Off-Label Promotion Claims in Opioid Wrongful Death Action Preempted, 11th Cir. Affirms

ATLANTA — Claims accusing Insys Therapeutics Inc. of promoting Subsys for off-label use are preempted by federal law because the plaintiff did not point to any state-law duty that the drug maker breached via its marketing of the opioid, a federal appellate court has affirmed.

In a Dec. 19 opinion, the 11th Circuit U.S. Court of Appeals found the plaintiff’s negligent marketing claim is preempted pursuant to Buckman v. Plaintiffs’ Legal Committee, which provides that any action to enforce the Food, Drug and Cosmetic Act “shall be by and in the name of the United States.”

Carolyn Markland was prescribed …