Cephalon Off-Label Marketing

Issue: Alleged unlawful off-label marketing

United States ex rel. Matthew Cestra v. Cephalon, No. 14-01842 (E.D. Pa.); United States ex rel. Bruce Boise, et al. v. Cephalon, No. 08-287 (E.D. Pa.)

Lieff Cabraser, with co-counsel, represents four whistleblowers bringing claims on behalf of the U.S. Government and various states under the federal and state False Claims Acts against Cephalon, Inc., a pharmaceutical company.

The complaints allege that Cephalon has engaged in unlawful off-label marketing of certain of its drugs, largely through misrepresentations, kickbacks, and other unlawful or fraudulent means, causing the submission of hundreds of thousands of false claims for reimbursement to federal and state health care programs.

The Boise case involves Provigil and its successor drug Nuvigil, limited-indication wakefulness drugs that are unsafe and/or not efficacious for the wide array of off-label psychiatric and neurological conditions for which Cephalon has marketed them, according to the allegations. The Cestra case involves an expensive oncological drug called Treanda, which is approved only for second-line treatment of indolent non-Hodgkin’s Lymphoma despite what the relators allege to be the company’s off-label marketing of the drug for first-line treatment. Motions to dismiss in both cases have been largely denied, and the cases will be headed into discovery.