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Arkansas Mom Files Zofran Lawsuit After Son Born with Clubfeet

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Another new Zofran lawsuit has been filed in federal court, and is likely to soon join the newly established Zofran MDL in the District of Massachusetts.

The Plaintiff, a resident of Arkansas, filed the complaint in the Eastern District of Louisiana against Zofran manufacturer GlaxoSmithKline (GSK). She blames the company for her son’s birth defects.

Mother Blames Zofran for Son’s Cleft Palate and Clubfeet

According to her complaint, the Plaintiff was prescribed Zofran (ondensatron) to treat and prevent her symptoms of morning sickness while she was pregnant with her son, B.H. She started taking the medication early in her first trimester and continued taking it through her third trimester. Her son was born in 2007.

Immediately after his birth, B.H. was diagnosed with several severe congenital defects. These included a cleft palate and bilateral clubfeet. His mother now believes it was because of his in utero exposure to Zofran that he developed these defects.

A cleft palate is a defect in which the baby’s mouth and face don’t develop properly. The tissues that make up the lip and palate normally fuse together between the second and third months of pregnancy, but this fails to occur in children with the defect, which leaves an opening where the connection would have taken place. Treatment typically requires surgery, and often more than one.

A clubfoot is the general name for a number of birth defects that affect the shape of the baby’s foot. Usually the foot is twisted or positioned awkwardly with the leg, to look like a golf club, with underdeveloped tissues connecting the muscles to the bone. About half the children who have this defect have it in both feet, including the Plaintiff’s son. Treatments typically include casting, repeated repositioning, stretching, use of braces for long periods of time, and sometimes surgery.

The Plaintiff states that she had no family history of any of these conditions, and that B.H. has two siblings who were born perfectly fine. She adds that neither she nor her doctor were aware of the potential risks in taking Zofran, and that had she known, she would have never taken it while pregnant.

FDA Did Not Approve Zofran for Pregnant Women

The plaintiff alleges in her case that GSK never tested their product in pregnant women to determine its safety. Indeed, they didn’t even have FDA approval to market it to pregnant women. The FDA had approved the drug only for use in those recovering from surgery or going through chemotherapy.

Though it is illegal for companies to advertise their drugs for so-called “off-label” or non-approved uses, GSK did just that, promoting Zofran to gynecologists as a treatment for morning sickness. “GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs,” the Plaintiff states.

GSK Pays $3 Billion to Settle Criminal Charges

Through its advertising campaigns, GSK pushed Zofran to become the number one most prescribed drug for morning sickness in the 2000s. They did this despite receiving reports of birth defects associated with Zofran starting in 1992. By the year 2000, GSK had received at least 32 of these reports, and to date, at least 200.

In 2012, GSK pled guilty to criminal charges for promoting their drugs, including Zofran, for off-label uses, and agreed to pay $3 billion in a settlement with the U.S. Department of Justice.