Gilman Law LLP Investigating Zofran Birth Defect Lawsuits on Behalf of Children Born With Cleft Palate, Cleft Lip, Heart Malformations and Other Congenital Defects, Allegedly Due to Their Mother’s Use of Zofran in Early Pregnancy

Gilman Law LLP Investigating Zofran Birth Defect Lawsuits

Gilman Law LLP, a leading pharmaceutical law and defective medical device plaintiffs’ law firm, is now investigating potential Zofran birth defect lawsuits on behalf of children who were born with serious congenital defects, allegedly due to their mothers use of Zofran during the first trimester of pregnancy.

Zofran is not approved by the U.S. Food & Drug Administration (FDA) to treat morning sickness or hyperemesis gravidarum. However, a report published in the August 2014 issue of the American Journal of Obstetrics and Gynecology found that about 1 million pregnant women per year are exposed to Zofran or generic versions of ondansetron for this purpose.

Gilman Law LLP is seeking to hear from parents and caregivers of children who may have sustained any of the following birth defects due to prenatal Zofran exposure:

Zofran Birth Defects Lawsuit

Zofran Birth Defects Lawsuit

  • Heart defects, including septal defects (holes in the heart)
  • Cleft lip and cleft palate
  • Club foot
  • Skull deformities (craniosynostosis)
  • Musculoskeletal Defects
  • Fetal growth restriction (poor growth in the womb)
  • Kidney defects
  • Hydronephrosis
  • Hypospadia

Alleged victims of Zofran-related birth defects may be entitled to significant financial compensation from GlaxoSmithKline. However, potential claimants should be aware that all personal injury claims, including those involving Zofran, are subject to strict statutes of limitations that vary by state. Individuals seeking to file suit against GlaxoSmithKline are urged to contact Gilman Law LLP today, TOLL FREE at 888-252-0048, to ensure that their right to recovery is not placed in jeopardy.

Zofran is currently approved by the U.S. Food & Drug Administration (FDA) to treat nausea and vomiting related to chemotherapy, radiation treatments and surgery. The drug is listed by the agency in Pregnancy Category B, which indicates it has not been well studied for use in pregnancy.

In 2012, Glaxo resolved criminal and civil charges over the marketing of several drugs, including Zofran, and paid $3 billion as part of a settlement with the U.S. Department of Justice. Among other things, the company had been accused of promoting the use of Zofran as a treatment for morning sickness, even though it had not been approved for this purpose by the FDA.

Court documents indicate that more than a half dozen Zofran birth defect lawsuits have been filed in U.S. courts since February, all of which accuse GlaxoSmithKline of fraudulently marketing the medication as a safe and effective treatment for morning sickness. Most recently, a complaint was filed in the U.S. District Court, Eastern District of Arkansas, on behalf of a child who was born with a partial cleft lip after his mother took Zofran to control nausea and vomiting during her first trimester. Like similar complaints filed in recent months, the lawsuit accuses GlaxoSmithKline of concealing hundreds of reports linking Zofran to birth defects from regulators, doctors and patients. The complaint also notes that a number of studies have suggested that exposure to Zofran during the first trimester of pregnancy increases the likelihood for birth defects, including a 2.37 times increased risk of cleft palate; 2 times increased risk of a heart defect; and 20 percent increased risk of any birth defect. (Case No. 15-284)

Gilman Law LLP is providing complimentary Zofran lawsuit consultations to families who believe their baby was harmed by this drug. For more information, please contact Gilman Law LLP today by visiting our website,, to fill out a free, no obligation case evaluation form, or call Toll Free at 1-888-252-0048.

About Gilman Law LLP
Gilman Law LLP, a leading pharmaceutical law and defective drug law firm, has been recognized for delivering successful results to their clients across a broad range of claims stemming from consumer product injury, mass tort, and class action lawsuits. For over 40 years, the Gilman Law LLP team of highly experienced lawyers has earned renown for tireless work on behalf of their clients on many of today’s most challenging and important legal issues.


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Bonita Springs, FL 34135-4208


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