Two manufacturers of generic drugs have agreed to settle in a class action lawsuit that claimed that their version of a popularly prescribed antidepressant was therapeutically not as effective as the brand name version. A federal judge has preliminarily approved the settlement, which covers up to 2.24 million Americans who took budeprion XL or bupropion hydrochloride XL, the generic versions of Wellbutrin, between 2006 and the present. The defendants deny liability.
U.S. District Court Judge Berle M. Schiller of Philadelphia has set a hearing May 25 to consider final approval and determine if the request for more than $4.5 million attorney fees and costs is suitable.
The settlement comes less than twelve months after the U.S. Supreme Court arrived at a landmark ruling in the case of Pliva v. Mensing, which sharply limited the claims that plaintiffs can make against drug manufacturers over drug warnings.
Impax Laboratories and Teva Pharmaceuticals USA have both agreed to change the labels on their products, and have also agreed to other actions that the plaintiffs contend will protect consumers. They will be changing references on the 300mg product to the trade name budeprion XL, and designating a senior quality and compliance officer to oversee the quality of bedeprion XL.
The plaintiffs are represented by Ku and Mussman of Miami Richard M. Golomb of Golomb Legal in Philadelphia, California and John Vail and Lou Bograd of the Center for Constitutional Litigation in Washington, Allan Kanner and Conlee S. Whiteley of Kanner & Whiteley in New Orleans, and Gillian Wade of Milstein Adelman in Santa Monica. Kanner is lead counsel, and Golomb Legal is liaison counsel.
According to the lawsuit, the plaintiffs claimed that the drug label stated that budeprion was therapeutically equivalent to Wellbutrin. However, the medicine was not acting as an extended relief drug although the label stated that it would provide five hours of maximum benefit and continue working for up to 10 hours. Since the generic version dissolved much faster in the body, it did not provide the lasting relief it promised.
The plaintiffs also noted that the drug companies claimed they tested the 300mg dose of the generic medicine, but they had only tested the 150mg dose.
“Given the precarious nature of plaintiffs’ case following the Mensing decision, the settlement is a striking success,” plaintiff counsel wrote. “The avoidance of such uncertainty and delay is clearly warranted given the substantive injunctive relief obtained, which requires defendants not only to change what information they provide to the marketplace but change the way they ensure the safety and efficacy of the drug product.”
Counsel for Impax and Teva did not respond to requests for comment by deadline.