GSK now has dozens more Zantac lawsuits to contend with.
Plaintiffs on Wednesday filed 88 suits against GSK in Delaware court on behalf of more than 7,000 claimants who allege the popular ranitidine heartburn products caused a range of cancers. Pfizer, Boehringer Ingelheim and Sanofi, which owned Zantac rights at various points in time, were also named in the suit, in addition to Thermo Fisher’s Patheon Manufacturing Services.
GSK has been named in about 3,000 personal injury cases as well as class action suits. Plaintiffs in multidistrict litigation in Florida initially named 10 types of cancer in the suit, but later withdrew breast, kidney, colorectal, prostate and lung. Those cancers are still being pursued in state courts, GSK said last month. And on Friday, a Sanofi spokesperson attributed the recent surge in state court filings to plaintiffs who exited federal MDL, or whose alleged injuries have been dropped.
“The recent increase in state court filings predominantly involve plaintiffs who have opted to exit the federal multi-district litigation and whose alleged injuries lead plaintiffs’ lawyers in the MDL have abandoned,” the spokesperson said. “As plaintiffs search for new venues, Sanofi will continue to vigorously defend itself against these claims, which the medical, scientific, and regulatory communities have extensively evaluated and have found to be without merit.”
The new cases allege nine types of cancer, including bladder, breast, colorectal and intestinal, esophageal, gastric, liver, lung, pancreatic and prostate.
Zantac was first approved as a prescription medicine for heartburn in 1983, and after a decade of record sales, GSK began working on an over-the-counter formulation. Several OTC forms were OK’d in 1995, and those sales rights later passed through the hands of Pfizer, Boehringer Ingelheim and Sanofi.
However, the blockbuster drug was recalled in 2019 over unacceptably high levels of a potential carcinogen known as NDMA. Plaintiffs say studies have shown that ranitidine can transform into NDMA in the body or on the shelf in high temperatures. Previous lawsuits have claimed that a single ranitidine pill can contain NDMA levels that are “hundreds of times higher” than the FDA’s acceptable limit. In 2020, the FDA requested the recall of all ranitidine products.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” former acting commissioner Janet Woodcock said around the time of the recall. “However, 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 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 NDMA levels in ranitidine are similar to levels in some foods such as grilled and smoked meats.
“There have been no material developments to what has been previously disclosed,” the GSK statement read. The company was not immediately available for comment.
“The overwhelming scientific evidence establishes that the use of Zantac is not associated with an increased risk of cancer,” a Boehringer Ingelheim spokesperson said on Friday. “We will defend any allegations otherwise and do not comment on specifics of pending litigation.”
Pfizer, Sanofi and Patheon did not respond to requests for comment as of press time.
Last month, GSK’s first scheduled Zantac cancer trial was voluntarily dismissed by the plaintiff. The company said it didn’t settle the claim or pay anything in exchange for dropping the case.
“The overwhelming weight of the scientific evidence supports the conclusion that there is no increased cancer risk associated with the use of ranitidine,” GSK said at the time.
