The much anticipated preemption case, Wyeth v. Levine, was argued yesterday before the US Supreme Court. Seth P. Waxman argued for Wyeth; Ed Kneedler for the FDA as amicus; and David Frederick for Ms. Levine.
While veteran Court watchers know it can be risky to read too much into questions asked, here is what jumped out at MassTortDefense from the oral argument.
1. Justice Kennedy: making a “comment” that it was not necessarily impossible for Wyeth to comply with the State law and at the same time the Federal label, as a textual matter, as a logical matter.
2. Each of the advocates being asked by multiple Justices, beginning with Justice Ginsberg, whether and to what degree the FDA specifically considered the risks and benefits of IV push versus IV administered the usual way by a drip bag. Frederick eventually agreeing with Chief Justice Roberts that if there was specific consideration of IV push as opposed to simply arterial exposure, then plaintiff below should lose.
3. Justice Ginsberg seemingly second-guessing the FDA’s assessments of risk and benefit because the drug was not a life-saving drug, and on the risk side you have the risk of gangrene. “No matter what benefit there was, how could the benefit outweigh that substantial risk?” Waxman responded that the right question was would this method ever be medically warranted? The testimony in this case and in the administrative record was “yes.”
Frederick told the Chief Justice that there was no way FDA could have made this determination because the risks of IV push are so catastrophic compared to the benefit. But Justice Scalia chimed in that he was “just contradicting the label. The fact is they could not have approved that label unless they made that determination.”
4. Waxman offered the Court a way to think about a narrow reversal: “members of this Court are concerned about applying a broad, vague, or free-wheeling analysis of implied conflict pre-emption, but this case is heartland. A jury was asked to look at the same information and conclude that the precise language that the FDA just didn't allow, the FDA required Wyeth to use, rendered that drug unreasonably unsafe.”
5. Kneedler conceding that there would be no preemption if the state law failure-to-warn claim was based on new information that the company didn’t furnish the FDA. Which got him into the quandary of when the information is brought it to the FDA's attention and the FDA just hasn't acted on it. He had some trouble with that one.
6. Frederick had a hard time clarifying whether his case depended upon the Court determining that the risk at issue here was a new risk that the FDA did not consider.
7. Frederick more or less conceded to Justice Alito that a claim would be pre-empted when the FDA considered and rejected a label change proposed on the basis of the same information or similar information that underlies the State claim.
8. Justice Scalia pointed out the difference between what juries do and the promotion of public safety through a balancing of benefits and costs. The former may be simply eliminating certain drugs which people could be benefited by.
9. Waxman doing an effective job of contrasting plaintiff’s current argument with what Levine argued to the jury. Plaintiff had not argued that the FDA hadn’t gotten information about the risks. Plaintiff below “stood up and said the FDA doesn't decide this question. You [the jury] decide this question. And there was never, ever a suggestion in the record in this case, nor could there have been, that Wyeth ever failed to bring every single adverse-event report to the FDA's attention, every analysis that it did to the FDA's attention.”
10. Justices Breyer and Scalia indirectly sparring through questions about who would have the "burden of proof" of bringing up new risk information, and who should lose if they did not do so. Justice Scalia noted that new information was not brought up by either side below, and he clearly did not buy the notion that it is the burden of the drug company to show an absence of new information.
It is always difficult to predict Supreme Court decisions. That being said, given the tenor of the Court’s questions, and some of the arguments advanced, the Court has plenty of ammunition to arrive at a relatively narrow decision, which could result in additional litigation concerning whether preemption is available under any different set of facts.