Roche Alleges Counterfeit Diabetes Medical Devices Sold on Amazon

Rocheone of the world's largest biotechnology companies, said that “dangerous counterfeits” of its diabetes medical devices ended up on sale in Amazon to be purchased by patients throughout the United States.

Roche accused India-based manufacturers and sellers of selling counterfeit versions of its Accu-Chek devices, which are used to measure blood glucose levels. The company made the claim in a federal lawsuit unsealed Friday night.

“Patients know that Roche's Accu-Chek medical devices are safe, sterile, and accurate,” the complaint said. Roche said counterfeit test strips are expired or nearly expired products that are repackaged with counterfeit labels displaying Roche's U.S. trademarks and false expiration dates.

It warned that counterfeit devices “are likely to provide false or inaccurate measurements of blood glucose levels, putting patients at risk of serious and life-threatening complications, such as hyperglycemia and excessive or insufficient doses of insulin.”

The lawsuit, which was filed under seal in May in U.S. District Court in the Brooklyn borough of New York City, named four companies and their executives, all based in India, as defendants. Roche seeks compensation for unspecified damages.

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

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

“Amazon currently has an untold number of these dangerous counterfeit medical devices in its warehouses across the country, ready to deliver to unsuspecting American consumers with the click of a button,” the complaint says.

Roche said the counterfeiters participated in Amazon's FBA program, through which “Amazon agrees to receive, store, and accept orders on behalf of counterfeiters; pick, package, and ship counterfeit products; and provide customer service.” to counterfeiters.” …Amazon, in return, receives a significant percentage of the revenue from sales of counterfeit products,” 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 products from being listed and continually monitor our store. If we identify an issue, we act quickly to protect customers.” customers and brands, including removing counterfeit listings and blocking accounts, and working with brands and authorities 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 from 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 Dileep Kumar Yadav, JMD International, JMD International owner and founder Abhishek Jain, Medical Hub_USA store, Medical Hub_USA owner Ratnakar Sharma, the Authentic Indian Store and the owner of the Authentic Indian Store. Atikur Rahman.

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

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

Roche's 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 test 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 of the counterfeit devices at the center of the lawsuit includes 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 counterfeits in late March when a whistleblower reached out with information, according to the complaint. Their investigators then purchased the products from the three Amazon stores listed in the complaint, according to the lawsuit.

In May, a customer left a negative review on Amazon's platform, complaining that he had ordered test strips from the DKY store but received a different product. In March, another customer said the lancets he purchased at DKY were fake.

Roche did not specify how long the counterfeit items were sold on Amazon, or how many ultimately 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 ones that were not authorized for sale in the U.S. at the time. , the FDA said defective test strips were being sold online. Markets and individual sellers.

In 2011, Johnson and Johnson said it found counterfeit versions of its glucose test strips in India.

CNBC reported in March on the results of an investigation into stolen items sold on the Amazon marketplace through retail organized crime networks. The report focused on millions of dollars in items stolen from Ulta Beauty that have been selling for more than a decade on the platform.

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