The Second Circuit denied an appeal by patients alleging that Pfizer Inc.’s former cholesterol drug Lipitor gave them Type 2 diabetes, agreeing with the trial court’s decision that their claims were either federally preempted or filed too late.
The three-judge panel did not delve deeply into its dismissal of the case led by named plaintiff Barbara Gayle, saying only that the circuit judges agreed with the reasons stated by the district court judge when the case was first dismissed, and that for those same reasons, the panel concluded leave to amend was futile.
In the April 2019 suit, Gayle and the other plaintiffs alleged that when Lipitor’s label changed in 2012, it only included a warning that the drug, known as a statin, could increase glucose levels and hemoglobin A1c, which binds to glucose. While those risks related to diabetes, the plaintiffs alleged that the label did not explicitly warn that Lipitor causes Type 2 diabetes, and their doctors would not have prescribed the drug if they’d known.
Lipitor is now owned by Viatris, which formed from the merger of Mylan N.V. and Pfizer’s off-patent medicine division in November 2020. Viatris is not a party to the appeal.
In April 2020, U.S. District Judge William H. Pauley III dismissed the case with prejudice, saying any of the patients’ claims stemming from after Pfizer changed its label in 2012 are preempted by the FDA.
In August, the plaintiffs went to the Second Circuit, arguing their claims aren’t preempted because the pharmaceutical company could have changed its label to warn about diabetes without FDA approval.
Then in October, Pfizer told the Second Circuit that federal preemption and the statute of limitations put the patients in an “inescapable” dilemma, as any of their post-2012 claims are barred because the FDA approved the updated label, while any claims before 2016 fall outside New York’s statute of limitations.
In this order, the panel agreed with Pfizer, and wrote that the plaintiff’s claims to be founded without merit.