Depakote Punitive Damage Award of $23M Added in Birth Defect Lawsuit

A St. Louis jury has ordered Abbott Laboratories and AbbVie to pay an additional $23 million in punitive damages to the family of a Minnesota girl born with birth defects after her mother used the epilepsy drug Depakote during pregnancy. The damages will be added to the $15 million in compensatory damages awarded earlier this week, for a combined verdict of about $38 million. 

The punitive damages came after additional jury deliberations during a second phase of the Depakote trial, where the family of 12-year-old Maddison Schmidt argued that the drug makers should be punished for their reckless actions surrounding the marketing of the anti-seizure drug without adequate warnings about the potential risks associated with use during pregnancy.

Schmidt was born with numerous health complications and birth defects after exposure to Depakote, including spina bifida.

The family argued that AbbVie and Abbott Laboratories attempted to hide the Depakote pregnancy risks of the drug from doctors and the public. The jury agreed, awarding the additional $23 million damages meant to punish the company for its behavior. The $15 million in compensatory damages are meant to cover the life-long medical care and loss of expenses suffered by the girl and her family.

Abbott Laboratories and AbbVie, a subsidiary it spun off earlier this year, continue to face hundreds of similar Depakote lawsuits in state and federal courts nationwide. While the outcome 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 Birth Defect Risks

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.