This week a St. Louis jury found that a Minnesota girl’s birth defects were caused by the epilepsy medication Depakote her mother took during pregnancy and the jury awarded the child $15 million in damages.
The jury returned the unanimous verdict on Tuesday and is now considering whether to award punitive damages as well, the St. Louis Post Dispatch reports.
During the trial, attorneys argued that drug maker Abbott downplayed the risks of Depakote use during pregnancy. “Abbott steadfastly refused to communicate the true nature and extent of the risk in its product labeling and warnings to physicians and consumers,” court documents say. The lawsuit also argues the drug was defectively designed and inadequately tested. Circuit Court Judge Steven Ohmer presided over the trial, the Post Dispatch reports.
The 12-year-old girl has a number of birth defects including spina bifida, a defect in the development of the spinal cord. According to the National Institute of Neurological Disorders and Stroke, complications of spina bifida can range from minor physical problems with little functional impairment to severe physical and mental disabilities. The Minnesota girl is one of two dozen plaintiffs in the suit. Abbott spun off its branded-drug business as AbbVie in 2013, with the new company required to assume business-related liabilities that occurred before the spinoff, according to the company’s annual report filed with the Securities and Exchange Commission. “[T]he commercial rights and associated responsibilities for Depakote passed to AbbVie,” Abbott said in a statement, according to the Post Dispatch.
Before 2007, when the drug’s patent expired, Depakote generated $1.5 billion in sales in the United States. In 2013, the Food and Drug Administration (FDA) warned about Depakote use during pregnancy. The class of drugs based on valproate sodium, the active ingredient in Depakote, was found to have risks to the fetus, and the FDA advised that pregnant women should not take valproate sodium to prevent migraines while pregnant. At that time, the FDA cited a study that found valproate sodium could cause decreased IQ scores in children whose mothers took the drug during pregnancy. The FDA said pregnant women with epilepsy or bipolar disorder should take Depakote only if other medications are not effective or are otherwise unacceptable in treating these conditions, according to the Post Dispatch. The FDA says the most common birth defects associated with Depakote affect the brain and spinal cord. Spina bifida or neural tube defects occur in one to two of every 100 babies born to mothers who use this medicine during pregnancy.
In 2012, Abbott agreed to a $1.5 billion settlement with the federal government for unlawfully promoting Depakote for uses not approved by the FDA, the Post Dispatch reports. Doctors may prescribe a drug for any use they deem appropriate but drug makers may not legally market or promote a drug except for uses approved by the FDA. Abbott was found to have promoted the “off-label” use of Depakote for elderly patients with dementia and for individuals with schizophrenia. The drug was approved only for the treatment of epilepsy, bipolar disorder, and migraines, the Department of Justice said in its statement about the settlement.