Generic drug makers are facing a new class action lawsuit over metformin tablets that were allegedly contaminated with a cancer-causing impurity.
The complaint, which was filed on March 3rd in the U.S. District Court, District of New Jersey, seeks damages on behalf of consumers who unknowingly took generic metformin tablets, unaware they were contaminated and might increase their risk of cancer. Actavis, Teva Pharmaceuticals, and CVS Health Corporation are among the defendants named in the metformin lawsuit. However, as many as 100 additional defendants are yet to be identified. (Case No. 2:20-cv-02324)
“At all times during the period alleged herein, Defendants represented and warranted to consumers that their generic metformin products were otherwise fit for their ordinary uses, and were otherwise manufactured and distributed in accordance with applicable laws and regulations,” the lawsuit states. “However, for years, Defendants willfully flouted federal current Good Manufacturing Practices and ignored other warning signs that Defendants’ Metformin products contained or likely contained NDMA and/or other impurities.”
Metformin is a first-line treatment for Type 2 diabetes sold under the brand names Glucophage, Carbophage, Fortamet, and Diabex. Dozens of drug makers also market generic versions of metformin.
This past December, the U.S. Food & Drug Administration (FDA) announced it was investigating reports that some metformin tablets contained high levels of N-Nitrosodimethylamine (NDMA) – a probable human carcinogen. The investigation followed several metformin recalls in Singapore that involved tainted diabetes drugs.
The FDA eventually acknowledged that its tests had detected NDMA in some metformin samples, but maintained that the levels found were far below its recommended daily limit of 96 nanograms. As a result, the agency did not request any metformin recalls in the United States.
Earlier this month, however, the online pharmacy Valisure announced its own testing had found excessive levels of NDMA in 16 of 38 metformin samples tested. The highest levels were detected in Amneal Pharmaceutical’s metformin, which in some cases contained as much as 16-times the FDA’s recommended daily limits. Several companies’ metformin contained more than 10 times the limit.
Valisure has since petitioned the FDA for a recall of the affected metformin lots, as well as an investigation into how NDMA came to contaminate the medications.
Valisure is the same company that discovered NDMA in Zantac, which has resulted in dozens of lawsuits that blame the popular heartburn medication for causing cancer.
In 2018, the discovery of NDMA in generic angiotensin II receptor blockers (ARBs) led drug makers around the world to recall valsartan, losartan, and irbesartan-containing heart and blood pressure medications. Hundreds of lawsuits have also been filed in connection with those recalls.