An Idaho couple argues that GlaxoSmithKline should have issued a more effective warning about the risk of Zofran birth defects.

Plaintiffs Emma and Randy B. bring this Zofran lawsuit on their own behalf and that of their minor child A.J.B. The couple says Emma was prescribed Zofran early in her pregnancy to treat her morning sickness.

When A.J.B. was born in April 2015, they say, he had a misshapen head, a caved-in chest. He also has anemia and hearing loss and is developmentally delayed, the couple claims.

Emma and Randy say that she never would have taken Zofran had she been properly alerted to the possibility of severe birth defects as Zofran side effects.

According to the couple’s Zofran lawsuit, Zofran is approved for the treatment of nausea and vomiting related to surgery, chemotherapy and radiation therapy.

It’s believed that Zofran works by inhibiting the activity of the neurotransmitter serotonin, which is associated with nausea and vomiting.

The plaintiffs say the FDA has never approved Zofran for the treatment of morning sickness.

Evidence of Zofran Birth Defects

Emma and Randy say that defendant GlaxoSmithKline, the maker of Zofran, has failed to properly warn patients and the medical community about the risks of Zofran birth defects.

They say federal law requires a drug manufacturer to add a warning to a drug’s labeling as soon as there is “reasonable evidence of an association of a serious hazard with a drug.”

A causal relationship does not need to be proved to trigger this requirement, the couple says.

They argue that the results of several studies and reports of Zofran side effects made directly to GSK have put the company on ample notice of an associated serious hazard.

Studies from as early as the mid-1980s showed Zofran could cross the placental barrier and expose the fetus to the drug, they say.

More recent epidemiology studies showed Zofran side effects could put offspring at elevated risks for cardiac malformations.

According to the plaintiffs, these studies showed that mothers who took the drug during pregnancy had more than twice the risk of giving birth to a baby with a congenital heart defect.

In addition to these study results, Emma and Randy say that GSK received hundreds of adverse event reports detailing birth defects that followed a course of Zofran early during pregnancy.

They say the company started receiving these reports as early as 1992, shortly after Zofran was made available to the U.S. market.

Reports received by the company allegedly chronicle cases of stillbirth, kidney malformation, anomalies of the diaphragm, congenital heart disease, and orofacial and musculoskeletal anomalies.

Yet the plaintiffs say that even with this much evidence of Zofran birth defects, GSK never bothered to disclose these reports to physicians or their patients.

In fact, the plaintiffs allege that GSK actively promoted Zofran to gynecologists and obstetricians as a suitable treatment for morning sickness.

Emma and Randy are seeking compensation to include compensatory damages, medical expenses related to A.J.B.’s care, and consequential damages to help prevent similar future behavior by GSK.

The Zofran Birth Defects Lawsuit is Case No. 1:16-cv-002023 in the U.S. District Court for the District of Idaho.