Depakote Class Action Lawsuit Filed Over Birth Defect Risks

A class action lawsuit has been filed against Abbott Laboratories on behalf of parents of children who were born with birth defects or malformations after the epilepsy drug Depakote was used during pregnancy.

The Depakote class action lawsuit was filed March 22 in St. Clair County Circuit Court in Illinois. The plaintiffs allege that the drug maker failed to adequately warn doctors and patients about the potential risk of Depakote side effects, which has been linked to a number of serious and potentially fatal health problems for infants born to women who used the medication as early as the first trimester.

Depakote (valproic acid) is an anti-seizure drug approved by the FDA in 1983 for the treatment of epilepsy. It belongs to a class of drugs based on valproate; which includes Depacon, Stavzor, and the first drug in the class, Depakene, which was first approved in 1978. It is also often used to treat bipolar disorder and depression.

In 2006, the FDA added a “black box” warning about the potential risk of a Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.

In May 2010, researchers found that Depakote problems for infants could occur after using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child.

A growing number of families throughout the United States have filed a Depakote lawsuit involving claims the children suffered health problems such as spina bifida, cleft palate, heart defects and other malformations.