The Judicial Panel on Multidistrict Ligitation (JPML) formed a multidistrict litigation (MDL) on February 6th, 2020 in the Southern Court of Florida regarding 15 Zantac (ranitidine) lawsuits and over 125 “tag-along” actions. The MDL accuses Pfizer Inc., Sanofi US Services Inc., GlaxoSmithKline and Boehringer Ingelheim Pharmaceuticals Inc. of concealing the presence of the probable carcinogen N-nitrosodimethylamine (NDMA) in their medications, failure to warn, false advertising and other claims. Plaintiffs in the MDL claim to have been diagnosed with bladder cancer, breast cancer, esophagus cancer, colon cancer and other cancers.
The MDL focuses on the presence of NDMA in ranitidine medications and the duty of care to test medications for the presence of NDMA which the corporations are responsible for. The U.S. Environmental Protection Agency (EPA) classifies NDMA as a probable carcinogen. Scientists intentionally give rats NDMA to give them cancer that they can study.
The pharmacy Valisure wrote the U.S. Food and Drug Administration (FDA) a letter in September 2019 urging them to recall all ranitidine products from the U.S. market. The letter stated that they “detected extremely high levels of [NDMA]… in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.” The FDA’s permissible daily intake limit for NDMA is 96 ng. Valisure tested 10 different ranitidine medications and found over 2,400,000 ng of NDMA per tablet in every medication they tested.
Testing laboratory Emery Pharma later petitioned the FDA in January 2020 to recall all forms of ranitidine from the U.S. market. They said they found that unacceptably high levels of NDMA were formed in ranitidine when the medication is exposed to heat. Emery found that a sample of ranitidine exposed to 158 degrees Fahrenheit for a five day period exceeded the FDA’s daily limit of 96 ng of NDMA and that the same sample contained 142 nanograms of NDMA after 12 days at the same temperature. Emery also found that the amount of NDMA in a sample exposed to 77 degrees Fahrenheit steadily increased over a 12 day period.
The MDL’s overseer will be U.S. District Judge Robin Rosenberg of Miami. This MDL will be Rosenberg’s first. The JPML called Rosenberg “an able jurist who has not yet had the opportunity to preside over an MDL.”
141 cases had been added to the MDL as of February 22, 2020. Experts expect to see over 100,000 claimants before the MDL ends and expect the MDL to end in settlement rather than a long trial.