Open Access. Powered by Scholars. Published by Universities.®
- Institution
- Publication
- Publication Type
Articles 1 - 7 of 7
Full-Text Articles in Entire DC Network
Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen
Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen
Articles
In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …
The Recent Enactment Of National Mandatory Gmo Labeling Law: Superior To A Voluntary Labeling Scheme But Unlikely To End The Labeling Controversy, Nan Feng
Seattle University Law Review
Part I of this Note provides background information about the major controversies related to GM foods, including the debate about whether such foods should be labeled, and the history of GMO labeling laws in the United States. Part II compares S. 764 with H.R. 1599 and explains why a national mandatory labeling approach is superior to the voluntary labeling approach advocated by the House. Part III discusses the potential drawbacks and effect of S. 764 and finally concludes that the rulemaking process that will follow may create controversies and litigation.
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
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.
Thoughts On Preemption In The Wake Of The Levine Decision, Erika Fisher Lietzan, Sarah E. Pitlyk
Thoughts On Preemption In The Wake Of The Levine Decision, Erika Fisher Lietzan, Sarah E. Pitlyk
Journal of Health Care Law and Policy
No abstract provided.
Weiland V. Telectronics Pacing Systems, Inc.: Illinois Reexamines Medical Device Preemption, Adrian S. Allen
Weiland V. Telectronics Pacing Systems, Inc.: Illinois Reexamines Medical Device Preemption, Adrian S. Allen
Indiana Law Journal
No abstract provided.
The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox
The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox
University of Michigan Journal of Law Reform
This Note argues that courts should impose a due diligence requirement on plaintiffs as a prerequisite to the use of market share theory. Part I examines traditional products liability theories along with alternative theories and explains the relationship of due diligence to market share theory. Part II argues that due diligence should be a prerequisite to market share liability. Part III discusses the nature of due diligence in this context. Finally, Part IV considers various objections to a due diligence requirement and argues that they are essentially without merit.