This week, the U.S. Supreme Court ruled that consumers cannot sue the makers of federally approved medical devices for design defects in state court.
The decision was a blow to the family of Charles Riegel. While undergoing a medical procedure to unclog an artery, a catheter burst and seriously injured Riegel. He died in 2004.
Riegel’s family sued the catheter’s manufacturer, Medtronic, Inc. The family alleged the catheter was defectively designed and had an inadequate warning label. Medtronic argued that because the U.S. Food and Drug Administration approved the catheter before it was introduced to the market, federal law preempted state court lawsuits.
In Riegel v. Medtronic, an 8-1 decision, the Supreme Court agreed. In an opinion written by Justice Antonin Scalia, the Court concluded that state lawsuits that could impose requirements that differed from federal regulations were prohibited.
Justice Ruth Bader Ginsburg dissented. She argued that when enacting federal laws governing medical devices, Congress never intended “a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices.”
Big business is applauding this ruling. According to the Associated Press, the health care technology industry is a $75 billion-a-year giant. This decision will further insulate big business from liability for their negligence. But for consumers – and for families like the Riegels – this ruling effectively prevents them from using one of the few tools left following an injury caused by a carelessly designed product.
