Zofran Lawsuits Delayed Over GSK's Petition To The FDA

Zofran Lawsuits Delayed Over GSK's Petition To The FDA

Introduction

The U.S. District Judge F. Dennis Saylor, in Boston, delayed the first bellwether trial scheduled for January 2020, as GlaxoSmithKline (GSK) is petitioning the FDA regarding Zofran's warning label.

According to a court memorandum filed last month, GSK filed a petition on November 1, asking the U.S. Food and Drug Administration to review Zofran’s warning label. In response to the request, the plaintiffs filed a memorandum questioning that the manufacturer is not asking the federal authorities to consider the most recent scientific developments or any regulations related to the drug. The memorandum further noted that the petition was filed before oral arguments whether the plaintiffs involved should be prevented from pursuing recovery under preemption.

Following a status conference held, Judge Saylor decided to move the trial from January 13 to May 4, giving time to the FDA to respond to the petition. The Daubert motions questioning the admissibility of expert witness testimony and the hearing on the request for summary judgment filed by the drug maker based on preemption will now be considered on January 15, 2020.

Zofran (Ondansetron) manufactured and originally marketed by GlaxoSmithKline is an antiemetic drug used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis. US FDA approved Zofran in January 1991. While Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss.

In the past few years, however, disturbing results from a number of studies surfaced linking Zofran to congenital birth defects. Mothers and families of babies born with serious mental and physical deformities are now pursuing lawsuits against the medication's maker, claiming they were misled and lied to about the drug's risks and safety.

More than 400 lawsuits have been filed against GSK alleging that the company knew about Zofran's pregnancy risks for several years yet failed to adequately warn the medical fraternity. Zofran lawsuits were centralized in October 2015, before Judge Dennis F. Saylor as a part of multidistrict litigation (MDL No. 2657; In Re: Zofran (Ondansetron) Products Liability Litigation) in the District of Massachusetts.