Zofran Cleft Palate: Can You Sue GlaxoSmithKline?

Are you the mother of a baby with a cleft palate or cleft lip? Did you take Zofran for morning sickness?

You and your baby may have a personal injury claim against GlaxoSmithKline. This means you could sue the company for compensation.
Contact our law firm for a free consultation with a lawyer.

What is Zofran?

Attorney David Coyle
Attorney David Coyle

Zofran (ondansetron hydrochloride) is used to prevent nausea and vomiting in cancer patients undergoing chemotherapy and radiation therapy. It is also “labeled” for use with anesthesia and surgery. This means these uses are on the product label and approved by the FDA. It is illegal to put a use on a prescription medication label if that use has not been approved by the FDA. Zofran use for morning sickness (nausea during pregnancy) has not been approved by the FDA, but doctors used it for that “off’-label” purpose.

Zofran is a GlaxoSmithKline product.

What Evidence is There That Zofran Causes Cleft Palate?

A study of over 10,000 pregnant women with morning sickness found a higher odds ratio for cleft palate among women exposed to ondansetron, the active ingredient in Zofran (aOR=2.37; CI, 1.18–4.76). In other words, women taking ondansetron were twice as likely to have children with cleft palates.

Study Citation: Anderka M, Mitchell AA, Louik C, Werler MM, Hernández-Diaz S, Rasmussen SA, et al. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol. 2012;94(1):22–30. Epub 2011 Nov 19.

What is a Cleft Palate?

Cleft lip and cleft palate generally happen during the first trimester of pregnancy. A cleft lip is a condition where lip tissue does not join completely, creating an opening in the upper lip.

A cleft palate is when the palate (roof of the mouth) does not join correctly, leaving part of the palate open. This can cause problems with feeding and talking. Other complications include hearing loss and problems with teeth.

Children with a cleft lip or a cleft palate often have problems with feeding and talking. They also might have ear infections, hearing loss, and problems with their teeth.

It takes surgery to close these openings.

Why Should You File a Lawsuit?

Below are 4 reasons you should file a lawsuit.

  1. A lawsuit will seek compensation that can be used for current and future medical expenses, including future surgeries and dental bills resulting from use of Zofran.
  2. A lawsuit will seek compensation for your baby for all harm caused by Zofran, and any money won can be placed in trust for your child.
  3. A lawsuit sends a message that medications should not be used on pregnant women unless they are rigorously tested and approved by the FDA.
  4. A lawsuit provides opportunities for getting corporate documents regarding the manufacture and marketing of the medication.

Free Consultation

You can click here now to request a FREE consultation regarding a lawsuit against GlaxoSmithKline for harm done to your baby. Our lawyers have won millions for children injured by defective products, including a recent settlement for over $10,000,000.00 for 7 babies sickened by an over-the-counter product.