June 3, 2015 — A jury in St. Louis, Missouri has awarded $38 million to the family of a girl who was born with numerous birth defects, including spina bifida, after her mother used the anti-seizure drug Depakote during pregnancy.
The St. Louis Post-Dispatch reports that attorneys for the 12 year-old plaintiff, Maddison Schmidt, argued that drug-maker Abbott Laboratories failed to adequately warn about the risk of birth defects.
Schmidt was awarded $15 million in compensatory damages for her pain and suffering, medical expenses, and more. The jury also awarded $23 million in punitive damages. She was one of two dozen plaintiffs named in the lawsuit.
Abbott is currently facing about 800 lawsuits involving Depakote, all making similar accusations that the drug-maker failed to warn about side effects.
This is not the first time Abbott has been accused of improperly marketing Depakote. In 2012, Abbott reached a $1.5 billion settlement to the Justice Department for “off-label” marketing.
The settlement resolved criminal and civil allegations that Abbott illegally promoted Depakote for unapproved uses in patients with dementia and schizophrenia between 1998-2006.
In 2013, the FDA issued a Safety Communication regarding medications in the valproate sodium class of medications, which includes Depakote. The FDA warned against using the medications to prevent migraine headaches and changed their pregnancy category from “D” to “X,” which means the risks clearly outweigh any possible benefits.
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