Depakote Birth Defects Lawsuit Filed Over Congenital Malformations

Abbott Laboratories faces a product liability lawsuit brought by a California woman who indicates that she gave birth to three children who suffered birth defects and congenital malformations that were allegedly caused by side effects of Depakote, an antiseizure medication she received throughout all three pregnancies.

The complaint (PDF) was filed earlier this month by Shavon Hawkins in the U.S. District Court for the Southern District of Illinois, on behalf of herself and her three boys, who were born in 2003, 2005 and 2007.

According to allegations raised in the Depakote lawsuit, as a result of Abbott’s failure to warn about the risks associated with using the epilepsy drug during pregnancy, Hawkins’ children were born with a seizure disorder, kidney defect and an airway defect, among other congential malformations and birth defects.

“Abbot knew or should have known it had a duty to warn doctors and patients that women who were taking Depakote should not get pregnant, and that women who might become pregnant should not take Depakote,” the lawsuit states. “This simple warning, commonplace with countless pharmaceuticals, would have spared each plaintiff a lifetime of pain and suffering, inordinate healthcare costs, severe emotional and physical distress, and loss of earning potential.”

Depakote Birth Defect Risks

Depakote (valproic acid) was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy risks have been associated with the development of severe birth defects and malformations, including spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems; 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.

Earlier this month, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women.

The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines. In addition to Depakote and Depacon, other drugs that are affected by the warning include Depakene, Stavzor and generic equivalents.

A Class D classification means that a drug’s benefits may be acceptable despite known potential risks to pregnant women. A Class X designation means that the risks of a drug outweigh the benefits for pregnant women. However, the FDA still considers the side effects to be an acceptable risk for the treatment of epilepsy and manic episodes associated with bipolar disorder, but not migraines.

Hawkins joins a growing number of families throughout the United States who are pursuing a Depakote birth defect lawsuit against Abbott Laboratories, alleging that if the medication had carried earlier warnings about the risks associated with use during pregnancy, children may have avoided suffering permanent and debilitating injuries.