Last fall, we warned that a Supreme Court decision on medical device companies’ liability would remove a powerful incentive for device manufacturers to ensure their products’ safety. In that case,Â Riegel v. Medtronic, the Court ruled that as long as devices are FDA-approved, consumers injured by the devices can’t sue the manufacturers for liability in state courts – in short, FDA approval preempted those lawsuits. This wouldn’t be such a problem if FDA weren’t such a woefully under-resourced agency.
We feared that the Court might again rule in manufacturers’ favor in a similar case, this one involving pharmaceuticals. But in Wyeth v. Levine, the Court upheld a jury verdict awarded to musician Diana Levine, whose arm had to be amputated after an incorrectly administered injection of Wyeth’s anti-nausea drug Phenergan. (Levine claimed Wyeth’s warning against the administration method she received should have been stronger.)Â The New York Times’ Adam Liptak explains why the Court’s decision on pharmaceuticals differed from its decision on medical devices, and what the larger implications are:
The Supreme Court has been sympathetic in recent years to arguments that federal law should pre-empt state injury suits. Last year, in Riegel v.Â Medtronic, an eight-justice majority of the court ruled that many state suits concerning injuries caused by medical devices were barred by the express language in a federal law. Wednesdayâs decision addressed implied pre-emption, a different legal standard.
Drug companies and other businesses, supported by the Bush administration, had hoped the Vermont case would establish broader protections. They relied not on express language in a statute enacted by Congress, as in Riegel, but on what might be implied from federal regulatory standards and policies â in this case, from the drug agencyâs authority to approve drug labels.
Producers of goods as different as antifreeze, fireworks, popcorn, cigarettes and light bulbs have sought to take refuge behind federal oversight in recent years to fend off litigation. After Wednesdayâs decision, those efforts are most likely to succeed if they are based on express language in a Congressional statute or a specific regulatory action that makes compliance with state requirements impossible.
As for the remaining concerns about medical devices, some members of Congress are working toÂ effectively undo that decision by passingÂ legislation granting consumers the right to sue medical device companies. In the meantime, and regardless of new legislation, it’s still worthwhile to work on strengthening the FDA review process for drugs and devices.