Federal Judge Accepts Misbranding Case Settlement Regarding Allegedly Illegal Off-Label Marketing of Depakote, the Consumer Justice Foundation Reports

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The Consumer Justice Foundation, a for-profit corporation whose team of professional consumer advocates aspire to provide the public with free online information regarding the potential dangers of using certain prescription medications, has a Web site URL located at http://www.depakotebirthinjury.com. The CJF hereby alerts the public that a federal judge in Virginia has accepted the terms of the settlement between the Department of Justice and Abbott Laboratories regarding the allegedly illegal off-label marketing of the anticonvulsant medication Depakote. The settlement will require Abbott Laboratories to pay a total of $1.6 million in fines, penalties and damages.

The Consumer Justice Foundation, a for-profit corporation whose team of professional consumer advocates is dedicated to providing consumers with free online educational resources regarding the potential dangers of using certain medications, hereby announces that a federal judge in Virginia has accepted the terms of a settlement negotiated by Abbott Laboratories and the Department of Justice. This settlement concerns charges regarding the allegedly illegal practice of marketing its anticonvulsant medication Depakote for off-label purposes.

Specifically, the case was known as USA v. Abbott Laboratories and it was filed in the Western District of Virginia (Abingdon). It was assigned a case number of 1:12-cr-00026-SGW-1 and Judge Samuel G. Wilson oversaw the proceedings and ultimately approved the terms of the Depakote lawsuit settlement that was successfully negotiated.

This settlement concerned a total payout by Abbott Laboratories of $1.6 billion. $700 million of that total is to be paid for fines and other costs associated with this alleged illegal marketing of Depakote. This includes $100 million that will be paid to different states across the country to resolve consumer protection matters within those jurisdictions. Finally, $800 million will be paid by Abbott Laboratories for a civil settlement with state and federal officials.

This entire Depakote lawsuit issue concerned allegations that Abbott Laboratories engaged in illegal marketing practices regarding this drug that has been approved by the FDA for problems that include epilepsy and migraine headaches. However, representatives of Abbott Laboratories allegedly engaged in the marketing of Depakote to senior centers and to other facilities for use with such conditions as dementia.

Depakote has never been approved by the FDA for such uses, which constitutes the term of marketing for ‘off-label’ uses. Using drugs for purposes other than what they were approved for is illegal and can lead to both civil and criminal liability for those who engage in this conduct. As such, Abbott Laboratories’ alleged misconduct was classified as a misdemeanor by the court.

About the Consumer Justice Foundation

The Consumer Justice Foundation, whose Web site is located at http://www.consumerjusticefoundation.com, is a public resource that's been built and maintained by a group of concerned professionals who want to provide general information for consumers regarding the potential dangers involved with the use of Depakote while pregnant. This resource is not to be considered as medical or legal advice, which should only be dispensed by a licensed medical doctor or a Depakote lawyer.

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Faith Anderson
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