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On Nov. 7, the U.S. Court of Appeals for the 11th Circuit in Atlanta upheld a lower court’s dismissal of a class-action lawsuit against the makers and distributors of Zantac, a heartburn medication alleged to have caused cancer in many people who used the medication routinely for heartburn symptoms.
The week prior, the Circuit Court upheld the dismissal of two individual cases involving prostate, abdominal and ovarian cancer, allegedly caused by the drug’s previous ranitidine formulation, which had been voluntarily removed from the market right before an U.S. Food and Drug Administration (“FDA”) request to do so was issued in April of 2020.
In August of 2022, the first Zantac lawsuit scheduled for trial was dropped suddenly after the plaintiff in Illinois settled with a generic maker of the drug for $500,000.
Zantac, which has been sold by several companies, is used to relieve and treat heartburn symptoms, acid indigestion, gastric ulcers and GERD. Its active ingredient formerly was ranitidine, which can be unstable and produce high levels of N-Nitrosodimethylamine, or NDMA, a known chemical carcinogen, under humid or hot conditions, such as during transport or storage of the drug.
The product began to be pulled from the market voluntarily in 2019 before the FDA issued a recall in 2020 citing the risk of high level exposure to the carcinogen after use of the drug.
A reformulated Zantac 360, with famotidine as a replacement for ranitidine, is being sold now but not in prescription strength.
Zantac Lawsuit Dismissal Cites ‘Shotgun Pleadings
This latest dismissal involved the Plumbers & Pipefitters Union Local 630 Welfare Fund, which had been paying for the product and providing it for its members. The union is based in South Florida and went before the U.S. Southern District of Florida court, which originally dismissed the lawsuit.
The union was claiming fraud, negligence and other torts against manufacturers. The circuit court of appeals in Atlanta ruled that the union failed to challenge the drug manufacturers’ assertion that the charges were “shotgun pleadings,” which are legal complaints that set forth an excessive number of facts with no clear organization, using those facts to assert a cause of action. Shotgun pleadings are impermissible under federal court rules.
In the same week, the circuit court also dismissed two individual cases that originally were part of another group filing dismissed earlier under the same “shotgun pleading’’ issues.
Plaintiff Arthur Cartee, from Illinois, said he started taking Zantac in 2006 and developed prostate cancer in 2012. Marilyn Williams, from Alabama, began using Zantac in 2011 and developed ovarian and abdominal cancer in 2016.
Cancer Linked to NDMA
NDMA has been linked to several cancers in various studies, including liver, kidney, esophagus, colon, lung, gastric, colorectal, prostate and stomach cancers.
The International Agency for Research on Cancer has said NDMA is “probably carcinogenic to humans.” It is classified by the FDA as a group 2 carcinogen, based on the evidence that it could cause cancer in humans.
Various studies have shown a possible connection between Ranitadine and NDMA where NDMA forms as a result of a chemical reaction when Ranitadine is broken down in the body. Plaintiffs have said that the drugmakers knew about the potential cancer risk for years but refused to inform the public and continued selling the drug at a risk to their health.
Drug companies have continued to insist there is no link to cancer from Zantac with its original formulation including Ranitadine, and that the levels of NDMA present were similar to what is found in many types of food.
Manufacturer GlaxoSmithCline maintains that there is no increased risk of cancer associated with the regular use of Ranitadine, based on the purported weight of scientific evidence. The company also has said it will defend itself against any claims alleging otherwise.
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