Judge Dismisses Lawsuits Against Medtronic

By Irene Collins
23:01, January 6th 2009
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Judge Dismisses Lawsuits Against Medtronic

A federal judge in St. Paul has dismissed dozens of patient lawsuits against Fridley-based Medtronic in connection with a recall of the company's Sprint Fidelis defibrillator leads in 2007. The ruling comes on the heels of the controversial February 2008 decision by the Supreme Court, which said victims of defective medical devices are barred from seeking damages in state courts once the device has been approved by the U.S. Food and Drug Administration.

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. Defibrillators are implanted devices that can shock failing hearts back into rhythm.

Medtronic recalled the Sprint Fidelis leads in October 2007, after it was found the wires had a tendency to break and may have contributed to five patient deaths and scores of injuries. But now it seems that heart patients who relied on the FDA to ensure the safety of their heart defibrillators were let down and left without legal rights to seek financial damages.

"This 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," Bill Hawkins, the company's chief executive officer, said in a release.

The court also issued a companion order that each case be dismissed with prejudice unless an individual plaintiff can establish his or her case survives the court's preemption analysis based on claims different from those that plaintiffs already have asserted. “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," Judge Richard Kyle said.
 



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