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Lawsuit Alleges Zofran During Pregnancy Caused Son’s Club Foot

baby with cast on leg

A New Jersey Couple has filed a Zofran lawsuit against GlaxoSmithKline, claiming the mother’s use of the drug caused their son to be born with serious health issues.

The now three-year-old child was born with a congenital disorder commonly referred to as clubfoot — a deformity involving one or both feet, causing them to appear to have been rotated internally at the ankle.

Zofran is a powerful drug designed to treat patients suffering from severe nausea caused by chemotherapy and radiation therapy. It is also used to treat and prevent nausea and vomiting after surgery. The drug blocks one of the body’s natural substances — serotonin — that causes vomiting.

Accusations leveled in Zofran birth defect lawsuit

Six months before getting pregnant, the mother underwent antepartum testing, had blood work done and had other tests conducted to assess her physical capacity to have a child. All tests revealed that she was healthy and able to carry a child. Additionally, she began taking prenatal vitamins, which she continued to take for the duration of her pregnancy.

The mother does not drink caffeine, is a nonsmoker and has not drank alcohol of any type in more than 15 years. Three weeks into her pregnancy, she was admitted to the hospital for dehydration and nausea. She was diagnosed with hyperemesis gravidarum, causing her to experience episodic periods of nausea and dehydration throughout the course of her pregnancy. To mitigate symptoms, she was prescribed Zofran to treat her morning sickness as early as five weeks into her pregnancy.

This is not an FDA-approved use of the drug, but doctors still prescribe Zofran off-label to diminish the effects of morning sickness.

While she was hospitalized, the Zofran was administered intravenously and after she was discharged, she was told to take ingestible 4 mg tablets every six hours. The nausea persisted eight weeks into her pregnancy, so her doctor increased her dosage level from four to eight mg. She maintained this dosage level for the duration of her pregnancy.

She was also prescribed a Zofran pump for approximately four days during the first trimester of her pregnancy. During this time, she received the drug by way of premixed injection through her stomach every four hours. The only other medication the mother took during her pregnancy was Advair — used for the treatment of asthma and COPD — for weeks.

Baby born with clubfoot

The mother carried the baby for 40 weeks and one day. He was born on September 24, 2011. At birth, his feet appeared to have been rotated internally at the ankle. Nine days later, his doctors gently manipulated tissues forming ligaments, joint capsules and tendons amid his feet — bending, straightening and ultimately inserting each foot into a plaster cast that ran from his toes to his mid-thighs. The plaster cast was put in place to isolate his legs, knees and feet so that his feet could be properly positioned to obtain the degree of correction.

One week later, his doctors cut and removed the plaster cast to examine the progress. They then recreated another plaster cast. This weekly process continued for the first two months of the child’s life. After two months, he was admitted into the hospital for a tentomy — a surgical act that involves the literal cutting and slicing of a division of an Achilles tendon. Afterwards, his feet were placed in a plaster cast again for several weeks.

The child’s medical condition has kept both him and his parents from enjoying a normal life. Recent examination has revealed that his condition has regressed, meaning he’ll require more surgery and a possible tendon transplant. The procedure has a 20% fail rate and will require the child to be in a plaster cast for another six months. The parents contend that the effects of his clubfoot will stay with him for the rest of his life.


  1. U.S. District Court for the District of New Jersey, Saro & Lee Mandoyan vs. GlaxoSmithKline LLC, and Does 1-50 Inclusive http://www.njd.uscourts.gov/

  2. WebMD, Zofran http://www.webmd.com/drugs/2/drug-30/zofran-oral/details

  3. Advair, http://www.advair.com/