Lawsuit Alleges Depakote Anti-Seizure Drug Caused Spina Bifida
A lawsuit alleging Abbott Laboratories failed to warn about the risk of birth defects with the anti-seizure drug Depakote is moving forward. The plaintiff in the lawsuit is a woman who took Depakote while pregnant. Her daughter, now 12-years-old, has spina bifida, a condition that affects the neural tube, a structure in the developing fetus that eventually becomes the brain and spinal cord. The lawsuit alleges that doctors performed a very complicated operation while the child was still in the womb to repair the spina bifida.
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 plaintiff and her unborn child were the 19th patients to undergo the procedure. Fortunately, the operation was a success and the hospital now displays photos of the child learning to walk and playing. However, the hospital explains that her muscles will never be able to reach full strength. The child sometimes uses a wheelchair, but can walk on her own. She also fatigues easily, the hospital says.
The lawsuit alleges that being exposed to Depakote in the womb caused the child to develop spina bifida, a condition whose cause is mostly unknown.
Abbott Laboratories argues that the plaintiff should have been aware that Depakote can lead to birth defects when she was pregnant in 2004. The company filed a motion to dismiss the lawsuit based on statute of limitations, arguing that too much time has passed. However, a federal judge rejects this argument and has allowed the case to proceed. U.S. District Judge Nancy Rosenstengel dismissed Abbott’s motion on Oct. 19, stating that the lawsuit is not barred for this plaintiff. “…it is undisputed that the Illinois statute of limitation does not bar the current claim.” the judge stated.
In Illinois, minors can sue for injuries at any time, as well as two years after they turn 18. As such, the plaintiff’s lawsuit is moving forward.
In January, another Depakote birth defects lawsuit was filed on behalf of eight plaintiffs from different states. Alleged birth defects included spina bifida, cleft palate, cleft lip, limb and digit deformities, facial dysmorphism, mental developmental delays, genitourinary malformations and heart defects. The suit alleges Abbott was aware of the risks before marketing the drug, and misled physicians about its risks.
The U.S. Food and Drug Administration (FDA) has been notifying healthcare professionals about the risk of birth defects with Depakote since 2009. Lawsuits, however, allege that women were unaware of the risks when they were pregnant.
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.
The warning label for Depakote now clearly states that the drug can lead to serious birth defects in pregnant women. The FDA warns that birth defects are “much higher” than average or 12.5 times worse in children exposed to Depakote in the womb. In 2013, the agency 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).