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A proposed class action filed Thursday in Manhattan federal court accused Pfizer Inc. of misleading consumers about the health risks associated with the over-the-counter heartburn medicine Zantac.

The lawsuit targeted the New York-based drugmaker over its former production of the medicine, which includes NDMA, an organic chemical that has been linked to certain forms of cancer. According to the filing, Pfizer manufactured Zantac from 2000 to 2006, but never listed NDMA as an ingredient or disclosed the chemical's cancer-causing properties.

"While defendant represented that its Zantac formulation was safe for use, Zantac contains dangerously high levels of NDMA, rendering the product dangerous and unfit for human consumption," attorneys from Bursor & Fisher in New York wrote in 22-page complaint.

In a statement, Pfizer said that it had not sold Zantac in 13 years, and was planning to respond to the suit.

"We believe this proposed class action complaint is without merit and will respond to it in due course," the company said.

The suit was filed on behalf of plaintiff Dana Viola, a New Jersey resident who began purchasing Zantac in 2000. Viola said she stopped using Zantac in 2016, after several drugmakers and pharmacies began recalling branded and generic versions of Zantac.

A spate of recent lawsuits have accused Sanofi-Aventis, the current maker of branded Zantac in the U.S., and an array of generic drugmakers of similar violations. Sanofi, GlaxoSmithKline, Novartis and others have all issued voluntary recalls after the U.S. Food and Drug Administration found NDMA in the drugs this past September.

Viola's suit cited figures by Valisure, an FDA-registered online pharmacy, which found that certain lots of Zantac contained between 2.5 million and 2.8 million nanograms per tablet. The FDA, the suit said, limits the permissible intake limit of NDMA at 96 nanograms per day.

"These medications are worthless, as they contain harmful levels of NDMA. As the medications expose users to NDMA well above the legal limit, the medications are not fit for human consumption," the lawsuit said. "Plaintiff is further entitled to statutory damages, damages for the injury sustained in consuming high levels of acutely-toxic NDMA, and for damages related to defendant's conduct."

The lawsuit, which estimates a proposed class in the "tens of thousands," alleged breaches of warranty, unjust enrichment, fraud, fraudulent concealment and violations of the New Jersey Consumer Fraud Act. It seeks compensatory, statutory and punitive damages, as well as restitution and attorney fees.

Viola also asked that the court to approve a "subclass" of plaintiffs who bought Zantac in New Jersey. Viola is represented by Andrew Obergfell and Joseph Marchese of Bursor & Fisher in New York and Neal Deckant from the firm's Walnut Creek, California, office.

The case, filed in the U.S. District Court for the Southern District of New York, has not yet been assigned to a judge.

 

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