Last week, a jury in federal court in East St. Louis, Illinois sided with a ten-year old boy who was born with spina bifida. The boy’s lawsuit, filed by his mother, alleged that AbbVie’s popular bipolar medication, Depakote, was the cause of his birth defect and that his mother had not been given adequate warnings that the drug could cause such problems if taken while pregnant. The jury handed down a verdict in the boy’s favor with a $15M award of compensatory damages.
Stevie Gonzalez was born with spina bifida, a birth defect in which part of the spinal column fails to form properly and leaves the spinal cord and nerves exposed. His mother, Christina Racquel, took AbbVie’s Depakote for her bipolar condition while pregnant with Stevie. The compensatory damages award is meant to pay Stevie’s medical bills and cover the future care the boy will need throughout his life. However, the jury declined to award punitive damages. This is the second Depakote trial that AbbVie has lost.
Abbott Laboratories, Inc. spun off AbbVie in 2013. The spin-off company took all rights – and subsequent responsibilities – for Depakote. Currently, almost 700 birth defect lawsuits are pending against AbbVie.
John Boundas, lawyer for the plaintiffs, argued that Abbott (and, therefore, AbbVie) executives were aware that Depakote was “one of the most toxic drugs to a human baby,” but downplayed the risks of birth defects. Depakote has been linked to birth defects in various studies. In fact, federal regulators mandated that Abbott put a strong warning to that effect on the label back in 2006.
According to Mr. Boundas, Abbott concealed the risk factor from doctors. The risk of birth defects is 10.7% and Mr. Boundas referred to an internal company memo, authored in May 2004, showing that the company was aware that the risk factor had increased dramatically over what was printed on the label. Further, argued Mr. Boundas, while the memo was drafted prior to Stevie’s conception, the company never updated the warning or advised doctors of the increased risk. The lawsuit alleges that Depakote’s birth defect risk was four times that of other companies’ drugs.
AbbVie’s attorneys argued that the risks were properly and adequately disclosed and that Christina Racquel chose to use Depakote while pregnant despite the risks. One of the defense team, Joel Smith, also told the jury that Christina had severe mental illness and had attempted to take her own life twice when in her teens.
It’s true that she had been diagnosed with bipolar disorder at 19. Mr. Smith’s argument was that she insisted on taking Depakote due to her other medications not being as effective. Mr. Smith told the jury, “Christina knew her medicine. She was no shrinking violet when it came to her meds.”
In the end, the jury declined to believe the argument.
Depakote lawsuit results have not been consistent across the country. Twenty-four plaintiffs were awarded a total of $38M by a Missouri state court jury in 2015. However, that same year saw a federal jury in Ohio absolve the company of all liability. And in February of this year, another federal jury in Ohio found in favor of AbbVie.