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The FDA approved the drug Depakote (valproic acid) for the treatment of epileptic seizures in 1983, and later for the prevention of migraine headaches. Post-marketing reports, however, indicate that some mothers who took the drug during pregnancy gave birth to babies with birth defects. These included spina bifida, cleft palate, limb deformations, heart defects, skeletal defects, and growth retardation.

In 2010, the New England Journal of Medicine published a study linking the use of Depakote during pregnancy with an increased risk of birth defects. Since then, many patients have come forward to file a Depakote lawsuit. One of the recent cases was filed on June 7, 2012, by more than a dozen plaintiffs who claim to have suffered birth defects because of Dapakote use during pregnancy.

Studies Link Depakote with Birth Defects

Researchers from the University of Groningen in the Netherlands reported that when mothers used valproic acid in the first trimester they were 12.7 times more likely to give birth to a baby with spina bifida. The researchers analyzed 98,000 pregnancies, and also found increased risks for atrial septal heart defects, craniosynostosis, and cleft palate.

These findings supported previous recommendations by the American Academy of Neurology to avoid the use of Depakote during pregnancy. They also confirmed the results of an earlier 2006 Neurology study that found major congenital malformations and fetal death were significantly more common in pregnancies of women taking Depakote compared with women taking other anti-epileptic drugs.

Awareness Increases Depakote Lawsuits

With the increased awareness of these birth defects, many patients have come forward to file lawsuits. For example, in January 2012 an Illinois woman alleged that her daughter was born with severe birth defects, including spina bifida, caused by her use of Depakote during pregnancy. She seeks to hold manufacturer Abbott Laboratories liable for her daughter's injuries.

In April 2012, a Chicago woman filed a case in Cook County Court alleging her son was born with a penile birth defect because she took Depakote during pregnancy. Then, on June 7, 2012, Nicolas Battle, individually and on behalf of more than a dozen others, filed a new case in Illinois. All plaintiffs allege that they were born with spina bifida and other birth defects because their mothers took Depakote during pregnancy. Battle alleges that his mother was one of many women prescribed the drug without being alerted to the risks.

Abbott Laboratories Settles Federal Lawsuit

This latest lawsuit comes only weeks after Abbott Laboratories settled a lawsuit with the government for illegally promoting Depakote for the treatment of conditions not approved by the FDA. According to a federal investigation, Abbott marketed the drug to doctors for the treatment of schizophrenia and dementia, when it is approved to treat only epilepsy, migraines, and manic episodes associated with bipolar disorder. Abbott reportedly also gave doctors kickbacks to prescribe the medication. The $1.6 million settlement, however, does not include any patients who were affected by the drug.

Plaintiffs filing lawsuits against Abbott claim the company defectively designed the drug, then failed to conduct adequate safety tests. Finally, they claim the company’s warnings about side effects were not accurate. It was not until 2009 that the FDA required the label on Depakote to include a warning alerting women to the risks of birth defects.

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