The U.S. Judicial Panel on Multidistrict Litigation has transferred all Zantac personal injury lawsuits to the U.S. District Court for the Southern District of Florida for coordinated or consolidated pretrial proceedings pursuant to 28 U.S.C. § 1407.
According to a Feb. 6 consent order, Judge Robin L. Rosenberg will oversee the docket. A transfer order issued shortly thereafter stated that the Southern District of Florida is an appropriate transferee district for this litigation, given that a “large number of Zantac actions are pending in the Southern District of Florida.”
Zantac was first sold in the United States by GlaxoSmithKline in 1983. It is part of a class of drugs known as H2-receptor antagonists (or H2 blockers) which treat heartburn, indigestion and other gastric disorders by decreasing acid produced in a patient’s stomach. The drugs have also been used to treat stomach ulcers. Within a few years of its introduction, Zantac achieved “blockbuster status” with sales of more than $1 billion each year.
In 1996, Zantac became available to patients without a prescription and generic versions of ranitidine were first sold in 1997. Even with the availability of a generic formulation, sales of the brand name version of Zantac remained strong for many years.
In the fall of 2019, a citizen’s petition was filed with the FDA seeking a safety review of Zantac and ranitidine by an independent testing company that noticed excessive levels of NDMA in drugs it had tested as a part of its work in analyzing generic drugs, identifying counterfeit medications, and performing quality control checks on medications manufactured overseas. Shortly thereafter, several recalls were issued in the United States and internationally with notifications to patients, retailers, pharmacies, and suppliers and the manufacturers announced the suspension of the sale and distribution of the drugs while the potential link between NDMA and cancer could be properly investigated. Many retailers (including CVS, Walmart, Walgreens, Rite Aid, etc.) also issued notices of recall and stopped selling Zantac and generic formulations of ranitidine, including versions of the products sold as store brands by the retailers. Before this, The U.S. Judicial Panel on Multidistrict Litigation has transferred all Zantac patients were unaware of the risks of potential exposure to NDMA, which was not included in the warning labels provided by the manufacturers to healthcare providers, patients, and regulatory authorities. In 2018, there were also recalls of several generic medications used for high blood pressure and heart failure (including valsartan, losartan, and irbesartan) due to NDMA in some of those medications, which was attributed to defective manufacturing processes.
These lawsuits focus on the presence of NDMA (also known as N-Nitrosodimethylamine), a known carcinogen, in Zantac and ranitidine formulations. Numerous studies have shown that NDMA causes cancer in animals (including stomach, intestinal, and colon cancer) and is likely to pose health risks to patients. NDMA has been classified as a probable human carcinogen by the Environmental Protection Agency (“EPA”) and International Agency for Research on Cancer (“IARC”). It is not believed that NDMA in Zantac or ranitidine is due to contamination from the manufacturing process. Instead, it is believed that NDMA is present due to a defective design of the drug where the drug molecules break down in a patient’s body and NDMA is created as a part of that process combined with the processing of food in a patient’s stomach. The biological explanation for this chemical process is complex but relates to the pH levels in the stomach and levels of nitrites. NDMA is also believed to be a mutagen, so it can cause changes in animal and human cells, which may lead to tumors and cancer.
Epidemiological studies relating to NDMA exposure in humans have shown an increased risk of certain cancers including colorectal, gastric, and digestive tract cancers. These studies were not specific to ranitidine or Zantac products, but are of concern. There have also been a few published studies in the past that have raised concerns about the potential risks that patients might face with chronic use of ranitidine and Zantac, including possible association with an elevated risk of bladder cancer, stomach cancer, and other digestive tract cancers, although more study is warranted. That these threshold safety questions remain decades after Zantac and ranitidine were first marketed and ingested by patients is one of the primary liability issues that will be the focus of the pending individual lawsuits and class action cases. There are also allegations in the lawsuits that some studies relied upon by the drug companies were designed in a manner to avoid detecting early signs of the presence of excessive levels of NDMA and potential signals of an unacceptable risk of cancer for patients.
If you have ingested Zantac or ranitidine products in the past and have developed colon, stomach, bladder, or digestive tract cancer, you may have a claim against the manufacturers and retailers of these products. Please contact Steve Leshner for a free consultation.