Pfizer, the U.S.-based pharmaceutical giant, announced on September 16th, 2021 that they were expanding their nationwide recall of their smoking-cessation drug known as Chantix. This updated recall now includes all lots of the drug and its derivatives , and the reason for this expansion has to do with unhealthy amounts of N-nitroso-varenicline, a chemical that is recognized as being carcinogenic.
Since then, the company has become embroiled with new lawsuits from Chantix users from all over the country. One of the claims, and perhaps the most noteworthy, is a new class-action lawsuit that has recently been filed in the Western District of Pennsylvania.
Claimant Alleges Pfizer Falsely Marketed Varenicline Drugs
Court records indicate that the plaintiff for the class-action claim resides in Pittsburgh, and her claim alleges that she purchased multiple anti-smoking drugs, which are also referred to as varenicline-containing drugs (VCDs). The drugs were branded with a National Drug Code that identified them as being produced and distributed by Pfizer, and they were marketed in the same manner as Chantix, a longstanding Pfizer product.
The claimant has alleged that the products in question were not Chantix, and were actually of lower quality than Pfizer represented them to be.
Chantix is an oral medication that is intended to help users resist the urge to smoke. The drug was introduced to domestic markets in early 2006, and it didn’t take long to become one the company’s best-selling drugs. In 2020 alone, Chantix brought in over $900 million in sales, and it has eclipsed the $1 billion mark multiple times.
The drug is patent protected until 2023, which prevents any other manufacturers from producing generic alternatives. That being said, Pfizer marketed their other VCDs as being equivalent in use and efficacy to brand-name Chantix. The class-action claim alleges that the VCDs purchased by the plaintiff were not only misrepresented, but also contaminated with N-nitroso-varenicline, and possibly other harmful substances.
Class-Action Plaintiff Hopes to Represent All U.S. Chantix Claims
Pfizer began announcing recalls of their VCDs in July 2021 because of potentially unhealthy amounts of N-nitroso-varenicline. Then in mid-September, they expanded this recall to include all of their Chantix products as well.
According to her claim, the plaintiff has alleged that because the products feature N-nitroso-varenicline, that reclassifies them as different drugs that have not been properly approved. The suit states that the new drugs have “additional active ingredients (such as nitrosamines in the subject VCDs),” which means that they cannot be branded with the same label as brand-name drugs (Chantix), because at that point “the two products are no longer the same.”
She adds that if nothing else, drugs with unlabeled and dangerous ingredients are misrepresented and falsely branded, which makes them illegal to sell to the general public. The claimant hopes to represent all U.S. consumers who have purchased a VCD that was produced or distributed by Pfizer.
Examples of Other Drugs That Have Been Recalled for Nitrosamine Impurities
Unfortunately, Chantix is only one of multiple drugs that have faced litigation after being contaminated by nitrosamines. Zantac, valsartan, losartan, and metformin are all widely-prescribed drugs that are currently facing similar recalls and lawsuits. Nitrosamines such as N-nitroso-varenicline and N-nitrosodimethylamine (NDMA) are widely considered to be carcinogenic to humans, and they can appear in prescription drugs as byproducts of either storage errors or negligent design practices.
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