April 22, 2015 — A lawsuit has been filed in federal court in Texas on behalf of a child who was born with serious birth defects after being exposed to Zofran in the womb.
The Texas Zofran lawsuit (PDF) was filed in the U.S. District Court for the Eastern District of Texas on April 17, 2015, against GlaxoSmithKline (GSK).
The plaintiff, Julia Shonkwiler of Texarkana, Texas, is the mother and natural guardian of a child identified only as “B.C.W.” She used Zofran to treat morning sickness early in her first trimester of pregnancy.
Unfortunately, B.C.W. was born last year and diagnosed with congenital heart defects, brain defects, developmental delays, and will need multiple corrective surgeries as a result of numerous birth defects.
There is no history of birth defects in the child’s family or genetic anomalies. Before B.C.W. was born, Shonkwiler gave birth to a healthy boy after a pregnancy in which she did not use Zofran.
The lawsuit cites several three studies published in the last two years that have found evidence linking Zofran and heart defects. One study (Andersen, et al.) found a 30% increased risk of birth defects and a doubled increased risk of heart defects associated with Zofran.
Another study (Danielsson, et al.) reported that mothers who took Zofran in early pregnancy had a 62% increased risk of having a baby with a cardiovascular defect, and were twice as likely to have a baby with a “hole in the heart” (septal defect) compared to women who did not use Zofran.
The defendant, GlaxoSmithKline (GSK), has already resolved a federal litigation involving improper “off-label” marketing of Zofran to pregnant women. Zofran is a chemotherapy drug that is not approved or recommended for use during pregnancy, but it is one of the most common prescription medications for morning sickness.