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Regulating Communications

In re: Zofran (Ondansetron) Products Liability Litigation


In re: Zofran (Ondansetron) Products Liability Litigation (U.S. District Court, D. Massachusetts, June 1, 2021): A Massachusetts federal judge ruled that state-law claims of failure to provide an adequate warning label are preempted by federal law. The decision shuts down multi-district litigation consolidating more than 420 lawsuits against GlaxoSmithKline alleging its anti-nausea medication, Zofran, caused birth defects. The court held that the claims were preempted because the Food and Drug Administration (FDA) declined to add a warning label to the drug for pregnant women despite (1) several opportunities to do so and (2) knowledge that the drug was being prescribed to pregnant women in large numbers. The same judge had denied an earlier petition for summary judgment in 2019, opting to send the preemption question to a jury, but the Supreme Court’s 2019 ruling in Merck v. Albrecht found that judges, not juries, should resolve issues regarding FDA regulation. Read the full decision here.

View all cases in the Judicial Trends in Public Health – July 16, 2021.

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