Roche claims counterfeit medical devices for diabetes have been sold on Amazon

Rocheone of the world's largest biotech companies, said “dangerous counterfeits” of its diabetes medical devices have been put up for sale on Amazon to be purchased by patients throughout the United States.

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

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

It warned that the counterfeit devices are “likely to provide false or inaccurate readings of blood glucose levels, putting patients at risk of serious and life-threatening complications, such as hyperglycemia and over- or under-dosing of insulin.”

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

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

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

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

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; collect, pack, and ship the counterfeit goods; and to provide customer service to the counterfeiters…Amazon in return receives a significant percentage of the revenue from the sale of counterfeit products,” the complaint states.

An Amazon spokesperson told CNBC that the company “has a zero-tolerance policy toward counterfeit products. We have taken proactive measures to prevent counterfeit products from being listed and are constantly monitoring our store. If we identify an issue, we act quickly to protect customers and brands, including removing spoofed listings and blocking accounts, and working 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 New York-based law firm Patterson Belknap Webb & Tyler.

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

CNBC has reached out to the defendants for comment but has not yet received a response.

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

Roche's Accu-Chek medical devices for diabetes care, 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 from pharmacies and online marketplaces, including Amazon.

The lancets are specialized disposable needles used to draw blood for research.

According to the complaint, the packaging of the counterfeit devices at the center of the lawsuit contains a misspelling of the product name, as well as false serial numbers and expiration dates.

The company launched an investigation into the counterfeits in late March when a whistleblower contacted them with information, the complaint said. The investigators then purchased the products from the three Amazon stores listed in the complaint, the lawsuit said.

As recently as 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 she bought from 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 came to light in 2019 when the Food and Drug Administration warned against using test strips from a previous owner or test strips that were not approved for sale in the US. At the time, the FDA said defective test strips were being sold online. marketplaces and individual sellers.

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