On May 27, 2015, a St. Louis jury ordered Abbott Laboratories to pay $38 million to a girl who suffers from spina bifida after her mother took the anti-seizure medication Depakote during pregnancy. The verdict includes $23 million in punitive damages. The jury found the drug maker failed to adequately warn about risks of birth defects from ingestion of Depakote during pregnancy.
Depakote was initially approved by US Food and Drug Administration in 1978 as a treatment for epilepsy. It was later approved for use in the treatment of bipolar disorder and migraines. Depakote has since been linked to an increased risk of severe birth defects, including spina bifida, cleft palate, abnormal cranial development, holes in the heart, malformed limbs and urinary tract problems, especially when taken by the mother during the first trimester of pregnancy. In a 2009 announcement, the FDA indicated that Depakote had been linked to a 20% increase in neural tube defects, like spina bifida, when taken during the first 12 weeks of pregnancy.
In 2013, the US Food and Drug Administration issued a safety announcement warning about the use of Depakote, and other medications, during pregnancy. In the safety announcement, the FDA warned that the drug should not be used by pregnancy women unless other medications are not effective in treating their epilepsy or bipolar disorder. In the same announcement, the FDA changed Depakote, when used in the treatment of migraines, to a pregnancy category “X” from a category “D.” Pregnancy category “X” means that the use of the drug in pregnancy clearly outweighs any possible benefit.
If you, or a loved one, have experienced a birth defect after taking Depakote pregnancy, you may be entitled to compensation. Contact the law offices of Houssiere, Durant & Houssiere, LLP for a free consultation.