In a closely watched case, the US Supreme Court voted to 8-1 that patients can't file lawsuits against device makers when their products were approved by the FDA.
The court reviewed a lawsuit that pitted Medtronic against a woman whose now-deceased husband suffered a disabling injury when a balloon catheter burst during angioplasty. Medtronic argued that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.
In the decision, Justice Antonin Scalia wrote that the FDA's approval process was "rigorous'' and precluded imposition of any additional requirements under state product-liability law (Please see page 4 of the ruling). Justice Ruth Bader Ginsburg was the only dissenter.
The ruling gives device makers an eagerly anticipated defense in product-liability lawsuits. The decision may also gladden drugmakers, which have appealed to the Supreme Court in two separate cases to restrict the ability of patients to file suits in state courts. Unlike medical devices, however, there is no statute providing for preemption for drugs. This separate battle centers on whether decisions by state courts and juries should have the right to trump an FDA rule, which the agency and industry say is the final word on safety and effectiveness.
The court's ruling will affect devices most frequently targeted in lawsuits, such as bone screws and defibrillator wires that undergo the FDA's "pre- market approval'' process. By contrast, companies that year filed 3,130 applications under rules that provide for fast-track review of devices similar to those already on the market, Bloomberg News notes. In 1996, in another case involving Medtronic, a splintered Supreme Court allowed product-liability suits over devices cleared under the fast-track process.
In the latest case, device makers and the White House argued that the more rigorous federal pre-market system should preclude state-law claims that companies ought to have done more to ensure safety. Device makers said that invoking state laws would subject them to different legal standards around the country. Patient advocates, however, argued that a ruling in favor of Medtronic would leave patients unable to get adequate compensation for injuries caused by the most dangerous medical devices.