In a December 15 press release, DOJ announced Irish drug manufacturer Elan Corporation, PLC (Elan) and its U.S. subsidiary, Elan Pharmaceuticals, Inc. (EPI) agreed to pay $203.5 million to resolve criminal and civil liability arising from the illegal promotion of the ant-epilepsy drug Zonegran. Zonegran was approved as an adjunctive therapy to treat partial seizures in adults over the age of 16. However, Elan promoted the sale of Zonegran for a variety of illegal off-label uses including psychiatric disorders, migraine headaches, chronic daily headaches, eating disorders, weight loss, Parkinson's Disease, monotherapy, and for seizures in children. Elan's off label marketing efforts included illegal kickbacks to doctors. Under the plea Elan agreed to pay a criminal fine of $97,050,266, plead guilty to a misdemeanor, forfeit $3.6 million in substituted assets, pay $102,890,517 to settle civil federal and state Medicaid claims under the False Claims Act.
[1] U.S. Department of Justice Press Release "Pharmaceutical Companies to Pay $214.5 Million to Resolve Allegations of Off-Label Promotion of Epilepsy Drug" (December 15, 2010).
[1] U.S. Department of Justice Press Release "Pharmaceutical Companies to Pay $214.5 Million to Resolve Allegations of Off-Label Promotion of Epilepsy Drug" (December 15, 2010).
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