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A federal jury in Illinois has awarded $15 million in damages to a California boy and his mother, after finding that AbbVie failed to adequately warn about the pregnancy side effects of Depakote, an epilepsy drug that allegedly caused the child to be born with spina bifida.
The verdict comes in a lawsuit was filed by Christina Raquel, on behalf of her 10 year old son, Stevie Gonzalez. Racquel alleged at trial that AbbVie knew or should have known about the link between Depakote and birth defects, yet failed to warn her or her doctors about the risks associated with use of the drug during pregnancy.
Raquel was prescribed the drug to treat bipolar disorder while she was pregnant, and indicates that her son was born with a split spine, is confined to a wheelchair, and has had to undergo 12 surgeries.
The case was originally brought against Abbot Laboratories, but AbbVie spun off from the company and is now liable for birth defect damages from Depakote. The jury ordered AbbVie to pay $15 million to cover Gonzalez’s medical bills and to pay for his future care needs. However, the jury declined to levy additional punitive damages against AbbVie for recklessly endangering users and their children.
Abbott Laboratories and AbbVie continue to face hundreds of similar Depakote birth defect lawsuits pending in state and federal courts nationwide, each raising similar allegations.
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.
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.