January 29, 2014: Seven Oncologists Ordered to Pay Nearly $2.6 Million for Importing Unapproved Drugs
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
January 29, 2014
United States Attorney
Northern District of Ohio
Contact: Mike Tobin
Seven Ohio oncologists have been ordered to collectively pay nearly $2.6 million after pleading guilty to importing cancer medications that had not been approved by the Federal Drug Administration, said Steven M. Dettelbach, United States Attorney for the Northern District of Ohio.
The doctors pleaded guilty to causing the shipment of misbranded drugs, a misdemeanor violation of the Food, Drug and Cosmetic Act. They were sentenced to probation and ordered to pay fines and restitution. Their names, ages, the city where they practiced medicine and the amount they were ordered to pay are as follows:
Ranjan Bhandari, 56, Liverpool, $1,139,532.
Timmappa Bidari, 68, Parma, $158,418.
David Fishman, 62, Euclid, $150,000.
Su-Chiao Kuo, 60, Brunswick, $179,840.
Marwan Massouh, 54, Westlake, $609,150.
Poornanand Palaparty, 62, Cleveland, $128,160.
Hassan Tahsildar, 55, Euclid, $179,316.
"These doctors used drugs that had not been approved by the FDA," Dettelbach said. "Our office is committed to working with our partners to make sure patients are getting medicine that has been properly inspected."
Antoinette V. Henry, Special Agent in Charge, FDA's Office of Criminal Investigations, said: "FDA's regulatory standards are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers. We will continue to work to investigate all persons, including medical professionals, who disregard regulatory requirements and jeopardize the public health by participating in the distribution of misbranded products."
"The introduction of misbranded prescription medications and the subsequent billing of Medicare for such medication is improper and illegal," said Lamont Pugh III, Special Agent in Charge, U.S. Department of Health & Human Services, Office of Inspector General - Chicago Region. "This conduct is potentially harmful to patients as it circumvents the laws that were enacted to ensure medications are safe for use and further squanders vital taxpayer dollars."
"The OIG will continue to work with our law enforcement partners to ensure that these types of violations are identified, investigated and prosecuted to the fullest extent of the law."
The doctors are accused of obtaining drugs, including Zometa, Kytril, Taxotere, Gemzar, Eloxatin and others, from outside the United States, where the drugs were not approved by the FDA, according to the charges.
A drug may be considered misbranded even if it is identical in composition to an FDA-approved drug (that is, a drug labeled and packaged in compliance with the FDA's standards) and even if it was made by the same manufacturer in the same facility as the FDA-approved version.
These cases were prosecuted by Assistant U.S. Attorneys Michael L. Collyer and James L. Bickett following investigations by the FDA - Office of Criminal Investigations and the Department of Health and Human Services - Office of Inspector General.
Anyone suspecting health care fraud, waste or abuse can report it by calling the U.S. Department of Health and Human Services, Office of Inspector General at 800-447-8477. To learn more about health care fraud prevention and enforcement go to www.stopmedicarefraud.gov.