Class Action Claims Walgreens Sold NDMA-, NDEA-Contaminated Valsartan to Illinois Consumers

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A proposed class action alleges Walgreens sold the now-recalled heart failure drug valsartan without disclosing to Illinois consumers that the medication was contaminated with the carcinogens NDMA (nitrosodimethylamine) and NDEA (n-nitrosodiethylamine).

Filed in Cook County circuit court, the lawsuit notes that the FDA in July 2018 announced a nationwide recall of valsartan after an NDMA impurity was detected. According to the complaint, valsartan tablets contained “as much as 20,000 nanograms” of NDMA, more than 200 times the acceptable 96 nanogram limit for daily consumption. Two months later, the suit says, the FDA discovered an additional valsartan impurity, this time of NDEA, a known animal and suspected human carcinogen. 

The lawsuit alleges that Walgreens “made misrepresentations and omissions of material fact” with regard to valsartan containing dangerous levels of NDMA and NDEA. Cited in the case are personal prescription information documents given to proposed class members at the time they bought valsartan from Walgreens. According to the suit, the documents “stated that consumers were receiving Valsartan, and only Valsartan”—not a drug that contained elevated and unsafe levels of the two probable carcinogens.

As the case tells it, the presence of NDMA and NDEA in valsartan is material to consumers, who believed they were purchasing a drug that was safe and fit for its ordinary uses.

“Because the Valsartan that Walgreens sold was not safe, was unfit for its ordinary and intended uses, and contained impurities and carcinogens in unreasonably high levels, those representations were false, misleading, and deceptive,” the case says.

The plaintiff asserts that neither he nor proposed class members would have bought valsartan from Walgreens had they known the drug posed an “undisclosed risk of injurious health consequences such as cancer.”