Depakote Birth Defects—Autism Lawsuits Next?

Birmingham, ALOver the years many parents have wondered whether Depakote birth defects include autism and ADHD—and whether they can file a Depakote lawsuit. Physiological birth defects such as cleft palate and spina bifida have been directly linked to Depakote. Since the FDA’s warning (June 30), birth defects from the anti-seizure drug could also include developmental delays and learning disabilities.

Andy Hollis of Hollis, Wright, and Couch, PC, is keeping abreast of new research and studies to ascertain whether they directly link autism to the taking of Depakote. "There definitely have been studies that link cognitive and other developmental disabilities associated with the brain," says Hollis. "The jury's still out in regard to autism and ADHD but not other cognitive causes that occur because of taking Depakote by a mother during pregnancy. I have taken cases where there has been brain damage, severe learning disabilities and all that is associated with that."

Warnings of Depakote's (valproic acid) physiological birth defects are clearly described in the drug label, but cognitive problems, including autism, are so far not mentioned. (Currently manufactured by Abbott Laboratories, Valproic acid is the generic form of Depakote, which is classified as a pregnancy category D medication. Since FDA approval in 1983, Depakote is estimated to have been used by over 2 million people to treat epilepsy, migraines, seizures and bipolar disorder. Valproic acid is now one of the most commonly prescribed antiepileptic drugs available.)

As well as the FDA warning in June, a study published in the Journal Neurology found a correlation between pregnant epileptic women who took the active ingredient in Depakote and autism in their children. The study included 632 children from the womb to birth to childhood for a period of six years—2000 to 2006. About half the children were exposed to a number of epilepsy drugs in the womb, while the other half were not. Researchers found that children who were exposed to the drug sodium valproate (Depakote) were seven times more likely to later develop autism than the children who were not exposed to any epilepsy drug.

Statistically, only nine of the 632 children received an autism diagnosis. In other words, this study did not show that Depakote is the cause of autism. Rather, doctors suggest that autism develops because the mother, during pregnancy, is not taking the drug. "Prolonged seizure could cause blood flow problems to the baby, which could cause injury," said Dr. Michael Goldstein, with Western Neurological Associates in Salt Lake City.

How does that explain complaints from the following parents whose children have been diagnosed with developmental problems—when the mothers took Depakote during their entire pregnancy?

"A neurologist prescribed Depakote to control epilepsy and I took it during the pregnancies of both my sons," says Karin. "They have both been diagnosed with fetal valporate syndrome, Asperger Syndrome, and Autism Spectrum Disorder. My sons have to live with permanent, developmental disabilities caused by Depakote. Expenses alone include diagnosis, treatment, therapies, educational support and other lifelong supports and services."

Monica says she was prescribed Depakote 1000 mg during her pregnancy—she had no idea that birth defects were side effects. "My child's injuries include growth retardation, severe developmental delay, and several physiological defects.”

"My wife was on Depakote during her pregnancy and our son has been diagnosed with autism and ADHD," says Anthony. This has caused a huge emotional drain on his family and more… "There is of course all the time and effort to get all the therapy he needs and finding a special school to suit his educational needs…"