ALM Properties, Inc.
Page printed from: Corporate Counsel
Select 'Print' in your browser menu to print this document.
Judge Hits Abbott Laboratories with $700M in Fines for Off-Label Drug Marketing
A federal district judge inVirginia on Monday hit Abbott Laboratories with the second-largest criminalfine for a single drug.
The pharmaceutical company wasordered by U.S. District Court Judge Samuel Wilson of the Western Districtof Virginia to pay a criminal fine amount of $500 million, a forfeiture of$198.5 million, and $1.5 million to the Virginia Medicaid Fraud Control Unitfor marketing the drug Depakote for uses not approved as safe and effective bythe U.S. Food and Drug Administration.
Depakote was being promoted tocontrol behavioral disturbances in dementia patients and to treatschizophrenia. According to a Justice Department press release, these uses werenever approved by the FDA.
The fines are connected withAbbotts guilty plea to a criminal misdemeanor charge for misbranding last May.
Abbott also entered a civilsettlement agreement under which it agreed to pay $800 million to the federalgovernment and several states to resolve claims that its practices caused falseclaims to be submitted to government healthcare programs.
The ruling also required Abbott toenter into a five-year probationary period. As a result, every year Abbott'sCEO and board of directors will need to personally certify that the company iscomplying with the law.
Abbott has also agreed to enter afive-year corporate integrity agreement with the Office of the Department ofHealth and Human Services that requires enhanced accountability andtransparency, as well as monitoring activities conducted by internal andindependent external reviewers.
Stuart Delery, acting assistantattorney general for the DOJs Civil Decision, said in the DOJ releasethat, Todays sentencing confirms that the resolution we reached withAbbott in May is the right result. And it emphasizes the importance of the U.S.government's coordinated efforts to combat healthcare fraud.
In a written statement, Abbott spokesman Scott Stoffel said the company was happy to resolve the matter.
"Abbott takes our responsibility to our patients and health care providers very seriously and has comprehensive compliance and training programs," said Stoffel. "We're pleased to resolve this matter and look forward to the successful completion of our obligations under the agreements."
This article originally appeared as a post on The BLT: The Blog of LegalTimes.