Roche Alleges Counterfeit Diabetes Devices Were Sold on Amazon

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Roche Alleges Counterfeit Diabetes Medical Devices Were Sold on Amazon

Germany’s Roche, one of the world’s largest biotech companies, has taken legal action against manufacturers and sellers based in India for allegedly distributing counterfeit versions of its Accu-Chek diabetes medical devices on Amazon. These devices, used for testing blood glucose levels, were sold to unsuspecting patients across the United States, posing significant health risks.

The Allegations

In a lawsuit unsealed on Friday, Roche accused the defendants of selling expired or nearly expired test strips that were repackaged with counterfeit labels. These labels bore Roche’s registered U.S. trademarks and fake expiration dates. The company warned that these counterfeit products are likely to provide false or inaccurate blood glucose readings, potentially leading to severe and life-threatening complications such as hyperglycemia and incorrect insulin dosages.

Details of the Lawsuit

The lawsuit was filed in May under seal in the U.S. District Court in Brooklyn, New York. Roche named four companies and their executives as defendants: JMD Enterprises (operating as DKY Store USA), JMD International, Medical Hub_USA Store, and Authentic Indian Store. Executives Dileep Kumar Yadav, Abhishek Jain, Ratnakar Sharma, and Atikur Rahman were also named. Roche is seeking unspecified damages and has already obtained a temporary restraining order to halt the sale of these counterfeit products.

Amazon’s Role

While Amazon is not a defendant in the case, Roche alleges that the e-commerce giant played a part in the distribution scheme by storing and shipping the counterfeit products from its U.S. warehouses, including facilities in Brooklyn. These counterfeit items were sold through Amazon’s Fulfillment by Amazon program, which involves Amazon receiving, storing, packing, and shipping products on behalf of sellers, and providing customer service. Amazon receives a percentage of the sales revenue in return.

Amazon’s Response

Amazon stated that it has a zero-tolerance policy for counterfeit products and employs proactive measures to prevent such listings. An Amazon spokesperson emphasized that the company acts swiftly to protect customers and brands by removing counterfeit listings, blocking accounts, and cooperating with law enforcement.

Roche’s Statement

Roche, through its spokesperson, declined to comment on the ongoing litigation but emphasized the importance of ensuring that their Accu-Chek medical devices are safe, sterile, and accurate for users. The company highlighted the risks associated with counterfeit products, which can compromise patient safety and lead to dangerous health outcomes.

Background on Accu-Chek Devices

Roche’s Accu-Chek diabetes care devices, which include glucometers, blood glucose test strips, and lancets, are used by millions of patients globally. These devices can be purchased both with and without a prescription at pharmacies and online marketplaces, including Amazon. The availability of counterfeit versions of these products on such a large platform underscores the significant risks posed to public health.

Legal and Market Implications

The case against the counterfeiters in India marks a critical step in Roche’s efforts to combat the distribution of fake medical devices. The outcome of this lawsuit could set a precedent for how counterfeit medical products are handled in the future and could lead to stricter regulations and enforcement measures to protect consumers.

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Source: CNBC