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Jury Awards $15M in Damages for Birth Defects Linked to Depakote

May 28, 2015

A St. Louis jury has awarded $15 million in damages to a Minnesota girl for birth defects the jury found were caused by the anti-epileptic drug Depakote her mother took during pregnancy.

Deliberations began last Friday and the unanimous verdict was returned on Tuesday. The jury must now decide whether to award punitive damages, the St. Louis Post Dispatch reports.

Attorneys for the child argued that drug maker Abbott downplayed the risks of Depakote. "Abbott steadfastly refused to communicate the true nature and extent of the risk in its product labeling and warnings to physicians and consumers," court documents say. The lawsuit also argues the drug was defectively designed and inadequately tested. The case was tried before Circuit Court Judge Steven Ohmer, the Post Dispatch reports.

The 12-year-old plaintiff has a number of birth defects including spina bifida. She is one of two dozen plaintiffs in the suit; some are from the St. Louis area. Abbott spun off its branded-drug business as AbbVie in 2013, but the new company was required to assume business-related liabilities that occurred before the spinoff, according to the company's annual report filed with the Securities and Exchange Commission. "[T]he commercial rights and associated responsibilities for Depakote passed to AbbVie," Abbott said in a statement, according to the Post Dispatch.

Depakote generated $1.5 billion in sales in the U.S. before 2007 when the drug’s patent expired. In 2013, the Food and Drug Administration (FDA) issued a safety announcement a safety announcement about the use in pregnancy of the class of drugs based on valproate sodium, the active ingredient in Depakote. The FDA found that pregnant women should not take valproate sodium to prevent migraines while pregnant. At the time of the safety alert, the FDA cited a study that found the drugs, including Depakote, could cause decreased IQ scores in children whose mothers take them during pregnancy. The FDA said the women with epilepsy or bipolar disorder should take Depakote only if other medications are not effective or otherwise unacceptable in treating the two conditions, according to the Post Dispatch. According to the FDA, the most common birth defects with Depakote affect the brain and spinal cord and include spina bifida and neural tube defects. These defects occur in one to two of every 100 babies born to mothers who use this medicine during pregnancy.

In 2012, Abbott agreed to a $1.5 billion settlement with the federal government for unlawfully promoting Depakote for uses not approved by the FDA. Abbott promoted the "off-label" use of Depakote for elderly patients with dementia and for individuals with schizophrenia. The drug, however, was approved only for the treatment of epilepsy, bipolar disorder and migraines, according to a 2012 statement from the Department of Justice. Doctors may prescribe a drug for any use they deem appropriate but drug makers may not legally market or promote a drug except for uses approved by the FDA.

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