Pharmaceutical Company Agrees To Pay $214.5 Million To Resolve Allegations That It Engaged In Off-Label Marketing Of Seizure Medication

On December 15, 2010, the U.S. Department of Justice announced that it had reached a settlement agreement with the Irish pharmaceutical manufacturer Elan Corporation, PLC to resolve civil and criminal allegations that the company unlawfully marketed the anti-seizure drug Zonegran for uses that were not approved by the Food and Drug Administration.  According to the Government, Zonegran – which the FDA had approved only for treatment of partial seizures for adults with epilepsy – was promoted by Elan as being effective for treating a wide variety of other disorders, such as bipolar disorder, mania, eating disorders, migraine headaches, obesity, Parkinson’s Disease, and a variety of seizures in children under the age of 16.

Elan has agreed to pay $214.5 to resolve all allegations, with approximately $103 million of the settlement to go toward resolving civil allegations that the company violated the False Claims Act by causing false claims to be submitted to government healthcare programs for payment for off-label use of Zonegran.  The civil settlement resolves a qui tam whistleblower lawsuit filed on behalf of the Government in the District of Massachusetts.  As a reward for disclosing Elan’s fraud to the Government, the whistleblower will receive a $10 million share of the overall settlement.



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