For Case To Be
BY KEN LITTLE
U.S. Magistrate Judge Dennis Inman may rule this week on three defense motions in the government's case against Dr. Anindya K. Sen and his wife, Patricia Posey Sen.
Motion arguments concluded Monday morning. The defendants, their lawyers and prosecutors then appeared to discuss trial details before U.S. District Judge J. Ronnie Greer.
Greer will preside at the trial, which is scheduled to begin Dec. 3.
The Sens were both in federal court Monday.
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).
Inman indicated he may rule on the defense motions this week.
One motion seeks dismissal of the case because of "vindictive prosecution, prosecutorial misconduct and selective prosecution."
A second motion seeks to strike certain wording from the second superseding indictment filed last month by the government, including the term "misbranded unapproved drugs" and other words that defense lawyers said inaccurately reflect the facts of the case.
The third motion asks the judge to suppress evidence, including allegedly misbranded drugs seized by agents on April 5, 2012, at Dr. Sen's East Tennessee Cancer and Blood Clinic (ETCBC) office on Tusculum Boulevard in Greeneville.
The Sens are scheduled to be tried together, but, depending on how Inman rules on the defense motions, prosecuting Assistant U.S. Attorney M. Neil Smith said the government may request separate trials.
Smith also told Greer that a third superseding indictment against the Sens may be presented to a federal grand jury this week in Knoxville.
That indictment would not add more charges but would change some of the language in the charges against the Sens.
The East Tennessee Cancer and Blood Clinic is listed as a defendant in the case, along with the Sens.
But Smith told Greer that, because of information that came to light during a motions hearing before Inman last week, the government may not prosecute ETCBC as an entity.
Sen, who operates ETCBC clinics on Tusculum Boulevard in Greeneville and in Johnson City, apparently does not do business as a corporate entity, Smith said. For that reason, the government may file a motion to dismiss ETCBC as a defendant.
The trial could last as long as two weeks, Smith said.
Edward M. Yarbrough and J. Alex Little represent Anindya Sen. Daniel D. Warlick represents Patricia Posey Sen, ETCBC practice manager, and ETCBC.
A second superseding indictment filed in October includes 83 counts involving all defendants.
Patricia Sen and ETCBC are charged with 44 felony counts of health-care fraud.
Anindya Sen, Patricia Sen and ETCBC 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.
The 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 second superseding 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 and ETCBC 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.
The charges were included in a first superseding indictment, filed on July 9. That indictment charged her with willfully making a false statement to government agents, a felony.