BY KEN LITTLE
Dr. Anindya Kumar Sen and his wife, Patricia Posey Sen, entered not guilty pleas to federal charges Thursday in U.S. District Court in Greeneville.
The Greeneville oncologist, 64, and his wife, 65, were indicted earlier this month by a federal grand jury on charges of conspiracy to commit health care fraud, conspiracy to commit offenses against the U.S., 29 counts of introduction into interstate commerce of a misbranded drug, and seven counts of knowingly importing merchandise contrary to law.
Their business, East Tennessee Cancer & Blood Center, P.C. (ETCBC), is also named in the indictment.
Sen is managing physician and president of ETCBC, with offices at 1406 Tusculum Blvd., and in Johnson City. Patricia Sen, his wife, is ETCBC practice manager.
The medical offices remain open and Dr. Sen continues to see patients.
TRIAL DATE SET
A federal grand jury in Greeneville returned an indictment naming the Sens on June 11.
The Sens entered not guilty pleas Thursday before U.S. Magistrate Judge Dennis H. Inman, who set a trial date of Sept. 4. U.S. District Judge J. Ronnie Greer will preside.
The Sens were released pending trial.
If convicted, the Sens face terms of up to 20 years in prison on the health care charge and each of the unlawful importation charges, along with fines of up to $250,000 per count and up to three years of supervised release, according to a news release from the U.S. Attorney's Office.
In an interview following the June 11 indictment, Patricia Sen strongly maintained the couple's innocence.
"We are completely, totally innocent. We plan on pleading not guilty because we are not guilty," Patricia Sen said on June 13.
The indictment said that as part of the treatment of patients with cancer and other diseases, ETCBC bought "large amounts of assorted prescription drugs," including chemotherapy drugs, which were prescribed by Anindya Sen "and were administrated and dispensed through ETCBC."
The medical office then sought reimbursement from Medicare and TennCare Medicaid programs, along with other health benefit providers, the indictment said.
It states that the Sens purchased the drugs from a company in Alberta, Canada, called Clinical Care.
Clinical Care sold drugs "which had been obtained from foreign sources and which had not been approved by the U.S. Food and Drug Administration (FDA) for distribution and use in the United States," the indictment said.
The Sens began ordering drugs from Clinical Care in April 2009, "and Clinical Care began shipping misbranded unapproved drugs to ETCBC," the indictment said.
The drugs came from foreign sources not inspected and approved by the FDA, the indictment said, "to include drugs which had been distributed in Turkey, India, the European Union, and elsewhere."
When nurses and other staff raised concerns that packaging for chemotherapy drugs purchased by ETCBC from Clinical Care had labeling in foreign languages, "establishing that the drugs were not approved for use in the United States, defendant Patricia Posey Sen told the staff that there were no problems with the drugs, or words to that effect," the indictment said.
TIME FRAME ALLEGED
ETCBC obtained misbranded unapproved drugs from 2009 to March 2012, "purchasing over $3 million in (those drugs) and providing those drugs to their patients," according to the indictment.
Medicare, TennCare and other benefits programs were then billed about $3.2 million, according to the indictment.
Drugs the government alleges were misbranded and administered to patients at ETCBC include Aloxi, Altuzan, Avastin, Bonviva, Mabthera, Neupogen and Venofer.
The indictment states that the purpose of the conspiracy for the defendants was to "unlawfully enrich themselves by, among other things, submitting false and fraudulent claims to Medicare, TennCare and other health benefit programs."
The indictment came after an investigation by the Food & Drug Administration Office of Criminal Investigation, FBI and the Tennessee Bureau of Investigation.
"We're fighting it all the way. It's absolutely untrue," Patricia Sen said earlier this month of the allegations in the indictment.
Assistant U.S. Attorney Neil Smith and Special Assistant U.S. Attorney Ben Cunningham will represent the government.
The Sens have retained Nashville lawyer Edward M. Yarbrough, of the Walker, Tipps & Malone PLC law firm.
Before joining the law firm, Yarbrough served as U.S. Attorney for the Middle District of Tennessee.
Yarbrough did not immediately return a phone call Thursday afternoon about the case.