May 27, 2015 — The mother of a baby who was born with cleft lip after being exposed to Zofran in the womb has filed a lawsuit against GlaxoSmithKline (GSK) for failing to warn about the risk of birth defects.
The woman, Jill Cox, is a resident of Arkansas. The lawsuit (PDF) was filed on May 21 in the U.S. District Court for the Eastern District of Arkansas (Case No. 4:15-cv-00284-BRW).
Cox was prescribed Zofran in September 2011 for the prevention of morning sickness. After taking Zofran beginning early in her first trimester, she gave birth to a boy in June 2012.
Unfortunately, the child was born with cleft lip, a birth defect that causes a gap in the upper lip. When the boy was just three months old, he underwent corrective surgery at the Arkansas Children’s Hospital.
According to the complaint:
“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 child had delays in speech and walking, for which he has visited a speech therapist, physical therapist, and developmental therapist. These sessions have been “unduly burdensome” on the Cox family, the complaint states.
The lawsuit accuses GSK of negligence for promoting Zofran “off-label” to pregnant women, and then failing to provide adequate warnings about the possible risk of birth defects.
This is not the first time GSK has been sued on behalf of a child with cleft lip from Zofran. Last month, a very similar lawsuit was filed in federal court in Montana on behalf of a girl who was born in 1998 with cleft lip and cleft palate.
A study published in Birth Defects Research in 2012 reported that babies exposed to Zofran in the first trimester were 2.4-times more likely to be born with cleft palate. Several other studies have also found evidence that Zofran increases the risk of birth defects.