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Through a federal lawsuit unsealed last week, Roche has accused manufacturers and sellers in India of selling counterfeit versions of its diabetes medical devices, specifically its Accu-Chek devices, on Amazon. First filed under seal in May in the US District Court in the Brooklyn borough of New York City, the lawsuit named four companies and their executives as defendants, including 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 Indian Store, and Authentic Indian Store owner Atikur Rahman.<\/span><\/p>\n In the lawsuit, the company claimed these entities are selling expired or nearly expired test strips that have been repackaged with counterfeit labels showcasing Roche\u2019s registered US trademarks and fake expiration dates. Using such product, according to the claim, which was <\/span>reported by <\/a><\/span>CNBC<\/a><\/span>, have the likelihood of giving \u201cfalse or inaccurate measurements of blood glucose levels, putting patients at risk of severe and life-threatening complications, such as hyperglycemia and over- or under-dosages of insulin.\u201d<\/span><\/p>\n The judge overseeing the case has since granted Roche\u2019s request for a temporary restraining order to stop these companies from continuing to sell the counterfeit products, according to <\/span>CNBC<\/span><\/span>.<\/span><\/p>\n Launching an investigation into the fakes in late March after a whistleblower reached out with information, the lawsuit wrote that Roche then had investigators purchase the products from the three Amazon stores listed in the complaint. It was not specified how long the counterfeit items were sold on Amazon, or how many made it to customers, however it was reported that as recently as May a customer left a review on Amazon complaining that they had ordered the testing strips from the DKY Store but received a different product. Additionally, in March, a different customer said that the Accu-Chek lancets she purchased from the same storefront were fake.<\/span><\/p>\n Of note, the company\u2019s testing strips and lancets can be purchased with or without a prescription at pharmacies and online stores like Amazon.<\/span><\/p>\n Noting packaging differences on the counterfeit devices, the lawsuit wrote that the fakes include a misspelling of the product name \u2014 Accu-Chek Softclix vs. Accu-Chek SoftClick spellings \u2014 as well as fake serial numbers and expiration dates.<\/span><\/p>\n The companies embroiled in the lawsuit, according to Roche, participated in Amazon\u2019s Fulfillment by Amazon program, in which Amazon agrees to receive, store, and accept orders on behalf of the companies, then pick, pack, and ship its goods to customers. In return, Amazon is entitled to a percentage of the revenue gained from sales.<\/span><\/p>\n Amazon is not a defendant in the case, but the complaint does claim it is part of the scheme as all of the products sent to the US were stored at its warehouses. \u201cAmazon 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,\u201d the complaint said.<\/span><\/p>\n A spokesperson for Amazon told <\/span>CNBC<\/span><\/span> that it has a \u201czero tolerance policy for counterfeit products. We have proactive measures in place to prevent counterfeit products from being listed and continuously monitor our store. If we identify an issue, we act quickly to protect customers and brands, including removing counterfeit listings and blocking accounts, and collaborating with brands and law enforcement to protect our customers from bad actors attempting to abuse our store.\u201d<\/span><\/p>\n A member of Roche\u2019s counsel for the case, Geoffrey Potter, Esq., a partner at Patterson Belknap Webb & Tyler, recently posted about the lawsuit on <\/span>LinkedIn<\/a><\/span>.<\/span><\/p>\n