In yet another incident of pharmaceutical companies allegedly putting profits before people, a federal jury in Illinois ruled against drug company AbbVie on Friday. The decision awarded $15 Million to a 10-year-old boy with spina bifida (improper development of the spinal cord) whose mother took the drug Depakote® (divalproex sodium) during her pregnancy. The drug is used to treat seizures, migraines, and bipolar disorder.
The Illinois jury determined that neither the boy’s mother nor her doctors had been fully informed of the dangers of Depakote. The case alleges that fetuses have more than a 10 percent risk of developing spina bifida when their mothers take the drug while pregnant. However, the mother’s doctors testified that according to information on the drug label, there was only a 1 to 2 percent chance of such birth defects. Depakote contains valporic acid, a chemical said to cause the potential problems.
The boy who won this case uses a wheelchair for mobility, and has had 12 surgeries due to his spinal condition. His monetary award will be used to cover current and future health care bills. While Abbvie has responsibility for this and other Depakote lawsuits, the company was formed in 2013 after becoming independent of Abbott Laboratories.
A Long History of Side-Stepping the Truth
Depakote has been approved to treat bipolar disorder, which is why the boy’s mother was taking the drug. It is also prescribed for seizures and migraine headaches. In 2006, Abbott Laboratories was ordered by federal authorities to include information on Depakote’s label about possible birth defects. The boy’s family alleged that this warning grossly underestimated the possibility of spina bifida, and that Abbott Laboratories had known about the misinformation for years.
A memo about the drug that circulated internally suggests that by May of 2004, the company realized that the occurrence of spina bifida was higher than suggested on the label. At the same time, they failed to adjust the warning accordingly. Depakote was an extremely profitable drug for Abbott Laboratories, and their first pharmaceutical to earn more than $1 Billion in sales. Evidently they disregarded the truth over fear of jeopardizing those profits.
Approximately 700 lawsuits against AbbVie are still winding their way through the courts. In 2015, a jury in Missouri awarded a plaintiff with spina bifida $38 Million. Another Depakote case will be heard in Missouri state court in July, and a federal case is slated to be heard in an Illinois court in September.
The FDA has also issued a warning regarding Depakote and other drugs in its class of anti-seizure medications. Children whose mothers took such drugs while pregnant may “have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.” The FDA advises that women who may become pregnant either not take such drugs, or take birth control simultaneously to prevent possible birth defects.
Deception on Top of Deception
This court battle was the latest in a long line of lawsuits and allegations over the effects and marketing of Depakote. In May of 2012, Abbott Laboratories paid $1.5 Billion as part of guilty plea involving numerous criminal and civil cases. The company was charged with marketing Depakote for treating conditions that had not been approved, including schizophrenia.
Additionally, the drug was promoted to nursing homes as a way to calm dementia patients when they were angry or unnerved. Clinical testing had not yet sufficiently demonstrated that Depakote was either safe or effectual for these conditions.
AbbVie claims that the plaintiffs in these cases cannot prove their spina bifida was caused by Depakote. At the same time, the company’s knowledge of the risk seems clear, and their attempt to disguise the truth is inexcusable. No corporation will admit they are willing to poison children for increased profits, but in the case of Depakote, the evidence seems to point strongly in that direction.