When is Amazon liable for selling, warehousing, and delivering counterfeit medical devices?
A third-party seller allegedly sold U.S. patients counterfeit and misbranded diabetes medical devices via Amazon. The sales were allegedly fulfilled by Amazon.com itself.
Case Details
In March 2024, Roche received a whistleblower complaint about counterfeit diabetes medical devices allegedly being sold on Amazon.
An investigation revealed a medical device counterfeiting ring based in India allegedly using Amazon to sell counterfeit Accu-Chek Softclix® lancets and SmartView test strips as well as other diverted diabetes medical devices to patients across the U.S.
This ring allegedly operated third-party storefronts on Amazon to ship the counterfeit items from India to customers in the U.S. But the ring also took part in Amazon's Fulfilled by Amazon (FBA) program, which means the counterfeiters allegedly shipped quantities of their counterfeit items to Amazon to be held and distributed out of Amazon warehouses in the U.S.
Roche's complaint shared images of the counterfeit items and their packaging.
According to the complaint filed by Roche, they did test buys of the lancets and test strips and testing showed the items to be counterfeit. The complaint alleges, "Of the test purchases made from Defendants on Amazon.com, most of the counterfeits were stored in Amazon warehouses and delivered directly by Amazon... 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 says that purchasers on Amazon have left comments about the allegedly fake products warning others to not buy them because they are falsely advertised as something they are not. For example, according to the comlaint, a customer in March said: "These lancets are fake. They will not fit in your device properly and won’t work. Do not buy!”
Attorneys in the U.S. quickly filed the necessary documents in federal court that would give them a "Letter of Request" to be submitted to the High Court in India to shut down these counterfeiters.
Black market sales of glucose test strips are endemic in the U.S. – on and off the internet. Watch PSM's video about a case involving black market sales in Florida.
Why is this such a bad situation?
Court documents allege that the devices were being manufactured in non-sterile conditions in back alley apartments in New Delhi and that the counterfeit devices gave off a strong chemical odor when opened.
Test strips are more fragile than you think. The active ingredients in the test strips degrade naturally, which is why they have an expiration date. Test strips are also temperature sensitive and when they are exposed to heat above 86 degrees, they tend to record higher levels of glucose in blood samples than actually exist. After getting an inaccurately high reading, a diabetes patient could give themselves an overdose of insulin, which can cause coma or death.
Allegedly, the needles on lancets in the kits were not produced in a sterile environment, exposing any patient who used them to the risk of infection. Injecting yourself with a dirty needle is dangerous because it bypasses most of your body’s immune system.
So what’s the solution?
Since this story first came out, the U.S. Consumer Product Safety Commission found Amazon responsible under federal safety laws for "faulty carbon monoxide (CO) detectors, hairdryers without electrocution protection, and children’s sleepwear that violated federal flammability standards."
We are sympathetic to the volume of products that Amazon and Fulfilled By Amazon juggle every day. However, we think that for patient safety, they should not be in the business of selling medical products, either on their platform or through their Fulfilled By Amazon program.
Additionally, we believe that Congress should pass the SHOP SAFE (S2934 / H8684) legislation. This legislation would reduce the burdens on platforms like Amazon to vet their products. By ensuring that Amazon knows their customers and can identify them for the manufacturers of record, it helps companies like Roche more effectively screen out fake products on Amazon to protect public safety.