Depakote Class Action: Epilepsy Drug Investigated For Birth Defects

The Depakote class action has emerged recently, targeting the manufacturer’s anticonvulsant drug that has been prescribed to hundreds of thousands of Americans to treat epilepsy, bipolar mania, and migraines. The Depakote class action was filed in response to birth defects allegedly caused by exposure to Depakote in the womb. Including cardiovascular defects, brain defects, spina bifida and other spinal defects, face or skull defects, as well as polydactyly. Depakote is the brand name for the generic drugs divalproex sodium, valproate, and valproic acid. It is manufactured by Abbott Laboratories, the defendant in this suit.

The plaintiffs in the Depakote class action are suing Abbott for failure to warn them of the possible side effects. In 2009, the FDA began requiring Abbott to place a warning label on the drug. Ensuring that women of childbearing age are aware of the risk of major birth defects. The class of plaintiffs is made up of women who gave birth to children while using Depakote prior to the inclusion of the warnings.

The FDA decided to issue this requirement after analyzing data from the American Antipileptic Drug Pregnancy Registry. It indicated that over 10 percent of women who took an average of 1,000 mg per day of Depakote, or any of the generic version of it, gave birth to children with some sort of defect. The complaint states that Abbott knew or should have known of the risks of taking Depakote for pregnant women prior to the FDA’s decision. Subsequently, they failed to warn consumers of this risk.

No cases have been litigated to completion involving drug defects and Depakote. However, similar cases have been litigated involving the anti-depressant Zoloft, and drug defects it allegedly caused. In the Zoloft case, it was found that Pfizer, the manufacturer of Zoloft, had indeed placed a sufficient warning on its product. This label warned physicians to weigh the benefits of the medicine against the risks to pregnant women before prescribing it.

In order to prevail, the plaintiffs in the Depakote class action will prove causation between the defects and the drug. As well as that Abbott knew of or reasonably should have known of these risks. Subsequently failing to warn users of them. In order to prove causation or a lack thereof, both parties will want to hire perinatal epidemiology experts. Particularly ones who have extensively studied the effects of drugs, such as Depakote, on human fetal development.