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Abbott Laboratories and AbbVie, Inc. face a product liability lawsuit over birth defects from Depakote, indicating that the drug makers failed to warn that user of the epilepsy drug during pregnancy may cause severe birth defects, including physical malformations and cognitive impairments.
The complaint (PDF) was filed by Reesci Gillespie in the U.S. District Court for the Southern District of Illinois on October 3, on behalf of herself and her minor child, identified only as “R.G.” in the lawsuit.
Depakote (valproate) is a medication prescribed for treatment of seizures and bipolar disorder, as well as migrain headaches, which has been linked to a number of serious health concerns for unborn children in recent years.
Gillespie indicates that she took the drug consistently during her pregnancy in 2003, as the drug makers failed to provide any warnings about the potential link between Depakote and malformations reported among children, including spina bifida, cleft palate, abnormal skull development and other birth defects; 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 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.
Gillespie maintains that the drug makers knew about the pregnancy risks with Depakote long before the FDA warning, yet withheld information from women and the medical community.
“Defendants knew or should have known by the time of Plaintiff Reesci Gillespie’s pregnancy in 2002-2003 that valproate was a human teratogen and should not be prescribed to pregnant women, or women of childbearing years who are likely to become pregnant,” the lawsuit states. “In fact, the first report of valproate teratogenicity was published in the medical literature in 1980, within two years of the initial introduction of valproate to the market.”
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.
The case joins a number of other Depakote birth defect lawsuits filed over malformations and other problems experienced by children nationwide.
Gillespie presents clais of design defect, defect due to inadequate warning, negligence, negligent misrepresentation and fraud, breach of warranty, medical and related expenses. She is seeking compensatory and punitive damages.