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 of the preemption doctrine.
Note, Medtronic v. Lohr: State Lawsuits May Proceed against Medical Device Manufacturers, 11 J.L. & Health 221 (1996-1997)