The Appellate Division of the New Jersey Superior Court handed down its decision today in an interlocutory appeal from a ruling denying generic drug manufacturers’ motions to dismiss certain failure to warn claims in the consolidated Reglan/metoclopramide mass tort litigation in that state. In In re: Reglan Litigation, an appeal argued by CCL Chief Litigation Counsel Louis Bograd, the appellate court unanimously affirmed trial court rulings that failure to warn claims based upon the generic defendants’ failure to timely update their product labeling to reflect new warnings approved by the FDA for the brand Reglan label are not preempted by federal law governing generic drugs, distinguishing Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011).

The Court found persuasive and adopted the reasoning of the U.S. Court of Appeals for the Sixth Circuit in Fulgenzi v. Pliva, Inc., 711 F.3d 578 (6th Cir. 2013), another appeal handled by CCL.  In Mensing, the Supreme Court found failure to warn lawsuits preempted by a 5-4 vote, because it determined that it was impossible for the generic manufacturers to make label changes without FDA approval, a disability that is not true of brand-name manufacturers. However, in Fulgenzi and the new New Jersey decision, the situation was quite different. Generic manufacturers are not prohibited from making changes that have already been approved by the FDA and, in fact, are required to mimic the labeling used by the name-brand product. Thus, the New Jersey court held that “plaintiffs' claims based on the Generic Defendants' failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.”