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An Illinois Infant’s Heart Defects Linked to Zofran in New Lawsuit

GlaxoSmithKline, the makers of the popular anti-nausea drug, Zofran (ondansetron), is currently facing more than 30 lawsuits involving infants born with birth defects. Last week, a mother in Salem, Illinois filed on of the latest lawsuits against the manufacturer after her baby was born with severe heart defects.

According to the lawsuit, filed in the United States District Court of the Southern District of Illinois, the plaintiff, Michelle Lynn Forbes, states that she was prescribed Zofran during the first trimester of her pregnancy. She was prescribed the medication as an off-label use for morning sickness after experiencing nausea and vomiting early in her pregnancy.

In February, 2009, Forbes gave birth to a baby son. Five months after his birth, the infant was diagnosed with a ventricular septal defect, a condition in which there is a hole in the wall of the heart’s two main pumping chambers.

The baby, now a 6-year-old child, still wears diapers when he goes to sleep each night and has difficulties with fully participating in life activities, such and running around and playing with other kids, the court documents state.

In addition, Forbes alleges that her son “exhibits emotional difficulties not demonstrated by his two older siblings.” The plaintiff’s two older children were never exposed to ondansetron.

Numerous different studies on Zofran, including the Andersen study and the Danielsson Study, indicate that taking Zofran while pregnant increases the risks of babies being born with severe birth defects. One of the defects is heart problems and heart malformations. In fact, the Danielsson Study, which reviewed each and every birth in Sweden from 1998 and 2012, shows that babies exposed to Zofran while in utero are twice as likely to develop cardiac septal defects, also known as a “hole in the heart.”

Zofran is only approved by U.S. FDA for use by cancer and surgery patients experiencing nausea and vomiting due to invasive treatment options, such as chemotherapy. However, GlaxoSmithKline (GSK), the makers of Zofran, began marketing the medication as use for morning sickness, tapping into a market of pregnant women, which would boost the company’s sales. Yet, since Zofran has never been approved for morning sickness, physicians have been prescribing it for off-label use.

The plaintiff alleges that GSK promoted a dangerous pharmaceutical medication and failed to warn the public about the potential risks involved in taking ondansetron while pregnant. The lawsuit also accuses GSK of a “nationwide fraudulent marketing campaign,” stating that,


“Zofran was placed into the hands of unsuspecting pregnant women and in the 2000s became the number one most prescribed drug for treating morning sickness in the United States. These women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea. Zofran would never have become the most prescribed morning sickness drug in the United States, and Plaintiff would never have taken it, if GSK had not misleadingly marketed the drug as a safe and efficacious treatment for morning sickness.”


This isn’t the first time GSK has been accused of falsely marketing medications. In 2012, the drug company settled a $3 billion fraud settlement with federal prosecutors. GSK was found guilty of falsely promoting many of its antidepressant medications, including Wellbutrin, Paxil, Avandia, and more.

Keep in mind that if you took Zofran while pregnant and your baby was born with birth defects, you also have the right to file a Zofran lawsuit against the responsible party, which can help you cover costs for medical expenses, lost wages, pain, suffering, and more.