Depakote is part of a class of drugs called anticonvulsants that help to manage brain activity. The drug, which was first introduced into the U.S. market in 1983, is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, epilepsy, and to prevent migraine headaches. Depakote comes in different dosage forms. Depakote tablets are used to treat bipolar disorder and to prevent migraine headaches, whereas Depakote Sprinkle Capsules are used to treat epileptic seizures.
In 1988, the FDA categorized Depakote as a Pregnancy Category D. This means, “there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.”
In 2000, the New England Journal of Medicine published the first major study on the teratogenicity of anticonvulsant drugs, such as Depakote. During the course of the study, conducted from 1986 to 1993, researchers went to five maternity hospitals in the Boston area and concluded, “a distinctive pattern of physical abnormalities in infants of mothers with epilepsy is associated with the use of anticonvulsant drugs during pregnancy, rather than with epilepsy itself.”
In 2006, the FDA issued a black-box warning to Depakote cautioning women in their child bearing years of the risk of potential birth defects associated with taking the drug during the early stages of pregnancy. The FDA was careful to stress that Depakote poses a threat to all women within child bearing years, not just women who are pregnant, because birth defects can begin in the first month of pregnancy before the mother even knows she is pregnant. Further, the agency noted that the most common birth defects associated with Depakote were defects in the brain and spinal cord, such as spina bifida, neural tube defect or lower IQ.
The findings of the New England Journal of Medicine study have more recently been reinforced by a four-year study conducted in the United Kingdom. In January 2013, the Journal of Neurology, Neurosurgery & Psychiatry concluded that the likelihood of a neurodevelopmental disorder increased in children exposed to Depakote in the womb.
In May 2013, the FDA reclassified Depakote as a Pregnancy Category X drug, which is a drug “that studies in animals or humans have shown positive evidence of fetal risk, and the risk of the drug in pregnant women clearly outweighs any possible benefits.”
Babies born to mothers who took Depakote allegedly are more likely to suffer from several birth defects, including:
- Spina bifida and other neural tube defects (spinal cord or brain damage);
- Malformed limbs, skull or brain;
- Extra fingers or toes (polydactyl);
- Cleft palate (facial malformation);
- Heart defects (including atrial septal defect); and
- Lower intelligence (including autism).
The plaintiffs in the litigation seek compensation, damages and other relief pursuant to allegations that Depakote was and is a defective product, unreasonably dangerous in light of its nature and intended use. As a result, children were born with spina bifida and neural tube defects, among other congenital malformations and birth defects, as listed above.