Tuesday, November 4, 2008

News from Wyeth v. Levine's Oral Argument

Legal commentators have already begun speculating about the upcoming Supreme Court decision in Wyeth v. Levine.  After yesterday's oral argument, Tony Mauro of the Legal Times reports that "the case could be decided narrowly, giving little guidance about a broader pre-emption issues beyond the area of drug labeling."  Here's an excerpt:

Appearing for Wyeth, former Solicitor General Seth Waxman told the justices that the FDA took into account the possibility of gangrene as a result of that kind of injection, but balanced it with the benefits of the drug. That produced a sharp response from Justice Samuel Alito Jr., who asked, "How could the FDA conclude that IV-push was safe and effective" when the benefit was relief of nausea while the risk was gangrene?

Justice Ruth Bader Ginsburg also asked incredulously, "No matter what benefit there was, how could the benefit outweigh that substantial risk?"

Waxman, a partner at Wilmer Cutler Pickering Hale and Dorr, answered that the label provided "ample, lavish warning" about the IV method, but the FDA determined that the method could be medically warranted in some circumstances -- the kind of considered judgment that a jury, looking at a single case, would not make. Justice David Souter also took Wyeth to task for not, on its own, going back to the FDA to urge changes in the label to prohibit IV-push administration: "Wyeth could have done that at any time, and it simply didn't do it."

Waxman pointed out that Wyeth in fact did ask for stronger language, but the FDA rejected it.

David Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel, representing Levine, picked up on Souter's point and said the law would have allowed Wyeth to make a unilateral change in its label. The FDA, he said, never weighed the comparative risks of different types of IV administration of Phenergan.

"The idea that a label is set in stone for all time misunderstands the way the process works," argued Frederick. "No reasonable person could have made this balance."

"If you're telling me the FDA acted irresponsibly, then sue the FDA," said Justice Antonin Scalia. Scalia and several other justices seemed to have been persuaded that Wyeth had acted responsibly in informing the FDA about the risks and should not be punished for doing what the agency ordered it to do.

"You're saying FDA approval doesn't give you any protection at all?" asked Scalia. Frederick responded that it gives a company "a basis for marketing" a product but does not end the company's duty to reveal problems that arise with that product.

Here's a link to the Wall Street Journal Law Blog on Wyeth.   



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