Depakote Lawsuit Filed For Children with Spina Bifida, Other Birth Defects

Abbott Laboratories is being sued by the families of 40 children and one mentally disabled adult who were born with birth defects, such as spina bifida and neural tube malformations, after their mothers took the epilepsy drug Depakote during the first trimester of pregnancy. 

The Depakote lawsuit was filed on May 3 in St. Clair County Circuit Court in Illinois by a group of plaintiffs from across the country.

The complaint alleges that Abbott Laboratories failed to fully research the potential side effects of the antiepileptic drug for pregnant women, and failed to adequately warn about the risk of spina bifida and other birth defects from Depakote.

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

According to allegations raised in the complaint, Abbott knew about the potential risk of Depakote birth defects on or before the date it began marketing the drug in the United States, but failed to adequately warn women or the medical community about the true nature and extent of the risk.

As early as 1995, a study reported an incidence rate of neural tube defects from Depakote, such as spina bifida, that was ten times greater than with other anti-epileptic drugs. Other research has found that more than one out of every ten infants exposed to Depakote during the first few weeks of pregnancy may develop major congenital abnormalities, or birth defects.

Despite information about the potential side effects, the families allege that Abbott attempted to minimize the risk of Depakote birth defects and downplayed the danger on the product labeling. The drug maker has also allegedly worked to expand the drug’s use through “off-label” promotions for depression, bi-polar disorder and treatment of migrains, although other alternatives are available that do not carry the same risk of birth defects.

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. Birth defects associated with Depakote include spina bifida, 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.

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