Retailers and generics manufacturers asked a Florida federal court to let them exit a multidistrict litigation over heartburn medication Zantac, arguing they’re the wrong targets for the claims regarding a carcinogen found in the drug.
In the second half of a two-day hearing before U.S. District Judge Robin L. Rosenberg, retailers, which make up about a third of the defendants in the MDL, told the court the plaintiffs allege the cancer-causing chemical nitrosodimethylamine, or NDMA, would have formed in the medication regardless of what retailers did, so retailers, therefore, can’t be held liable for it.
“The plaintiffs say outright that it’s true there’s nothing retailers could’ve done,” Sarah Johnston of Barnes & Thornburg LLP told the court.
But J.J. Snidow of Walsh Law PLLC, who argued on behalf of the plaintiffs, said the complaint also alleges Zantac — and its generic equivalent ranitidine — degrades into NDMA more quickly when exposed to high heat and humidity. The label said the drug needed to be kept in a cool and dry place, but the retailers opted to ship it through ordinary mail methods that could potentially expose it to heat and humidity.
The suits accuse Sanofi SA, Pfizer Inc., Boehringer Ingelheim Pharmaceuticals Inc. and GlaxoSmithKline — as well as generic-drug makers, retailers, distributors and active pharmaceutical ingredient makers — of false advertising, failure to warn and other claims associated with the alleged discovery of NDMA in the medication.
The U.S. Food and Drug Administration issued a warning in September 2019 that trace amounts of NDMA were found in Zantac and similar generic drugs. On April 1, 2020, it pulled all prescription and over-the-counter ranitidine drugs from the market over concerns that the drugs, when stored at temperatures higher than room temperature, could result in exposure to unacceptable levels of the carcinogen.
The FDA has set an allowable daily limit of 96 nanograms of NDMA, but researchers have found more than 3 million nanograms in a dose of Zantac.