Pfizer Prevails In Proposed Class Action Over Chantix Recall

A New York federal judge threw out a proposed class action over Pfizer’s Chantix recall, ruling that the consumers haven’t adequately alleged that Pfizer made any misrepresentations as to the presence of a possible carcinogen in the drug.

U.S. District Judge Denise L. Cote granted Pfizer’s motion to dismiss the suit, which centered on the presence of N-nitroso-varenicline — which is a nitrosamine, or chemical compound classified as possibly carcinogenic — in the smoking cessation drug. Pfizer recalled Chantix after learning about the N-nitroso-varenicline contamination.

Plaintiffs Roslyn Harris and Mary Allen claimed in their suit that they didn’t know Chantix contained N-nitroso-varenicline and they wouldn’t have purchased it had they known. They accused Pfizer of misrepresenting that the product contained only the active ingredient varenicline.

But Judge Cote said that Harris and Allen were required to plausibly allege that Pfizer represented or warranted that its product was free of nitrosamines — or at least that Pfizer had a duty to disclose any nitrosamine contamination. They haven’t done so, she said.

Neither the product label nor the medication guide stated that varenicline was the only biologically active ingredient in Chantix. Judge Cote also rejected the consumers’ contention that the contamination meant that the medication they bought is distinct from the Chantix that was approved by the U.S. Food and Drug Administration.

And the consumers haven’t alleged that Pfizer knew its drug was contaminated at the time that Harris and Allen purchased it. Nor have they plausibly alleged that Pfizer had a duty to disclose anything to them, as they weren’t in a fiduciary or special relationship with the company.

According to the consumers’ first amended complaint, Pfizer recalled Chantix last year due to contamination from N-nitroso-varenicline. Harris, a New Jersey resident, said she purchased four boxes of Chantix that were subject to recall. Meanwhile, Allen, of New York, said she purchased three boxes.

Both women said they paid a co-pay for Chantix and then took at least some of the medication before it was recalled. Neither Harris nor Allen contends that their health has suffered as a result.  Rather, they claimed that they didn’t see N-nitro-varenicline listed as an ingredient on the medication’s box or labeling, and the presence of the compound has rendered the product worthless.


Leave a Reply