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 …

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 …

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.

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 …

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

Cardozo Law Review

No abstract provided.

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 …

Administering Health Innovation, Rachel E. Sachs

Cardozo Law Review

Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the expertise of agencies like the National Institutes of Health, Food and Drug Administration, and Centers for Medicare and Medicaid Services has expanded the range of tools contemplated by scholars who had previously focused largely on the United States Patent and Trademark Office.

Yet much of this attention has so far focused on the capacities of single agencies, acting alone. This Article expands the existing scholarly …

The Antitrust Duty To Charge Low Prices, Ramsi A. Woodcock

Cardozo Law Review

Over the past forty years, antitrust has come to embrace a goal of consumer welfare maximization that cannot be achieved solely through condemnation of collusive or exclusionary conduct. To address cases in which firms achieve the power to raise prices and harm consumers without engaging in collusive or exclusionary conduct, antitrust should impose a general duty on businesses to charge a price no higher than economic cost. Courts would not need to set prices to enforce this duty, because violations would be punishable only by nominal damages, and shame, rather than by an injunction setting a reasonable price. Although the …

How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis

Cardozo Law Review

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention. I term this method of regulation "subterranean …

From Pay-For-Delay To Product Hopping: The Limited Utility Of Antitrust Law In The Pharmaceutical Industry, Joseph Fielding

Cardozo Law Review

The note examines the intersection of patent law and antitrust policy, particularly in the context of pharmaceutical drug competition. It argues that while antitrust enforcement is an effective solution to address "pay-for-delay" agreements, it is less suitable for resolving "product-hopping" issues. Instead, the article contends that closing regulatory loopholes in the Hatch-Waxman framework would be a more effective approach to curbing anticompetitive product-hopping practices. The analysis focuses on two key cases—Federal Trade Commission v. Actavis, Inc. and Schneiderman v. Actavis LLC—to illustrate the legal and economic implications of these strategies.

Up In Smoke? Unintended Consequences Of Retail Marijuana Laws For Partnerships, Lauren A. Newell

Cardozo Law Review

The article examines the legal challenges faced by partnerships in Colorado's retail marijuana industry due to the conflict between state and federal laws. While Colorado has legalized marijuana, federal law continues to classify it as illegal, creating uncertainty and risks for partnerships operating in this sector. The illegal purpose doctrine and preemption issues further complicate the legal landscape, threatening the validity and protections of such partnerships. The analysis highlights the need for legislative or judicial solutions to address these conflicts and provide clarity for businesses.

Keeping It In The Kitchen: An Analysis Of Intellectual Property Protection Through Trade Secrets In The Restaurant Industry, Sarah Segal

Cardozo Law Review

No abstract provided.

Taxing Legalized Marijuana: How Courts Should Treat Drug Tax Statutes In Light Of The Fifth Amendment's Self-Incrimination Clause And Executive Non-Enforcement Of The Controlled Substances Act, Joseph A. Goldstein

Cardozo Law Review

No abstract provided.

Side Effects: State Anti-Fraud Statutes, Off-Label Marketing, And The Solvable Challenge Of Causation, Isaac D. Buck

Cardozo Law Review

While the American public remains preoccupied with the lurching implementation of the Affordable Care Act, the regulation of pharmaceutical companies for their off-label marketing and promotion of drugs features a regulatory environment within the health industry that seems to be in wild flux. Following the Second Circuit's decision in United States v. Caronia, commentators and providers are unsure about the future of federal regulation in this area, with the FDA seeking to minimize the opinion and pharmaceutical companies celebrating its impact. Much of the understandably spirited reaction to the Caronia case has omitted a discussion of the relevant and …

Depressing Diagnosis: Stringent Particularity Requirement Of The Rule 9(B) Pleading Standard As A Critical Bar To Off-Label Promotion Fraud Whistleblowers, Emily T. Chen

Cardozo Law Review

No abstract provided.

Unequal Protection Under The Law: Why Fda Should Use Negotiated Rulemaking To Reform The Regulation Of Generic Drugs, Marie Boyd

Cardozo Law Review

The duty to ensure the safety of drug products, through adequate warnings or other means, should ultimately rest with the drug's manufacturer regardless of whether the drug is a generic drug or a brand-name drug. Recent U.S. Supreme Court holdings, however, suggest that while the manufacturer of a brand-name drug is always responsible for its label's content, this is not the case for generic drugs. In addition, by holding that failure-to-warn claims against generic drug manufacturers based on state law are preempted, the Court has removed the protections and compensation that state tort law can provide consumers of generic drugs …

High Federalism: Marijuana Legalization And The Limits Of Federal Power To Regulate States, David S. Schwartz

Cardozo Law Review

The conflict between state marijuana legalization and the blanket federal marijuana prohibition of the Controlled Substances Act (CSA) has created a federalism crisis in which the duties of state officials to adhere to state or federal law are unclear. Current federalism doctrine cannot even tell us whether or not a local police officer who encounters a person in state-authorized possession of marijuana must arrest the person and seize the marijuana. The two most clearly applicable federalism doctrines - the Tenth Amendment anti-commmandeering doctrine and federal preemption of state law under the Supremacy Clause - offer only unsatisfactory answers. Anti-commandeering doctrine …

Citizen Petitions: An Empirical Study, Michael A. Carrier, Daryl Wander

Cardozo Law Review

In recent years, brand-name drug companies have engaged in an array of conduct that has delayed generic competition. While some of the activity - such as settlements between brand and generic firms and "product hopping" from one drug version to another - has received attention, another behavior has, until now, flown under the radar.

This Article examines the activity of "citizen petitions." A citizen petition is a request for the U.S. Food and Drug Administration (FDA) to take an action such as evaluating a drug's safety or effectiveness. When used appropriately, it could raise awareness of legitimate concerns with a …

Doctors, Patients, And Pills - A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Cardozo Law Review

This Article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century; and regulatory necessity due to the limits of science and the innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based on genetic expression). Although both factors have changed immensely, the standard for drug approval …

Voices From The Field: An Inter-Professional Approach To Managing Critical Information

Cardozo Law Review

No abstract provided.

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Cardozo Law Review

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness.

Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories and provides an early empirical test of these models using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models and …

Publicity, Pressure, And Environmental Legislation: The Untold Story Of Availability Campaigns, Molly J. Walker Wilson, Megan P. Fuchs

Cardozo Law Review

The availability heuristic - a cognitive rule of thumb whereby events that are easily brought to mind are judged to be more likely - is employed by decision-makers on a daily basis. Availability campaigns occur when individuals and groups strategically exploit this cognitive tendency in order to generate publicity for a particular issue, creating pressure to effect legislative change. This paper is the first to argue that environmental availability campaigns are more beneficial than they are harmful. Because they result in pressure on Congress, these campaigns serve as a catalyst for the enactment of critical new legislative initiatives. Specifically, these …

Criminal Responsibility And The Disappearing Person, Stephen J. Morse

Cardozo Law Review

No abstract provided.

Furthering Consumer Safety Of Medical Devices: The Necessity Of A Device-Specific State Law As Required For Express Preemption Under The Mda, Rachel Mervis

Cardozo Law Review

No abstract provided.

Breaking The Shield Of The Learned Intermediary Doctrine: Placing The Blame Where It Belongs, Sheryl Calabro

Cardozo Law Review

No abstract provided.