Criminal Prosecution of Elan Corporation
In February 2011, the Irish pharmaceutical manufacturer Elan Corporation, PLC paid $60 million to resolve FCA allegations arising from its off-label marketing of the epilepsy drug Zonegran for a variety of uses other than those approved by the Food and Drug Administration (FDA) as adjunctive therapy for the treatment of partial seizures in epilepsy for adults over the age of 16. The United States alleged that this conduct caused false claims to be submitted to federal health care programs for off-label uses of the drug between April 2000 and April 2004. A subsidiary, Elan Pharmaceuticals, Inc., pled guilty to a misdemeanor violation of the FDCA. It paid a criminal fine of $97 million and forfeited $3.6 million in substituted assets.
Source: HHS Health Care Fraud and Abuse Control Program, Annual Report for FY 2011
This article was posted on July 15, 2012.