This article begins with a brief recap of the state of current preemption doctrine and how it governs the interaction of federal regulation of product manufacturers and state tort actions related to the actions of those manufacturers. Second, the article provides observations on how that doctrine might apply to vaccine injury litigation. Bruesewitz v. Wyeth, Inc. involves the preemptive scope of the Vaccine Act and the unique compensation system Congress created to respond to vaccine injuries. Bruesewitz was decided on February 22, 2011, and held that design defect claims are expressly preempted by the Vaccine Act. This article endeavors to explain Bruesewitz in the context of express preemption doctrine generally. This article also provides observations on the continuing value of state tort law in the assessment of unreasonable risk. Finally, comments in response to Judge Calabresi's framing question, asking how to address the uncertainty inherent in acquisition of risk information, will build on the preemption analysis from Bruesewitz to encourage a narrow application of the scope of preemption doctrine particularly in the case of pharmaceuticals and medical devices.
Mary J. Davis, The Case Against Preemption: Vaccines & Uncertainty, 8 Ind. Health L. Rev. 293 (2011).