A mother from New Jersey whose child was born with serious congenital heart defects has filed a birth defects lawsuit, alleging that the defects were caused by the drug Zofran.

Plaintiff Beth M. is bringing a claim on behalf of her minor child, who Beth says suffered birth defects resulting from prenatal exposure to Zofran.

She is suing pharmaceutical manufacturer GlaxoSmithKline, the maker of Zofran, and medical supplier McKesson Corporation, who Beth says marketed, sold and distributed the Zofran she took.

According to her birth defects lawsuit, Beth took Zofran during pregnancy as a treatment for morning sickness. An ultrasound at 20 weeks revealed her child had multiple cardiac defects including a double right ventricle outlet, a leaky valve, coronary arteries not where they should be normally, and a narrow aortic arch.

The child had to undergo open-heart surgery four days after she was born in 2005. She later needed surgery for placement of a stent, then a third surgery to correct her narrow aortic arch. She may need a fourth surgery to address her leaky heart valve, according to the Zofran lawsuit.

GSK Allegedly Concealed Zofran Birth Defects Risk

Beth believes that as early as the 1980s, GlaxoSmithKline knew about the risk of birth defects associated with Zofran yet purposely concealed this risk from physicians and patients. She recounts in detail the results of several studies on animals in which administration of Zofran to pregnant animals was followed by severe birth defects in their offspring.

The Zofran lawsuit also states that as early as 1992, GSK had been receiving reports of birth defects in humans that occurred in conjunction with Zofran use. Most of the reports were of congenital heart defects; others told of dysmorphism, kidney malformation, orofacial defects, and intrauterine death.

Had Beth known about those risks, she says, she would never have taken the morning sickness treatment during pregnancy and her child would not have been born with Zofran birth defects.

Furthermore, Beth alleges GlaxoSmithKline improperly promoted Zofran as a treatment for morning sickness without FDA approval for that use.

As early as 1998, the company was carrying on a promotional campaign that included payments to health care providers and industry “thought leaders” to incentivize them for prescribing and promoting Zofran as a treatment for morning sickness. She says the company continued this campaign despite being ordered by the FDA to cease it in March 1999.

Zofran Off-Label Promotion

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.

Zofran, also known by its generic name ondansetron, was approved by the FDA in 1991 as a treatment for nausea related to chemotherapy and radiation therapy. It is now also approved to treat postoperative nausea and vomiting. It has not been approved for treatment of nausea in any other context.

The Zofran Birth Defects Lawsuit is Case No. 3:15-cv-03722 in the U.S. District Court for the Northern District of California.