Digital Commons Network^™

Meat, The Future: The Role Of Regulators In The Lab-Grown Revolution, Joseph B. Davault, Michael S. Sinha

All Faculty Scholarship

The United States is one of the largest consumers of meat globally. The production of meat contributes substantially to climate change due to the levels of greenhouse gasses emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Traditional meat production is another major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.

Advocates for policy change aimed at addressing the risks associated with meat production have typically focused on reducing meat consumption, alternatives to meat, …

I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha

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In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”).¹ The MOU proscribes that the FTC regulates truth in advertising relating to foods, drugs, devices and cosmetics while the FDA controls labeling and the misbranding of foods, drugs, devices, and cosmetics shipped in interstate commerce.² The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century.³

Importantly, the FDA and the …

Unpatenting Product Hops, Michael S. Sinha

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On July 9, 2021, President Joseph R. Biden signed Executive Order 14036 (“Promoting Competition in the American Economy”), which directed the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to collaborate on new approaches to increasing competition and lowering prices in the pharmaceutical marketplace. In response, the USPTO outlined several new initiatives, among them an intent to improve the robustness and reliability of issued patents.

A major impetus for the Executive Order was the pervasive nature of pharmaceutical product hopping, which occurs when manufacturers introduce new follow-on versions of lucrative pharmaceutical products to the …

Ai Renaissance: Pharmaceuticals And Diagnostic Medicine, Ty J. Feeney, Michael S. Sinha

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The explosive growth of Artificial Intelligence (AI) in the modern era has led to significant advancements in the world of medicine. In drug discovery, AI technology is used to classify proteins as drug targets or non-targets for specific diseases, more accurately interpret and describe pharmacology in a quantitative fashion, and predict protein structures based on only a protein sequence for input. AI methods are used in drug development to generate predictive models for drug screening purposes, refine and modify candidate structures of drugs to optimize compounds, and predict a drug’s physiochemical properties, bioactivity, and toxicity. For medical devices, the advancement …

Reproductive Rights And Medico-Legal Education Post-Dobbs: A Fireside Chat, Michael S. Sinha, Anna Krotinger, Maya A. Phan, Louise P. King

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The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization was a pivotal moment that reshaped the landscape of abortion policy and delivery of abortion care in the United States. To create a space for critical reflection on the implications of Dobbs for the teaching and learning of abortion care in both medical and legal education, the authors engage in a dialogue highlighting the varied perspectives of professionals and professionals-in-training in both the medical and legal professions. As new attacks on reproductive autonomy continue at both state and federal levels, we foreshadow a tumultuous landscape for abortion policy …

Brief Amici Curiae Legal Scholars Of Sex And Gender In Support Of Plaintiff-Appellant, Kyle Velte, Ezra Young, Jeremiah A. Ho, M. Dru Levasseur, Nancy C. Marcus, Dara E. Purvis, Eliot Tracz, Ann E. Tweedy

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This amicus brief was filed in Griffith v. El Paso County, Colorado, case no. 23-1135 (10th Circuit) in support of appellant Darlene Griffith. Amici curiae are legal scholars of sex and gender. They offer
expertise in their personal capacities to assist the Court of Appeals for the Tenth Circuit in assessing whether the El Paso County Sheriff officials violated Ms. Griffith’s Fourteenth Amendment right to equal protection when they refused to house Ms. Griffith, a transgender woman, in the women's unit of the El Paso County Jail as a pretrial detainee.

Public Health Product Hops, Michael S. Sinha

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Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered …

Dobbs In A Technologized World: Implications For Us Data Privacy, Jheel Gosain, Jason D. Keune, Michael S. Sinha

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In June of 2022, the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, overturning 50 years of precedent by eliminating the federal constitutional right to abortion care established by the Court’s 1973 decision in Roe v. Wade. The Dobbs decision leaves the decision about abortion services in the hands of the states, which created an immediately variegated checkerboard of access to women’s healthcare across the country. This in turn laid bare a profusion of privacy issues that emanate from our technologized world. We review these privacy issues, including healthcare data, financial data, website tracking and …

The Psychology Of Science Denialism And Lessons For Public Health Authorities, Brenna Moreno, Molly J. Walker Wilson

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As it wreaked tragedy on the world, the outbreak of COVID-19 helped expose a pandemic of a different kind, one steeped in distrust and contrarianism. This movement, termed science denialism, has been lurking and undermining public health efforts for decades. Specifically, it is “the employment of rhetorical arguments to give the appearance of legitimate debate where there is none, an approach that has the ultimate goal of rejecting a proposition on which a scientific consensus exists.” Unlike skepticism, which is “doubt as to the truth of something” and works to progress both science and society, denialism is characterized by individuals’ …

Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha

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In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a $40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter.

Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under …

Common Sense Recommendations For The Application Of Tax Law To Digital Assets, Linda M. Beale, Jeremy Bearer-Friend, Jennifer Bird-Pollan, Samuel D. Brunson, Luís Calderón Gómez, Bryan Camp, Adam Chodorow, Mark Cochran, Lin William Cong, Matthew Foreman, Phil Gaudiano, I. Richard Gershon, Nathan C. Goldman, Jillian Grennan, Megan Justice, Young Ran (Christine) Kim, Herbert I. Lazerow, Tao Li, Lawrence Lokken, Omri Y. Marian, Orly Mazur, Stephanie Hunter Mcmahon, Tyler Menzer, Matt Metras, Ann M. Murphy, Henry Ordower, Amanda Parsons, Daniel Rabetti, Alex Raskolnikov, Tracey M. Roberts, Kerry A. Ryan, Edward A. Zelinsky

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In response to the Joint Committee on Taxation’s July 2023 request for comments on application of various Internal Revenue Code sections on digital assets, we propose a consistent set of rules to apply current law to digital assets. We highlight that the underlying economics and characteristics of transactions should be the primary concern for the application of rules and the valuation of digital assets. We believe any digital asset rules should (1) treat classes of digital assets with unique characteristics differently based on their economics, (2) minimize incentives for users to engage in tax-motivated structuring of transactions, and (3) allow …

Protecting A Real Or Imagined Past: Justice Samuel Alito And The First Amendment, Derigan Silver, Dan V. Kozlowski

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This article examines the First Amendment jurisprudence of Justice Samuel Alito. In this article, we argue that the principles behind his decision-making are not always necessarily traditional methods of constitutional analysis, and litigants should understand the frames and lenses Alito uses to make decisions when making their arguments to him. The article concludes with a discussion of Alito’s overall approach to the law and some thoughts on how he is attempting to reshape the First Amendment. We write that, above all, it is clear he is seeking to protect a real or imagined past that, in his mind, is under …

Protecting Patients From Physicians Who Inflict Harm: New Legal Resources For State Medical Boards, Elizabeth Pendo, Tristan Mcintosh, Heidi Walsh, Kari Baldwin, James M. Dubois

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State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians.

Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary …

What Covid-19 Laid Bare: Adventures In Workers’ Compensation Causation, Michael C. Duff

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This essay performs a close analysis of workers’ compensation coverage of COVID-19 and arrives at the conclusion that it should not be “impossible” to prove in a legal sense that an employee’s COVID-19 was caused by work. Scientific proof is not the same as legal proof: workers’ compensation law has never required that claims must be supported by irrefutable scientific proof of workplace causation. Yet repeatedly one heard this suggestion during public discussion on workers’ compensation coverage of employees.

Still, there is good evidence that even when workers’ compensation undisputedly covers work-related disease employers seldom pay benefits (and states do …

Race, Rules, And Disregarded Reality, Marsha Griggs

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Exploring issues of racial bias and social injustice in the law school classroom is a modern imperative. Yet, important conversations about systemic inequality in the law and legal profession are too often dissociated from core doctrinal courses and woodenly siloed to the periphery of the curriculum. This dissociation creates a paradigm of irrelevancy-by-omission that disregards the realities of the lived experiences of our students and the clients they will ultimately serve. Using Evidence as a launch pad, Professor Deborah Merritt has paved a pathway to incorporate these disregarded realities in doctrinal teaching. This important pathway leads to safe spaces necessary …

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

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We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.

While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new …

Property And Intellectual Property In Vaccine Markets, Ana Santos Rutschman

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As biopharmaceutical forms of technology, vaccines constitute one of the most important tools for the promotion and maintenance of public health. Tolstoy famously wrote that [h]appy families are all alike; every unhappy family is unhappy in its own way.¹ Vaccine markets offer perhaps one of the most extreme embodiments of Tolstoy's principle² in the field of biopharmaceutical innovation.

Gaps In Worker Protections That Increase Essential Workers’ Exposure To Covid-19, Ruqaiijah Yearby

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States and localities designated more than 55 million Americans as essential workers. Essential workers not only comprise those employed by the health care and food and agriculture industry, but also include teachers, grocery store workers, transit and airline workers, mail and delivery workers, energy sector and utility workers, and domestic workers (Petition for Emergency, 2020). Racial and ethnic minorities are disproportionately employed as essential workers, with Black Americans the most likely to be essential workers (Petition for Emergency, 2020). Essential workers have been left vulnerable to workplace COVID-19 infections and deaths in large part due to the federal and state …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

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The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Lessons Learned: Strengthening Medicaid To Address Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

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COVID-19 has disproportionately harmed low-income people, especially Black and Latino populations, seniors, and people with disabilities. Medicaid plays an essential role in providing coverage and access to care for these populations. As COVID-19 disrupted employment, earnings, and insurance coverage, Medicaid enrollment increased, in part because Congress offered states increased Medicaid funding in return for maintaining eligibility and enrollment for the duration of the public health emergency (PHE). At the same time, many states expanded eligibility and streamlined enrollment to assure that people could secure and keep coverage. Such policies resulted in more than 5.3 million more Americans having Medicaid coverage …

Covid-19 Employee Health Checks, Remote Work, And Disability Law, Elizabeth Pendo

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The Americans with Disabilities Act (ADA) prohibits discrimination against people with disabilities, about 61 million individuals in the U.S. The law’s protections in the workplace are especially important during COVID-19, which has worsened pre-existing disparities experienced by people with disabilities. The ADA also applies to new strategies to reduce the risk of COVID-19 infection in the workplace. This Chapter will focus on two strategies that impact individuals with and without disabilities – employee health screening, testing and vaccination policies, and new or expanded remote work programs.

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

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This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Is There A Cure For Vaccine Nationalism?, Ana Santos Rutschman

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“[V]accine nationalism . . . should serve as a reality check for the status of global health cooperation in the twenty-first century.”

Systemic Racism, The Government’S Pandemic Response, And Racial Inequities In Covid-19, Ruqaiijah Yearby, Seema Mohapatra

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During the COVID-19 pandemic, the federal and state governments have ignored racial and ethnic minorities’ unequal access to employment and health care that results in racial inequities in COVID-19 infections and deaths. In addition, they have enacted laws that further exacerbate these inequities. Consequently, many racial and ethnic minorities are employed in low-wage essential jobs that lack paid sick leave and health insurance. This lack of benefits causes them to go to work even when they are sick and prevents them from receiving appropriate medical treatment. As a result, racial and ethnic minorities have disproportionately been infected and died from …

The Market As Negotiation, Rebecca E. Hollander-Blumoff, Matthew T. Bodie

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Our economic system counts on markets to allocate most of our societal resources. The law often treats markets as discrete entities, with a native intelligence and structure that provides clear answers to questions about prices and terms. In reality, of course, markets are much messier—they are agglomerations of negotiations by individual parties. Despite theoretical and empirical work on markets and on negotiation, legal scholars have largely overlooked the connection between the two areas in considering how markets are constructed and regulated.

This Article brings together scholarship in law, economics, sociology, and psychology to better understand the role that negotiation plays …

Disparities In Health Care: The Pandemic’S Lessons For Health Lawyers, Danielle Pelfrey Duryea, Nicole Huberfeld, Ruqaiijah Yearby

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Population-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects.

Access to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set …

Protecting The Rights And Wellbeing Of People With Disabilities During The Covid-19 Pandemic, Elizabeth Pendo

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The COVID-19 pandemic has exposed and exacerbated significant inequities experienced by people with disabilities. It has also emphasized the value of legal protections against discrimination based on disability. The Americans with Disabilities Act was enacted 30 years ago to eliminate discrimination against people with disabilities and ensure equal opportunity across major areas of American life (ADA, 2008). Together with an earlier law, the Rehabilitation Act of 1973 Rehabilitation Act, 2012), this landmark civil rights law impacts a broad range of issues raised by the COVID-19 pandemic and protects a large and growing number of Americans. This Chapter focuses on application …

Abolish Municipal Courts: A Response To Professor Natapoff, Brendan Roediger

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If we are serious about disrupting the generational reproduction of the racial social order, we are going to have to learn to let go. Taking up the legacy of criminal municipal courts and racial control, this Response argues against the practice of prescribing from the traditional “medication list” of liberal reforms (substantive, procedural, and “democratizing”) without grappling with whether a system or apparatus is so inextricably bound up with the maintenance of race and class hierarchy that it should be demolished. I assert that we should always ask whether something is redeemable before we ask whether it is reformable. In …

“One Of The Greatest Human Tragedies Of Our Time”: The U.N., Biden, And A Missed Opportunity To Abolish Immigration Prisons, Lauren E. Bartlett

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Children in cages, rampant sexual abuse, lack of access to life-saving medical treatment, and more. These human rights violations continue to occur in immigration prisons in the United States today, and given the scope, many, including the United Nations, are pushing the United States to abolish immigration prisons altogether. However, the Biden administration has demonstrated that is not interested in supporting the abolition of immigration prisons, not even in the international human rights arena.

After providing a brief overview of international human rights law prohibiting immigration prisons, this essay explores U.N. recommendations on immigration prisons from each of the Universal …

Artificial Intelligence And The Challenges Of Workplace Discrimination And Privacy, Pauline Kim, Matthew T. Bodie

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Employers are increasingly relying on artificially intelligent (AI) systems to recruit, select, and manage their workforces, raising fears that these systems may subject workers to discriminatory, invasive, or otherwise unfair treatment. This article reviews those concerns and provides an overview of how current laws may apply, focusing on two particular problems: discrimination on the basis of protected characteristics like race, sex, or disability, and the invasion of workers’ privacy engendered by workplace AI systems. It discusses the ways in which relying on AI to make personnel decisions can produce discriminatory outcomes and how current law might apply. It then explores …