The family of a 12-year-old child has filed a lawsuit on behalf of the young girl who underwent an extremely difficult operation, along with her mother, while she was still in the womb. The highly complicated open fetal surgery took place at Vanderbilt University Medical Center in Nashville, Tennessee. The operation was an attempt to repair the child’s spina bifida. This is a birth defect affecting a baby’s spinal cord, when the bones of the spine (vertebrae) don’t form properly around part of the baby’s spinal cord, according to WebMD.
Now, 12 years later, the young girl can walk on her own, although she uses a wheelchair sometimes. The child’s “muscles will never be able to gain full strength and she tires easily,” explains the hospital’s website.
Lawsuit Involving Depakote
Although the cause of spina bifida is largely unknown, the young girl’s family maintains that the anti-epilepsy drug Depakote, is responsible. The family is suing Abbott Laboratories, the Illinois-based manufacturer of Depakote.
Abbott Laboratories claims it is protected by the statute of limitations, although, United States District Judge Nancy Rosenstengel disagrees. On October 19, 2016, the federal judge dismissed a motion filed by Abbott Labs to drop the claim against it based on the statute of limitations. The judge’s reason was because Illinois laws allow minors to seek damages at any time and up to two years after they turn 18, thereby permitting the current claim against Abbott to move forward.
Depakote Background and Legal Issues
The U.S. Food and Drug Administration (FDA) has warned healthcare professionals about prescribing Depakote to pregnant women as far back as 2009. However, women who filed lawsuits across the country claim they were not aware of the dangers the drug posed during the course of the first trimester of their pregnancies. The FDA now clearly states that the birth defect risk in babies born to mothers who had taken valproate (marketed at Depakote) is “much higher” than average, or 12.5 times higher.
Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals and families who have experienced adverse effects as a result of pharmaceuticals.
Valproate was reported to be the second-most prescribed epilepsy drug in the United States in 2006. Depakote is approved also, to treat bipolar disorder and migraines. Off-label (meaning a drug used in a manner not approved by the FDA), Depakote has been aggressively marketed to treat conditions such as dementia. For this, a criminal investigation was launched and Abbot reached a $1.5 billion settlement with the FDA four years ago, for misbranding its product. Eight plaintiffs alleged that Abbot Laboratories and its competitor Abbie Vie both were aware of the risks valproate posed to unborn fetuses even before they actually began selling and marketing Depakote.
Abbott admitted to misbranding Depakote by marketing the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia. Neither of these uses was FDA approved. Abbott admits that from 1998 through 2006, the company “maintained a specialized sales force trained to market Depakote in nursing homes for the control, of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use,” according to the Department of Justice website.
Abbott was forced to discontinue a clinical trial of Depakote in 1999, in the treatment of dementia due to an increased incidence of adverse events, including somnolence (sleepiness), dehydration, and anorexia experienced by the elderly study participants given Depakote.
A European review in 2015 showed that up to 40 percent of children who were exposed to valproate in the womb may have developmental problems. Among the 35,000 women prescribed valproate, 375 become pregnant each year.
Developmental delays may include delayed walking and talking, memory problems, difficulty with speech and language, and lower intellectual ability. Previous research suggests that exposure to valproate in the womb is associated to an increased risk of childhood autism and autism spectrum disorders. These children are also at an 11 percent increased risk of malformations at birth including cleft palate and neural tube defects (abnormalities of the brain and spinal cord).
“The warnings on the risks of valproate in pregnancy have been further strengthened because we want to ensure that medical professionals inform women and girls of the latest information about the risks of developmental disorders in children exposed to valproate during pregnancy, in addition to the already well-known risks of birth defects,” said Dr. June Raine, director of the Medicines and Healthcare Products Regulatory Agency’s vigilance and risk management of medicines division.
Legal Help and Information for Depakote Users
If you or someone you know has been injured by Depakote birth defects, you may have valuable legal rights. Parker Waichman LLP is a nationwide, renowned law firm that has successful experience handling defective drug cases. We urge you to contact the Parker Waichman drug injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).