Amidst continuing Zofran birth defect litigation, the defendant has filed a motion with the U.S. Judicial Panel on Multidistrict Litigation, seeking to consolidate all federal claims for coordinated pretrial proceedings.

The Zofran lawsuits were filed on behalf of children born with heart defects, cleft palate, and other congenital malformations after their mothers took the anti-nausea medication Zofran while pregnant.

The consolidation request comes from the drug’s manufacturer, GlaxoSmithKline. GSK is facing at least 12 Zofran product-liability lawsuits filed in eight different states.

Due to similarities between these Zofran lawsuits, the company stated that consolidating the cases would be ideal for both parties, because it will reduce the chances of duplicative discovery, avoid conflicting pretrial rulings from different judges, and further serve the convenience of the parties. GSK has proposed to consolidate the cases in the U.S. District Court for the Eastern District of Pennsylvania.

Zofran Lawsuits

Plaintiffs in all of the Zofran lawsuits claim that GSK failed to warn consumers that Zofran could possibly cause serious birth defects. The mothers all claim that had they know of the risks, they would not have taken Zofran while pregnant. Doctors have likewise complained that GSK failed to provide adequate information regarding the risks of Zofran, and claim that they would not have prescribed Zofran for morning sickness if they knew what risks the drug posed to the fetus.

The plaintiffs further allege that GSK marketed Zofran to pregnant women, even after research suggested that the medication may pose a risk to unborn fetuses.

Overview of Zofran Birth Defect Allegations

Zofran (ondansetron) is a powerful anti-nausea medication typically prescribed to treat nausea in chemotherapy patients, or patients undergoing surgery or radiation treatment. Manufactured by GlaxoSmithKline, it was approved by the FDA as a nausea and vomiting treatment in 1991. While popularly prescribed to treat morning sickness in pregnant women, the FDA has never approved the drug for this purpose.

While it is not illegal for doctors to prescribe a drug for off-label purposes, it is illegal for manufacturing companies to advertise them for unapproved purposes.

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.

Birth defects that may be associated with Zofran include, but are not limited to:

• Cleft Palate
• Heart Defects
• Kidney Defects
• Musculoskeletal Defects
• Poor Fetal Growth
• Fetal Death