July 10, 2015 — A lawsuit has been filed against GlaxoSmithKline (GSK) by the parents of a boy who was born with clubfoot after his mother took the anti-nausea drug Zofran during pregnancy.
Zofran (ondansetron) is a chemotherapy drug that was marketed “off-label” for pregnant women with morning sickness. Recent studies have suggested that Zofran can increase the risk of birth defects by up to 30%.
The lawsuit (PDF) was filed by Saro and Lee Mandoyan, parents of a 3 year-old child named in the complaint as “B.M.,” on June 26 in the U.S. District Court for New Jersey (Case No. 2:15-cv-04536).
The mother, Lee Mandoyan, was admitted to the hospital for dehydration and nausea three weeks into her pregnancy. She was diagnosed with hypermesis gravidarum, the most severe form of morning sickness.
In the hospital, Mandoyan was given intravenous Zofran. After she went home, she used an injection pump to discharge Zofran though her stomach every four hours.
After four days of using the pump, she switched to an oral 4-mg dose of Zofran to take daily every six hours. When her nausea persisted, her doctor upped the dosage to 8-mg and she maintained that level throughout the remainder of her pregnancy.
In September 2011, Mandoyan gave birth to a boy with clubfoot, a serious orthopedic birth defect in which the feet are sharply rotated inward at the ankle. During the first few weeks of his life, his feet were bent and straightened, inserted into a hard plaster cast, and he had to have surgery to lengthen his Achilles tendon.
For six months after these procedures, he had to wear a Mitchell shoe, which is a type of footwear with a metal bar that fixes both feet at a 45º angle for 23 hours a day. He suffered pressure blisters and sores from wearing the Mitchell shoes.
As a consequence of his birth defect, B.M. has been unable to learn how to walk and has had to learn to urinate sitting down while wearing orthopedic devices. His parents are seeking compensation for his “horrific injury,” which has caused “day-to-day, hour-by-hour physical and emotional pain and suffering.”
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