On March 13, 2013, the US Court of Appeals for the Sixth Circuit issued an opinion in Fulgenzi v. PLIVA, Inc., holding that the Food, Drug, and Cosmetic Act (FDCA) does not preempt state failure to warn suits against generic drug manufacturers who fail to update their drug's labels to include subsequent warnings voluntarily given by their brand-name counterparts.

In this case, PLIVA placed the same warnings on its generic drug metoclopramide that were previously mandated by the FDA for the branded drug Reglan. However, PLIVA did not change metoclopramide's label to add the enhanced warnings that were later given voluntarily by Reglan's manufacturer.

Fulgenzi comes on the heels of the Supreme Court's 2011 decision in PLIVA, Inc. v. Mensing, where the Court held that state failure to warn suits against generic drug makers are preempted by the FDCA when a generic drug includes the same warnings as those mandated by the FDA for the name-brand version. Under the "sameness" doctrine, a generic drug manufacturer simply has no power to unilaterally change its warnings beyond those provided by the name-brand manufacturer.

Fulgenzi's claims, however, were not preempted under the "sameness" doctrine. Because the name-brand manufacturer voluntarily (and in compliance with FDA regulations) enhanced the previous FDA-approved warnings for Reglan, the "sameness" doctrine actually required PLIVA to enhance the warnings for metoclopramide.

The court further held that Fulgenzi's claims were not impliedly preempted by the FDCA. Although the FDCA excludes private rights of action to remedy violations of FDA regulations, the Sixth Circuit reasoned that Fulgenzi's suit was not actually premised on PLIVA's failure to comply with federal law (specifically, the "sameness" doctrine). Instead, the case rested on an independent state-law duty to provide adequate warnings.