Food and Drug Law Commons^™

Race, The Academy, And The Constitution Of The War On Drugs, Jeffrey Bellin, Bennett Capers

Vanderbilt Law School Faculty Publications

The war on drugs is widely viewed as a policy failure. Despite massive government intrusions on personal liberty, drug addiction, overdoses, and drug-related violence have only in- creased since the war was declared in 1971. David Pozen's new book, The Constitution of the War on Drugs, reveals a constitutional failure as well. Pozen chronicles a host of constitutional arguments that American litigants deployed to protect a "right" to use drugs with surprising, if fleeting, suc- cess. Pozen asks what might have been, exploring why the courts backtracked and effectively re- moved the Constitution as a meaningful obstacle to drug prohibitions. …

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law. They write to address the plaintiff, Novartis Pharmaceuticals Corporation (Novartis), contention that the Medicare drug price negotiation program effectuates a taking of personal property in violation of the Fifth Amendment. Amici submit this brief to provide the Court with the historical and legal background necessary to understand two issues: first, the constitutionality of government price negotiations and price regulations; second, the federal government’s use of patents. The amici explain how Courts have historically ruled on these questions, …

Public Patent Powers, Laura E. Dolbow

Michigan Law Review

Congress has created multiple structures for agencies to control how patents are used, but that institutional design choice has received little academic attention. This Article provides the first comprehensive survey of existing laws that expressly authorize agencies to control patents. I locate 113 express conditions across 68 laws that expressly authorize executive actors to make some form of decision about patents. These powers, which I refer to as “public patent powers,” allow the government to use patented inventions, to obtain patents, to authorize third parties to use patented inventions, and to regulate how patents are used. Agencies have used many …

Buyer, Beware Of Addiction, Erin E. Meyers, Clayton J. Masterman

Cardozo Law Review

Addictive products kill more than 700,000 people in the United States every year. Despite the large-scale risks that addiction poses, the law requires manufacturers of addictive products to disclose little-to-no information about the risk of addiction—the single most consequential characteristic of a class of products contributing to mass death every year.

While consumers understand that addictive products are, in fact, addictive, they generally do not understand the magnitude of the addiction risks that they face. Metaphorically, consumers understand that they are playing a game of “Russian roulette” when they consume an addictive product—but they play without knowing how many bullets …

The End(S) Of Bankruptcy Exceptionalism: Purdue Pharma And The Problem Of Social Debt, Jonathan C. Lipson, Pamela Foohey

Cardozo Law Review

The Supreme Court’s recent 5-4 decision in the controversial chapter 11 bankruptcy reorganization of opioid-maker Purdue Pharma ends the use of nonconsensual third-party “releases,” which discharge (eliminate) liabilities of nondebtors who may share liability with a corporate debtor. Although the majority opinion is correct that the Bankruptcy Code does not permit this, it failed to recognize the problematic exceptionalism of the lower courts which approved those releases or the “social” qualities of Purdue Pharma’s mass tort liability.

Bankruptcy exceptionalism has been a contested concept since it emerged over fifteen years ago and reflects a willingness to bend the rule of …

The End Of Fda Exceptionalism? Dissecting Deference To The Fda In Drug Disputes, Anjali Deshmukh

Cardozo Law Review

On April 7, 2023, a federal judge issued a nationwide stay on the United States Food and Drug Administration (FDA) approval of the abortifacient medication mifepristone. It was instantly a landmark case, decried as the first time in over one-hundred years that a federal court nullified an FDA drug approval. A few hours later, a second federal district court enjoined FDA restrictions on mifepristone. Two federal courts substantively evaluating FDA drug approval data in one day is unprecedented. It begs the question: will courts overturn FDA drug approvals again?

Conventional wisdom says no. Abortion exceptionalism, the trend of legislatures and …

The False Promise Of Breaking Patents To Lower Drug Prices, Adam Mossoff

St. John's Law Review

The Biden Administration, congressional leaders, and academic commentators have argued that patents cause high drug prices. They have proposed price controls as a solution. They allege that two federal statutes authorize the government to impose price controls on drug patents to lower drug prices: 28 U.S.C. § 1498 and the Bayh-Dole Act.

Neither § 1498 nor the Bayh-Dole Act authorize price controls on patents. Section 1498 is an eminent domain statute that applies only when a patent is used by and for the federal government, such for the military or by the U.S. Postal Service. The Bayh-Dole Act promotes the …

The Big Cost Of Small Farms, Tammi S. Etheridge

Scholarly Articles

Americans love meat. We celebrate our independence with steaks on the grill, we enjoy our favorite pastime with hot dogs, and we give thanks with turkey. Our love of meat is so ingrained in our culture that, historically, small increases in meat prices have driven the populace to riot. Today, meat prices are rising. Simultaneously, the largest meat processors and packagers are seeing record profits. Consumers, in turn, are outraged. Their emotions are being fueled by politicians who blame rising profits on a pandemic of greed and collusion and then argue that rigid antitrust enforcement is the only solution.

This …

Fraud In Feeding Our Future: An Analysis Of “The Largest Pandemic Relief Fraud Scheme Yet”, Alena Johnston

Criminal Law Practitioner

Since the 1930s, the public school system in the United States has provided a distinct place for students to develop, learn, and grow.  Public schools level the playing field for students in academics, allowing them to receive an education at no direct cost. However, students from economically disadvantaged backgrounds continue to face challenges, and their inability to secure nutritious meals can affect their ability to perform academically. In 1946, President Harry Truman signed the National School Lunch Act, forming the first Child Nutrition Program in the United States to remedy the food security issue.

 The program was implemented as “a …

Through A Glass Darkly: How Securities Disclosures Give A Distorted View Of The Economy, Gerald F. Davis

Seattle University Law Review

Our understanding of the American economy often relies on stylized facts derived from mandatory disclosures by listed corporations. Data vendors like Standard & Poor’s vacuum up 10Ks and proxy statements into databases, and scholars distill these into tentative maps. This may have been adequate for a postwar economy centered on asset-heavy manufacturers, but it is increasingly out of step with an information-based economy. Companies listed on the stock market are fewer in number and less representative than they were, light in tangible assets and people, and heavy on IP. Basic facts such as what industry they are in are increasingly …

Beyond Agency Authority: Regulating Sulfur Hexafluoride Under An Enhanced Title Ii Framework Of The Clean Air Act, Matthew Gawley

Fordham Environmental Law Review

This paper explores the critical need for robust Congressional action to regulate sulfur hexafluoride (SF6), a greenhouse gas with a global warming potential more than 20,000 times greater than carbon dioxide. Recent Supreme Court decisions––in West Virginia v. EPA and Loper Bright Enterprises v. Raimondo––to restrict EPA authority and end the Chevron doctrine have curtailed federal environmental agencies’ regulatory authority, shifting the responsibility for addressing major environmental challenges back to Congress. Despite being addressed under Title I of the Clean Air Act (CAA) through the 2022 Inflation Reduction Act (IRA), current SF6 regulations prove grossly inadequate. The utilities industry––the largest …

Abundance And Other Food Fixations, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

Although most people in the United States no longer devote the majority of their time to food production, processing, and distribution, food remains a daily fixation. This Article explores three driving food fixations--abundance, thinness, and health--and situates each against an inverse fear--scarcity, fatness, and illness, respectively. Mapping these threats onto U.S. food policy, this Article examines, among other policy arenas, food waste policy, nutrition and health claim labeling law, and food additive regulations. Across food policy, these fixations feed what this Article calls the “politics of abundance.” This politics helps to insulate the food industry from deeper systemic reform aimed …

A "One Health" Approach To Healthy Food, Katya S. Cronin

Brooklyn Law Review

Diet-related diseases are the number one killer of Americans. Nutrition and food healthfulness are increasingly seen as foundational to public health. As a result, the healthy foods industry is booming, the medical community is integrating nutrition into healthcare, and even insurance companies are subsidizing food prescriptions. The federal government invests heavily in nutrition, spending more than $166 billion a year on federal programs that provide healthy food to vulnerable populations. After the Biden Administration announced its agenda to “promote a healthy diet among Americans,” the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) sprang into …

Article Iii Standing For Cercla Private Cost Recovery Actions: How The Test's Strained Logic Belies Its Authority, Jonathan M. Palacios

Fordham Environmental Law Review

This Note examines how Article III standing doctrine applies to

private plaintiffs’ cost recovery actions under § 107(a)(4)(B) of the

Comprehensive Environmental Response, Compensation, and

Liability Act. A review of judicial decisions reveals inconsistencies

in the analysis of injury in fact and traceability, and suggests that

current Article III standing doctrine is misaligned with its purported

objectives. In response, this Note proposes a structured framework

for assessing injury in fact and a refined approach to analyzing

traceability that distinguishes between different forms of causal

uncertainty. These doctrinal adjustments should better align case

outcomes with Article III standing doctrine’s constitutional and …

Reflections And Gratitude: The Journal Of Food Law & Policy From A Twenty-Year Perspective, Margie Alsbrook

Articles

Twenty years after the Journal of Food Law & Policy published its first issue, I find myself looking back with deep gratitude for the people who helped create it, for the students who sustained it, and for the community that continues to make it thrive. What began as an untested idea has grown into a respected publication and a cornerstone of a still-growing field. This essay is both a reflection on that journey and a heartfelt thank-you to everyone who made it possible.

Don’T Trust The Process: The Viability Of Eighth Amendment Claims For Ultra-Processed Food Overconsumption In Prisons, Markus C. Johnson, Rita L. Rahoi-Gilchrest

Marquette Law Review

With the largest prison population worldwide, American prisons serve more food than anywhere else. To cut costs, American prisons overwhelmingly (or even entirely) serve prisoners ultra-processed foods, which, if overconsumed, have detrimental and long-lasting health effects. Prisoners taking issue with the food being served to them rely on the courts to counteract any inappropriate prison dietary practices, wielding the Eighth Amendment as a constitutional guarantee to be free from cruel and unusual punishment. But courts are failing to protect this constitutional guarantee by relying on precedent that is at odds with modern Eighth Amendment principles. Indeed, when it comes to …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Corporate Scenarios: Drawing Lessons From History, Madison Condon

Seattle University Law Review

As corporations are increasingly pressed to reveal information about their exposure to climate-related risks, they are often asked to undertake and disclose the outcome of “scenario analysis.” In this exercise, corporations, including financial institutions, examine how their business would fare under different pathways the future may take. One oft-used scenario, for example, is the International Energy Agency’s “Net-Zero by 2050: A Roadmap for the Energy Sector.” This Essay presents a history of the use of scenarios as a corporate planning tool, particularly in the oil industry, arguing that it is key for understanding our present moment and the role of …

Shareholder Expression In A Time Of Heightened Political Tension, Aaron A. Dhir

Seattle University Law Review

In this article, I provide context for my forthcoming research project on shareholder proposals and racial equity audits. Since the murder of George Floyd in May of 2020, progressive shareholder actors have increasingly used the proposal mechanism to advance diversity, equity, inclusion, and justice-related goals. These proposals have frequently gone beyond requesting the usual corporate fare of diversity trainings, intersectionality workshops, affinity groups, etc. Instead, a more ambitious type of proposal asks corporate America to conduct racial equity audits, defined as “an independent, objective and holistic analysis of a company’s policies, practices, products, services and efforts to combat systemic racism …

Corporate Governance Speech, Sarah C. Haan

Seattle University Law Review

The State has always regulated the intra-firm communications that make corporate governance possible, most commonly by mandating disclosures of information by a corporation to its shareholders. Some such laws are labeled “securities regulation,” but securities regulation is a broad category that extends to speech by actors who are outside the corporate enterprise as well. Also, the conventional securities regulation category does not capture all such laws; other examples, including informationforcing mandates, can be found in state corporate law. This Article uses the term “corporate governance speech” to describe the communications among shareholders, directors, and officers through which corporate governance is …