Aurobindo Pharma faces class action suit in US for concealing facts

Aurobindo Pharma allegedly concealed facts about cancer-causing agent NDMA in type-2 diabetes drug metformin

A class action suit has been filed against Aurobindo Pharma and Emcure Pharmaceuticals in a Florida court for allegedly concealing information about cancer-causing agent, N- nitrosodimethylamine (NDMA) presence in metformin medicine.

MSP Recovery Claims filed the petition on April 3 in 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 produced by Aurobindo and Heritage were contaminated with NDMA with levels between 37 and 266 ng per tablet.

As to Heritages 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 a comment.

The petition claimed that the defendants have manufactured and distributed metformin drugs throughout the United States, for which the litigants assignors paid approximately USD 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 cGMPs (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.

The petitioner claims are typical because the drug companies, through their misrepresentations and omissions, caused Plaintiffs and the Class Members to pay for adulterated and contaminated Metformin for which Plaintiff and the Class never should have had to pay, the petition alleged.

Aurobindo, Sandoz call off $900 mn deal

Aurobindo Pharma on Thursday said the USD 900 million deal to acquire Sandoz Inc's US-based generic oral solids and dermatology businesses, has been mutually called off.

"The decision was taken as approval from the US Federal Trade Commission for the transaction was not obtained within anticipated timelines," Aurobindo Pharma said in a regulatory filing.

In September 2018, Aurobindo Pharma had said its US subsidiary has entered into a pact to acquire commercial operations and three manufacturing facilities in America from Sandoz Inc, USA, for $900 million.

The acquisition was to be made through its wholly-owned subsidiary, Aurobindo Pharma USA Inc.