On May 27, 2015, a jury in St. Louis, Missouri awarded $38 million to a Minnesota girl injured by Depakote. The jury added $23 million in punitive damages to the $15 million they had earlier awarded the now 12-year-old girl. The jury agreed with plaintiff’s attorneys’ charges that Depakote, an epilepsy drug made by Abbott Laboratories, caused the girl’s birth defects, and that Abbott Labs failed to properly warn doctors about those risks. This was the first victory against Abbott over Depakote.
Update: The verdict is on appeal; so no recovery has been made despite the verdict.
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. The girl suffers from spina bifida.
800 Depakote Lawsuits
Abbott won the first Depakote trial, in April 2015, in Illinois, but it faces more than 800 lawsuits in which it stands accused of concealing Depakote’s links to birth defects.
Securities filings show Abbott officials have said that their Abbvie Inc. spinoff is responsible for all Depakote litigation. Abbvie officials said they planned to ask Missouri’s appellate courts to overturn the jury’s finding that Depakote caused Schmidt’s birth defects.
Abbott’s corporate statement echoed the core of Abbott’s attorneys’ arguments throughout the trial: “We believe the evidence in the case clearly showed the prescribing doctor and patient were well aware” (of Depakote’s birth-defect risks). In an email, Adelle Infante, a company spokeswoman, said Schmidt’s mother “made an informed decision” to take the medication.
Depakote profited Abbott more than $1.5 billion in 2007, the company’s second best seller that year.
Studies linking Depakote to birth defects prompted federal regulators to require Abbott to add a strong warning label in 2006 against using the drug during pregnancy. In 2007, Abbott and other anti-seizure drug makers were also required to beef up warnings about suicide risks tied to their medications.
In 2010, the New England Journal of Medicine published a study linking Depakote to increased risks of six different birth defects, including spina bifida.
$1.6 Billion Fine for Unapproved Marketing
Abbott paid $1.6 billion in 2012 to settle federal and state claims resulting from a probe of Abbott’s Depakote marketing schemes. Abbott illegally marketed the drug – which was approved for epilepsy, bipolar mania, migraine prevention – for unapproved uses such as dementia, according to federal prosecutors.
The Schmidt family charged that Abbott officials defectively designed Depakote, then hid the drug’s risks from patients and their doctors. Under Missouri law, in order to hand down punitive damages, jurors had to find that Abbott’s mishandling of Depakote showed a conscious disregard for Schmidt’s safety.
The case is Schmidt v. Abbott, CA No. 1222-CC-0247901, Missouri Circuit Court (St. Louis).