As reported by Law360, the US Judicial Panel on Multidistrict Litigation has consolidated in Massachusetts a number of lawsuits alleging that off-label promotion by GlaxoSmithKline of its anti-nausea drug Zofran for morning sickness led to serious birth defects. “The MDL panel found that 12 lawsuits, some of which are proposed class actions, warranted consolidation as they all involved common allegations that GlaxoSmithKline’s Zofran and its generic equivalent, Ondansetron … cause birth birth defects in children when their mothers ingest the drug while pregnant.”
The Panel went on to note that there have been at least 42 additional related federal actions filed in 22 district courts, and that these would be included in the MDL transfer to U.S. District Judge F. Dennis Saylor for pretrial proceedings.
The complaints generally allege that GlaxoSmithKline promoted Zofran aggressively for morning sickness despite lacking any evidence of its safety in pregnant women. The company only had FDA approval for the use of Zofran in the treatment of severe nausea relating to cancer and surgery.
Lieff Cabraser represents parents, and their children who developed birth defects, in lawsuits relating to the use of Zofran. Lieff Cabraser attorney Sarah London noted, “we are thrilled that the Panel has selected Judge Saylor, who has tremendous experience and skill in handling complicated cases involving serious injuries. We are anxious to move forward on behalf of our clients to hold GSK responsible for their wrongful conduct that hurt so many families.”
The lawsuits note that GlaxoSmithKline received over 200 complaints of Zofran-related birth defects, yet still has not updated warning labels on the product. In 2012, GlaxoSmithKline paid $3 billion to settle allegations of off-label promotion involving several drugs, including Zofran, which the U.S. Department of Justice indicated had been illicitly promoted for the treatment of morning sickness from 2002 through 2004.
Commenting on the news, Lieff Cabraser attorney Wendy Fleishman noted that “the Plaintiffs and their families are committed to moving forward in this extremely serious matter.”