Hagens Berman Sobol Shapiro Cases

Flonase

Date Filed: July 3, 2008

Court: U.S. District Court

Location: Eastern District of Pennsylvania

In July 2008, HBSS filed an antitrust lawsuit on behalf of drug wholesalers and other direct purchasers against pharmaceutical manufacturer GlaxoSmithKline ("GSK") alleging that GSK unlawfully delayed the entry into the United States market of a generic version of GSK's nasal allergy drug Flonase by filing sham citizen petitions with the Food and Drug Administration (FDA). HBSS leads the litigation in consultation with other direct purchaser counsel.

Direct purchasers argue that GSK filed a series of meritless citizen petitions with the FDA solely to prevent the approval and market entry of lower cost generic forms of GSK's blockbuster drug Flonase. The initial citizen petition was filed on the eve of the FDA's approval of a generic form of Flonase.

Direct purchasers argue that the issues raised to the FDA in GSK's citizen petitions did not relate to the safety and efficacy of the potential generic product and were not credible. However, because the FDA would take time to respond to the citizen petitions before approving a generic manufacturer's application, the citizen petitions served to delay the approval of the generic form so that GSK could continue to enjoy exclusive rights to market its own product, free from generic competition. For every month that a generic product was delayed, the case alleges GSK reaped tens of millions of dollars in ill-gotten profits from consumers and direct purchasers.

Plaintiffs' motion for class certification will be filed by the end of 2009.