Pfizer Hit with Class Action Over Sale of Chantix Pills ‘Adulterated’ with Probable Carcinogen

New to ClassAction.org? Read our Newswire Disclaimer

Pfizer faces a proposed class action for selling now-recalled Chantix medication despite the top-selling smoking cessation treatment’s alleged contamination with a probable human carcinogen. 

The 55-page lawsuit alleges that although Pfizer had warranted to consumers that Chantix (varenicline) was fit for its ordinary use as a first-line therapy to help smokers quit, the FDA-approved treatment is “not of the quality” represented by the pharmaceutical giant in that it’s adulterated with N-nitroso-varenicline and potentially with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). Nitrosamines are dangerous probable human carcinogens, the case stresses.

According to FDA testing, the type of medication at issue in the complaint, called varenicline-containing drugs (VCDs), contain NDMA levels “many times higher” than those allowed under the agency’s updated interim limits for NDMA and other nitrosamine impurities, the lawsuit says. The suit contends Pfizer’s labeling of Chantix is false given no disclosure is made as to the presence of N-nitroso-varenicline or other nitrosamines as ingredients. 

Pfizer initiated a voluntary recall of certain lots of Chantix in July 2021 because of unacceptably high N-nitroso-varenicline levels in the product. The recall was expanded on September 16 to include all lots of the drug, the case says, adding that the FDA has yet to release the full test results for other nitrosamine impurities in Chantix.

The lawsuit alleges the Chantix carcinogen contamination “dates back many years,” to the extent that Pfizer “had actual and/or constructive notice of the contamination.” 

“Ironically, the Defendant’s wrongful acts resulted in persons who sought to use smoking products less end up with a Chantix pill that contained a carcinogen,” the filing reads, alleging consumers have paid millions for adulterated, misbranded VCDs that were “illegally and willfully” introduced into the market. 

Per the complaint, Chantix stands apart from other smoking cessation aids in that it does not contain nicotine. The case relays Chantix works by interfering with the nicotine receptors in the brain, which has a dampening effect on the pleasure a person gets from smoking, leading to a reduction in the craving to smoke.

Pfizer first obtained FDA approval to sell Chantix, a first-of-its-kind treatment, in May 2006, and the product thereafter became one of the company’s top-selling drugs. According to the lawsuit, a 30-day supply of Chantix cost $485 in 2018, more than double its price in the three years prior. 

The lawsuit stresses that drugs are required by law to be manufactured in compliance with current good manufacturing practices, which establish benchmarks for quality control, processing, packaging and holding of drugs to assure they are safe and meet the quality and purity characteristics they are supposed to possess.

Any drug not manufactured in accordance with current good manufacturing practices is deemed “adulterated and/or misbranded” and may not be distributed or sold in the United States, the suit says, alleging Pfizer would have identified the presence of nitrosamine contaminants “almost immediately” had it not “routinely disregarded” the FDA’s manufacturing protocols. 

In light of the foregoing, the complaint contends the product purchased by the plaintiffs was not Chantix, but an adulterated and misbranded varenicline-containing drug not of the same quality represented by Pfizer and thus not approved by the FDA: 

“Because the VCDs ingested by Plaintiff were never approved or even reviewed by the FDA, the FDA never conducted an assessment of safety or effectiveness for these drugs. 

The presence of additional active ingredients (N-nitroso-varenicline and other nitrosamines), and potentially other deviations from Defendant’s NDA approval rendered Defendant’s VCDs of a lesser quality than FDA-approved Chantix.” 

The case states that Pfizer possesses extended patent protection on Chantix and will remain the exclusive seller of the varenicline product without generic competition through at least August 2022. 

The lawsuit looks to represent all individuals and entities in the United States and its territories and possessions who paid any amount of money for a varenicline-containing drug (intended for personal or household use) that was manufactured, distributed, or sold by Pfizer. 

Get class action lawsuit news sent to your inbox – sign up for ClassAction.org’s free weekly newsletter here.