Drug Maker Fined For Misbranding Depakote

The pharmaceutical manufacturer Abbott Laboratories, Inc., was ordered this month to pay a $500 million criminal fine after pleading guilty to unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective, the U.S. Justice Department announced in a press release. It’s the second largest criminal fine for a single drug.

The criminal fine handed down by U.S. District Judge Samuel G. Wilson of the Western District of Virginia is part of a larger $1.5 billion resolution of civil and criminal actions involving Abbott ‘s illegal promotional activity. Abbott promoted Depakote to control behavioral disturbances in dementia patients and to treat schizophrenia, even though the FDA had not approved either use, according to the Justice Department. The drug maker pleaded guilty earlier this year to a misdemeanor of misbranding Depakote in violation of the federal Food, Drug and Cosmetic Act.

The parallel civil settlement resolved a broader range of allegations involving Abbott’s off-label marketing of Depakote.

Drug makers have a legal responsibility to make and market drugs that are safe and effective when taken as directed and to provide adequate warnings of side effects. Pharmaceutical companies that misbrand drugs and make and market drugs that cause harmful side effects should be held to account.

The Food and Drug Administration approved Depakote, an anti-seizure and mood-stabilizing drug, to treat certain seizures in adults and children over age 10. But some serious side effects, including birth defects, are associated with the drug in women who become pregnant.

Depakote can cause spina bifida in children whose mothers used the drug during early pregnancy. Spina bifida is a birth defect affecting the brain and spinal cord. Approximately 1 percent to 2 percent of children born to women with epilepsy taking Depakote in the first 12 weeks of pregnancy had these defects, according to data from the U.S. Centers for Disease Control. The drug’s warning label says that Depakote also has been linked with other birth defects, including defects of the heart, bones and other parts of the body.

The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by pharmaceutical manufacturers and dangerous drugs. We have helped thousands of clients nationwide receive full and fair compensation from pharmaceutical companies and medical device manufacturers whose products caused harm. If you suspect that you or a loved one has been harmed by an unsafe drug, contact us at 314-932-3232 or use our online contact form for a free case review.

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