May 27, 2015 — A mother from Arkansas who took Zofran during pregnancy and had a child with cleft lip has filed a lawsuit against GlaxoSmithKline (GSK) in federal court.

The lawsuit (PDF) (Case No. 4:15-cv-00284-BRW) was filed on May 21 in the U.S. District Court for the Eastern District of Arkansas by plaintiff Jill Cox.

Around September 2011, Cox used Zofran early in the first trimester of pregnancy to prevent morning sickness. On June 1, 2012, she gave birth to a boy with a partial cleft lip. Three months later, the boy had surgery to repair the lip.

The complaint states:

“He suffered a permanent scar from the repair that is often red and inflamed. The bottom of his lip is not symmetrical. Besides corrective surgery from his cleft lip, Jacob Cox has also had developmental delays from the sedations.”

The developmental delays include speech and walking. His visits to a speech therapy, developmental therapist, and physical therapist have been “unduly burdensome” on the family, according to the lawsuit.

The plaintiff says she never would have used Zofran during pregnancy and her child would not have been born healthy had GSK adequately warned about the risk of birth defects.

This is at least the second lawsuit to be filed on behalf of a child who was born with cleft lip after being exposed to Zofran. The parents of “M.M.,” a girl who was born in 1998 with cleft lip, filed a similar lawsuit against GSK in federal court in Montana last month. Both of the lawsuits accuse GSK of negligence for marketing Zofran “off-label” to pregnant women and failing to warn about birth defects.

In January 2012, a study published in Birth Defects Research concluded that children were 2.4-times more likely to be born with cleft palate if they were exposed to Zofran during the first trimester.


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