Judge Dennis Saylor, US District Judge in Massachusetts, dismissed plaintiffs Tia Hancock, Joanna Tyler, and Dawn Barchiesi from multidistrict litigation that Zofran (ondansetron) causes birth defects.
The court dismissed the claims against GlaxoSmithKline for lack of personal jurisdiction. It sustained a complaint by Kierra Simmons of Missouri, ruling there was diversity jurisdiction because GSK is a citizen of Delaware. The case is In Re: Zofran (Ondansetron) )
Products Liability Litigation ) MDL No. 1:15-md-2657-fds.
Defendant GlaxoSmithKline, LLC manufactures the drug ondansetron under the brand name Zofran. It was first approved in 1991 for the prevention of post-operative nausea and vomiting associated with anesthesia and for nausea and vomiting caused by radiotherapy and chemotherapy.
In addition to those approved uses, GSK is alleged to have marketed Zofran “offlabel” for pregnancy-related nausea and vomiting, commonly known as “morning sickness.”
Plaintiffs in this multidistrict litigation allege that Zofran was in fact unsafe for use in pregnant women, and that in utero exposure to Zofran caused birth defects in children born to mothers who took the drug. All four plaintiffs bring eight counts against defendant GSK arising out of congenital heart defects suffered by their children and allegedly caused by the plaintiffs’ use of name-brand Zofran during pregnancy.
The FDA warned against Zofran use in pregnancy in 2013. It issued an updated warning against Ondansetran, better known by its brand name, Zofran, use in pregnancy discussed in OBGYN News. Zofran is a 5-HT3 receptor antagonist approved by the FDA for preventing nausea and vomiting related to cancer chemotherapy and surgery. It has been used off-label to treat nausea and vomiting in pregnancy.
Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy. There are also potential maternal risks associated with taking Zofran especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting. These risks include the Serotonin Syndrome which is a triad of cognitive or behavioral changes including confusion, agitation, autonomic instability, and neuromuscular changes. Therefore Zofran should not be taken during pregnancy.