The Supreme Court of Missouri recently upheld a jury’s award of $38 million to a girl born with spina bifida after her mother took the epilepsy drug Depakote, manufactured by Abbott Labs. The court ruled that there was evidence Abbott knew the birth defect risk surpassed what it listed on the drug’s warning label. The seven-member court voted unanimously to affirm a St. Louis jury’s award, including $23 million in punitive damages, to 14-year-old Maddison Schmidt on her claims that Abbott Labs failed to warn about the risk of birth defects posed by Depakote.
In its nine-page opinion, the court rejected Abbott’s argument that the Depakote label provided an adequate warning as a matter of law, stating that, even if the warning was in the proper form and contained the right type of information, it failed in its most fundamental test—to be complete and accurate so as not to mislead consumers. The court also noted that while Depakote’s label stated that use of antiepileptic drugs could increase the risk of birth defects, and that the Centers for Disease Control and Prevention had estimated the risk of spina bifida was one or two percent — but that Schmidt presented evidence that Abbott was aware of multiple studies showing the risk of birth defects was 10 percent or greater, and that the risk of spina bifida was even higher. “As Depakote’s label did not reflect this relevant information, a reasonable inference could be drawn from this evidence that Abbott’s arming was not complete and accurate and, therefore, did not adequately warn,” the court wrote in its opinion.
This ruling is only the latest in a string of legal and regulatory setbacks for Abbott Labs. In 2008, the FDA issued a safety alert regarding antiepileptic drugs such as Depakote. The FDA warned that patients who take antiepileptic drugs may have an increased risk for suicidal thoughts and behavior. The FDA subsequently required drug manufacturers to update their prescription labels to include a warning about this risk.Then, in 2013, the FDA issued another safety alert regarding Depakote and other valproate drugs, warning that, because these types of drugs are associated with lower IQs in children, pregnant women should not take them for the presentation of migraines. In addition, the FDA advises that pregnant women who are being treated for epilepsy or manic episodes associated with bipolar disorder should only take valproate drugs in instances in which the benefits of the drugs outweigh the risks of birth defects.
Under product liability law, manufacturers and sellers have a duty to ensure that their prescription drugs meet certain patient standards. Prescription drugs must be defect-free and safe for patients. If a prescription drug carries a product defect that is unreasonably dangerous, the drug’s manufacturer and sellers can be held responsible for any injuries that result.
Contact an Atlanta Products Liability Attorney
If you or a loved one has been injured by Depakote or any other drug, you may be able to recover through a products liability action. Contact the attorneys at Slappey & Sadd for a free consultation to discuss your case by calling 404.255.6677. We serve the entire state of Georgia, including the following locations: Columbus, Fort Benning, and Covington.