LEXINGTON, Ky. (WTVQ) – A Florida woman who ran a surgical supply company was sentenced Thursday six months in prison for selling counterfeits of Surgicel, an absorbable hemostat manufactured by Johnson & Johnson’s subsidiary Ethicon.
The products ultimately ended up in operating rooms at the University of Kentucky Medical Center.
She pleaded guilty In January in federal court in Lexington.
Janaina Nascimento, of Miami, ran a company called Lion Heart Surgical Supply LLC.
According to the government’s sentencing memo, Nascimento “ignored numerous red flags, concealed warnings from purchasers, and sold hundreds of units of misbranded, counterfeit Surgicel.”
She was charged with and pleaded guilty to a Food, Drug, and Cosmetic Act misdemeanor, a strict liability offense. The government recommended a sentence of three months’ imprisonment, or three years’ probation with conditions including six months of home detention.
Nascimento is also a defendant in a parallel civil lawsuit in the Middle District of Florida.
Court recordssay she purchased 70 boxes of materials the seller claimed was a sterile absorbable hemostat, used to control bleeding during surgery.
The report says the supplies were purchased from a company in the United Arab Emirates. Nascimento sold the supplies to another distributor, which returned them, telling her the supplies weren’t authorized for distribution in the United States.
The report says the company showed Nascimento a label on the product that said, “NOT FOR RE-EXPORT TO THE U.S.A.” The report says Nascimento disagreed and claimed the supplies had been legally imported.
Nascimento removed the export warning labels, sold the supplies to another company in Florida that in turn sold them to UK Hospital in April 2019, according court records.