U.S. Supreme Court

Case Status


Docket Number


Cert. Denied


Questions Presented

Whether the Massachusetts Supreme Judicial Court erred when it held, in direct conflict with the Seventh Circuit, that FDA’s rejection of warning language proposed in a Citizen Petition is not “clear evidence” sufficient to preempt state tort claims that the manufacturer was obligated to add the FDA rejected language to its drug’s labeling.

Case Updates

Cert. petition denied

January 19, 2016

U.S. Chamber files amicus brief

November 09, 2015

The U.S. Chamber filed an amicus brief in support of a petition for writ of certiorari to review a Massachusetts Supreme Judicial Court decision, which held that the Food Drug & Cosmetic Act did not preempt tort claims based on allegations that the labeling for Children’s Motrin carried insufficient warning regarding the risk of a rare side effect. The decision refused to find preemption even though the FDA had rejected the same warnings that plaintiffs alleged should have been included, reasoning that the FDA might have reached a different conclusion if the warnings had been proposed separately by the manufacturer, rather than in a petition by third parties.

The Chamber’s brief argues that the Supreme Judicial Court’s decision was premised on an implausibly narrow reading of the “clear evidence” preemption standard in Wyeth v. Levine, would undermine the federal drug labeling regime, and would invite abusive lawsuits.

Bert W. Rein and Karyn K. Ablin of Wiley Rein LLP served as co-counsel for the U.S. Chamber of Commerce on behalf of the U.S. Chamber Litigation Center.

Case Documents