A mother filed a Zofran defects lawsuit against GlaxoSmithKline (GSK) alleging the drug prescribed to treat her morning sickness caused her newborn son to be born with serious birth defects, specifically heart defects.

Plaintiff Christine R. alleges that her prenatal exposure to the generic equivalent of Zofran, known as ondansetron, caused her child to suffer injuries that could have been avoided had she not taken the drug.

Christine’s son was born in 2012 with multiple congenital defects, including congenital heart defects such as Still’s murmur and pulmonary flow murmur, the Zofran lawsuit states.

According to the child’s physician, no genetic cause was found for the conditions he suffered. Christine alleges these were Zofran defects caused by the morning sickness drug.

Christine has brought forth multiple allegations in her Zofran defects lawsuit including negligence, negligence per se, fraudulent misrepresentation, fraudulent concealment and negligent misrepresentation. She is requesting a jury trial.

As compensation for her son’s alleged Zofran defects, Christine is seeking general, consequential, compensatory and punitive damages along wth medical, incidental and hospital expenses, attorneys’ fees and costs of litigation in her Zofran lawsuit.

Alleged Zofran Defects

Zofran was developed to treat patients with the most severe form of nausea possible, namely cancer patients who were suffering severe side effects from their chemotherapy and radiation treatments.

However, according to the Zofran lawsuit, GSK decided to promote the drug in an “off label” fashion which meant that they targeted women with pregnancy-related morning sickness and vomiting to market their drug.

According to the complaint, GSK marketed to patients and physicians despite having never conducted a study showing the drug’s safety or effectiveness in pregnant women and their babies.

However, it is alleged that GSK knew as early as in the 1980s that the drug was unsafe for pregnant women based on animal studies of the drug, the Zofran lawsuit asserts.

These animal studies showed toxicity, uterine deaths, malformations in offspring and showed that Zofran crossed the placenta in pregnant animals to their fetuses, the lawsuit claimed.

In the late 1990s and early 2000s, shortly after GSK began promoting Zofran for morning sickness in 1998, reports of birth defects in newborns began to surface, according to the claim. Currently, more than 200 reports of Zofran defects have been reported to date.

Due to these claims, the United States Department of Justice became involved in an investigation into GSK’s off-label promotion of Zofran as a morning sickness treatment and the related Zofran defects claims that followed from mothers who had babies born with a variety of defects.

In 2012, GSK pled guilty to the charges brought forth by the U.S. DOJ for its off-label promotion of Zofran and other drugs. Around the same time, GSK agent over $1 billion to settle civil lawsuits with the United States that contained similar allegations, the lawsuit explained.

The Zofran Defects Lawsuit is Case No 1:15-cv-12133-FDS in the U.S. District Court for the Northern District of Alabama, Southern Division.

Filing a Zofran Lawsuit

If you were prescribed Zofran to treat morning sickness during your pregnancy and had a baby born with birth defects that were not genetic in nature, you may be eligible to file a legal claim.

Birth defects women have reported following Zofran use include: cleft lip, cleft palate, heart defects, kidney defects, musculoskeletal defects and fetal death related to a birth defect.

An experienced Zofran attorney can review your case for free and see if you qualify to file a Zofran defects lawsuit.