Democrats seek to reverse device court ruling
* Democrats seek to reverse limits on device lawsuits
* Bill would preserve patient right to sue for harm
* Device makers say measure won't improve safety
WASHINGTON, March 5 (Reuters) - U.S. Democrats on Thursday moved to reverse a U.S. Supreme Court decision that limited the ability of patients to sue medical devices manufacturers over harm from their products.
The lawmakers unveiled legislation to overturn a 2008 ruling that patients cannot sue device makers in state court when they are injured by a product that was approved by the Food and Drug Administration. The court found claims were pre-empted by a clause in a 1976 federal device law.
The decision ignored congressional intent and 30 years of experience with federal regulations and state lawsuits, Reps. Frank Pallone and Henry Waxman said in a statement.
The legislation "puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year," said Pallone, who chairs the House of Representatives Energy and Commerce subcommittee on health.
On Wednesday, the Supreme Court ruled differently in a pre-emption case involving drugmakers. The court found patients did have a right to file state liability claims against drug companies, who are governed by different laws and regulations, even if the manufacturers include FDA-approved warnings.
Pallone and Waxman, who chairs the full Energy and Commerce Committee, said Congress needed to move quickly on the measure to restore patients' right to sue over devices. A similar bill is pending in the Senate.
The device industry group Advanced Medical Technology Association (AdvaMed) attacked the measure, saying the FDA should determine if a product was too risky rather than state courts.
"This bill does not in any way improve patient safety," AdvaMed President Stephen Ubl said in a statement.
"It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health-care costs for all Americans," Ubl said.
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