GSK's first state-level Zantac trial delayed as judge reviews science behind the arguments: report

GSK has roughly four more months to hone its defense against claims the once-popular heartburn medication Zantac causes cancer.

The opening salvo in thousands of state-level Zantac claims, brought by California resident James Goetz, is now expected to go to trial in June or July, Reuters reports, citing comments from GSK spokespersons and Goetz’s attorneys.

No firm date has been set for the inaugural bellwether trial, which was originally scheduled to kick off in California Superior Court in Alameda County on Monday. The postponement comes as California Judge Evelio Grillo weighs expert testimony on both sides of the argument in what’s known as a Sargon hearing.

GSK told Fierce Pharma it could not provide further comment at this time.

In December, Pfizer, GSK, Sanofi and Boehringer Ingelheim eluded thousands of federal Zantac lawsuits. That month, U.S. District Judge Robin Rosenberg knocked out some 50,000 federal claims after rejecting the science used to back up arguments that Zantac and its generics cause cancer. Rosenberg’s ruling—which had no bearing on thousands of cases remaining in state court, such as Goetz’s—consisted of 300 pages detailing how plaintiffs’ experts used “unsound methodologies” to reach their conclusions.

Separately, Sanofi and Pfizer last year settled their cases with Goetz. A Sanofi spokesperson told Fierce Pharma at the time that the company resolved the case “not because it believes these claims have any merit, but rather to avoid the expense and distraction of a trial in California.”

The financial terms of the settlement have not been revealed.

GSK, for its part, chose to remain on-guard rather than settle, noting in a December 2022 press statement that it would continue to “defend itself vigorously, including against all claims brought at the state level.” The pharma giant has argued there’s “no consistent or reliable evidence” that the medicine causes cancer.

But a recent report in Bloomberg Businessweek contended GSK’s own scientists had long known about Zantac’s risks. A GSK spokesperson said the article "presents an incomplete and biased presentation of the facts surrounding the Zantac (ranitidine) litigation."

Zantac was pulled from the market in 2020 when it was linked to unacceptable levels of N-nitrosodimethylamine, a potential cancer-causing agent, which set off a storm of litigation against its developer GSK and its former commercial partners Boehringer Ingelheim, Pfizer and Sanofi as well as several generic manufacturers.