A Texas mother has filed a Depakote birth defects lawsuit against Abbott Laboratories and Abbvie Inc., alleging that they knew fetal exposure to the anti seizure medication carried a high risk for birth defects yet hid the information from patients for 30 years.

Plaintiff Katherine O. filed the Depakote birth defects lawsuit on behalf of herself and her minor child who was born in 2004 with cognitive and neurological disorders. Katharine is accusing manufacturers Abbott Laboratories and Abbvie of failing to warn patients, especially women in childbearing years — that Depakote carries a 25 percent increased risk of adverse fetal outcome.

According to the Depakote lawsuit, the anti seizure medicine contains the active ingredient valproate which medical research has shown since 1980 to be a human teratogen, which causes birth defects. Despite knowing this information, the plaintiff alleges the makers failed to mention the risk on the warning label.

Katharine states that makers Abbott and Abbvie “claimed in the product labeling from 1978 until 2006 that any potential increase in birth defects from Depakote, Depakene, and other valproate products was only a possibility, and that the risk was common to the entire class of anti-epileptic drugs.”

Katherine says she took Depakote to treat her seizure disorder consistently throughout her pregnancy unaware of the risks she was placing on her unborn child. Katherine claims that the defendants knew by the time she was pregnant in 2003-2004 that Depakote should not be given to pregnant women yet she was not adequately warned.

Her child was born with a low IQ, severely diminished adaptive behavioral abilities and borderline intellectual functioning. Katharine alleges that her child will not be able to live on her own and will most likely be dependent on her mother throughout her life. Katherine claims that had she been warned of the likelihood of Depakote birth defects she would have pursued other treatment options during her pregnancy.

What is Depakote?

Depakote was first approved by the FDA in 1983 as a treatment for seizures but it quickly began being prescribed for other ailments including bipolar disorder, manic depression and migraines. The drug has been found to be an effective anticonvulsant medication because it increases the amount of neurotransmitter gamma aminobutyric acid (GABA) in the brain and helps prevent brain signals that lead to seizures.

The seizure medication is prescribed to millions of Americans each year and now comes with an FDA warning for birth defects. Depakote is considered an FDA Pregnancy Category D, meaning there is evidence that fetal exposure of the medication may cause birth defects but in some cases the benefits may outweigh the risks. 

Commonly reported Depakote birth defects include:

• Cleft palate
• Heart defects
• Spina bifida and other spinal defects
• Face or skull defects
• Brain defects

Birth Defect Lawsuits

Katherine is seeking more than $75,000 from Depakote manufacturers to help her financially provide for her child who will need special care throughout her life. Katherine claims that she would have not exposed her unborn child to the unnecessary risks of taking Depakote as there were safer treatment options on the market available to her.

This Depakote birth defects lawsuit joins the growing number of lawsuits currently being filed against Depakote makers Abbott Laboratories and Abbvie. 

The Depakote Birth Defects Lawsuit is Case No. 3:15-cv-00495-NJR-SCW in the U.S. District Court for the Southern District of Illinois.