October 22, 2020 – Another Lawsuit Filed as Metformin Recalls Continue
Another lawsuit was filed against Heritage Pharmaceuticals, which does business as Avet Pharmaceuticals, over the alleged contamination of its generic metformin medication with NDMA, “a carcinogenic and liver-damaging impurity.”
Filed in August 2020, an amended complaint claims consumers would not have purchased the popular diabetes drug had they known it contained “dangerously high levels” of NDMA above the legal limit defined by the U.S. Food and Drug Administration (FDA). According to the case, the contaminated product is “worthless” and has injured consumers, who paid full-price for a medication “not fit for human consumption” and ingested “high levels of acutely-toxic NDMA.”
The lawsuits detailed on this page come amid a wave of recalls of metformin medications, though Avet has yet to issue any recalls for the drug at issue in these cases. In light of recent FDA testing that revealed higher-than-acceptable levels of NDMA in various metformin samples, voluntary recalls have been issued over the past few months by several manufacturers, including Apotex, Amneal, Marksans, Lupin, Teva, Bayshore, and Sun.
Click here to see the full list of recalled metformin medications.
The latest information about the recalls and testing can be found on the FDA’s website.
According to a proposed class action lawsuit, generic metformin manufactured by Heritage Pharmaceuticals, Inc. has been found to contain dangerously high levels of probable carcinogen N-nitrosodimethylamine (NDMA).
The complaint out of New Jersey states that online pharmacy Valisure announced on March 2, 2020 that it had detected high levels of NDMA in prescription metformin, a drug sometimes sold under the brand name Glucophage that’s used to control high blood sugar in patients with type 2 diabetes. According to the case, NDMA, which Valisure said was found in batches manufactured by Heritage, doing business as Avet Pharmaceuticals, was formerly used in the production of liquid rocket fuel and has been linked to liver damage and cancer in humans.
The lawsuit claims the defendant’s metformin was found to contain between 5.3 and nearly nine times the FDA’s daily intake limit for NDMA, which the case notes is “particularly troubling” given the medication is to be taken daily.
According to Valisure, the contamination may be linked to problems in the manufacturing process rather than “a fundamental instability of the drug molecule,” the case says. The lawsuit argues that Avet’s metformin medications would not be contaminated with NDMA if the drug had been “properly manufactured.”
Although Valisure recommended a recall of Avet’s metformin medications, the lawsuit claims the company has not only refused to pull the drug from the market but continues to tout on its website that it manufactures “high quality generic medicines.” The suit argues that the defendant’s customers have been, and continue to be, misled by Avet’s representations that its metformin is “safe and effective.”
“However, these representations are false,” the complaint scathes, “as Defendant’s metformin medication contains the carcinogenic impurity NDMA.”
The suit claims proposed class members would not have purchased the medication, or would have paid less for the drug, had they known Avet’s metformin was contaminated with “dangerously high levels” of NDMA.