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Drug & Device News

By ALM Staff | Law Journal Newsletters |
November 29, 2012

Huge Settlement in Misbranding Case

Federal District Court Judge Samuel Wilson on Oct. 1 imposed a massive fine on Abbott Laboratories for marketing its drug, Depakote, for uses never approved by the U.S. Food and Drug Administration (FDA). For promoting Depakote as a treatment for schizophrenia and as means of controlling undesirable behavior in dementia patients, the drug manufacturer was ordered to pay a fine of $500 million, to forfeit nearly $200 million, and to pay the Virginia Medicaid Fraud Control Unit $1.5 million. These amounts are in addition to the $800 million the company has already pledged to pay the federal government and a number of states to resolve claims that Depakote's fraudulent marketing caused false claims to be filed with those entities. According to the U.S. Department of Justice for the Western District of Virginia, which announced the judgment, this is the second-largest criminal fine of all time for the misbranding of a single drug.

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