Food and Drug Law Commons^™

“Contains: Gluten” And “Gluten Free”; Fda, It’S A No-Grainer!, Elizabeth Bulat

Cardozo Law Review

Reading food, drug, and cosmetic labels is a frequent practice for all individuals with allergies. However, unlike those who are allergic to peanuts, dairy, or another major food allergen, individuals with celiac disease (“celiac consumers”) are not offered a bold, capitalized statement clearly identifying the allergen they seek to avoid. Instead, celiac consumers are tasked with studying a list of ingredients and relying on their own ability to catch any sources of gluten. This Note considers the authority provided by Congress to the Federal Food and Drug Administration (FDA) to remedy this rash regime. Then, this Note proposes that the …

When Executions Don't Kill: The Stories Of Eight People Who Survived Their Date With Death, Austin Sarat, Julia Morgan-Canales, Aidan Gemme

Cardozo Journal of Equal Rights & Social Justice

This Article focuses on the eight people who have survived execution attempts in the last 100 years. Some of them faced a second attempt to carry out the sentence. Others escaped that fate only to die in prison; one reached an agreement with the state to allow them to remain in prison for the rest oftheir life, and the fate of another is up in the air.

By examining what went wrong in their executions and the accounts of those events offered by defense lawyers, state officials, and judges, this Article suggests that these executions fall into distinct genres. Each …

A Masque Of Red Death: The Fda's "Individual Risk-Based" Blood Donor Final Guidance Report Is A Poorly Constructed Facade Covering Continued Animus Toward Queer Men, Gerald Dryden

Cardozo Journal of Equal Rights & Social Justice

The note argues that the FDA's blood donation guidelines discriminatorily target queer men, perpetuating stigma and failing to align with contemporary science. These guidelines, while aiming to protect blood recipients, are unconstitutional and not tailored to avoid discrimination, thus requiring revision to reflect current scientific understanding and eliminate bias.

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 …

Squatters Squabbles: The Use Of Mediation To Provide Beneficial Solutions To Adverse Possession Claims In New Jersey, Bayla Zohn

Cardozo Journal of Conflict Resolution

In our society, law is a complex and ever-evolving field, constantly adapting to fit our needs. Yet, there are certain legal matters we would expect to have clear and obvious resolutions. Property ownership should be simple and unambiguous, governed by "established legal rules and precepts." Examine a deed, survey the stated legal owner of the tract of land, and your answer should be uncomplicated. Yet, there are a multitude of complex laws that allow individuals to obtain legal ownership of land in a seemingly illicit fashion.

Tackling The Thicket: A Comparative Analysis Of Biologic Drugs And Biosimilars In The United States And Abroad, Lauren Cutler

Cardozo International & Comparative Law Review

The note examines the legal and regulatory landscape surrounding biologic drugs and biosimilars in the United States and Europe, focusing on patent protections, litigation trends, and the impact of biosimilar competition on drug pricing. It highlights the challenges posed by patent thickets and evergreening strategies employed by brand-name biologic manufacturers, which delay biosimilar market entry and maintain high drug prices. The analysis underscores the differences in regulatory frameworks and market dynamics between the U.S. and Europe, emphasizing the need for policy reforms to enhance competition and affordability in the biologic market.

Fight For Your Life: A Study Of Fairness In The Ultimate Fighting Championship's Anti-Doping Policy Appeals Process, Brandon Hamroff

Cardozo Journal of Conflict Resolution

No abstract provided.

Pacifying Professional Negligence Disputes - The Prospective Path For Mediation Within The Psilocybin Industry, Miranda Sapoznik

Cardozo Journal of Conflict Resolution

No abstract provided.

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.

Advance To The Nearest Dispensary: How Quebec's Marijuana Monopoly Is A Model For Future Legalized States, Jason Levine

Cardozo International & Comparative Law Review

The note argues that a state-run monopoly model for marijuana sales, inspired by Quebec's approach, could more effectively promote public health and reduce black-market competition compared to the current license authorization model used in U.S. states like Colorado and California. By centralizing control over pricing, distribution, and product regulation, a monopolistic structure could address challenges such as high taxes, slow transition phases, and the dominance of illegal markets. The analysis draws parallels to alcohol sales frameworks and highlights how a government-run system could avoid federal tax burdens under Section 280E of the Internal Revenue Code.

Steering Loan Modifications Post-Pandemic, Pamela Foohey, Dalie Jimenez, Christopher K. Odinet

Articles

As part of federal and state relief programs created during the COVID-19 pandemic, many American households received pauses on their largest debts, particularly on mortgages and student loans. Others may have come to agreements with their lenders, likewise pausing or altering payment on other debts, such as auto loans and credit cards. This relief allowed households to allocate their savings and income to necessary expenses, like groceries, utilities, and medicine. But forbearance does not equal forgiveness. At the end of the various relief periods and moratoria, people will have to resume paying all their debts, the amounts of which may …

Smoke Without Fire: Employing Mediation To Create Workplace Accommodations For Medical Cannabis Use By Disabled Armed Forces Veterans, Brendan William Potocki

Cardozo Journal of Conflict Resolution

Over the course of a nearly twelve-year career in the Air Force, which included multiple tours of duty in Afghanistan and Iraq, Stephen Otero experienced unspeakable trauma. He has the scars-both visible and invisible-to prove it. Despite being diagnosed with post-traumatic stress disorder ("PTSD") in 2008, Otero once again placed country before self and reaffirmed his commitment to serving the United States by agreeing to complete another tour of duty. During this final deployment, Otero sustained extensive abdominal injuries as a result of a suicide bombing attack.

Autumn Is Coming: A Novel Liability Theory That May Kill Pharmaceutical Evergreening, Uri Y. Hacohen

Cardozo Arts & Entertainment Law Journal

Pharmaceutical evergreening-attempts by brand-name manufacturers to leverage patent rights to artificially extend legal protection for drugs-is among the most pressing and unresolved public policy challenges of our time. On July 14, 2021, in Sanofi et al. vs. Unipharm Ltd., the Israeli Supreme Court adopted a novel and internationally unprecedented legal policy to combat the evergreening pandemic. By using its equitable powers, the Israeli court empowered a generic manufacturer, Unipharm, to claim on behalf of the public interest the wrongly obtained monopoly profits that a brand-name manufacturer, Sanofi, obtained by improperly leveraging its improvement patent to impair generic market entry. This …

Post-Grant Adjudication Of Drug Patents: Agency And/Or Court?, Arti K. Rai, Saurabh Vishnubhakat, Jorge Lemus, Erik Hovenkamp

Articles

The America Invents Act of 2011 (AIA) created a robust administrative system-the Patent Trial and Appeal Board (PTAB)-that provides a route for challenging the validity of granted patents outside of district courts. Congress determined that administrative adjudication of the validity of initial patent grants could be cheaper and more scientifically accurate than district court adjudication of such validity.

For private economic value per patent, few areas of technology can match the biopharmaceutical industry. This is particularly true for small-molecule drugs. A billion-dollar drug monopoly may be protected from competition by a relatively small number of patents. Accordingly, the social cost …

The Prison Litigation Reform Act And The Physical Injury Requirement In The Context Of Transgender Inmates, Hunter Kravitz

Cardozo International & Comparative Law Review

The note examines the impact of the Prison Litigation Reform Act (PLRA) on transgender inmates, focusing on its physical injury requirement, which disproportionately bars access to justice for those with mental or emotional injuries. It highlights the ethical and constitutional concerns arising from the PLRA's application, particularly its unequal treatment of transgender inmates, and advocates for reforms to ensure equitable access to justice.

Trademark Enforcement And Statutory Incentives, Leah Chan Grinvald

Cardozo Arts & Entertainment Law Journal

The combination of the recent U.S. Supreme Court case, Romag Fasteners v. Fossil Group, Inc., and the diamond anniversary of the Lanham Act provides good grounds to reflect on how trademark enforcement and statutory incentives have evolved through the years. Although enforcement of one's trademarks through the use of the courts can be traced back to England in the 1790s, trademark litigation and other enforcement activities have exploded, in relative terms, since the enactment of the Lanham Act in 1946. Although not subject to an easy empirical correlation, this trend suggests that the statute has had an impact on increasing …

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

Cardozo Law Review

No abstract provided.

Competing Free Speech Rights: Evaluating Compelled Disclosures On Food Packaging In A Way That Reflects Scientific Realities - Or A Lack Thereof, Rakelle Shapiro

Cardozo Law Review

No abstract provided.

Patent Eligibility And Investment, David O. Taylor

Cardozo Law Review

Have the Supreme Court's recent patent eligibility cases changed the behavior of venture capital and private equity investment firms, and if so how? This Article provides empirical data about investors' answers to those important questions. Analyzing responses to a survey of475 investors at firms investing in various industries and at various stages of funding, this Article explores how the Court's recent cases have influenced these firms' decisions to invest in companies developing technology. The survey results reveal investors' overwhelming belief that patent eligibility is an important consideration in investment decision making, and that reduced patent eligibility makes it less likely …

Dirty Business: Accountability For Harmful Pesticide Use In Brazil, Anna Goldstein

Cardozo International & Comparative Law Review

The note argues that the alarming rise in pesticide use in Brazil, particularly under President Jair Bolsonaro, has severe human health and environmental consequences. It emphasizes the need for a binding international legal framework to hold multinational corporations accountable for human rights abuses and environmental harm in their supply chains. Current voluntary frameworks and domestic laws, such as Brazil's Law 7802, are insufficient due to weak enforcement and lack of binding standards. The proposed UN Draft Treaty on Business and Human Rights is presented as a critical solution to address these gaps and ensure corporate accountability.

Patents As Property: Oil States And Its Implications On The Takings Clause, Jordan T. Owens

Cardozo Law Review

No abstract provided.

Puff, Puff, Patent: Identifying And Addressing The Tensions Between The Medical Marijuana Industry, Patent Law, And The Controlled Substances Act, Dustin Boone

Cardozo Arts & Entertainment Law Journal

No abstract provided.

The Current Application Of The Myriad And Mayo/Alice Rulings On Patent Eligibility: Inconsistent Results And Contradistinguishing Biotechnology Products, Skye Cho

Cardozo Arts & Entertainment Law Journal

The note examines the inconsistent application of the patent eligibility framework under Section 101 of the Patent Act, particularly in biotechnology. It argues that despite efforts by the USPTO to clarify the framework through memos and examples, courts have applied it inconsistently, leading to discrimination against biotechnology products. The analysis focuses on key Supreme Court decisions, such as Myriad Genetics and Mayo, and their impact on the patent eligibility of biotechnological innovations. The note highlights the need for clearer guidance to ensure consistent outcomes and fair treatment of biotechnological inventions.

The "Natural" Response To Adjudicating Current Litigation When The Creation Of A Related Agency Rule Is Simultaneously Underway, Lauren Kostman

Cardozo Law Review

No abstract provided.

Owning Colors, Deborah R. Gerhardt, Jon Mcclanahan Lee

Cardozo Law Review

Color is powerful. Historically, colors have been invested with mystical, symbolic, and religious significance. We are biologically wired to respond to color cues. A particular color may stimulate emotion, activate memory, and influence perception of the passage of time. Yet the omnipresence of color in our visual world is just the beginning of the story. We have learned to attach many meanings to colors through our lived experiences. Colors have become heuristics for even our abstract ideas. They connect communities. They unite and divide sports fans. They may be shorthand for gender identity, sexual orientation, race, and political identity. Although …

Pass The Revenue: How Section 280e Is Harming The Medical Marijuana Industry, Liam Mckillop

Cardozo International & Comparative Law Review

The note argues that Section 280E of the Internal Revenue Code unfairly penalizes medical marijuana businesses by disallowing ordinary business expense deductions, despite their legality under state laws. It proposes that Congress should amend Section 280E to create an exception for medical marijuana companies, allowing them to deduct business expenses, thereby promoting industry growth and aligning tax policy with current societal and scientific understanding of marijuana's medical benefits.

Commercial Speech Protection As Consumer Protection, Felix T. Wu

Articles

The Supreme Court has long said that “the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides.” In other words, consumers—the recipients or listeners of commercial speech—are the ones the doctrine is meant to protect. In previous work, I explored the implications of taking this view seriously in three contexts: compelled speech, speech among commercial entities, and unwanted marketing. In each of those contexts, adopting a listener-oriented approach leads to the conclusion that many forms of commercial speech regulation should receive far less First Amendment scrutiny than …

Encouraging Food Safety Standard Negotiations In The One-Belt-One-Road Initiative, Yi Seul Kim

Cardozo International & Comparative Law Review

Participation and attendance in food safety negotiations such as Codex meetings are of critical importance. Common problems have existed throughout history in the area of food safety standards and their formulation regulations. First, there is a lack of interest by the public. Second, the public becomes interested only after a food safety crisis. Consequences are two-fold: with lack of public interest, governments often do not allocate enough budget and resources. Then, when the government turns to face the problem with a sudden spike in public interest, it is often too late. The situation becomes more of a crisis management, rather …