New Lawsuits Filed at the State Level
On September 14, law firm Baum Hedlund Aristei & Goldman filed 88 new lawsuits against GSK, Pfizer, Boehringer Ingelheim, and Sanofi in Delaware court on behalf of more than 7,000 claimants who allege that ranitidine heartburn products caused a variety of cancers.
And law firm Keller Postman filed claims on behalf of more than 10,000 clients from Delaware, California, Illinois, and Pennsylvania involving cancers no longer designated in the multi-district litigation created in 2020. The MDL now includes five types of cancer alleged to have been caused by ranitidine use—bladder, esophageal, gastrointestinal, liver, and pancreatic. Plaintiffs with breast, kidney, colorectal, prostate, and lung cancers are now pursuing their cases in state courts.
A Sanofi spokesperson said the recent surge in state court filings are due to plaintiffs who exited the federal multi-district litigation, or whose alleged injuries have been dropped from the MDL and reiterated their claim that there is no scientific evidence Zantac causes cancer.
Haleon Rejects Indemnification Requests
As reported by Reuters last week, London-based Haleon rejected indemnification requests from GSK (formerly GlaxoSmithKline plc) and Pfizer, with CEO Brian McNamara saying Haleon believes it is not liable for any claims that may arise from U.S. litigation over the heartburn drug, Zantac.
Zantac was originally marketed by a forerunner of GSK, and has been sold by several companies over the years, including Pfizer, Sanofi, Boehringer Ingelheim and many generic drugmakers.
In July, Haleon spun out of GSK as an independent company and comprises consumer health assets once owned by GSK and Pfizer. However Haleon has repeatedly said that it never marketed Zantac in any form in the United States, either as Haleon or GSK Consumer Healthcare.
Following a loss of market value due to uncertainty surrounding the litigation, McNamara wanted to make Haleon shareholders aware that they never agreed to accept a share of any liabilities if damages are accrued as a result of U.S. litigation over Zantac.
“We do not agree with Haleon’s position,” a GSK spokesperson said. “GSK believes that there are grounds for it to bring indemnification claims in respect of certain potential liabilities, including against Haleon.”
Pfizer was not immediately available for comment.
According to the National Institutes of Health, the heartburn preventative Zantac was approved for use in the United States in 1983 and by 1988 it had become the world’s best-selling drug. In 2004 generic ranitidine was approved for over-the-counter use in the U.S. and remained available until April 2020, when the FDA announced the withdrawal from the market of prescription, over-the-counter, and generic ranitidine and issued a warning to consumers. Nearly 15 million people were prescribed Zantac yearly prior to it being withdrawn from the market.
The active ingredient in Zantac is a substance called ranitidine and it works by decreasing the amount of acid your stomach makes. In 2018 ranitidine was found to have low levels of the known human carcinogen NDMA. N-nitrosodimethylamine is a stabilizing agent used in gasoline, rocket fuel, and other petroleum-based industrial products. The FDA found that the level of NDMA in ranitidine increased when the drug was stored in high temperatures and also as it got older.
Negative Effects of Zantac Use
According to the FDA, since 1983 there have been 73,240 cases reported with a negative effect from Zantac. This includes 55,891 serious cases, 4,926 deaths, and 66 percent of the cases were linked to cancer. In 2020 alone, however, reports of adverse reactions to Zantac spiked to 71,861. 70 percent of these reports mentioned cancers, the most common one being colorectal or colon cancer.
While the short-term risk of NDMA-caused cancer is thought to be low, there have not been full evaluations of longer-term exposure. However, Zantac and other ranitidine-based drugs have been linked to colorectal, kidney, bladder, prostate, esophageal, stomach, liver, pancreatic, lung, breast, gastrointestinal, uterine, testis, and thyroid cancers. Of the cancer deaths that were tied to taking Zantac, pancreatic cancer had the highest number of deaths, followed by liver, esophageal, colorectal, and stomach cancers.
Demographics of Zantac Injury
According to the FDA Adverse Event Reporting System (FAERS), 12,982 of the cases were reported by females, 8,437 cases were reported by males, but the majority of cases (51,821) did not specify gender.
Age was not specified in 39,002 cases. In the cases that did specify age, there were 19,027 reported cases in the 18-64 year range, 13,168 cases reported in the 65-85 year range, and all other age ranges had fewer than 1,000 cases reported.
Zantac-related cancers can take years to develop, so the serious adverse effects are not known in many cases for around four years.