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Americans have access to a civil justice system that protects them when large pharmaceutical corporations fail to act in patients’ best interests. The Depakote litigation is a prime example of a company’s failure and trial lawyers’ stepping in to hold it accountable for hurting people.

Depakote is an anti-seizure drug that was approved for the treatment of epilepsy, manic episodes associated with bipolar disorder, and migraine headaches. In 2006, the U.S. Food and Drug Administration (FDA) mandated the addition of a black box warning to Depakote’s label after a study revealed that 20 percent of women who took the drug while pregnant gave birth to a child with a birth defect. The warning notes “fetal risk, particularly neural tube defects and other major malformations,” as an adverse reaction.

Because of this risk, which may occur as early as the first trimester, the FDA goes on to say that Depakote should not be administered to a woman of childbearing potential unless the drug is essential in managing her medical condition. There may be safer solutions for the treatment of migraines, for example, and other non-life threatening conditions. The risk is so great, in fact, that the FDA also warns that women should use effective contraception while using Depakote, and those who are planning to get pregnant should be counseled on the risks and benefits of using Depakote during pregnancy.

However, in light of all this information, Abbott Laboratories continued to manufacture and market Depakote, putting women and babies throughout the U.S. at risk.

In 2011, the FDA issued another warning that children born to mothers who take Depakote — or related products like valproic acid and divalproex sodium — during pregnancy have an increased risk of giving birth to children with cognitive impairment. 

Shortly after that announcement, Abbott Laboratories Inc. pleaded guilty and agreed to pay a criminal fine and forfeiture totaling $700 million and civil settlements totaling $800 million to resolve liability suits arising from the company’s unlawful promotion of unapproved uses of Depakote. 

Separately, in 2015, a jury awarded a Minnesota girl $23 million in punitive damages in the first verdict against Abbvie Inc. — a subsidiary of Abbott — over birth defect allegations. The girl suffers from spina bifida, for which the family blamed the drugmaker. The family also obtained $15 million in compensatory damages.

More than 800 additional pending lawsuits against the manufacturer were moved into federal court in the U.S. District Court for the Southern District of Illinois. The Milestone team has worked with many of these families in a settlement planning capacity, helping ensure mothers and children are taken care of once litigation ends. Many of the settlement plans we have helped establish have been for small annuities for minors (to begin when they’re 18 or older) or trusts to pay for ongoing and future education and/or medical needs.

There is no way to excuse a company like Abbott for knowingly continuing to market Depakote when it comes with such huge, life-altering, irreparable side effects. It’s a classic example of putting profit over people. Milestone has been humbled to play a part in helping these families in their pursuit of justice, and in an attempt to move forward with their lives. 

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