Japanese pharmaceutical company Eisai, Inc. agreed to pay $11 million in civil damages under the False Claims Act to the United States and the States for the improper “off-label” marketing and billing of the anti-seizure drug Zonegran®, for the period of time after Eisai acquired the rights to the drug from Elan Corporation. A few months after Eisai settled, Elan settled its civil and criminal liabilities for its off label marketing for over $203 million (see related Elan settlement).
Our whistleblower client alleged that first Irish pharmaceutical manufacturer Elan and then later Japanese pharmaceutical company Eisai, which bought the rights to the drug from Elan in 2004, were liable for the off- label marketing. Zonegran, which was approved by the U.S. Food and Drug Administration (“FDA”) only for reducing seizures, was marketed for weight loss and mood stabilization as well. The drug was not approved for either of those uses, thus marketing the drug for those indications constituted off-label marketing.
The increase in drug prescriptions resulting from this off-label marketing not only caused improper billings to the federal and state governments, but it also undercut the authority of the FDA, which determines the safety and efficacy of drug products and approves (and limits) their uses.