An Illinois mother has filed a dangerous drug lawsuit against the manufacturer of Zofran, alleging the popular morning sickness treatment caused her son to be born with serious birth defects.

Plaintiff Michelle F., mother of S.F., began taking the pharmaceutical Zofran (ondansetron) as prescribed by her doctor for morning sickness, according to the Zofran birth defects lawsuit. 

Michelle began taking the drug in the first trimester of her pregnancy and continued using it through her third trimester. Five months after her son S.F. was born, he was diagnosed with a ventricular septal defect.

Commonly known as a “hole in the heart,” this defect occurs in the wall of the heart that separates the lower chambers. Instead of being kept separately, the blood passes through the hold 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 the activities that other children can, 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 if she or 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 Zofran birth defects lawsuit further alleges that the drug maker’s fraudulent marketing of the drug was misleading and led Michelle and her physicians to believe the medication was safe to use during pregnancy for the treatment of nausea, morning sickness and vomiting.

Michelle brings counts 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. She is seeking statutory, direct and consequential damages, fees and costs.

Zofran History of Use

Zofran is only FDA approved to treat the most severe nausea caused by chemotherapy and radiation treatments. It was approved in 1991 for this use.

According to Michelle’s Zofran birth defects lawsuit, the medication has been marketed “off label” since the beginning of 1998 as a safe, effective treatment of morning sickness despite any studies ever being conducted on pregnant women.

Additionally, in the 2000s, Zofran became the most commonly prescribed drug for pregnant women to treat nausea in the U.S. These women blindly trusted that the drug was safe and had no way of knowing that it was not tested for safety in pregnancy.

Decades before in the 1980s, GlaxoSmithKline (GSK), the maker of Zofran, conducted animal studies on the drug and they showed intrauterine deaths, toxicity and malformations in offspring, and that the active ingredient in the drug crossed the placental barrier and exposed fetuses to the drug.

These Zofran birth defects have been reported by women who have taken the drug to treat morning sickness during pregnancy. Later GSK found in another study that Zofran crossed the human placenta and exposed the fetus to high concentrations of the drug but did not disclose this to women or their physicians.

Zofran Birth Defects Lawsuit Information

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

If you or someone you love was prescribed Zofran during pregnancy and had a baby born with a heart defect or other birth defect, you may be entitled to legal compensation.

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