Zofran birth defect claims allowed to proceed

Claims alleging anti-nausea medication Zofran^® caused life-threatening birth defects in unborn children will be allowed to move forward to trial following a ruling Feb. 5, 2019 denying a defense motion for summary judgment. Motley Rice appellate attorney Lou Bograd argued against the motion for summary judgment on behalf of plaintiffs.

While Zofran is approved to treat nausea and vomiting associated with chemotherapy, the drug is at times prescribed off-label to treat morning sickness in expectant mothers. Some pregnant women who took the drug in their first trimester have reported birth defects in their infants, including severe heart defects. Federal multidistrict litigation filed by affected women and families is currently being litigated in the District of Massachusetts. Motley Rice medical attorney Kimberly Barone Baden is co-lead counsel and a member of the Plaintiffs’ Steering Committee for the MDL, In re: Zofran (Ondansetron) Products Liability Litigation.

Zofran manufacturer GlaxoSmithKline (GSK) filed a motion for summary judgment in the litigation and a hearing was held in September to discuss the company’s claims that the MDL should be barred by federal preemption. The defense claimed that an “exhaustive” review of Zofran’s safety was conducted by the FDA prior to it being placed on the market. Plaintiffs, however, argued that the FDA would have  reconsidered Zofran’s labeling and potential complications had GSK not withheld significant results from foreign studies that showed a correlation between Zofran and birth defects in animals. 

Judge F. Dennis Saylor IV denied summary judgment on Feb. 5, ruling that a jury should ultimately decide whether or not the studies might have been significant enough to sway the FDA’s initial handling of the drug.

We continue to review Zofran cases. If you took Zofran during your first trimester of pregnancy and your child suffers from heart or other serious birth defects, you may contact Kimberly Barone Baden by email or call 1.800.290.6612 for more information on the litigation.