A Tennessee mother filed a Depakote birth defects lawsuit against Abbott Laboratories and AbbVie, alleging the seizure medication caused her child to be born with serious birth defects.

Plaintiff Angela B. accuses Abbott and its subsidiary, AbbVie, of products liability, inadequate warnings, negligence, and fraud.

Angela alleges that she was not aware the drug could cause such complications until recently, and had not been given proper disclosure at the time she was prescribed Depakote.

According to the Depakote lawsuit, Angela took Depakote as prescribed to control her bipolar disorder. Her child was born in December 2007 and suffers several significant congenital anomalies, cognitive and behavioral impairments and neurological disorders allegedly as a result of using Depakote during pregnancy.

The birth defects lawsuit alleges the drug companies knew, or should have known, the drug was a “human teratogen” and should not be prescribed to pregnant women or women of childbearing years who are likely to become pregnant. Angela further accuses Abbott of failing to warn of a risk of cognitive impairment until they were forced to update the Depakote label in 2011.

What is Depakote?

Depakote (divalproex sodium) is a popular antiepileptic drug. The medication is also prescribed for the prevention of migraines and for the treatment of bipolar disorder’s manic phases. Depakote is sometimes prescribed in conjunction with selective serotonin reuptake inhibitors (SSRIs).

Abbott Laboratories introduced Depakote in the U.S. in 1983. Since 2013, Abbott’s spinoff AbbVie has manufactured the drug. Over the years, millions of patients have taken the medication.

Depakote Birth Defects: Black Box Warning

The FDA first acknowledged the risk of birth defects to the public in 2006, after researchers found that 20% of babies born to mothers using Depakote had birth defects. After these findings, the FDA required Depakote product packaging to include a warning.

In 2009, the FDA released a more detailed warning of Depakote side effects. Specifically, it cited the possibility of heart, craniofacial, and neural tube defects in developing embryos.

The New England Journal of Medicine published a study in 2010 revealing that six specific birth defects occurred at a high rate when pregnant women used Depakote during the first trimester of pregnancy. For example, pregnant Depakote users saw a 12-fold increase in babies born with spina bifida.

The FDA released another Depakote warning in 2012. When compared with the children of non-Depakote users, those exposed to Depakote in the womb typically scored lower in IQ tests and other measures of cognitive function.

Depakote Birth Defects Lawsuits

A large number of birth defects are caused by pharmaceutical drugs. While many drugs are safe during pregnancy, others pose serious dangers. Often the warning about a dangerous or defective drug comes months or years after the initial link to birth defects are discovered.

In general, Depakote lawsuits are filed individually by each plaintiff and are not class actions.

The Depakote Birth Defects Lawsuit is Case No. 3:15-cv-01098-NJR-SCW, in the U.S. District Court for the Southern District of Illinois.