October 14, 2015 — The Judicial Panel on Multi-district Litigation (JPML) has consolidated twelve Zofran lawsuits involving birth defects into one federal court in Massachusetts.

The cases will be centralized and coordinated for pretrial proceedings under Judge F. Dennis Saylor in the District of Massachusetts, Multi-District Litigation (MDL No. 2657).

An additional 42 federal lawsuits are pending in 22 district courts. All of the lawsuits claim Zofran causes birth defects and accuse GlaxoSmithKline (GSK) of promoting it “off-label” for pregnant women with morning sickness.

According to the transfer order (PDF):

“Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.”

The judges chose the District of Massachusetts because five lawsuits are already pending there, including the first-filed lawsuit of Tomisha LeClair in February 2015. LeClair blames Zofran for causing her daughter’s heart defects and developmental delays.

Attorneys for LeClair told Law360 that Massachusetts is an appropriate venue because of its proximity to the Slone Epidemiology Center at Boston University, where researchers linked Zofran with a 2.4-fold increased risk of cleft palate in 2012.

The Justice Department also filed criminal charges against GSK in Massachusetts district court in 2009 and 2012. The charges led to a $3 billion settlement for off-label promotion and paying kickbacks to doctors who prescribed Zofran.


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