Amid increasing concerns about the risk of cancer from Zantac, a product liability lawsuit filed by an Ohio woman indicates that chemical byproducts produced by the popular heartburn drug led to the development of Stage IV kidney cancer, and the need for kidney removal surgery.

The complaint (PDF) was filed by Sandra J. Payne in the U.S. District Court for the Northern District of Ohio on November 20, indicating that she received a renal cancer diagnosis earlier this year, after taking two Zantac pills per day for the past 12 years.

The lawsuit, which names Boehringer Ingelheim, Sanofi, Chattem Inc., Pfizer, Inc., and GlaxoSmithKline as defendants, indicating that the drug makers concealed information about the risk that the active ingredient in Zantac (ranitidine) may convert inside the body to N-Nitrosodimethylamine (NDMA), which is a carcinogen that may increase the risk of kidney cancer, bladder cancer, liver cancer and other problems when it is digested by the human body.

Payne brings the case in the wake of massive Zantac recalls issued over the past few months, which have impacted most versions of the ranitidine-based drug, after independent testing found “unacceptable” levels of NDMA in all versions of the medication.

The lawsuit indicate that NDMA has been in Zantac since it first hit the market in the early 1980s, yet the drug has continued to be aggressively promoted, while the manufacturers actively concealed, downplayed or otherwise suppressed the risk of cancer caused by Zantac.

“Going back as far as 1981, two years before Zantac entered the market, research showed elevated rates of NDMA, when properly tested. This was known or should have been known by Defendants,” Payne’s lawsuit states. “Defendants concealed the Zantac—NDMA link from consumers in part by not reporting it to the FDA, which relies on drug manufacturers (or others, such as those who submit citizen petitions) to bring new information about an approved drug like Zantac to the agency’s attention.”

In September, the online pharmacy Valisure filed a Citizens Petition with the FDA, calling for all versions of Zantac to be recalled from the market, after testing confirmed that NDMA was created due to the inherent structure of the active pharmaceutical ingredient in the heartburn drug, indicating that all users may be exposed to unacceptably high levels of the cancer-causing chemical.

Since the information was publicly released, dozens of Zantac lawsuits have been filed by individuals throughout the United States, each involving similar allegations that plaintiffs developed kidney cancer, stomach cancer, bladder cancer, colorectal cancer, esophageal cancer or other cancers along the digestive tract, as ranitidine contained in Zantac broke down into NDMA inside the body.

As lawyers continue to investigate potential Zantac cancer claims over the coming months and years, it is widely expected that thousands of lawsuits will be brought throughout the federal court system.

Tags: Boehringer Ingelheim, Cancer, Drug Recall, GlaxoSmithKline, Heartburn, Heartburn Drug, Kidney Cancer, NDMA, Pfizer, Sanofi, Zantac