Claims Targeting Sorin Group’s Valve Replacement Preempted, Mass. Federal Judge Rules

BOSTON — A Massachusetts federal judge has awarded Sorin Group summary judgment in a lawsuit targeting its Mitroflow valve replacement, ruling that the claims are preempted because federal law does not require manufacturers to provide the FDA with adverse event reports.

In a Feb. 5 order, Judge Allison D. Burroughs of the U.S. District Court for the District of Massachusetts found that a duty to warn doctors under the learned intermediary doctrine does not correspondingly impose a duty to report to the FDA.

The Mitroflow, a piece of bovine pericardium sewn onto a polyester stent, is intended to “replace …