On March 5th a Florida woman was sentenced to six months in prison for selling counterfeit medical/surgical pads she purchased from the United Arab Emirates (UAE) that are used to control bleeding.
When the woman’s first customer (medical supplies distributor) complained, she sold it to another customer who then shipped the counterfeits to a medical center in Kentucky where surgeons complained.
According to the U.S. Department of Justice (DOJ) press release, the Florida woman pled guilty to one count of introducing into interstate commerce a “misbranded” medical device, in violation of the Food, Drug, and Cosmetic Act.
Here are a few details:
“January 2019, she purchased 70 boxes of Surgicel from a distributor in the United Arab Emirates.
“When she attempted to re-sell the product to a United States purchaser, that buyer cautioned her that the Surgicel was not authorized for sale in the United States, pointing to a warning label on the box that stated ‘NOT FOR RE-EXPORT TO THE U.S.A.’
“Instead of investigating potential problems with the Surgicel, [she] removed individual packages of the product from their boxes with the warning label, and sold 828 such packages to a company called XS Supply, LLC, which then resold those 828 units to the University of Kentucky Medical Center, in April 2019.
“After complaints from several surgeons about the product, an investigation determined that the 828 units of Surgicel sold by Nascimento were a non-sterile counterfeit.”
The following plea agreement gives more detail:
Part of the information made available in the public court record was the email exchange between the Florida woman and the first customer she had sold the counterfeits to who alerted her to the notice that it was not authorized for export to the U.S.
And the WhatsApp exchange between the Florida woman and the exporter in the United Arab Emirates (UAE.)
You cannot help shake your head at reading this exchange. Instead of accepting responsibility and immediately try to make it right, she defends her criminal behavior and urges the customer to notify the FDA, discards the “NOT FOR RE-EXPORT TO THE U.S.A.” labels, then sells the sub-standard products to another medical supplier.
Here are a few excerpts:
“… you just shipped to me. I am very disappointed in this shipment, as it is 100% clearly product that does not belong here in the United States, and either you have imported or bought from someone who has.”
“…these products have not RE EXPORT control by the USA department of commerce , therefore there is not restriction for importing/re selling but FDA which we complied.”
“If you know the country of origin, please provide that too. I will be holding this product until you send me this info. I will not be paying you for this product.”
“We will accept a return on this (here is the label for it over the next days) or payment a per invoice terms if not we will send this to collection, we don’t see any other way to deal with this.”
“You sold me goods that are clearly marked as not to be re‐exported to the USA, and that’s a huge problem. I’d rather it not be for you, therefore I am asking you again for who you bought these items from.”
“From our side I’m just letting you know that of course we will not abandon our goods and unfortunately we will have to send this collection.”
“I’ll be taking this now to our attorneys and asking for them to get an opinion from the FDA.
“The bottom line is that these products do not legally belong in the United States, so I want to understand the FDA’s thoughts, which is why I asking you to tell me who imported them and sold them to you.”
“We have nothing to hide from our side with FDA as you are fully aware we gave you our import registration before starting working with your company.
You are welcome to contact them about this products, they were imported legally as everything we deal with. Products are FDA approved, Products are legally imported to the USA.”
WHATSAPP EXCHANGE BETWEEN CRIMINAL AND UAE DISTRIBUTOR
2018‐07‐17 13:24:12 ‐04:00 “I dont mind to buy good quantity for stock since price is good“
2018‐07‐17 13:24:57 ‐04:00 <Distribuidor pure Care Ali ” Target price??“
2018‐07‐17 13:25:01 ‐04:00 “let me know which products you can have good prices“
2018‐07‐17 13:25:14 ‐04:00 : “offer me your best“
2018‐07‐17 13:25:23 ‐04:00 <Distribuidor pure Care Ali : Ethicon surgicel
2018‐07‐24 16:45:33 ‐04:00 : “May I have ur company name and phone
“Pure Care Traders FZE Ajman UAE“
This case represents the true heartlessness of counterfeiters.
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