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,
Ruben Honik and
Kenneth Grunfeld of Golomb & Honik 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 & Honik 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.