A class action lawsuit has been brought against a number of drug manufacturers over generic metformin, a widely used diabetes medication and the latest drug to become embroiled in the ongoing N-nitrosodimethylamine (NDMA) controversy. The lawsuit was filed by Joseph Brzozowski in the U.S. District Court for the District of New Jersey on March 3, and seeks class action status to pursue damages on behalf of all generic metformin users who took the drug, unaware that it could be contaminated with NDMA and increase their risk of cancer. If you have been diagnosed with cancer and you believed NDMA exposure from metformin or another tainted medication to be the culprit, do not hesitate to seek legal help. The NDMA contamination controversy is rapidly expanding and affected consumers have the right to hold the drug makers financially accountable for their medical bills, pain and suffering and other losses.
A number of popular pharmaceutical drugs have been found to be tainted with NDMA and other cancer-causing chemicals since 2018, including the heartburn drug Zantac (ranitidine) and the generic blood pressure and heart failure drugs valsartan, losartan and irbesartan. This new class action lawsuit comes on the heels of a citizen’s petition indicating that some versions of the diabetes drug metformin distributed in the United States were also tainted with NDMA. NDMA is a chemical byproduct classified by the International Agency for Research on Cancer (IARC) as a probable human carcinogen, or a substance capable of causing cancer in humans.
Over the past several months, widespread drug recalls for Zantac, valsartan, losartan, irbesartan and other widely used medications were issued by federal regulators after samples of the drugs tested positive for NDMA contamination. Concerns about the potential for metformin to be tainted with NDMA first arose late last year, after the presence of NDMA was discovered in some versions of the diabetes drug sold outside the United States. At that time, the FDA decided against issuing a metformin recall in the U.S., reporting that “no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA.”
Earlier this month, Valisure, the independent online pharmacy that first alerted the FDA to the presence of NDMA in Zantac last year, filed a citizen’s petition urging the agency to recall metformin. Valisure stated in the petition that the pharmacy “has tested and detected high levels of N-Nitrosodimethylamine (‘NDMA’) in specific batches of prescription drug products containing metformin.” The petition warned that “The carcinogenic nature of nitrosamines in general, and NDMA specifically, has been well documented in the scientific community since the 1960s” and that “the presence of this probable carcinogen in a medication that is taken daily by adults and adolescents for a chronic condition like diabetes, makes this finding particularly troubling.”
Metformin is a generic medication widely prescribed for the purpose of controlling high blood sugar in patients with Type 2 diabetes. The drug is sold under several brand names, including Carbophage, Glucophage, Diabex, Fortamet and Riomet, and is generally considered the “gold standard” of diabetes treatment. According to Brzozowski’s class action lawsuit, he took metformin from April 2009 until September 2017, and during that period, received several drug products that have since been found to contain NDMA. The complaint alleges, among other things, that the defendants’ metformin drugs were adulterated, or unfit for ordinary use, and were “illegally introduced into the American market for Defendants to profit from their sale to American consumers, such as Plaintiff and Class Members.”
Among the defendants named in the metformin class action lawsuit are Actavis, Teva Pharmaceuticals and CVS Health Corporation, each of which is accused of failing to warn consumers and healthcare providers that contaminated metformin pills may contain NDMA. “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 complaint 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.”
While the FDA continues to investigate the underlying cause of the NDMA contamination in pharmaceutical drugs like metformin, Zantac and valsartan, many consumers diagnosed with cancer in recent years are pursuing product liability lawsuits against the drug manufacturing companies. Each of the lawsuits involves similar allegations that the plaintiffs could have avoided a cancer diagnosis had they been warned that the drugs could be tainted with NDMA and increase their risk of developing cancer. To discuss the possibility of filing a product liability lawsuit over a cancer diagnosis allegedly caused by a contaminated metformin drug, contact an experienced drug injury attorney today.