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United States Files Complaint Against Forest Laboratories for Allegedly Violating the False Claims Act
Date:2/25/2009

by failing to disclose the results of the negative study. The same study was among those later considered by the FDA when it mandated that Forest add a "black box" warning to both the Celexa and Lexapro labels.

The Complaint alleges that Forest sought to induce physicians and others to prescribe Celexa and Lexapro by providing them with various forms of illegal remuneration, including cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment and other valuable goods and services, all in violation of the federal anti-kickback statute.

Neither Medicaid nor TRICARE ordinarily cover drugs for off-label uses unless the off-label use is for a medically accepted indication. The United States alleges that federal health care programs have paid thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest.

Prior to filing its Complaint, the government had intervened in two separate whistleblower actions against Forest that had been commenced under the qui tam provisions of the False Claims Act. The False Claims Act allows for private persons to file whistleblower suits to provide the government information about wrongdoing. Under the statute, if it is established that a person has submitted or caused others to submit false or fraudulent claims to the United States, the government can recover treble damages and $5,500 to $11,000 for each false or fraudulent claim filed. If the Government is successful in resolving or litigating its claims, a proper whistleblower can receive a share of between 15 percent and 25 percent of the amount recovered.

This investigation was conducted by the U.S. Attorney's Office for the District of Massachusetts, the Civil Division of the U.S. Department of Justice, the Federal Bureau of Inve
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SOURCE U.S. Department of Justice
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