Minnesota Judge Rules Federal Law Blocks Medtronic Heart Device Suits

October 29, 2009

A Minnesota state court judge has dismissed a batch of lawsuits against Medtronic Inc. stemming from the October 2007 recall of the medical device maker’s Sprint Fidelis defibrillator leads.

Minnesota District Court Judge Denise Reilly last week granted a motion by Medtronic to dismiss 600 separate personal injury claims related to use of the leads, which connect an implantable cardioverter defibrillator to a patient’s heart and are the conduit for the electricity used to shock the heart back into normal rhythm.

The judge ruled the claims are preempted under federal law, according to court papers.

In January, a U.S. district court judge dismissed a group of federal cases consolidated in Minnesota, citing the U.S. Supreme Court’s 2008 Riegel v. Medtronic ruling that reaffirmed the U.S. Food and Drug Administration approval process for determining the safety and effectiveness of medical devices.

A bill pending in Congress, called the Medical Device Safety Act, could repeal the FDA’s preemption authority and nullify the Supreme Court’s Riegel decision if passed.

Medtronic recalled the Sprint Fidelis line of leads in 2007 after several patients died, possibly because their leads had fractured. The Minneapolis-based company, the largest maker of ICDs to treat abnormal heart rhythms, later said as many as 13 deaths may have been linked to the leads.

(Reporting by Susan Kelly, editing by Gerald E. McCormick)

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