Research Proved Zofran Lead to Birth Defects Beforehand

In addition to promoting Zofran off-label, the company allegedly did it despite information that foreshadowed a link to birth defects, according to a petition that a plaintiff filed at federal court in Massachusetts.

“Plaintiff’s minor child, A.S., was born in 2000 with numerous congenital defects after her mother … was prescribed and began taking Zofran beginning early in her first trimester of pregnancy to alleviate the symptoms of morning sickness,” reads the complaint. “After birth, echocardiograms evidenced that A.S. suffered from an atrial septal defect, right ventricular hypertension and aortic arch hypoplasia. A.S. has also subsequently been diagnosed with facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia, and webbed toes.”

Could the manufacturer have known about the risk of birth defects associated with an expectant mother’s use of Zofran?

3 Billion Dollar Settlement

Indeed, GSK in 2012 agreed with the U.S. Justice Department to pay a then-record $3 billion to settle its criminal and civil liability arising, in part, from the corporation’s “unlawful promotion of certain prescription drugs,” including Zofran, as the Justice Department’s 2012 statement read. Drugs marketed for unapproved purposes are said to be promoted “off-label.”

Zofran, the generic of which is ondansetron, “is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery,” according to the U.S. National Library of Medicine.

But the drug eventually was marketed for morning sickness, as well.

Zofran Lawsuit Updates 2026

Since 2015, when the first Zofran lawsuit was filed over birth defect claims, the drug’s maker GlaxoSmithKline (GSK) has been under fire for the promotion of the anti-nausea medication without FDA authorization. Plaintiffs claimed the drug’s warning label did not list the increased risk of birth defects to unborn children when taken during pregnancy. 

Birth defects alleged in the lawsuits included heart defects, cleft palate, skull deformities, and other congenital abnormalities.

Plaintiffs also alleged that GSK was actually aware Zofran was unsafe for pregnant women based on animal studies done in the 1980s, which revealed evidence of toxicity, intrauterine deaths, and malformations in offspring, and that this evidence was further supported by birth defect reports submitted to GSK in the 1990s and 2000s.

Key Timeline of the Zofran Birth Injury Lawsuits

In October 2015, twelve Zofran lawsuits were consolidated into multidistrict litigation (MDL No. 2657) under Judge F. Dennis Saylor in the District of Massachusetts. By January 2016, there were 211 consolidated lawsuits, and Judge Saylor denied GSK’s motion to dismiss. 

The MDL eventually grew to over 700 cases.

The Final Appeal in the Zofran MDL – 2023

The U.S. Court of Appeals for the First Circuit denied the plaintiffs’ appeal, upholding the MDL judge’s decision dismissing all cases under the doctrine of “clear evidence preemption.” After nearly eight years of litigation, the Zofran birth defect litigation came to an end. 

We are still taking Zofran lawsuits in 2026.

Contact a Zofran Lawyer For a Free Consultation

Patients who’s children were injured by Zofran may be able to obtain compensation to pay for medical care, therapy, pain and suffering, lost work time and productivity and other damages. The experienced personal injury attorneys at Reich & Binstock can provide a free, confidential consultation to help you understand your options and protect your rights. Please call us today at 713-622-7271.