Mass. Federal Medtronic Defibrillator Action Dismissed as Preempted

BOSTON — A Massachusetts federal judge has dismissed a lawsuit alleging injuries caused by a Medtronic defibrillator and associated leads and devices, ruling that the breach of warranty and negligence claims are preempted because they challenge FDA-approved warnings.

In a March 18 order, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts explained that common law actions based on state tort law that requires a device to be safer than the model that the FDA has approved are preempted by the Medical Device Amendments to the Food, Drug and Cosmetic Act pursuant to the U.S. Supreme …