“A Distinction Without a Difference”?: Bartlett Going Forward

October 1, 2015

This Note addresses the question of whether federal law preempts state design defect claims against generic drug manufacturers regardless of which test state law uses to determine whether a drug is defective. This issue, arising out of the U.S. Supreme Court’s interpretation of preemption jurisprudence and fundamental tort law as stated in Mutual Pharmaceutical Co. v. Bartlett, is significant because it plays a large role in determining to what extent generic drug manufacturers are immune to civil liability arising out of injuries caused by their generic drugs. In an age of rising medical costs and jury awards, both plaintiff and defendant, and the political arena, are considerable stakeholders.

First, this Note provides an overview of the battle over the Food and Drug Administration’s (FDA) regulatory authority, preemption jurisprudence (highlighting physical impossibility preemption), design defect law, and relevant Supreme Court jurisprudence. Second, this Note introduces the conflict among the lower courts as to whether the type of test a jurisdiction uses to determine a product’s defectiveness plays any role in an analysis of applicable FDA regulations’ preemptory effect on state design defect law. Finally, this Note concludes that after Bartlett, so long as state design defect law adheres to strict liability principles, federal law preempts state design defect causes of action against generic drug manufacturers.

October 2015

No. 1