Abbott Laboratories Settles with Texas on Off-Label Use of Drug

A company that unlawfully marketed an anti-seizure drug has settled with Texas and other states.

Texas Attorney General Greg Abbott today announced the resolution of a two-phase Medicaid fraud and deceptive marketing investigation into Abbott Laboratories.

The investigation focused on what Greg Abbott’s office called an unlawful promotional scheme regarding the sales of Abbott Laboratories’ anti-seizure drug Depakote.

The attorneys general assert that Abbott Laboratories promoted the off-label use of Depakote for treating schizophrenia, agitated dementia, and autism. Depakote has not been approved for use for anything other than treating seizures by the U.S. Food and Drug Administration.

In a separate Medicaid fraud case, the company is believed to have unlawfully exploited the state’s Medicaid program in marketing Depakote from 1998 until 2008.

Under the terms of the settlement, Abbott Laboratories must not make false claims about Depakote’s benefits, or promote it for off-label uses. The company must also ensure that financial incentives do not promote off-label use of the drug.

The settlement allocates $14 million to the State of Texas for improper Medicaid overpayments, and an additional $5.8 million for violations of the Deceptive Trade Practices Act.