A total of 26 women have recently filed lawsuits claiming the makers of the anti-seizure drug Depakote illegally marketed the drug for off-label purposes and failed to warn of the side effects of the drug.
Each of the women, according to a report from The Madison Record (an online legal journal), claim they were prescribed and took Depakote just before getting pregnant or during the first trimester of their pregnancy and that caused them to give birth to children with a wide array of severe and some life-threatening birth defects.
Even for women who suffer from epilepsy, taking a drug like Depakote just prior to or during the early stages of pregnancy can lead to birth defects like spina bifida, cleft palate, cleft lip, limb and digital deformities, facial dysmorphism, mental developmental delays, genitourinary malformations, and heart defects. Expecting mothers who are also epileptics face the dilemma of continuing the drug through their pregnancy and risking giving birth to a child with these possible birth defects or of suffering an epileptic seizure that could endanger the lives of themselves and the baby they’re carrying.
The lawsuit against the makers of the drug, Abbott Laboratories, claims the pharmaceutical company illegally marketed the drug for conditions other than epilepsy or others which can cause seizures. Off-label treatments of Depakote include mild depression, bipolar disorder, and chronic pain but it is illegal for Abbott to market the drug for these indications as it has not received federal approval to be used among these patients. It is not illegal for a doctor to prescribe the drugs for these conditions, though.
In addition to the illegal marketing accusations, the more than two dozen women who’ve filed their lawsuit in St. Clair County Court recently claim they were never warned that taking Depakote so close to or during the early stages of pregnancy could result in birth defects to their children.
“Even now, when medical science has proven beyond all doubt 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 refuses to state that risk on its product label, instead obliquely referring to a misleading statistic regarding a single specific defect,” the lawsuit states, according to the report.
Further studies have shown that babies born to mothers who took Depakote during their pregnancy were more likely to have developed intellectual levels most closely associated with mental retardation and those children typically score seven or eight points lower on IQ tests than children whose mothers did not take Depakote during the pregnancy.
The lawsuit is seeking damages to compensate for the severe and permanent injuries and experienced physical impairment, disfigurement, pain, and suffering their children face as a result of the birth defects caused by Depakote.