Lawsuit Claims Zantac Caused Man’s Stomach Cancer, Gall Bladder Damage
A lawsuit filed in November in federal court in Florida alleges that a Florida man developed stomach cancer and gall bladder damage because he took over the counter Zantac.
The lawsuit names numerous defendants, including:
Brand-name manufacturers: Boehringer Ingelheim; GlaxoSmithKline; Pfizer; Sanofi
Generic manufacturers: Acic Pharmaceuticals; Ajanta; AmerisourceBergen; Amneal; ANDA Repository; Ani Pharmaceuticals; Apotex; Appco Pharma LLC; Autobindo; Contract Pharmacal; Dr. Reddy’s; Geri-Care; Glenmark; Granules; Heritage; Hikma; Hi-Tech; JB Chemicals; Lannett; Mylan; Nostrum; Novitium; PAI; Par Pharmaceutical; Perrigo; Sandoz; Strides; Taro; Teva; Torrent; VKT; Wockhardt; Zydus-Cadila
Distributors: Amerisource Bergen; Cardinal Health; Chattem; McKesson
Retailers: Walmart Inc. f/k/a Wal-Mart Stores, Inc.
Repackagers: Denton Pharma; GSMS; Precision Dose
The man used Zantac and/or generic ranitidine from around 2017 to 2019, according to the lawsuit.
The lawsuit asserts numerous causes of action, including strict products liability – failure to warn, strict products liability – design defect, strict products liability – manufacturing defect, negligence – failure to warn, negligent product design, negligent manufacturing, general negligence, negligent misrepresentation, breach of express warranties, breach of implied warranties, violation of Florida Statute § 501.201-501.213, unjust enrichment, and loss of consortium (on behalf of the man’s wife).
The FDA asked that all products containing ranitidine be removed from the United States market in April because of concerns over NDMA, which the Environmental Protection Agency and the International Agency for Research on Cancer consider a probable carcinogen. There are concerns that drugs containing ranitidine may be contaminated with NDMA, or may form NDMA during storage or while inside the human body.
GlaxoSmithKline seemed to acknowledge they were aware that NDMA might form in a human stomach when they responded to experiment results in 1981 which discovered “toxic and mutagenic effects” which occurred when Zantac was exposed to gastric fluid and nitrites. Dr. Silvio de Flora stated these effects may have been due to the “formation of more than one nitroso derivative.”
A 1979 news article stated that NDMA had caused cancer in almost every lab animal tested.
Emery Pharma found that NDMA forms in Zantac pills in storage, and that it forms more quickly as it is exposed to more heat. The testing lab found that a sample exposed to 158 Fahrenheit exceeded the FDA’s daily intake limit for NDMA after only five days. More alarmingly, the lab found that a sample exposed to 77 Fahrenheit contained over a quarter of the FDA’s daily intake limit after only 12 days.