As alleged, the scheme was complex. First, RBP engaged in a “product hop,” introducing a new, patented formulation of Suboxone so that generics could not be substituted for the brand product at the pharmacy counter. Next, RBP mounted a campaign to disparage the original tablet formulation, claiming without valid scientific basis that the tablets carried a higher risk of accidental pediatric exposure, diversion, and abuse – to convert the market to the new form – and advising physicians that the old formulation would be discontinued. After stalling the FDA’s efforts to mandate a shared safety protocol plan between RBP and the prospective generic competitors, RBP filed a citizen petition with the FDA to block approval of the generics. Ultimately, the FDA denied the citizen petition and approved generic competitors in 2013, but the scheme was allegedly successful in converting physicians and patients to the new “sublingual film” formulation.
Hagens Berman is one of three co-lead counsel for the proposed class of direct purchaser plaintiffs. In addition to a separate class of end payors, a group of 42 state attorneys general is also pursuing antitrust claims seeking disgorgement of profits from Reckitt Benckiser.
The litigation, captioned In re Suboxone Antitrust Litigation (Civil Action No. 2:13-md-2445) is pending in the U.S. District Court for the Eastern District of Pennsylvania before the Honorable Mitchell S. Goldberg.
Expert discovery closed on May 30, 2019. On September 27, 2019, the Court certified the class of direct-purchaser plaintiffs. Indivior was granted permission to appeal the class certification ruling and that appeal is pending in the Third Circuit Court of Appeals.