Food and Drug Law Commons^™

A Healthy Diet Of Preemption: The Power Of The Fda And The Battle Over Restricting High Fructose Corn Syrup From Food And Beverages Labeled 'Natural', Adam C. Schlosser

Journal of Food Law & Policy

America is unhealthy. America faces an obesity epidemic. The food consumed by Americans is making them fat. Americans, bombarded every single day by negative headlines like these, are becoming more and more health conscious. This newfound commitment to health is reflected in the food and beverages Americans purchase.

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, …

Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray

Michigan Telecommunications & Technology Law Review

If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …

Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah

Michigan Telecommunications & Technology Law Review

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation …

When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller

Michigan Telecommunications & Technology Law Review

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part II, and offers a …

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 …

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” …

The Fda Preamble: A Backdoor To Federalization Of Prescription Warning Labels?, 41 J. Marshall L. Rev. 161 (2007), Cristina Rodríguez

UIC Law Review

No abstract provided.

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.

The Final Battle For Preemption: The Fda And Prescription Drug Labeling Product Liability Actions, Mary J. Davis

ExpressO

The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In the FDA’s 100 year history, it has not taken the position that federal prescription drug labeling regulations preempt common law tort claims until the last few years, beginning with Motus v. Pfizer in 2002. This position, radical to many and rational to others, places federal preemption of prescription drug …

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

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.

Discovering The Boundaries: Federal Preemption Of Pharmaceutical Labeling Product Liability Actions, Mary J. Davis

ExpressO

Federally approved prescription drug labeling has not been considered conclusive on the reasonableness or adequacy of the label for assessing tort liability on the manufacturer because federal regulations in this field set a minimum standard rather than an optimal one. That fundamental statement of black-letter tort law is under attack. The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In …

Medicaid Third-Party Liability And Claims For Restitution: Defining The Proper Role For The Tort System In Regulating The Food Industry, Coby Warren Logan

Journal of Food Law & Policy

This comment contends that tort liability can complement legislative and administrative government regulation of the food industry, providing sellers and manufacturers of food with an incentive to prevent consumers from over-consumption and becoming obese. Specifically, this comment supports the proposition that after government regulations are promulgated by Congress, claims should be allowed by state attorneys general to recoup Medicaid costs incurred in treating health conditions and illnesses caused by obesity.

Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation medical malpractice and products liability-and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for …

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 Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

George Mason University School of Law Working Papers Series

This paper is a critique of Margaret Berger and Aaron Twerski, “Uncertainty and Informed Choice: Unmasking Daubert”, forthcoming the Michigan Law Review. Berger and Twerski propose that courts recognize a cause of action that would allow plaintiffs who claim injury from pharmaceutical products, but who do not have sufficient evidence to prove causation, to recover damages for deprivation of informed choice. Berger and Twerski claim inspiration from the litigation over allegations that the morning sickness drug Bendectin caused birth defects. Considering the criteria Berger and Twerski suggest for their proposed cause of action in the context of Bendectin, it appears …

Note: A Painful Catch-22: Why Tort Liability For Inadequate Pain Management Will Make For Bad Medicine, James R. Blaufuss

William Mitchell Law Review

Part I of this note reviews current issues relating to pain treatment. Part II examines theoretical justifications of proposed tort liability for inadequate pain management. Part III examines how pain mismanagement does not fit within traditional notions of medical malpractice. Part IV studies the issues relating to a physician’s role as “gate-keeper” for opioids and suggests why tort liability could compromise this legislatively imposed role. Part V examines the issue of pain management in the context of end-of-life care. Part VI discusses current shifts in pain management philosophies and explains how these movements will effectuate the changes suggested by advocates …

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 …

Pharmaceutical Tort Liability: A Justifiable Nemesis To Drug Innovation And Access?, 38 J. Marshall L. Rev. 987 (2005), Paula Jacobi

UIC Law Review

No abstract provided.

Patients Beware: Preemption Of Common Law Claims Under The Medical Device Amendments, 39 J. Marshall L. Rev. 75 (2005), Michael P. Dinatale

UIC Law Review

No abstract provided.

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

Oklahoma Law Review

No abstract provided.

Strictly Speaking About Ephedra: A Baseball Tragedy Helping To Define The Dynamic Between Warning Defect And Design Defect, Michael Kane

Jeffrey S. Moorad Sports Law Journal (1994 - )

No abstract provided.

Weight-Loss Advertising Too Good To Be True: Are Manufacturers Or The Media To Blame?, Jodie Sopher

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Mandatory Recall Authority: A Sensible And Minimalist Approach To Improving Food Safety, Michael T. Roberts

ExpressO

No abstract provided.

State Law Tort Claims And The Fda: Proposing A Consumer-Oriented Prescription In Medical Device Cases, Sasha B. Rieders

Cardozo Law Review

No abstract provided.

Web Of Manipulation: The Learned Intermediary Doctrine And Direct-To-Consumer Advertising On The World Wide Web, 35 J. Marshall L. Rev. 97 (2001), April L. Foreman

UIC Law Review

No abstract provided.

Lindsey V. Tacoma-Pierce County Health Department: Cipollone Revisited, Billboards, State Law Tort Damages Actions, Federal Preemption And The Federal Cigarette Labeling And Advertising Act, Harold C. Reeder

Seattle University Law Review

The Article evaluates Lindsey and other recent cases dealing with local regulations restricting tobacco advertising; it also examines their respective preemption analyses, suggesting that the use of the FCLAA's preemption provision against such regulations is unwarranted. The article argues that in Lindsey, the Ninth Circuit misconstrued the Supreme Court's discussion of the preemptive scope of the FCLAA by failing to read it in the proper contex and that the FCLAA's preemption provision was not intended to prevent the particular types of regulations involved in Lindsey and these other cases. It argues that the preemption provision was only meant to …

Cigar Warnings: Proceed With Caution, 33 J. Marshall L. Rev. 521 (2000), Patricia A. Davidson

UIC Law Review

No abstract provided.