Babies who were born with birth defects or spina bifida from Depakote have been been paid multi-million dollar settlements and massive jury awards in recent years. Hundreds of lawsuits have been filed against Abbott Laboratories.

UPDATE: $38 Million Depakote Payout Survives Appeal

In November 2016, judges in St. Louis Circuit Court issued an order (PDF) upholding a $38 million jury award to a girl who was severely disabled by birth defects caused by Depakote, rejecting an appeal from Abbot Labs.

Depakote Birth Defect Lawsuit Awarded $38 Million

On May 27, 2015, a jury in St. Louis, Missouri awarded a $38 million payout to a 12 year-old girl from Minnesota named Maddison Schmidt who was born with birth defects after her mother took Depakote while pregnant.

Maddison was born with spina bifida, microcephaly, eye defects, brain defects, severe intellectual disabilities (bottom 1%), nerve damage that makes her incontinent, and is paralyzed from the waist down. She has also had several spinal surgeries and shunts placed in her skull.

Lawyers File Over 800 Depakote Lawsuits

Abbott Laboratories is facing around 800 lawsuits from the parents of children like Maddison. Lawyers say the company knew about the risk of birth defects and intentionally downplayed it to protect billions of dollars in sales. Abbott made $1.1 billion off Depakote in 2002 alone, the same year Maddison’s mother took it when she was pregnant.

Abbott Knew Depakote Was a “Dirty Drug”

During the trial, a sales director for Abbott testified that Depakote was known within the company as a “dirty drug” because it had serious side effects that made it hard to sell. Even so, sales reps turned Depakote into Abbott’s most profitable drug between 1996 and 2002. Lawyers say that indicates Abbott’s “goal was to squeeze every dollar and every prescription out of the market for Depakote while it could.”

Corporate Profits Over Safety?

Depakote was aggressively marketed as a first-line treatment for epilepsy, bipolar disorder, and migraine headaches — including for women of childbearing age — at a cost of $50-100 million per year. Despite internal concerns that Depakote was a “dirty drug,” Abbott did not spend any money on conducting independent safety studies.

Abbott Knew of Depakote Risks in 1980s

Birth defect concerns are nothing new for anti-epileptic drugs — many other drugs in this class were linked to birth defects before Depakote was approved. In 1983, Abbott sent out a “Dear Doctor” letter to warn about birth defects from Depakote, and later a “Black Box” warning.

Decades of Outdated Birth Defect Warnings

These warnings remained unchanged for the next 20 years, and falsely claimed there was not enough data on specific birth defects. In fact, Abbott actually knew about multiple studies concluding that:

  • 1) Depakote was far more likely to cause birth defects than any other anti-epileptic drug on the market
  • 2) At least 10% of pregnant women who took Depakote had a baby with at least one birth defect
  • 3) The “1-2% risk of spina bifida” on the label downplayed the actual risk of spina bifida
  • 4) Depakote actually increased the risk of spina bifida by 2,060% compared to the general population

FDA Classifies Depakote as Pregnancy Category X

The FDA warns that Depakote (valproic acid) is a Pregnancy Category X medication — the most serious class for any medication — and it should not be taken by pregnant women or women of childbearing age unless it is absolutely essential to a serious medical condition (i.e, not migraine headaches) and only after ofter treatments have failed.

Depakote Class Action Lawsuits

Lawyers have filed hundreds of lawsuits, but not as part of a Depakote class action. Instead, they are individual lawsuits by people with their own attorney representing their legal interests. Class actions can have disadvantages for people who were severely injured by medications.

Birth Defects Linked to Depakote

  • Spina bifida
  • Cleft palate
  • Abnormal skull formation
  • Malformed limbs
  • Heart defects
  • Mental disabilities
  • And more

Abbott Pays Out $1.5 Billion Depakote Settlement

In 2012, the Justice Department announced a $1.5 billion settlement after Abbott Labs agreed to plead guilty and resolve civil and criminal liability for illegally promoting Depakote “off-label” in elderly patients with dementia — a use not approved by the FDA.


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