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Whistleblower to receive over $11 million as part of DOJ settlement with pharmaceutical companies to resolve allegations of FCA violations

Irish pharmaceutical manufacturer Elan Corporation PLC has agreed to pay $102,890,517 to resolve civil allegations under the False Claims Act (FCA) and related state statutes that the company illegally promoted the drug Zonegran off-label and caused false claims to be submitted to government health care programs for a variety of uses that were not medically accepted indications and, therefore, not covered by those programs, the DOJ has announced. In a separate civil settlement, Japanese drug marketer Eisai Inc, which purchased the drug from Elan, will pay $11 million to resolve civil liability for off-label marketing of Zonegran.

The federal share of the civil settlement with Elan is $59,491,477, and the state Medicaid share of the civil settlement is $43,399,040. The civil settlement with Elan resolves a whistleblower lawsuit filed by Dr. Lee Chartock, a Massachusetts physician, under the qui tam or whistleblower provisions of the False Claims Act that is pending in the District of Massachusetts (Dkt No. 04-11594-RWZ). As part of the resolution with Elan, Dr. Chartock will receive payments totaling more than $10 million from the federal share of the civil recovery. The civil settlement with Eisai also resolves allegations in the Chartock action. Dr. Chartock will receive payments totaling more than $1 million from the federal share of the Eisai civil recovery.