Women who take the antiepileptic drug Depakote (divalproex sodium and valproic acid) during pregnancy may have an increased risk of giving birth to babies with spina bifida, a severe defect of the spine in which part of the spinal cord and its meninges are exposed through a gap in the backbone.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with spina bifida after the mother took Depakote during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.
Update: Special Master Appointed in Depakote Birth Defects Trial
April 11, 2017 – U.S. District Judge Nancy J. Rosenstengel has tapped retired state judge Daniel J. Stack as special master in an upcoming trial alleging spina bifida from Depakote. Stack’s initial role will be to organize the parties’ objections to deposition designations and then make recommendations on those issues, but these duties may be expanded before the trial begins next month.
Study Links Depakote in Pregnancy to Spina Bifida
Research published in the New England Journal of Medicine (NEJM) in June 2010 suggested that the active ingredient in Depakote, valproic acid, could cause severe birth defects in babies exposed to the drug in the womb. Researchers conducted a meta-analysis from 8 different studies, translating into data from 1,565 pregnancies with data on the mother’s use of Depakote or other forms of valproic acid.
They found that pregnant women who took Depakote had a much higher risk of about a half-dozen severe birth defects, including spina bifida and cleft palate. These problems occurred most often when women took Depakote during the first trimester of pregnancy.
“The use of valproic acid monotherapy in the first trimester was associated with significantly increased risks of several congenital malformations, as compared with no use of antiepileptic drugs or with use of other antiepileptic drugs,” the study’s authors concluded.
What is Spina Bifida?
Spina Bifida is divided into two subclasses, Spina Bifida Cystica and Spina Bifida Occulta.
Spina Bifida Cystica -This includes meningocele and myelomeningocele. Meningocele is less severe and is characterized by herniation of the meninges, but not the spinal cord, through the opening in the spinal canal. Myeolomeningocele involves herniation of the meninges as well as the spinal cord through the opening.
Spina Bifida Occulta -In this type of neural tube defect, the meninges do not herniate through the opening in the spinal canal.
Spina bifida (Latin: “split spine”) is a developmental birth defect caused by the incomplete closure of the embryonic neural tube. Somevertebrae overlying the spinal cord are not fully formed and remain unfused and open. If the opening is large enough, this allows a portion of the spinal cord to protrude through the opening in the bones. There may or may not be a fluid-filled sac surrounding the spinal cord. Other neural tube defects include anencephaly, a condition in which the portion of the neural tube which will become the cerebrum does not close, and encephalocele, which results when other parts of the brain remain unfused.
Spina bifida malformations fall into four categories: spina bifida occulta, spina bifida cystica (myelomeningocele), meningocele andlipomeningocele. The most common location of the malformations is the lumbar and sacral areas . Myelomeningocele is the most significant form and it is this that leads to disability in most affected individuals. The terms spina bifida and myelomeningocele are usually used interchangeably.
Spina bifida can be surgically closed after birth, but this does not restore normal function to the affected part of the spinal cord. Intrauterine surgery for spina bifida has also been performed and the safety and efficacy of this procedure is currently being investigated. The incidence of spina bifida can be decreased by up to 75% when daily folic acid supplements are taken prior to conception.
There is no cure for spina bifida, but there are a number of treatments available to help manage the disease and prevent complications. In some cases, babies who are diagnosed before birth can undergo surgery while still in the womb in an effort to repair or minimize the spinal defect.
Post-birth treatments may include ongoing surgery, prescription medications and physical therapy. Children with the mildest form of the disease, spina bifida occulta, may not require treatment.
FDA Links Depakote to Neural Tube Defects Including Spina Bifida
Recently the U.S. Food & Drug Administration linked the use of Depakote, Depakote ER, Depakene, Depacon, Stavzor, valporate sodium and other related drugs to the development of neural tube defects. Learn more here: https://www.schmidtandclark.com/depakote-fda-black-box-warning
Judge Upholds $38 Million Depakote Settlement
February 6, 2017 – A St. Louis judge has affirmed a $38 million payout to a girl who was born with spina bifida and other severe birth defects after her mother took Depakote during pregnancy. In May 2015, a St. Louis jury awarded $15 million in compensatory damages and $23 million in punitive damages to Maddison Schmidt after finding that Abbott had failed to warn her mother about the risk of birth defects with Depakote. Abbott appealed the verdict and requested a new trial; however, in November 2016, the Missouri Court of Appeals upheld the award.
Depakote Birth Defects Update 1/24/13: A new study has determined that Depakote can cause lowered IQ’s and other cognitive deficiencies in children born to mothers who take the drug during pregnancy. Specifically, the research found that babies exposed to Depakote in the womb had IQ’s that were seven to 10 points lower than other children at age six, as well as reduced language skills and memory capacity. Click here to learn more.
Do I Have a Depakote Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Depakote lawsuits. We are handling individual litigation nationwide and currently accepting new spina bifida cases in all 50 states.
Again, if your child or other loved one was born with spina bifida after the mother took Depakote in pregnancy, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.