Depakote birth defect lawsuits are gaining the increased interest of lawyers around the country.
Like Topamax, Depakote is an anticonvulsant used to prevent epileptic seizures. In 1978, the FDA approved Abbott Laboratories’ New Drug Application (NDA) for Depakene. In 1982, the FDA approved Abbott’s NDA for Depakote which was also marketed to doctors as a medication for limiting or eliminating seizures.
The Problem with Depakote
Depakote is a known human teratogen. Plaintiffs’ lawyers allege that it is associated with a number of congenital malformations and cognitive deficits. Possible harmful effects include heart defects, hydrocephalus, craniofacial defects, spinal bifida, microcephaly, heart defects, limb and digital defects, urogenital defects, cleft lip and palate, decreased IQ, mental retardation, and developmental delay.
When do these injuries happen? Early in the pregnancy. These malformations generally occur in the first nine weeks of gestation. Depakote specifically affects cells and neurons, including those which develop the brain, face, and limbs. The thumbs are completely formed by sixteen weeks, but the absolute dysmorphia occurs in the first nine weeks.
After years on the market, the FDA required Abbott to include a “Boxed Warning” alerting doctors and patients – most notably, mothers and women of childbearing age who might become pregnant – of the risk of birth defects as a result of Depakote use. There are also risks on the box now about hepatotoxicity and pancreatitis. These are serious and potentially fatal conditions.
Depakote lawsuits that involve birth defects such as spina bifida, craniofacial defects, cardiovascular malformations, and similar malformations in young children whose moms were taking Depakote when they were pregnant.
2018 Update: In 2018, there were 255 lawsuits in federal court alleging birth defects related to Depakote. Settlement negotiations are ongoing.
More Depakote Information
Specifically, there is data suggesting that:
- Infants whose mothers took Depakote during the first trimester were more than 12 times more likely to have spina bifida than mothers who were not on Depakote; (Note: all of this data is for valproic acid. Valproic acid is the active and key ingredient in Depakote.)
- Babies whose mothers took Depakote were also 2.5 times more likely to have a heart defect;
- Depakote users who became pregnant were five times as likely to have a baby with a cleft palate or a penis abnormality;
- Children of moms on Depakote were more than two times as likely to have an extra digit on their hand; and
- Mothers on Depakote are seven times – seven times – more likely to have premature fusion of the skull during fetal development which limits brain growth.
- They found women who took Depakote early in their pregnancy had two to 12 times the risk of having a baby with one of six specific birth defects compared to women who took no epilepsy drugs.
Can you see why plaintiffs’ lawyers are predicting a lot of Depakote lawsuits? You would think there would have been a recall. But instead of a recall – which still has not happened – this problem has festered on for years. How on earth is this possible? I have no idea. Ultimately, this may prove to be the tip of the iceberg in terms of birth defects from Depakote.
Let’s make matters worse. The United States is investigating Abbott for federal violations of impermissible off-label marketing of Depakote as a treatment for agitation and aggression in the elderly, and health care fraud arising out of that allegedly improper use. So not only were they not keeping us abreast of the real risks, they may have been pushing Depakote for uses that were not approved by the FDA.
If your child has suffered a birth injury and you or the child’s mother was taking Depakote, do two things: (1) tell the FDA and (2) call a lawyer to get more information.
Have you had a good or a bad experience with Depakote? Let us all know by making a comment in the space below.