Supreme Court on Wednesday made it harder for consumers to sue manufacturers of federally approved medical devices

Wed, Feb. 20, 2008 | Court limits suits over medical devices | By PETE YOST | Associated Press Writer

WASHINGTON -- The Supreme Court on Wednesday made it harder for consumers to sue manufacturers of federally approved medical devices.

In an 8-1 decision, the court ruled against the estate of a patient who suffered serious injuries when a catheter burst during a medical procedure.

The case has significant implications for the $75 billion-a-year health care technology industry, whose products range from heart valves to toothbrushes.

In a recent three-month span, federal regulators responded to over 100 safety problems regarding medical devices.

At issue before the Supreme Court was whether the estate of Charles Riegel could sue a company under state law over a device previously cleared for sale by federal regulators.

Under federal law, a company must substantiate the safety and effectiveness of a medical device before the U.S. Food and Drug Administration will approve it for the marketplace.

State lawsuits are barred to the extent they would impose requirements that are different from federal requirements, said the ruling by Justice Antonin Scalia.

In dissent, Justice Ruth Bader Ginsburg said that Congress never intended "a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices."

But Scalia, in response, said, "It is not our job to speculate upon congressional motives." ...