New Orleans, LA Zofran Class Action Lawsuit Lawyers
Claims are arising across the country against the manufacturer of Zofran (ondansetron) alleging that the drug prescribed to women during pregnancy caused their children to be born with birth defects. Our firm, Herman Herman & Katz LLC, is investigating claims on behalf of those who were affected by the drug Zofran.
What is Zofran?
Zofran is a 5-HT3 receptor antagonist that blocks the action of serotonin, which is a natural chemical produced by the body that can cause nausea and vomiting. Approved by the FDA in 1991, Zofran ranked 20th in brand name drug sales in the United States in 2006, with $1.3 billion in sales in the first 9 months of the year. Zofran is approved to treat nausea and vomiting in patients undergoing chemotherapy, radiation therapy, and surgery; it has never been approved for pregnant women, despite gaining an increasingly widespread market share as an “off-label” prescription for morning sickness. Children of women who took Zofran during pregnancy have suffered from various birth defects, including heart malformations (congenital heart defects), cleft lip, cleft palate, musculoskeletal anomalies, jaundice, club feet, and craniosynostosis (an abnormally shaped skull that may not have enough space for the brain, which can cause vision problems, eating issues, and mental impairment).
Zofran Causes Birth Defects
In 2006, a Hong Kong study determined that Zofran definitely and readily crosses human placenta in the first trimester of pregnancy, and was detected in every sample of fetal tissue from the 41 patients in the study. American researchers confirmed this determination in July 2014, finding that Zofran crosses human placenta in relatively high concentrations (approximately 40% of maternal plasma levels) after just three oral doses due to Zofran’s high lipid solubility. The Slone Epidemiology Center of Boston University, the National Center on Birth Defects and Developmental Disabilities, and the Centers for Disease Control and Prevention published a study in 2012 of over 9,000 pregnant women taking Zofran. The study concluded that taking the drug for nausea and vomiting during the first trimester of pregnancy doubled the risk for cleft palate birth defects. A Denmark study published in August 2013 showed the results of evaluating approximately 900,000 pregnant women between 1997 and 2010. This study concluded that Zofran use in the first trimester of pregnancy doubled the risk of cardiac malformations in the babies, resulting in an overall 30% increased risk of major congenital malformations. Another morning sickness drug was studied at the same time, and did not increase the risk for birth defects. In November 2013, based on recent studies of the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts, the FDA updated the warning against Zofran use by pregnant women. An August 2014 study in Sweden found Zofran significantly increased the risk for cardiac septum defects in children of women who took the drug during the first trimester of pregnancy.
Zofran Manufacturer Plead Guilty to Fraud Allegations and Failure to Report Safety Data
London-based GlaxoSmithKline, a top-ten worldwide pharmaceutical company in terms of sales, developed Zofran in the mid-1980s and continues to manufacture the drug. In 2012, GlaxoSmithKline paid a $3 billion settlement with the U.S. Department of Justice regarding charges of paying bribes and kickbacks related to Zofran. The settlement included $1 billion in criminal penalties; GlaxoSmithKline plead guilty to federal criminal health care fraud charges for violations of the Food, Drug, and Cosmetic Act in connection with three of its branded drugs, including Zofran. The $2 billion in civil penalties were from a federal whistleblower lawsuit that included claims that GlaxoSmithKline promoted Zofran for off-label promotion for pregnant women and paid kickbacks to doctors to prescribe for such use. The settlement did not include claims by individual patients or their families.
For Those Who Have Been Injured by Zofran
If you or a loved one have been injured by Zofran, please feel free to contact our firm with any questions you may have regarding your rights. Learn about your legal rights from an experienced class action lawyer by calling 1-844-943-7626 or by filling out our free, no obligation case review form. All consultations are free and completely confidential.