Abbott Laboratories has lost its first Depakote lawsuit, after a jury in St. Louis, Mo., ordered it to pay $38 million in damages to a Minnesota girl who was born with spina bifida and other birth defects which allegedly developed from her mother’s use of the epilepsy medication during her pregnancy.

The jury hearing the case of Maddison S. found that the girl’s family deserved the $38 million award because of the Depakote birth defects and disagreed with Abbott’s contention that it adequately warned patients of the risks of taking Depakote while pregnant.

According to court documents filed in St. Louis Circuit Court, the verdict was rendered on May 26, at which time the jury awarded the now 12-year-old girl $15 million in compensatory damages. Three days later, the jury ordered Abbott to pay an additional $23 million in punitive damages.

FDA Warns of Depakote Risks

Depakote (also known as valproate or valproic acid) is a popular drug used to treat epilepsy and manic episodes of bipolar disorder. However, there are reportedly many Depakote birth defects associated with the anti-convulsant, such as spina bifida, that have resulted in Depakote lawsuits.

The U.S. Food and Drug Administration (FDA) classified Depakote into pregnancy category D due to its likelihood of causing serious and potentially life-threatening birth defects.

In December 2009, the FDA warned of an increased risk of neural tube defects, such as spina bifida, and other major birth defects in babies exposed to valproate medications prior to birth.

The FDA alert was prompted by data from the National Antiepileptic Drug Pregnancy Registry which indicated the rate of major malformations in babies born to women taking valproate was almost 4 times higher than the rate of major malformations in babies born to women taking a different antiepileptic drug.

In 2013, the federal agency issued a “safety announcement” about pregnant women’s use of a class of drugs based on valproate sodium, which includes Depakote.

The FDA found that pregnant women should not take valproate sodium to prevent migraines while pregnant. At the time, the FDA cited a recent study that found the drugs, including Depakote, can cause decreased IQ scores in children.

The FDA also said the drug should only be taken by pregnant women with epilepsy or bipolar disorder if other medications are not effective or otherwise unacceptable in treating the two conditions.

Depakote Lawsuit Claims

Abbott is currently facing some 800 Depakote lawsuits, all alleging the drug company hid the association between the anti-seizure medication and birth defects. Among other allegations, plaintiffs assert that Abbott refused to communicate the true nature and extent of the birth defect risk in its Depakote labeling and warnings to physicians and consumers. They also assert that the drug was defectively designed and manufactured.