A St. Louis, Missouri, jury has awarded a girl $15 million in damages for birth defects that she suffered as a result of the anti-epileptic drug Depakote that her mother took while pregnant.
The jury returned a unanimous verdict on Tuesday after starting deliberations on Friday. Jurors are now considering whether to award punitive damages. Drugmaker Abbott, Depakote’s manufacturer, was accused in the lawsuit of downplaying the dangers of the drug. The lawsuit also alleged that the drug was defectively designed and inadequately tested, according to the St. Louis Post-Dispatch (Post-Dispatch).
“Abbott steadfastly refused to communicate the true nature and extent of the risk in its product labeling and warnings to physicians and consumers,” the suit, obtained by Post-Dispatch, states.
According to the lawsuit, Maddison Schmidt, 12, has spina bifida and numerous other birth defects. The girl is one of two dozen plaintiffs in the suit. Abbott is named in the suit, though AbbVie Inc. would be the verdict’s financially responsible party, regulatory filings viewed by Post-Dispatch show. Abbott spun off its branded drug business as AbbVie Inc. in 2013, at which time it required the new company to assume business-related liabilities that occurred before the spinoff, according to the company’s annual report filed with the U.S. Securities and Exchange Commission, which Post-Dispatch obtained.
“With the separation the commercial rights and associated responsibilities for Depakote passed to AbbVie,” a statement provided by Illinois-based Abbott reads.
The U.S. Food and Drug Administration (FDA) issued a “safety announcement” in 2013 concerning pregnant women’s use of a class of sodium valproate drugs, including Depakote. The agency warned that expectant mothers should not use sodium valproate drugs to prevent migraines, as a then-recent FDA study had found that the drugs can decrease IQ scores in children, according to Post-Dispatch.
The agency also said at the time that Depakote and other sodium valproate drugs should only be used by pregnant women suffering with epilepsy or bipolar disorder if other medications are not effective or unacceptable for whatever reason in treating the conditions, Post-Dispatch reported.
In 2012, Abbott agreed to pay $1.5 billion to settle allegations by the federal government that the company unlawfully promoted Depakote for uses not approved by the FDA. The drug maker promoted Depakote for off-label use in elderly patients with dementia and in individuals with schizophrenia. A 2012 statement from the U.S. Department of Justice that was obtained by Post-Dispatch shows that Depakote was approved only for the treatment of epilepsy, bipolar disorder and migraine headaches.