The anti-nausea and morning sickness drug Zofran (ondansetron) has been linked to an increased risk of cardiac defects and other congenital birth defects in children whose mothers used the drug while pregnant. Lawsuits filed against GSK, the manufacture of Zofran, have accused the company of marketing Zofran as a treatment for morning sickness despite the fact that it has received dozens of reports of heart defects and other birth defects linked to the use of the drug during pregnancy.
Zofran was first approved by the FDA in 1991 as a treatment for nausea and vomiting caused by cancer, chemotherapy, radiation therapy, or surgery. The drug helps to prevent nausea by blocking the activity of serotonin within the body. Serotonin is a naturally produced chemical that plays a role in nausea and vomiting.
In addition to the injectable version of Zofran that was first approved by the FDA, the agency has also approved versions of the drug that are available in the form of a tablet, a premixed injection, an oral solution, and a dissolving tablet. By 2006, Zofran had become one of the highest selling drugs in the United States, with sales of $1.3 billion over the first nine months of that year. In addition to the brand-name version of the drug, Zofran is also available in 
generic versions manufactured by TEVA Pharmaceuticals USA, SICOR Pharmaceuticals, and dozens of other drugmakers.
Zofran Linked to Increased Birth Defects Risk
Some of the most serious birth defects linked to the use of Zofran while pregnant include:
- Congenital heart defects
- Septal defects, including atrial septal defects (ASD) and ventricular septal defects (VSD)
- Cleft palate
- Cleft lip, including unilateral cleft lip and bilateral cleft lip
- Other major malformations
According to documents uncovered during Zofran lawsuits filed against GSK, the company was aware as early as 2000 of the link between Zofran and birth defects. However, even though the company received dozens of reports of birth defects among children whose mothers used the anti-nausea drug to prevent morning sickness during pregnancy, for years it continued to illegally promote the drug to doctors for use on pregnant women in clear violation of federal law. Reports received by GSK of birth defects linked to the use of Zofran included cases involving congenital heart diseases, dysmorphism, intrauterine death or stillbirth, kidney malformations, congenital diaphragmatic anomalies, congenital musculoskeletal anomalies, and orofacial anomalies.
In 2012, GSK agreed to pay $3 billion as part of a settlement with the Department of Justice for illegally promoting drugs such as Zofran for off-label uses that had not been approved by the FDA. According to the DOJ lawsuit against GSK, the company was accused of making illegal payments to doctors so that they would promote and prescribe Zofran to pregnant women with morning sickness. The lawsuit also accused GSK of providing doctors with false or misleading information about the safety and effectiveness of using Zofran to treat morning sickness.
Heygood, Orr & Pearson and Birth Defects Lawsuits
Zofran lawsuits on behalf of children who were born with birth defects caused by the off-label use of this drug have been filed against GSK in Pennsylvania, Massachusetts, and California. These lawsuits have accused the company of illegally promoting Zofran to treat pregnant women who were suffering from morning sickness or nausea, despite the fact that the company knew this could lead to serious heart defects or other birth defects.
When drug companies fail to warn parents about risk the birth defects and other complications that could be caused by the use of drugs such as Zofran, they may be placing newborns at risk of serious and potentially life threatening birth defects. Despite efforts by the FDA and other health authorities to protect children from prescription drugs linked to an increased risk of birth defects—including SSRI antidepressants such as Zoloft, Celexa, Effexor, Paxil, Prozac, and Lexapro; drugs containing valproate (valproic acid) like Depakote, Depakene, Depacon, and Stavzor; or the acne medication Accutane—thousands of babies are born every year with preventable birth defects due to prenatal exposure to prescription medications.
Women who used Zofran to treat morning sickness during the first trimester of pregnancy and who gave birth to a child with heart defects or other birth defects may be eligible to file a lawsuit and receive compensation for their child’s injuries. The first step in filing a lawsuit against Zofran is to talk with an experienced attorney who can guide you through the process of filing a case.
Heygood, Orr & Pearson has represented numerous patients in pharmaceutical liability lawsuits after they suffered complications caused by prescription drugs. Our lawyers have tried hundreds of cases to verdict and reached settlements in hundreds more, achieving verdicts and settlements totaling more than $200 million.
If your child was born with congenital heart defects or other birth defects after you were prescribed Zofran during pregnancy, you may be qualify to file a lawsuit against the manufacturer of this medication. For more information about your legal rights and to find out whether you may be eligible to file a lawsuit on behalf of your child, contact the law firm of Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form located on this website.