First Zofran Bellwether Delayed Indefinitely Due To COVID-19

By Chris Villani
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Law360 (March 18, 2020, 4:39 PM EDT) -- The first bellwether in multidistrict litigation over whether GlaxoSmithKline's anti-nausea medication Zofran causes birth defects has been postponed indefinitely amid the coronavirus pandemic, and a federal judge said Wednesday there is no timetable for when the long-running case may finally go to trial.

During a monthly status conference, held via telephone due to the COVID-19 crisis, U.S. District Judge F. Dennis Saylor IV in Massachusetts said there was no need to delve into adjusting the proposed schedule for the first trial, which was slated to begin May 4 and will decide a case brought by Carla Rodriguez.

"It's anybody's guess when Rodriguez is going to be set for trial, we just have to see how all of this unfolds," Judge Saylor said at the hearing's conclusion.

"It isn't simply getting this back on the calendar," he added. "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."

The judge also asked the parties to let the U.S. Food and Drug Administration know about the indefinite delay. GSK has asked the FDA to weigh in on the dispute, which centers on whether Zofran's label should have included a birth defect warning.

The suit, consolidated in Massachusetts in 2015, claims GSK promoted Zofran for morning sickness despite lacking any evidence of its safety for pregnant women and only having FDA approval for the treatment of nausea related to cancer and surgery.

GSK has moved to end all of the 419 suits, citing federal preemption because the FDA rejected a warning label. The company filed a citizen petition with the FDA and argues that, even with additional information about the drug presented to the federal government, a warning label would still not be needed. If the FDA agrees after reviewing the citizen petition, GSK says that would likely resolve the preemption issue.

Tobias Millrood of Pogust Millrood LLC, a lawyer for the plaintiffs, noted that the FDA may have more pressing matters on its plate at the moment.

"My understanding is the FDA is under extraordinary pressure dealing with a lot of things relative to the pandemic, and there's even been reports they are going to be slowing down and putting to the side approvals and updates as it relates to other drugs," Millrood said.

He added, "I don't know the extent to [which] they feel urgency relative to the GSK citizen petition, to the extent they feel like they needed to get an answer before a May trial."

Even if the GSK petition is not a top priority for the FDA in the current emergency climate, Judge Saylor thought it was fair to tell the FDA not to rush in answering the petition, "given where we are."

The preemption issue was a question that may have gone to a jury, but the U.S. Supreme Court's ruling in Merck v. Albrecht said that judges must be the ones to decipher FDA rules.

Judge Saylor, who is the district's chief judge, said a ruling on the preemption motion is not imminent, but that he may be able to dig into some of the other pretrial discovery motions if the court calendar slows.

"People keep saying I am going to be bored and sitting with nothing to do and I can just work on these opinions," he said.

While that hasn't been the case so far, he added, "that's my hope. All of this has been pending too long. I don't want this to go on forever, but it is a dynamic situation."

The parties are slated to connect for another telephone conference on April 15, and Judge Saylor indicated a trial schedule could be on the agenda then.

The plaintiffs are represented by Tobias L. Millrood of Pogust Millrood LLC, Kimberly D. Barone Baden of Motley Rice LLC, M. Elizabeth Graham of Grant & Eisenhofer PA, Robert K. Jenner of Jenner Law PC and James D. Gotz of Hausfeld LLP.

GSK is represented by Jennifer Stonecipher Hill, Madeleine M. McDonough and Jennifer M. Stevenson of Shook Hardy & Bacon LLP and Lisa S. Blatt of Williams & Connolly LLP.

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.

--Editing by Orlando Lorenzo.

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