Food and Drug Law Commons^™

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 …

Green Amendments And Ham: How Green Amendment Jurisprudence Can Inform Maine’S Right To Food, Sarah M. Everhart

Maine Law Review

Maine’s constitutional right to food is the first state constitutional right to food and the extent of the rights created by the amendment is largely unknown. The right to food, as enacted in Article I, Section 25 of the Maine Constitution, provides: Section 25. Right to food. All individuals have a natural, inherent and unalienable right to food, including the right to save and exchange seeds and the right to grow, raise, harvest, produce and consume the food of their own choosing for their own nourishment, sustenance, bodily health and well-being, as long as an individual does not commit trespassing, …

Constitutionalizing The Human Right To Food In Maine: A People’S Tool To Advance Food Sovereignty In The U.S., R. Denisse Cordova Montes, Heather Retberg, Photini Kamvisseli Suarez

Maine Law Review

On November 2, 2021, Maine voters overwhelmingly supported a statewide referendum approving an amendment to enshrine the right to food in Maine’s constitution. This vote was preceded by a decade of food sovereignty advocacy in Maine. This advocacy was led by small farmers and homesteaders and supported by people looking to opt out of the industrial food system, which is dominated by a few corporate monopolies and promotes charity-based solutions to hunger. This vote was a resounding proclamation by the people of Maine in support of the right to food, the right to save and exchange seeds, and the right …

Realizing The Right To Food In Maine: Insights From International Law, Smita Narula

Maine Law Review

In November 2021, Maine made history as the first U.S. state to constitutionally recognize the right to food. Maine’s right to food amendment—which sought to address widespread food insecurity and corporate control of the food supply—proclaims food as a “natural, inherent and unalienable right,” and empowers Mainers to grow and consume food of their own choosing, affirming their right to food sovereignty. This Article makes three key contributions to scholarly examinations of this historic amendment. First, it situates the amendment within the broader landscape of domestic and global struggles for the right to food and food sovereignty. Second, the Article …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

Corrupt Or Charitable? Patient Assistance Programs And The Case For Narrowing The Breadth Of The Federal Anti-Kickback Statute, Isaac Strauss

Cardozo Law Review

No abstract provided.

A Hot Topic: Is The Fda’S Approach To Sunscreen Regulation Failing Consumers?, Haley Westman

Seattle University Law Review

This Note suggests a better balance between allowing sunscreen innovation and protecting the public from unsafe products. Part I of this Note will review the factual background of the public’s attention to sunscreen, explain the current sunscreen issues in the news, and highlight the different actors involved in the growing discourse surrounding sunscreen. Part I will also show that the actors involved in the sunscreen industry—scientific researchers, social media influencers, and the public at large—have considerable influence on consumers’ trust in sunscreen, their buying habits, and the FDA’s approach to sunscreen regulation. Part II of this Note will outline the …

Making Executioners Out Of Pharmacists: Why South Carolina Should Not Adopt A Lethal Injection Secrecy Statute, Elizabeth T. French

South Carolina Law Review

No abstract provided.

Oklahoma V. Purdue Pharma: Public Nuisance In Your Medicine Cabinet, Justin Kaufman

Cardozo Law Review

No abstract provided.

When "Things" Go Wrong: Redefining Liability For The Internet Of Medical Things, Bethany A. Corbin

South Carolina Law Review

No abstract provided.

Antiquated Relics Or Misunderstood Mess, Why South Carolina Liquor Laws Are Ripe For Restructuring, Annie Day Bame

South Carolina Law Review

No abstract provided.

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …

Update On Fda Regulation Of Mhealth And Wellness Devices, Barbara Zabawa

Faculty Works

This article provides an update on the evolving regulatory landscape of mobile health (mHealth) and wellness devices, focusing on changes introduced by the Food and Drug Administration (FDA) through its 2017 Draft Guidance. These updates aim to clarify inconsistencies in the definitions and regulatory status of various categories of devices, such as mobile medical apps, general mobile apps, and low-risk wellness devices. The Draft Guidance redefines certain wellness devices, emphasizing that those related to chronic diseases or conditions may now be recognized as medical devices but remain under FDA's enforcement discretion if they pose minimal safety risks. Additionally, the article …

Pay-For-Delay: How Brand-Name And Generic Pharmaceutical Drug Companies Collude And Cost Consumer Billions, Raymond J. Prince

South Carolina Law Review

No abstract provided.

Opening The Barnyard Door: Transparency And The Resurgence Of Ag-Gag & Veggie Libel Laws, Nicole Negowetti

Law Faculty Publications

Over the past several decades, as the agricultural system became increasingly industrialized and the steps from farm to plate multiplied, consumers became farther removed from the sources of their food. Until recently, most consumers in America were content to eat their processed, cheap, and filling foods without giving a second thought to how these foods were produced. The tides are changing. Increasingly, consumers are calling for more transparency in the food system. Repulsed by images of animal cruelty and shocked by unsavory food production practices, consumers want the food industry’s veil lifted and are demanding changes in food production. The …

One Size Does Not Fit All, David Spratt

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Regression By Progression Unleveling The Classroom Playing Field Through Cosmetic Neurology, Helia Garrido Hull

Faculty Scholarship

No abstract provided.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Scholarly Articles in Law Reviews & Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …

The Deregulatory State, Lawrence O. Gostin

O'Neill Institute Papers

Public health can be achieved only through collective action, not through individual endeavor. Collective goods are essential conditions for health, but can be secured only through a well-regulated society. Yet, successive governments have eroded health and safety protections, with serious consequences. Think about the death of miners, lead in children’s toys, industrial solvents in toothpaste, salmonella in peanut butter, e-coli in spinach, and unsafe or ineffective pharmaceuticals such as COX-2 inhibitors or non-statin cholesterol medications.

Conservatives have waged a campaign against the administrative state that has created and reinforced deep-seated concerns about over-bearing government, particularly at the national level. The …

Addressing The Global Tragedy Of Needless Pain: Rethinking The United Nations Single Convention On Narcotic Drugs, Allyn L. Taylor

O'Neill Institute Papers

The lack of medical availability of effective pain medication is an enduring and expanding global health calamity. Despite important medical advances, pain remains severely under-treated worldwide, particularly in developing countries. This article contributes to the discussion of this global health crisis by considering international legal and institutional mechanisms to promote wider accessibility to critical narcotic drugs for pain relief.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Journal Articles

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck

O'Neill Institute Papers

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise …

A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck

O'Neill Institute Papers

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. …

Cold Comfort Pharmacy: Pharmacist Tort Liability For Conscientious Refusals To Dispense Emergency Contraception, Kristen Marttila Gast

ExpressO

The past several years have seen an increasing number of pharmacists refuse to dispense emergency contraception, an effective, post-coital form of contraception, on the grounds that the drug violates their personal beliefs. This Article addresses the impact of those pharmacist refusals under existing principles of tort law. The Article draws on existing pharmacy case law, state-specific refusal clauses, and ethics statements promulgated by professional pharmacy associations to investigate whether pharmacists have a legal duty to dispense emergency contraception, notwithstanding religious or ethical objections. Concluding that in most states, such a legal duty does exist, the Article develops a “wrongful conception” …

Hemp ... Why Not?, Jared B. Kahn

ExpressO

Hemp ... Why Not?

By: Jared Kahn

(Abstract)

Industrial hemp has been utilized as a commodity crop for centuries in the United States, and for millennia throughout the world. Today, the crop is cultivated for industrial uses in thirty countries, but not the United States. United States citizens may import hemp, eat hemp, wear hemp, and do whatever they please with a manufactured hemp product, but nobody grows the valuable crop in the U.S. Several states have legalized industrial hemp cultivation, however, the federal Drug Enforcement Agency (DEA) interprets the Controlled Substances Act (CSA) to prohibit the growing of hemp …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.