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Citing a recent U.S. Supreme Court decision, a federal judge in St. Paul on Monday dismissed dozens of lawsuits filed by patients who claimed they were injured by a heart device made by Medtronic Inc.
The patients were implanted with an electrical lead used in a defibrillator system known as Sprint Fidelis made by the Fridley-based medical technology company.
In October 2007, Medtronic's popular Sprint Fidelis lead was recalled by the Food and Drug Administration (FDA), because some had a tendency to fracture.
At the time of the recall more than 257,000 patients were implanted with the potentially defective product.
Shortly after the recall, aggrieved patients across the country began filing lawsuits against the company alleging negligence, fraud, and breach of warranties, and other claims.
In February, a Judicial Panel on Multidistrict Litigation consolidated 27 of those actions into one case in U.S. District Court in Minneapolis. Scores of other cases were later transferred into the case as well.
Also that month, the U.S. Supreme Court ruled that if federal regulators approved a medical device -- in this case, the FDA -- then product liability lawsuits could not be filed under state law, a legal doctrine known as preemption.
The Fidelis lead is part of an implantable cardioverter defibrillator, a stopwatch-sized device implanted in the chest that shocks an errantly beating heart back into rhythm. The device is connected to the heart by an insulated wire, or lead.
In his ruling Monday, U.S. District Judge Richard 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 plaintiffs assert claims for which the court simply cannot provide a remedy."
In a statement, Medtronic CEO Bill Hawkins said the decision "supports the principle that the U.S. Food and Drug Administration is the appropriate body to determine the safety and efficacy of innovative technologies."
Janet Moore • 612-673-7752