Abbott Labs Fined $700M for Off Label Marketing

off label marketing For off label marketing of the drug Depakote, a federal district judge last week ordered Abbott Laboratories to pay a $500 Million criminal fine, to forfeit $198.5 Million, and to pay $1.5 Million to the Virginia Medicaid Fraud Control Unit.

In May, Abbott Laboratories pled guilty to off-label marketing of Depakote for dementia and schizophrenia, uses not approved by the FDA.  It also settled allegations that it marketed Depakote for psychiatric illnesses in children, including conduct disorders, attention deficit disorder and autism, and other psychiatric illnesses in adults, including depression, anxiety, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol and drug withdrawal, agreeing to pay $1.6 Billion.

Whistleblowers get a share of these settlements as a reward for reporting fraud under the False Claims Act.

Explains the LA Times:

Lawsuits filed by four groups of whistle-blowers alleged that Abbott marketed the drug for off-label uses, including for treatment of schizophrenia, dementia and autism. The Justice Department intervened in those suits to determine whether the company’s marketing of the drug violated civil and criminal laws, including fraudulently charging Medicare and Medicaid.


Those lawsuits alleged that Abbott encouraged and trained its salespeople to market Depakote off-label to nursing-home directors, geriatric doctors and other long-term-care providers. The company also gave doctors illegal kickbacks to talk about off-label uses of the drug to boost sales, according to the whistle-blower suits, which were filed in federal courts in Illinois, Virginia and the District of Columbia.

Although doctors are allowed to prescribe drugs for off-label uses, or uses that have not been approved by the Food and Drug Administration, it is illegal for drug companies to market them for such uses.  When drug companies engage in off label marketing, false claims are made to the government, which purchases the drugs through Medicare and Medicaid programs.  Depakote has only been approved for certain types of seizures, for manic episodes of bi-polar patients, and to prevent migraines.

“Abbott unlawfully targeted a vulnerable population, the elderly, through its off-label promotion.  The court’s sentence makes clear that those who engage in such conduct will be prosecuted and held accountable,” said Timothy Heaphy, U.S. Attorney for the Western District of Virginia.

This is the second-largest criminal fine for an individual drug.

Sources:  U.S. Department of Justice Press Release 10/2/2012 and L.A. Times “Abbot Labs Agrees to pay $1.6 billion to settle Depakote cases”

If you have non-public information about off-label pharmaceutical marketing or other pharmaceutical fraud, a whistleblower attorney can help you determine whether you have a case and can guide you through the steps that need to be taken.  Call 1-877-255-2676 today or contact us.

For more on what appears to be a disturbing trend of off label marketing to children, especially children with ADD, see Off-label Drug Marketing of Antipsychotic Drugs for Children? and GlaxoSmithKline to Pay $3 Billion in Pharmaceutical Whistleblower Case



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