Florida Woman Sentenced to Six Months for Selling Counterfeit Medical Devices

LEXINGTON, Ky. – A Hollywood, Florida, woman, Janaina Nascimento, 38, was sentenced on Thursday, by U.S. District Judge Karen Caldwell, to six months in federal prison, after previously being convicted of selling counterfeit Ethicon Surgicel® Original Hemostat (“Surgicel”), an absorbable surgical mesh used to control bleeding, that was ultimately purchased by the University of Kentucky Medical Center.

Nascimento pled guilty to one count of introducing into interstate commerce a “misbranded” medical device, in violation of the Food, Drug, and Cosmetic Act.  In her plea agreement, Nascimento admitted that in 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, Nascimento 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.

Following her term of imprisonment, Nascimento will be on supervised release for a period of one year, during which time she will be prohibited from operating or working for any company engaged in the sale of medical devices.  Nascimento also paid restitution of $24,012 to the University of Kentucky Medical Center.

Carlton S. Shier, IV, Acting United States Attorney for the Eastern District of Kentucky; Mark S. McCormack, Special Agent in Charge, U.S. Food and Drug Administration, Office of Criminal Investigations, Metro Washington Field Office; and Phillip Burnett, Jr., Acting Commissioner of the Kentucky State Police, jointly announced the sentence.

The investigation was conducted by the U.S. Food and Drug Administration, Office of Criminal Investigations and the Kentucky State Police.  The United States was represented by Assistant U.S. Attorney Paul McCaffrey.