Justices focus on FDA in preemption case

Did the FDA know enough? Was Wyeth vigilant enough? Those questions seem to be at the heart of the Supreme Court's deliberation over that much-publicized Supreme Court case Wyeth v. Levine [1]. As you know, the Justices heard arguments yesterday in the case, which pits the drugmaker against Vermonter Diana Levine, who lost her arm after an IV "push" of the antinausea treatment Phenergan.

The case has drawn so much attention because it could shift legal doctrine. Businesses that comply with federal rules, the idea goes, shouldn't be subject to state lawsuits from consumers. Specifically to Wyeth, the FDA's approval of Phenergan and its labeling would "pre-empt" lawsuits from patients.

But the Justices seemed wary of granting such a broad legal shield. Justice Anthony Kennedy specifically said he didn't agree that FDA approval should prevent juries from questioning the agency's decisions. And Justice David Souter said Wyeth could have raised safety concerns about Phenergan "at any time," but didn't. Justice Samuel Alito seemed to agree, suggesting that Phenergan's FDA-approved label was inadequate. Justice Antonin Scalia, however, said that juries shouldn't be able to overrule the risk-benefit analysis FDA has already made.

Of course, guessing what the Justices might do is a cottage industry in itself, and we're not lawyers. But the analyses we've checked out suggest that the Court might look to balance consumer and business concerns. By zeroing in on what the FDA knew and what Wyeth did, the Justices hinted that, had the drugmaker kept the agency apprised of all safety info--and the agency properly analyzed and acted on that data--then patients shouldn't be able to sue. But we've included a link to the transcript so you can gauge the mood for yourselves.

- read the Boston Globe story [2]
- see the article [3] in the Wall Street Journal
- check out the WSJ Law Blog's take [4]
- get the transcript [5] at Pharmalot

Related Articles:
Supremes sing on preemption today [1]
Memos show FDAers fought preemption [6]
NJ Supremes to hear Vioxx preemption claims [7]
Waxman attacks FDA preemption rule [8]
Reps introduce anti-preemption bill [9]
States: Say no to pre-emption [10]