Note to Wyeth, other drugmakers and business groups hoping that the Supreme Court rules that FDA-approval of drug labeling preempts state law tort claims: it looks like Justice Antonin Scalia is on your side.
But note to Diana Levine, the American Association for Justice and others who hope the Court goes the other way: Justice Anthony “Swing Vote” Kennedy might be on your side.
During oral arguments today in Wyeth v. Levine, neither Scalia nor Kennedy masked their feelings about the case.
Almost from the moment Wyeth’s attorney Seth Waxman took the podium, Kennedy made it clear that he didn’t think the implied-preemption-based-on-impossibility argument held much water.
“Just at the outset, I’ll just make one comment,” Kennedy said just seconds into Waxman’s opening. “You argue that it’s 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, I just don’t understand that. I think I could design a label that’s completely consistent and that meets the requirements that the Respondents wish to urge.
“Now, if you want to say that any alteration of the label violates Federal law, that’s something else,” Kennedy continued. “But as a textual matter, as a logical matter, as a semantic matter, I don’t agree with it.”
When Frederick read from FDA’s own regulations to make his point that responsibility lies with the drugmaker for policing the safety of the products and amending the label to reflect risks, Scalia interrupted.
“Excuse me,” Scalia said. “Those risks were set forth on the labeling approved by the FDA. Surely [the regulation] means it shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard that the FDA has not considered. And that is not already addressed on the labeling.
“I mean to read it as opening up stuff that’s already been considered by the FDA would make mush out of it,” Scalia said.
When Frederick argued that there were risks that were never considered by the FDA, Scalia jumped in again.
“If you’re telling me the FDA acted irresponsibly, then sue the FDA,” Scalia said.