Law Commons^™

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

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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, …

Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha

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Energy drinks first rose to popularity in the 1980s. Red Bull energy drinks were the first of its kind, opening the door to a new consumer and regulatory landscape. Since Red Bull first launched, multiple companies have released countless new energy drink products. Some energy drinks, like Red Bull, contain less than 100 mg of caffeine per 8 oz can. However, other energy drinks contain much higher amounts of caffeine. A 12 oz can of Celsius contains 200 mg of caffeine, and up until recently, Celsius offered a product called Celsius Heat, a 12 oz can containing 300 mg of …

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 …

Immunity Through Bankruptcy For The Sackler Family, Daniel G. Aaron, Michael S. Sinha

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In August 2023, the U.S. Supreme Court temporarily blocked one of the largest public health settlements in history: that of Purdue Pharma, L.P., reached in bankruptcy court. The negotiated bankruptcy settlement approved by the court would give a golden parachute to the very people thought to have ignited the opioid crisis: the Sackler family. As the Supreme Court considers the propriety of immunity through bankruptcy, the case has raised fundamental questions about whether bankruptcy is a proper refuge from tort liability and whether law checks power or law serves power.

Of course, bankruptcy courts often limit liability against a distressed …

The Commodification Of Children And The Poor, And The Theory Of Stategraft, Daniel L. Hatcher

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Across the country, human service agencies, juvenile and family courts, prosecutors, probation departments, police officers, sheriffs, and detention and treatment facilities are churning impoverished children and adults through revenue operations with starkly disproportionate racial impact. Rather than being true to their intended missions of improving welfare and providing equal justice for vulnerable populations, the institutions are mining them with extractive practices that are harmful, unlawful, unconstitutional, and unethical. This Essay considers such commodification schemes under the lens of Professor Bernadette Atuahene’s excellent and important theory of stategraft. The examples discussed provide support for Atuahene’s theory, and this Essay simultaneously urges …

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 …

Who Cares Whether A Monopoly Is Efficient? The Sherman Act Is Supposed To Ban Them All, Robert H. Lande

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Section 2 of the Sherman Act was designed to impose sanctions on all firms that monopolize or attempt to monopolize regardless whether the firm engaged in anticompetitive conductor, and regardless whether the firm is efficient. This conclusion emerges from a textualist analysis of the language of Section 2. This article briefly analyzes contemporaneous dictionaries, legal treatises, and cases, and demonstrates that when the Sherman Act was passed the word “monopolize” simply meant that someone had acquired a monopoly. The term was not limited to monopolies acquired through anticompetitive conduct or monopolies that were inefficient. An attempt to monopolize also had …

The Slogans And Goals Of Antitrust Law, Herbert J. Hovenkamp

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This is a comparative examination of the slogans and goals most advocated for antitrust law today – namely, that antitrust should be concerned with “bigness,” that it should intervene when actions undermine the “competitive process,” or that it should be concerned about promoting some conception of welfare. “Bigness” as an antitrust concern targets firms based on absolute size rather than share of a market, as antitrust traditionally has done. The bigness approach entails that antitrust cannot be concerned about low prices, or the welfare of consumers and labor. Nondominant firms could not sustain very high prices or cause significant reductions …

Comments Of American Economic Liberties Project On 2023 Draft Merger Guidelines, Robert H. Lande, Erik Peinert

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The American Economic Liberties Project (“Economic Liberties”) is a nonprofit research and advocacy organization dedicated to understanding and addressing the problem of concentrated economic power in the United States. We submit this comment with Professor Robert H. Lande, the Venable Professor of Law Emeritus at the University of Baltimore School of Law, in response to the Draft Merger Guidelines proposed by the Department of Justice Antitrust Division and the Federal Trade Commission (together, “the Agencies”). Economic Liberties and Professor Lande write together in support of the Agencies’ efforts to improve the Merger Guidelines, last updated in 2010, to match the …

The Trouble With Time Served, Kimberly Ferzan

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Every jurisdiction in the United States gives criminal defendants “credit” against their sentence for the time they spend detained pretrial. In a world of mass incarceration and overcriminalization that disproportionately impacts people of color, this practice appears to be a welcome mechanism for mercy and justice. In fact, however, crediting detainees for time served is perverse. It harms the innocent. A defendant who is found not guilty, or whose case is dismissed, gets nothing. Crediting time served also allows the state to avoid internalizing the full costs of pretrial detention, thereby making overinclusive detention standards less expensive. Finally, crediting time …

Cyber Borders: Exercising State Sovereignty Online, Beth Simmons, Rachel Hulvey

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The internet brings challenges that threaten national identities and the foundations of what it means to be a state. Well-known challenges include difficulties maintaining important national values, competition threatening local economic plans, and even the inability to maintain a meaningful informational environment for self-governance. These influences are plausibly understood as challenges to some of the basic functions of a sovereign state. Despite these challenges, we identify the social practice of establishing control over mercurial mediums. States have responded by erecting cyberborders with a collection of laws, practices, and internet architecture designed to filter digital information within the territorial jurisdiction of …

Law Without Order, Then Too Much Order, Then Not Enough?, Ronald Weich

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No abstract provided.

The Intersectional Origins Of Modern Feminist Legal Advocacy, Serena Mayeri

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Intersectionality, reproductive justice, abolitionism, LGBTQ+ liberation, and democracy defense have moved to the center of twenty-first century feminist legal thought and advocacy, with feminists of color and queer scholars and activists at the forefront. But it wasn’t always so. Or was it?

The ‘Weaponized’ First Amendment At The Marble Palace And The Firing Line: Reaction And Progressive Advocacy Before The Roberts Court And Lower Federal Courts, Seth F. Kreimer

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It once seemed that the First Amendment doctrine developed by the Supreme Court stood as a bulwark protecting grassroots struggles for social change. In the twenty-first century, however, particularly since the appointments of Chief Justice Roberts and Justice Alito in 2005, a number of observers have begun to view the Supreme Court’s First Amendment work as a “weaponized” redoubt of reaction.

This sense of the rightward tilt of Supreme Court decisions is rooted in reality. Examining 104 Supreme Court First Amendment cases decided during the 2005–2020 Terms, it turns out that successful litigants are four times as likely to come …

When Claims Collide: Students For Fair Admissions V. Harvard And The Meaning Of Discrimination, Cara Mcclellan

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This term, the Supreme Court will decide Students for Fair Admissions v. President and Fellows of Harvard College (SFFA v. Harvard), a challenge to Harvard College’s race-conscious admissions program. While litigation challenging the use of race in higher education admissions spans over five decades, previous attacks on race-conscious admissions systems were brought by white plaintiffs alleging “reverse discrimination” based on the theory that a university discriminated against them by assigning a plus factor to underrepresented minority applicants. SFFA v. Harvard is distinct from these cases because the plaintiff organization, SFFA, brought a claim alleging that Harvard engages in intentional discrimination …

Equitable Ecosystem: A Two-Pronged Approach To Equity In Artificial Intelligence, Rangita De Silva De Alwis, Amani Carter, Govind Nagubandi

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Lawmakers, technologists, and thought leaders are facing a once-in-a-generation opportunity to build equity into the digital infrastructure that will power our lives; we argue for a two-pronged approach to seize that opportunity. Artificial Intelligence (AI) is poised to radically transform our world, but we are already seeing evidence that theoretical concerns about potential bias are now being borne out in the market. To change this trajectory and ensure that development teams are focused explicitly on creating equitable AI, we argue that we need to shift the flow of investment dollars. Venture Capital (VC) firms have an outsized impact in determining …

Standards And The Law, Cary Coglianese

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The world of standards and the world of laws are often seen as separate, but they are more closely intertwined than many professionals working with laws or standards realize. Although standards are typically considered to be voluntary and non-binding, they can intersect with and affect the law in numerous ways. They can serve as benchmarks for determine liability in tort or contract. They can facilitate domestic and international transactions. They can prompt negotiations over the licensing of patents. They can govern the development of forensic evidence admissible in criminal courts. And standards can even become binding law themselves when they …

Geography As Due Process In Immigration Court, Valeria Gomez

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Using the procedural due process framework set forth by the Supreme Court in Mathews v. Eldridge, I argue that the current geographic distribution of immigration courts violates respondents’ rights to procedural due process by inhibiting their ability to appear, present evidence, and secure counsel. In so doing, I highlight the detrimental effects that geography has on remote communities, such as their ability to build pipelines towards access to counsel. Finally, I weigh and propose alternative solutions that balance the government’s interests in efficiency with the respondents’ interests in having a meaningful opportunity to avoid the harsh consequences of deportation.

Allowing The Courts To Step In Where Needed: Applying The Plra's 90-Day Limit On Preliminary Relief, Catherine T. Struve

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The Prison Litigation Reform Act responded to two major assertions—that prison and jail inmates were swamping the courts with frivolous lawsuits and that federal-court injunctions were imposing unwarranted requirements on prison and jail systems. The first assertion led to the PLRA provisions restricting prisoner lawsuits. The second assertion gave rise to the PLRA’s limits on injunctions “in any civil action with respect to prison conditions.” These limits (1) set requirements for the entry of any injunction, (2) provide for the termination of existing permanent injunctions, and (3) constrain the entry of preliminary injunctions. As to the first of these limits, …

Commodified Inequality: Racialized Harm To Children And Families In The Injustice Enterprise, Daniel L. Hatcher

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This article addresses the systemic racialized harm of a vast injustice enterprise, with a focus on the symbiotic operations of agencies and justice systems monetizing vulnerable children and families, including the impact of contractual revenue schemes uncovered in my new book, Injustice, Inc. Our foundational justice systems are permeated by a history of racial injustice, and that history reverberates into factory-like operations that churn children and the poor into revenue. The revenue-generating mechanisms used by juvenile and family courts, prosecutors, probation departments, police, sheriffs, and detention facilities all draw the concerning historical connection—interlinked with the practices of child and …

Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany Lee

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Medical devices are increasingly connected, both to cyber networks and to sensors collecting data from physical stimuli. These cyber-physical systems pose a new host of deadly security risks that traditional notions of cybersecurity struggle to take into account. Previously, we could predict how algorithms would function as they drew on defined inputs. But cyber-physical systems draw on unbounded inputs from the real world. Moreover, with wide networks of cyber-physical medical devices, a single cybersecurity breach could pose lethal dangers to masses of patients.

The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices to ensure safety and …

Solving The Congressional Review Act’S Conundrum, Cary Coglianese

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Congress routinely enacts substantive statutes that require federal agencies to adopt regulations. When agencies issue regulations under these statutes, their rules are then subject to potential disapproval by Congress under a process outlined in a separate procedural statute known as the Congressional Review Act (CRA). If Congress passes a CRA disapproval resolution, this voids the disapproved regulation and triggers a provision in the CRA that prohibits the agency from adopting any subsequent regulation that is “substantially the same” as the disapproved one. But a CRA disapproval resolution does nothing to eliminate the agency’s obligation under the substantive statute to put …

Demonstrating Law Library Value Through Mission-Centered Assessment, Amanda Watson, Amanda Karel, Amanda Runyon, Leslie Street

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This paper presents a history of evaluation in U.S. academic law libraries, shares survey results about our collective professional mindset, and offer practical steps for law libraries that are ready to abandon a pervasive culture of evaluation.

Bibb Balancing: Regulatory Mismatches Under The Dormant Commerce Clause, Michael S. Knoll

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Courts and commentators have long understood dormant Commerce Clause doctrine to contain two types of cases: discrimination and undue burdens. This Article argues for a more nuanced understanding that divides undue burdens into single-state burdens—which arise from the application of a single state’s law alone—and mismatch burdens, which arise from legal diversity. Although the Supreme Court purports to apply Pike balancing in all undue-burden cases, we show that the Court’s approach in mismatch cases differs substantially. Specifically, unlike in single-state cases, balancing in mismatch cases involves an implicit and potentially problematic comparison by the Court between the challenged state’s regulation …

Equal Protection In Dobbs And Beyond: How States Protect Life Inside And Outside Of The Abortion Context, Reva Siegel, Serena Mayeri, Melissa Murray

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In two paragraphs at the beginning of Dobbs v. Jackson Women’s Health Organization, the Supreme Court rejected the Equal Protection Clause as an alternative ground for the abortion right. As the parties had not asserted an equal protection claim on which the Court could rule, Justice Alito cited an amicus brief we co-authored demonstrating that Mississippi’s abortion ban violated the Equal Protection Clause, and, in dicta, stated that precedents foreclosed the brief’s arguments. Yet, Justice Alito did not address a single equal protection case or argument on which the brief relied. Instead, he cited Geduldig v. Aiello, a 1974 case …

Regulating Machine Learning: The Challenge Of Heterogeneity, Cary Coglianese

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Machine learning, or artificial intelligence, refers to a vast array of different algorithms that are being put to highly varied uses, including in transportation, medicine, social media, marketing, and many other settings. Not only do machine-learning algorithms vary widely across their types and uses, but they are evolving constantly. Even the same algorithm can perform quite differently over time as it is fed new data. Due to the staggering heterogeneity of these algorithms, multiple regulatory agencies will be needed to regulate the use of machine learning, each within their own discrete area of specialization. Even these specialized expert agencies, though, …

Worker Welfare And Antitrust, Herbert J. Hovenkamp

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The important field of antitrust and labor has gone through a profound change in orientation. For the great bulk of its history labor has been viewed as a competitive threat, and the debate over antitrust and labor was framed around whether there should be a labor “immunity” from the antitrust laws. In just the last decade, however, the orientation has flipped. Most new writing views labor as a target of anticompetitive restraints imposed by employers. Antitrust is increasingly concerned with protecting labor rather than challenging its conduct.

Antitrust interest in labor markets is properly focused on two things. The smaller …

Antitrust Interoperability Remedies, Herbert J. Hovenkamp

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Compelled interoperability can be a useful remedy for dominant firms, including large digital platforms, who violate the antitrust laws. They can address competition concerns without interfering unnecessarily with the structures that make digital platforms attractive and that have contributed so much to economic growth.

Given the wide variety of structures and business models for big tech, “interoperability” must be defined broadly. It can realistically include everything from “dynamic” interoperability that requires real time sharing of data and operations, to “static” interoperability which requires portability but not necessarily real time interactions. Also included are the compelled sharing of intellectual property or …

The Right To Migrate, Matthew J. Lindsay

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Since the late-19th century, the Supreme Court has insisted that the preservation of national sovereignty requires a constitutional chasm between immigration law and ordinary law. If the Court is to bridge that chasm, it must reimagine the long-standing premise of the federal immigration power that the presence of noncitizens in U.S. territory menaces the nation’s sovereignty and security. This Article contributes to that reimagining by chronicling a compelling alternative worldview with a venerable historical pedigree—that of a quintessentially American right to migrate.

During the Founding Era, American statesmen described the impoverished subjects of Europe’s monarchies as protagonists in an unfolding …