The Supreme question

In February, the court ruled in favor of national FDA pre-emption in Riegel v. Metronic, in which the product in question was a catheter made by Medtronic Inc. But Wyeth -- and drugs -- are a different matter, as Chief Justice John Roberts immediately pointed out to Wyeth counsel Seth Waxman, who was U.S. solicitor general from 1997 to 2001 and is now partner at Wilmer Cutler Pickering Hale and Dorr LLP.

"In the medical device area, of course, you have an express pre-emption clause, while here in contrast you don't," Roberts said. "And one reason perhaps that it didn't is that when the Drug Act was passed, you had an established background of state actions; when the Medical Device Act was passed, you didn't."

So why not sue the FDA, Justice Antonin Scalia asked. Levine's counsel, David Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel PLLC, argued that because labels can change based on new evidence, the drugmaker bears the burden of bringing the new data to light. Justice Ruth Bader Ginsburg said the FDA can't possibly monitor and be proactive about potential changes for thousands of marketed drugs. Especially in its drastically underfunded state. Wyeth should have moved years ago to ban IV push for Phenergan, as Pfizer Inc. did in the 1970s with its drug Vistrol, Frederick said. With prompting from Scalia, U.S. Deputy Solicitor General Edwin Kneedler acknowledged that a company that doesn't bring new data to light is open to tort remedy.

Ginsburg said the FDA traditionally believed "tort suits were a helpful adjunct to the FDA's own efforts to protect consumers." But as the American Association for Justice -- formerly the Trial Lawyers Association -- pointed out in a recent report, the FDA's position shifted as part of a wider Bush administration effort to shield corporations from product liability by rewriting agency regulations.