Yesterday the United States Supreme Court delivered a catastrophic blow to plaintiffs seeking to recover damages associated with FDA approved medical devices. The 8-1 decision bars attorneys from filing lawsuits against medical device makers in cases where the device received FDA approval before being introduced into the market. Most of the more complex and more risky devices such as heart valves and pacemakers are covered under the new ruling. Justice Scalia in the majority opinion for the Court held that concern for those injured by these devices is overshadowed by the concern “for those who would suffer without new medical devices if juries were allowed to apply the (injury) law of 50 states to all innovations.”
Scalia cited a provision of the 1976 federal law prohibiting states from enforcing any requirements for medical devices that differed from FDA standards. A jury’s finding that the catheter was improperly manufactured or labeled, despite FDA approval, would amount to an additional requirement, he said.
The FDA spends an average of 1,200 hours evaluating the efficacy and safety of each device before approval is granted. The consensus among the majority is that the rigorous scrutiny employed by the FDA during the approval process constitutes a “reasonable assurance” of the “safety and effectiveness” of a device.
The decision provides a very strong defense against product liability lawsuits brought forth against medical device manufacturers. The Court does leave open the ability to bring suits against companies that violate manufacturing specifications or labeling rules.
The ruling may have far reaching implications throughout the medical device and pharmaceutical community. Last month the Court agreed to hear the case of Wyeth v Levine, in which the plaintiff argues that Wyeth’s nausea drug Phenergan was unsafe, despite proper use of the medication according to the FDA’s official labeling. If the Court rules in favor of Wyeth using similar logic to yesterday’s decision big pharma could be let off the hook for thousands of lawsuits involving defective medications.
But it remains unclear which way the Supremes will go in that case. In today’s Medtronic decision, the justices relied heavily on a federal law that applies only to medical devices.