Angela Kutzer took ondansetron (brand name: Zofran to alleviate morning sickness symptoms while pregnant with her son, G.K. She and G.K.’s father, Bryan Kutzer, discovered their son was born with only one kidney. But sadly, they aren’t the only parents learning too late about the link between Zofran and kidney defects.
Angela Kutzer and Bryan Kutzer vs GlaxoSmithKline
According to the case, G.K.’s remaining kidney functions at about 38%. This has resulted in significant expenses for G.K.’s parents and has also caused the child to miss out on regular activities. For instance, he will no longer be able to play sports because aggravation and injury could be dangerous to his health. It was also discovered that G.K. does not have a fully functioning vas deferens, making it extremely difficult to nearly impossible for him to produce children when he is older.
Angela and Bryan Kutzer allege prenatal exposure to Zofran caused G.K.’s condition. The Kutzer’s lawsuit against GlaxoSmithKline (GSK) includes the following allegations:
- fraudulent product misrepresentation
- concealment, among other charges
Some claims involve previous GSK fraud allegations. According to the U.S. Department of Justice, in 2012, GSK pled guilty and paid $3 billion to resolve fraud allegations and for failing to report safety information. So far, GSK’s payout is the largest health care fraud settlement in U.S. history.
The drug company paid prior Zofran settlements over illegal marketing practices. GSK resolved allegations the company promoted the drug for off-label use during pregnancy. GSK also allegedly paid kickbacks to physicians for Zofran prescriptions. Physicians prescribed the medication off-label to pregnant women without securing FDA approval. The only FDA-approved use is to prevent nausea and vomiting in chemotherapy patients. But as more parents worry about the link between Zofran and kidney defects, GSK may face further litigation and settlements going forward.
Zofran and Kidney Defects Can Cause Other Congenital Issues for Newborns
Zofran and kidney defects aren’t the only complication risks during pregnancy. The medication is also linked to heart damage, cleft lip or palate, and club foot. According to Bernstein Liebhard LLP, at least 33 Zofran birth defect cases are underway. GSK filed for multidistrict litigation (MDL) to consolidate these cases. However, the company and plaintiffs cannot agree on an appropriate venue.
GSK proposed the MDL occur in the U.S. District Court, Eastern District of Pennsylvania. Yet plaintiffs argue for a different location, stating other districts are more appropriate. That’s because the Eastern District of Pennsylvania is overwhelmed with ongoing MDLs.
Compensation for Families Affected by Zofran and Kidney Defects
Many parents spend thousands on Zofran and kidney defects as well as congenital heart issues in newborns. They often require reconstructive surgery and have far-reaching effects on children. If you or a loved one took Zofran during pregnancy and your baby has birth defects, we can help. See if you may qualify for compensation through a Zofran lawsuit. Seek legal advice today to determine whether you’d like to pursue a Zofran claim.
Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.