A Zofran birth defects lawsuit alleges that the anti nausea medication had caused an Alabama woman’s son to be born with heart defects.

GlaxoSmithKline (GSK) is facing growing litigation from distraught parents, whose children were born with birth defects in alleged result of taking Zofran.

One of these Zofran birth defects lawsuits was filed by Alabama plaintiff Rebecca K. on behalf of her son who was born in 2014 with congenital heart defects.

According to her Zofran birth defects lawsuit, Rebecca had been prescribed the anti nausea medication during her first trimester of pregnancy. She had been contending with morning sickness, and was looking for a treatment to stave off the early pregnancy symptoms.

Rebecca alleges that in direct result of her son being exposed to Zofran at an early stage of his development, he had developed these serious heart defects.

She opted to file legal action against GlaxoSmithKline for allegedly failing to warn her against the dangers of Zofran birth defects. Rebecca states she never would have taken the anti nausea medication if she had known the risk.

Overview of Zofran Birth Defects

Zofran (Ondansetron) was approved by the FDA in 1991 to be an anti nausea medication for chemotherapy and radiation patients. This drug is a 5-HT3 receptor antagonist, which works by blocking the serotonin signals in the stomach and throat to prevent nausea and vomiting.

Soon after its release, physicians began prescribing Zofran for off label purposes to pregnant women to treat their morning sickness. GlaxoSmithKline had reportedly picked up on this trend, and began to market Zofran to expectant mothers.

While it is not illegal for physicians to prescribe a drug for off label purposes, it is illegal for manufacturing companies to market the drug for unapproved FDA purposes.

Even though Zofran never went through pre-clinical testing on pregnant women, GlaxoSmithKline still promoted the anti nausea medication as a safe and effective treatment for morning sickness.

This marketing campaign allegedly resulted in numerous reports of Zofran birth defects, leaving families to contend with the life long consequences.

GlaxoSmithKline eventually had to pay $3 billion due to their fraudulent advertising claims regarding a number of their drugs, including Zofran.

Rebecca alleges that she had relied on the claims of GlaxoSmithKline, and had no reason to expect Zofran birth defects. In addition, she states there were no mentions of Zofran birth defects on the warning label nor did the company warn her or her physician.

She filed her Zofran birth defects lawsuit against GlaxoSmithKline on various counts of negligence and misrepresenting a product.

The Zofran Birth Defects Lawsuit is Case No. 1:15-cv-13786-FDS, in the U.S. District Court of Northern Alabama.