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Full-Text Articles in Law
Meeting The Objectives Of The Mda: Implied Preemption Of State Tort Claims By The Medical Device Amendments, Theresa J. Pulley Radwan
Meeting The Objectives Of The Mda: Implied Preemption Of State Tort Claims By The Medical Device Amendments, Theresa J. Pulley Radwan
Journal of Law and Health
This article attempts to reconcile the competing purposes of the MDA, and to offer one alternative to effectuate Congress' purposes without preempting some claims and permitting others. First, this article will describe the arrangement of the MDA, including the classification provisions for medical devices and the preemption provision of the MDA. Next, this article will interpret the caselaw regarding preemption in general, and specifically preemption of state tort claims by the MDA. Finally, this article seeks to reconcile two competing purposes of Congress in enacting the MDA through implied preemption of state tort claims, with exceptions for devices which have …
The Politics Of Reducing Tobacco Use Among Children And Adolescents: Why The Food And Drug Administration Cannot Regulate Tobacco And A Proposed Policy For States And Local Communities, Timothy J. Degeeter
The Politics Of Reducing Tobacco Use Among Children And Adolescents: Why The Food And Drug Administration Cannot Regulate Tobacco And A Proposed Policy For States And Local Communities, Timothy J. Degeeter
Journal of Law and Health
This paper will reveal that although the FDA has a compelling argument from a public health point of view to regulate tobacco products, the proposed federal rule is beyond the scope of the FDA's authority. The FDA cannot unilaterally assert jurisdiction over tobacco products in order to implement restrictions for children and adolescents without specific Congressional action. Instead, Congress has specifically delegated such regulatory authority to the states. Moreover, the proposed rule lacks necessary enforcement mechanisms to adequately keep tobacco products out of the hands of children and adolescents.
Medtronic V. Lohr: State Lawsuits May Proceed Against Medical Device Manufacturers, Robert A. Gerberry
Medtronic V. Lohr: State Lawsuits May Proceed Against Medical Device Manufacturers, Robert A. Gerberry
Journal of Law and Health
This comment discusses the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act and its effect on the marketing of medical products. Part II examines the statutory language of the MDA and its regulatory impact on medical devices. Part III explores the history of the preemption doctrine established by the Supreme Court Cipollone. Part IV delineates the facts and procedural history of Medtronic v. Lohr and analyzes the effect of this case on the federal preemption of state common law suits. Finally, Part V assesses the impact of this decision on the medical device industry and the expansiveness …