A sweeping order ending more than 400 cases alleging GlaxoSmithKline’s anti-nausea medication Zofran causes birth defects provides a “roadmap” for fending off multidistrict litigation with the help of a landmark U.S. Supreme Court ruling, experts say.
The June 1 ruling by U.S. District Judge F. Dennis Saylor IV granted GSK summary judgment and stopped the MDL in its tracks just months ahead of what would have been the first bellwether trial. Judge Saylor found the U.S. Food and Drug Administration had rejected a warning label for birth defects on Zofran, and that all the suits were therefore preempted under federal law.
Shawn Collins, a shareholder at Stradling Yocca Carlson & Rauth, said other drug companies could view GSK’s work to keep the FDA in the loop as a powerful litigation strategy.
“It gives you a roadmap on how you head off these big, incredibly costly pieces of litigation by feeding a lot of that information to the FDA in advance and allowing the FDA to make your case in advance,” Collins said. “You can almost fortify yourself against these massive MDLs.”
Zofran was first approved in 1991 for the treatment of nausea induced by chemotherapy or post-surgery vomiting. The FDA did not require any labeling changes after it asked for more information about the effect of the drug on pregnant women in 2010, Judge Saylor noted in his order.
The agency also rejected labeling changes in 2013 after a citizen petition; in 2015, after a proposed label change submitted by the current manufacturer of the drug, Novartis; after GSK’s 2019 citizen petition; and after another proposed label change submitted by Novartis in 2020, the judge wrote.
The FDA’s action, or inaction, beefed up GSK’s “impossibility preemption” defense, meaning any state law claims against the company would have been blocked by federal regulation.