Lawsuit Over Zofran Cleft Lip Alleges Failure to Warn Pregnant Women

GlaxoSmithKline faces another product liability lawsuit over their popular anti-nausea drug, alleging that side effects of Zofran use during pregnancy caused a child to suffer a cleft lip birth defect.

The complaint (PDF) was filed last month in the U.S. District Court for the Eastern District of Arkansas, by Cory and Jill Cox, on behalf of their minor son. The boy, Jacob, was born on June 1, 2012 with a partial cleft lip allegedly caused by Zofran exposure before he was born.

Zofran (ondansetron) is a prescription medication for treatment of nausea and vomiting, which is only approved for use among cancer and surgery patients. However, it is commonly used among pregnant women for treatment of morning sickness or pregnancy-associated nausea and vomiting.

According to allegations raised in the lawsuit, GlaxoSmithKline failed to adequately warn women or the medical community about the potential risks children may face following exposure to Zofran during the first trimester of pregnancy.

As a result of the birth defect suffered by Jacob Cox, the family indicates the boy had to undergo surgery to repair the facial deformity when he was only about three months old, which has left him with permanent facial scarring. The scar is often red and inflamed and the bottom of his lip is not symmetrical, according to the complaint. Jacob has also suffered developmental delays due to sedations, he suffered speech delays and it took him longer to learn to walk than most children. The family indicates that he needs the services of a speech therapist, developmental therapist and a physical therapist.

The case joins a growing number of Zofran lawsuits filed in recent months by families throughout the United States, brought on behalf of children who have suffered cleft lip, cleft palate, heart defects or other congenital malformations.

Like other plaintiffs, the Cox family indicates that they never would have agreed to take Zofran for morning sickness if GlaxoSmithKline had provided adequate warnings about the potential pregnancy risks.

Zofran Birth Defect Risks

Although Zofran is not approved by the FDA for treatment of morning sickness, GlaxoSmithKline has allegedly engaged in illegal marketing. As a result, a false assumption exists within the medical community that the medication is safe during pregnancy, despite a number of studies that have highlighted Zofran pregnancy risks when the drug is used during the first trimester.

As early as 2006, a study published by Hong Kong researchers confirmed that Zofran crosses the placenta in significant amounts when taken by pregnant women. Researchers concluded that the “developmental significance of this drug exposure requires further investigation,” yet millions of women have continued to be prescribed the medication without warnings about the potential Zofran birth defect risks.

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity like Jacob’s, which can occur when development of the fetus is impacted during the first trimester.

Additional studies have also identified potential Zofran heart defect risks. An August 2013 study that reviewed data on more than 900,000 pregnancies in the Danish Medical Birth Registry found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure. Heart murmurs following Zofran use during pregnancy may be a sign or symptom of these heart problems.

More recently, a study published by the medical journal Reproductive Toxicology in October 2014 found that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

The Cox lawsuit charges GlaxoSmithKline with negligence, product liability, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, breach of warranty, and negligent infliction of emotional distress. The lawsuit seeks punitive and compensatory damages.