Homicide

7/19/23

California State Board of Pharmacy
2720 Gateway Oaks Dr, Suite 100
Sacramento, CA 95833
Attn: Public Records Desk

Bloomberg Article
04/07/20
Aurobindo Pharma Faces Class Action Suit In U.S. For Hiding Facts

A class action suit has been filed against some drug manufacturers, including Aurobindo Pharma Ltd. and Emcure Pharmaceuticals, in a U.S. court for allegedly concealing facts about a cancer-causing agent, N- nitrosodimethylamine presence in metformin medicine.

Florida-based law firm MSP Recovery filed the petition on April 3 in the U.S. District Court for the Southern District of Florida on behalf of similarly-situated healthcare insurers to recover payments unlawfully induced by the drug makers- Aurobindo Pharma, Aurolife Pharma, LLC, and Heritage Pharmaceuticals LLC.

Metformin is the most prescribed oral pharmaceutical drug for patients with type-2 diabetes. The petition was based on tests done by Valisure, an online pharmacy. Valisures tests revealed that the metformin produduced by Aurobindo and Heritage were contaminated with NDMA with levels between 37 and 266 ng per tablet.

As to Heritage's metformin products, the NDMA present was up to 8.6 times the FDAs interim daily limit. The Valisure, while posting the results on its website, however, indicated that Aurobindo passed the FDA test for the NDMA presence. Officials of Aurobindo could not be reached for their comments. The petition claimed that the defendants have manufactured and distributed metformin drugs throughout the United States, for which the litigants' assignors paid approximately $124 million on behalf of their members.

The drug makers breached their express warranties with respect to their Metformin drugs because the drugs did not comply with current good manufacturing practices, were adulterated and contaminated, were not bioequivalent to branded drugs, and could not lawfully be sold, the petitioner alleged.

The defendants knowingly and with an intent to defraud, concealed from plaintiff and class members the material facts concerning their pervasive cGMP violations "...made express and implied representations to plaintiffs 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 consumption and fit for their intended purpose when, in truth and in fact, the Metformin drugs were contaminated with a probable human carcinogen, the petition said.

Valisure
5 Science Park
New Haven, CT 06511

Valisure

Valisure
Citizen Petition
03/02/20
pdf file , 16 pages
jpg
first page

Valisure acquired metformin batches from all companies reasonably available to it through its pharmacy suppliers. Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches from 11 companies where NDMA levels were detected above the 96 ng daily acceptable intake limit, which was factored using a common number of tablets taken per day. Several batches contained over 10 times the daily acceptable intake limit and there was significant variability from batch to batch, even within a single company; underscoring the importance of batch-level chemical analysis and the necessity of overall increased quality surveillance of medications.

Valisure’s results will be of significant concern to medical practitioners who already struggle to prescribe safe medications and who rely on external government and private sector oversight to ensure contaminant-free drugs. Due to the discovery of significant levels of NDMA contamination, Valisure’s pharmacy will not sell the affected batches of metformin it has acquired and Valisure cannot obtain a refund for these tainted products because they have not been recalled.

Petitioner urges the Commissioner and FDA to expeditiously request recalls on the affected batches of medication so they are removed from the American drug supply, and to take other such actions outlined in this Petition as deemed appropriate.

My letter to Valisure, dated 4/17/22
email response, dated 4/28/22, from Jill Nailor
Valisure will do the test. They need 6 pills. It will cost $500.

Philip G Rice
11268 E Linvale Dr
Aurora, CO 80014

(970) 235-0470
phil.rice@mkgappraisal.com

-- End of Letter --

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