Depakote Birth Defect Lawsuit Over Spina Bifida Filed

An Illinois mother has filed a lawsuit against Abbott Laboratories, alleging that her daughter suffered a birth defect known as spina bifida from Depakote use during pregnancy. 

The complaint was filed by Rhealyn Alexander in St. Clair County Circuit Court on October 17, arguing that the drug maker failed to adequately warn that use during pregnancy could cause birth defects due to side effects of Depakote.

Alexander’s daughter was born with spina bifida in October 2007, which is a neural tube defect that occurs when some vertebrae overlying the spinal cord are not fully formed and remain fused and open.

The Depakote birth defect lawsuit accuses Abbott of negligence, and seeks compensatory damages for medical expenses, loss of income and legal fees.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy use has been linked to an increased risk of a number of severe birth defects, especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect. In addition to spina bifidia, other birth defects associated with Depakote include, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.

In May 2010, researchers found that Depakote problems for infants could occur after using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child. The FDA also recently issued warnings that Depakote and similar drugs may be linked to cognitive impairments in newborns as well.

In recent months, a number of similar Depakote lawsuits over spina bifida and other birth defects suffered by children born to women who were given the epilepsy drug during pregnancy. The complaints allege that Abbott failed to adequately research the medication or warn consumers about the risks associated with becoming pregnant, placing their desire for profits before patients safety.

Earlier this week, it was reported that Abbott recently agreed to pay $1.3 billion to settle claims by the federal government that the company illegally marketed Depakote by promoting it for uses not approved by the FDA. The company is expected to pay about $800 million to address claims of off-label marketing, and $500 million in criminal fines. While neither Abbott or the Department of Justice (DOJ) has confirmed the amounts involved, both have said that a settlement in the works.

While doctors are able to prescribe a drug for whatever need they see fit, it is illegal for companies to promote a drug for uses that have not been approved by the FDA.