Law Commons^™

Safe But Not Wholesome: The Troubling State Of Trans Fat Regulation, Ross Williams

Journal of Food Law & Policy

On March 7, 2007, the New York Times reported that Starbucks, the retail coffee chain which sells millions of baked goods every day from its over 8,700 U.S. stores, had asked its suppliers to eliminate all trans fats from their products by the end of the year. The big story for New York readers, though, was not that Starbucks was requiring the elimination of trans fats from its baked goods. In fact, New York City had just passed an ordinance strictly limiting the use of artificial trans fats, the type present in partially hydrogenated vegetable oil (PHVO), by virtually all …

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

A Corporate Duty To Rescue: Biopharmaceutical Companies And Access To Medications, Rebecca E. Wolitz

Indiana Law Journal

Controversies regarding the pricing of biopharmaceutical products are pervasive. Patients must choose between treatment and rent, prescriptions go unfilled, and health systems are forced to restrict access to life-saving medications— all because of cost. Though there is often consensus that these issues are problematic, there is disagreement as to what are appropriate solutions and who has responsibility to bring about those solutions. Most efforts to address biopharmaceutical pricing concerns focus on governmental regulation. This Article has a different focus. It provides a legal and normative analysis of a form of corporate self-regulation that could help address access and pricing concerns—a …

A Hard Pill To Swallow: Symptoms And Prognosis Of The Drug Manufacturer Preemption Defense In 2018, Brandon Stephens

Touro Law Review

No abstract provided.

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.

Discrimination And Business Regulation, Eileen Kaufman

Touro Law Review

No abstract provided.

"A Distinction Without A Difference"?: Bartlett Going Forward, Steven A. Schwartz

Fordham Law Review

This Note addresses the question of whether federal law preempts state design defect claims against generic drug manufacturers regardless of which test state law uses to determine whether a drug is defective. This issue, arising out of the U.S. Supreme Court's interpretation of preemption jurisprudence and fundamental tort law as stated in Mutual Pharmaceutical Co. v. Bartlett, is significant because it plays a large role in determining to what extent generic drug manufacturers are immune to civil liability arising out of injuries caused by their generic drugs. In an age of rising medical costs and jury awards, both plaintiff …

Check Please: Using Legal Liability To Inform Food Safety Regulation, Alexia Brunet Marks

Publications

Food safety is a hotly debated issue. While food nourishes, sustains, and enriches our lives, it can also kill us. At any given meal, our menu comes from a dozen different sources. Without proper incentives to encourage food safety, microbial pathogens can, and do enter the food source--so much so that according to the Centers for Disease Control and Prevention (CDC), each year roughly one in six Americans (or forty-eight million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. What is the optimal way to prevent unsafe foods from entering the marketplace?

Safety in the food …

Sacrificial Lambs: Compensating First Subscribers To Fda-Approved Medications For Postmarketing Injuries Resulting From Unlabeled Adverse Events, Rodney K. Miller

Catholic University Law Review

No abstract provided.

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Drug-Drug Interaction Alerts: Emphasizing The Evidence, Sharona Hoffman, Andy Podgurski

Faculty Publications

Many analysts and users of contemporary clinical decision support ("CDS") systems have expressed grave concerns about the technology’s efficacy and functionality. Alerts generated by CDS systems are often inaccurate, and an excess of alerts leads some physicians to experience "alert fatigue" and to turn off CDS altogether. This article formulates recommendations to improve drug-drug interaction (DDI) alerts.

The paper comments upon a proposal by Susan Ridgely and Michael Greenberg, who call for the development of a consensus-based "clinically significant drug-drug interaction list" that could generate limited liability protection for users. We argue that instead of creating a list of always-contraindicated …

The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness

Law Faculty Scholarly Articles

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In …

Wyeth V. Levine And Its Implications, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.

After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, …

“There's Danger Here, Cherie!”: Liability For The Promotion And Marketing Of Drugs And Medical Devices For Off-Label Uses, Richard C. Ausness

Law Faculty Scholarly Articles

Physicians often prescribe prescription drugs and other medications for uses that are not approved by the Food and Drug Administration ("FDA"), and such "off label" prescription is widely accepted within the medical community as a legitimate form of treatment. However, the federal government discourages off-label prescription and use in various ways. For example, the FDA restricts the dissemination of information by drug companies about potential off-label therapies. In addition, federally funded health insurance programs such as Medicaid do not reimburse health care providers for off-label uses. Because drug companies make large profits from off-label prescriptions, they are often tempted to …

Fda Regulatory Compliance Reconsidered, Carl W. Tobias

Law Faculty Publications

Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA's regulatory power has expanded systematically, albeit gradually, while legislatures and courts in the fifty American jurisdictions broadened liability exposure for manufacturers that sold defective products that injured consumers. Observers have recently criticized the agency for overseeing pharmaceuticals too leniently, even as states increasingly narrowed manufacturers' liability …

The Battle Over Implied Preemption: Products Liability And The Fda, Mary J. Davis

Law Faculty Scholarly Articles

A mere five years ago, the Food and Drug Administration (the "FDA") began, for the first time in its 100-year history, to take the position that its prescription drug labeling regulations defeated the ability of injured plaintiffs to pursue common law tort claims based on the adequacy of the labeling. This position, radical to many and rational to others, places federal preemption of prescription drug labeling actions directly in the center of the debate over the proper roles of federal regulation and state tort laws in promoting product safety. The U.S. Supreme Court has contributed to this debate with several …

Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann

Law Faculty Articles and Essays

Reprocessing single-use medical devices is a growing but controversial industry subject to an increasingly complex and fast-developing set of regulations and a wide range of unresolved legal issues.

“After You, My Dear Alphonse!”: Should The Courts Defer To The Fda’S New Interpretation Of § 360k(A) Of The Medical Device Amendments?, Richard C. Ausness

Law Faculty Scholarly Articles

Under the provisions of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act certain medical devices are subject to premarket approval of the Food and Drug Administration (FDA). Section 360k(a) of the MDA provides that states may not establish “any requirement” which relates to safety or effectiveness of a medical device and "which is different from, or in addition to" any requirement imposed by the FDA. Until recently, the FDA maintained that § 360k(a) did not preempt most common law tort claims; however, in recent amici briefs, the FDA has aggressively asserted that most, if not all, …

A Prescription For Drug Liability And Regulation, Victor E. Schwartz, Phil Goldberg

Oklahoma Law Review

No abstract provided.

Stomaching The Burden Of Dietary Supplement Safety: The Need To Shift The Burden Of Proof Under The Dietary Supplement Health And Education Act Of 1994, Morgan J. Wais

Seattle University Law Review

This article gives a brief historical perspective on dietary supplement regulation and discusses the evolution of drug regulation by the FDA. Part II concludes with a discussion of the political environment in which these regulations occur. Part III gives examples and show how the current system has caused injury and harm to consumers of dietary supplements. Part IV discusses the current burden of proof and how it was applied in the case of ephedra. Part V discusses how, under the current regulatory structure, consumers cannot be adequately protected, either by the FDA or the tort system. Part VI discusses the …

Panel Remarks On Liability: Liability For Farming?, Rachel G. Lattimore

Richmond Journal of Law & Technology

Good afternoon. To begin, I’d like to thank Ed Wallis and the Richmond Journal of Law & Tech- nology for inviting me to speak on such a distinguished panel. And I’d like to tell you one thing about myself that is not in my fancy lawyer biography. I grew up on a small family farm down in North Caro- lina, so I learned from an early age about the different types of genetic manipulations that go on a farm, from breeding cattle to grafting apple trees, which if you’re fourteen years old, consists of spending your entire Spring Break taking …

Panel Remarks On Liability: Liability For Refusing To Use Agricultural Biotechnology, Drew Kershen

Richmond Journal of Law & Technology

Good afternoon. I’m very pleased to be here. I appreciate the offer and the invitation from the Richmond Journal of Law & Technology to speak at this conference. This final panel is really about liability issues related to genetically modified foods or transgenic crops. Now I just want to quickly introduce these three people, and I’m going to start on my far side with Rachel Lattimore. Rachel Lattimore is a lawyer with the firm of Arent Fox in Washington D.C., and she is going to focus her talk – and we’ve sort of agreed among ourselves so we don’t step …

Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok

Seattle University Law Review

This Comment will explore whether Washington courts should recognize direct-to-consumer advertising as an exception to the learned intermediary rule. With the ultimate goal of advocating the best protection for the consumer, the discussion will suggest that Washington courts should not create an exception. A review of other exceptions to the learned intermediary rule does not support abandoning the doctrine when a drug company advertises its product directly to consumers. Nevertheless, advertising does affect consumer purchases and does influence consumer choices, and drug companies should accept the responsibility to present balanced information. This responsibility should encompass more than meeting the minimum …

Limits On Preemption And Punitive Damages: Can They Be Related?, Peter Zablotsky

Touro Law Review

No abstract provided.

The Preemption Pentad: Federal Preemption Of Products Liability Claims After Medtronic [V. Lohr], Robert B. Leflar, Robert S. Adler

Robert B Leflar

Taking the language of the federal consumer protection statutes out of historical context and inattentive to those laws' original purposes, judges dissatisfied with the expansion of state products liability law have in recent years read preemption provisions of these federal statutes to bar a wide range of claims that would otherwise be viable under state law. In Medtronic v. Lohr, the Supreme Court (per Justice Stevens) severely constrained the scope of the federal preemption defense in the context of the federal medical device law. But the implications of the Medtronic decision for cases involving products in other regulatory categories remain …

Prescription Drug Design Liability Under The Proposed Restatement (Third) Of Torts: A Reporter's Perspective, James A. Henderson Jr.

Cornell Law Faculty Publications

No abstract provided.

Public Accountability And Medical Device Regulation, Robert B. Leflar

Robert B Leflar

In enacting the Medical Device Amendments of 1976, Congress instituted a flexible system of regulatory controls over a vast array of health care products. Analyzing the complex statute and its legislative history, Professor Leflar finds at the law's core a structure designed to ensure the Food and Drug Administration's accountability to the public for its regulatory actions. Reviewing the history of FDA's implementation of the medical device law, however, the author demonstrates that FDA has strayed widely and, he contends, illegally from the congressionally mandated structure of public accountability. In particular, in its review of new-model medical devices in the …

The Intrauterine Device: A Criticism Of Governmental Complaisance And An Analysis Of Manufacturer And Physician Liability, Walter Lee Mccombs, James F. Szaller

Cleveland State Law Review

It is difficult to understand how a product so intimately connected with a bodily function and presenting such a potential for serious harm was allowed on the market without pre-market clearances assuring that it had met at least minimum standards of safety. This development is especially distressing since there exists a governmental agency whose sole function is to protect the public interest in precisely this type of situation. Since the law of products liability should not deny a remedy to the unwary consumer whose reliance on the overzealous representations of the manufacturer ended in tragedy, this note will examine the …

Federal Food, Drug, And Cosmetic Act - 20 Years Of Health Protection, Irvin Kerlan

Cleveland State Law Review

Twenty years of major public health protection have been provided since enactment of the Federal Food, Drug, and Cosmetic Act of 1938. The Food and Drug Administration, a constituent of the United States Department of Health, Education, and Welfare, enforces this Act and thereby carries out the purpose of Congress to insure that foods are safe, pure, and wholesome, and made under sanitary conditions; drugs and therapeutic devices are safe and effective for their intended uses; cosmetics are safe and prepared from appropriate ingredients; and that all of these products are honestly and informatively labeled and packaged. Man and animals …