Zofran is an anti-nausea drug. It has been linked to serious birth defects when used during pregnancy. In 2015, a federal panel created the special multidistrict litigation docket for victims who had been using the Zofran drug made by GlaxoSmithKline (GSK).
The defendant, GSK, filed a motion in this federal district court claiming that the lawsuit was pre-empted by federal law under the U.S. Supreme Court decision in Wyeth v. Levine. In that case, it was held that federal regulatory clearance of a medication does not shield the manufacturer from liability under state law. The U.S. District Court in the Massachusetts district, however, denied the motion stating that the judge was “loath to dismiss” the claims without giving families a chance to develop the facts of their respective cases through discovery.
Zofran was first approved by the federal Food and Drug Administration in 1991. It is intended to control extreme cases of nausea such as with cancer medications or following an invasive surgery. It has not been approved for use during a pregnancy. However, the drug Zofran has been prescribed by physicians to expectant mothers to lessen the symptoms of morning sickness.