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Full-Text Articles in Law
Safe But Not Wholesome: The Troubling State Of Trans Fat Regulation, Ross Williams
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 …
The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey
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
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
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
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
Discrimination And Business Regulation, Eileen Kaufman
Touro Law Review
No abstract provided.
"A Distinction Without A Difference"?: Bartlett Going Forward, Steven A. Schwartz
"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 …
Sacrificial Lambs: Compensating First Subscribers To Fda-Approved Medications For Postmarketing Injuries Resulting From Unlabeled Adverse Events, Rodney K. Miller
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
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.
A Prescription For Drug Liability And Regulation, Victor E. Schwartz, Phil Goldberg
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
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
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
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
Limits On Preemption And Punitive Damages: Can They Be Related?, Peter Zablotsky
Touro Law Review
No abstract provided.
The Intrauterine Device: A Criticism Of Governmental Complaisance And An Analysis Of Manufacturer And Physician Liability, Walter Lee Mccombs, James F. Szaller
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
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 …