Depakote Birth Defect Lawsuit Results in Defense Verdict

An Ohio federal jury has returned a defense verdict in one of the first trials over the risk of birth defects from Depakote, finding that the plaintiffs failed to establish that the manufacturers of the anti-seizure drug withheld information about the risks associated with use by pregnant women.

The judgment (PDF) in favor of the Abbott Laboratories and AbbVie was entered on February 2, following a 12 day trial in case filed by Kevin and Christin Hutchens, who claimed that their son, identified only by the initials Z.H., was born in 2003 with microcephaly due to side effects of Depakote prescribed to the mother during pregnancy.

The birth defect involves an abnormally small skull, and the parents claimed that the drug makers failed to adequately warn women and the medical community about the potential Depakote pregnancy risks.

According to the jury verdict form (PDF) from the U.S. District Court for the Northern District of Ohio, the plaintiffs failed to meet the necessary burden of proof to establish that the drug makers failed to provide adequate warnings about the risks of Depakote, or that the drug was defective due to failure to conform to the representations made by the defendants.

Abbott Laboratories and AbbVie, a subsidiary it spun off, continue to face hundreds of similar Depakote birth defect lawsuits pending in state and federal courts nationwide, each raising similar allegations. However, the judgment in this early trial will not have any binding impact on other cases.

In 2006, the FDA added a “black box” warning about the potential Depakote pregnancy 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.

Exposure to Depakote during pregnancy has been linked to a number 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.

At trial, the drug makers argued that that an attempt to place a label warning on the drug in 2009, about the risk of developmental delays, was rejected by the FDA.

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.