The outcry against the Supreme Court has begun--even on the Court. In the wake of yesterday's ruling that expressly allows state liability suits against federally regulated drugs, drugmakers complained of "second-guessing" and chaos. State courts shouldn't be involved, a Merck spokesman said, adding that allowing juries to decide about drug risks would cause "mass confusion." Wyeth, which was a party to the suit, issued a statement saying, "The medical and scientific experts at FDA are in the best position to weigh the benefits and risks of a medicine and to assess how those benefits and risks should be described in the product's label."
Meanwhile, the dissenting justices sounded like pharma spokespeople themselves: The decision makes injury suits into a "frontal assault on the FDA's regulatory regime for drug labeling," Justice Samuel Alito wrote. How dare the court question the FDA?
As you know, the FDA had considered state lawsuits to be a help, not a hindrance, to its own regulation of drugs--until a few years ago, when the Bush Administration mounted an effort to make federal agencies the final word on product safety. FDA decreed that state law interfered with its mission. But in writing for the majority, Justice John Paul Stevens stated that the position was "inherently suspect" and called the Bush Justice Department's supporting brief irrelevant. What's relevant, he wrote, is that "Congress has repeatedly declined to preempt state law."
What's likely to be the fallout from this case? Well, state liability suits that had stalled will be taken up with gusto. Plaintiffs who'd felt pressured to settle, in case preemption should survive its Supreme Court hearing, won't feel that pressure anymore. And, as Jim Edwards points out at BNet, drugmakers are likely to start strengthening the warning language on their labels. "Expect to see a flurry of press releases" about new labeling, he predicts. Our in-boxes are open.
- get Wyeth's response
- read the New York Times article
- check out the story in the Wall Street Journal
- see BNet Pharma's take