States: Say no to pre-emption

Forty-seven states are weighing in on the legal battle over pre-emption--and predictably enough, they're against it. The pre-emption doctrine would, of course, enshrine FDA approval as the be-all and end-all of drug safety. If the agency has blessed a drug for sale, then drugmakers are covered; nobody could sue drugmakers for damages in state court. Or so the reasoning goes.

The states aren't convinced. They're asking the U.S. Supreme Court to uphold a Vermont ruling in Wyeth v. Levine, the case of a professional musician whose arm had to be amputated after she was injected with one of the drugmaker's products. The musician was awarded $6.8 million in damages, and Vermont's high court wasn't convinced by Wyeth's argument that FDA approval should shield it from liability.

Now, the U.S. Supremes are set to hear the case in November, and various parties are lining up on either side of the case. The federal government supports pre-emption. Trial lawyers are fighting it. It will be closely watched: If the Court blesses pre-emption, drug suits across the country could be tossed.

As you know, the Court sided with device makers on pre-emption this spring, but devices are governed by different law, so there's no guarantee that it will do the same in the Wyeth case. Plus, Congress quickly started working to revamp the device law to protect the people's right to sue.

- read the story in the Boston Globe