Abbott Labs has pleaded guilty and has agreed to pay $1.5 billion to ends its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote. Abbott pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of those uses was FDA approved. Abbott admitted that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients despite the absence of scientic evidence that Depakote was safe and effective for that use. In addition, from 2001 to 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia even after clilnical trial failed to demonstrate that adding Depakote was any more effective than an atypical antipsycholtic drug alone for that use. The FDA had approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines. In addition, in 1999, Abbott was forced to discontinue a clinical trial of Depakote in the treatment of dementia due to an increased incidence of adverse events including somnolence, dehydration and anorexia experienced by the elderly study participants. Also, Abbott entered into contracts that provided long term care pharmacy providers with payments of rebates based on increases in the use of Depakote in nursing homes serviced by those providers. The cases arise from four lawsuits filed in federal court under the qui tam or whistleblower provisions of The False Claims Act which allow a private citizen to bring a civil action on behalf of the United States and share in any recovery. Those whistleblowers will receive $85 million from the federal share of the settlement.