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Dismissal of Medtronic Defibrillator Cases Leaves Thousands Injured without Justice
AAJ Urges Swift Passage of Medical Device Safety Act as Court Looks to Congress to Restore Consumers’ Rights
Judge Says Remedy Lies with Congress, Not Court
Washington, DC— Last week’s dismissal of cases involving a recalled, faulty medical device leaves thousands of people injured and unable to get justice, according to the American Association for Justice (AAJ). AAJ calls on Congress to act swiftly in light of U.S. District Judge Richard Kyle’s opinion which cites Congressional action as the only way for those injured to receive justice.
“The recent denial of justice to thousands of injured people shows how imperative it is that Congress act quickly,” said Les Weisbrod, President for AAJ. “Judge Kyle’s opinion directly states that only Congress can fix this issue.”
The case involves over a 1,400 individuals with heart defibrillators that are attached by defective Medtronic leads. The leads, the part of the defibrillator that attaches the device to the heart, have been known to malfunction and send repeated shocks to patients, sometimes for hours, often leaving patients debilitated until the device can be disabled. The leads were recalled in October 2007 after Medtronic filed 120 reports of problems with the FDA. This was seven months after Medtronic was informed that patients were experiencing problems with the leads.
Judge Kyle dismissed the case arguing that approval of the defibrillator leads by the FDA prevents the court from acting, citing the Supreme Court case Riegel v. Medtronic. In that ruling, the Supreme Court opinion stated Congress decided to limit medical device manufacturers’ liability in the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act.
Senator Kennedy and other Members of Congress disagree with the U.S. Supreme Court’s assessment of the Medical Device Amendments and introduced legislation last session to restore the rights of consumers injured by medical devices.
The Medical Device Safety Act (MDSA) would address the Supreme Court’s decision in Riegel by clarifying that the MDA was never intended to totally eliminate individuals’ right to hold manufacturers accountable through state courts.
Stressing that Congress has a duty to clarify their intent, Judge Kyle’s opinion in the Medtronic decision reads, “Plaintiffs’ remedy, therefore, lies with Congress, and not with this Court.”
“We hope the recent decision will show Congress the urgency to restore the right of injured parties to get justice,” added Weisbrod.