The Wall Street Journal (1/7, Burton) reports, "A federal judge threw out lawsuits on behalf of thousands of patients with heart-defibrillator wires...concluding that a recent Supreme Court opinion made the dismissals inevitable." Citing a ruling "that federal law 'pre-empts' product-liability lawsuits under state law," U.S. District Judge Richard H. Kyle dismissed lawsuits alleging that Medtronic's Sprint Fidelis defibrillator lead caused patients to die. The lead "had been surgically implanted in 268,000 patients world-wide when" Medtronic "concluded it was fracturing at a higher rate than that of its more robust predecessor, the Sprint Quattro." Patients whose wires fractured died either "because the defibrillator failed to dispatch electrical therapy to the heart or because the massive and multiple shocks may have caused patients' hearts to stop."
The "Food and Drug Administration (FDA) approved new wiring for the company's defibrillators" in December 2007, which Judge Kyle ruled "protects the makers from lawsuit," the AP (1/7) adds. Medtronic stated that "the decision was consistent with a Supreme Court ruling" in favor of the company last year. In that suit, Medtronic was "sued because a patient suffered from a burst balloon catheter during an angioplasty procedure." The court decided that "the plaintiffs' claims were pre-empted because the FDA had approved the catheter."
Commenting on Judge Kyle's ruling, 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," Minnesota's Star Tribune (1/7, Moore) notes. The Wall Street Journal (1/6, Goldstein) Health Blog also covered the story.
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