CHICAGO (CN) - A mother claims in court that her baby was born with a penile birth defect because she took the epilepsy drug Depakote while she was pregnant.
Keona Clay claims in Cook County Court that Abbott Laboratories knew but failed to warn that its drug was dangerous for pregnant women.
Abbott, based in North Chicago, reported more than $38 billion in revenue last year. It has sold and marketed Depakote as an anti-epileptic drug since 1978.
Clay claims her 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."
She claims that Abbot's drug "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."
Hypospadia is a male birth defect in which the opening of the urethra develops abnormally, usually on the underside of the penis. In severe cases, the condition may make it impossible for a man to urinate standing up.
"By the mid-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."
The complaint states: "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.
"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. ...
"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."
Clay seeks damages for product liability and negligence.
She is represented by Allen Schwartz, with Kralovec, Jambois & Schwartz.
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