Roche claims counterfeit diabetes medical devices have been sold on Amazon

RoshOne of the world's largest biotech companies said “dangerous counterfeits” of its diabetes medical devices have ended up for sale online. Amazon To be purchased by patients across the United States.

Roche has accused manufacturers and sellers based in India of selling counterfeit copies of Accu-Chek devices, which are used to test blood sugar levels. The company made the claim in a federal lawsuit that was unsealed late Friday.

“Patients know that Roche’s Accu-Chek medical devices are safe, sterile and accurate,” the complaint states. Roche said the counterfeit test strips are expired or about to expire products being repackaged with counterfeit labels bearing Roche's U.S. registered trademarks and falsified expiration dates.

It warned that counterfeit devices “are likely to give false or inaccurate measurements of blood glucose levels, putting patients at risk of severe and life-threatening complications, such as hyperglycemia and over or underdosing of insulin.”

The lawsuit, which was filed in May in US District Court in New York City's Brooklyn borough, names four companies and their executives, all based in India, as defendants. Roche is seeking unspecified damages.

After the lawsuit was filed, the judge granted Roche's request for a temporary restraining order to prevent the defendants from selling counterfeit products. Amazon stores that were offering the products for sale appear to have been removed.

Amazon is not a defendant in this case, but Roche claims that as part of the alleged scheme, all counterfeit products sent to the United States were stored in Amazon warehouses across the country, including in Brooklyn. Products are typically shipped to businesses and individuals within 48 hours of arriving at Amazon facilities.

“Amazon currently has countless numbers of these dangerous counterfeit medical devices in its warehouses across the country, ready to deliver to unsuspecting American consumers at the click of a button,” the complaint reads.

Roche said the counterfeiters participated in Amazon's Fulfillment by Amazon program, through which Amazon “agrees to receive, store, and accept orders on behalf of the counterfeiters; select, package, and ship counterfeit goods; and provide customer service to the counterfeiters.” …In return, Amazon receives a large percentage of the revenue from counterfeit sales,” according to the complaint.

An Amazon spokesperson told CNBC that the company has a “zero-tolerance policy for counterfeit products. We have proactive measures to prevent counterfeit listings and constantly monitor our store. If we identify a problem, we act quickly to protect customers and brands, including removing counterfeit listings and banning accounts.” “And cooperate with brands and law enforcement to protect our customers from bad actors trying to abuse our store.”

The complaint was filed on behalf of Roche Diabetes Care Inc. Roche Diabetes Care GmbH and Hoffmann-La Roche Inc, by attorneys at the New York-based law firm Patterson Belknap Webb & Tyler.

The defendants are JMD Enterprises doing business as DKY Store USA, JMD Enterprises founder and owner Dilip Kumar Yadav, JMD International, JMD International owner and founder Abhishek Jain, Medical Hub_USA Store, Medical Hub_USA owner Ratnakar Sharma, Authentic Indian Store, Authentic Indian Store Owner . Atikur Rahman.

CNBC has contacted the accused for comment, but has not yet received responses.

A Roche spokesperson told CNBC that the company does not comment on ongoing litigation.

Roche Accu-Chek diabetes care medical devices, used by millions of patients, include Accu-Chek glucometers, blood glucose test strips and lancets. The company's blood glucose testing strips and lancets can be purchased with or without a prescription at pharmacies and online marketplaces, including Amazon.

Lancets are specialized disposable needles used to draw blood for testing.

The packaging on the counterfeit devices at the heart of the lawsuit included a misspelling of the product name as well as false serial numbers and expiration dates, according to the complaint.

The company began an investigation into the counterfeit products in late March, when a whistleblower arrived, according to the complaint. Its investigators then purchased the products from the three Amazon stores listed in the complaint, the lawsuit said.

Last May, a customer left a negative review on Amazon, complaining that he ordered test strips from DKY but received a different product. In March, another customer said the scalpels she bought from DKY were fake.

Roche did not specify how long the counterfeit items had been sold on Amazon, or how many items eventually reached customers.

The issue of potentially dangerous glucose test strips arose in 2019 when the Food and Drug Administration warned against using test strips from a previous owner or those not authorized for sale in the United States. At the time, the FDA said defective test strips were being sold through online marketplaces and individual sellers.

In 2011, Johnson & Johnson She said she had found fake copies of glucose test strips in India.

CNBC reported in March the results of an investigation into stolen items sold on Amazon's marketplace via retail organized crime gangs. The report focused on stolen items worth millions of dollars Alta Beauty Which have been sold for over a decade on the platform.

And in 2023, a CNBC investigation revealed how counterfeiters illegally alter prescription medications, which are then routed into the gray market supply chain for resale to pharmacies and ultimately to patients.