Cancer doctor working in Lodi, California and his wife, who acted as his office administrator admit no wrongdoing, but pay Federal Government $300,000 to settle allegations that they treated patients with counterfeit, imported cancer medication.
The U.S. Department of Justice (DOJ) announced May 9th that Dr. John F. Kiraly and wife Rena Kiraly have agreed to pay a fine of $300,000 to settle false claims act allegations relating to their purchase of non-FDA approved cancer medication. According to the DOJ, the Kiralys allegedly imported chemotherapy drugs from Warwick Healthcare Solutions also known as Richards Pharma. Richard Taylor, owner of, Richard Pharma, was convicted and sentenced to 18 months in jail for shipping non-FDA approved medication to medical offices and clinics throughout the United States in 2013.
Altuzan is not approved for use in the United States. Additionally, the FDA tested a batch of Altuzan from the Kiralys’ office and found that it lacked the active ingredient for the medication, and was in fact counterfeit, the DOJ reports.
According to the Sacramento Bee, the Kiralys are alleged by federal prosecutors to have administered the counterfeit medication to patients, and also to have billed Medicare for the cost of genuine medication. Two other San Joaquin County doctors have also settled similar allegations by federal prosecutors in the past year. Dr. Neelesh Bangalore paid the Federal government $736,000 and Dr. Prabhjit Purewal paid $550,000 to settle allegations that he also purchased and administered counterfeit cancer medication.
According to the DOJ, “Bangalore administered certain of these medications to his patients, billing several federal healthcare programs, including Medicare. One medication he purchased from Warwick was Altuzan, a drug not approved by the FDA. In addition, the FDA tested a batch of Altuzan that Bangalore had purchased from Warwick and determined that it was counterfeit and lacked the active ingredient bevacizumab.”
In the DOJ’s press release on the Purewal case, the DOJ alleges that “Dr. Purewal had, over a two year period ending in May 2011, purchased chemotherapy drugs from Warwick Healthcare Solutions, Inc., also known as Richard’s Pharma (“Warwick”), administered the drugs to his patients, and improperly sought and received reimbursement for the drugs from Medicare and other public insurers.”
The Sacramento Bee notes that no explanation was offered as to why there is currently no criminal case against the Kiralys. The Bee also spoke with California Medical Board spokeswoman Susan Wolbarst who is “looking into the case.”
Lisa L. Malinowski, Special Agent in Charge, FDA Office of Criminal Investigations’ Los Angeles Field Office, was quoted by the DOJ: “Patients receiving cancer treatment drugs should be able to trust that these drugs have been the subject of the FDA-approval process, which requires that the drugs have been proven to be safe and effective for treating their medical conditions. The FDA will continue its vigilance over the prescription-drug supply chain to ensure that the drugs reaching patients have been proven to be both safe and effective, and that those who attempt to circumvent the agency’s oversight will be brought to justice.”