Judge dismisses suits over Fidelis lead

  • Article by: JANET MOORE , Star Tribune
  • Updated: January 6, 2009 - 10:52 PM

The federal court said it was not the place for providing a remedy for hundreds of patients who claim they were injured by the defective Medtronic heart product.

Citing a recent U.S. Supreme Court decision, a federal judge in St. Paul on Monday dismissed a series of lawsuits filed by hundreds of patients who claimed they were injured by a heart device made by Medtronic Inc.

The patients were implanted with a lead, or insulated wire, used in an implantable cardioverter defibrillator system made by the Fridley-based medical technology company.

In October 2007, the Sprint Fidelis lead was recalled by the Food and Drug Administration (FDA) because some fractured, causing painful electrical shocks. At the time, Medtronic said five deaths were linked to defective devices, but the company said Tuesday it has been unable to determine the exact number of deaths. At the time of the recall, more than 257,000 patients had received the potentially defective product.

Shortly afterward, aggrieved patients across the country began filing lawsuits against the company alleging negligence, fraud, breach of warranties, and other claims.

As of late November, about 930 Fidelis-related lawsuits had been filed against Medtronic, representing about 1,450 individual personal injury cases, according to company spokesman Christopher Garland.

'Court is not unsympathetic'

In February, the U.S. Supreme Court ruled that if federal regulators approved a medical device, then product liability lawsuits could not be filed under state law, a legal doctrine known as preemption.

On Monday, Judge Richard Kyle granted Medtronic's motion to dismiss cases consolidated in U.S. District Court in St. Paul. About 235 cases still are pending in Hennepin County District Court, Garland said.

In his ruling Monday, Kyle wrote: "The court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight." But "the court simply cannot provide a remedy."

Daniel Gustafson, a Minneapolis attorney and lead counsel in the consolidated federal cases, said Tuesday the ruling "is very frustrating for people hurt by this product." The judge interpreted the Supreme Court ruling "too broadly," he said.

In a statement, Medtronic CEO Bill Hawkins said the decision supports the principle that the FDA "is the appropriate body to determine the safety and efficacy of innovative technologies."

Janet Moore • 612-673-7752

  • get related content delivered to your inbox

  • manage my email subscriptions





Connect with twitterConnect with facebookConnect with Google+Connect with PinterestConnect with PinterestConnect with RssfeedConnect with email newsletters