Cleft Palate & Lip Lawsuits & Settlements

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Cleft Palate & Lip Lawsuits & Settlements

Cleft palate and cleft lip are common birth defects that happen early in pregnancy. In a normal pregnancy, the tissues that grow into the lip and mouth fuse between weeks 8 and 12. When these tissues partially or do not fuse at all, a cleft palate or lip in the baby results.

A baby can be born with a cleft palate or a cleft lip separately. There also are cases where the baby is born with a cleft lip and a cleft palate. They can happen on one side of the mouth, which is known as a unilateral cleft, or on both sides, which is a bilateral cleft.

If your child was born with a cleft lip or cleft palate, this birth defect could have been caused by taking certain drugs during pregnancy. You could be entitled to compensation in a cleft palate and lip lawsuit.

Cleft Palate vs Cleft Lip

A cleft palate refers to the roof of the mouth. Skin tissue does not fuse and causes a split in the roof of the mouth. Cleft palates can be soft or hard. A soft cleft palate involves the soft skin in the rear of the roof of the mouth. A hard cleft palate is where separation occurs in the front of the roof of the mouth where there is more bone. (

A cleft lip is where a small, narrow portion of skin tissue does not form in the upper lip. The gap extends from the upper lip to the base of the nose. Some cleft lip cases involve the upper jaw and upper gum.

What Causes Cleft & Lip Palates?

There are many reasons these birth defects occur. The first is simply hereditary. But these birth defects also can be caused by outside factors, such as a drug being taken by the mother during pregnancy. One of them is from the drug Zofran developed by GlaxoSmithKline (GSK). Zofran was promoted starting in the early 1990s to combat morning sickness during pregnancy. There were no warnings from GSK that taking Zofran could lead to cleft palate and cleft lip in newborns. Since 1991, there have been many instances of birth defects in mothers who had no family history of these birth defects.

Several clinical studies were performed to determine if Zofran had a link to a higher risk of cleft palate in the first trimester. A 2012 study by the Centers for Disease Control and the Sloan Epidemiology Center, taking Zofran during a pregnancy’s first trimester caused a doubling of the risk of a child being born with a cleft palate.

Some of the other drugs that can increase the risk of cleft lip and cleft palate are:

  • Methotrexate: to treat cancer, arthritis, and psoriasis
  • Accutane: to treat acne
  • Antidepressants
  • Topamax: To treat seizures and convulsions
  • Zofran: to treat morning sickness

Other drugs that can increase the risk of cleft palate and cleft lip are Depakote, Tegretol, Paxil, Zoloft, Effexor, Celexa, Lexapro and Prozac.

If you took one of these drugs during your pregnancy and your child has suffered a birth defect, you may want to speak to a cleft palate and cleft lip attorney today.

Problems Cause by Cleft Lip and Cleft Palate

Parents of children with cleft lip or cleft palate often seek relief in a personal injury lawsuit. Their children will probably have substantial medical and health complications and expenses from their birth defect:

  • Eating and nutrition problems: Breastfeeding and ingesting critical nutrition is important in early development. This is compromised by a cleft lip or palate. The cleft lets the formula or food to go through the cleft. This causes problems for the child to get proper nutrition. Until the problem is fixed in surgery, a baby with a cleft may use a special bottle or mouth guard to aid in feeding.
  • Hearing problems and infections: Studies indicate that a cleft lip or palate allows fluid to build up in the middle ear. This leads to ear infections. When these infections are not treated, they can cause hearing loss. There are procedures available to put drainage tubes into the ear to prevent fluid from building up. People with cleft lips or palates need to have yearly hearing tests.
  • Speech problems: Speech is made from power from the lungs, vibration in the voice box, and resonation via the throat, nose, mouth and sinuses. Because of the cleft lip or cleft palate, the child’s voice will usually be weak and making it harder to understand him. Surgery can often repair the issue, but speech therapy may be needed.
  • Dental issues: Another problem with these birth defects is a higher rate of dental problems, including cavities and missing, extra or displaced teeth. This can lead to expensive dental procedures that normal children and adults do not experience. (gov)

Recent Cleft Palate and Lip Settlements

In 2013, Johnson & Johnson was ordered to pay damages for Topamax birth defects. A Philadelphia jury determined that taking Topamax, which is used to combat seizures, during pregnancy can cause birth defects such as a cleft lip. There are now at least 130 Topamax lawsuits filed for children who have suffered from birth defects from their mother taking the drug during pregnancy.

The jury in the 2013 case awarded the mother of a boy born in 2007 with a cleft lip $11 million in damages. The award will cover the boy’s medical costs, including several corrective surgeries. The $11 million settlement was the second for Johnson & Johnson, after a $4 million award a few months earlier in 2013.

Another Topamax trial in late 2013 resulted in the jury telling the drug makers to pay $4 million to a woman whose son was born with several birth defects. At trial, the woman said she had taken Topamax for 180 days during her pregnancy.

J&J stated they did provide sufficient Topamax warnings, but in 2011, FDA released a warning about a risk of cleft palate and cleft lip associated with Topamax.

More recent cleft palate and cleft lip settlements are:

  • July 2012: 27 months filed a product liability lawsuit against Abbott Laboratories, alleging that Depakote caused birth defects in their children.
  • March 2014: A jury in Pennsylvania awarded $3 million to the family of a boy who was born with a cleft lip after he was exposed to Topamax during pregnancy.
  • March 2015: A judge upheld an $11 million jury award in a Topamax lawsuit filed by the family of a boy with a cleft lip, even though Janssen Pharmaceuticals appealed.

Why Drug Manufacturers Should Be Held Liable for Cleft Lip Birth Defects

Cleft lip and cleft palate are serious birth defects that often are caused by a child’s exposure to dangerous drugs during the mother’s pregnancy. Like many congenital birth defects, cleft lip and palate happens in the early weeks of pregnancy before some women even know they are pregnant. The families of children born with these serious birth defects are filing lawsuits against drug manufacturers for these reasons:

  • Designing and marketing dangerous drugs to pregnant women
  • Not researching pregnancy risks of dangerous drugs
  • Misrepresenting drug benefits and ignoring risks
  • Not providing enough information about birth defect risks
  • Failing to provide enough warnings to doctors and consumers about drug risks to fetal development

Get Legal Help Now for Your Child’s Birth Defect

If you were prescribed Zofran, Topamax or another drug during pregnancy that led to a birth defect in your child, you could have the right to compensation for your child by filing a personal injury lawsuit against GSK or another drug manufacturer. These companies may be held liable for aggressively pushing the sale of products that are known to cause serious birth defects.

You could be entitled to receive compensation for your medical costs and out of pocket expenses related to treatment and procedures your child needs over the years for their pain and suffering and emotional trauma. For more information about your legal rights or to determine if you have a case that is worth pursuing, please contact our cleft palate and lip lawsuit attorneys today.


  1. Causes of Cleft Lip and Cleft Palate. (n.d.). Retrieved from
  2. Cleft Lip and Palate.(n.d.). Retrieved from
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