STORY FROM: Drugs & Medical Devices

Warning Claims Based on Failure to Timely File Adverse Event Reports Dismissed in Sprint Fidelis Action

FORT WAYNE, Ind. — An Indiana federal judge has dismissed for lack of causation a plaintiff’s failure-to-warn claims that are based upon Medtronic’s alleged failure to timely provide the FDA with adverse event reports regarding its Sprint Fidelis Defibrillator Lead.

In a May 5 order issued in response to Medtronic’s motion for reconsideration, Judge Robert L. Miller Jr. of the U.S. District Court for the Northern District of Indiana found the plaintiff failed to show how Medtronic’s alleged delay in filing the reports caused or contributed to his injuries.

In November 2010, Ronald McAfee experienced shocks in his ...

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