In Illinois, another birth defect lawsuit against the makers of the anti-seizure drug Depakote has been filed on behalf of a child who was born with a serious cardiac defect.
In her Depakote birth defect lawsuit, Michelle Cowin-Gantz claims that the child referred to as “J.G.”, on whose behalf she sues as “next friend”, was born with a severe heart defect as a result of the mother’s use of Depakote during pregnancy. According to this claim, the child will suffer permanent injury, life-long medical care and monitoring, emotional distress, the loss of a normal life, and additional psychological and financial damages as a result of this Depakote birth defect. This plaintiff also claims that the makers of Depakote, Abbott Laboratories Inc., failed to adequately test this allegedly dangerous drug and failed to provide proper warnings of the risk of Depakote birth defects.
Depakote (valproic acid, valproate) has been approved by the FDA since 1983 to help prevent seizures associated with epilepsy. Since then, this anti-epileptic drug has also been approved to treat some cases of depression and bipolar disorder. While women who suffer from seizure disorders must often take a drug like Depakote to help prevent potentially harmful or fatal seizures, they must also work with their doctors to evaluate all possible risks of the drug in relation to the perceived benefits. In the case of Depakote and other seizure medications, one risk women must be fully aware of is the increased chance of giving birth to a child with a severe birth defect after taking Depakote during pregnancy.
In the past decade alone, mounting evidence in the form of scientific studies and adverse event reports has suggested that use of Depakote during pregnancy may substantially increase the risk of numerous serious birth defects, including the heart defect noted in the above-mentioned Depakote lawsuit. In fact, a study published in the journal Neurology in 2006 concluded that of all anti-seizure drugs, “valproate poses the highest risk to the fetus. For women who fail other antiepileptic drugs and require valproate, the dose should be limited if possible. The results of this study led the FDA to issue a Black Box warning about Depakote birth defect risks later that year. In addition to heart defects, use of Depakote during pregnancy may also increase the risk of neural tube defects like spina bifida, skull malformations, extra digits, oral cleft defects like cleft lip and cleft palate, pulmonary stenosis, and even potentially decreased IQ.
While the FDA did issue the Depakote birth defect Black Box warning in 2006, many parents of children born with serious birth defects after exposure to Depakote in the womb now allege that Abbott Laboratories knew or should have known of this risk long before that and willfully failed to warn of it. Again, women must carefully weigh all benefits against all known risks of any medication they take during pregnancy—but this is only possible if the woman is informed of these risks.
When pharmaceutical companies fail to disclose known birth defect risks associated with their drugs, innocent patients and their babies may suffer catastrophic and devastating results. If a child you love was born with a serious birth defect after his or mother used a seizure medication such as Depakote or Topamax during pregnancy, you may be owed compensation for medical expenses, pain and suffering, and other damages. To learn more about your rights, please contact us to schedule a free legal consultation.