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AG announced Depakote settlement

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Attorney General Greg Zoeller announced Monday that Indiana will recoup millions of dollars in two separate settlements of multistate lawsuits against pharmaceutical maker Abbott Laboratories over illegal off-label marketing of its drug, Depakote.

In a case investigated by the Attorney General’s Consumer Protection Division, Indiana will receive $1,978,345 in the settlement with Abbott Laboratories. The Indiana settlement is part of a larger $100 million settlement with 44 other states and the District of Columbia that is the largest consumer protection-based pharmaceutical settlement ever reached.

In a separate action, the AG’s Medicaid Fraud Control Unit on Monday joined in a multistate settlement that included the federal government to resolve allegations that Abbott Laboratories engaged in illegal marketing practices involving Depakote that resulted in false claims being submitted to the Medicaid program for reimbursement. Indiana will recover $4,923,742.07 in the Medicaid settlement, as part of a larger $1.5 billion civil and criminal settlement between Abbott and the federal government, 48 other states and the District of Columbia. According to the U.S. Department of Justice, the $1.5 billion settlement is the second-largest recovery ever from a pharmaceutical company through a single civil-and-criminal settlement.

“Pharmaceutical companies that illegally market drugs for off-label purposes must be held accountable for their actions and this settlement should serve as a warning to others,” Zoeller said. “The substantial payments to states under these dual agreements and the marketing restrictions imposed will address many concerns identified in the parallel investigations, including prohibiting any false representation of the drug in the future.”

Depakote is approved by the U.S. Food and Drug Administration for treatment of seizure disorders, mania associated with bipolar disorder and prevention of migraines. While it is not illegal for physicians to prescribe drugs for off-label uses the FDA has not approved, it is unlawful for drug companies to market drugs to doctors, healthcare providers and institutions for unapproved uses.

Additional information about the Depakote complaints is available on the AG’s website.


 

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  • How?
    What, when, where, why and how. It would have been interesting to know how Abbott was marketing off label (for what use).

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