Consumers have hit Pfizer Inc. with a proposed class action lawsuit. Plaintiffs claim that the pharmaceutical company should have known its heartburn drug Zantac (known generically as Ranitidine) was contaminated with NDMA, a “carcinogenic and liver-damaging impurity” but failed to warn consumers, according to Law360. NDMA is short for N-nitrosodimethylamine. Additional consumers have filed at least two more similar lawsuits, one each in Florida and Colorado.
New Jersey resident Dana Viola took Zantac regularly since 2004. Had she known about the presence of NDMA in Zantac, she would not have bought it in the first place.
Viola claims that the company should have known that NDMA was present in Zantac. She further claims the drug became contaminated with the impurity through improper manufacturing practices, and that Pfizer withheld this information from consumers until last fall when the FDA issued a safety communication.
Pfizer received approval to market an over-the-counter version of Zantac from the Food and Drug Administration (FDA) in 2004. Pfizer was the primary manufacturer of the drug for years.
Sanofi-Aventis U.S. now owns the rights to Zantac. The company recalled the medication in October after the FDA issued a warning that it had detected NDMA in several ranitidine-containing drugs. Several other drugmakers issued recalls of their ranitidine-containing products as well.
Viola’s proposed class action Zantac lawsuit seeks to represent U.S. residents who have purchased Zantac. In addition, she seeks to represent a subclass of all New Jersey residents who have purchased the drug.
Zantac is one of the most popular drugs in history, with $1 billion in gross sales since 1986.