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Pfizer’s Stop-Smoking Drugs Recalled for Contamination Class Action

Pfizer, Inc. makes Chantix, its brand-name drug that contains varenicline and helps people to stop smoking. The market for this varenicline-containing drug (VCD) is robust, but the complaint alleges that the VCDs in Chantix are “adulterated, misbranded, and unapproved” because they have been contaminated with the probable human carcinogen n-nitroso-varenicline and possibly with other potential nitrosamines as well.

The National Class for this action is all individuals and entities in the US and its territories and possessions who paid any amount for a varenicline-containing drug, for personal or household use, that was made, distributed, or sold by Pfizer. An Illinois Subclass has also been defined, for individuals and entities in that state.

Chantix has been one of Pfizer’s most popular and profitable products. The number of its prescriptions for Medicare beneficiaries has increased by more than 13,000%. Not only has the number of prescriptions increased; its price has drastically increased as well, from $113.98 when it was introduced to $485 in 2018. That year, Pfizer made just short of a billion dollars on it. It has become Pfizer’s eighth-best-selling product.

Pfizer extended its patent protection of the drug to cover it through August 2022, meaning that it is currently the only varenicline product on the market.

The complaint alleges that when Pfizer began making its own generic VCDs, it represented to consumers that they “were therapeutically equivalent to and otherwise the same as” Chantix, which was approved by the Food and Drug Administration (FDA). But the complaint claims that this is not true: Pfizer “willfully ignored warnings about the operating standards, and knowingly and fraudulently manufactured, sold, labeled, marketed, and/or distributed adulterated and/or misbranded VCDs for purchase in the United States by consumers.”

The complaint contends that the VCDs were 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’).”

The complaint adds, “According to FDA testing, the VCDs subject to this action contained NDMA contamination levels many times higher than the FDA’s updated interim limits for NDMA and other nitrosamine impurities.”

In July 2021, Pfizer issued two recalls of its VCDs; it extended the recalls in September to include all Chantix.

But the complaint alleges that the contamination has been going on for many years, and that Pfizer has known of the contamination. The complaint claims that the company “illegally and willfully” put the contaminated drugs on the market and sold them.

The counts include breaches of warranties and fraud, among other things.

Article Type: Lawsuit
Topic: Consumer

Most Recent Case Event

Pfizer’s Stop-Smoking Drugs Recalled for Contamination Complaint

Pfizer, Inc. makes Chantix, its brand-name drug that contains varenicline and helps people to stop smoking. The market for this varenicline-containing drug (VCD) is robust, but the complaint alleges that the VCDs in Chantix are “adulterated, misbranded, and unapproved” because they have been contaminated with the probable human carcinogen n-nitroso-varenicline and possibly with other potential nitrosamines as well.

Pfizer’s Stop-Smoking Drugs Recalled for Contamination Complaint

Case Event History

Pfizer’s Stop-Smoking Drugs Recalled for Contamination Complaint

Pfizer, Inc. makes Chantix, its brand-name drug that contains varenicline and helps people to stop smoking. The market for this varenicline-containing drug (VCD) is robust, but the complaint alleges that the VCDs in Chantix are “adulterated, misbranded, and unapproved” because they have been contaminated with the probable human carcinogen n-nitroso-varenicline and possibly with other potential nitrosamines as well.

Pfizer’s Stop-Smoking Drugs Recalled for Contamination Complaint
Tags: Contaminated with Harmful Substances, Pharmaceuticals