Prosecutors Say Sens Acted Out Of 'Greed'; Defense Says Sens Hoodwinked By Drug Companies
BY KEN LITTLE
Opening statements were heard Tuesday in the joint trial of Greeneville oncologist Dr. Anindya Kumar Sen and his wife, Patricia Posey Sen, in U.S. District Court.
Anindya Sen is charged with 29 misdemeanor violations of causing the introduction into interstate commerce of misbranded drugs, and Patricia Sen is charged with 29 felony violations of the same statute.
Patricia Sen is also charged with seven counts of receiving merchandise imported contrary to law and 44 counts of engaging in a scheme to defraud health care benefit programs, in addition to two counts of making a false material statement to a special agent of the U.S. Food and Drug Administration's Office of Criminal Investigation.
In all, Patricia Sen, practice manager of clinics run by her husband in Greeneville and Johnson City, is charged by the government with 83 counts.
The government dropped some of its charges against Anindya Sen in later indictments, including a third superseding indictment on Nov. 20.
Both defendants maintain their innocence and entered not guilty pleas before the start of the trial.
Opening statements began late in the day Tuesday, after jury selection.
Assistant U.S. Attorney M. Neil Smith told jurors that the Sens' actions were rooted in one motive.
"That is greed," Smith said.
The government alleges that reimbursement for misbranded chemotherapy and other drugs purchased for use in the Sens' East Tennessee Cancer and Blood Center (ETCBC) clinics was sought from Medicare, TennCare and private healthcare providers such as Blue Cross/Blue Shield, at the rate paid for FDA-approved drugs.
ETCBC was named in June as a separate defendant, but was not included in the third indictment filed on Nov. 20.
The indictment alleges that many of the drugs were allegedly ordered from a company called Clinical Care based in the Canadian province of Alberta. Other drugs with origins in countries such as India and Turkey were mailed directly from another location in the United Kingdom.
Beginning in 2009, Patricia Sen began purchasing "unapproved and misbranded foreign-labeled drugs from a foreign source of supply," Smith said.
The cancer-treatment drugs were imported into the U.S. "contrary to law," he said.
'ALL ABOUT MONEY'
The unapproved drugs can be purchased at about 80 percent of the cost of FDA-approved drugs, Smith said.
The indictment alleges that, between April 2009 and March 2012, the Sen medical practice purchased more than $3 million in misbranded, unapproved drugs, provided the drugs to patients, and then billed Medicare and other providers approximately $3.2 million for the unapproved drugs.
"The only way to increase the profits is to figure out some way to buy the drug cheaper, and the only way to do that is to buy unapproved foreign drugs," Smith said. "It was all about money."
Anindya Sen didn't order the drugs but knew his wife was ordering them, Smith said.
Smith told the jury that evidence will show beyond a reasonable doubt that the Sens are guilty of the charges against them.
Edward M. Yarbrough and J. Alex Little represent Anindya Sen. Daniel D. Warlick represents Patricia Sen.
In their opening statements, Yarbrough and Warlick also urged the jury to carefully consider the evidence presented and use their common sense in coming to a verdict.
Yarbrough detailed Dr. Sen's extensive education and experience. Sen, 65, has practiced medicine in Greeneville for more than 19 years.
He said Sen is completely devoted to the well-being of his patients.
"This is not a man who tries to defraud the government. This is not a man who cares anything about the money," Yarbrough said.
There is no proof Sen did what he is accused of by the government, said Yarbrough, who is former U.S. Attorney for the Middle District of Tennessee.
Yarbrough said not one of Sen's patients was ever harmed by the drugs they received from ETCBC.
"We anticipate the government will have no proof to offer you. There is nothing wrong with any of the drugs administered by Dr. Sen," he said.
Yarbrough said that, if there is a guilty party, proof will show "the real culprit" in the case are those who sell and distribute misbranded drugs.
A 'NUMBERS PERSON'
Warlick echoed Yarbrough's praise for Dr. Sen.
"This is probably the most kind and most considerate oncologist you ever met in your life," he said.
ETCBC never turned a patient away because they didn't have insurance, so the government's contention of greed on the part of the Sens "flies in the face of logic," Warlick said.
Patricia Sen is "a numbers person" with no formal medical training and was told by Clinical Care that the drugs sold by the company and distributed to ETCBC through a Chicago warehouse were all FDA-approved.
An FDA investigation found out that at least 19 small clinics "were fooled," ETCBC among them, Warlick said.
What Patricia Sen told the FDA agent showed she did not make a distinction between "foreign drugs" and "illegal drugs," and nothing more, Warlick said.
Any illegal drugs sent to the ETCBC were sent back or the order was not accepted, Warlick said.
"The government knows that the drugs are not counterfeit or what you would call bogus," he said.
The Sens "loved those patients, (and) those patients became the family of an oncology clinic," Warlick said.
'NOT IN THE LOOP'
Patricia Sen was "not in the loop" and did not package or unpackage drugs arriving at the clinics, he said.
Warlick said his client "does not lie, cheat or steal."
"She's not lying to anybody. She told him the truth," he told the jury. "They tried to catch her on a technicality."
Patricia Sen "is not guilty of anything except dedication to her husband and trying to do the best job she could for her husband and his practice," Warlick said.
Prosecution testimony began this morning. U.S. District Judge J. Ronnie Greer is presiding.
The trial could last two weeks, court officials said.