A mother filed a Depakote lawsuit on behalf of her child after the child was born with birth defects allegedly caused by the epilepsy medication.

Plaintiff Katherine G. took Depakote during her pregnancy in order to treat her bipolar disorder. (Although the drug is more commonly used as an epilepsy medication, many patients use it to treat bipolar disorder as well.) In March 2002, C.K. was born with Depakote birth defects briefly described in the Depakote lawsuit as “several significant congenital anomalies and cognitive and behavioral impairments.”

Lack of Depakote Birth Defect Warning

The Depakote lawsuit claimed that the drug manufacturer knew, or should have known, that Depakote use during pregnancy could lead to birth defects at the time that Katherine took the drug. It was suggested that the drug manufacturer could have become aware of Depakote side effects as early as 1980, shortly after the drug was released.

No official warning was added to Depakote’s warning label until 2011. The Depakote lawsuit alleged that even this warning was not strong enough stating, “Defendants still did not warn that Depakote should be a drug of last resort or completely contraindicated in women of childbearing potential.”

Finally, in 2013, a black box warning was added to the label warning reading, “Valproate can cause major congenital malformations, particularly neural tube defects (e.g. spinia bifida). In addition, valproate can cause decreased IQ scores following in utero exposure.” The Warning continued to read that the drug should only be used if other epilepsy medications have failed.

Birth defects associated with Depakote (valproate) include, according to the Depakote lawsuit, “cleft palates, cardiac defects, hypospadias and skeletal abnormalities,” in addition to other birth defects.

Depakote Side Effects

Many women who take Depakote are required to take the drug daily in order to maintain an effective treatment. This presents a danger when a woman becomes pregnant as many are required to take the epilepsy medication for their safety as well as for the safety of the fetus. This necessity combined with the lack of warning about Depakote birth defects has put many women at risk of giving birth to children with severe birth defects.

In fact, one study showed that women who used Depakote during pregnancy were 25 percent more likely to give birth to a child with a birth defect if they took the drug every day while pregnant.

Katherine claimed that had she been aware of Depakote side effects before pregnancy, she would have attempted other treatment options to avoid the risk to her child. The Depakote lawsuit is seeking compensation for medical treatment, special education, speech and language therapy, occupational therapy, and many other costs that were allegedly caused by Depakote birth defects.

This Depakote Lawsuit is Case No. 3:15-cv-00467, in the U.S. District Court for the Southern District of Illinois.