Schwartz and Goldberg Discuss Sixth Circuit Ruling on Preemption for Branded Drug Companies

Shook, Hardy & Bacon Public Policy Partners Victor Schwartz and Phil Goldberg have authored a Product Liability Law & Strategy article countering the myth that "federal drug law preempts product liability suits against generic drug companies, but not brand name manufacturers." Titled "Ending the Myth That Branded Drug Companies Cannot Benefit from Preemption; The Sixth Circuit Properly Holds That the Doctrine Bars a Design Claim," the article explains that preemption applies "when it would be impossible for a prescription drug manufacturer to comply with both the FDA's [Food and Drug Administration's] requirements and what a plaintiff's lawyer alleges as its duty under tort law… It does not matter whether the defendant made a generic or a brand-name name drug."

Discussing  Yates v. Ortho-McNeil-Janssen, No.15-31049 (6th Cir. Dec 11, 2015), the article finds that the Sixth Circuit's ruling clarifies the doctrine derived from three U.S. Supreme Court cases addressing warning defect and design defect claims. "In Yates, the Sixth Circuit became the first federal appellate court to apply the U.S. Supreme Court's impossibility preemption analysis from Levine, Mensing and Bartlett to a design defect claim against the manufacturer of a brand-name drug," note Schwartz and Goldberg. "The court dismissed the design defect claim under the impossibility preemption doctrine, stating that the manufacturer of branded drugs cannot change a drug's formula without FDA's pre-approval."


As the Sixth Circuit recognized, federal preemption supersedes state tort law when it is impossible to comply with obligations under both federal regulatory law and a finding of defect under state product liability law. It does not matter whether the manufacturer sells branded or generic drugs. Whether in federal or state court, judges can and should employ the sound reasoning in Yates.