GSK now faces dozens of other lawsuits against Zantac.
On Wednesday, plaintiffs filed 88 lawsuits against GSK in a Delaware court on behalf of more than 7,000 plaintiffs who allege popular ranitidine heartburn products have caused a range of cancers. Pfizer, Boehringer Ingelheim and Sanofi, which owned the rights to Zantac at various times, were also named in the lawsuit, in addition to Thermo Fisher’s Patheon Manufacturing Services.
GSK has been named in approximately 3,000 personal injury cases as well as class action lawsuits. Plaintiffs in a multidistrict litigation in Florida initially named 10 types of cancer in the lawsuit, but later opted out of breast, kidney, colorectal, prostate and lung. These cancers are still being prosecuted in state courts, GSK said last month. And on Friday, a Sanofi spokesperson attributed the recent increase in state court filings to plaintiffs who left the federal MDL or whose alleged injuries were discharged.
“The recent increase in state court filings primarily involves plaintiffs who opted out of multidistrict federal litigation and whose alleged injuries were dropped by MDL lead plaintiff attorneys,” the spokesperson said. . “As plaintiffs seek further remedies, Sanofi will continue to vigorously defend against these claims, which the medical, scientific and regulatory communities have widely assessed and found to be without merit.”
The new cases allege nine types of cancer, including bladder, breast, colorectal and bowel, esophagus, stomach, liver, lung, pancreas and prostate.
Zantac was first approved as a prescription heartburn medicine in 1983, and after a decade of record sales, GSK began work on an over-the-counter formulation. Several OTC forms were approved in 1995, and these sales rights subsequently passed through the hands of Pfizer, Boehringer Ingelheim and Sanofi.
However, the blockbuster drug was recalled in 2019 due to unacceptable levels of a potential carcinogen known as NDMA. Plaintiffs say studies have shown that ranitidine can convert to NDMA in the body or on the shelf at high temperatures. Previous lawsuits have claimed that a single ranitidine pill can contain levels of NDMA that are “hundreds of times higher” than the FDA’s acceptable limit. In 2020, the FDA requested a recall of all ranitidine products.
“We did not observe unacceptable levels of NDMA in many of the samples we tested,” former acting commissioner Janet Woodcock said at the time of the recall. “However, since we do not know how or for how long the product may have been stored, we have decided that it should not be available to consumers and patients unless its quality can be assured.”
GSK said in a statement last month that regulatory agencies, including the FDA, have since concluded there is no evidence of a link between ranitidine and cancer. In November 2019, the FDA determined that the levels of NDMA in ranitidine are similar to levels in certain foods such as grilled and smoked meats.
“There has been no hardware development beyond what was previously disclosed,” the GSK statement read.
“The overwhelming weight of scientific evidence supports the conclusion that there is no increased risk of cancer associated with the use of ranitidine. GSK will continue to vigorously defend itself against all claims to the contrary,” noted the company on Friday.
“Overwhelming scientific evidence establishes that Zantac use is not associated with an increased risk of cancer,” a Boehringer Ingelheim spokesperson said Friday. “We will defend any allegations otherwise and will not comment on details of pending litigation.”
Pfizer and Patheon did not respond to requests for comment at press time.
Last month, GSK’s planned first cancer trial of Zantac was voluntarily rejected by the plaintiff. The company said it did not settle the claim or pay anything in exchange for dropping the case.
“The overwhelming weight of scientific evidence supports the conclusion that there is no increased risk of cancer associated with the use of ranitidine,” GSK said at the time.
This story has been updated to include comment from GSK.