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Otsuka to Pay More Than $4 Million to Resolve Off-Label Marketing Allegations Involving Abilify
Date:3/27/2008

promoted Abilify off-label for the treatment of dementia-related psychosis.

From the global civil settlement amount of $4 million, the federal recovery is approximately $2.3 million. Otsuka also will pay approximately $1.7 million to the Medicaid programs in the participating states. Also, as part of today's settlement, Otsuka entered into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.

This settlement resolves the remainder of the allegations made in a False Claims Act qui tam action entitled United States ex rel. Piacentile v. Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co., Ltd., Civil Action No. 05-10196-MLW (D. Mass.). The Department of Justice settled claims based on the same allegations with BMS in September 2007.

The False Claims Act allows for private persons to file a qui tam or whistleblower suit on behalf of the government. If the government is successful in resolving or litigating its claims, the whistleblower may receive a share of the recovery. The whistleblower, Joseph Piacentile, a physician, will receive a total of approximately $348,000 as his share of the federal recovery amount from today's settlement, and an additional share of the state settlement amount.

This matter was investigated by the Boston offices of the Office of Inspector General for the Department of Health and Human Services, the Federal Bureau of Investigation and the Food and Drug Administration's Office of Criminal Investigations, and was handled by United States Attorney's Office for the District of Massachusetts and the Department of Justice Civil Division.


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SOURCE U.S. Department of Justice
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