Zofran manufacturer GlaxoSmithKline (GSK) faces a growing number of birth defect lawsuits, as plaintiffs allege the widely prescribed “morning sickness” drug was never actually tested to see if it was safe to use during pregnancy.

The latest Zofran lawsuit filed by plaintiff Melisa A., a resident of California, claims she was prescribed the medication for morning sickness relief during the first trimester of her pregnancy and her child was later born with birth defects including kidney problems.

According to Melisa, manufacturer GlaxoSmithKline aggressively marketed Zofran to pregnant women in order to ease morning sickness symptoms while not having FDA approval to do so.

The Zofran birth defect lawsuit alleges, “GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.” The plaintiff claims GlaxoSmithKline has received more than 200 reports of Zofran birth defects, yet the company has not cautioned pregnant women of the potential birth defect risks.

This latest complaint joins several other similar Zofran birth defect lawsuits filed this year, which may indicate the cases are heading toward a multidistrict litigation. GSK has requested that the current Zofran lawsuits filed in 10 different districts be transferred and consolidated in the Eastern District of Pennsylvania. The manufacturer indicated that the Judicial Panel on Multidistrict Litigation may consider the motion in October.

Common Zofran Birth Defects

The U.S. Food and Drug Administration (FDA) approved Zofran (ondansetron) in 1991 as an anti-nausea medication prescribed to cancer patients. However, shortly after its release, Zofran started being commonly prescribed “off-label” to pregnant women to help alleviate morning sickness symptoms.

Hundreds of women have since reported that fetal exposure to Zofran caused their babies to be born with severe birth defects including:

• Cleft palate
• Cleft lip
• Kidney defects
• Congenital heart defects
• Musculoskeletal defects
• Congenital diaphragmatic anomaly

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 Lawsuits

Melisa A. is just one of many who have filed Zofran birth defect lawsuits this year. In recent months, other parents have accused Zofran of causing glaucoma, seizure disorders, congenital heart defects and developmental delays. Most often, Zofran lawsuits are filed by parents on behalf of their children as a way to financially help support the continuous medical treatments required to manage their conditions.

In general, birth defect lawsuits allege that GlaxoSmithKline should have conducted clinical trials before promoting Zofran as a morning sickness drug. Numerous dangerous drug lawsuits claim GSK failed to warn of the life-threatening birth defect risks of taking Zofran during pregnancy especially since the warning label carries no caution of fetal harm.

If you took Zofran while pregnant and later had a child born with a birth defect, contact a Zofran attorney to find out if you have legal claim.

The Zofran Birth Defect Lawsuit is Case No. 2:15-cv-05544, in the U.S. District Court for the Central District of California.