BY KEN LITTLE
Jury selection begins today in the U.S. District Court trial of Greeneville Dr. Anindya K. Sen and his wife, Patricia Posey Sen.
Both were indicted in June by a federal grand jury on charges connected with the alleged sale and administration of misbranded drugs, which the government claims came from foreign sources not approved by the U.S. Food and Drug Administration (FDA).
U.S. District Judge J. Ronnie Greer will preside at the trial. Because of the volume of evidence expected to be presented, prosecutors have said the trial may last several weeks.
Sen operates the East Tennessee Cancer and Blood Clinic (ETCBC) on Tusculum Boulevard in Greeneville and in a Johnson City location.
Patricia Sen is charged with 44 felony counts of health-care fraud.
Anindya Sen and Patricia Sen are also charged with 25 counts of interstate commerce of misbranded drugs and six counts of receiving merchandise imported contrary to law, charged as felonies.
An indictment charges Anindya Sen with 29 misdemeanor violations of causing the introduction into interstate commerce of misbranded drugs, and Patricia Sen with 29 felony violations of the same statute.
The indictment said that, as a component of treatment for patients with cancer and other diseases, ETCBC purchased chemotherapy and other prescription drugs prescribed by Dr. Sen, and administered and dispensed them through the medical practice.
Reimbursement for the drugs and their administration was sought from the Medicare and TennCare programs, along with other health care benefit programs.
The indictment said that, in April 2009, Patricia Sen "began ordering and directing others to order drugs" from Clinical Care, a company based in Alberta, Canada.
Clinical Care "began shipping misbranded unapproved drugs to ETCBC," where they were administered to patients, and claims for reimbursement were submitted to health benefits programs," the indictment alleges.
UNAPPROVED DRUGS ALLEGED
The unapproved drugs originated from foreign sources that were not inspected and approved by the U.S. Food and Drug Administration, the indictment alleges.
ETCBC purchased more than $3 million worth of drugs from Clinical Care from April 2009 through March 2012, the indictment said.
The government claims Patricia Sen committed health care fraud by submitting claims for reimbursement to public health care benefit programs by "falsely representing" the drugs through codes for FDA-approved drugs, "when in fact they were not [FDA-approved]."
Patricia Sen was indicted on two counts of willfully making a false statement to government agents, a felony, in connection with the statements made on March 27 and April 5 to special agents of the FDA's Office of Criminal Investigation and the FBI.