Medtronic Inc., the world’s largest maker of heart devices, has agreed to pay $268 million to settle lawsuits over claims that fractured wires in a line of its cardiac defibrillators caused at least 13 deaths. The company is resolving claims that wires connecting implantable Sprint Fidelis defibrillators to patients’ hearts were defective. Medtronic halted sales of the so-called defibrillator leads in October 2007 after they were linked to users’ deaths.
The settlement covers about 8,100 cases or “virtually all” U.S. claims, Garland said. The settlement resolves cases in both federal and state courts. It will provide an average payout of more than $33,000 to patients who have defibrillators with wires that have broken or are considered likely to break. The amount will depend on the extent of the injuries and defects. Medtronic had more than 50% of the $5.8 billion global market for defibrillators before sales of the leads were halted. The wires deliver electrical jolts from the stopwatch-size defibrillators to regulate faltering heartbeats. About 268,000 patients had the targeted leads at one time, according to the company. They were introduced in 2004, the officials said. The company estimates that 170,000 people worldwide still have defibrillators with the Sprint Fidelis leads inside them.
The fractures were caused by poor welding and quality control at Medtronic’s manufacturing facility in Puerto Rico. Patients also alleged the wires were defectively designed. Medtronic acknowledged in March 2009 that the flawed wires “may have been a possible or likely contributing factor” in 13 deaths. U.S. District Judge Richard H. Kyle in Minnesota, who is overseeing all suits over the heart wires filed in federal courts around the U.S., dismissed those cases in January 2009 after finding they were preempted by federal law. The ruling was being reviewed by a federal appeals court in St. Louis when the settlement was reached. The settlement over the Sprint Fidelis defibrillators is the second such resolution over a line of the Medtronic’s heart devices. The company agreed in 2007 to pay more than $114 million to settle lawsuits over its Marquis line of defibrillators.
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