Class Action Metformin Lawsuit Filed Over Recalls Due To NDMA Contamination

Some diabetes drug makers now face a class action lawsuit, which calls for them to compensate those who purchased generic metformin that was recalled following the discovery that pills may be contaminated with a cancer-causing chemical byproduct of the manufacturing process.

Masao Hendrix filed the complaint (PDF) late last month in the U.S. District Court for the Eastern District of California, naming Avkare, Inc. and Amneal Pharmaceuticals as defendants, as well as up to 100 unnamed defendants.

Hendrix says he and other class plaintiffs paid for generic metformin products tainted with high levels of N-nitrosodimethylamine (NDMA); a known cancer causing agent. His lawsuit indicates if he and others had been told about the NDMA contamination, they would have never bought the products.

“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 warnings signs that Defendants’ Metformin products contained or likely contained NDMA and/or other impurities.”

The complaint joins a growing number of class action metformin lawsuits filed against various generic drug manufacturers in recent months. While this seeks compensation for what some plaintiffs see as wasted money spent on metformin, as well as the need for future medical monitoring, additional complaints have also been filed by individuals who claim they developed cancer following years of exposure to metformin containing the carcinogenic byproduct.

NDMA is considered a human carcinogen, and has been found to contaminate other pharmaceutical drugs to manufacturing or design problems. A number of Zantac recalls and valsartan recalls have been issued over the past few years, after dangerously high levels of NDMA were detected in the popular heartburn and blood pressure medications, and users reported developing stomach cancer, bladder cancer, liver cancer and other injuries following long-term use.

Late last year, reports first warned about the potential risk of metformin NDMA contamination problems, after some versions of the drug sold outside the United States tested positive for the chemical, raising concerns that metformin recalls may be necessary. However, the FDA indicated at that time that testing of products distributed in the U.S. found that the NDMA levels in metformin were undetectable or below federal limits for exposure to the chemical.

In March, the independent online pharmacy Valisure filed a citizen’s petition urging the FDA to issue metformin recalls, after independent testing found levels of NDMA in certain pills was higher than the agency’s recommended daily exposure threshold of 96 nanograms.