GSK's bellwether Zantac court date pushed to July
GSK’s first Zantac trial has been postponed until July, the company confirmed on Friday.
The California state court trial, brought by James Goetz who alleged the popular heartburn medication caused his bladder cancer, was initially slated to begin on Monday. However, jury selection has been pushed back until July 24, as judge Evelio Grillo continues to deliberate over expert testimony, a GSK spokesperson told Endpoints News.
The news comes just a couple months after a Florida judge dismissed thousands of federal claims that Zantac and its related heartburn products caused a range of cancers upon finding that the allegations were based on “flawed” and “unreliable” evidence. The sprawling multidistrict litigation had also named Pfizer, Boehringer Ingelheim and Sanofi, which owned Zantac rights at various points in time, as well as Thermo Fisher’s Patheon Manufacturing Services.
That leaves state cases, including Goetz who settled with Sanofi and Pfizer in December, according to a Bloomberg report.
Zantac was first approved as a prescription medicine for heartburn in 1983, leading to record sales and eventually several over-the-counter forms. However, the drug was recalled in 2019 over unacceptably high levels of a potential cancer-causing substance known as NDMA.
Plaintiffs argued that ranitidine can transform into NDMA in the body or on the shelf in high temperatures, and though former acting commissioner Janet Woodcock said that the FDA “didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” regulators requested a recall of all ranitidine products the following year.
Woodcock said at the time that “since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”
GSk previously argued that “there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.”