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Mother Files Depakote Lawsuit over Son’s Penile Birth Defect

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Keona Clay of Chicago has filed a lawsuit in Cook County Court against Abbott Laboratories over the epilepsy drug Depakote, alleging that the drug caused her son to be born the hypospadia birth defect. According to the lawsuit, Abbott Laboratories knew that Depakote was dangerous to the unborn children of pregnant women but they failed to warn physicians and consumers about the dangers.

Clay’s son was born in April 2010 “with a birth defect known as hypospadia. This injury was caused by his mother’s ingestion of Depakote during pregnancy, and specifically, during her first trimester of pregnancy.” Hypospadia is a condition which causes the urethra to develop, most commonly, on the underside of the penis.

The lawsuit claims, “Depakote was defectively designed, inadequately tested, dangerous to human health and unborn, and lacked proper warnings as to the true danger associated with its use, and he suffered injury as a result of the mother’s ingestion of Depakote.” The suit continues, “Abbott knew or should have known of the dangerous condition of its product Depakote, but failed to adequately warn of instruct physicians and consumers of the risks, dangers, and proper uses of the drug.”

According to the lawsuit filed by Clay, in the 1990s, “scientific articles began to single out Depakote as among the most – if not the most – teratogenic of all AEDs [anti-epileptic drugs],” the complaint states. “One study in 1995 reported an incidence rate of neural tube defects (such as spinal bifida) ten times greater than with other AEDs. Another study found major congenital abnormalities in 11 percent of all infants exposed to Depakote during the earliest weeks of pregnancy.”

Clay alleges that “Instead of working to warn doctors and women of childbearing age about the sharply heightened risks of ingesting Depakote during the early weeks of pregnancy, Abbott has sought to minimize the risk and downplay the dangers in its product labeling of Depakote.” The suit continues, “Medical science has proven that one out of every eight or ten babies whose mothers take Depakote during the first weeks of pregnancy will suffer some form of major congenital anomaly,” Courthouse News Service reports.

The lawsuit seeks damages of an unknown amount. disclaimer: This article: Mother Files Depakote Lawsuit over Son’s Penile Birth Defect was posted on Wednesday, April 25th, 2012 at 7:44 pm at and is filed under Medical Device Lawsuits.

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