According to court documents filed in the lawsuit, which involves claims from two plaintiffs, Zofran is only approved to treat severe nausea in cancer patients undergoing chemotherapy and radiation. Despite this, GlaxoSmithKline allegedly marketed Zofran off-label as a safe treatment for nausea and vomiting linked to pregnancy. (Although it is not illegal for doctors to prescribe medications off-label, it is illegal for drug companies to market their medications for unapproved uses.)
“GSK engaged in this ‘off-label’ marketing despite never having conducted a single study on the effects of Zofran on pregnant women or their unborn children,” the lawsuit alleges.
“GSK chose not to study Zofran in pregnant women or seek FDA approval before marketing the drug for treatment during pregnancy.”
Despite not testing the drug on pregnant women, the lawsuit alleges GSK knew there was a risk thanks to animal studies from the 1980s that suggested use of Zofran was linked to intrauterine deaths or malformations. Furthermore, the studies reportedly suggested that Zofran’s active ingredient could cross the placental barrier and expose fetuses to the drug.
By 2000, the lawsuit alleges, GSK knew of 32 reports of birth defects associated with Zofran and has reportedly received more reports since. The lawsuit claims GSK did not share information about these studies or potential risks with physicians or with pregnant women.
READ MORE ZOFRAN BIRTH DEFECT LEGAL NEWS
The birth defects lawsuit argues that inadequate testing on GSK’s part showed a “callous, reckless, and willful indifference to the health, safety and welfare of pregnant women and their unborn children.”
The plaintiffs in the case allege their children were born with defects including ventricular septal defect, atrial septal defect and ventricular arrhythmia.
The lawsuit is Coughlin and Swann v. GlaxoSmithKline, case number 15-1815, in the US District Court for the Western District of Louisiana.