Zofran, the brand-name of ondansetron, is an anti-nausea medication made by GlaxoSmithKline (GSK). In 1991, the Food and Drug Administration (FDA) approved it for chemotherapy and surgery patients with severe nausea and vomiting. However, it has been prescribed “off-label” for pregnant women suffering from morning sickness despite the FDA never having approved Zofran for use by pregnant women.
Two women have sued GSK, the manufacturer of Zofran in Massachusetts and Texas federal courts, accusing the drug maker of fraudulently marketing its anti-nausea drug Zofran as an off-label morning sickness remedy while concealing the risk that ingestion of the drug by pregnant woman can cause serious birth defects.
On April 17, 2015, Plaintiff, Kim Duong filed a complaint against GSK in the U.S. District Court for the District of Massachusetts asserting that taking Zofran while pregnant caused her unborn baby to develop severe and life-threatening fetal defects, forcing her to terminate the pregnancy. On that same day, Plaintiff, Julia Shonkwiler filed a complaint against GSK in the U.S. District Court for the Eastern District of Texas, asserting that her ingestion of the drug while pregnant caused her son to be born with congenital defects.
Plaintiffs’ assert that GSK marketed the drug “off-label” as a safe and effective treatment for morning sickness, despite it having conducted no studies on the effects of the drug on pregnant woman. Plaintiffs allege that GSK knew as early as 1997 that Zofran was unsafe for ingestion by expectant mothers, yet failed to convey such warning.
The Complaints state, “GSK failed to state prominently in the Indication and Usage section of its drug label that there is a lack of evidence that Zofran is safe for the treatment of morning sickness in pregnant woman, despite GSK’s knowledge that the safety of Zofran for use in human pregnancy had and has not been established; there have been hundreds of reports of birth defects associated with Zofran use during pregnancy; and epidemiology studies report an increased risk of birth defects in babies exposed to Zofran during pregnancy.”
In the 1980s, GSK conducted animal studies that revealed evidence of toxicity, intrauterine deaths and malformations in offspring, and further showed that Zofran’s active ingredient transferred through the placental barriers of pregnant mammals to fetuses. Plaintiffs contend that a later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta barrier and exposed fetuses to substantial concentrations, but GSK did not disclose this information to pregnant woman or their doctors.
Plaintiffs assert, “In 1992, GSK began receiving mounting evidence of reports of birth defects associated with Zofran. GSK had received at least 32 such reports by 2000, and had received more than 200 such reports to date. GSK never disclosed these reports to pregnant woman or their physicians. In addition, scientists have conducted large-scale epidemiological studies that have demonstrated an elevated risk of developing birth defects such as those suffered in this case. GSK has not disclosed this to pregnant woman or their physicians. Instead, GSK sales representatives specially marketed and promoted Zofran as a morning sickness drug.” In 2012, GSK paid more than one billion dollars to settle civil charges brought by the government of its “off-label” marketing of various drugs, including Zofran.