Rocheone of the world's largest biotech companies, said that “dangerous counterfeits” of its diabetes medicines had landed on the market for sale. Amazon purchased by patients throughout the United States.
Roche has accused India-based manufacturers and sellers of selling counterfeit versions of its Accu-Chek devices, used to measure blood sugar levels, the company made the claim in a federal court lawsuit filed late Friday.
“Patients know that Roche's Accu-Chek medical devices are safe, sterile and accurate,” the complaint states. Roche said the counterfeit test strips are expired or nearly expired products that are repackaged with counterfeit labels bearing Roche's U.S.-registered trademarks and false expiration dates.
The company warned that the counterfeit devices “are likely to 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 May in the US District Court in Brooklyn, New York, 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 prevent the defendants from selling the counterfeit products. The Amazon stores that offered the products for sale were apparently shut down.
Accu-Chek brand glucose test strips from Roche Diabetes Care Inc. are prepared for a photograph in the Brooklyn borough of New York, USA, Thursday, April 4, 2019.
Alex Flynn | Bloomberg |
Amazon is not a defendant in the case, but Roche claims that as part of the alleged scheme, all counterfeit products shipped to the U.S. were stored in Amazon warehouses across the country, including in Brooklyn. The products are typically shipped to businesses and individuals within 48 hours of arriving at Amazon facilities.
“Amazon currently has countless of these dangerous counterfeit medical devices in its warehouses across the country, ready to be delivered to unsuspecting American consumers at the push of a button,” the complaint states.
Roche said the counterfeiters participated in Amazon's “Fulfillment by Amazon” program. Under this program, “Amazon agrees to receive, store, and accept orders on behalf of the counterfeiters, select, package, and ship the counterfeit goods, and provide customer service to the counterfeiters. … In return, Amazon receives a substantial percentage of the revenue from the sale of the 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 steps to prevent counterfeit products from entering our store and continuously monitor our store. When we identify a problem, we act quickly to protect customers and brands. This includes removing counterfeit listings and suspending accounts. We also work with brands and law enforcement to protect our customers from malicious actors attempting to abuse our store.”
The lawsuit was filed on behalf of Roche Diabetes Care Inc., Roche Diabetes Care GmbH and Hoffmann-La Roche Inc. by attorneys at the New York law firm Patterson Belknap Webb & Tyler.
The defendants are JMD Enterprises, trading as DKY Store USA, Dileep Kumar Yadav, founder and owner of JMD Enterprises, JMD International, Abhishek Jain, owner and founder of JMD International, Medical Hub_USA Store, Ratnakar Sharma, owner of Medical Hub_USA, Authentic Indian Store and Atikur Rahman, owner of Authentic Indian Store.
CNBC has asked the defendants for comment but has not yet received a response.
A Roche spokesman told CNBC that the company does not comment on ongoing litigation.
Counterfeit medical devices
Roche's Accu-Chek diabetes care products, used by millions of patients, include Accu-Chek glucose meters, blood glucose test strips and lancets. The company's blood glucose test strips and lancets can be purchased with or without a prescription at pharmacies and online marketplaces such as Amazon.
Roche Accu-Chek SoftClix
Source: Roche
Lancets are special disposable needles used to take blood for testing.
According to the complaint, the packaging of the counterfeit devices at issue in the case contains a misspelled product name as well as fake serial numbers and expiration dates.
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These counterfeit Roche products have the product name misspelled.
Source: Filing in U.S. District Court
The company launched an investigation into the counterfeits in late March when a whistleblower shared information with the company, the lawsuit says. Investigators then purchased the products from the three Amazon stores named in the lawsuit, the lawsuit says.
Just in May, a customer left a negative review on the Amazon platform, complaining that he had ordered test strips from the DKY store but received a different product. In March, another customer claimed that the lancets she had purchased from DKY were fake.
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Another indication of counterfeits are fake identical serial numbers on the packaging.
Source: Filing in U.S. District Court
Roche did not provide any information on how long the counterfeit items were sold on Amazon and how many of them ultimately found their way to the customer.
The problem of potentially dangerous blood glucose test strips arose in 2019, when the US Food and Drug Administration (FDA) warned against using test strips that had been previously owned or were not approved for sale in the US. At the time, the FDA said that faulty test strips were being sold through online marketplaces and by private individuals.
In 2011, Johnson & Johnson said it had found counterfeit versions of its blood glucose test strips in India.
CNBC reported in March on the results of an investigation into stolen items sold through organized retail crime rings on Amazon's marketplace. The report focused on millions of dollars worth of items sold by Ulta Beauty that have been sold on the platform for over a decade.
And in 2023, a CNBC investigation revealed how counterfeiters illegally alter prescription drugs that are then funneled into a gray market supply chain and resold to pharmacies and ultimately to patients.
