Depakote Maker AbbVie Ordered To Pay $15M To Boy Born With Spina Bifida

Pharmaceuticals giant AbbVie must pay $15 million to the family of a 10-year-old boy who was born with spina bifida after an Illinois jury found the company failed to properly warn doctors about the risk of birth defects associated with Depakote, a prescription drug used to treat bipolar and seizure disorders. 

A federal jury in the Southern District of Illinois awarded [PDF] the child — represented by his mother Christina Raquel — $15 million to cover.

According to the lawsuit against Abbott Laboratories — from which AbbVie was spun off in 2013 — the company did not warn doctors or patients of potential health risk to children born to parents taking Depakote. Raquel was prescribed the medication to treat bipolar disorder while she was pregnant.

Lawyers for the family argued that the company knew the medication was toxic to unborn children but downplayed the possibility of associated birth defects.

Lawyers for the drugmaker claimed [PDF] the company provided warnings to doctors, and that there was not sufficient evidence to support that Depakote caused the boy’s health issues.

Bloomberg reports that following studies linking Depakote to birth defects federal regulators in 2006 required the company to put pregnancy-use warnings on the products.

However, the family’s lawyer claims that while these measure were taken before the boy was conceived, Abbott failed to alert doctors that the overall birth defect risk for patients using the drug was more than 10%.

Consumerist has reached out to AbbVie for comment on Friday’s jury verdict. We’ll update this post if we hear back.

Friday’s verdict is just the most recent against Abbott. Reuters reports that in 2015 a jury in Missouri awarded $38 million to 24 plaintiffs. Another case in 2015 ended in favor of the drugmaker.

The millions of dollars in damages from these individual cases, while significant, are nothing compared to the amounts that Abbott paid to close the book on federal regulators’ investigations.

In May 2012, the drugmaker entered a guilty plea and agreed to pay a total of $1.5 billion to resolve criminal and civil charges that Abbott was promoting Depakote for unapproved uses.

As part of that deal, Abbott admitted to maintaining a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, even though the drug had not been proven safe and effective for this use. The company also marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after Abbott’s clinical trials failed to demonstrate that the addition of Depakote made these other drugs any more effective.

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