Abbot Hit With Massive Off-Label Fines

Abbott Laboratories was just hit with a massive fine for off-label practices, the second-largest such criminal fine for a single medication.

A federal district judge in Virginia ordered Abbott Laboratories to pay a $500 million criminal fine and a forfeiture of $198.5 million, said LegalTimes. U.S. District Court Judge Samuel Wilson of the Western District of Virginia also ordered the pharmaceutical company to pay another $1.5 million to the Virginia Medicaid Fraud Control Unit.

The fines were levied against Abbott following its guilty plea last May to a criminal misdemeanor charge over misbranding of its marketing of the drug, Depakote. The accusations include that Depakote, an anti-seizure medication, was promoted off-label to control behavioral issues in patients diagnosed with dementia and for the treatment of schizophrenia, said LegalTimes. A Justice Department (DOJ) press release stated that neither of these uses has been approved by the U.S. Food & Drug Administration (FDA).

In a civil settlement, Abbott also agreed to pay $800 million to the federal government and several states to resolve claims that its practices resulted in the submission of false claims to government healthcare programs, said LegalTimes. Abbott, under the ruling, has been required to enter into a five-year probationary period. Under this agreement, Abbott’s CEO and its board of directors must personally certify Abbott is in compliance with the law.

Abbott has also entered a five-year corporate integrity agreement with the Office of the Department of Health and Human Services. This mandates increased accountability and transparency, said LegalTimes, and also includes that monitoring activities be accomplished both internally and by independent, external reviewers.

Stuart Delery, DOJ acting assistant attorney general for Civil Decision, said in the Department’s release that, “Today’s sentencing confirms that the resolution we reached with Abbott in May is the right result. And it emphasizes the importance of the U.S. government’s coordinated efforts to combat healthcare fraud.”

In its written statement, Abbott spokesman, Scott Stoffel, said “We’re pleased to resolve this matter and look forward to the successful completion of our obligations under the agreements,” wrote LegalTimes.

We previously wrote that 26 women filed lawsuits claiming the makers of the Depakote illegally marketed the drug for off-label purposes and failed to warn of the side effects of the drug. Each of the women claimed they were prescribed and took Depakote just before getting pregnant or during the first trimester of their pregnancy and that the drug caused them to give birth to children with a wide array of severe and some life-threatening birth defects.

It is illegal for Abbott, or any drug maker, to market a drug for uses not approved by the FDA, although physicians are free to prescribe drugs for off-label purposes.

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