Last month, a judge declined to sanction Zofran manufacturer GlaxoSmithKline (GSK) over claims it recently engaged in “covert lobbying” of the U.S. Food and Drug Administration (FDA), as Law360 reported.
The decision came after attorneys for the more than 500 families suing GSK claimed the pharmaceutical giant hid a November 2019 phone call with the FDA from the plaintiffs.
In finding for GSK, U.S. District Judge F. Dennis Saylor IV agreed that the corporation’s disclosure of the FDA call had been “more sluggish than ideal,” but he maintained that FDA rules appear to allow such communications even in the midst of ongoing litigation, according to Law360.
“Because I see no violations, I see no reason to impose or even consider a sanction,” Saylor said.
Saylor further declined to approve “the fairly extreme sanction of the preclusion of an entire legal theory” that the plaintiffs’ attorneys had pushed for.
The legal theory at issue was whether GSK could move forward with a preemptive defense. This defense, according to attorneys for GSK, hinges on the theory that Zofran is safe to use during pregnancy because the FDA has repeatedly declined to add a birth defect warning to Zofran’s label.
According to Law360, the cases should be heard by a judge, rather than a jury, based on the FDA’s record of backing the safety of Zofran and a pivotal Supreme Court decision.
No warning label, says FDA
Zofran has been prescribed to treat nausea in cancer patients for decades. It wasn’t until 2010 that the FDA realized that doctors were prescribing Zofran to a significant number of pregnant women to relieve morning sickness — an off-label use. That year, the agency asked GSK for supplemental information on Zofran’s use in pregnancy, per Wolters Kluwar.
GSK provided safety data, and the FDA didn’t require labeling changes to Zofran. Then in 2015, after Novartis bought the rights to Zofran from GSK, it submitted a new proposal asking the FDA to add a warning label to Zofran. The proposed label would have advised pregnant women not to take Zofran due to the risk of birth defects. The FDA again rejected a warning.
Because of this record of repeated rejections, GSK argues that the lawsuits over Zofran fall under the Supreme Court decision Merck v. Albrecht, meaning the cases shouldn’t be heard by a jury. That high court ruling holds that judges bear the responsibility for interpreting FDA rules on warning labels.
First Zofran trial this spring
Judge Saylor has stated that although "this preemption issue out there . . . could conceivably be a showstopper," he has scheduled the first bellwether trial in case the preemption defense fails.
“We are in year five of this litigation,” Saylor said. “Let's impanel a jury and get going on case one.”
GSK has received more than 200 complaints of Zofran-related birth defects, according to court filings by the plaintiffs. In 2012, after a sweeping investigation by the U.S. Department of Justice, GSK paid $3 billion in penalties and pleaded to criminal charges for off-label promotion of Zofran.