Depakote Spina Bifida Lawsuit Filed by Parents of Twins

A Depakote lawsuit has been filed by the parents of two Illinois girls who were born with severe health problems, including spina bifida and neural tube defects, which were allegedly caused by side effects of the anti-seizure drug.   

The drug-induced birth defect lawsuit was filed late last month against Abbott Laboratories in Madison County Circuit Court in Illinois.

According to the complaint, Mindy Pyszkowski claims that she took Depakote during pregnancy to help prevent epileptic seizures, not knowing that her unborn children would face an increased risk of spina bifida birth defects from Depakote.

Pyszkowski gave birth to twin daughters who suffered from spina bifida, which is a neural tube defect that occurs when some vertebrae overlying the spinal cord are not fully formed and remain fused and open. The condition can result in a life-long disability and injury for the child.

The lawsuit claims the drug maker failed to warn doctors or patients about the potential side effects of Depakote, alleging that if the couple had known about the spina bifida risk, Mindy Pyszkowski would have taken an epileptic drug with less of a pregnancy risk. The family has charged Abbott Laboratories with negligence and strict liability.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy use has been linked to an increased risk of a number of severe birth defects, especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect. In addition to spina bifidia, other birth defects associated with Depakote include, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.

In May 2010, researchers found that Depakote problems for infants could occur after using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child. The FDA also recently issued warnings that Depakote and similar drugs may be linked to cognitive impairments in newborns as well.

In recent months, a growing number of Depakote spina bifida lawsuits have been filed against Abbott Laboratories by families of children born with the birth defects or other malformations.