A class action suit has been filed against the manufacturer of Depakote, a commonly used anti-convulsant medication used to treat hundreds of thousands of people with epilepsy, bipolar disease, and migraines. The focus of the legal action is the risk of birth defects that the plaintiffs attorneys alleged have been caused by exposure to Depakote in the womb. The defects include brain damage, spina bifida, face and skull defects, as well as polydactyly syndrome. The generic name for the drug is divalproex sodium, valproate, and valproic acid, manufactured by Abbott Laboratories.

The claim is that Abbott Labs did not warn patients of this possible side effect of Depakote. In 2009 the FDA required a warning label on the drugs to ensure that women of childbearing age were aware of the risks of major birth defects. The class action lawsuit is on behalf of women who gave birth to children while using Depakote before the warnings were required. An FDA study at the time of the requirement found that more than 10% of women who took a specific level of the drug gave birth to children with at least one of the defects.

To date, no cases have gone to trial regarding the Depakote-birth defect claims, but similar cases have been litigated involving the anti-depressant drug Zoloft. Juries found that the manufacturer of Zoloft knew or should have known of the potential for birth defects but failed to warn consumers and physicians about the risks. To prevail in the Depakote lawsuit, the plaintiffs will have to prove that the drug actually caused, or increased the risk of, serious birth defects. Epidemiologists – doctors who study patterns, causes and effects of health and disease conditions in defined populations – will undoubtedly be key experts that both sides will use to support their position.