Multi-million dollar settlements and jury awards have been paid to children with birth defects or spina bifida caused by Depakote (valproic acid), an anti-seizure and migraine drug made by Abbott Laboratories.
UPDATE: Court Upholds $38 Million Depakote Award
In November 2016, judges in St. Louis Missouri rejected an appeal from Abbott Laboratories and upheld a $38 million jury award to a girl who was born with spina bifida and other major birth defects after her mother took Depakote during pregnancy.
Jury Awards $38 Million in Depakote Birth Defect Lawsuit
The $38 million jury award included $15 million in compensation and $23 million in punitive damages to the family of Maddison Schmidt, a 12 year-old girl from Minnesota.
She was born with spina bifida, microcephaly, eye defects, brain malformations, intellectual disabilities, and is paralyzed from the waist down. She has required several spinal surgeries and skull shunts.
Over 800 Depakote Lawsuits Filed
Abbott Laboratories made $1.1 billion in sales of Depakote in 2002, the year Maddison’s mother took it to prevent migraines and seizures. Lawyers say Abbott downplayed the risk to protect billions in sales. Over 800 lawsuits have been filed in recent years.
Depakote Known as a “Dirty Drug”
Depakote was Abbott’s most profitable drug from 1996 to 2002, but even within the company it was called a “dirty drug” because safety issues made it hard to sell, according to testimony by a sales director for Abbott. Lawyers say Abbott’s “goal was to squeeze every dollar and every prescription out of the market for Depakote while it could.”
Profits vs. Public Safety
Abbott knew Depakote was a “dirty drug,” but spent $50-100 million per year advertising Depakote as a first-line treatment for women with epilepsy, bipolar disorder, and migraines — including women of childbearing age. No money was spent on independent safety studies.
Birth Defect Warnings Issued in 1980s
In 1983, Abbott sent a “Dear Doctor” letter to warn about the risk of birth defects from Depakote. Those warnings remained unchanged and outdated in 2002, the year Maddison’s mother took Depakote.
Outdated Warnings Downplayed Risk for Decades
The label falsely claimed there was not enough information about birth defects, when in fact Abbott knew of multiple studies concluding that:
- 1) Depakote was by far the most dangerous anti-epileptic drug on the market for causing birth defects
- 2) Birth defects occurred in at least 10% of babies exposed to Depakote
- 3) The risk of spina bifida was significantly higher than the 1-2% stated on the label for Depakote
- 4) The risk of spina bifida amounted to a 2,060% increased risk compared to people who do not take Depakote
Depakote: Pregnancy Category X
The label on Depakote now warns that it is a “Pregnancy Category X” medication — the most dangerous class. It should not be used by women who are pregnant or of childbearing age unless it is essential to treat a severe medical condition after other treatments have failed.
Depakote Class Action Lawsuits
Abbott is facing approximately 800 Depakote birth defect lawsuits, but not as part of a class action. Instead, they are individual lawsuits that were filed by lawyers who focus on seeking compensation for people who suffered the most serious injuries from dangerous medications.
List of Depakote Birth Defects
- Spina bifida
- Cleft palate
- Abnormal skull formation
- Malformed limbs
- Heart defects
- Mental disabilities
- And more
$1.5 Billion Depakote Settlement Resolves Civil & Criminal Liability
In May 2012, the Justice Department announced that Abbott would plead guilty and pay a $1.5 billion settlement for illegally promoting Depakote for “off-label” use in elderly dementia patients and downplaying the risks apparent from its own clinical studies.