Abbott Laboratories Slapped With $23 Million in Punitive Damages in Depakote Birth Defects Trial

 

Abbott Laboratories has been ordered to pay $23 million in punitive damages to a 12-year-old Minnesota girl whose family alleges the company’s epilepsy drug Depakote caused her birth defects, in the first verdict against the company over the medication.

A state jury in St. Louis, Missouri, concluded that Maddison Schmidt’s spina bifida was the result of her mother’s use of Depakote during pregnancy. The jury awarded the girl $15 million in compensatory damages, as well. More than 800 Depakote lawsuits have been filed against the drug maker by plaintiffs claiming the company hid the drug’s links to birth defects, according to Insurance Journal.

Abbott said in securities filings obtained by Insurance Journal that Abbvie Inc. is responsible for all Depakote litigation. Abbott separated its branded-drug business in 2013. Abbvie officials say they will seek to have the verdict overturned by Missouri’s appellate courts.

“We believe the evidence in the case clearly showed the prescribing doctor and patient were well aware” of the drug’s birth-defect risks and Schmidt’s mother “made an informed decision” to take the medication, Adelle Infante, a company spokeswoman, said in an email to Insurance Journal.

Depakote generated more than $1.5 billion in sales for Abbott in 2007, making it the company’s second-largest drug before the medication lost patent protection the following year. Federal health officials required Abbott to add a strong warning against use of Depakote during pregnancy in 2006 after studies showed the medication could cause birth defects. The U.S. Food and Drug Administration (FDA) also made Abbott and other manufacturers strengthen warnings about suicide risks tied to the drug. In 2010, The New England Journal of Medicine published a study linking Depakote to spina bifida and five other birth defects, Insurance Journal reported.

In 2012, Abbott paid the government $1.6 billion to settle federal and state allegations that the company had been marketing Depakote for unapproved uses including dementia. The drug is only approved to treat epilepsy, bipolar mania and migraine prevention, according to Insurance Journal.

Schmidt’s family alleged in the suit obtained by Insurance Journal that Abbott officials defectively designed Depakote and then hid its risks from patients and their doctors. Jurors had to find that Abbott’s handling of the medication was evidence of conscious disregard for the safety of Maddison Schmidt under Missouri law in order to hand down a punishment award, Insurance Journal reported.

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