A mother from Illinois has filed a Zofran lawsuit against the pharmaceutical manufacturer GlaxoSmithKline, alleging that the medication caused her son’s birth defect.

Plaintiff Michelle F. began taking Zofran (ondansetron) during her first trimester of pregnancy to help treat morning sickness. She continued taking the medication as prescribed by her doctor through her third trimester.

Five months after Michelle’s son, S.F., was born, he was diagnosed with a ventricular septal defect. Commonly known as a “hole in the heart,” this Zofran birth defect occurs in the wall of the heart that separates the lower chambers. Instead of being kept separately, the blood passes through the hole from the right to the left side of the heart, and the oxygenated blood is pumped to the lungs rather than to the body, making the heart work harder.

As a result of this congenital defect, S.F. cannot fully participate in common childhood activities such as playing sports or roughhousing, and is held back from fully participating in life. He also experiences emotional difficulties not experienced by his older siblings, and has severe developmental delays, including the need to wear a diaper at night at six and a half years old.

Michelle states that if she and her physicians were aware that there was an increased risk in birth defects as a result of taking Zofran, she would not have taken the drug and her son would not have been born with birth defects.

The resulting Zofran lawsuit alleges that manufacturer GSK’s fraudulent marketing misled Michelle and her physicians into believing Zofran was safe to use during pregnancy.

Michelle’s Zofran lawsuit is based on theories of negligence, strict products liability, design defect, failure to warn, breach of express and implied warranty, fraudulent and negligent misrepresentation, violation of the Illinois Deceptive Trade Practices Act and loss of consortium.

The Zofran Birth Defects Lawsuit is Case No. 3:15-cv-00902-NJR-PMF in the U.S. District Court for the Southern District of Illinois.

Zofran History of Use

The FDA approved Zofran in 1991 to treat severe nausea caused by chemotherapy and radiation treatments. The FDA never approved it for use as a morning sickness drug, and the manufacturer did not conduct any studies on pregnant women. Despite these limitations, Zofran has allegedly been marketed “off label” since 1998 as a safe, effective treatment for morning sickness.

The drug is so popular that, according to Michelle’s Zofran lawsuit, Zofran was the most commonly prescribed anti-nausea drug for pregnant women in the U.S. during the 2000s.

Decades before, in the 1980s, GlaxoSmithKline conducted animal studies on Zofran. Those studies showed that the active ingredient in the drug crossed the placental barrier and exposed fetuses to the drug. The studies also showed intrauterine deaths, toxicity and malformations in offspring. Women who have taken Zofran while pregnant have reported giving birth to children with similar birth defects.

GlaxoSmithKline allegedly found in another study that Zofran can cross the human placenta and expose the fetus to high concentrations of the drug, but did not disclose this finding to women or their physicians.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Birth Defects Lawsuit Information

If you took Zofran during pregnancy and had a baby with a heart defect or other birth defects, you may be entitled to legal compensation. Experienced attorneys are available to provide you with a no-risk evaluation of your situation and consult with you free of charge.