Pfizer faces a class action lawsuit over Chantix recalls filed in recent months, which alleges the presence of toxic impurities makes the smoking cessation drug an unacceptable risk of cancer for users.
The complaint (PDF) was filed by Rosalyn Harris in the U.S. District Court for the Southern District of New York on August 12, seeking class action status to pursue damages for all consumers who purchased recalled Chantix pills.
Chantix (varenicline) was introduced by Pfizer in 2006, as a prescription medication designed to help people quit smoking. However, the manufacturer halted Chantix distribution in June, when it was discovered pills may contain dangerous levels of a chemical byproduct, known as nitrosamines, which may increase the risk of cancer.
Pfizer announced a Chantix recall in the U.S. a month later, and has since expanded the warnings to include additional lots of the medication that may contain N-nitroso-varenciline and other carcinogenic impurities.
Harris, of New Jersey, indicates she purchased several packs of Chantix which were later included in the recall, saying Pfizer represented Chantix as a safe and effective means, free from defects, to help her stop smoking.
“Ms. Harris relied on these representations and warranties in deciding to purchase Chantix from Defendant, and these representations and warranties were part of the basis of the bargain, in that she would not have purchased Chantix from Defendant on the same terms if she had known that it was not, in fact, properly manufactured and free from defects,” her lawsuit states.
Over the last few years, several drugs, such as Zantac, valsartan and metformin, have faced similar recalls, primarily to do the presence of a nitrosamine known as N-Nitrosodimethylamine (NDMA).
Pfizer indicates it has received no reports of adverse events linked to this recall.
Harris’s lawsuit presents claims of breach of warranty, violation of the New Jersey Consumer Fraud Act, unjust enrichment, and fraud. She seeks both compensatory and punitive damages for herself and other class members.