Hagens Berman Sobol Shapiro Cases

Ketek

Date Filed: January 1, 2009

Court: United States District Court

Location: Eastern District of New York

In early 2008, HBSS and others commenced litigation on behalf of a nationwide class of third-party payors against Sanofi-Aventis, manufacturer and marketer of the branded anti-biotic Ketek. The proposed class action alleges Sanofi-Aventis illegally marketed Ketek, fraudulently representing the drug as scientifically proven to be safe and effective for a wide range of anti-microbial purposes and as having valid regulatory approval for broad antibiotic indications.

The FDA approved Ketek for three indications in early 2004 - sinusitis, bronchitis, and community-acquired pneumonia - on the basis of a 24,000-person clinical study conducted by Sanofi-Aventis. Sanofi-Aventis knew the study was rife with problems, including serious data integrity issues at a number of the study's sites, but nonetheless submitted the fraudulent data to the FDA in support of its application for approval. Following the commencement of investigations by the FDA's Office of Criminal Investigation and by Congress and the revealing of the serious concerns plaguing the underlying clinical study, the FDA withdrew two of Ketek's three indications in February 2007.

As a result of Sanofi-Aventis's actions, the complaint alleges, class members paid millions of dollars for Ketek prescriptions that otherwise would not have been written absent the fraud on the medical and scientific community and third party payors.

Briefing on the plaintiffs' motion for class certification is underway and will finish in the spring of 2010.