Does federal law prevent a drug manufacturer from enhancing its label to reflect truthful risks revealed in its clinical trials when the relevant FDA regulations allow a manufacturer to make unilateral labeling changes and when the FDA encouraged the manufacturer to utilize those regulations to submit an appropriate labeling change?

QUESTION PRESENTED In Wyeth v. Levine, 555 U.S. 555 (2009), this Court held “impossibility pre-emption is a demanding defense” and, “absent clear evidence that the FDA would not have approved a change to [a drug’s] label, we will not conclude that it was impossible for [drug manufacturer] to comply with both federal and state requirements.” Id. at 571, 573. In this case, the Seventh Circuit vacated a jury’s verdict and found that, notwithstanding the fact “[the drug manufacturer] re-analyzed the placebo-controlled data on [its drug] and found a link between [its drug] and suicide in adults” (App. 23), the manufacturer was not permitted to issue a warning because FDA had implemented a class-wide suicide warning for such drugs which did not extend to adult patients beyond age 24. Id. The court found preemption even though an FDA expert testified the manufacturer was permitted to add its drug-specific suicide warning and the FDA had advised the manufacturer to submit its drug-specific warning using a procedure that allows manufacturers to strengthen warnings. App. 47-55. In vacating the jury’s verdict, the Seventh Circuit opined “no reasonable jury could find that the FDA would have approved an adult-suicidality warning ...” (App. 22). The court failed to appreciate the heightened evidence required under Levine, and failed to review the evidence in a light most favorable to the plaintiff. The question presented is: Does federal law prevent a drug manufacturer from enhancing its label to li QUESTION PRESENTED — Continued reflect truthful risks revealed in its clinical trials when the relevant FDA regulations allow a manufacturer to make unilateral labeling changes and when the FDA encouraged the manufacturer to utilize those regulations to submit an appropriate labeling change?