July 10, 2015 — The parents of a boy who was born with clubfoot has filed a lawsuit claiming the anti-nausea drug Zofran is to blame for his severe birth defect.
The lawsuit (PDF) was filed against GlaxoSmithKline (GSK) in federal court in New Jersey on June 26 (Case No. 2:15-cv-04536).
Plaintiffs Saro and Lee Mandoyan accuse GSK of marketing Zofran for unapproved, “off-label” uses in pregnant women without studying the risks or warning about potential side effects. Zofran is only approved for chemotherapy patients. Recent studies suggest it may increase the risk of birth defects by 30% when it is used in the first trimester of pregnancy.
The victim, a 3 year-old boy named in the lawsuit as “B.M.,” was born on September 2011 with clubfoot. This orthopedic defect occurs when tendons, ligaments, and muscles in the ankle and calf are under-developed, resulting in a sharply inward-twisting foot.
In his first few years of life, “B.M.” has had to wear hard plaster casts, undergo extensive physical therapy, and surgery to lengthen his Achilles tendon. When he outgrew the casts, he had to wear Mitchell shoes, which brace the feet at a 45º angle for 23 hours a day. As a result, he suffered pressure blisters, sores, was unable to learn how to walk, and had to urinate sitting down.
Lee Mandoyan blames Zofran for causing her son’s “horrific injury” and “day-to-day, hour-by-hour physical and emotional pain and suffering.” ”B.M.” was exposed to large amounts of Zofran during the first trimester.
In the first few weeks of pregnancy, Mandoyan was hospitalized with severe morning sickness (hypermesis gravidarum) and given intravenous Zofran. For four days after she was sent home, Mandoyan used an injection pump to deliver Zofran into her stomach every four hours. She also used 4-mg oral Zofran every six hours, but had to increase to 8-mg when her nausea persisted. She continued taking Zofran throughout her pregnancy.