Depakote’s Active Ingredient May Lead to Spina Bifida

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Expert Testifies that the Active Ingredient in Epilepsy Drug Tied to Spina Bifida

In a lawsuit brought over the anti-epilepsy medication Depakote (divalproex sodium), the prior head of the U.S. Centers for Disease Control and Prevention’s (CDC) birth defect division, Dr. Godfrey Oakley Jr., told an Illinois federal jury that the active ingredient in Abbott Laboratories’ Depakote significantly raises risks for the development of spina bifida in fetuses. The case is E.G. et al. v. Abbott Laboratories Inc., case number 3:15-cv-00702, in the Southern District of Illinois.

Dr. Oakley Jr., took the stand as the plaintiffs’ first witness in a trial for a lawsuit filed by the mother of a boy who was born with spina bifida. The lawsuit accuses the device maker of neglecting to appropriately warn doctors about Depakote’s impact on fetal development. Dr. Oakley Jr. also told the jury that the rate of birth defects in babies born to women who take valproic acid, the active ingredient in Depakote, is between 10 and 15 percent. Specifically, the rate is between one and two percent for spina bifida, which is approximately 40 and 80 times the rate for babies born in the United States to mothers who do not take Depakote, Dr. Oakley Jr. also said, according to Law360.

“There is no question on this drug that it causes spina bifida,” Dr. Oakley Jr. told the jury. He compared the increase in the risk of spina bifida to the likelihood a person will develop cancer if he or she smokes two packs of cigarettes a day for 20 years, Law360 reported.

The woman, whose son has been diagnosed with spina bifida and various other health issues, sued Abbott in 2015. She alleges that Abbott knew more about the dangers of Depakote than the drug maker indicated on Depakote’s labeling. The mother was prescribed Depakote to manage her severe bipolar depression and was taking the drug when her son was conceived.

Dr. Oakley Jr. was part of a team of doctors in 1982. The team first discovered the tie between valproic acid and spina bifida. The one to two percent figure was the result of research on French mothers. The study, published in medical journals in 1982, revealed that the French women who took valproic acid experienced a more than 20-fold increase in the incidence of spina bifida in their children, he said, Law360 reported. When asked if physicians would be aware of the 20-fold increase from the one to two percent figure Abbott places on its label, Dr. Oakley Jr. said that, “It would be a very rare physician” who would do the math to figure that out. He added the he felt doctors should have that information, according Law360.

Dr. Oakley Jr. told the jury that the malfunctions in fetal development that lead to spina bifida take place within the first 24 to 28 days after conception. “It happens before a woman knows she’s pregnant,” he said; therefore, ceasing Depakote after she learns she is pregnant is not sufficient to reduce or eliminate the risk of spina bifida.

This lawsuit is the sixth to reach trial as a mass litigation over Depakote. Cases have been tried in federal courts in Illinois and Ohio and in state court in Missouri, in which the jury awarded a group of 25 plaintiffs $38 million. The current trial is expected to last about three weeks and the lawsuit seeks damages to cover the child’s care, according to Law360.

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.

Depakote Background

In 2009, the U.S. Food and Drug Administration (FDA) started advising healthcare professionals concerning risks of defects associated with Depakote. Plaintiffs in the litigation allege that users and healthcare professionals were unaware of Depakote’s risks to pregnant women. The FDA also approved Depakote to treat migraines and bipolar disorder. Consumer Affairs pointed out that Depakote was the second-most prescribed drug to treat epilepsy in 2006.

Depakote’s warning label now states that the drug may cause serious birth defects in pregnant women and the agency warns that Depakote birth defects are “much higher” than average. In 2013, regulators warned that Depakote and drugs in its class are contraindicated for the treatment of migraines in women who are pregnant. The FDA also cited research that revealed that Depakote is associated with decreased IQ scores in children whose mothers took Depakote when pregnant.

Abbott has faced government allegations over the way in which the drug maker marketing Depakote for off-label uses, which is illegal. In a May 2012 press release issued by the Department of Justice (DOJ), Abbott pleaded guilty and agreed to pay $1.5 billion to settle allegations that it marketed Depakote for elderly patients diagnosed with dementia, despite that the FDA had not approved Depakote for this indication. At that time, James M. Cole, Deputy Attorney General said that, “Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud.” He added, “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 maintaining a specialized sales force concentrated on marketing Depakote in nursing homes to control agitation and aggression in elderly patients with dementia. The government also indicated that Abbott marketed Depakote in combination with other medications to treat schizophrenia despite clinical evidence that reveals otherwise.

Spina bifida occurs in three forms and each vary in severity, according to the Mayo Clinic. Spina bifida oculta is the mildest form and Spina bifida meningocele is a rare form of the disease and involves the protective membranes around the spinal cord (meninges) pushing through the opening in the vertebrae.

Spina bifida myelomeningocele (open spina bifida) is the most severe form, according to the Mayo Clinic. This is the most severe form and the form that is typically referred to when discussing spina bifida. In this form, the baby’s spinal canal remains open along a number of vertebrae in the lower or middle back, allowing the membranes and the spinal cord to protrude at birth, forming a sac on the baby’s back. Sometimes skin covers the sac; however, tissues and nerves are typically exposed, making the baby prone to life-threatening infections. What’s more, neurological impairment is common and includes muscle weakness of the legs, sometimes involving paralysis; bowel and bladder problems; seizures, generally if the child requires a shunt; and orthopedic problems, including deformed feet, uneven hips, and a curved spine (scoliosis)

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).