Palm Harbor Oncologist Sentenced to Nearly Six Years for Treating Patients with Unapproved Cancer Drugs

Healthcare Compliance Perspective:

A culture of compliance and ethics requires manager/owner’s intent to do the right thing. Today’s case study shows the impossibility of creating such a culture when the manager/owner’s intent is to misrepresent for purposes of monetary advantage.

Tampa, Florida – A U.S. District Judge sentenced an oncologist to 5 years and 10 months in federal prison for receipt and delivery of misbranded drugs, smuggling goods into the United States, health care fraud, and mail fraud. As part of her sentence, the Court also entered a money judgment in the amount of $848,671.19, the proceeds of the criminal conduct. A federal jury found the doctor guilty on November 18, 2016.

According to testimony and evidence presented during the nine-day trial, the woman–a licensed physician in Florida, was the head doctor, owner, and operator of a cancer treatment clinic located in Palm Harbor. Beginning in at least May 2009, she directed others at the clinic to order- drugs from foreign, unlicensed distributors, including Quality Specialty Products (“QSP”). The drugs sold to the clinic and other foreign, unlicensed distributors were not FDA-approved. In fact, QSP had reportedly sold counterfeit versions of a chemotherapy medication that did not have the key ingredient in the drug. The doctor learned of this, but she continued to have QSP drugs administered to patients. When QSP shut down, the doctor bought drugs from another foreign, unlicensed distributor. Many of the drugs were shipped directly to the clinic from a location outside the United States, usually from the United Kingdom. The packaging and shipping documents indicated that they were manufactured and packaged for distribution in foreign countries, such as Turkey, India, and Germany.

After administering these drugs to patients, the cancer treatment clinic submitted claims for reimbursement to Medicare. In submitting those claims, the doctor falsely represented that the FDA-approved versions of the drugs had been administered, when she knew that unapproved and misbranded versions had been given to patients. In so doing, the doctor intended to generate profits from the difference between the Medicare reimbursement rates for the FDA-approved drugs and the discounted prices of the misbranded versions of those drugs purchased from foreign distributors.

(Website of Department of Justice, U.S. Attorney’s Office, Middle District of Florida)