After pleading guilty to a misdemeanor violation of illegally promoting Zonegran, an epilepsy drug, Elan Pharmaceutics will pay $97 million in criminal fines, according to a news release from the Federal Bureau of Investigations.
Elan violated the Food Drug and Cosmetic Act by marketing the epilepsy drug for off-label uses, including psychiatric disorders, migraine headaches, eating disorders, weight loss, Parkinson's Disease and seizures in children under the age of 16.
In addition to the criminal fines, Elan will forfeit $3.6 million in substituted assets. It has also agreed to pay $102 million to resolve civil allegations under the False Claims Act. The federal share of the civil settlement is $59 million and the Massachusetts Medicaid share of the civil settlement is $43 million.
The company's settlement also resolves a whistleblower lawsuit pending in Massachusetts. As part of the resolution, the whistleblower will receive payments totaling more than $10 million from the federal share of the civil recovery.
Read the FBI release on Elan Pharmaceuticals.
Read more about pharmaceutical fraud:
- Former Johnson & Johnson Employee Files Whistleblower Suit Alleging Medicaid Fraud
- 5 Pharmaceutical Drugmakers Pay North Carolina $25M for Off-Label Marketing, Kickbacks
- DOJ Intervenes in Suits Against Illinois' Abbott Laboratories For Off-Label Drug Marketing
Elan violated the Food Drug and Cosmetic Act by marketing the epilepsy drug for off-label uses, including psychiatric disorders, migraine headaches, eating disorders, weight loss, Parkinson's Disease and seizures in children under the age of 16.
In addition to the criminal fines, Elan will forfeit $3.6 million in substituted assets. It has also agreed to pay $102 million to resolve civil allegations under the False Claims Act. The federal share of the civil settlement is $59 million and the Massachusetts Medicaid share of the civil settlement is $43 million.
The company's settlement also resolves a whistleblower lawsuit pending in Massachusetts. As part of the resolution, the whistleblower will receive payments totaling more than $10 million from the federal share of the civil recovery.
Read the FBI release on Elan Pharmaceuticals.
Read more about pharmaceutical fraud:
- Former Johnson & Johnson Employee Files Whistleblower Suit Alleging Medicaid Fraud
- 5 Pharmaceutical Drugmakers Pay North Carolina $25M for Off-Label Marketing, Kickbacks
- DOJ Intervenes in Suits Against Illinois' Abbott Laboratories For Off-Label Drug Marketing