ABINGDON, VIRGINIA – In a shocking turn of events, global healthcare company Abbott Laboratories Inc., pleaded guilty in May 2012 to unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration.
As part of its plea agreement with the federal government, the company agreed to pay $1.5 billion to resolve criminal and civil liability arising from the company’s conduct.
The company 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 these uses was FDA approved.
The company is currently on probation for this conduct and is implementing a series of changes designed to prevent off-label marketing in the future.
"The federal prosecution of Abbott Labs resulted in a total settlement of $1.5 billion, the largest single-drug settlement of an off-label pharmaceutical fraud case in Department history," said U.S. Attorney Heaphy today.
"Substantial cases like this one help deter waste, fraud, and abuse in our healthcare system. The Assistant United States Attorneys in the Western District of Virginia have a long, distinguished track record of successfully bringing cases against drug manufacturers. We will continue to prioritize healthcare fraud cases and ensure that federal healthcare dollars are responsibly utilized," he added.
The company’s guilty plea and settlement are a significant blow to the pharmaceutical industry, highlighting the importance of accountability and transparency in the development and marketing of prescription drugs.
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Key Facts
- State: Virginia
- Category: Drug Trafficking|Fraud & Financial Crimes
- Source: DOJ Press Release â†â€â€
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