Rheumatologist Agrees To Resolve False Claims Act Allegations Related To Unapproved Drugs

CHARLOTTE, N.C. - Steven L. Mendelsohn, a medical doctor specializing in rheumatology, has agreed to pay $549,554.26 to resolve False Claims Act allegations arising from the submission of reimbursement claims to Medicare for prescription arthritis drugs that were not approved by the Food & Drug Administration for marketing and distribution in the United States, U.S. Attorney Russ Ferguson announced today.

This settlement resolves allegations that, in 2019, Dr. Mendelsohn sought reimbursement from Medicare for immunosuppressive drugs that were administered intravenously to his patients to treat rheumatoid arthritis that were not purchased from a licensed or authorized drug distributor. The United States alleged that the drugs were intended for foreign markets. Those drugs were thus not approved by the FDA for marketing and distribution in the United States.

"When patients receive intravenous drugs, they have no insight into what is being put inside their bodies. The FDA plays an important role in ensuring only safe and proper pharmaceuticals are used," said U.S. Attorney Russ Ferguson. "Dr. Mendelsohn sidestepped that oversight to buy cheaper drugs abroad yet receive full reimbursement from Medicare at the expense of the American taxpayer. This settlement holds him accountable and ensures that Medicare funds are only used for FDA-approved drugs."

"Health care professionals are legally obligated to uphold the integrity of the Medicare program," said Kelly Blackmon, Special Agent in Charge at the Department of Health and Human Services Office of Inspector General (HHS-OIG). "Protecting the safety of Medicare patients is essential, and HHS-OIG is committed to ensuring taxpayer dollars are not spent on unapproved or unauthorized treatments that put patients at risk."

"The FDA's comprehensive regulatory framework is designed to ensure the safety, efficacy, and quality of drugs distributed to American consumers," said Acting Special Agent in Charge Juan Berrios, FDA Office of Criminal Investigations Miami Field Office. "We commend the efforts of the Department of Justice to protect public health and hold accountable those who place profits over patient safety."

Assistant U.S. Attorney Holly H. Snow handled this affirmative civil enforcement matter with assistance from the Office of Inspector General of the Department of Health and Human Services and the FDA Office of Criminal Investigations.

The claims resolved by the settlement are allegations only. There has been no determination of liability.