Maddison Schmidt was born with major birth defects after her mother took Depakote while she was pregnant to prevent epileptic seizures.
Those birth defects include spina bifida, microcephaly, eye defects, brain defects, intellectual disabilities (bottom 1%), and nerve damage that causes incontinence and paralysis from the waist down. She has had several spinal surgeries and the placement of shunts in her skull.
In May 2015, a jury in St. Louis County Circuit Court awarded Maddison $15 million in compensation for her injuries, plus another $23 million in punitive damages against Abbott Laboratories for failing to warn her mother about the risk of birth defects.
Abbott appealed the verdict and requested a new trial. On November 8, 2016, the Missouri Court of Appeals upheld the $38 million award. The drug-maker is facing hundreds more Depakote lawsuits.
Abbott made $1.1 billion in sales of Depakote in 2002, the same year Maddison’s mother took it during pregnancy. Her lawyers accuse the drug-maker of putting billions of dollars in profit ahead of public safety.
During the trial, a sales director at Abbott testified that Depakote was known internally as a “dirty drug” because it had warning labels about birth defects and spina bifida since 1983, which made it hard to sell.
Lawyers say Abbott’s “goal was to squeeze every dollar and every prescription out of the market for Depakote while it could,” and spent $50-100 million per year on marketing but nothing on safety studies.
Those marketing efforts included “off-label” use as a chemical restraint in elderly patients with dementia, for which the company paid a $1.1 billion settlement with the Justice Department in 2012 — but also as a first-line treatment for migraines, epilepsy, and bipolar disorder.
Many of those patients were women of childbearing age who were on Depakote when they became pregnant, or pregnant women who did not know about the risk, who later had babies with major birth defects.
Depakote is now known as a “Pregnancy Category X” drug that should only be used as a last resort for women of childbearing age. Decades of studies have shown it to be one of the most dangerous medications to take during pregnancy for a growing baby.
However, when Maddison’s mother took Depakote in 2002, the label had not been updated since 1983. It was so outdated that lawyers accused Abbott of intentionally downplaying the risk to protect sales.
The label claimed there was not enough data on birth defects, when in fact lawyers say Abbott knew of multiple studies concluding that Depakote was by far the most dangerous anti-epileptic drug on the market for birth defects.
The label did warn that 1-2% of babies would develop spina bifida, which sounds low, but actually means Depakote increases the risk of spina bifida by 2,060% compared to non-users. Depakote is now known to cause birth defects in at least 10% of babies who are exposed to it.
At least 800 lawsuits have been filed against Abbott on behalf of children who were born with birth defects. These lawsuits have not been centralized as a class action, but are proceeding individually.