On November 18, 2016, a Florida federal jury found D. Anda Norbergs, a Palm Harbor, Florida oncologist, guilty of a plethora of federal crimes involving a scheme to smuggle counterfeit and misbranded cancer drugs into the United States, administer the drugs to unsuspecting cancer patients and then bill Medicare for the full price of the drugs.  Many of the counterfeit cancer drugs were manufactured in foreign countries such as Turkey, India and Germany and did not contain the key ingredient of the actual FDA-approved version of the drug.

According to evidence presented at trial, Norbergs, a licensed physician in Florida, was the head doctor, owner, and operator of East Lake Oncology (“ELO”), a cancer treatment clinic located in Palm Harbor, Florida. Beginning in at least May 2009, she began to order drugs from foreign, unlicensed distributors, including Quality Specialty Products (“QSP”).  These drugs were not FDA-approved and did not contain the key ingredients of the actual cancer drugs.  Norbergs learned of the lack of key ingredients from other sources yet continued to have counterfeit drugs administered to patients. Many of the drugs were shipped directly to ELO from a location outside the United States, usually from the United Kingdom. The packaging and documents shipped with the drugs showed that they were manufactured and packaged for distribution in foreign countries and some of the packaging for the drugs was in foreign languages, without any English translation.

Unbeknownst to patients, these counterfeit drugs were then administered for cancer treatments under Norbergs’ care at ELO. After administering these drugs to patients, ELO submitted claims for reimbursement to Medicare. In submitting those claims, Norbergs falsely represented that the FDA-approved versions of the drugs had been administered, when in fact the counterfeit versions had been given to patients.  In so doing, Norbergs generated 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.

Norbergs was found guilty of 17 counts of receipt and delivery of misbranded drugs, 12 counts of smuggling goods into the United States, 11 counts of health care fraud, and 5 counts of mail fraud. She faces a maximum penalty of 20 years in federal prison for each mail fraud and smuggling offense, 10 years’ imprisonment for each health care fraud count, and 3 years for each count of receipt and delivery of misbranded drugs. Her sentencing hearing is scheduled for February 16, 2017.

The case against Norbergs is a criminal case.  However, under the qui tam provisions of the False Claims Act, whistleblowers with information about similar fraud against the government may bring a civil case on behalf of the United States. If successful, the government can recover three times the amount the defendants fraudulently billed the government and monetary penalties for each false claim.  The whistleblower, who originally filed the case, is entitled to 15-30% of the government’s recovery as well as their attorney’s fees.