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Litigation Update: FDA Denies Request to Add Birth Defect Warning to Zofran’s Label

Litigation Update: FDA Denies Request to Add Birth Defect Warning to Zofran’s Label

The FDA has notified Novartis that it has rejected their request to add a birth defect warning to Zofran’s label. Plaintiffs claim that Zofran, a drug used to treat nausea for cancer and surgery patients, was also promoted by GlaxoSmithKline – the original developer of the drug – as an off-label treatment for morning sickness without specifying any fetal harm risks or lacking any evidence of its safety on pregnant women.

Novartis acquired Zofran from GlaxoSmithKline in 2015. The MDL, which has been overseen by U.S. District Judge F. Dennis Saylor since 2015, is comprised of more than 400 lawsuits. It is worth noting that Zofran was one of many drugs for which GSK paid $3 billion in 2012 to settle claims with the DOJ for marketing pharmaceuticals for off-label purposes.

This was not the first time that the FDA rejected a request to modify Zofran’s label and GSK will be leaning on that issue at their upcoming hearing. GSK argues that since the FDA declined their request to change Zofran’s label, the company had no ability to include the risks on their label; this is what plaintiffs claim should have occurred, and in GSK’s view, the failure-to-warn lawsuits are thus preempted by federal law. The label warnings did change in Europe a few years back after regulators there learned of some additional studies.

Back in 2019, plaintiffs claimed that GSK hid information from the FDA, which could have made a difference in the agency’s decision. GSK claims that the FDA had access to all the information and even after the agency reviewed other studies as well, they were still not satisfied that drug causes birth defects.

A bellwether case scheduled for May has been delayed due to the Covid-19 pandemic.

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