U.S. Federal Judge Anita B. Brody signed off on the deal with the class of direct purchasers, led by Meijer Inc. and American Sales Co., that was hammered out in December. Indirect purchaser plaintiffs also have asked for approval of a $45 million class action settlement with GSK, which is still pending.
Direct and indirect Flonase purchasers and generic drug developer Roxane Laboratories Inc. alleged that GSK flooded the U.S. Food and Drug Administration with sham citizen petitions shortly before its Flonase market exclusivity period expired.
Days before the FDA was set to approve Roxane's abbreviated new drug application for a generic version of Flonase, GSK began filing petitions to delay approval of any ANDAs for Flonase until the agency established guidelines to determine the bioequivalency of nasal spray products, the plaintiffs claimed.
The direct purchasers said GSK's alleged abuse of the citizen petition process allowed the company to unlawfully maintain monopoly power and overcharge direct purchasers to the tune of millions of dollars.
They also said, in a memorandum supporting their Dec.11 motion for preliminary approval of the settlement, that the only other case alleging that sham citizen petitioning delayed a drug's generic entry resulted in a jury verdict for the defendant and no money for a class that was nearly identical to the one in the instant suit.
That case, brought in New York by Louisiana Wholesale Drug Co. Inc. against Sanofi-Aventis over an arthritis drug called Arava, wrapped up in 2008.
The three biggest class members in the direct purchaser case — AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. — support the $150 million deal, the memorandum said, adding that collectively, those three members account for 81 percent of the class's purchases.
Discovery in the case was substantial and included the production of millions of documents, 45 depositions and third-party discovery from the FDA and generic drugmakers, said the memorandum.
The direct purchaser class covers persons or entities in the U.S. who bought Flonase directly from GSK between May 19, 2004, and March 6, 2006.
The direct purchaser class is represented by Joseph Meltzer, Terence Ziegler and Cassandra Murphy of Kessler Topaz Meltzer & Check LLP and Thomas M. Sobol, Edward Notargiacomo and Kristen Johnson Parker of Hagens Berman Sobol Shapiro LLP.
GSK is represented by Stephen Kastenberg of Ballard Spahr LLP.
The case is In Re: Flonase Antitrust Litigation, case number 2:08-cv-03149 in the U.S. District Court for the Eastern District of Pennsylvania.
--Additional reporting by Ben James. Editing by Richard McVay.
