Roche, one of the world’s largest biotech companies, has reported the sale of “dangerous counterfeits” of its diabetes medical devices on Amazon, potentially endangering patients across the United States. The company claims that manufacturers and sellers based in India have been distributing counterfeit versions of its Accu-Chek devices, which are crucial for testing blood glucose levels. These allegations were revealed in a federal lawsuit unsealed late Friday.
Roche’s complaint states that patients rely on the safety, sterility, and accuracy of its Accu-Chek medical devices. However, the counterfeit test strips in question are either expired or near expiration, repackaged with fake labels bearing Roche’s trademarks and false expiration dates. Such counterfeit devices can provide incorrect blood glucose measurements, posing severe health risks, including hyperglycemia and incorrect insulin dosages.
The lawsuit, initially filed in May in the U.S. District Court in Brooklyn, New York, names four companies and their executives based in India as defendants. Roche is seeking unspecified damages. Following the lawsuit, a judge granted Roche’s request for a temporary restraining order to prevent the defendants from selling the counterfeit products. The Amazon stores selling these products have since been taken down. Although Amazon is not a defendant in the case, Roche alleges that all counterfeit products were stored in Amazon warehouses across the country, including Brooklyn. These products were typically shipped to businesses and individuals within 48 hours of arrival at Amazon facilities.
The complaint claims, “Amazon currently has untold 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.” Roche further alleges that the counterfeiters used Amazon’s Fulfillment by Amazon program, where Amazon agrees to receive, store, and ship orders on behalf of the sellers, while also providing customer service. In return, Amazon receives a significant percentage of the revenue from these counterfeit sales.
An Amazon spokesperson stated that the company has “a zero-tolerance policy for counterfeit products,” and implements proactive measures to prevent such listings. They also monitor the store continuously and act quickly to protect customers and brands by removing counterfeit listings, blocking accounts, and collaborating with brands and law enforcement.
The complaint was filed on behalf of Roche Diabetes Care Inc., Roche Diabetes Care GmbH, and Hoffmann-La Roche Inc., by the law firm Patterson Belknap Webb & Tyler. The defendants include JMD Enterprises, its founder Dileep Kumar Yadav, JMD International, its owner Abhishek Jain, Medical Hub_USA Store, its owner Ratnakar Sharma, Authentic Indian Store, and its owner Atikur Rahman.
Roche has declined to comment on the ongoing lawsuit, and attempts to reach the defendants for comment have so far been unsuccessful.
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