Pandemic May Push 1st Zofran MDL Bellwether To 2021

By Chris Villani
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Law360 (June 23, 2020, 4:35 PM EDT) -- A Massachusetts federal judge told lawyers representing GlaxoSmithKline and plaintiffs who claim its anti-nausea medicine Zofran caused birth defects that he's open to creative ways to hold a complex jury trial with social distancing, but he may have no choice but to wait until 2021.

At one point joking that the trial could be held at Fenway Park, U.S. District Judge F. Dennis Saylor IV said during the multidistrict suit's monthly status conference Tuesday that a case brought by Carla Rodriguez, once scheduled for trial in May, might not go to a jury this year due to the ongoing COVID-19 pandemic.

If people need to remain six feet apart from one another when the court does restart in-person jury trials, a one-defendant criminal trial with 12 to 16 people on a panel would likely max out the courtroom space, Judge Saylor said. A civil case, on the other hand, could be held with as few as six jurors, but the judge said he isn't a fan of such small panels.

"It does raise the issue of whether we could try a case like this, meaning like Rodriguez, with all the lawyers involved and the personnel involved to try a case of the complexity and maintain social distancing. And I'm just not sure we can, frankly," Judge Saylor said.

He invited the parties to think about it and come up with their own ideas for how to make it work. Judge Saylor said there has been "vague discussion" about the possibility of holding the trial in a hotel ballroom or a large public space.

Adding to the challenges will be a backlog of higher-priority criminal cases and the fact that the court's plan for bringing the public back into the building prevents too many trials from happening simultaneously. The federal court clerk told Law360 in May that only one case will be empanelled at a time when in-person hearings start back up.

"It's all kind of an ugly picture in terms of getting Rodriguez tried, but that's where we are," Judge Saylor said Tuesday. "I was hopeful we could get this case tried in November or December of this year. I haven't given up on that, but it's looking like it's less achievable than I had hoped."

Judge Saylor said he is not in a position to set a firm trial date yet. He told the legal teams, which have filled up the tables in his courtroom even for routine conferences, that they may be limited to two attorneys per side during the trial with the rest watching via videoconference. Holding an entire trial via Zoom or similar technology would be a "last resort," the judge said.

The trial could be held in-person in a more typical fashion if social distancing does not need to be observed and other precautions, such as masks, are enough to suffice, the judge added.

The suit was consolidated in Massachusetts in 2015. The plaintiffs claim GSK promoted Zofran for morning sickness despite lacking any evidence of its safety for pregnant women and only having approval from the U.S. Food and Drug Administration for the treatment of nausea related to cancer and surgery.

There are 423 cases in the MDL, the parties said Tuesday, and GSK has moved to end them all, citing federal preemption because the FDA rejected a warning label.

GSK has asked the FDA to weigh in on the preemption issue, which is still pending before Judge Saylor.

"As far as we understand it, the FDA is kind of in an indefinite hold here while they address issues relating to the COVID pandemic and we don't have any estimated time frame," said Tobias Millrood of Pogust Millrood LLC, an attorney for the plaintiffs.

Judge Saylor is tasked with deciding the preemption issue due to the U.S. Supreme Court's 2019 ruling in Merck v. Albrecht , which found that judges are responsible for deciphering FDA rules. He said he remains interested in the FDA's input but won't wait forever.

"At some point, I just have to simply decide it," he said.

In the meantime, he invited the lawyers to suggest ways to safely hold a trial during a pandemic. Judge Saylor noted that cleaning procedures, including wiping down projectors and other equipment used in the courtroom, would also need to be considered.

"It does sort of reduce the drama of your one-question redirect if someone has to come in and clean in between," he joked.

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 Alyssa Miller.

For a reprint of this article, please contact reprints@law360.com.

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