First Verdict in Depakote Litigation. A state-court jury in St. Louis, Missouri ordered Abbott Laboratories to pay $23 million in punitive damages in a case over the company’s anti-seizure drug, Depakote.
Bloomberg reports that it is the first verdict against Abbott over the drug, which allegedly caused birth defects in a Minnesota girl. The family alleged that use of Depakote during pregnancy is to blame for the girl’s spina bifida.
According to Bloomberg, there are more than 800 lawsuits alleging that Abbott hid Depakote’s risks of birth defects. In April, the jury found for Abbott in the first case that went to trial in Illinois.
The punitive damages were awarded after the jury 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.
According to a securities filing by Abbott, the company’s spin-off Abbvie is responsible for all litigation involving Depakote. Abbvie intends to ask Missouri’s appellate courts to overturn the finding, Bloomberg reports.
Abbott lost its patent protection for Depakote in 2008
Abbott lost its patent protection for Depakote in 2008. Prior to that, Depakote has been the company’s second-biggest drug. In 2007, Depakote sales reached $1.5 billion.
The U.S. Food and Drug Administration (FDA) required Abbott to place a black box warning on Depakote in 2006 in light of 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.
Abbott agreed to pay $1.6 billion in 2012 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.