October 14, 2010 (Minneapolis, Minnesota) — Medtronic has agreed to pay $268 million to settle the lawsuits precipitated by the 2007 recall of its Sprint Fidelis defibrillator leads .
Medtronic pulled Sprint Fidelis from the market three years ago when it discovered the leads failed in about 2.3% of patients. Data collected after the recall showed a 3.75% annual failure rate, but the company advised patients and doctors not to extract the leads, because the major complication rate with extraction was as high as 7.3%.
Under the agreement announced October 14, Medtronic will pay $268 million to settle over 8100 individual complaints in the US related to the Fidelis failures, and the plaintiffs will terminate their appeals pending before the US Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals. These cases were appealed to that court after a lower court dismissed them on the grounds of federal preemption. The plaintiffs have also agreed to terminate any other Fidelis-related cases throughout the country.
"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 says. The company expects to record the Sprint Fidelis lead litigation settlements as a special charge in its second fiscal quarter ending October 29, 2010.
Heartwire from Medscape © 2010 Medscape, LLC
Cite this: Medtronic Settles Fidelis Suits for $268 Million - Medscape - Oct 14, 2010.