GSK Tries to Quash Fast-Growing Zofran Birth Defect Lawsuits

Tuesday, January 12, 2016

After years of speculation that the popular anti-nausea drug Zofran may cause birth defects when prescribed for pregnancy morning sickness, a federal panel last year created a dedicated court for victims to file claims.

However, as the number of Zofran lawsuits have swelled to several hundred, the maker of the drug, GlaxoSmithKline (GSK), has filed a request to dismiss all claims in an effort to block the rights of families to recover damages.

Last month, the Judicial Panel on Multidistrict Litigation reported that 200 Zofran cases had already been filed in under a year, since the lawsuits were consolidated in a Massachusetts federal court for expedited handling. The case, known as MDL No. 2657, IN RE: Zofran (Ondansetron) Products Liability Litigation, is being handled by U.S. District Judge F. Dennis Saylor IV.

GSK claims that the cases should be thrown out since no human studies specifically address the birth defect risks of taking Zofran during pregnancy. However, this is only because the FDA never approved the drug for use during pregnancy.

The lack of FDA approval certainly didn’t stop GSK from pushing Zofran for use in treating morning sickness. In 2012, the company was fined a record $3 billion for illegally promoting drugs for uses not approved by the FDA, including the promotion of Zofran for morning sickness. This pushed Zofran to over $1.5 billion in sales each year before it lost its patent.

Families suing the company over alleged birth defects point out that animal studies show a risk of birth defects from Zofran, as do multiple records-based studies in the US and Europe. And, FDA records show more than 500 reports of birth defects from the drug.

In 2011, a U.S. study of more than 20,000 women in 10 states showed twice the risk of cleft palate birth defects. A 2013 study of records from nearly 1 million women in Denmark showed double the risk of fetal heart defects from Zofran use, and a 2014 Swedish study found a 62% higher risk of infant heart septal defects from the drug.

The Zofran MDL court has yet to rule on the request from GSK to block victims’ cases. Lawyers continue to help those affected file claims, and are available to discuss your case today. Contact us for more information.



Field, E. Families Say Animal Studies Back Their Claims in Zofran MDL. Law 360 (January 6, 2016). Retrieved from

JPML Pending MDL Cases as of December 15, 2015. Retrieved from


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