By Chris Villani

Law360 (April 21, 2021, 2:04 PM EDT ) A federal judge said during a Wednesday hearing that a ruling on whether claims that GlaxoSmithKline's anti-nausea medication Zofran triggers birth defects are preempted will be coming soon, a decision he's called a potential "showstopper" in the multidistrict suit.

Both the mothers bringing suit and lawyers for GSK told U.S. District Judge F. Dennis Saylor IV during the suit's monthly status conference that the time is nigh to determine whether the U.S. Food and Drug Administration rejected any warning label for Zofran. If Judge Saylor finds that the agency rejected adding a birth defect warning, it would end the case ahead of a planned first bellwether trial in the fall.

"From my standpoint this is important," Judge Saylor said. "I do need to resolve this issue, this has been dangling much too long."

Arguing for the mothers, Tobias Millrood of Pogust Millrood said there has been communication between the FDA and Novartis, which currently owns the drug, and nothing else the agency says is going to have any bearing on the preemption question.

The preemption issue was initially one for a future jury. But it landed on Judge Saylor's desk because of the U.S. Supreme Court's 2019 ruling in Merck v. Albrecht, which found that judges are responsible for deciphering FDA rules. GSK attorney Hildy Sastre of Shook Hardy & Bacon LLP agreed the issue is ripe for Judge Saylor to decide, but the drugmaker says the FDA has consistently said that the science does not support a birth defect warning for Zofran.

"FDA said in, candidly, the clearest terms possible," Sastre began before Judge Saylor cut her off.

"I don't need the whole thing reargued, I understand the issues as well as I am going to understand them," he said. "I have read the Albrecht case at least 25 times."

GSK argues that it could not possibly have complied with any state law requirements the plaintiffs say it should have followed if the FDA said a birth defect warning label for Zofran was not needed, thereby making their claims preempted by federal law.

If Judge Saylor rules that the suits are preempted, the litigation, first consolidated in Massachusetts in 2015, comes to an end. He called the issue a potential "showstopper" during a February 2020 hearing.

If he rules the issue is not preempted, he said he would "bang through" some motions and get the first bellwether ready for trial in the fall.

Judge Saylor said Wednesday that he does not foresee having to delay the trial date at this time due to the COVID-19 pandemic. But he said all things are subject to change, as has been the case throughout the health crisis. Boston's federal courthouse is starting to ramp up jury trials with a high-profile criminal case ready to go before a jury next week, but Judge Saylor said that the plaintiff in a recent civil trial tested positive for the virus on one of the case's final days.

"Our health experts say 'everything was fine' as long as everyone was distant and wearing masks, but it does give you pause," Judge Saylor said.

Still, the judge said he would hold the trial date and stressed that the first trial in the case now going on its seventh year "is going to be a priority, assuming we get that far, for me and for the court."

In addition to the preemption motion, GSK lawyers argued in March that more than 300 cases in the product liability suit should be nixed because the plaintiffs' own expert determined there is no link between the drug and cardiac birth defects.

But the mothers countered by arguing that GSK is taking the expert's comments out of context. The expert is saying the epidemiology does not show a link, but that doesn't mean a link does not exist, and more evidence is needed to sort it out, the plaintiffs argue, saying the issue should be one for the jury to decide. Judge Saylor is weighing that motion, as well.

The suits say GSK marketed Zofran for morning sickness without having any proof that it was safe for pregnant women and with FDA approval only for treatment of nausea related to cancer or surgery.

GSK paid $3 billion in 2012 to settle allegations of off-label promotion involving several drugs, including Zofran, which the U.S. Department of Justice said had been illicitly promoted for morning sickness from 2002 through 2004.

The plaintiffs are represented by Tobias L. Millrood of Pogust Millrood, 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, Hildy Sastre, Madeleine M. McDonough and Jennifer M. Stevenson of Shook Hardy & Bacon 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 Amy Rowe.

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