The U.S. Court of Appeals for the First Circuit affirmed the entry of summary judgment in favor of GlaxoSmithKline (GSK) in the Zofran multidistrict litigation (MDL) on January 9, 2023. The MDL involved over 400 lawsuits alleging that GSK failed to warn that Zofran could cause birth defects if taken by pregnant women. Zofran was initially approved by the Food and Drug Administration (FDA) for nausea resulting from chemotherapy treatment but was regularly prescribed off-label by physicians for pregnancy-related nausea. The plaintiffs alleged that an additional warning should have been added to the label regarding the risk of birth defects. These allegations were based upon three Japanese animal studies sponsored by GSK in the 1980s which were not submitted to the FDA when it considered a label change in 2010 related to the use of Zofran during pregnancy.
GSK initially moved for summary judgment in early 2019, which was denied. Subsequently, the U.S. Supreme Court decided Merck Sharp & Dohme Corp. v. Albrecht in May of 2019, holding that preemption is a matter of law for a judge, rather than a jury, to decide. GSK then filed a renewed motion for summary judgment.