Zofran lawsuits allege use of anti-nausea drug during pregnancy caused heart defects, congenital birth defects

by Michael Heygood

Women in Pennsylvania and Massachusetts have filed lawsuits alleging that their children were born with heart defects and other congenital birth defects caused by taking the drug Zofran during pregnancy. The lawsuits accuse GlaxoSmithKline, the manufacturer of Zofran, of promoting the drug to treat morning sickness and nausea during pregnancy despite the fact that it was never approved for pregnant women by the FDA.

The first Zofran lawsuit filed against GlaxoSmithKline involved a Pennsylvania woman whose two children were born with serious congenital heart defects after she was prescribed the anti-nausea drug during pregnancy. The second lawsuit, recently filed in Massachusetts, involves a women whose daughter was born with birth defects, including heart defects, after she was also prescribed the drug during her pregnancy.

Zofran (sold generically as ondansetron) was approved by the Food and Drug Administration in 1991 to treat nausea and vomiting in cancer patients who are undergoing chemotherapy or radiation therapy, as well as for patients who have undergone surgery. The drug works by affecting serotonin levels in the brain. Although the agency has not approved the drug for use during pregnancy, Zofran is sometimes prescribed off-label to relieve symptoms of nausea and vomiting with pregnant women.

According to the Zofran lawsuits filed against the company, GlaxoSmithKline knew as early as the 1980s about the potential risk of miscarriage and congenital birth defects for women who used the drug during pregnancy. The lawsuits allege that despite this knowledge, the drug company deliberately promoted Zofran for off-label use among pregnant women. The company continued to promote Zofran for these off-label uses despite the existence of other FDA-approved drugs such as doxylamine and pyridoxine to treat nausea, vomiting, and morning sickness in pregnant women, the lawsuits also allege.

In 2013, GlaxoSmithKline was forced to pay a $3 billion settlement with the U.S. Department of Justice for unapproved marketing practices concerning a number of medications, including Zofran. FDA rules specifically prohibit drug companies from promoting their products among patients or to treat conditions that have not been approved by the agency.

Zofran Linked To Increased Heart Defects, Birth Defects Risk

Recent studies have raised concerns about the danger of birth defects caused by taking Zofran while pregnant. In August 2013, a Danish study found that pregnant women who used Zofran were twice as likely to give birth to a child with heart defects and 30% more likely to give birth to a child with major congenital birth defects.

A second study published by the American Journal of Obstetrics and Gynecology in December 2014 also raised concerns about the risk of danger to the fetus caused by the use of Zofran during pregnancy. Most alarmingly, the study found that 1 million women who suffer from nausea and vomiting during pregnancy were prescribed Zofran each year, meaning that hundreds of thousands of children could be at risk of heart defects and other birth defects.

Studies have found that the risk of heart defects and other birth defects associated with the use of Zofran while pregnant occurs during the first trimester of pregnancy. Studies of other drugs that affect serotonin levels in the brain—including SSRI antidepressants such as Paxil, Prozac, and Zoloft—have shown that the chemical changes caused by these medications can affect the development of the fetus during the first trimester, increasing the risk of serious heart defects such as:

  • Atrial Septal Defects (ASD) and Ventricular Septal Defects (VSD)
  • Persistent Pulmonary Hypertension of the Newborn (PPHN)
  • Hypoplastic Left Heart Syndrome (HLHS)
  • Tetralogy of Fallot
  • Patent Ductus Arteriosus (PDA)

Birth Defects Caused by Zofran During Pregnancy

Women who gave birth to a child with heart defects or other birth defects (including cleft lip or cleft palate) after taking Zofran while pregnant may be eligible to file a lawsuit and receive compensation. The first step in filing a lawsuit is to speak with an experienced attorney with the knowledge and resources to handle pharmaceutical liability claims.

The lawyers at Heygood, Orr & Pearson have years of experience handling cases involving defective drugs, as well as injuries caused by dangerous medical devices and other products. Our attorneys are trial lawyers in the truest sense of the term, and can handle your case from the very beginning all the way to a verdict or settlement in order to ensure that you receive the best results possible.

For more information about filing a lawsuit and to find out whether you may qualify to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us 24 hours a day by following the link to our free case evaluation form and answering a few simple questions.

by Michael Heygood

Michael Heygood is a licensed attorney and partner at HO&P who focuses on insurance and corporate litigation, and other civil arenas. Michael has been named multiple times to the Super Lawyers List.