Medical Device Manufacturers Receive Protections

This Wednesday the Supreme Court issued a major anti-consumer opinion, 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.
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.
Charles Riegel’s family alleged that 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. He died in 2004.
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.”
Not surprisingly, 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.