FDA pre-emption case at the US Supreme Court

The US Supreme Court has heard oral arguments in Riegel versus Medtronic, a dispute over whether the express pre-emption provision of the 1976 Food and Drug Cosmetic Act overrides state legislation that allows people to claim damages for injuries caused by drugs and medical devices. The case involves USA-based medical device manufacturer Medtronic, but involves the same legislation as for drug safety claims. Drugmakers argue that compliance with the Food and Drug Administration's safety requirements should not be "second-guessed" by juries and state judges.

According to Rob Clark, a spokesman for the firm, drug companies are in a "Catch-22 between complying with FDA regulations on the one hand and still being subject to state liability on the other." Trial lawyers, who can collect up to one third of damage awards, and consumer groups argue that the federal agency is not capable of ensuring that the data on which safety decisions are made is accurate. There are also concerns about the FDA's resources for policing drug safety. A recent study by the FDA's Science Board "found that the agency was so poorly organized and short of funds that it could not adequately protect the public from dangerous drugs," the Los Angeles Times reported.

Opposing this viewpoint, Karen Barth Menzies, a lawyer, told the LA Times that a ruling in favor of Medtronic would "take away the last possible safety net against unfettered corporate misbehavior and negligence."