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Bill would toss protection for medical device makers

Associated Press / March 6, 2009
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WASHINGTON - A day after the Supreme Court decided that federal rules do not protect drug makers from state lawsuits, Democrats in Congress moved to overturn a decision that has shielded medical device companies from similar legal action.

On Wednesday the court turned away Wyeth's claim that it could not be sued in state courts for its drug Phenegran, because it had already been approved by the federal Food and Drug Administration. The ruling upheld a $6.7 million award to a Vermont woman who lost her arm after she was improperly injected with the company's nausea medication.

Seizing on the decision, Democrats reintroduced a bill that would allow similar lawsuits against companies that make heart devices, catheters, hip replacements, and other devices.

"Yesterday the Supreme Court rightfully upheld a patient's right to legal recourse after sustaining an injury from a pharmaceutical product," said Representative Frank Pallone, of New Jersey. "Today, we introduce legislation that gives patients that same right when injured by a medical device."

The idea that corporations are shielded from state liability claims by federal rules is relatively new and was pushed under the Bush administration.

Last year, the Supreme Court agreed with the preemption policy in a case involving medical devices, ruling a patient injured by a Medtronic catheter could not sue under state laws. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices. There's no similar provision for drugs. Since then thousands of lawsuits against Medtronic and other device companies have been dismissed by lower courts.

But Pallone and other Democrats said that decision ignored decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level. The bill to restore liability claims against device makers is cosponsored by Representative Henry Waxman, who chairs the Energy and Commerce Committee. He is expected to hold hearings on the issue.

The device industry's chief lobbying group slammed the effort, saying it will "produce a chilling effect on medical innovation, create more lawsuits, and ultimately result in higher healthcare costs."

The Advanced Medical Technology Association said the legislation would allow state courts to second-guess medical experts at the FDA and create a "patchwork of inconsistent and confusing guidance."

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