Zofran Faces More Birth Defects Claims

New Orleans, LAAnother Zofran birth defects claim has been filed in court, alleging women who took Zofran while pregnant gave birth to infants with birth defects. The most recent Zofran lawsuit was filed against GlaxoSmithKline and alleges the company marketed Zofran off-label and knew there were risks for pregnant women associated with the anti-nausea medication but failed to warn about those risks.

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.

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.

In 2012, GSK settled claims brought by the US Department of Justice that the company improperly marketed its drug for off-label uses. Among the charges GSK pled guilty to were marketing Zofran for unapproved uses; making false and unsubstantiated claims about the safety and efficacy of Zofran when used for pregnancy-related nausea; and illegally compensating health care professionals for prescribing and promoting Zofran.

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.