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An Ohio couple filed a lawsuit against the manufacturer of Zofran, GlaxoSmithKline (GSK), for a fatal birth defect that their newborn was born with. This Ohio Zofran lawsuit was filed after the family’s daughter died three days after birth due to a fatal heart defect that she developed in utero.
What is Zofran?
Zofran, also known as Ondansetron, is an antiemetic pharmaceutical drug that is effective against nausea and vomiting. The manufacturer of the drug has been advertising Zofran off-label to treat morning sickness in pregnant mothers.
The FDA previously issued statements regarding GSK’s marketing and advertising of the drug for off-label use. Zofran was only approved by the FDA for use to treat nausea in patients undergoing chemotherapy and radiation, as well as for post-operative use.
Several studies have shown an increased risk of birth defects developing in infants whose mothers took Zofran during pregnancy. The risk is heightened if the mother was prescribed and took Zofran during the first trimester of the fetus’s development.
Facts About the Ohio Zofran Lawsuit
Patrick and Valerie Regan, Ohio residents, filed a complaint on June 10, 2015 in the U.S. District Court for the Northern District of Ohio against the Zofran manufacturer GlaxoSmithKline under case number 3:15-cv-1166. Click here to read the complaint filed with the U.S. District Court.
The complaint alleges that the mother’s ingestion of Zofran during her pregnancy caused serious heart defects in their daughter, including a right ventricle heart defect. Their daughter passed away three days after birth due to her fatal heart defect. The family alleges that GSK advertised the pharmaceutical drug as a safe and effective anti-nausea morning sickness drug for use by pregnant women.
The Regan’s noted that GSK has never studied the effects of Zofran on pregnant women in clinical trials. In order to obtain FDA approval for use as an anti-nausea medication safe for pregnant women, GSK would need studies showing the safety and effectiveness for use during pregnancy.
What Should You Do If Your Child Has a Birth Defect Resulting from Zofran Use?
If you were prescribed and ingested Zofran during your pregnancy, it is important to speak with your child’s pediatrician in order to discuss the potential side effects and consequences. If your child has developed a birth defect and you believe that it may be associated with Zofran use, contact an experienced Zofran attorney today in order to discuss your family’s legal rights.