Justices rule on medical device case
WASHINGTON (AP) - February 20, 2008 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."
Seven federal appeals courts including the one in Riegel's case
have interpreted federal law on medical devices as prohibiting
state lawsuits. The 11th U.S. Circuit Court of Appeals in Atlanta
and the Illinois Supreme Court have ruled otherwise.
Charles Riegel's family alleged that the catheter produced by
Metronic Inc. had a design defect and an inadequate warning label.
Riegel survived the procedure to unclog an artery, though he had
permanent disabilities, his family says. He died in 2004.
The Bush administration sided with industry, saying unfavorable
state jury verdicts would compel companies to alter product designs
or labels that had already gotten FDA approval.
Lawyers for Riegel's estate argued that a manufacturer can use
FDA approval as a legal defense, but cannot use the law to block
state lawsuits altogether.
Lawyers for Riegel's estate said that FDA procedures are far
less rigorous than Medtronic says.
The case is Riegel v. Medtronic, 06-179.