Congressional Democrats draft legislation to reverse pre-emption ruling

WASHINGTON Democrats irritated by a recent Supreme Court decision shielding medical device companies from state liability lawsuits plan to unveil legislation to reverse the ruling, the first of many expected efforts to chop away at federal rules that restrict consumers' ability to sue, according to published reports.

House Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., and House Oversight and Government Reform Chairman Henry Waxman, D-Calif., will introduce legislation before the Independence Day recess that would explicitly state that FDA regulation does not trump medical device patients' ability to seek damages under state law, a Pallone spokesman said.

The two were spurred to act after the Supreme Court ruled in February that patients injured by defective medical devices can not sue for damages in state courts if the FDA approved the marketing of the product.

The justices found that the 1976 Medical Device Amendments pre-empted the right of injured patients to sue for damages in state courts against the most complicated or high-risk devices that undergo FDA's strictest approval process. Justices are in various stages of weighing pharmaceutical pre-emption cases.