On August 13, 2015, a mother from Salem, Illinois filed the latest lawsuit claiming GlaxoSmithKline’s anti-nausea drug Zofran caused a child’s birth defect. In her complaint, the mother says prenatal exposure to Zofran, beginning in the first trimester of pregnancy, eventually led to her son’s ventricular septal defect.
The claim, filed in the US District Court for the Southern District of Illinois under case number 3:15-cv-00902, can be found below:
Zofran Exposure Caused Severe Heart Defect, Developmental Delays, Claims Illinois Woman
The boy, named S.F. in court documents, was born in February 2009, but only diagnosed with a cardiac septal defect five months later, according to the mother’s lawsuit.
S.F. allegedly suffers from “emotional difficulties” and developmental delays as a result of his congenital abnormality, a hole in the wall separating the heart’s two lower pumping chambers. He is unable to “run or play many sports or play hard with other children,” his mother claims. She says he continues to need a diaper at night, “even though he is now six and a half years old.”
Plaintiff contrasts S.F. to her two older children, neither of whom were exposed to Zofran during fetal development. Both of S.F.’s siblings “were born healthy and vibrant after [Plaintiff] carried them for full-term pregnancies during which she did not ingest Zofran or ondansetron,” Zofran’s active ingredient.
Zofran Litigation Continues To Grow
With this most recent lawsuit now filed in Federal Court, the Zofran birth defect litigation includes at least 34 individually-filed personal injury lawsuits.
In each complaint, another American family accuses GlaxoSmithKline of promoting Zofran, a drug never approved for use during pregnancy, as a “safe and effective” morning sickness treatment. But on the contrary, parents say the company has been concealing evidence of the nausea medication’s link to increased birth defect risks for more than two decades.
A majority of the complaints have been filed in relation to congenital heart defects, on the back of several major studies that have found an association between prenatal exposure to Zofran and an increased risk for “cardiac septal defects.”
In a Danish study, completed in 2013, a review of more than 900,000 birth records revealed that babies exposed to Zofran during the first trimester were 2.3 times more likely to be born with ventricular septal defects, like the abnormality with which S.F. was allegedly born.
Several complaints have been filed in relation to orofacial clefts (like cleft palate), and a recent surge has seen families filing lawsuits involving renal defects, including one complaint in which a child was missing a kidney entirely.