Plaintiff Sarah G. of Pennsylvania has filed a Depakote lawsuit on behalf of herself and her minor child, who was born with severe birth defects. She is suing AbbVie and AbbVie’s parent company, Abbott Laboratories, the makers of Depakote.

Sarah says she took Depakote as a treatment for bipolar disorder while she was pregnant. She gave birth to her child in April 1998.

According to the Depakote lawsuit, the child was born with several significant physical and behavioral impairments, including a large ventricular septal defect (a heart defect). The child’s behavioral and cognitive impairments include motor delays, impaired language and math skills, possible dyslexia, and Attention Deficit Hyperactivity Disorder.

Sarah attributes all these birth defects to the Depakote she took while pregnant.

Depakote’s History

Depakote’s active ingredient, valproate, first entered the U.S. market in 1978 under the brand name Depakene. Depakene was approved for the treatment of seizures. Abbott Laboratories then introduced Depakote in its current form in 1983. The FDA has also approved it as a seizure treatment.

Sarah’s Depakote lawsuit says reports of an association between valproate and birth defects appeared in medical literature as early as 1980. She alleges that by 1983, scientists had reported finding a 20-fold increase in the incidence of spina bifida among infants whose mothers took valproate during pregnancy – a rate of incidence as high as 5 percent, compared to 0.1 percent in the general population.

The Depakote birth defects lawsuit says that by 1984, medical literature recognized “fetal valproate syndrome” as a real condition associated with “characteristic facial features, major malformations, learning disabilities and central nervous system dysfunction, among other disorders.” The complaint alleges valproate exposure during early pregnancy can also lead to “cleft palates, cardiac defects, hypospadias and skeletal abnormalities.”

Sarah contends that the labeling for Depakote from 1978 to 2006 did not accurately represent the risk of Depakote birth defects, saying that the label described the risk as only a possibility, while it was common to a whole class of drugs.

Sarah’s allegations are consistent with a recent warning issued by the FDA. In May 2013, the FDA released a Drug Safety Communication warning that pregnant women should not take valproate products for migraine headaches because of an increased risk of lower IQ scores in offspring. The FDA downgraded valproate’s pregnancy category as a migraine treatment from “D” to “X,” meaning “the risk of use in pregnant women clearly outweighs any possible benefit of the drug.”

For treatment of epilepsy and manic episodes of bipolar disorder, the FDA kept valproate in pregnancy category “D,” which means “the potential benefit of the drug in pregnant women may be acceptable despite its potential risks.” The FDA endorses that particular treatment only where “other medications are not effective in treating the condition or are otherwise unacceptable.”

The FDA based its decisions on results of the Neurodevelopmental Effects of Antiepileptic Drugs, or NEAD, study. That study found that by age 6, children whose mothers took valproate while pregnant had reductions in IQ of eight to 11 points compared to children whose mothers had taken other anti-epileptic drugs.

Sarah’s Depakote lawsuit raises claims for defective design, inadequate warning, negligence, misrepresentation, fraud, and breach of warranty. She seeks compensation for past and future expenses such as medical bills and child care, and for non-economic damages such as pain and suffering and emotional distress. She also seeks an award of punitive damages and attorneys’ fees.

The Depakote Lawsuit is Case No. 13:15-cv-00494, in the U.S. District Court for the Southern District of Illinois.