Goldberg and Gramling: Pharmaceutical Preemption Defense Demanding But Attainable

A 2009 U.S. Supreme Court ruling prompted widespread confusion as to when the U.S. Food and Drug Administration’s (FDA) approval of drug labeling would preempt state failure-to-warn claims against drug makers, but a 2019 ruling helped fill in the gaps, according to Shook Public Policy Practice Group Co-Chair Phil Goldberg and Partner Christopher Gramling.

In a Legal Opinion Letter for the Washington Legal Foundation titled "A Prescription for Pharmaceutical Preemption,” Goldberg and Gramling discuss the 2019 case—Merck Sharp & Dohme Corp. v. Albrecht—and the body of case law that has followed, providing a guide for drug makers on how to navigate a preemption defense. 

“These cases revealed that, although preemption is a demanding defense, it is certainly attainable,” they said. “Further, the courts did not establish bright-line rules for when preemption exists. Each drug’s story is different, and the trial judges dove into the substance of the cases to determine whether preemption was appropriate based on the facts, medical science, and circumstances of the specific drug at issue.”

Read the Legal Opinion Letter at the Washington Legal Foundation >>