Medtronic To Pay $268M To Settle 3,700 Claims Involving Sprint Fidelis Leads

MINNEAPOLIS -- (Mealey's) Medtronic Inc. on Oct. 14 said it has agreed to pay $268 million to settle about 3,700 lawsuits and claims in the United States related to the recall of its Sprint Fidelis implantable cardiac defibrillator leads. In its most recent Form 10-Q report filed with the U.S...

Split 8th Circuit Panel Affirms Sprint Fidelis Preemption Ruling

ST. LOUIS - A day after the parties announced a $268 million settlement and an end to the appeal, a split panel of the Eighth Circuit U.S. Court of Appeals on Oct. 15 affirmed that the plaintiffs' claims involving the Medtronic Sprint Fidelis heart device leads are preempted and that the plaintiffs...

Medtronic Escapes Fraud Claims In Off-Label Stent Litigation

BOSTON - (Mealey's) Finding that two whistle-blowers' False Claims Act (FCA) allegations failed to meet federal pleading requirements for fraud, a Massachusetts federal judge on July 27 dismissed claims that Medtronic Inc. promoted biliary stents for off-label use ( United States of America,...

Drug Pump Claims Preempted Expressly, Implicitly, 9th Circuit Panel Majority Says

SAN FRANCISCO - (Mealey's) In a 2-1 ruling, a panel of the Ninth Circuit U.S. Court of Appeals said April 16 that claims that a Medtronic drug pump and spine catheter caused a plaintiff to become a paraplegic are preempted explicitly and implicitly by federal medical device law and by U.S. Supreme...

Supreme Court Grants Certiorari In Dispute Over Cardiac Device Patents

WASHINGTON, D.C. - (Mealey's) The question of whether a patent licensee bears the burden of proving that its products do not infringe in a declaratory judgment action filed pursuant to MedImmune Inc. v. Genentech Inc. (549 U.S. 118, 137 [2007]) will be decided by the U.S. Supreme Court, which on...

U.S. Supreme Court Won’t Hear Drug Pump Adverse Event Preemption Case

WASHINGTON, D.C. — (Mealey’s) The U.S. Supreme Court on June 23 let stand a federal appeals court ruling that there is no preemption of a claim that medical device manufacturer Medtronic Inc. violated its duty under federal law to report adverse events to the Food and Drug Administration...