You wanted nothing more than to keep your baby safe. As your pregnancy and your unrelenting nausea continued, your concern about your unborn baby’s development increased. You talked to your doctor about your inability to keep food down and your doctor decided that you needed the help of a prescription medication.

Zofran was the drug that was prescribed. You gladly took it, hoping for relief, but did you have all of the information that you needed to make an informed decision? Could the drug your doctor prescribed have caused your baby to suffer a birth defect?

Zofran: What Is It?

Zofran is an anti-nausea drug manufactured by GlaxoSmithKline that has been approved by the FDA since the 1990s. The medication works by blocking certain chemicals in the body that trigger nausea and vomiting. Currently, Zofran is approved for three uses by the Federal Drug Administration (FDA). Those uses include preventing nausea and vomiting caused by:

  • Chemotherapy.
  • Radiation therapy.
  • Surgery.

The drug is not now, and has never been, approved for us of pregnancy-related nausea or vomiting. The FDA currently classifies Zofran as pregnancy category B—which means that, according to the FDA, there is no evidence of risk to humans. However, doctors such as yours sometimes prescribe the medication to pregnant women suffering from severe morning sickness or hyperemesis gravidarum.

Zofran Lawsuit Filed in United States District Court

Many women are, understandably, looking for relief and they are trusting the drug manufacturer to provide them with a safe product to relieve them from their unrelenting nausea and vomiting. However, some children have allegedly been hurt by Zofran that was taken by their mothers during pregnancy.

In 2015, a lawsuit was filed in a United States District Court. The plaintiffs in the case allege that:

  • Their children suffered birth defects after fetal exposure to Zofran.
  • GlaxoSmithKline was aware of evidence linking Zofran to heart birth defects and other birth defects.
  • Since at least 1992, GlaxoSmithKline has had evidence that Zofran can cause harm to babies that are exposed to the drug in utero. Specifically, GlaxoSmithKline knew that Zofran crosses the placenta and that animal studies indicate that Zofran is not safe for use by pregnant women.
  • Since 1992, GlaxoSmithKline has received hundreds of reports of birth defects associated with the use of Zofran use during pregnancy.
  • GlaxoSmithKline continued to knowingly market Zofran for use during pregnancy without a birth defect warning despite knowing the risks and not having FDA approval.
  • GlaxoSmithKline concealed information about potential birth defects from doctors, healthcare professionals, and expecting parents and illegally promoted the use of Zofran for pregnant women.

And these plaintiffs are not alone.

Zofran Is the Subject of Other Cases

In February 2015, a case similar to the one described above was filed in Massachusetts. In that case, the mother had been prescribed Zofran for nausea and vomiting during pregnancy and her child was born with heart defects, facial dysmorphia, and other birth defects.

Additionally, the federal government has been investigating GlaxoSmithKline. In 2012, GlaxoSmithKline settled a health care fraud case with the United States government. The multibillion dollar settlement included a finding that the drug manufacturer promoted Zofran for use in pregnant women when it did not have FDA approval to do so.

Has Your Child Been Hurt?

Zofran has been potentially linked to the following types of birth defects:

  • Congenital heart defects.
  • Cleft lip.
  • Cleft palate.
  • Kidney problems.
  • Other birth defects.

Any one of these conditions could change the course of your child’s life. If you were prescribed Zofran while pregnant then it is important for you to understand your child’s legal rights and to protect his legal recovery so that you can help protect his future.

Has Your Family Been Impacted By A Birth Injury?

If your family has been impacted by a birth injury you need to speak with an experienced birth injury attorney as soon as possible. Contact us online or call our office directly at 888.450.4456 to schedule a free consultation.


Mark K. Gray
Connect with me
Louisville attorney serving the seriously injured in Kentucky