On January 22, 2016, a federal judge in Massachusetts denied GlaxoSmithKline’s motion to dismiss all claims in multidistrict litigation alleging that the drug company’s off-label promotion of its anti-nausea drug Zofran (ondansetron) for morning sickness led to birth defects.
U.S. District Judge F. Dennis Saylor IV denied the pharmaceutical company’s motion to dismiss, saying that he was loath to dismiss claims without giving the families the chance to develop facts, Law360 report. The judge said the motion was premature at best.
Zofran is approved for the prevention of nausea and vomiting caused by chemotherapy and radiation therapy and is also used to prevent and treat nausea and vomiting after surgery. It works by blocking one of the body’s natural substances (serotonin) that causes vomiting, according to WebMD.
GSK had argued that the families’ claims under state law were preempted by federal law under the Supreme Court decision in Wyeth v. Levine. When federal law conflicts with a state law, federal law will trump, or “preempt,” state law. A federal preemption defense requires the drug maker to demonstrate “clear evidence” that the Food and Drug Administration (FDA) would have rejected a label change if the company unilaterally strengthened the warning label for its drug, according to Law360.
The drug maker had argued that the FDA’s negative response to a citizen petition requesting that the agency reclassify the pregnancy risk for Zofran demonstrates that the agency had made a decision about the Zofran warnings. “In effect, GSK argues that the court need not consider evidence of how the FDA might have answered a change request, because the petition response itself contains the actual answer,” the judge said. GSK’s position is “problematic,” the judge said. The phrase “clear evidence” involves some kind of fact-based evaluation, the judge said. “The court is reluctant to issue a ruling on a motion to dismiss without giving the plaintiffs some opportunity to develop the facts, whatever those facts may be,” Saylor wrote.
The judge said it is not clear at this point if the warnings that the families claim that GSK should have provided compare with the label changes and warnings that the FDA rejected in response to the citizen petition, Law360 reports.
The families argued that since the FDA has not approved Zofran to treat morning sickness, only GSK has control over the relevant evidence of the foreseeable risks of using Zofran while pregnant. But the families say a number of animal studies show a connection between the drug and the alleged defects.
The families say they have reason to believe that GSK has evidence about the link between Zofran and alleged birth defects, such as several animal studies conducted by the pharmaceutical company in Japan after the company launched sales of the drug in the United States. One of the studies revealed the same heart defect alleged by many of the complaints, according to Law360.