Iowa Court Protects Brand Makers, Opens Door to Generics Liability

Iowa’s Supreme Court once again confirmed that brand manufacturers can’t be held liable for injuries sustained when patients take a generic version of their drug. But the ruling also left generics makers slightly more liable to product injuries than in most recent “failure-to-warn” cases.

The case centers on a lawsuit filed by an Iowa woman against brand firms Wyeth, Schwarz Pharma and generic maker Pliva. The plaintiff claimed that prolonged exposure to Pliva’s generic version of Schwarz’s acid reflux medication Reglan (metoclopramide) caused her to develop a neurological disorder. Wyeth was the original producer of Reglan until it sold its rights to the drug to Schwarz.

As in other cases, the court ruled that Schwarz and Wyeth cannot be held liable for injuries allegedly sustained by taking Pliva’s generic. The plaintiff never took the branded drug, according to the ruling.

But the court did not throw out all of the plaintiff’s injury claims against Pliva. Specifically, the court sent some claims back to the lower court for further litigation on the question of whether protections under the 2011 Supreme Court, Pliva, Inc. v. Mensing — which found generics makers can’t be held liable for not changing the drug’s label if the FDA hasn’t authorized it beforehand — apply in this case.

The issue centers on the fact that in 2004, roughly five months after the plaintiff started taking the drug, the FDA had authorized a label change warning patients not to take Reglan or its generics for more than 12 weeks. But Pliva didn’t change its label in 2004, and the plaintiff took the drug for another year and half, according to the court.

The plaintiff’s claims against Pliva can move forward the court said, paving the way for possible liability despite Pliva’s claims that patients cannot sue to enforce federal law, specifically the Food, Drug, and Cosmetics Act.

The case comes as the FDA is considering a controversial rule that would allow generics makers to change their drug labels prior to agency approval, something only brand makers now have the authority to do. Without that rule, most patients attempting to sue generics companies in so-called failure-to-warn cases have been unsuccessful because the manufacturer can claim federal law requiring pre-approval for label changes precludes them from other liabilities. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.