Class Claims Filed over NDMA in Diabetes Medication

Elizabeth DiNardo, Esq. | Associate Counsel



On March 30, 2020, class claims were filed in New Jersey federal court against Heritage Pharmaceuticals, Inc. (d/b/a Avet Pharmaceuticals Inc.), alleging that the defendant has been manufacturing, distributing and selling the generic medication metformin that contains dangerously high levels of the carcinogen N-nitrosodimethylamine (“NDMA”) which can cause serious damage to the liver.

In the complaint, named plaintiff Michael Hann disclosed that on March 2, 2020 the U.S. Drug Enforcement Agency and FDA-registered online pharmacy Valisure detected high levels of NDMA in specific batches of prescription drug products containing metformin. Plaintiff argues that despite these findings, the defendant consistently marketed metformin as safe and effective.

Metformin is used to control high blood sugar in patients with Type 2 diabetes and has achieved a large customer base with over 78.6 million prescriptions written in the U.S. The suit alleges that had Avet properly manufactured the medication, it would not contain dangerously high levels of NDMA. The complaint goes on to detail how NDMA is a probable human carcinogen which is known to cause tumors on the liver, in the respiratory tract, on the kidneys and in blood vessels, as revealed in animal testing. Valisure found that Avet’s metformin contains around 5.3 to nearly 9 times the accepted daily human intake level of NDMA. The suit alleges that the medication is worthless as it contains such harmful levels of NDMA and is therefore not fit for human consumption.

The plaintiff is seeking to represent a class made up of all persons in the U.S. who purchased metformin manufactured by Avet, excluding all persons who made such purchase for the purpose of resale, plus the defendant, defendant’s officers, directors, agents, and trustees. The suit brings causes of action for breach of implied warranty of merchantability, unjust enrichment, fraudulent concealment, fraud, conversion, violation of California’s Consumers Legal Remedies Act and violation of California’s Unfair Competition Law.

The case is: Michael Hann v. Heritage Pharmaceuticals Inc., Case No.: 3:20-cv-03415, in U.S. District Court for the District of New Jersey.

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