Two federal appeals courts recently reached different conclusions on whether “failure to update” labeling claims against a generic drug manufacturer are preempted by federal law. These cases illustrate continuing disagreement among the lower courts concerning proper implementation of the Supreme Court’s generic preemption decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).
In Fulgenzi v. PLIVA, Inc., No. 12-3504, 2013 WL 949096 (6th Cir. Mar. 13, 2013), the Sixth Circuit held that plaintiff’s claim was not preempted under Mensing because it was not impossible for PLIVA to update its label to match the branded counterpart, as both federal and state law required PLIVA to do so. 2013 WL 949096, at *5. The Court also found that permitting state law actions against “sameness-violating” defendants would not frustrate federal objectives. Finally, the Court held that plaintiff’s claim was not impliedly preempted under Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), because the allegations sounded in “an independent state duty” relating to the adequacy of the warnings. Id. at *7.
One month earlier, the Fifth Circuit reached the opposite conclusion in Morris v. PLIVA, Inc., No. 12-30319, 2013 WL 563506 (5th Cir. Feb. 14, 2013), a case involving the same generic manufacturer and branded drug as Fulgenzi. In a non-precedential opinion, the Fifth Circuit rejected the argument that a generic manufacturer could be held liable for failing to update the generic drug label to match a revised brand-name label. Plaintiff had sought leave to add a claim that the generic defendant had failed to update its label to match the branded company’s 2004 version. But the Court held that such a claim for a breach of a federal labeling obligation is preempted under Buckman because it “sounds exclusively in federal (not state) law.” 2013 WL 563506, at *2. The Court also noted that the proposed amendment was futile since plaintiff alleged elsewhere in its complaint that no pre-2009 label was adequate.