Superior Court Judge Evelio Grillo for the County of Alameda, who oversees the California Ranitidine Product Cases Judicial Council Coordinated Proceedings (JCCP), has set a trial date of October 10, 2022, for the first cancer case trial. Drug makers Sanofi, GlaxoSmithKline, Pfizer, Boehringer Ingelheim, and Chattem will move forward as defendants. Although the JCCP functions similarly to a federal multidistrict litigation (MDL), these cases are adjudicated within the California state court system.
Basis of the Zantac Lawsuits
In 2019, the first Zantac lawsuits emerged in California. In the first action, plaintiffs allege that Sanofi and Boerhringer Ingelheim manufactured, marketed, and sold a product they knew or should have known had been contaminated with a cancer-causing chemical.
Research had shown a link between Zantac active ingredient ranitidine and cancer. When the ingredient comes into contact with water, it causes a chemical reaction that produces a probable human carcinogen. The pharma companies had access to this information, and yet they chose not to warn consumers or the government about the
Health Risks of Ranitidine
In 1999, via a Citizen’s Petition, the online pharmacy Valisure notified the FDA of having discovered “extremely high levels” of N-Nitrosodimethylamine (NDMA)—a probable human carcinogen—in ranitidine products, including Zantac. While the U.S. Food & Drug Administration (FDA) establishes that a “safe” level of NDMA consumption for humans taps out at a ceiling of 96 nanograms 2 per day, Valisure reported that a single Zantac tablet contained more than 3 million nanograms of the carcinogen.
In April 2020, the FDA requested that manufacturers withdraw their prescription and over-the-counter (OTC) ranitidine drugs from the market. The FDA explained that the move was prompted by the detection of NDMA in ranitidine drugs, which are perhaps better known by the brand name Zantac).
According to the FDA, an ongoing investigation of ranitidine suggested that the NDMA contaminants increase over time and when the drug is stored at “higher than room temperatures.” The Environmental Protection Agency (EPA) reports that laboratory tests show that various animal species exposed to NDMA have developed tumors in the kidneys, liver, respiratory tract, and blood vessels. The federal agency classifies NDMA as a known hepatotoxin, meaning it causes liver cancer.
Humans can ingest NDMA through a wide range of foods, including smoked or cured fish and meats, as well as through some cosmetic products and smoking cigarettes. However, these levels of exposure are too low to pose health risks to humans.
Signs that you may have suffered overexposure to NDMA include:
- Enlarged liver
- Abdominal cramps
- Reduced liver function
- Reduced function of kidneys
- Reduced function of lungs
Although the EPA reports that NDMA occurs in both natural and industrial processes, the chemical was once used in the making of liquid rocket fuels, additives for lubricants, and antioxidants.
Previous Order Thins Out the Range of Zantac Defendants
The pretrial order comes on the heels of a federal judge’s dismissal of claims against makers of generic Zantac, as well as those against pharmacies and retailers. Among the retailers now off the hook for claims that Zantac caused cancer are the following:
- Amazon.com Inc.
- Albertsons Cos. Inc.
- Costco Wholesale Corp.
- CVS Pharmacy Inc.
- The Kroger Co.
- Walgreen Co.
In her decision to dismiss cases against these retailers, U.S. District Judge Robin L. Rosenberg stated that the cases failed to present a “concrete allegation of breach,” something the judge deemed to be essential before such a “weighty allegation” could become plausible.
Judge Rosenberg dismissed cases against the generic form of Zantac. Her reasoning was that federal law prohibits generic products from carrying labels different than those approved for the brand versions of drugs.