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Family Sues Zofran Makers Over Child’s Clubfoot

A family in New Jersey filed a lawsuit last month against GlaxoSmithKline, the makers of the popular anti-nausea medication, Zofran, after their infant was born with clubfoot.

According to court documents, the plaintiffs, a family from  Bergen County, New Jersey, filed the lawsuit after their son, born in 2010, developed a severe case of clubfoot, in which both of his feet were twisted inward, facing his ankles.

Clubfoot and The Mitchell Shoe

In addition, the court documents indicate that the baby boy has endured a series of invasive treatments in an attempt to correction his medical condition. One of the treatments included a tenotomy. A tenotomy is a surgical procedure that involves cutting the Achilles tendon and then lengthen the tendons in order to straighten out the baby’s feet. The plaintiffs allege that their baby went through an extensive tenotomy,  which ended with the baby wearing a cast for numerous weeks, as well as a “Mitchell shoe,” used to treat clubfoot.

The Mitchell shoe, however, is a metal bar attached to the bottom of both, making it uncomfortable to move around. The baby wore the Mitchell for six months, 23 hours a day. Now a 3-year-old, the child still has to wear the Mitchell shoe at night, which makes it difficult for him to get peaceful sleep.

Zofran During Pregnancy

The mother of the infant experienced severe nausea and vomiting during the first trimester of her pregnancy. She was prescribed Zofran by her physician for off-label use for morning sickness. She was originally prescribed 4mg of Zofran, but the doctor increased to 8mg, taken twice a day, when he morning extended past the first trimester. Shortly after, she was given a Zofran pump, which dispersed Zofran into her system every four hours.

The plaintiffs allege that Zofran is the cause of their baby’s clubfoot. In turn, they are suing GlaxoSmithKline, the makers of Zofran, for negligence and and illegal promotion of the medication. Zofran is currently approved by the FDA for use by cancer patients only. Yet, numerous doctors have been prescribing for morning sickness by indicating it’s for “off-label” use. The plaintiffs also brought in documentation that shows over 200 cases of birth defects in which the mothers were prescribed Zofran during pregnancy.

GlaxoSmithKline Ignores Zofran Risks

GlaxoSmithKline allegedly knew about the risks associated with pregnant women and Zofran, yet failed to warn the public and failed to perform extensive studies on the medication to determine all of its risks. Furthermore, numerous studies have shown a heightened risk of birth defects if women take Zofran while pregnant, yet GlaxoSmithKline has refused to acknowledge the studies and continues to claim innocence.

The plaintiffs in the current case join at least 15 other people who’ve filed a Zofran lawsuit against GlaxoSmithKline. The other cases all involve infants born with severe birth defects after their mother took Zofran during pregnancy. In a few of the cases, the mother was forced to terminate the pregnancy after life-threatening malformations were detected during a routine prenatal screening.

The amount of damages that the plaintiffs seek in the New Jersey case is still uncertain.

Keep in mind that if you were prescribed Zofran while pregnant and your baby was born with birth defects, you have the legal right to file a Zofran lawsuit against the negligent drug manufacturer. You may be eligible for compensation for medical expenses, pain, suffering, lost wages, and more.

Sources

US District Court for the District of New Jersey: 2:15-cv-04536-JLL-JAD