Former CDC Head Tells Jury Depakote Increases Risk of Birth Defects

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Depakote Birth Defects Lawsuit Goes to Trial

The anti-epilepsy drug Depakote increases the risk of a birth defect, spina bifida, when used in pregnant women, an Illinois jury heard. Plaintiffs in the litigation presented expert witness testimony from Dr. Godfrey Oakley Jr., former director of the Centers for Disease Control and Prevention’s Division of Birth Defects and Developmental Disability. He was the first witness to testify in the Depakote birth defect case.

Parker Waichman LLP has years of experience representing clients in lawsuits alleging birth defects and other injuries. The firm continues to offer free legal consultations to anyone with questions about filing a Depakote birth defects lawsuit.

The lawsuit is filed on behalf of a boy born with spina bifida, a condition where the bones around the spine do not form properly. Plaintiffs allege that Abbott, the manufacturer of Depakote, failed to warn of the risks. The boy’s mother filed the lawsuit in 2015. She began taking the drug in 2015 to treat her severe bipolar disorder.

According to Law360, Dr. Oakley told jurors that among mothers taking valproic acid, the active ingredient in Depakote, the rate of birth defects is 10 to 15 percent. The rate of spina bifida among this population is between 1 and 2 percent, which is between 40 and 80 times higher than babies who were not exposed to Depakote in the womb. “There is no question on this drug that it causes spina bifida,” he said, according to Law360.

Dr. Oakley was part of a study published in 1982 showing that Depakote was associated with over a 20-fold increased risk of spina bifida. He said that doctors should have been informed of this risk. Spina bifida develops during the first 24 to 28 days after conception, Oakley told jurors. “It happens before a woman knows she’s pregnant,”

According to Law360, the trial is expected to last three weeks. The plaintiff is seeking damages for costs related to the spina bifida, which could total $30 million. This is the sixth Depakote spina bifida lawsuit to go to trial. In Missouri, a group of 25 plaintiffs were awarded $38 million.

Recently, a European study found that Depakote was linked to an increased risk of birth defects. The French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration found that the medication is “highly teratogenic”, or harmful to a developing fetus.

Depakote Birth Defects Background

In 2009, the U.S. Food and Drug Administration (FDA) began notifying healthcare professionals about the risk of birth defects associated with Depakote. Plaintiffs in the litigation allege that users and healthcare professions were unaware of the risks to pregnant women.

According to Consumer Affairs, Depakote was the second-most prescribed drug to treat epilepsy in 2006. The FDA has also approved the drug to treat migraines and bipolar disorder.

Now, the warning label for Depakote states that the drug can lead to serious birth defects in pregnant women. The FDA warns that birth defects are “much higher” than average. Children born to mother who took Depakote are 12.5 times more likely to develop birth defects. In 2013, regulators warned that Depakote and related drugs are contraindicated in pregnant women for migraines. The FDA cited a study showing that the drug was linked to decreased IQ scores in children whose mothers took Depakote while pregnant.

Abbott has also faced government allegations of off-label marketing with Depakote. According to a May 2012 press release issued by the Department of Justice, the company pleaded guilty and agreed to pay $1.5 billion to settle allegations that it marketed Depakote for elderly patients with dementia, even though the FDA had not approved it for this indication. “Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud,” said James M. Cole, Deputy Attorney General, according to the release. “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

According to the DOJ, Abbott admitted to having a specialized sales force focused on marketing Depakote in nursing homes to control agitation and aggression in elderly patients with dementia. The government also said Abbott marketed Depakote in combination with other medications to treat schizophrenia despite clinical evidence showing otherwise.

Filing a Depakote Birth Defects Lawsuit

If you or someone you know has questions about filing a Depakote birth defects lawsuit, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).