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GSK’s Motion to Dismiss Zofran Lawsuits Denied

Last month, A federal judge in Massachusetts denied GlaxosmithKline’s (GSK) motion to dismiss hundreds of Zofran birth defects lawsuits, that were recently consolidated into a multidistrict litigation.

According to court documents, GSK, the makers of Zofran, argued that the plaintiff’s complaints, which state that GSK failed to warn them of potential birth defects while taking the medication during pregnancy, was based on state laws, not federal laws. The multidistrict litigation was moved to federal court last October, but GSK claims that the plaintiffs’ cases shouldn’t be there, given that they come from different states, which have numerous state laws on the issue.

Additionally, GSK argued that the FDA would have denied a label change on the medication, which stems from a Supreme Court ruling that a “failure-to-warn” lawsuit claim can be thrown out if a federal agency didn’t require warnings. In the case of Zofran, GSK argued that the FDA denied a citizen’s petition to change the labeling on the drug. Plaintiffs countered by stating that GSK’s attempt to dismiss the lawsuits is “unprecedented and violates established federal law.”

District Judge F. Dennis Saylor IV sided with the plaintiffs and denied GSK’s request on January 22. The judge cited a Supreme Court ruling from 2008 that stated a citizen’s petition alone is not “clear evidence” that the FDA would have denied the label change. According to Saylor,

“The plaintiffs [should be given] some opportunity to develop the facts, whatever those facts may be.” 

Why is GSK Being Sued?

GSK is currently facing the multidistrict lawsuit after hundreds of parents filed against them when their babies were born with birth defects. Each mother in the lawsuit was prescribed Zofran during pregnancy for morning sickness treatment, even though the FDA never approved the medicine to be used for that purpose. Physicians prescribed the drug as “off-label” use for morning sickness, but none of the plaintiffs were warned that taking Zofran while pregnant heightens the risk of infants developing birth defects.

According to numerous studies performed on the medication, the following birth defects cannot be ruled out when women take Zofran while pregnant:

  • Cleft lip and cleft palate
  • Heart abnormalities
  • Club foot
  • Jaundice
  • Facial deformities
  • Hearing and vision problems
  • Fetal growth restriction
  • Hip dysplasia, and more

GSK Previous Lawsuit is Eerily Similar to Current Zofran Lawsuits

This isn’t the first time GSK has faced lawsuits for falsely representing their medications. In 2012, the company pleaded guilty to the U.S. Department of Justice for falsely representing several of their antidepressant medications. In turn, GSK paid $3 billion in settlements for unlawfully promoting several drugs and failing to report the drugs’ safety data.

Keep in mind that if you’re pregnant, it’s highly recommended to learn as much as possible about Zofran before agreeing to take it. Some doctors continue to prescribe the medication to pregnant women despite the evidence that shows it’s dangerous, because they’re allegedly offered kickbacks from GSK.

If you already took Zofran while pregnant and your baby was injured as a result, you have the legal right, just as the other plaintiffs, to file for damages against the responsible party. Each month, more and more women who took Zofran while pregnant are coming forward after their babies were born with devastating birth defects. If you’re in the same situation, keep in mind that you may be eligible for compensation for medical expenses for your child, pain, suffering, lost wages, and more.



Judge F. Dennis Saylor, IV: ORDER entered. MDL ORDER NO. 9 – Memorandum and Order On Defendant’s Motion ToDismiss all Claims on Preemption Grounds. Associated Cases: 1:15-md-02657-FDS et al.