Two Florida parents are suing GlaxoSmithKline over allegations that company’s drug Zofran caused their son’s birth defects.

Plaintiffs Robin and Stanley Z. are bringing this claim on behalf of their minor son, identified in the Zofran lawsuit as S.Z. The parents say that when Robin became pregnant with S.Z. in 2005, she took Zofran as a treatment for morning sickness.

In 2006, S.Z. was born with a bilateral cleft lip and palate. They say that his first intervention for this alleged Zofran birth defect was only a few weeks after he was born, and he had his first surgery before he turned one year old.

Robin and Stanley say that S.Z., now age nine, has had multiple surgeries and other treatments. They allege he continues to have difficulty eating, speaking and hearing. Robin and Stanley blame these troubles on the Zofran Robin took during pregnancy – not just because of the drug’s alleged defects, but also because of manufacturer GlaxoSmithKline’s promotion of the anti-nausea drug, which the plaintiffs say was misleading and fraudulent.

Zofran, known generically as ondansetron, is approved by the FDA as a treatment for nausea and vomiting associated with surgery, chemotherapy and radiation therapy. Since receiving initial FDA approval in 1991, the drug has not been approved for nausea related to any other cause.

Robin and Stanley cite evidence they say shows that GlaxoSmithKline was aware of a risk of Zofran birth defects. The company’s own studies from as early as the 1980s found evidence of intrauterine deaths and offspring malformations in animals. A subsequent study found that in humans, Zofran is capable of crossing the placenta in pregnant mammals and reaching the fetus.

In 1992, the plaintiffs say, GlaxoSmithKline started receiving reports of birth defects found in conjunction with Zofran use. They say that to date the company has received over 200 such reports.

The 2012 Zofran Settlement

Yet despite the results of studies and postmarket reports, GlaxoSmithKline never disclosed that information to doctors or their patients, say the plaintiffs. In fact, they say, the company actively promoted the drug as a treatment for morning sickness despite the lack of specific FDA approval for that use.

They cite a settlement reached in 2012 between GlaxoSmithKline and the U.S. Justice Department that resolved both criminal and civil allegations concerning many of GlaxoSmithKline’s marketing practices, including those related to Zofran.

The settlement addressed allegations that GlaxoSmithKline promoted Zofran for treatment of pregnancy-related nausea, despite the lack of FDA approval for that use. The plaintiffs say that GlaxoSmithKline engaged in this promotion despite there never having been any clinical studies of the effects of the drug in pregnant women.

The company also allegedly made “unsubstantiated and false representations” about the safety and efficacy of Zofran for those off-label uses. GlaxoSmithKline also allegedly offered illegal compensation to health care providers to promote and prescribe the medication. As part of the settlement, GlaxoSmithKline was required to pay over $1 billion in civil penalties.

Robin and Stanley’s Zofran birth defect lawsuit is Case No. 3:15-cv-05098 in the U.S. District Court for the Northern District of California.