Wendy Dolin told the court the Seventh Circuit’s decision that her claims were barred conflicts with the Third Circuit’s ruling in the Fosamax case.
The Supreme Court’s resolution of that case, Merck, Sharp & Dohme Corp. v. Albrecht, will provide guidance for determining when the standard for preemption has been met, Dolin said.
The Merck case is set for argument Jan. 7.
The court should grant Dolin’s petition for review and hold it until the Fosamax decision, she said. Then the Seventh Circuit’s decision should be vacated and remanded.
Dolin alleged GSK, which created the label, should be held liable for failing to warn that Paxil could lead to suicide deaths in older adult users. Stewart Dolin was 57 when he died.
A jury awarded Dolin $3 million.
But the Seventh Circuit said federal drug labeling law blocked her claims because GSK, which controlled the labeling for Paxil and its generic versions, couldn’t have changed the label without running afoul of federal law.
The regulatory history for Paxil shows “clear evidence” the Food and Drug Administration wouldn’t have permitted a labeling change, the standard for preemption, the court said.
But the Seventh Circuit erred in making that determination, Dolin said.
Here, the FDA requested that a uniform suicide warning be implemented for all antidepressants in the same class of drugs as Paxil.
But the FDA specifically told GSK that, if it wanted to enhance the label concerning Paxil-specific suicide risks, it should either use the “changes being effected” procedure as it statutorily was permitted to do, or request a formal meeting to discuss the matter further, Dolin said.
GSK did neither, her petition for review said.
The FDA’s suggestion that GSK use the CBE to issue a Paxil-specific warning in a place on the label that wouldn’t conflict with the class-wide portion “can hardly be considered or interpreted as a rejection of a paroxetine-specific adult suicide warning,” she said.
Alternatively, the court should review this case on its own merits, Dolin said.
Baum Hedlund Aristei & Goldman, P.C., and the Rapoport Law Offices, P.C., represent Dolin.
The case is Dolin v. GlaxoSmithKline, LLC, U.S., No. 18-803, petition 12/19/18.