Janssen Pharmaceuticals, Inc. v. A.Y.

U.S. Supreme Court

Question(s) Presented

Whether federal law preempts state-law claims that a manufacturer failed to provide adequate warnings relating to the off-label use of their products, where federal law bars the manufacturer from unilaterally altering its labeling to provide such warnings.

Tab Group

Petition Stage

U.S. Chamber files coalition amicus brief urging U.S. Supreme Court to grant review in FDA preemption case

March 8, 2021

Click here to view the coalition brief filed by the U.S. Chamber, Pharmaceutical Research and Manufacturers of America, and American Tort Reform Association. The brief argues that federal law preempts state-law claims alleging that a drug manufacturer failed to warn of risks associated with off-label uses. Michael X. Imbroscio and Paul W. Schmidt of Covington & Burling LLP and the U.S. Chamber’s Litigation Center served as co-counsel for the U.S. Chamber.

Case Documents

Opinion -- Janssen Pharmaceuticals, Inc. v. A.Y. (Superior Court of Pennsylvania).pdf

U.S. Chamber Coalition Amicus Brief -- Janssen Pharmaceuticals, Inc. v. A.Y. (U.S. Supreme Court).pdf