Last December, GlaxoSmithKline (GSK) argued that all the federal Zofran lawsuits be thrown out of the court, but the federal judge sided with over 200 plaintiffs who claimed that GSK failed to give warning on their anti-nausea drug links to birth defects. They believe it was their responsibility to warn patients of Zofran’s links to birth defects so that users could decide whether to use the drug or not.
According to drugwatch.com, GSK claimed that the cases be dismissed since claimants’ allegations of failure to warn are centered on various state laws, not federal, and the FDA would have rejected a bid for label change. However, Judge Saylor gave a go ahead in the plaintiffs’ case against the Zofran manufacturer. As much as the judge verdict came as a victory for many plaintiffs, their lawyers have a real task on their hand.
Zofran was never approved by the FDA as it was deemed not necessary due to the fact that the drug was mainly used for morning sickness off label only. Moreover, there isn’t considerable public proof confirming Zofran causes birth defects when used by pregnant women. However, Zofran manufacturer, GSK may be telling us less than they know.
A California mother, Zinat Torres filed a Zofran lawsuit last December claiming that GSK carried out further animal studies after Zofran entered the US market that showed increased risks of harm to fetuses in animals exposed to ondansetron [Zofran’s active ingredient] prenatally. It is on the basis of this lawsuit that plaintiffs use to argue their case.
Claimants in their lawsuit (the case is In Re: Zofran [Ondansetron] Products Liability Litigation, case number 1:15-md-02657, in the U.S. District Court for the District of Massachusetts) argue that GSK carried out a couple of “animal teratogenicity studies” in Japan where pregnant animals gave birth to offspring with heart defects, i.e. ventricular septal defects. These studies were never made public by GSK. Instead, Zofran’s warning label reads as follows:
“Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron.”
Is GSK withholding important information?
While it is not the first time that GSK appears to be withholding information as far as Zofran is concerned, it could prove to be critical for those still using the anti-nausea drug.
Torres’s lawsuit (MDL No. 1:15-md-2657-FDS) also claims that GSK didn’t perform a few medical trials establishing the efficacy and safety of Zofran for treating pregnant women before it promoted Zofran off label for morning sickness. While studies are usually NOT conducted on pregnant women, GSK performed animal studies in the 1980s that caused malformations in offspring and, intrauterine deaths and also revealed that Zofran’s active ingredient could be passed to the fetuses from pregnant mammals. It isn’t rocket science to figure out that the same could happen in pregnant women.