Disclaimer: Results of this case are not necessarily indicative of future cases.
A stunning development out of St. Louis where a jury awarded a 12-year-old plaintiff Maddision Schmidt $15 million in compensatory damages and $23 million in punitive damages for birth defects she suffered from her mother taking Depakote while pregnant. The verdict represents a devastating blow to Abbott Labs’ contention that it adequately warned patients of the risks of taking Depakote while pregnant. Judging from the size of the verdict, the jury wasn’t convinced.
Abbot Labs maintained the drug was safe for pregnant woman who suffered from epilepsy, bipolar disorder and migraines. Abbot Labs also promoted “off-label” use of the drug for patients suffering from dementia and schizophrenia.
The drug generated $1.5 billion in U.S. sales in 2007 before its patent expired the following year, according to a regulatory filing by Abbott.
Separately, in 2012, Abbott agreed to pay a $1.5 billion settlement with the federal government for unlawful promotional practices of Depakote for uses not approved by the FDA.