Zofran Birth Defects Lawsuit

The anti-nausea drug Zofran may pose extreme dangers to the unborn child. The medication has been prescribed “off-label” to unwarned mothers for treatment of nausea and vomiting (morning sickness) during pregnancy. Reports show that when taken while pregnant, and especially in the first trimester, Zofran may cause severe birth defects.

Did you take Zofran during Pregnancy for Morning Sickness?

You may have a legal case against the makers of Zofran. The lawyers at Marc Whitehead & Associates are investigating Zofran lawsuits on behalf of parents whose children were born with tragic birth defects, which may be tied to their mother’s use of Zofran while pregnant. These birth defects may include congenital heart defects, cleft palate and cleft lip, neural tube defects, spina bifida, limb deformities and brain deformities.

If you have questions, let us help you understand your options.

Talk to our lawyers about your child’s possible
birth defects caused by Zofran.
Call 1-855-423-3666 or fill out the form to the right.

There is no cost or obligation to discuss your case with us. As more parents are learning about the possible link between Zofran and serious side effects, our attorneys are here to offer compassionate and strategic legal counsel.

We can help you see if you have a case. We will discuss the possibility of filing a Zofran injury lawsuit on behalf of your child, to gain vital financial compensation for the child’s damages and injuries; or in the case of death, a wrongful death lawsuit.




Our free e-book, The Zofran Tragedy, contains essential information about Zofran and its potential dangers when taken during pregnancy.

Aimed to help families protect their rights, we urge you to download your complimentary copy.

What Is Zofran Used For?

Zofran is a leading medication used to prevent the severe nausea and vomiting that is caused by chemotherapy and radiation therapy for cancer patients, as well as post-operative nausea. It is manufactured by GlaxoSmithKline (GSK).

The active ingredient, ondansetron, works by blocking a chemical in the brain called serotonin, a natural substance that triggers nausea and vomiting.

What Is “Off Label” Use of Zofran?

Off label use means a drug is prescribed in a manner for which it has not been approved.

The manufacturer, GSK, may not market Zofran for any use other than what the Food & Drug Administration (FDA) has specifically authorized. The FDA has not approved Zofran for use in pregnant women.

However, the FDA does not regulate physicians. Even though the safety of the drug for use in human pregnancy has not been established, doctors may prescribe Zofran to pregnant women to reduce the nausea of morning sickness, when they believe the benefits outweigh the risks.

Zofran is frequently prescribed to pregnant women suffering from the condition “hyperemesis gravidarum” – an extreme form of morning sickness that poses risks to both mother and fetus.

Zofran Lawsuits and Settlements

In 2012, the U.S, Department of Justice (DOJ) held GlaxoSmithKline accountable on criminal and civil charges. The Court stated that GSK knowingly promoted Zofran to physicians as a treatment for morning sickness—without the FDA’s approval for that use, and without warning the public or medical community about the risks of Zofran side effects and birth defects.

The DOJ also held that the pharmaceutical giant offered kickbacks to physicians and healthcare providers in exchange for prescribing Zofran for morning sickness.

GSK was ordered to pay $3 billion to settle federal criminal and civil charges arising from its unlawful promotion of these drugs. This became the largest healthcare fraud settlement in U.S. history to date.

Zofran and Pregnancy: What Are the Side Effects?

Studies indicate potential side effects of Zofran taken during pregnancy include:

  • Cleft Palate and Cleft Lip – These deformities occur due to deficient formation of the mouth and lip during gestation. Oral clefts can cause great difficulty with eating, speaking and hearing for a child. Surgery is typically recommended to help alleviate these conditions during the baby’s first 12 to 18 months.
  • Heart Defects – Babies are born with cardiac malformations including atrial septal defect, which occurs as holes in the walls of the heart chambers; also, heart murmur.
  • Neural Tube Defects – Defects of the brain and spinal cord, where during development, the spinal cord does not close completely. Nerve damage and loss of function exhibited at birth are usually permanent.
  • Spina Bifida – One form of neural tube defect in which the fetal spinal column does not fully close. Nerve damage typically occurs causing some degree of leg paralysis.
  • Brain Deformities – Craniosynostosis, a condition in which the sutures in the developing baby’s skull close prematurely, resulting in a misshapen skull and possibly insufficient space for the brain.
  • Limb Deformities – Affecting development of muscle and bone in the baby’s limbs, these abnormalities may range from missing or incompletely formed limbs, hands or joints, to clubfoot defects.
  • Fetal growth restriction and low birth weight.
  • Kidney defects where one or both kidneys may not develop normally, and reflux of the bladder
  • Infant death

Call the Zofran Lawyers at Marc Whitehead & Associates

Contact us without delay if you suspect your child developed any Zofran-related birth defect. Call 1-855-423-3666 or submit the Contact Form on the right. You will get a free case evaluation from a respected attorney with decades of experience.

We handle cases on a contingency fee basis. There are no payments for our legal work until we succeed in getting financial compensation for you.

At Marc Whitehead & Associates, we put every effort and our tremendous resources toward helping these children. When a drug company markets the use of a high-powered drug to expecting mothers, they are promoting it to unborn babies as well.

When drug makers put profits over public safety, terrible injury to countless unsuspecting people can result. By holding powerful pharmaceutical companies accountable through our legal system, we help families obtain the financial compensation they need to put their lives back together and begin to find peace.

Attorney Marc Whitehead is a Board Certified Personal Injury Trial Lawyer and has been practicing injury law for more than 20 years. The Texas law firm of Marc Whitehead & Associates is a national personal injury firm representing clients in dangerous drug and medical device litigation in all 50 states.

Practice Areas: Defective Drugs