Pfizer Chantix Adulterated with N-Nitroso-Varenicline Class Action

One of Pfizer, Inc.’s most popular products is the varenicline-containing drug (VCD) Chantix. Chantix is designed to help people stop smoking, and, unlike many other products for this use, it does not contain nicotine. However, the complaint for this class action alleges that the drugs have recently been contaminated with N-nitroso-varenicline, and possibly other substances as well. The complaint alleges this renders the drugs unfit for their intended use and worthless.

The National Class is all entities in the US and its territories and possessions who paid any amount of money for a varenicline-containing drug, for personal or household use, that was made, distributed, or sold by Pfizer. A Minnesota Subclass has also been defined, for those in the above class in Minnesota.

Pfizer received approval from the Food and Drug Administration (FDA), the complaint alleges, “to sell Chantix as a first of its kind treatment in May 2006.” The complaint alleges it quickly became one of the company’s fastest-growing products. “For example,” the complaint alleges, “from its launch through 2015, the number of Chantix prescriptions for Medicaid beneficiaries increased 13,277%.”

The price has also grown, the complaint alleges, beginning at $113.98 for a thirty-day supply, then increasing to $254.50, and finally to $485 in 2018.

However, the complaint alleges that Pfizer has disregarded the standards required for producing Chantix and instead has “knowingly and fraudulently” been making and selling adulterated and misbranded VCDs instead.

What’s wrong with the purported but misbranded Chantix? The complaint alleges that it has experienced “contamination with a probable human carcinogen known as N-nitroso-varenicline. Additionally, [Pfizer] was on notice of other potential contamination from nitrosamines such as N-nitrosodimethylamine (‘NDMA’) and N-nitrosodiethylamine (‘NDEA’).

The complaint alleges that this occurred because Pfizer did not maintain current good manufacturing practices (cGMPs) or adhere to other proper practices and regulations when it produced the drugs.

The complaint claims, “According to FDA testing, [Pfizer’s] VCDs contained nitrosamine levels many times higher than the FDA’s updated interim limits for nitrosamine impurities.” It claims that the FDA and other authorities regard nitrosamines as “dangerous probably human carcinogens.”

Pfizer began recalling the drugs in July 2021, the complaint alleges, with the recall including all Chantix products by September 2021.

“On information and belief,” the complaint alleges, “N-nitroso-varenicline contamination of [Pfizer’s] VCDs dates back many years, at which point [Pfizer] had actual or, at minimum, constructive notice of the contamination.” The complaint claims that Pfizer has been unjustly enriched by the sales of these contaminated drugs.

Article Type: Lawsuit
Topic: Consumer
Tags: Contaminated with Harmful Substances, Contamination During Preparation or Use, Deceptive Advertising, Deceptive Labels, Pharmaceuticals