In September 2019, the independent pharmacy Valisure wrote a letter to the U.S. Food and Drug Administration (FDA) regarding the safety of the heartburn medication Zantac and its generic counterparts. Less than six months later, a Zantac multidistrict litigation hearing was held to decide how to proceed with over 100 lawsuits filed alleging that the makers of Zantac and its counterparts concealed fatal defects in the drug’s ingredients.
Multidistrict Litigation (MDL): The consolidation of complex federal cases for management in a single court, designed to speed the process.
The Zantac multidistrict litigation is being brought against Sanofi US Services Inc., Pfizer Inc., Boehringer Ingelheim Pharmaceuticals Inc., and GlaxoSmithKline who have all produced Zantac or a generic version of the drug at some point. These corporations are being accused of false advertising, failure to warn and other claims associated with the FDA’s discovery of N-nitrosodimethylamine (NDMA) in their products.
The Zantac multidistrict litigation centers almost entirely on the presence of NDMA in ranitidine products and the corporations’ duty of care to test their product for NDMA. This is a serious health risk as NDMA has been suggested to be linked to occurrences of:
- Bladder cancer
- Colorectal cancer
- Esophageal cancer
- Gastric (stomach) cancer
- Kidney cancer
- Liver cancer
- Lung cancer
- Nasal cancer
- Pancreatic cancer
In the lawsuit, plaintiffs have claimed to have contracted cancers of the colon, esophagus, breast, bladder, and more.
With more and more cases arising, in early 2020 the Judicial Panel on Multidistrict Litigation (JPML) had to decide whether to consolidate all of these claims. On Feb. 6, 2020, the JPML consolidated 15 lawsuits and more than 125 “tag-along” actions in the Southern Court of Florida under U.S. District Judge Robin Rosenberg of Miami. The Zantac Multidistrict Litigation will be Rosenberg’s first MDL but the panel confidently identified Judge Rosenberg as “an able jurist who has not yet had the opportunity to preside over an MDL.”
By Feb. 22, 2020, 141 people had added their cases to the Zantac multidistrict litigation. One of the driving factors for these lawsuits have been the recallssparked by Valisure’s letter. According to the pharmacy in their letter to the FDA, it “detected extremely high levels” of NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”
The FDA has stated that the limit of safe NDMA exposure is 96 billionths of a gram (ng). So when it described NDMA levels as extremely high, the pharmacy followed it up by stating “Valisure has detected NDMA in excess of 3,000,000 ng per tablet when analyzing ranitidine products, likely due to an inherent instability of the ranitidine molecule.” 3,000,000 ng is equal to 3 milligrams or over 30,000 times the safe exposure rating approved by the FDA.
Legal experts expect that before the Zantac multidistrict litigation has concluded, at least 100,000 claimants will come forward. Those same experts expect that Rosenberg will more likely oversee a settlement than a drawn-out trial.
By James Parker
James Parker is a news writer and fact-checker from Coral Springs, Florida. He majored in Communication and Media Studies at Stetson University, where he spent much of his time bringing the cutting edge of medical research to his peers’ attention. When he’s not writing, he enjoys rewatching “Almost Famous” or curling up with a good book.