Depakote® / Depakene

• Heart defects
• Craniosynostosis (premature closure of sutures in skull)
• Limb defects (such as club foot or multiple fingers/toes)
• Cleft palate/lip
• Eye defects
• Hypospadias (abnormal location of urethra in males)
• Other major malformations

Abbott Pharmaceuticals and AbbVie Inc. face hundreds of lawsuits by children alleging serious birth defects caused by the drug Depakote, which the children’s mothers took during pregnancy. Depakote is prescribed to treat epilepsy, bipolar disorder, and for migraine prophylaxis. The lawsuits involve claims that Depakote caused serious birth defect injuries, such as spina bifida, heart defects, cleft palate, and neurological complications that can result in autism spectrum disorders and developmental delays. All of these injuries can have devastating impacts on children and their families.
Jury Verdict: Depakote Caused Birth Defects
On May 26, 2015, a St. Louis jury ruled in favor of a family who alleged exposure to Depakote® during pregnancy caused their child to develop birth defects, including spina bifida. The jury found that Abbott failed to warn the mother that taking Depakote® while she was pregnant would expose her child to an unnecessary risk of serious birth defects.
The jury awarded $15 million in compensatory damages and $23 million in punitive damages. Abbott is expected to appeal.
Abbott’s $1.5 Billion Criminal Sanction
In 2012, Abbott pleaded guilty to criminal and civil charges by the U.S. government that it illegally promoted Depakote. Abbott was required to pay $1.5 billion as part of a settlement of those charges. This settlement followed an investigation by the Department of Justice, which found that Abbott promoted Depakote for unapproved uses.
Restrictions on Use of Depakote in Pregnancy
As a result of the risk of birth defects with Depakote, in 2013 Abbott revised the Depakote label to warn that due to the risks to developing babies, Depakote should not be taken by pregnant woman to treat migraine headaches. With regard to treatment of migraines, the Depakote was changed to “Pregnancy Category X,” which means the risk to pregnant women clearly outweighs the benefit of the drug. The revised label also warns that Depakote should only be used during pregnancy as a last resort for seizures or bipolar disorder, if other drugs are not effective in treating the pregnant mother’s symptoms.
The updated warning label also confirms that Depakote can cause decreased IQ scores in children exposed to the drug in the womb.
BURG SIMPSON is currently investigating legal claims regarding children whose mothers took Depakote during pregnancy and who developed birth defects. Contact us today for a confidential, free, no-obligation consultation.

Depakote® has also been associated with an increased risk of neural tube defects, including spina bifida. While the rate of neural tube defects in the general population is 0.1 to 0.2%, the incidence rate in children exposed to Depakote® in the first trimester is reported to be as high as 5%.

• Low IQ
• Autism Spectrum Disorder
• Autistic Disorder
• Asperger’s Disorder
• Pervasive Developmental Disorder (“PDD-NOS”)