AbbVie has been ordered to pay $15 million to compensate a family who says the company's drug Depakote caused spina bifida.

Spina Bifida Graphic

A federal jury in Illinois has awarded $15 million in compensation to a mother who blames the popular anticonvulsant medication Depakote for her son's severe birth defects, according to Reuters.

Seizure Drug Lawsuit Ends In Huge Jury Verdict

At trial, the woman's attorneys argued that AbbVie, the pharmaceutical company behind Depakote, failed to warn their client and other patients of the drug's severe risks. Without adequate warnings, the lawyers say, the mother had no way of knowing that the drug she took during pregnancy to treat her bipolar disorder would result in fetal malformations. The mother's son, named as E.R.G. in court documents, was born with spina bifida, a major neural tube defect in which the spinal cord fails to develop properly.

Court records show that E.R.G., now 10 years old, has been forced to undergo 12 different surgical procedures. He is confined to a wheelchair.

Compensation Will Pay For Spina Bifida Care

Spina bifida is a truly terrible birth defect that leads to an early death in many cases. One in three children born with spina bifida die from complications of the disorder within their first five years of life, according to researchers at the University of London. Those children who survive usually require extensive medical treatment, along with occupational and rehabilitative therapies.

The jury, gathered together in the US District Court for the Southern District of Illinois, debated AbbVie's liability for over two days, finally concluding that the company could have done more to warn the public and health community of Depakote's risks. The $15 million judgment is meant to pay for E.R.G.'s past and future medical expenses. Punitive damages, occasionally awarded to punish defendants for particularly egregious conduct, were not granted in the case.

700 Depakote Lawsuits Await Their Day In Court

Crucial evidence came in the form of internal corporate memos, which suggest that AbbVie executives knew that medical researchers' findings conflicted with risk estimates printed on the drug's labeling, Bloomberg Technology reports. During closing arguments, one of the family's attorneys told jurors that high-level employees at the company were well aware that Depakote is "one of the most toxic drugs to a human baby," but chose to conceal that information from parents. The trial lasted nine days.

Around 700 similar Depakote lawsuits are still pending in state and federal courts across the country.

FDA Works To Reduce Pregnancy Exposures

Depakote, with the active ingredient divalproex sodium, has been approved by the US Food & Drug Administration for the treatment of three disorders:
  • seizures
  • manic or mixed episodes associated with bipolar disorder
  • migraine headaches
Doctors frequently prescribe the drug off-label, for unapproved uses, including schizophrenia and alcohol dependence. In fact, the medication's original developer, Abbott Laboratories, was sued by the federal government over allegations that the company had promoted Depakote for off-label use. The manufacturer eventually settled the accusations for a total of $1.6 billion.

The drug's dramatic risks for unborn children have not gone unnoticed by federal health regulators.  In 2006, experts at the FDA forced Abbott to strengthen the drug's warning label, adding a "black box" alerting patients that Depakote "can produce teratogenic effects such as neural tube defects (e.g., spina bifida)." Teratogens are chemicals or other substances that can impair fetal development. Over the last decade, federal safety officials have reiterated the drug's dangers multiple times.

The Legal Herald

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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