In the recent landmark decision in Wyeth v. Levine, the Supreme Court put drug manufacturers on notice that they can and should be liable for state tort claims for the harm their products cause regardless of Federal Drug Administration ("FDA") approval of the drug's use and warning labels. Part II of this paper analyzes the history and background of federal preemption to give context to the current environment after Wyeth. Part III analyzes the Supreme Court's decision in Wyeth, holding that the FDCA and corresponding regulations do not preempt state tort claims. Finally, Part IV discusses and analyzes what drug makers may do now to continue to produce and market pharmaceuticals profitably while limiting their liability for state tort claims.
Wyeth v. Levine: What Does It Mean and Where Do Pharmaceutical Companies Go from Here,
Rich. J. L. & Pub. Int.
Available at: https://scholarship.richmond.edu/pilr/vol13/iss2/4