In June, 2015, a Missouri jury returned a verdict against Pharmaceutical giant Abbott Laboratories, finding that the company had failed to warn the plaintiff’s mother about possible birth defects that could result from use of the seizure disorder drug Depakote. The victim, now 12, was born with spina bifida, as well as a number of other defects. The jury awarded $15 million in compensatory damages, but also found that Abbott’s conduct warranted punitive damages (of $23 million).The lawsuit is one of approximately 800 such cases that have been filed thus far against Abbott.
Abbott Laboratories marketed Depakote from 1998 through 2006. Though the drug had FDA approval, officials at the U.S. Department of Justice say that the company promoted the drug for uses not approved or authorized by the FDA. After complaints were filed, the Justice department began a criminal investigation. Abbott paid $1.5 billion in 2012 to settle both criminal and civil allegations by state and federal officials. The FDA has also labeled Depakote a “pregnancy category X” drug, saying that the potential risks tied to use outweigh the benefits.
Depakote was a highly profitable product for Abbott before the problems surfaced, generating $1.5 billion in revenue in 2077 alone. According to plaintiff’s lawyers, the drug, which was approved for epilepsy, bipolar mania and migraines, was illegally marketed for dementia as well. They say that Abbott intentionally designed the product so that patients and their doctors would not be aware of the risks.
Abbott has indicated that it will appeal the verdict, contending that Schmidt’s mother was well aware of the risks when she took the drug.