Dangerous Drugs

Depakote Lawsuits Allege the Drug Can Cause Birth Defects

This Alert Affects:

Women who took Depakote (divalproex sodium) while pregnant and delivered children with birth defects.

What Is Depakote?
Depakote is used to treat epilepsy and bipolar disorder, and also works to prevent migraines. It has also been marketed under the brand names Depakene, Stavzor and Depacon.
What Are the Allegations?
Mothers allege that if Depakote is taken during the first trimester of pregnancy, it can cause serious birth defects including malformations, developmental delays and heart defects in unborn children.
Abbott Laboratories
Type of Lawsuit
Mass Tort

Abbott Laboratories is currently facing lawsuits alleging that Depakote can put unborn children at risk for serious birth defects if mothers take the drug while pregnant. Of all antiepileptic drugs, Depakote is the most likely to cause serious malformations in unborn children, according to the lawsuits. Despite allegedly knowing that Depakote has been linked to heart defects, developmental delays and certain deformities, lawsuits claim that Abbott did not take proper steps to warn doctors and women about these risks.

Did you take Depakote while pregnant and deliver a child with birth defects? Do you have questions about your legal rights? If so, fill out our free case review form today for more information. You may be entitled to compensation.

What Are the Lawsuits Saying About Depakote?

Mothers who have filed lawsuits against Abbot allege that their children were born with one or more of the following birth defects:

  • Developmental delays

  • Cleft palate

  • Cleft lip

  • Facial dysmorphism

  • Spina bifida (incomplete closure of the neural tube)

  • Genitourinary (reproductive organ) malformations

  • Heart defects

These women claim Abbot is responsible for their children’s injuries because:

  • Depakote is defective and unreasonably dangerous
  • Abbott knew or should have known that if Depakote is used during the first trimester of pregnancy it could put unborn children at risk for serious birth defects

  • Abbott failed to adequately warn physicians and women of childbearing age that Depakote could cause birth defects

  • Newer and better antiepileptic drugs were available that were equally as effective as Depakote but carried fewer risks

  • Abbott marketed Depakote for off-label uses including treatment of mild depression and schizophrenia

  • Abbott acted in willful and wanton disregard for the public’s safety to increase the use of Depakote

The mothers are seeking compensation for physical pain and suffering, mental anguish, embarrassment, loss of enjoyment of life, loss of earnings and past and future medical bills.

How Much Does a Lawyer Cost?

Your lawyer will typically only charge you if he or she wins your case. If so, he or she will collect a percentage of your final verdict or settlement.

Is This a Class Action?

No, the Depakote lawsuits will not proceed as a class action. Women who delivered children with birth defects after using the antiepileptic drug will have to file individual lawsuits with their own attorneys. 

Birth Defects Linked to Active Compound in Depakote

Several studies have found that the active ingredient in Depakote, valproate sodium, may cause children to be born with birth defects. According to these studies, the risk of birth defects is especially high if mothers took the drug during their first trimester of pregnancy, as this is when crucial formations such as closure of the neural tube occur.

The earliest reported study on birth defects in children exposed to valproate sodium was published in 1995. According to that study, the incidence rate of neural tube defects was ten times greater in mothers taking Depakote compared to mothers taking different antiepileptic drugs.

FDA Changes Depakote’s Labeling to Highlight Birth Defect Risk

In 2009, the FDA announced it would be changing the labels for valproate sodium-based drugs to include the risks of major birth defects such as craniofacial defects and cardiovascular malformations. According to the FDA, the label change was spurred by research from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which found a sharp increase in the number of birth defects in children exposed to valproate sodium-based drugs.

According to the NAAED, 1 in 1,500 children in the United States are born with neural tube defects, but this risk increases to 1 in 20 if the child is exposed to valproate sodium during the first 12 weeks of development. Furthermore, when compared to other antiepileptic drugs, valproate sodium-based drugs were associated with four times as many children being born with neural tube defects.

In separate notices, the FDA has also warned women that Depakote may cause developmental delays and/or lower cognitive scores. Most recently, the FDA changed Depakote’s pregnancy category for the prevention of migraines from a “D” to an “X,” meaning that the risk of its use in pregnant women clearly outweighs any possible benefit.

What Can I Collect Through a Depakote Lawsuit?

If you delivered a child with birth defects after taking Depakote, you may be able to seek compensation for past and future medical bills and pain and suffering. If you have questions about your legal options or would like help filing a lawsuit, fill out our free case review form today.

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Case Resources

Feliciano et al. v. Abbott Laboratories Inc. Complaint
Case number 2011L008508, State of Illinois Circuit Court of Cook County
FDA Drug Safety Alert, December 2009
The FDA warns that taking valproate sodium-based drugs including Depakote during the first trimester of pregnancy may be linked to various birth defects in unborn children.
FDA Drug Safety Communication, May 2013
The FDA announces that Depakote is contraindicated (should not be used) for the prevention of migraines in pregnant women after finding that the drug may cause decreased IQ scores in children.