Two generic drugmakers have agreed to the national settlement of a class action claiming their version of a popular antidepressant drug was not as therapeutically effective as the brand name drug.
Drugmakers Teva Pharmaceuticals USA and Impax Laboratories have agreed to give injunctive relief to the class by changing their product labels and taking other measures that the plaintiffs say will protect consumers.
The settlement comes less than a year after the U.s. supreme Court made a landmark ruling in Pliva v. Mensing that sharply curtailed the claims that pharmaceutical plaintiffs can make against generic drugmakers over drug warnings.
A federal trial judge has approved preliminarily the settlement of the class action covering as many as 2.24 million Americans who took bupropion hydrochloride XL or budeprion XL, generic forms of Wellbutrin, from 2006 to the present.
Plaintiff lawyers including Brian Ku and M. Ryan Casey of Ku and Mussman in Miami are seeking $4.5 million in attorney fees, costs and service awards. They said the amount is less than the $8 million combination of costs and the lodestar, or the reasonable amount of hours spent by attorneys working on the case multiplied by reasonable hourly billing rates. The plaintiff lawyers also said they spent $650,000 on experts and consultants in preparing the case.
“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.”
The plaintiffs also are represented by Richard M. Golomb, Ruben Honik and Kenneth Grunfeld of Golomb & Honik in Philadelphia; Allan Kanner and Conlee S. Whiteley of Kanner & Whiteley in New Orleans; Gillian Wade of Milstein Adelman in Santa Monica, California and John Vail and Lou Bograd of the Center for Constitutional Litigation in Washington.
Kanner is lead counsel, and Golomb & Honik is liaison counsel.
The plaintiffs claim Teva and Impax’s generic formulation was not as therapeutically effective as Wellbutrin, according to the plaintiff memorandum in support of preliminary approval.
The defendants deny liability.
The plaintiffs claim the label indicated that the budeprion label was equivalent therapeutically to Wellbutrin, including that it would have five hours of maximum benefit and work for up to 10 hours including during the time period when the drug was wearing off, Golomb said.
“It really wasn’t acting as an extended relief drug,” and the generic version dissolved in the human body faster, he said.
The plaintiffs also said the defendants claimed they tested the 300-milligram generic version of the drug, but they only tested the 150-milligram version.
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 attorney fees and costs is suitable.
The defendants have agreed to undertake seven actions of injunctive relief, including changing references on the 300-milligram product to the trade name budeprion XL, and designating a senior quality and compliance officer to oversee the quality of bedeprion XL.
Impax defense counsel Asim M. Bhansali of Keker & Van Nest in San Francisco and Teva defense counsel Joseph Serino, Jr. of Kirkland & Ellis in New York did not respond to requests for comment by deadline.
