On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether individual and class action lawsuits filed over the recalled Zantac should be consolidated before a single federal judge. Zantac, also known as ranitidine, has been used by millions of patients for decades as an antacid. Ranitidine is available in both brand name and generic formulations and has been used by patients through a prescription and purchased over-the-counter.
This panel of federal judges is known as the Judicial Panel on Multidistrict Litigation and determines whether consolidation of mass tort lawsuits is appropriate and would lead to efficiency for the parties and the court system. This consolidation is known as “multidistrict litigation” or an “MDL” and involves the transfer of all pending lawsuits in the federal court system to a single judge who oversees generic discovery, expert witness testimony, trial preparation, settlement talks, and overall management of complex cases. This system is efficient as MDLs often involves hundreds, if not thousands of individual lawsuits, and having generic issues applicable to all the cases decided by hundreds of judges would be highly inefficient and likely lead to inconsistent rulings and a waste of resources.
The request was filed seeking establishment of an MDL for the Zantac product liability lawsuits and class action claims was filed by 15 plaintiffs (from California, Colorado, Connecticut, Florida, Illinois, New Jersey, and New York) with pending federal court lawsuits as of November of 2019 and seeks a transfer of all the pending lawsuits and future Zantac lawsuits to the federal court for New Jersey. In its brief, the plaintiffs have argued that New Jersey federal court is the most convenient forum for the consolidated proceedings since many of the defendant drug companies are headquartered nearby, it is a venue very accessible to all parties, and the special expertise of federal judges in New Jersey based upon their experience managing numerous complex pharmaceutical and medical device MDL proceedings (including 66 settled MDL cases involving tens of thousands of plaintiffs since 1972).
The Zantac litigation effort involves several international drug companies, including Boehringer Ingelheim Pharmaceuticals (based in Connecticut); Boehringer Ingelheim Corporation (German parent company); Sanofi US Services, Inc. (based in New Jersey); Chattem, Inc. (based in Tennessee and a subsidiary of Sanofi); Pfizer (based in New York); and GlaxoSmithKline (based in Pennsylvania). There are also some pending lawsuits that include retailers as defendants. At various times over the past few decades, these pharmaceutical companies were involved in developing, manufacturing, marketing, distributing and retailing Zantac and ranitidine antacid medications and interacting with the Food & Drug Administration and other drug safety regulators. The lawsuits and class actions include claims that Zantac and ranitidine were negligently and defectively designed; insufficiently tested before being placed on the market; inadequately monitored for safety risks after they were sold to patients, including failure to properly report adverse events to the FDA and that the drug manufacturers failed to conduct ongoing safety evaluations and clinical studies; failed to provide proper warnings of the risks of Zantac and ranitidine to patients and healthcare providers; provided inaccurate risk versus benefit information about the drugs; and violated various state consumer protection statutes.
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, 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.
Zantac Injuries and Harm
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. The defective drug lawyers at Searcy Denney Scarola Barnhart & Shipley have decades of experience in litigating claims involving substandard, dangerous or recalled drugs and are available to consult with you regarding your potential claims.