October 14, 2015 — Federal judges have centralized Zofran lawsuits into a Multi-District Litigation (MDL No. 2657) in the District of Massachusetts under Judge F. Dennis Saylor.
The Judicial Panel on Multi-district Litigation (JPML) issued a transfer order (PDF) on October 13 for twelve lawsuits. Another 42 lawsuits pending in 22 district courts may also be moved into the MDL.
The lawsuits accuse GlaxoSmithKline (GSK) of negligence for promoting Zofran to pregnant women for the “off-label” (unapproved) treatment of morning sickness. Plaintiffs also claim that Zofran causes birth defects.
According to the judges:
“Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.”
The litigation has grown steadily since the first lawsuit was filed in February by Tomisha LeClair, a woman whose daughter was born with heart defects and developmental delays after exposure to Zofran in the womb.
The District of Massachusetts was selected because five lawsuits are already pending there, including the LeClair case. Her attorneys told Law360 that the venue is also appropriate because the Justice Department filed criminal charges against GSK in Massachusetts. Those charges led to a $3 billion settlement for off-label promotion and kickbacks in 2012.
The Slone Epidemiology Center at Boston University is also located in Massachusetts, where researchers published a massive study linking the use of Zofran during pregnancy with a 2.4-fold increased risk of cleft palate.