Zofran Off-Label Promotion. U.S. District Judge F. Dennis Saylor IV has denied GlaxoSmithKline’s motion to dismiss all claims in multidistrict litigation alleging that the company’s off-label promotion of its anti-nausea drug Zofran (ondansetron) for morning sickness led to birth defects.
Judge Saylor denied the pharmaceutical company’s motion to dismiss, saying that he was unwilling to dismiss the claims without giving the families who brought suit the chance to develop facts, Law360 report.
Zofran has FDA approval for the prevention of nausea and vomiting caused by chemotherapy and radiation therapy and also for the prevention and treatment of nausea and vomiting after surgery.
GSK has marketed Zofran as a safe and effective treatment
But GSK has marketed Zofran as a safe and effective treatment for nausea and vomiting suffered during pregnancy, although the drug is not approved for that use. About 80 percent of women experience some nausea and vomiting during pregnancy, and for about 15 percent, the problem is serious enough to require treatment.
Nausea and vomiting are usually worst during the first trimester and this is when there is the greatest danger that a drug will have harmful (teratogenic) effects on the development of the fetus.
GSK argued that claims the families made 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,” the 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 the FDA to 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. But Judge Saylor found GSK’s position “problematic.”
The phrase “clear evidence,” he wrote, involves some kind of fact-based evaluation and “[t]he 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,” according to Law360.
The judge said it is not clear at this point if the warnings that the families claim that GSK
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 Zofran use during pregnancy.
The families believe 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.