Roche Diabetes Care’s Accu-Chek brand glucose test strips are displayed for a photo on Thursday, April 4, 2019, in Brooklyn, New York, the United States.
Alex Flynn | Bloomberg | Getty Images
RocheOne of the world’s largest biotech companies says “dangerous counterfeits” of its diabetes medical devices ended up being sold online Amazon Available to patients across the United States.
Roche accused manufacturers and sellers in India of selling counterfeit Accu-Chek devices, which are used to test blood sugar levels. The company made the claim in a federal lawsuit filed late Friday.
“Patients know that Roche’s Accu-Chek medical devices are safe, sterile and accurate,” the complaint states. Roche said the fake test strips were expired or near-expired products that were repackaged with false labels that said Roche in the U.S. registered trademark and false validity period.
It warns that counterfeit devices “may provide false or inaccurate measurements 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 U.S. District Court in Brooklyn, New York City, in May names four companies and their executives, all based in India, as defendants. Roche is seeking unspecified damages.
After the lawsuit was filed, a judge granted Roche’s request for a temporary restraining order to stop the defendants from selling counterfeit products. The Amazon store that sold the products appears to have been taken down.
Amazon is not a defendant in the case, but Roche claims that as part of the alleged scheme, all counterfeit products shipped to the United States were stored in Amazon warehouses across the country, including in Brooklyn. Products typically ship to businesses and individuals within 48 hours of arrival at Amazon facilities.
“Amazon currently stocks countless dangerous counterfeit medical devices in warehouses across the country, where they can be delivered to unsuspecting American consumers at the click of a button,” the complaint states.
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, pack and ship counterfeit goods; and provide customer service to the counterfeiters.” In return, Amazon receives a significant percentage of its revenue from counterfeit sales.
An Amazon spokesperson told CNBC that the company “has a zero-tolerance policy against counterfeit products. We take proactive steps to prevent counterfeit products from reaching our shelves and continually monitor our stores. If we discover an issue, we act quickly to protect Benefits to clients and consumers.
The complaint was filed by attorneys at the New York-based law firm Patterson Belknap Webb & Tyler on behalf of Roche Diabetes Care Inc., Roche Diabetes Care GmbH and Hoffmann-La Roche Inc.
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, Authentic Atikur Rahman, owner of Indian Store and Authentic Indian Store.
CNBC reached out to the defendants for comment but has not yet received a response.
A Roche spokesperson told CNBC that the company does not comment on ongoing litigation.
Counterfeit medical equipment
Roche’s Accu-Chek diabetes care medical devices are used by millions of patients, including Accu-Chek blood glucose meters, blood glucose test strips and lancets. The company’s blood glucose test strips and lancets can be purchased at pharmacies and online marketplaces, including Amazon, with or without a prescription.
Roche Accu-Chek SoftClix
Source: Roche
A lancet is a disposable needle designed to draw blood for testing.
The packaging of the counterfeit devices at the center of the lawsuit included misspellings of the product names and false serial numbers and expiration dates, according to the indictment.
The product names of these counterfeit Roche products are misspelled.
Source: U.S. District Court Filings
The company launched an investigation into counterfeit products in late March after a whistleblower provided information, according to the complaint. Investigators then purchased the products from three Amazon stores listed in the complaint, the lawsuit says.
Just in May of this year, a customer left a negative review on the Amazon platform, complaining that he ordered test strips from the DKY store but received a different product. In March this year, another customer said the lancet she purchased from DKY was fake.
Counterfeit identical serial numbers on packaging is another sign of counterfeit products.
Source: U.S. District Court Filings
Roche did not specify how long the counterfeit goods had been sold on Amazon or how many of the counterfeit goods ended up in the hands of customers.
The issue of potentially dangerous blood glucose test strips arose in 2019, when the FDA warned against using test strips from previous owners or test strips that were not authorized for sale in the U.S. The FDA said at the time that defective test strips were being sold online and individual sellers.
in 2011, Johnson & Johnson Says fake glucose test strips found in India.
CNBC reported in March the findings of an investigation into stolen merchandise sold on Amazon’s marketplace through organized retail crime groups. Report focuses on items worth millions of dollars stolen ultimate beauty These products have been sold on the platform for more than a decade.
In 2023, a CNBC investigation revealed how counterfeiters illegally alter prescription drugs, then funnel them into gray market supply chains for resale to pharmacies and ultimately to patients.
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