The public was recently made aware of growing Zofran litigation regarding the use of Zofran and birth defects in unborn children.
What is Zofran?
Zofran is an anti-emetics. Anti-emetics are administered to patients who are suffering from nausea and vomiting. However not all anti-emetics are created equal or used in all patients.
The active ingredient in Zofran is Ondansetron, is a serotonin 5-HT3 receptor antagonist. Common side effects in adults are constipation, dizziness, and headaches.
Zofran was first approved by the U.S. Food and Drug Administration in 1991. The FDA approval allowed the drug to be used in two types of patients: those suffering from nausea after being placed under anesthesia and patients suffering from nausea as the result of chemotherapy and radiation. Zofran was not approved for use in pregnant women to treat morning sickness.
Ignoring the fact that the FDA had not approved Zofran for use in pregnant women, GlaxoSmithKline, the creators of Zofran, decided to market the drug to OB/GYN’s and the public as a treatment for morning sickness.
In 1999, GSK received a warning letter from the FDA regarding the “off-label” marketing of the drug.
The letter stated that “the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed this material and has determined that it promotes Zofran in a manner that is false or misleading because it lacks fair balance.”
Later, the U.S. Department of Justice filed a lawsuit against GSK which included allegations that GSK had unlawfully promoted the use of several medications “off-label”. In 2012, GSK agreed to settle the lawsuit. The settlement included fines of around 3 billion dollars.
On February 16th, 2015 the first Zofran lawsuit was filed in the United States District Court of the District of Massachusetts under case number 1:15-cv-10429. The lawsuit reported that the plaintiff, a woman who had been prescribed Zofran during her pregnancy, gave birth to a daughter in 2000.
The daughter was diagnosed with congenital heart defects as well as several other defects. She needed to undergo thirteen different surgeries over the course of a couple years and has suffered from developmental delays. The lawsuit alleges that these congenital defects were the direct result of the child being exposed to Zofran while still in the womb.
Since that lawsuit there have been numerous other filed against GSK, all alleging the same thing: that exposure to Zofran caused birth defect in unborn children. In some cases, the reported birth defect resulted in the death of the child.
Birth Defects Reported
Cleft Lip and Cleft Palate
Cleft lip and cleft palate occur when the lip or mouth don’t form properly during pregnancy. A child can have a cleft lip, cleft palate, or both. Children with this defect can have difficulty eating and speaking. Surgical correction is the only way to repair the defect and the child may have to undergo multiple surgeries as they grow.
Congenital Cardiac Defects
Several heart defects have been reported including:
- Atrial Septal Defect (ASD) – This defect is an opening in the wall of the atria, or two upper chambers of the heart. Large ASD’s can cause damage to the heart and lungs. Surgical repair may be necessary.
- Ventricular Septal Defect (VSD) – This defect is an opening in the all of the ventricle, the lower two chambers of the heart. Similar to the ASD, a large opening can require surgery to repair the defect, otherwise the heart may be damaged.
- Aortic Arch Hypoplasia – Occurs when there is a blockage in the aorta. This blockage requires surgical intervention to fix.
Other Defects Reported
Additional defects that have been noted in lawsuits include light sensitivity, injueno hernias, webbed toes, and kidney malformations.
Prior to marketing Zofran to the medical community and the public as a treatment for morning sickness, GSK never conducted any studies or clinical trials on human patients to determine if Zofran was safe for the unborn child.
By the year 2000, GSK was allegedly aware of 32 cases in which birth defects had been reported. Today there are over 200 cases reported.
Since the first reports were made, numerous studies have been performed, examining the effect of Zofran on the fetus. In one study, researchers and Harvard and Boston University worked in conjunction with the Centers for Disease Control while reviewing data of 10,383 births. Their data indicated that pregnant women who had taken Zofran during the first trimester were 2.37 times more likely to deliver a baby with a cleft palate.
Should Pregnant Women Have Known About The Risks?
No. Mothers and the medical community were not provided with a warning from GlaxoSmithKline or notice of the alleged reports of birth defects.
What Are The Statute Of Limitations?
A statute of limitations is the time frame in which a lawsuit must be filed in order to be considered eligible for a claim. Each state has different statute of limitations, however most lawyers argue that because of GSK’s concealment of the risk involved with taking Zofran, the statute of limitations should go into effect from the time that the plaintiff became aware of the cause of action.