1st Cir. Certifies ‘Adverse Events’ Question to Mass. High Court in Valve Replacement Action

BOSTON — The 1st Circuit U.S. Court of Appeals has asked Massachusetts’ highest court in a case involving a valve replacement device to answer the question of whether a manufacturer's failure to report adverse events to the Food and Drug Administration gives rise to liability under commonwealth law.

In its Jan. 11 request, the appellate panel explained there is “no definitive guidance” on the issue, therefore it requested the Massachusetts Supreme Judicial Court to give “an authoritative answer.”

Allison Plourde, was born in 1991 with an interrupted aortic arch that required surgery when she was two weeks old. She …