Doctor Pleads Guilty to Ordering “Misbranded Medication.” Who Pays Retail?

Medical Justice provides consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a consultation – or use the tool shared below.

What practice doesn’t want to save money?  

There’s a line that should not be crossed. In a Department of Justice News Release, Dr. James Heroman, was identified as a physician who should have shopped locally. He just pled guilty to ordering and receiving “a misbranded medication.”  

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. 

Note, this is a criminal offense with criminal penalties. Sentencing date 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. 

Dr. Heroman and his corporate entity also agreed to pay $450k to resolve they violated the False Claims Act when they submitted for payment to Medicare claims related to the administration of unapproved medications.  

More from the DOJ: 

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.” 

We have written on this topic before. Pharmaceuticals that are purchased for use in practice must be approved for use in commerce by the FDA. Some physicians have picked up medications that are almost if not entirely equivalent to US analogs. That does not matter. If the medication in the vial you purchase is not approved for distribution in the US, it will be considered “misbranded.” And that can trigger criminal liability and civil penalties. 

Dr. Heroman’s ophthalmology practice, CRVC, is now closed.  

Sometimes it is best to pay retail. 

Medical Justice provides consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a consultation.

Learn how Medical Justice can protect you from medico-legal mayhem… 

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2021 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With decades of combined experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.