On June 10, 2015, a couple filed a wrongful death lawsuit in the United States District Court for Northern Ohio. The couple alleges that Zofran contributed to the death of their daughter in 2006.
Alleged Link Between Zofran and Heart Defects
The manufacturer of the drug, GlaxoSmithKline, is a defendant in the litigation. The suit alleges that the mother-to-be took Zofran to treat morning sickness when she was pregnant. While the child was in her mother’s womb, the girl developed heart defects. As a result of the cardiac problems, she did not survive. The couple alleges that Zofran directly contributed to these fatal heart problems.
Zofran Approved Over 20 Years Ago
Zofran (Ondansetron) is an anti-nausea medication first approved by the FDA in 1991. It was initially intended to treat both nausea and vomiting in patients who were undergoing chemotherapy or radiation treatments, or who recently had surgery.
FDA Never Approved Drug to Treat Morning Sickness
Zofran has never been formally approved for use in treating morning sickness, but it has been widely prescribed for that use. Physicians can prescribe certain drugs for non-approved purposes, but pharmaceutical companies cannot advertise drugs for use for non-approved purposes.
In 2012, the U.S. Department of Justice required GlaxoSmithKline to pay $3 billion to settle false advertising allegations regarding Zofran.
Right Ventricle Heart Defect
Immediately after the child was born, doctors diagnosed her with a right ventricle heart problem, and hospital personnel moved her to the neonatal ICU. However, she died three days later. The suit alleges that the pharmaceutical company improperly advertised Zofran to treat morning sickness. The couple also alleges that they were not properly informed of the potential side effects, including heart abnormalities, that Zofran is allegedly linked to. In this recently filed case, the couple is seeking both compensatory and punitive damages in federal court.
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