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Metformin Class Action Lawsuit Filed Over NDMA Contamination

Posted on 05/06/2020Back

Why Was The Metformin Class Action Lawsuit Filed?

A multi-million-dollar class action lawsuit has recently been filed against two manufacturers of the popular type-2 diabetes drug, Metformin.

The class action lawsuit claims that Aurobindo Pharma and Emcure Pharmaceuticals breached the express warranty (a warranty that explicitly makes a promise about the quality of the product) that the Metformin they produced complied with Current Good Manufacturing Practices (cGMPs). The suit, filed on April 3, claims that express warranty was breached after a study found certain batches of Metformin to be contaminated with dangerous levels of the probable human carcinogen, NDMA.

The complaint states that “[the defendants] made express and implied representations to Plaintiff assignors and Class Members that their Metformin drugs conformed to applicable standards of quality, purity, identity and strength, were not adulterated, and were merchantable, fit for human consumptions and fit for their intended purpose when, in truth and in fact, the Metformin drugs were contaminated with a probable human carcinogen.”

Due to the concealment of the NDMA contamination, the petition alleges that the “defendants knowingly and with an intent to defraud, concealed from plaintiffs and class members the material facts concerning their pervasive cGMP violations.”

As a result of the allegedly fraudulent misrepresentations made by the two drug makers about the compliance of their Metformin with safety regulations, the petition claimed that health insurers purchased $124 million worth of contaminated Metformin.

However, the petition claims, if the contamination had not been concealed from health insurers, that they never would have purchased the Metformin. Therefore, the class action lawsuit is an attempt to recovery the $124 million loss.

Who are the Defendants?

The Metformin class action lawsuit names drug manufacturers Aurobindo Pharma (based in Hyderabad, India), Aurobindo USA Inc. and Aurolife Pharma LLC (U.S. affiliates of Aurobindo Pharma), Heritage (based in New Jersey), and Heritage’s parent company Emcure Pharmaceuticals (based in India).

Who are the Plaintiffs?

Florida-based law firm MSP Recovery filed the petition for the class action lawsuit in the U.S. District Court for the Southern District of Florida on behalf of healthcare insurers such as Emblem Health, Summacare Inc., and Connecticare Inc. The class action intends to recover payments for contaminated Metformin produced by drug makers and subsequently purchased by the healthcare insurers.

The petition highlights what MSP Recovery says are repeated deviations from drug manufacturing quality and safety standards and the fact that the defendants’ allegedly knowingly or recklessly misrepresented their Metformin drugs as safe.

MSP explained that, “Simply put, no doctor would prescribe, no patient would consume, and no insurance company would pay for, a drug that contained NDMA, a probable human carcinogen. Plaintiff’s assignors and the class members would not have continued paying for the drugs if they had known the drugs were adulterated, which meant the drugs could not lawfully be sold or distributed, and were, therefore, worthless.”

The plaintiffs allege that the healthcare insurers have paid about $124 million since 2012 for generic Metformin that was contaminated.

What is the Evidence?

The class action lawsuit against the two manufacturers of Metformin is based on test results from the online pharmacy Valisure, who detected unacceptable amounts of the probable human carcinogen NDMA in Metformin and reported their test results to the Food and Drug Administration (FDA) on March 2, 2020.

Valisure’s test results revealed that certain batches of Metformin produced by Aurobindo and Heritage were contaminated with levels of NDMA between 37 and 266 nanograms (ng) per tablet of Metformin. The FDA’s daily acceptable intake limit of NDMA is 96 ng.

What Is Metformin?

Metformin is the most commonly prescribed drug for patients suffering from type-2 diabetes. Overall, Metformin is also the fourth most prescribed drug in the United States with 81 million prescriptions in the last year alone.

Metformin was first sold by Bristol-Myers Squibb Co. in 1995 in the United States under the brand name Glucophage. However, since 1995 the FDA has approved more than 20 generic versions of Metformin to enter the U.S. drug market and those generic Metformin drugs are produced by a variety of drug manufacturers.

NDMA contamination in pharmaceutical drugs has been linked to various cancers, such as:

  • Stomach cancer
  • Bladder cancer
  • Intestinal cancer (in both the large and small intestine)
  • Colon cancer / Colorectal cancer
  • Esophageal cancer
  • Liver cancer
  • Prostate cancer
  • Pancreatic cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Kidney cancer
  • Multiple Myeloma
  • Breast Cancer
  • Testicular Cancer
  • Uterine Cancer

How can GoldenbergLaw Help You?

If you or a loved one has been diagnosed with cancer after taking metformin, contact GoldenbergLaw for a free consultation on a metformin lawsuit today. Our Minnesota Cancer Attorneys have over 30 years of experience fighting pharmaceutical corporations and will deliver the Gold standard advocacy you deserve.

Category Dangerous Drugs News