The federal Judicial Panel on Multidistrict Litigation has transferred a dozen Zofran birth defect lawsuits from around the country into a single multidistrict litigation in Massachusetts.

Generally, the plaintiffs in these Zofran lawsuits are parents who claim that their children’s birth defects were caused by GlaxoSmithKline’s anti-nausea drug Zofran.

The consolidated claims will proceed as a single multidistrict litigation, or MDL, before Judge F. Dennis Saylor of the District of Massachusetts. The panel noted that 42 other Zofran lawsuits are currently pending in federal court, and that these other actions may also qualify for consolidation into the MDL.

Multidistric Litigation

An MDL is a procedure used in cases such as large-scale pharmaceutical products liability litigation, where several different claims share common legal or factual issues. Transferring these cases to a single court allows pre-trial procedures to be conducted more efficiently and consistently.

The panel selected the District of Massachusetts as the transferee district because it is the most convenient venue for the majority of the parties. The panel also noted that five of the twelve Zofran lawsuits were already pending in that district – four of them before Judge Saylor, who has experience as an MDL judge.

Plaintiffs in these Zofran lawsuits generally claim that GSK improperly marketed Zofran as a treatment for morning sickness, even though the FDA has not approved it for that use. They claim that GSK had no reliable information about the safety or effectiveness of Zofran as a morning sickness medication.

Plaintiffs also allege GSK neglected to update the warning label for Zofran despite having received over 200 complaints of birth defects associated with courses of Zofran treatment.

Zofran Birth Defects

The birth defects allegedly associated with Zofran treatment include congenital heart defects, some of which required corrective surgery shortly after birth.

Other children have been born with an atrial septal defect, in which the wall between the two upper chambers of the heart fails to fully form. Still other children have reportedly been born with aortic arch hypoplasia, a failure of the aortic arch to properly form. Other alleged Zofran birth defects include cleft lip, cleft palate, club foot, or deformities of the skull.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Zofran, or ondansetron, has been on the market since it was initially approved by the FDA in 1991. It’s indicated as a treatment for nausea and vomiting associated with surgery, chemotherapy, or radiation therapy. It has not been FDA-approved to treat nausea from any other source.

The Zofran Birth Defects Lawsuit MDL is titled In re: Zofran (Ondansetron) Products Liability Litigation. It will proceed in the U.S. District Court for the District of Massachusetts under MDL no. 2657.