For the first time, a verdict has been issued against Abbott over claims that its anti-seizure drug Depakote caused birth defects. Bloomberg reports that a state-court jury in St. Louis, Missouri ordered the company to pay $23 million in punitive damages. According to Missouri state law, the jury must find that Abbott intentionally disregarded the plaintiff’s safety in order to hand down punitive damages. The case that went to trial was filed on behalf of a 12-year old girl with spina bifida; her family alleges that her condition was caused by the use of Depakote during pregnancy.
There are more than 800 lawsuits against Abbott over Depakote’s risks of birth defects, Bloomberg reports. In April, the first case went to trial in Illinois; the jury found for Abbott.
The jury previously awarded $15 million in compensatory damages. “We thought some things needed to be changed” with how Abbott handles Depakote, said juror Kirk Ray to Bloomberg. Abbott said in a securities filing that the company’s spin-off Abbvie is responsible for all litigation involving Depakote. According to Bloomberg, Abbvie plants to ask Missouri’s appellate courts to overturn the finding.
In 2008, Abbott lost its patent protection for Depakote. Prior to that, Depakote has been the company’s second-biggest drug. Depakote sales reached $1.5 billion in 2007.
In 2012, Abbott agreed to pay $1.6 billion to settle allegations that it marketed Depakote for off-label, or unapproved uses. According to state and federal allegations, the company promoted the drug for uses such as dementia, epilepsy, bipolar mania, and migraine prevention.
In 2006, the U.S. Food and Drug Administration (FDA) required Abbott to place a black box warning on Depakote. The boxed warning, which is the strongest type of warning, was prompted by research about the drug’s birth defect risks. Regulators required Abbott and other manufacturers of anti-seizure medications to place stronger warnings about suicide risks in 2007. In 2010, the New England Journal of Medicine published a study showing that Depakote was linked to spina bifida and five other birth defects.