Most often, cleft palate is thought to be genetic, and is just the way a baby developed. However, genes only partly explain the condition, as cleft palate causes may also be environmental in nature.

What is Cleft Palate?

Many individuals have heard of the term cleft palate and know that it is congenital condition that babies are born with.

Specifically, cleft lip and cleft palate are malformations of the body’s facial and oral structures where not enough tissue has formed in the area, creating a gap (cleft).

Cleft palate in particular can affect the hard palate in the mouth, where the bony roof of the mouth is in the front, or it can affect the soft palate region in the back portion of the roof of the mouth.

Because the palate and lip grow at different times, the conditions can develop separately and a child may be born with just one, or may be born with both conditions.

What are Cleft Palate Causes?

As the fourth most common birth defect in the United States, cleft lip and cleft palate causes are largely unknown.

While scientists believe cleft palate causes can be genetic and environmental, there has not been a particular gene sequencing responsible for the development of cleft palate.

One environmental issue that has been determined as a linked factor for cleft palate causes is the medication that mothers ingest during pregnancy.

Certain classes of drugs have had a stronger link to an increased risk of developing cleft palate: anticonvulsant drugs to treat seizures, Accutane and other acne drugs and methotrexate, a drug used to treat arthritis psoriasis and cancer.

Zofran Nausea Medication

Another medication that has been linked to development of cleft palate is Zofran, a drug used to treat nausea.

Zofran was developed to treat the most severe forms of nausea- which is the nausea associated with radiation and chemotherapy treatments for cancer.

However, the makers of Zofran began marketing the drug to physicians and pregnant women as a treatment for morning sickness. For many women, their unrelenting nausea was finally under control with Zofran, but for some, it came with a price.

Zofran never received FDA clearance as a nausea medication for treatment for morning sickness. In fact, GlaxoSmithKline (GSK), makers of Zofran, allegedly knew as early as the 1980s that this medication was unsafe for use in pregnant women.

Animal studies carried out by GSK showed that Zofran crossed the placental barrier caused toxicity, congenital malformations in offspring and uterine deaths.

Human studies showed the drug crossed the placenta, exposing babies to high concentrations of the anti nausea medication.

DOJ Investigates Zofran Safety

After numerous Zofran adverse events reports by parents reporting birth defects in their children, the U.S. Department of Justice launched an investigation into the off-label promotion of Zofran by GlaxoSmithKline.

As a result of the investigation, GSK pled guilty to the charges in 2012 and paid more than $1 billion to settle civil cases that were brought against the company at the same time.

Filing a Zofran Birth Defects Lawsuit

If your child was born with cleft palate, cleft lip or another birth defect and you took Zofran as a treatment for morning sickness, you may be entitled to legal compensation.

A Zofran attorney can provide you with a free case review and discussion of your legal options.