Cleft Palate

Between the early 1980s and the mid 2010s, pregnant women who experienced nausea and vomiting associated with morning sickness had no FDA-approved drug to help them cope with these symptoms. A previously-approved drug – Bendectin – had been discontinued after the manufacturer was sued multiple times by plaintiffs who claimed the drug caused birth defects. The absence of any approved treatment for morning sickness led to the “off-label” use of several drugs. “Off-label” meant that doctors would prescribe the drug either for a condition that the drug was not intended to treat or to a group of patients for whom the drug was not intended. Zofran was one such drug.

Zofran was originally intended and approved to treat nausea and vomiting in patients who had recently undergone a surgery or whose symptoms were caused by chemotherapy treatments. Despite warnings from the Food and Drug Administration (FDA) stating that Zofran should not be used by pregnant women, more and more pregnant women were receiving prescriptions for Zofran to help them cope with the symptoms of morning sickness. It has only recently been discovered that this “off-label” use of Zofran can lead to birth defects such as cleft palate.

What is a Cleft Palate Birth Defect?

A cleft palate is a birth defect that occurs when there is a split or opening in the roof of the mouth due to a lack of tissue or tissue that does not join together properly. A cleft palate can either affect the hard palate (found toward the front portion of the roof of the mouth), the soft palate (the soft back portion of the mouth), or both. A cleft palate can present along with a cleft lip, but the two conditions are separate and can appear without the other.

If uncorrected, a cleft palate places a child at an increased risk of certain health problems such as:

  • Eating problems, since the separation allows food and liquids to pass from the mouth to the nose. Some children must wear man-made palates in order to eat properly until the cleft palate can be surgically repaired;
  • Ear infections, due to an increased occurrence rate of fluid buildup in the middle ear. If these ear infections are not treated, permanent hearing loss can result;
  • Speech problems that may or may not be fixed through surgery. Oftentimes a speech pathologist is needed to help the child resolve his or her speech difficulties; and
  • Dental problems, such as an increased risk for cavities.

We Are Here to Help You

If you or a loved one took Zofran while pregnant and your child was born with a cleft palate or other birth defect, contact us right away at 1-800-883-9858. You may be entitled to compensation for the injuries and expenses you or your newborn experienced. However, your ability to recover compensation may depend on how quickly your claim is filed. So do not delay – contact us today if your newborn suffered a Zofran-related birth defect.