Medtronic pulled the leads from shelves worldwide in October 2007, but not before they were implanted in an estimated 268,000 patients. Because of fractures in the wires, defibrillators could either fail to deliver the shock needed to regulate a haywire heartbeat or send unneeded shocks. The defective leads are implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities had the leads as a “possible or likely contributing factor.”
Minnesota District Court Judge Denise Reilly granted the company’s motion to dismiss 600 of the cases filed against Medtronic, ruling that the plaintiffs’ claims are preempted under federal law because the Food & Drug Administration approved the leads.
Reilly’s decision hews to the preemption rule enshrined by the Supreme Court in Riegel vs. Medtronic (PDF). In that case, the Supremes held that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing — in other words, the federal approval preempts state law.
The action in Minnesota state court follows a similar move by Judge Richard Kyle of the U.S. District Court for Minnesota, who in January dismissed the consolidated federal litigation against Medtronic over the defective leads.