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Birth Defects Lawsuit Results in $15M Verdict

pregnant motherThe Saint Louis Dispatch recently reported on a landmark verdict involving the anti-seizure drug Depakote and birth defects. The case, which was tried in a St. Louis Circuit Court before Judge Steven Ohmer, argued that the anti-epileptic medication caused the plaintiff’s now 12-year old daughter to develop life-threatening congenital malformations, including spina bifida.

After deliberating for three days, the jurors returned a unanimous verdict, ordering the defendant AbbVie Inc. to pay $15 million in damages to a Minnesota girl whose mother took the drug while pregnant. AbbVie Inc. may also be facing additional punitive damages, which the panel is currently deliberating.

$15 million verdict in birth defects case involving Depakote

It wasn’t until 2013 that the FDA published a safety communication warning that pregnant women should not take drugs containing valproate sodium (the active component in Depakote). Health regulators cited research that suggested Depakote and other products made with valproate sodium were tied to lower IQ scores in children whose mothers took the drug while pregnant.

The complaint alleged that Depakote was defectively designed and that “Abbott steadfastly refused to communicate the true nature and extent of the risk in its product labeling and warnings to physicians and consumers.”

Ongoing concern regarding Zofran risks during pregnancy

Allegations raised in this Depakote case are similar to those raised in recent Zofran lawsuits. According to plaintiffs, the anti-nausea medication was promoted as a morning sickness treatment without proper warnings regarding risk of fetal harm. Zofran is designed and manufactured by GlaxoSmithKline (GSK) and was approved in the U.S in 1991. In 2006, the first generic counterparts also became available.

Some mothers who took the medication while expecting contend that their children were born with heart defects, musculoskeletal anomalies, cleft lip and other malformations that necessitated costly and invasive medical intervention. Recent litigation has alleged that GSK knew of Zofran risks during pregnancy based on prior animal trials that showed the drug crossed the placental barrier, but was more concerned about sales than public safety. Furthermore, Zofran was never approved by the FDA to treat morning sickness, and was strictly prescribed “off-label,” a legal practice which is widespread in the United States.

While some pregnant women have found relief from their pregnancy-induced nausea and vomiting through Zofran use, others have brought birth defect complaints demanding compensation from GSK.

It remains to be seen whether lawsuits regarding Zofran during pregnancy will return favorable judgments for plaintiffs, considering more research is needed to verify birth defect risks. The only anti-nausea medication approved for pregnant women in the U.S. is Diclegis: a Category A, FDA-cleared prescription for morning sickness.

Litigation involving Zofran and birth defects

Though only a handful of civil actions have been filed against GSK thus far over alleged Zofran complications, claimants are suing based on fraudulent misrepresentation, strict liability, breach of warranty and failure to warn.

Zofran injury lawsuits are seeking damages for:

  • Past, present and future medical expenses
  • Lost earning potential
  • Loss of income
  • Pain and suffering
  • Emotional distress

  1. St. Louis Post Dispatch, St. Louis jury awards $15 million in damages in Depakote lawsuit

  2., Depakote

  3. Canadian Family Physician, Is ondansetron safe for use during pregnancy?