Judges dismisses cases against Medtronic
Device Regulation Alert: Safety, Compliance and Reimbursement News, January 12, 2009
U.S. District Judge Richard Kyle dismissed dozens of patient lawsuits against Medtronic, saying the claims were preempted by the device’s FDA approval.
In October 2007, the FDA issued a recall of Medtronic’s Sprint Fidelis lead, part of an implantable defibrillator system, because some tended to fracture. Patients filed suits for fraud, negligence, and breach of warranty.
However, in February 2008, the U.S. Supreme Court ruled that medical device makers are immune from liability for personal injuries if their devices passed the FDA’s most stringent pre-marketing review. The plantiffs suing Medtronic claimed the company lost that preemption protection when the leads were recalled. In his decision, Kyle ruled the recall does not deprive Medtronic of its preemption argument and the plaintiffs’ claims are all preempted.
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