In 1991, the Food and Drug Administration (FDA) approved Zofran, which is manufactured by GlaxoSmithKline LLC (GSK) for use in cancer patients who require chemotherapy or radiation therapy. An Ohio couple has sued GSK, the manufacturer of Zofran, alleging that it fraudulently promoted its anti-nausea drug Zofran as an off-label remedy for morning sickness while failing to warn that it could lead to fatal birth defects.

A June complaint filed in the United States District Court for the Northern District of Ohio alleges that a woman’s ingestion of Zofran while pregnant caused their daughter to be born with heart defects. She died three days after being born. The couple alleges that GSK touted Zofran as a safe and effective solution for pregnancy -related nausea while knowing that the drug is dangerous when taken during pregnancy.

zofran tabletsPlaintiffs allege that GSK has known since at least 1998 that doctors were prescribing Zofran off-label to treat morning sickness and that this off-label use was associated with a significant risk of causing birth defects. Despite this knowledge, GSK has failed to include to any warning regarding the risk of birth defects arising from the use of Zofran during pregnancy in the drug’s prescribing information or other labeling.

“By 2000, dozens of physicians reports began to show a high rate of teratogenicity, with Zofran use being associated with congenital heart defects, kidney malformation, and cleft palate and other defects,” Plaintiffs assert. “Furthermore, data were showing intrauterine deaths, still births, death shortly after births, and serious congenital defects in children who survived.”

“GSK’s concealment and omission of material facts concerning, among other things, the safety and efficacy of Zofran for pregnancy-related nausea was made purposefully, willfully, wantonly, and/or recklessly, to mislead physicians, hospitals and healthcare providers, and expectant mothers into reliance, continued use of Zofran, and to cause them to promote, purchase, prescribe, and/or dispense Zofran,” Plaintiffs’ assert.

Plaintiffs assert that, had they known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, the plaintiff never would have taken Zofran while pregnant and their daughter would not have been born with fatal birth defects. The complaint includes claims of breach of express and implied warranties, design defect, failure to warn, fraud, infliction of emotional distress, loss of consortium, negligence, negligent misrepresentation, and punitive damages.

The complaint also states, “Safe alternatives to Zofran existed and were known and available to GSK, but GSK chose nonetheless to promote Zofran as a solution to pregnancy- related nausea. GSK misled the Regans, the Regans’ physicians, the medical community, the public in general, and regulators about Zofran; and GSK created express and implied warranties regarding Zofran and breached those.”