Depakote Settlement Reached in Birth Defect Lawsuit as Jury Deliberates

The parents of a boy who was born with severe birth defects from Depakote have reached a settlement with the manufacturer of the anti-epilepsy drug, as a federal jury was in the process of deliberating about whether the company should be held liable for failing to warn women and the medical community about the risks associated with using the medication during pregnancy.

The Depakote lawsuit was filed by Thomas and Beth Forbes, whose minor child, identified only as B.F., was born spina bifida and severely disfiguring birth defects that were allegedly caused by use of the seizure drug when the mother was pregnant.

Following ten days of trial in the U.S. District Court for the Eastern District of Missouri, court minutes (PDF) entered on June 6 indicate that the parties had reached a settlement. While terms of the deal were not disclosed, District Judge Charles A. Shaw informed the deliberating juries of the agreement and passed the case for settlement, indicating that court approval will be sought by the parties since the claim involves an injury to a minor.

According to the original complaint (PDF) filed by the family in July 2012, Beth Forbes began taking Depakote in April 2003 for depression and became pregnant while using the drug. The lawsuit accused Abbott and The Medicine Shoppe of failing to provide adequate warning that the drug could cause birth defects if taken by pregnant women.

Abbott Laboratories and AbbVie, a subsidiary it spun off, continue to face hundreds of similar Depakote lawsuits in state and federal courts nationwide. While the settlement of this case will not have any binding impact on the other claims, it may influence eventual negotiations to reach Depakote settlements with families that may be necessary to avoid individual trials in courts throughout the U.S.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, side effects of Depakote in pregnancy 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 Depakote birth defects side effects, 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 May 2013, 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 using it to treat epilepsy. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines.

Before the drug’s patent expired in 2007, Depakote was a blockbuster drug generating about $1.5 billion in annual sales for AbbVie’s predecessor.