5/28/2015
A young girl got a $15M jury verdict for birth defects she suffered because her mother took Depakote, an anti-epileptic drug, while pregnant. The St. Louis, MO jury was unanimous in the verdict, which came down after only a few days’ deliberation.
The $15M is just for damages; the jury is now considering adding punitive damages as Abbott, the Big PharmaCo behind Depakote, may have downplayed the dangers of taking the drug. The plaintiff alleged that Depakote was also defectively designed and inadequately tested.
A copy of the suit was obtained by the St. Louis Post-Dispatch. According to the suit, “Abbott steadfastly refused to communicate the true nature and extent of the risk in its product labeling and warnings to physicians and consumers.”
Maddison Schmidt, the 12-year-old plaintiff, has spina bifida and several other birth defects. She is one of two dozen plaintiffs in the case. While Abbott is a named defendant, AbbVie, Inc., a spin-off company in charge of Abbott’s branded drugs, is the one on the hook for the $15M.
The FDA issued a safety announcement in 2013 warning of the dangers of a class of sodium valproate drugs, including Depakote, and use by pregnant women. The study conducted at the time stated that it could result in decreased IQ scores in children.
It also advised that only those expectant mothers with bipolar disorder or epilepsy should use Depakote and its ilk and only if no other treatments worked. At this time, the drug class was also used to treat migraines headaches.
This isn’t the first time Abbott has been in hot water over Depakote. The company agreed to a $1.5B (yes, that’s billion!) settlement in 2012 as a result of government allegations that the company illegally promoted Depakote for off-label uses. At one point, Abbott was pushing the drug for elderly patients with dementia and for those with schizophrenia. The FDA only approved the drug for epilepsy, bipolar disorder and migraine headaches.
Yet another case of Big Pharma thinking with its balance sheet instead of common sense. I’m so happy Abbott got spanked for this one! I hope the money – never a truly adequate compensation for such suffering – makes Miss Schmidt’s life somewhat easier, as well as those of the other plaintiffs. If there’s a shred of justice in the world, that jury will come back with punitives somewhere near triple the actual damages.
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