A new Zofran lawsuit from a California mother says GlaxoSmithKline’s anti-nausea drug was responsible for her child’s congenital heart defects.

Plaintiff Paige M. says she was prescribed Zofran for morning sickness about four weeks into her pregnancy. Her child A.M. was born in May 2010 with congenital heart defects. Paige says A.M.’s family has no history of congenital heart defects or of any other types of birth defects.

In her Zofran lawsuit, Paige says she was also unaware of any connection between taking Zofran during pregnancy and later development of birth defects. She says that had she known about such a risk, she would not have taken Zofran during pregnancy, and A.M. would therefore not have been born with congenital heart defects.

Zofran is also known by its generic name, ondansetron. It’s currently approved by the FDA as a treatment for nausea and vomiting related to chemotherapy, radiation therapy, and surgery. Zofran has never been approved by the FDA for use in pregnant women.

Zofran Lawsuit Alleges Illegal Marketing

Paige alleges that drug maker GlaxoSmithKline marketed Zofran for morning sickness despite the lack of FDA-approval. GSK did so even though it had never done a single clinical study to evaluate the effects of Zofran during pregnancy.

She alleges that because of this marketing campaign, pregnant women throughout the United States took Zofran for morning sickness with no way of knowing if the drug was safe for them to take.

At the same time, and despite the lack of clinical trials directly on point, GSK had reason to know that Zofran was unsafe to take during pregnancy, Paige says. Her Zofran lawsuit refers to animal studies conducted in the 1980s that resulted in toxicity, intrauterine deaths, and malformations in offspring. Later studies on human subjects showed that Zofran taken by an expecting mother could find its way to the fetus.

Then in 1992, after Zofran had entered the market, GSK began receiving reports of birth defects associated with Zofran. She says the company had received at least 32 such reports by 2000 and has received over 200 such reports to date.

Paige alleges GSK never disclosed these reports to patients or their doctors, nor has the company disclosed the results of certain large-scale epidemiological studies that Paige says showed an elevated risk of birth defects related to Zofran.

Paige also notes in her Zofran lawsuit that in 2012 GSK settled a broad federal investigation with a guilty plea to criminal charges and $3 billion in penalties. Among other allegations, federal authorities had taken issue with GSK’s allegedly illegal promotion of certain of its products, including the promotion of Zofran as a treatment for pregnancy-related nausea.

The settlement agreement also shows the government’s allegations that GSK made false representations about the safety of Zofran for morning sickness, and that the company offered and paid illegal kickbacks to health care professionals to get them to promote and prescribe Zofran.

This Zofran lawsuit (Paige M. v GlaxoSmithKline) is part of a consolidation of similar claims that are being processed together as a single multidistrict litigation, or MDL. The Zofran birth defects MDL is No. 2657, pending in the U.S. District Court for the District of Massachusetts.