Depakote Birth Defect Injury Lawsuits. On June 9, 2017, a jury in federal court in East St. Louis, Illinois took the side of a ten-year-old boy who was born with the birth defect, spina bifida. The boy’s mother filed the lawsuit alleging that AbbVie’s popular bipolar and antiepileptic medication Depakote , was the cause of her son’s birth defect and she maintains if she had been given proper warnings that the drug could cause such problems if taken while pregnant, she never would have taken the drug. The jury ruled in favor of the boy with a $15 million award of compensatory damages. The presiding judge was Nancy J. Rosenstengel.
What is Spina Bifida?
The boy was born in 2007 with spina bifida, a birth defect where part of the spinal column fails to form correctly and leaves the spinal cord and nerves exposed. His mother took AbbVie’s Depakote to treat her bipolar condition while pregnant with her baby. The mother sought compensation for past and future medical expenses, life-care, and future lost wages or reduced earning capacity. The compensatory damages award is meant to take care of the boy’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 did not go well for AbbVie.
Abbott Laboratories, Inc. separated from AbbVie in 2013. The spin-off company took all rights – and subsequent responsibilities – for Depakote. At this time, there are nearly 700 birth defect lawsuits pending against AbbVie.
National law firm Parker Waichman LLP has extensive experience and success representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.
Was Risk Factor Concealed by Manufacturer?
The lawyer for the plaintiffs disagreed that Abbott (and, therefore, AbbVie) executives were aware that Depakote was “one of the most toxic drugs to a human baby,” but downplayed the risk of birth defects. Depakote has been linked to birth defects in various studies. In fact, federal regulators required that Abbott put a strong warning to that effect on the label as far back as 2006.
According to the plaintiffs’ lawyer, Abbott hid the risk factor from doctors. The risk of birth defects is 10.7 percent and the lawyer referred to an internal company memo, written 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 the plaintiffs’ attorney, while the memo was drafted prior to the 10-year-old boy’s conception, the company never updated the warning or advised doctors of the increased risk. The lawsuit claims that Depakote’s birth defect risk was four times that of other companies’ drugs.
Prior Depakote Lawsuits
Depakote lawsuit outcomes have not been consistent nationwide. In 2015, twenty-four plaintiffs were awarded a total of $38 million by a Missouri state court jury. In contrast, that same year, a federal jury in Ohio absolved AbbVie of all liability. Then, in February 2017, another federal jury in Ohio ruled in favor of AbbVie.
Depakote has been aggressively marketed to treat conditions such as dementia. For this, a criminal investigation was launched and Abbot reached a $1.5 billion settlement with the FDA four years ago, for misbranding its product. Eight plaintiffs alleged that Abbot Laboratories and its competitor at the time, AbbieVie, both were aware of the risks valproate posed to unborn fetuses even before they began selling and marketing Depakote.
Depakote is a medication approved to prevent seizures, to treat manic episodes associated with bipolar disorder, for migraine prophylaxis, and to treat specific types of seizures.
Over 20 different antiepileptic drugs (AEDs) are on the market, and some of the newer anticonvulsants are better tolerated than the older AEDs. Some anti-seizure medications have a higher incidence of birth defects, such as Depakote (valproate), considered to be the riskiest. If valproate is taken in the first 28 days of pregnancy, there is a one to two percent risk of neural tube defects or lack of spinal cord closure.
Research from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD), found that women taking valproic acid during pregnancy gave birth to babies that developed a lower than average IQ (intelligence quotient). These children may have an average IQ of 92, which is six points lower than average, as well as an increased risk of autism. Depakote also raises the risk of spina bifida and other structural deformities to approximately 10 percent.