Claims of Failure to Warn the FDA Not Preempted, Ind. Federal Judge Rules in Sprint Fidelis Lead Case

FORT WAYNE, Ind. — Claims based upon Medtronic’s failure to provide the FDA with adverse event reports regarding its Sprint Fidelis Defibrillator Lead are not federally preempted because they parallel federal requirements, an Indiana federal judge has ruled.

In a June 4 order, Judge Robert L. Miller Jr. of the U.S. District Court for the Northern District of Indiana explained that under state law, the duty to warn extends to third parties like the FDA and, as such, the claims do not add to federal requirements.

In November 2010, Ronald McAfee experienced shocks in his chest, was hospitalized, and had …