A Melville father of four says he developed a rare bladder cancer after regularly ingesting Zantac — which was pulled from the market by federal regulators in early April — in a federal lawsuit that names the manufacturers of the popular heartburn drug as defendants.
Douglas Rochler, 52, and his wife, Anna Maria Rochler, claim in the lawsuit, filed April 21 in the Southern District of Florida, that the manufacturers of the drug knew for decades that Zantac produced a toxic carcinogen when ingested but did not disclose the risks to the U.S. Food and Drug Administration or consumers.
The FDA asked manufacturers to withdraw prescription and over-the-counter Zantac, described in the lawsuit as “a cancerous poison,” on April 1. The lawsuit is one of dozens filed against the manufacturers that have been consolidated in U.S. District Judge Robin L. Rosenberg’s court.
“Despite the weight of scientific evidence showing that Zantac exposes people who take it to unsafe levels of the carcinogen NDMA, no defendant ever disclosed this risk to the FDA, not on the drug’s label, and not by any other means,” the lawsuit said.
“Instead, defendants put profits ahead of safety and aggressively marketed an inherently, unreasonably dangerous drug, reaping massive profits from exposing millions of people to cancer-causing chemicals,” the lawsuit added.
The defendants include GlaxoSmithKline, which manufactured and marketed Zantac from 1983 to 2009; Boehringer Ingelheim Pharmaceuticals, which manufactured and marketed an over-the-counter Zantac product from 2006 to 2017 in the United States; and Sanofi, which controlled the U.S. rights to over-the-counter Zantac from January 2017 to the present.
Spokeswomen for GSK and Sanofi declined to comment. Boehringer representatives did not immediately return a call for comment.
“We take this issue very seriously as patient safety is our utmost priority,” the GSK spokeswoman said.
Craig Silverman, a New York attorney with the firm of Sullivan Papain Block McGrath Coffinas & Cannavo P.C. which represents the plaintiffs, said Douglas Rochler has received treatment for his cancer and is in recovery.
“He’s doing well right now,” said Silverman, adding Rochler was diagnosed with cancer in May 2017 when he was 49. “He is in good spirits.”
The lawsuit said Zantac, the commercial name for ranitidine, produces the carcinogen N-nitrosodimethylamine (NDMA) when ingested. NDMA, according to the court papers, is used to cause cancer in animals for laboratory testing and is a waste-product in the manufacture of rocket fuel. The complaint claims Rochler used Zantac products four or five times a week from 2014 to September 2019, when some retailers announced they would no longer sell the product due to NDMA concerns.
The lawsuit claims GSK tried as early as 1981 to discredit studies that indicated ingesting Zantac would create the carcinogen in the body when ingested.
“As a result of the foregoing acts and omissions, Plaintiff was and still is caused to suffer serious and dangerous side effects, as well as other severe and personal injuries,” the lawsuit said.
The plaintiffs are seeking compensation for lost earnings, medical expenses, pain and suffering and legal fees. The amount is not specified in the lawsuit, but the papers say it is in excess of $75,000.