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A St. Louis jury has determined that AbbVie should pay $15 million to the family of a Minnesota girl born with spina bifida, indicating that the drug maker failed to adequately warn about the risk of birth defects from Depakote use during pregnancy.
The verdict came in a product liability lawsuit brought by the family of 12 year-old Maddison Schmidt, who was born with numerous health complications, which were allegedly caused by her mother’s use of the anti-seizure medication Depakote before she was born.
The jury determined that AbbVie, which owns Depakote after Abbott Laboratories spun off the company, should pay $15 million in compensatory damages to cover Schmidt’s life-long medical costs, pain and suffering and other expenses. AbbVie may face additional punitive damages during a second phase of the trial, if the jury decides to award additional damages to punish the company for recklessly endangering unborn children.
AbbVie faces a number of similar Depakote lawsuits brought by families throughout the U.S., which raise similar allegations that inadequate warnings about the pregnancy risks were provided for women and the medical community.
Depakote Birth Defect Risks
Depakote 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 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.