[Image courtesy of Wikimedia Commons]

The California State Court Judge overseeing litigation related to Zantac (ranitidine) issued a pretrial order scheduling the first of four bellwether trials for February 13, 2022, in Oakland.

Honorable Judge Evelio M. Grillo for the California Superior Court of Alameda County will preside over the litigation. Before the cases head to trial, Judge Grillo will verify that the experts tapped by the plaintiffs and defendants used sound logic in arriving at their scientific conclusions. Then, if plaintiffs’ experts persuade the judge, the first bellwether trial will proceed.

The heartburn medication Zantac, launched in 1983, was the best-selling drug in history in 1996. First developed by Glaxo Holdings Ltd, ranitidine remained popular until FDA yanked it from the market in 2020. The agency noted that the drug frequently contained the potentially cancer-causing contaminant N-nitrosodimethylamine (NDMA). The level of NDMA can increase with time and when the drug is stored at elevated temperatures.

NDMA is also found in low levels in some foods and drinking water.

NDMA belongs to a large class of N-nitrosamines.

Before the FDA pulled ranitidine from the market, the drug was available as an OTC and prescription medicine. In 2019, physicians prescribed ranitidine almost 14 million times.

Several drug companies have manufactured ranitidine internationally, including Boehringer Ingelheim, Sanofi, Roche, Pfizer and GlaxoSmithKline (GSK).

The U.S. patents for the drug expired in 1993.

Sanofi now holds the branding rights for Zantac. The company has substituted ranitidine for famotidine, another histamine H2 receptor antagonist.

The second bellwether trial is currently scheduled for May 1, 2023. The third is slated for August 7 and the fourth for October 23, 2023.