In an important preemption case, Fulgenzi v. Pliva, Inc., the 6th Circuit unanimously ruled today that a generic drug manufacturer may be sued under state law where it failed to provide all of the warnings approved by the FDA for the equivalent brand-name drug.

The court rejected the argument that plaintiff’s claim was preempted on grounds of impossibility under the U.S. Supreme Court’s 2011 ruling in Pliva, Inc. v. Mensing, stating: “not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process, but it had a federal duty to do so. As a result, compliance with federal and state duties was not just possible; it was required. Impossibility preemption is inappropriate in such a case.”

The court also rejected defendant’s argument that Ms. Fulgenzi’s claim was preempted under Buckman v. Plaintiffs Legal Comm. (2001), as an attempt to privately enforce federal law: “Here, Fulgenzi’s suit is not even premised on violation of federal law, but rather on an independent state duty. The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption.”

The Fulgenzi decision represents a significant limitation on the reach of the Supreme Court’s generic drug preemption ruling in Mensing. The decision takes on added significance in light of a recent study which found that more than 2/3 of generic drug labels lack warnings found on the labels of the equivalent branded drugs. Consistency in the safety labeling of bioequivalent medications, Pharmacoepidemiology and Drug Safety (2012).

The appeal in Fulgenzi was briefed and argued by CCL Senior Litigation Counsel Louis Bograd.  Find news coverage here.