Woman who sold fake medical product to University of Kentucky sentenced to prison
A Florida business owner has been sentenced to six months in federal prison after selling a potentially dangerous counterfeit mesh that turned up in an operating room at the University of Kentucky Medical Center during brain surgery.
Attorneys for the woman, Janaina Nascimento, sought a probated sentence for her, saying she didn’t know the product she sold was counterfeit.
But U.S. District Judge Karen K. Caldwell said the sentence needed to deter others who might be tempted to sell counterfeit medical goods, or be careless in vetting such products.
“The law puts pressure on purchasers and suppliers to exercise care and diligence in their dealings because the public simply cannot tolerate the risk to human life that this kind of error presents,” Caldwell said, according to a transcript of the sentencing.
The six-month sentence for Nascimento was the maximum under advisory guidelines.
Caldwell sentenced Nascimento, of Miami, last week in federal court in Lexington.
Nascimento also paid $24,012 to UK to cover what it paid for the product.
The case traces to May 2019 when a neurosurgeon at UK operating on a patient’s brain noticed a problem with a product called Surgicel, a fiber hemostat used to control bleeding that can be left in after surgery to be absorbed into a patient’s body, according to court documents.
The doctor and nurses noticed the hemostat didn’t feel or work like the one they typically used and did not put it in the patient, according to court documents.
The surgeon made two more complaints about the mesh that month to the manufacturer, Ethicon, a subsidiary of Johnson & Johnson, according to court documents.
Johnson & Johnson traced the hemostat to Nascimento’s company, Lion Heart Surgical Supply LLC, in Hollywood, Fla.
An investigation by Johnson & Johnson showed the hemostats originated from a company called Medserve in Delhi, India, before passing through a company in the United Arab Emirates to Nascimento.
When Johnson & Johnson got a court order to search at the Indian company in October 2019, company representatives and police found a man named Pritamdas Arora had put pieces of non-sterile fabric gauze into packages labeled as Surgicel on the floor of his apartment, according to a court declaration from Geoffrey Potter, a New York attorney who represents Johnson & Johnson.
The apartment was “visibly unclean and certainly not a sterile environment,” so the mesh was contaminated, Johnson & Johnson said in one court document.
In addition, tests showed the counterfeit product did not appear have the proper qualities to control bleeding or to be absorbed into a person’s body after surgery, raising the potential it could cause complications such as infection and scarring, according to Johnson & Johnson.
Nascimento came to the U.S. from Brazil and worked hard at a variety of jobs before starting her medical-supply company, her attorneys said.
She registered with the U.S. Food and Drug Administration, unlike many competitors, and took precautions to check the validity of the Surgical at issue in the case. She believed it was genuine, her attorneys said in a sentencing memorandum.
However, the prosecutor, Assistant U.S. Attorney Paul McCaffrey, said Nascimento ignored red flags that the product was not legitimate.
After she initially sold it to another supply company, the owner of that company told her the label said it wasn’t supposed to be re-exported to the U.S. and sent it back.
Nascimento then sold the hemostats to another company, but removed the individual packages from the boxes with the warning label before shipping it, according to court documents.
McCaffrey said Nascimento was charged with a misdemeanor because there was conflicting evidence on whether she intended to defraud or mislead anyone.
Still, her conduct was “reckless in the extreme,” the prosecutor said.
The counterfeit Surgical was used in many patients, creating “a real potential for harm to them,” McCaffrey said during the sentencing last week.
The government asked for a three-month sentence for Nascimento.
Caldwell doubled it, saying that although Nascimento was charged with a misdemeanor, it was among the most serious of offenses.
The kinds of medical devices involved in the case “can make the difference in the life or death of patients who have absolutely no control over the products that are used on their bodies or, in this case, left in their bodies,” Caldwell said, according to a transcript of the sentencing.
“Here, there is clearly no room for fraud,” Caldwell said. “There is no room for recklessness. There is no room for error.”
