A lawsuit against a generic drug manufacturer over its failure to update a warning label can proceed, a federal appeals court ruled.

Wednesday's ruling by a three-judge panel of the 6th U.S. Circuit Court of Appeals in Eleanor Fulgenzi v. Pliva Inc. overturns a lower court ruling that dismissed the case.

Ms. Fulgenzi was prescribed the generic drug metoclopramide, which was sold originally under the brand name Reglan, for three months beginning in September 2004 and for more than a year from 2006 to 2007. She alleges the drug caused her to develop tardive dyskinesia, an often irreversible neurological disorder that causes involuntary movements, especially of the lower face, according to the ruling.

Initially, the only disclaimer on the Reglan label was, “Therapy longer than 12 weeks has not been evaluated and cannot be recommended.” In July 2004, in light of mounting evidence that its long-term use caused tardive dyskinesia, the Federal Drug Administration approved a labeling change proposed by Reglan's manufacturer that said, in bold-face type, “Therapy should not exceed 12 weeks in duration.” Pliva however, “never updated its metoclopramide labeling to include the new warning, nor communicated the change to physicians,” said the ruling.

In 2009, Ms. Fulgenzi filed suit against Pliva, a unit of Zagreb, Croatia- based Teva Pharmaceuticals Industries Ltd., charging it with failure to warn of the risk of developing tardive dyskinesia, among other related claims.

The appellate court decision said the U.S. Supreme Court in 2009 held in Wyeth v. Levine — a case that centered around a warning label on the antinausea drug Phenergan — that state failure-to-warn suits were not pre-empted by federal law.

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However, in 2011, the high court held in Pliva Inc. v. Mensing that these cases could not go forward against generic drug manufacturers because it is impossible for them to comply simultaneously with the state duty to adequately warn and “their federal duty of sameness,” the federal law that requires generic drug labels to be the same as their branded counterpart.

The U.S. District Court in Akron, Ohio, agreed with Pliva that Ms. Fulgenzi's suit was pre-empted by the Mensing ruling. The appellate court, however, disagreed. It said that “not only could Pliva have independently updated its labeling to match that of the branded manufacturer … it had a federal duty to do so.”

It noted, though, that to ultimately prevail, Ms. Fulgenzi “must argue that Pliva should have included the language contained in the updated Reglan label by soon after July 2004, and that the failure to include that language proximately caused her injuries.”

The case was remanded to the lower court for further proceedings.

Meanwhile, the U.S. Supreme Court will consider the issue of generic drug manufactures' potential liability in arguments scheduled to be heard next week in Bartlett v. Mutual Pharmaceutical Co.

In January, the Alabama Supreme Court held in Wyeth Inc. et al. v. Danny Weeks and Vicki Weeks — a case in which the plaintiff allegedly developed tardive dyskinesia by taking metoclopramide — that brand-name drugmakers can be held liable for injuries caused by drugs produced by generic manufacturers.