New Zofran Lawsuit Alleges That Zofran Caused Child’s Clubfoot

Zofranlegal.com has reported that a New Jersey family has filed a complaint alleging that their son was born with a clubfoot due to exposure to Zofran while still in the womb.

Zofran is an anti-nausea medication that is manufactured by GlaxoSmithKline. First approved by the U.S. Food and Drug Administration in 1991, the drug was only approved for use when a patient had nausea relating to chemotherapy and radiation, or if a patient experienced nausea after being under anesthesia.

GlaxoSmithKline, without FDA approval, also marketed the drug to medical professionals and the public as a treatment for pregnant women experiencing morning sickness. Prior to marketing the drug in this manner, GSK never performed any human clinical trials or studies proving that Zofran was safe for the unborn child. By the year 2000, GSK allegedly knew of 32 cases where children were born with birth defects after the mother had been prescribed Zofran.

In 2012, GSK agreed to a settle a lawsuit which had been filed by the U.S. Department of Justice. The Department of Justice alleged that GSK had unlawfully marketed several drugs, including Zofran, “off-label”. GSK agreed to pay fines of 3 billion dollars in the settlement.

On June 26th, 2015, New Jersey parents filed a lawsuit against GSK on behalf of their 3-year-old son in the United States District Court for the District of New Jersey under case number 2:15-cv-04536-JLL-JAD. The lawsuit states that “GSK knew that Zofran was unsafe for ingestion by expectant mothers. In the late 1980’s, GSK conducted animal studies, which revealed evidence of toxicity, intrauterine deaths and malformations in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses. A later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta barrier and exposed fetuses to substantial concentrations.”

The mother, in this case, was treated for hyperemesis gravidarum and was given Zofran throughout her pregnancy, beginning as early as five weeks into the pregnancy. When her son was born on September 24th, 2011, he was diagnosed with a birth defect commonly known as a clubfoot. Both of his feet are affected and appear to be internally rotated at the ankle.

To treat his birth defect, doctors spent the first two months manipulating his tendons and ligaments by straightening the foot and placing it in plaster casts which were changed every week. After two months, a surgical procedure known as a tenotomy was performed, which cuts the Achilles tendon in the hope that the tendon will lengthen and his feet will regain proper alignment.

Since the surgery, the child has had to wear special orthopedic devices which caused blisters and pressure sores. His parents spend 45 minutes a day doing physiotherapy on his feet. Throughout all of this, their son was unable to learn how to crawl or walk, and his parents have had difficulty finding a school that can accommodate his needs.

The lawsuit alleges that “The effects of his clubfoot will last him a lifetime.”

For more information regarding this press release contact Michael Monheit, Esquire of ZofranLegal.com at 877-620-8411.

 

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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