Testimony Ends In Complex Trial; Defense Calls No Witnesses
BY KEN LITTLE
Jury deliberations began this morning in the U.S. District Court trial of Greeneville Dr. Anindya Sen and his wife, Patricia Posey Sen.
The government alleges that Sen's practice, East Tennessee Hematology, Oncology and Internal Medicine, ordered foreign drugs that are not approved for domestic use by the U.S. Food and Drug Administration.
Medicare, Blue Cross/Blue Shield and other health care providers were then billed $3.2 million for drugs administered to clinic patients between 2009 and 2012, prosecutors said.
In a series of indictments starting in June, the government gradually shifted the majority of charges alleging ordering unapproved drugs and billing-related fraud to Patricia Sen, office manager of the practice.
The Sens have maintained their innocence.
The prosecution rested its case Tuesday after calling about 20 witnesses over six days of testimony.
The defense rested its case without calling any witnesses. Anindya and Patricia Sen did not testify.
Defense lawyers and Assistant U.S. Attorney M. Neil Smith offered closing arguments Tuesday afternoon before Judge J. Ronnie Greer gave jury instructions.
Smith suggested to the jury that Patricia Sen willfully planned to defraud the government by submitting benefit claims for misbranded drugs.
Trial testimony by employees of the Greeneville practice showed that chemotherapy nurses and others who worked there had specific duties, most of which did not involve ordering drugs or opening packages from suppliers.
Avastin, an FDA-approved cancer treatment drug that was frequently mentioned during the trial, was allegedly replaced with another drug called Altuzan, ordered from a Canadian company called Clinical Care. The government alleges the practice billed Medicare and other providers for Avastin.
Smith said Patricia Sen reviewed all billing materials received by the practice.
"Who was the one person in the practice who saw everything? Patricia Posey Sen," he said.
Some of the "misbranded" drugs allegedly purchased by the practice were manufactured in countries such as Turkey and India and containedinstructions in languages other than English, according to prosecution witnesses.
Some of the drugs were shipped directly to the Greeneville clinic from a supplier in the United Kingdom, Smith said.
Smith said that Patricia Sen professed "deliberate ignorance when it came to knowledge of what drugs were being used by the practice."
"You can't not know something you just have to know," Smith said.
As the only doctor in the practice, Anindya Sen either had to know what was being administered to patients or he "failed his duty under the law," Smith said.
In doing so, Dr. Sen "put patients at risk," Smith said.
"He had a responsibility to prevent that," he said. "He's the captain of the ship."
Smith said in his opening statement to the jury that greed was the motivating factor in substituting unapproved drugs for FDA-approved medications.
Trial testimony showed that the foreign-brand drugs cost 80 percent or less than their U.S. counterparts.
Patricia Sen "was going out there trying to make an extra dollar by buying drugs on the cheap," Smith said.
DEFENSE CLOSING ARGUMENTS
Edward M. Yarbrough, who along with J. Alex Little represents Anindya Sen, said in his closing argument that FDA Special Agent Robert West was so intent on making a case against the Sens that he ignored some key facts and fabricated others.
Yarbrough said Patricia Sen willingly provided labeling, packaging and other information requested by the FDA.
"If (she) is interested in concealing the truth and hiding things, why would she turn it all over to him?" Yarbrough said.
Insurance company employees, members of law enforcement and a doctor who testified for the prosecution had no direct knowledge of the case and often had to refer to notes to answer questions. Yarbrough called it "trial by Power Point."
The Sens are both charged with interstate commerce of misbranded drugs. Yarbrough asked why the government did not also go after the supplier.
"The only one to introduce anything into interstate commerce is Clinical Care," he said.
Trial testimony by clinic employees suggested that Anindya Sen is hard-working and dedicated to the well-being of his patients. Several nurses testified that any questions about the business aspect of the practice were routinely referred by Sen to his wife.
"There is no proof Dr. Sen prescribed anything other than American brand names," Yarbrough said.
About half of the FDA-approved drugs marketed in the U.S. are manufactured in another country, he added.
"How are we going to convict somebody on the basis of having foreign drugs, because everybody's got them?" Yarbrough said.
Much of the evidence against the Sens is circumstantial, he said.
Dr. Sen "never ordered it, seen it, touched it," Yarbrough said.
Daniel Warlick, Patricia Sen's lawyer, asked the jury at the start of the trial to pay close attention to the evidence presented.
The government did not meet its burden of proof during the trial, Warlick said.
He asked if members of the jury consider the Sens criminals.
"Let's get real about this case," he said. "I wanted you to know all the facts in this case and didn't try to hide a single thing from you."
Warlick said the Sens were drawn into the government's net after an investigation into the McLeod Cancer and Blood Center in Johnson City that resulted in a two-year prison sentence imposed in June by Judge Greer on Dr. William Ralph Kincaid.
Kincaid pleaded guilty in December 2012 to receiving misbranded drugs with intent to defraud or mislead in violation of the Food, Drug and Cosmetics Act.
The government's strategy was, "Let's Google all the other local mom and pop stores and see what we can find (and) they found A.K. Sen," Warlick said.
"It worked. These guys knew what they were doing," he said.
West didn't know key facts about FDA regulations, such as one that allows languages other than English to be on drug labels and packaging, Warlick said.
"(West) wasn't lying about that. I just think he didn't know," Warlick said.
The government, Warlick told jurors, "is urging on you things that are just not true."
'SET UP' BY GOVERNMENT
Patricia Sen "was lied to and set up" by investigators, Warlick said.
Because the government couldn't go after Clinical Care and what prosecutors called a "criminal enterprise," prosecutors "decided to take on the low end of a mom and pop oncology store in Greeneville, Tennessee," Warlick said.
Seventy percent of the drugs purchased by the practice are from Oncology Supply, an American company selling FDA-approved drugs, Warlick said.
Warlick countered the government's contention of "reckless indifference" by the Sens by his characterization of an "assumption or presumption" strategy by prosecutors.
"You are not required to dispense with your common sense," he told the jury in urging a not-guilty verdict for Patricia Sen.
"She deserves it, and justice demands it," Warlick said.
Before closing arguments, Greer denied defense motions to acquit the defendants because of insufficient evidence.
The validity of invoices, billing documents and other evidence questioned by defense lawyers in the motions need to be decided by the jury, Greer said in explaining his decision.
Final prosecution witness LeAnn Lanz, an FBI forensic accountant, testified Tuesday morning about her analysis of drug purchases made by the Sen practice between April 2009 and February 2012.
Lanz focused on 20 cancer and blood disorder treatment drugs purchased by the practice during that time frame.
She testified that the Sen practice purchased about $3 million worth of FDA-approved drugs from Clinical Care and nearly $7 million worth of medications from Oncology Supply.
Lanz said that, during the period covered in the analysis, the practice bought FDA-approved Avastin 57.5 percent of the time from Oncology Supply, and Altuzan 42.5 percent of the time from Clinical Care.
The percentage of alleged unapproved drugs purchased by the clinic varied with each drug, Lanz told Warlick on cross-examination.
Lanz said she did not examine "specific health care records in support of claims."
"I have no way of knowing which patient received the drug from Clinical Care and which patient received the drug from Oncology Supply," Lanz testified.
Lanz said that the Sen practice billed more than $3 million in false claims to Medicare and other health care providers.
"The Clinical Care drugs were cheaper," she said.
CHARGES AGAINST SENS
Anindya Sen is charged with 29 misdemeanor violations of causing the introduction into interstate commerce of misbranded drugs. Patricia Sen is charged with 29 felony violations of the same statute.
The government has also charged Patricia Sen with 44 counts of engaging in a scheme to defraud health care benefit programs, seven counts of receiving merchandise imported contrary to law, in addition to two counts of making a false material statement to West.