The U.S. Supreme Court has issued several consequential decisions over the past 15 years setting guidelines for when federal regulations over prescription drug warnings preempt state failure-to-warn claims. Shook Partners Phil Goldberg, who co-chairs the firm’s Public Policy Group, and Chris Gramling, working with Associate Sarah O’Rourke, explore these cases in an article published in the Rutgers Journal of Law & Public Policy.
The article, titled “A Prescription for Pharmaceutical Preemption,” was published in the Fall 2022-Spring 2023 issue. It examines key cases from the Supreme Court—Wyeth v. Levine and Merck Sharp & Dohme Corp. v. Albrecht—and subsequent judicial rulings applying them to assist courts and counsel in their preemption analyses. Drug & Device Law said the article “contains sober legal analysis, clear thinking, and realism.”
Goldberg, Gramling and O’Rourke conclude that judges are finding for preemption when warranted based on in-depth assessments of the substance and science, “not a formalistic adherence to process or a battling of expert testimonies to lay juries.”
“By following these guideposts, district judges have been issuing thoughtful and thorough analyses of what the manufacturers and FDA knew, when they knew it, what they did with that knowledge, and, ultimately, what the FDA decided was the proper public health decision with regard to the drug’s labeling,” they said. “There is no doubt that a preemption remains a demanding defense, but it is also attainable.”