Medtronic Pays $268M to Settle Faulty Device Suits
Medtronic, Inc., said Thursday that it has agreed to pay $268 million to settle U.S. lawsuits related to faulty defibrillator wires that may have played a role in 13 deaths.
The settlement involves 8,100 plaintiffs and 3,700 lawsuits relating to Medtronic's Sprint Fidelis family of defibrillation leads, approximately 268,000 of which have been implanted in patients worldwide.
Fridley-based Medtronic recalled the leads in October 2007. At that time, the company said a small number of them could fracture, rendering them useless-or repeatedly deliver an electric shock to users. At the time of the recall, the company cited five deaths that may have been a result of the malfunctioning product.
In total, more than 100 reports have been submitted to the U.S. Food and Drug Administration (FDA) alleging that the heart device wire may have contributed to a patient death. In March 2009, a panel of independent physicians examined the leads on behalf of Medtronic and determined that there were actually 13 patient deaths in which “a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.”
The defibrillator itself is used to treat abnormal heart rhythms that can cause the heart to suddenly stop; the lead is a thin wire that connects the device to the heart. The Sprint Fidelis models in question are 6930, 6931, 6948, and 6949.
In early 2009, a U.S. District Court judge in Minnesota dismissed two lawsuits related to the Sprint Fidelis leads-one multi-district litigation lawsuit on behalf of plaintiffs who claimed to have received faulty defibrillation wires, and another class-action lawsuit on behalf of Medtronic shareholders. In the ruling, the judge said that state lawsuits were overruled by the FDA's federal decision to approve the devices.
Medtronic said in a news release that the parties involved in the lawsuits “will file joint requests to terminate the multi-district litigation and Minnesota state court proceedings related to the Sprint Fidelis leads, and to dismiss the plaintiffs' appeals pending before the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals.” The parties involved in the lawsuits also will request that other Fidelis-related cases throughout the country be dismissed, Medtronic said.
“The settlement is a compromise of disputed claims, and the parties have not admitted any liability or the validity of any defense in the litigation,” Medtronic said in the release.
Medtronic spokesman Christopher Garland said Thursday afternoon that one class-action lawsuit related to the Sprint Fidelis leads is still pending in Canada, but he would not reveal whether the company has plans to settle that suit as well.
Medtronic expects to record the Sprint Fidelis lead settlement as a special charge in its second quarter, which will end October 29. Medtronic is Minnesota's ninth-largest public company based on revenue for the fiscal year that ended in April 2009, which totaled $14.6 billion. The company reported revenue of $15.82 billion for its most recent fiscal year.