Pfizer Sold Misbranded Chantix Containing Probable Carcinogens, Class Action Claims

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Pfizer Chantix Class Action Lawsuit Overview: 

• Who: Albert Edwards filed a class action lawsuit against Pfizer, Inc. 
• Why: The plaintiff alleges Pfizer knowingly sold misbranded varenicline-containing drugs (“VCDs”) under the brand name Chantix. The drugs contained probable human carcinogens.
• Where: The class action lawsuit was filed in Pennsylvania federal court. 

Pfizer, Inc. willfully ignored warnings about the operating standards and knowingly and fraudulently manufactured, sold, labeled, marketed and/or distributed varenicline-containing drugs (VCDs) under the brand name Chantix in the United States, a new class action lawsuit alleges. 

Plaintiff Albert Edwards claims Pfizer represented and warranted to consumers that its VCDs were therapeutically equivalent to and otherwise the same as the FDA-approved brand name drug Chantix. Specifically, the defendant represented and warranted that the VCDs were fit for their ordinary uses, met the specifications of defendant’s FDA-approved labeling materials and were manufactured and distributed in accordance with all applicable laws and regulations. 

However, the VCDs were found to be contaminated with a probable human carcinogen known as N-nitroso-varenicline. Additionally, Pfizer was on notice of other potential nitrosamines as well, such as n-nitrosdimethylamine (NDMA) and n-nitrosodiethlamine (NDEA). 

“According to the FDA and other global health authorities, nitrosamines are dangerous probable human carcinogens,” the class action lawsuit states. 

FDA testing showed the VCDs in question contained NDMA contamination levels many times higher than the FDA’s updated interim limits for NDMA and other nitrosamine impurities. 

On July 2, 2021 and July 19, 2021, Pfizer initiated recalls of VCDs “because [the product] may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit.” On Sept. 16, 2021, Pfizer extended its recall to all Chantix.

“The Class plaintiffs paid for VCDs that were illegally and willfully introduced into the market by defendants, which caused them and the millions of other VCD consumers to sustain economic damages,” the class action lawsuit states.

Pfizer’s VCDs were not fit for their ordinary use, and the company has been unjustly enriched through the sale of these knowingly adulterated and/or misbranded drugs. The defendant’s conduct also constitutes actionable common law fraud, consumer fraud and other violations of state and federal law, according to the class action.

Edwards seeks to represent a nationwide Class of consumers and a Pennsylvania Subclass of consumers who paid any amount of money for a varenicline-containing drug (intended for personal or household use) that was manufactured, distributed, or sold by the defendant. 

Class Action Claims Pfizer Sold VCDs Under the Chantix Name That Contained Probable Carcinogens

The plaintiff’s allegations stem from his purchase of one or more of the defendant’s VCDs. Pfizer expressly and impliedly warranted to Plaintiff Edwards (either directly or indirectly by adopting warranties that were passed along to and incorporated by another defendant further downstream) that their respective VCDs were the same as the branded Chantix. But in fact, Plaintiff Edwards bought a product that was not the same as Chantix. 

“Had plaintiff Edwards known the product was not the same, [he] would not have paid for these defendant’s VCDs,” the class action lawsuit states.

Likewise, had the defendant’s deception about the impurities within their products been made known earlier, Edwards would not have paid for the VCDs, the lawsuit states. 

The plaintiff is requesting compensatory damages and preliminary and/or final injunctive relief, including restitution, for himself and all Class Members. He also requests the creation of a medical monitoring fund and/or program that is reasonably necessary to detect the elevated cancer risk.

Have you purchased VCDs under the brand name Chantix without knowing they were misbranded and contained probable carcinogens? Let us know in the comments! 

The plaintiff is represented by Ruben Honik and David J. Stanoch of Honik LLC. 

The Pfizer Chantix Class Action Lawsuit is Edwards, et al. v. Pfizer, Inc., Case No. 2:21-cv-04275-GEKP, in the U.S. District Court for the Eastern District of Pennsylvania.

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