The Food and Drug Administration approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. The two women have sued GlaxoSmithKline (GSK), the maker of Zofran, accusing it of promoting its anti-nausea drug Zofran as an off-label morning sickness remedy while concealing the risk that ingestion of the drug by pregnant women can cause serious birth defects.
In a complaint filed in the United States District Court for the District of the Western District of Louisiana, Two plaintiffs allege that their ingestion of Zofran while pregnant caused their children to be born with serious and dangerous respiratory and heart defects. Plaintiffs assert that these defects include accelerated ventricular arrhythmia, atrial septal defect, intermittent tachypnea, and perimembranous ventricular septal defects.
The plaintiffs assert, “By 2000, GSK had received at least 32 reports of birth defects of congenital heart disease, dysmorphism, intrauterine death, stillbirth, kidney malformation, congenital diaphragmatic anomaly, congenital musculoskeletal anomalies, and orofacial anomalies, among others.” Despite this knowledge, GSK has failed to include any warning regarding the risk of birth defects arising from the use of Zofran during pregnancy.
“To date, GSK has received more than 200 reports of birth defects in children who were exposed to Zofran while in utero. Upon information and belief, the number of such event that were actually reported to GSK comprises only a small fraction of all such events.”
Plaintiffs assert claims of breach of express and implied warranties, fraudulent concealment, fraudulent misrepresentation, negligence, negligence per se, negligent infliction of emotion distress, negligent misrepresentation, strict products liability and violation of the Louisiana Product Liability Act. They are seeking compensatory and punitive damages. Plaintiffs’ asset that had they known the truth about Zofran’s unreasonable risk of harm, they never would have taken Zofran and their children would have not been injured.