Generic Drug Label May Leave Maker Liable

CINCINNATI (CN) - A woman who developed a neurological disorder while taking a generic acid reflux drug can pursue her failure-to-warn claims in state court, the 6th Circuit ruled.

Eleanor Fulgenzi developed tardive dyskinesia, a neurological disorder characterized by involuntary movements of the lower face, after she took the generic gastroesophageal reflux medication metoclopramide for over a year from 2006 to 2007.

In a federal complaint, she noted a stipulation that the Food and Drug Administration made in approving a labeling change for the drug's branded form, Reglan, in 2004. The FDA had said "therapy should not exceed 12 weeks in duration," but Fulgenzi said PLIVA failed to update the labeling of its generic version and did not notify any physicians.

In March 2012, however, a federal judge in Akron, Ohio, found that U.S. law pre-empted Fulgenzi's claims against PLIVA, citing the Supreme Court's 2011 decision PLIVA Inc. v. Mensing.

The court also found that Fulgenzi's allegations failed to state a claim under Ohio law, since there is no private cause of action for violations of FDA regulations.

A three-judge panel of the 6th Circuit revived the failure-to-warn claim last week, concluding federal law does not pre-empt all cases against generic drugmakers.

"In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the Changes Being Effected (CBE) process, but it had a federal duty to do so," Judge Danny Boggs wrote for the court. "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 opinion also clarified how Fulgenzi must proceed with the suit.

"We note at this point that Fulgenzi's claims survive only to the extent PLIVA's actions were permitted by federal law," Boggs wrote. "She cannot claim that PLIVA should have included an aggressive black-box warning; any such allegations are preempted under Mensing. Instead, she is left to argue only that PLIVA's warning was inadequate to the extent that it did not include the language contained in the updated Reglan label from 2004. This leaves her with a weaker case than if she were suing a branded-drug manufacturer, but that is the statutory scheme provided to us by Congress."

The panel said it disagreed with PLIVA that "Ohio law does not require the manufacturer of a generic drug product to update its labeling to match the branded equivalent."

"This misstates Fulgenzi's claim," Boggs wrote. "PLIVA's violation of the federal duty of sameness is essential to her case - but only to avoid preemption under Mensing. On the merits, whether PLIVA has violated its federal duties is irrelevant to the adequacy of its warnings. A jury need not know about the duty of sameness at all to determine whether the warning label used by PLIVA in 2004 and 2006 was inadequate, and whether the failure to include the updated warning was a proximate cause of Fulgenzi's injuries."

Boggs concluded: "While her allegation that any warning short of the FDA's 2009 'black-box' warning was unreasonable is preempted, she is free to argue in the alternative that any label lacking Reglan's 2004 updated warning was inadequate. Further, there is nothing in the Ohio product-liability law inconsistent with a claim that a defendant failed to warn, even inadequately. In a failure-to-warn case, the plaintiff must show that '[t]he manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided.' Ohio Rev. Code 2307.76. Since Fulgenzi alleges that the non-updated warning used by PLIVA in 2004 does not meet the standard of reasonable care, this element is satisfied."

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