Product News and Recalls

Zofran Maker Wants MDL for Birth Defect Lawsuits

GSK asks for Zofran MDLReuters reports that Zofran maker GlaxoSmithKline has asked the U.S. Judicial Panel on Multidistrict Litigation to centralize all pending Zofran birth defect lawsuits in a multidistrict litigation. The pharmaceutical giant has requested the Zofran lawsuits be consolidated in federal court in Pennsylvania, near the company’s U.S. headquarters.

Zofran is an antiemetic drug used to treat nausea and vomiting in chemotherapy, radiation therapy, and surgery patients. Zofran is also frequently prescribed to pregnant mothers for morning sickness, an “off-label” use not approved by the U.S. Food and Drug Administration. Unfortunately for many mothers-to-be, Zofran may be increasing the risk that their child is born with birth defects. Research from the last four years points to an increased incidence of birth defects in children whose mothers took Zofran during pregnancy. Studies from 2012 and 2014 both linked use of Zofran during the first trimester of pregnancy to a more than doubled risk of congenital birth defects.

In 2012, GlaxoSmithKline paid the federal government $3 billion dollars to resolve allegations of fraud and failure to report drug safety data. Included in the settlement (the largest of its kind in U.S. history) were penalties for off-label marketing of Zofran. Several years afterwards, patients continue to file Zofran lawsuits alleging GlaxoSmithKline promoted their drug for unapproved uses. Plaintiffs in Zofran lawsuits further claim that GlaxoSmithKline failed to properly warn doctors and patients about the drug’s risks.

If you or someone you had a child with birth defects after taking Zofran for morning sickness, contact the pharmaceutical lawyers at Lopez McHugh for a free legal consultation. We can help determine whether a Zoran lawsuit is right for your family.