On February 5, 2019, the Massachusetts judge presiding over the Zofran (ondansetron) birth defect multi-district ligation rejected GlaxoSmithKline’s (GSK) motion for summary judgment based on preemption. U.S. District Judge F. Dennis Saylor IV said that questions remain about whether GSK fully disclosed key data to the FDA about the anti-nausea drug, and if this data may have impacted the federal regulator’s decision on Zofran’s warning label. “In other words, GSK must essentially show that the FDA either had the disputed information, or that the disputed information would not have made a difference had it been provided,” he said. Now, following this ruling, the preemption defense will not prevent the claims from being heard by a jury.
Zofran (ondansetron) is an anti-nausea drug approved by the FDA for use in cancer patients and those who underwent major surgery, but has been allegedly promoted off-label, for unapproved uses. Plaintiffs in these lawsuits claim that GSK illegally promoted Zofran (ondansetron) to treat morning sickness in pregnant women, and that the drug caused birth defects such as congenital heart defects and cleft palate.
Plaintiffs’ firm Grant & Eisenhofer filed the first case in the country and over 20 others on behalf of women and families affected by Zofran (ondansetron)—and also serves as co-lead on the Plaintiffs’ Executive Committee in the litigation. Call us today at 877-978-0169 if you or a loved one took Zofran (ondansetron) during your first trimester and your child was born with a congenital heart defect or cleft palate.