Zofran Bellwether Delay Halts Litigatory Momentum

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The first bellwether trial in the multidistrict litigation involving Zofran, an anti-nausea medication manufactured by GlaxoSmithKline (GSK), has been postponed “indefinitely amid the coronavirus pandemic,“ according to Law360. The Zofran bellwether delay has halted over 400 cases claiming that Zofran is responsible for birth defects when taken by pregnant women.

The Zofran bellwether delay was announced during a status conference, which took place by phone due to COVID-19 concerns. During the conference, U.S. District Judge F. Dennis Saylor IV stated it was unnecessary to delve into rescheduling the May 4, 2020 trial involving plaintiff Carla Rodriguez.

When speaking about the trial date following the Zofran bellwether delay, Judge Saylor said it’s currently “anybody’s guess.” He justified the vagueness of the schedule by noting, “there is going to be pent-up demand for criminal cases and everything else once we get back to a normal trial calendar. I am not going to speculate about how that is going to unfold.”

In addition to announcing trial status, Judge Saylor requested that the parties inform the U.S. Food and Drug Administration (FDA) about the delay. Most parties agree that the legal question of GSK’s liability for recommending off-label uses of Zofran is taking a backseat to general public health measures.

As reported by MedTruth, GSK has already made motions to dismiss the 419 civil suits. According to GSK lawyers, these lawsuits have been federally preempted since the FDA has rejected warning labels for Zofran on multiple occasions. With the new information presented by the plaintiffs, GSK has filed a citizen petition addressed to the FDA asking the organization to assert its claims. If the FDA assents to GSK’s petition, the 419 consolidated cases may be dismissed on preemption grounds.

By James Parker

James Parker is a news writer and fact-checker from Coral Springs, Florida. He majored in Communication and Media Studies at Stetson University, where he spent much of his time bringing the cutting edge of medical research to his peers’ attention. When he’s not writing, he enjoys rewatching “Almost Famous” or curling up with a good book.

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