Abbott Laboratories was ordered to pay $23 million in punitive damages to a Minnesota girl whose family blamed the company’s epilepsy drug Depakote for causing her birth defects. It was the first verdict against the drugmaker over the medication.
A state-court jury in St. Louis, Mo., handed down the punitive award after concluding Maddison Schmidt’s family deserved $15 million in compensatory damages for defects tied to her mother’s use of Depakote during pregnancy. Schmidt, 12, suffers from spina bifida.
The verdict doesn’t bode well for Abbott, which faces more than 800 lawsuits in which it’s accused of hiding the anti-seizure drug’s links to birth defects. The company won the first case, which went to trial in Illinois in April.
“We thought some things needed to be changed” with Abbott’s handling of the epilepsy drug, Kirk Ray, one of the jurors who heard Schmidt’s case, said.
Abbott officials have said in securities filings that its Abbvie Inc. spinoff is responsible for all Depakote litigation. Abbott separated its branded-drug business in 2013.
Abbvie officials said they planned to ask Missouri’s appellate courts to overturn the jury’s finding that Depakote caused Schmidt’s birth defects and the $23 million punishment award.
“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.
Depakote generated more than $1.5 billion in sales in 2007, making it Abbott’s second-biggest drug before the medication lost patent protection the following year.
Studies linking Depakote to birth defects prompted federal regulators to require Abbott to put a strong warning against use during pregnancy on the drug’s safety label in 2006. The next year, Abbott and other makers of anti-seizure drugs also were required to beef up warnings about suicide risks tied to the medications.
The New England Journal of Medicine published a study in 2010 tying Depakote to increased risks of six different birth defects, including spina bifida.
In 2012, Abbott paid $1.6 billion to settle federal and state claims resulting from a probe of the company’s Depakote marketing practices. Abbott marketed the drug, approved for epilepsy, bipolar mania and migraine prevention, for unapproved uses such as dementia, federal prosecutors said.
Schmidt’s family alleged in its suit that Abbott officials defectively designed Depakote and then hid its risks from patients and their doctors.
Under Missouri law, jurors had to find Abbott’s mishandling of the drug showed a conscious disregard for Schmidt’s safety to hand down a punishment award.
The case is Schmidt v. Abbott, CA No. 1222-CC-0247901, Missouri Circuit Court (St. Louis).
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