The Supreme Court has ruled 8-1 in favor of a medical device manufacturer in a decision that will make it harder for consumers to sue manufacturers of federally approved medical devices.
Charles Riegel underwent a procedure to unclog an artery and was left with permanent disabilities as a result of a catheter bursting during the procedure, dying in 2004. In Riegel v. Medtronic, 06-179, his family alleged that the catheter used, a product of Medtronic Inc. of Fridley, Minn., outside Minneapolis, had a design defect and an inadequate warning label.
The issue before the Supreme Court was not the defectiveness of the device. The issue 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. The FDA had already approved the medical device for the marketplace.
The ruling by Justice Antonin Scalia in this case says that state lawsuits are barred to the extent they would impose requirements differing from federal requirements. The Bush administration sided with industry, saying that unfavorable state jury verdicts would compel companies to alter product designs or labels that had already gone through the process to obtain FDA approval.
Justice Ruth Bader Ginsburg, the one dissenter, saw the decision as “a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices”.
Prior to this Supreme Court ruling, not all federal appeals courts had agreed on whether state lawsuits were allowed. Seven interpreted federal law on medical devices as prohibiting state lawsuits while two ruled otherwise.
The health care technology industry earns companies about $75 billion a year for sales of products from toothbrushes to heart valves. The Associated Press reports that “in a recent three-month span, federal regulators responded to over 100 safety problems regarding medical devices”.
We think this issue goes to tort reform and individual rights. What do you think?