CHARLOTTE, N.C. – Dr. James W. Heroman, 43, formerly of Charlotte, appeared before U.S. Magistrate Judge David S. Cayer on Monday, October 4, 2021, and pleaded guilty to receiving and delivering a misbranded medication, announced William T. Stetzer, Acting U.S. Attorney for the Western District of North Carolina.
Derrick L. Jackson, Special Agent in Charge, U.S. Department of Health and Human Services, Office of Inspector General for the region including North Carolina, and Justice C. Fielder, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations (FDA-OCI), Miami Field Office, join Acting U.S. Attorney Stetzer in making today’s announcement.
Dr. Heroman is an ophthalmologist and the former owner of a now-closed ophthalmology clinic, Carolina Retina and Vitreous Consultants (CRVC). According to plea documents filed with the court, as early as September 2013, Dr. Heroman caused CRVC to order and receive an unapproved, foreign and cheaper drug which he used to treat patients with macular degeneration, instead of using Lucentis®, the medication approved by the Food and Drug Administration (FDA) for the treatment of the condition in the United States. As Dr. Heroman admitted in court yesterday, he purchased the foreign, unapproved medication because it cost less than the name brand Lucentis®. At the same time, Dr. Heroman caused CRVC to bill Medicare for the non-covered and non-reimbursable unapproved medication as if it were FDA-approved and kept the difference in price as profit.
In addition to pleading guilty to the criminal charge, Dr. Heroman and CRVC have also agreed to pay $450,000 to resolve the United States’ allegations that they violated the False Claims Act, when they knowingly submitted or caused to be submitted false claims for payment to Medicare related to the administration of unapproved medications. The claims resolved by the civil settlement are allegations only and there has been no determination of liability.
In making today’s announcement, Acting U.S. Attorney Stetzer said, “Dr. Heroman sought to increase his profit margins by using an unauthorized medication, potentially putting the health of his patients at risk. Together with our law enforcement counterparts, we will investigate and prosecute physicians who choose to fill up their pockets at the expense of their patients.”
“Physicians who provide non-FDA approved drugs to their patients unnecessarily place those in their care at risk,” said Special Agent in Charge Jackson. “Working with our law enforcement partners, our oversight agency will investigate such fraud schemes that threaten the health of patients and the integrity of federal health care programs.”
“U.S. patients rely on FDA oversight to ensure that the drugs and medical devices they use are safe and effective. Rogue health care professionals who obtain foreign unapproved medical products, and dispense and administer those products to their patients, put the health of those patients at significant risk,” said Special Agent in Charge Fielder. “We will continue to pursue and bring to justice those who choose to put the public’s health at such risk.”
A sentencing date for Dr. Heroman has not been set. The charge of receiving and delivering a misbranded medication carries a maximum penalty of a year in prison and a $1,000 fine.
In making today’s announcement, Acting U.S. Attorney Stetzer commended HHS-OIG and and FDA-OCI for their investigation of the case.
Assistant U.S. Attorney Michael Savage is prosecuting the criminal case. Assistant U.S. Attorney Katherine Armstrong is in charge of the civil proceedings.
USAO - North Carolina, Western;
Department of Health and Human Services OIG