U.S. Supreme Court bars state lawsuits against FDA-approved medical devices
The U.S. Supreme Court is making 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 more than 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 what the federal government requires, said the ruling by Justice Antonin Scalia.
In dissent, Justice Ruth Bader Ginsburg said Congress never intended "a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labelled 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 the catheter produced by Medtronic Inc. of Fridley, Minn., outside Minneapolis 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 unfavourable 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.