Zofran MDL Bellwether Trial To Kick Off In October

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On Wednesday, Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts, overseeing the Zofran product liability litigation, announced that he is considering October as the start date for the first bellwether trial in the multidistrict litigation (MDL).

Zofran (Ondansetron) manufactured and originally marketed by GlaxoSmithKline (GSK) is an antiemetic drug used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis.

It was never tested or approved for use by pregnant women, but 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.

The company is facing hundreds of lawsuits, each claiming that the drug was promoted for morning sickness despite having no evidence of its safety for pregnant women, and only having FDA approval for the treatment of nausea related to cancer and surgery.

The first bellwether trial was initially scheduled to begin in May 2020 but was put on hold in March due to the coronavirus pandemic.

Judge Saylor, during a monthly status conference, said that he proposed starting the trial on Monday after the Columbus Day holiday as he was feeling compelled to get a date back on the books. He also noted that the vaccination program in the state is also picking up and existing plans to have everyone in the court system vaccinated could help ease current jury trial restrictions.

The company and the plaintiffs involved in the litigation agreed for opening arguments to tentatively begin on October 18, this year, and told the judge that the trial should last for two to four weeks.

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