A federal judge in New York has tossed a class-action lawsuit against Pfizer, ruling that the company did not have to disclose that its smoking cessation drug, Chantix, was contaminated with a carcinogenic substance, Reuters reported.
U.S. District Judge Denise Cote stated that there was no proof that Chantix’s product labels were misleading, nor that the presence of the cancer-causing compound made the drug unfit to help users quit smoking.
Chantix was approved in 2006. On Sept. 16, 2021, Pfizer voluntarily recalled all lots of Chantix 0.5 mg and 1 mg tablets because of higher than acceptable levels of nitrosamine, a compound that has been associated with a risk of cancer in humans when consumed over a lengthy period of time.
Pfizer began recalling Chantix in July 2021 before extending the recall nationwide by September.
Judge Cote said that because Pfizer offered full rebates for unused Chantix, the lawsuit sought damages only for tablets that the plaintiffs consumed.
Two plaintiffs representing the class claimed they never would have purchased Chantix had they known about the contamination. The plaintiffs also claimed that the presence of nitrosamine made the drug worthless in their efforts to cease smoking.
The complaint accused Pfizer of misrepresenting the safety of the drug to consumers by failing to properly test Chantix for the “carcinogenic impurity” despite warnings from regulators.
The complaint also alleges that Pfizer had known about Chantix nitrosamine contamination for many years but failed to warn consumers or alert public health authorities.
Responding to the federal judge’s decision to throw out the class action, Pfizer said in a statement, “We continue to stand behind the safety and efficacy of Chantix, which has helped millions of Americans quit cigarette smoking.”
In 2020, sales of Chantix nearly reached $1 billion. Last year, due to the recall, Chantix profits dropped 57%. The drug had been prescribed to over 13 million people in the 15 years Pfizer manufactured and marketed it.