as some states have a history of underinvesting in social programs, especially in certain communities. Second, many of the states with the deepest needs are poorly equipped to respond to emergencies due to low taxes and distrust of government, …

Contractual Incapacity And The Americans With Disabilities Act, Sean M. Scott

Faculty Scholarship

The doctrine of contractual incapacity allows people with mental disabilities to avoid their contractual liability. Its underlying premise is that the law has an obligation to protect people with such disabilities both from themselves and from unscrupulous people who would take advantage of them; mental incapacity provides this protection by rendering certain contracts unenforceable. The Disability Rights Movement ("DRM"), however, has challenged such protective legal doctrines, as they rest on outmoded concepts about people with mental disabilities.

This essay argues that the mental incapacity doctrine undermines the goals of the DRM and the legislative goals of the Americans with Disabilities …

“Unusual Care”: Groupthink And Willful Blindness In The Support Study, George J. Annas, Catherine L. Annas

Faculty Scholarship

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. …

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …

Covid-19 And Lgbt Rights, Suzanne B. Goldberg

Faculty Scholarship

Even in the best of times, LGBT individuals have legal vulnerabilities in employment, housing, healthcare and other domains resulting from a combination of persistent bias and uneven protection against discrimination. In this time of COVID-19, these vulnerabilities combine to amplify both the legal and health risks that LGBT people face.

This essay focuses on several risks that are particularly linked to being lesbian, gay, bisexual, or transgender, with the recognition that these vulnerabilities are often intensified by discrimination based on race, ethnicity, age, disability, immigration status and other aspects of identity. Topics include: 1) federal withdrawal of antidiscrimination protections; 2) …

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 …

Driver For Contactless Payments, Ronald J. Mann

Faculty Scholarship

As a consumer, my primary experience with cash before the virus was standing in checkout lines observing the sluggish pace of cash transactions in front of me. Like so many things in our lives, the advent of the virus has changed the situation markedly. From the earliest days of infection, it has been far more unsettling to observe cash transactions knowing that the virus persists on paper and metal surfaces for days.

The dynamic that has driven the choices merchants offer in face-to-face retail transactions will change as well. Driven by the private exigencies of the retail environment, the last …

Covid-19 And Prisoners’ Rights, Gregory Bernstein, Stephanie Guzman, Maggie Hadley, Rosalyn M. Huff, Alison Hung, Anita N.H. Yandle, Alexis Hoag, Bernard E. Harcourt

Faculty Scholarship

As COVID-19 continues to spread rapidly across the country, the crowded and unsanitary conditions in prisons, jails, juvenile detention, and immigration detention centers leave incarcerated individuals especially vulnerable. This chapter will discuss potential avenues for detained persons and their lawyers seeking to use the legal system to obtain relief, including potential release, during this extraordinary, unprecedented crisis.

Child Welfare And Covid-19: An Unexpected Opportunity For Systemic Change, Jane M. Spinak

Faculty Scholarship

The COVID-19 pandemic has already wrecked greater havoc in poor neighborhoods of color, where pre-existing conditions exacerbate the disease’s spread. Crowded housing and homelessness, less access to health care and insurance, and underlying health conditions are all factors that worsen the chances of remaining healthy.Workers desperate for income continue to work without sufficient protective measures, moving in and out of these neighborhoods, putting themselves and their families at risk. During periods of greater disruption, tensions are heightened and violence more prevalent. Already some experts are warning of an onslaught of child maltreatment cases, citing earlier examples of spikes in foster …

Federalism, Erisa, And State Single-Payer Health Care, Erin C. Fuse Brown, Elizabeth Mccuskey

Faculty Scholarship

While federal health reform sputters, states have begun to pursue their own transformative strategies for achieving universal coverage, the most ambitious of which are state-based single-payer plans. Since the passage of the Affordable Care Act in 2010, legislators in twenty-one states have proposed sixty-six unique bills to establish single-payer health care systems. This paper systematically surveys those state legislative efforts and exposes the federalism trap that threatens to derail them: ERISA's preemption of state regulation relating to employer-sponsored health insurance. ERISA's expansive preemption provision creates a narrow, risky path for state regulation to capture the employer health care expenditures crucial …

Antibiotic Development & Economic, Regulatory And Societal Challenges, Kevin Outterson, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, John Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

Privacy And Pandemics, Clarisa Long

Faculty Scholarship

The beginning of 2020 marked an unexpected turn for the world, the global pandemic of COVID-19 has affected every aspect of life. It has also created an unprecedented opportunity for governments to justify the expansion of their surveillance and collection of data. The foregoing essay, which was first published in Faculty Publications at Scholarship Archive of the Columbia Law School focuses on two types of data collection – governmental mass collection of nonanonymized location data and state-collected nonanonymized data on people's health and immunity status. Several countries have applied one or both practices and it is relevant to look into …