GlaxoSmithKline Files A Motion To Dismiss Zofran Lawsuits
By Laurence Banville
The MotionGSK, the manufacturer of the drug Zofran, has requested that all federally filed lawsuits regarding the drug be dismissed because they believe that there is enough evidence to show that the U.S. Food and Drug Administration (FDA) wouldn’t have allowed the creation of a warning label that the plaintiffs claim would have informed the public and medical community of certain risks associated with the drug. They noted that the FDA has already denied a citizens’ petition to have the warning label changed to include that the drug may cause birth defects.
The Plaintiff’s ResponsePlaintiffs filed a response on January 5th, 2016, stating that “Defendant GlaxoSmithKline, LLC’s request to dismiss all cases at the initial pleadings stage is unripe, unprecedented and violates established federal law.”
A status conference was set for January 14th, where both parties reviewed the motion with Judge F. Dennis Saylor. A determination has yet to be announced.
Zofran LawsuitsThe decision to file this motion by GSK is hardly surprising. Over 200 lawsuits have been filed against the company, each one alleging that the drug Zofran caused a birth defect in an unborn child.
Zofran is one of the most popular drugs prescribed to expectant mothers as a treatment for morning sickness. The drug was first approved by the FDA in 1991, but what patients weren’t aware of was that the drug was not approved for pregnant women. Zofran was approved for the treatment of nausea and vomiting but only in patients undergoing anesthesia, radiation, and chemotherapy.
GSK marketed the drug “off-label”, however, and indicated to the medical community and the public that the drug was “safe” and “effective” as a treatment for morning sickness. But shortly after the company began this marketing campaign, they allegedly received multiple reports indicating that woman who took Zofran during pregnancy had given birth to children with birth defects.
Today, the birth defects noted in the complaints include cleft lip, cleft palate, atrial septal defect, ventricular septal defect, transposition of the greater vessels, respiratory distress syndrome, and kidney defects. Every child who suffers from one of these defects has required ongoing medical care and most have had to undergo at least one surgical procedure. In some cases, the family claims that the birth defect resulted in the child’s death.