U.S. District Judge Anita B. Brody said the settlement was “fair, reasonable and adequate” to a class of indirect purchasers of Flonase and other plaintiffs who alleged GSK abused the U.S. Food and Drug Administration's citizens petition process to delay entry of lower-cost alternatives to its prescription nasal spray.
GSK said in a statement that it was “pleased that Judge Brody has approved the settlement” and said the company has admitted no wrongdoing. The pharmaceutical company said it struck a deal with plaintiffs to “avoid the protracted disruption, expense and uncertainty of continuing litigation”
The settlement is intended to reimburse individuals in the U.S. who purchased Flonase and third-party health benefit providers or health plans that reimbursed participants, employees or insureds for the cost of the treatment. The class period is between May 19, 2004, and March 31, 2009.
Judge Brody approved an $11.6 million payout to the team of attorneys that represented members of the plaintiffs class and separate bonuses totaling $10,000 a piece to Medical Mutual of Ohio and other entities that represented the class during the litigation.
Plaintiffs have until February 1, 2014, to file a request for a share of the settlement fund, according to Judge Brody's order. The court granted preliminary approval of the deal in January.
The settlement ends litigation that dates back to 2008. GSK was accused of flooding the FDA with sham citizen petitions shortly before its Flonase market exclusivity period expired. The lawsuits alleged that GSK inflated the price of its Flonase and sought to protect itself from market competition.
The cost of a bottle of Flonase increased from $60 to $70 per bottle from August 2004 until March 2006, when generic versions of the drug finally made it to market, according to the plaintiffs. By March 2009, the price of the drug leveled out to $20 per bottle, court documents said.
The plaintiffs claim that Flonase would have been less expensive sooner if generic versions of the drug could have come to market two years earlier. The deal approved Wednesday is the second GSK settlement Judge Brody approved this month to resolve litigation stemming from its business dealings related to Flonase.
The indirect purchasers are represented by Marvin A. Miller and Lori A. Fanning of Miller Law LLC; Michael M. Buchman of Pomerantz Grossman Dalhstrom Hufford & Gross; and Nicholas E. Chimicles and Benjamin F. Johns of Chimicles & Tikellis LLP.
GSK is represented by Leslie E. John, Arthur Makadon, Stephen J. Kastenberg, Jason A. Leckerman and Roger P. Thomasch of Ballard Spahr LLP.
The case is In re Flonase Antitrust Litigation, case number 2:08-cv-03301, in the U.S. District Court for the Eastern District of Pennsylvania.
--Editing by Melissa Tinklepaugh.


