Judge Expected Today To Rule On Whether Some Prosecution Evidence May Be Heard In Court
BY KEN LITTLE
Invoices, packing slips and other documents the prosecution hopes will lay the foundation for their case against Dr. Anindya Sen and his wife, Patricia Posey Sen, were the focus Wednesday during the first day of testimony at the Sens' U.S. District Court trial.
Assistant U.S. Attorney M. Neil Smith called two employees of the East Tennessee Cancer and Blood Center (ETCBC) operated by the Sens to testify about orders from a Canadian company known as Clinical Care for drugs that the government maintains were misbranded and not federally approved.
U.S. District Court Judge J. Ronnie Greer sent the jury home in the afternoon after Anindya Sen defense lawyers Edward M. Yarbrough and J. Alex Little raised objections about the admissibility of planned testimony by Dr. Charles E. Lee, of the U.S. Food and Drug Administration's (FDA) Office of Compliance.
Lee's planned testimony includes analysis of drugs similar to the ones allegedly used at the practice that the government claims are misbranded.
Much of the evidence the prosecution plans to present "is inadmissible," argued Yarbrough, lead defense lawyer for Anindya Sen and former U.S. Attorney of the Middle District of Tennessee.
"Dr. Sen has a right for this court to examine this proof," Yarbrough said. "We have two clients who have been shattered and cut down by this trial."
Little earlier argued that the admissibility of invoices already presented at trial is also in question because of their unclear origins.
Greer responded that objections and motions should have been filed before the trial began, but agreed that a "substantial question" had been raised.
Greer heard Lee's planned testimony Wednesday afternoon and then was to review motions filed by the defense and a response from Smith before prosecution testimony resumes this morning.
Anindya Sen, 65, 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 an FDA special agent.
Both sat with their lawyers Wednesday and listened intently to witness testimony. Sen and his wife, who is office manager of clinics operated by the practice in Greeneville and Johnson City, are being jointly tried by the government.
In its most recent indictment of the Sens, prosecutors refer to ETCBC as East Tennessee Hematology Oncology and Internal Medicine, or simply as "the practice."
ETCBC was an initial defendant in the case but was not named in a third superseding indictment filed on Nov. 20.
Sen and his wife maintain their innocence and opted to go to trial.
Tammy Seabolt, a longtime clinic employee who oversees accounts payable at the practice, was the first prosecution witness.
Smith reviewed dozens of medical practice documents with Seabolt. They included invoices and packing slips received from Clinical Care for drugs shipped to the Greeneville office between 2009 and March 2012, when the practice stopped buying drugs from the company.
"Ms. Posey would order the medication. I don't know how they shipped it," Seabolt told Smith.
Smith asked who handled any questions about administration of the business.
"(Dr. Sen said) to ask Patricia about it," Seabolt said.
Under cross-examination by Yarbrough, Seabolt testified she did not know who prepared the billing documents sent to the practice from Clinical Care, or where they were prepared.
Yarbrough asked if she knew if the invoices and packing slips "are true or false."
"No," she said.
NO QUESTIONS RAISED
Seabolt testified she never raised any questions about the validity of the drugs from Clinical Care, but added that it was not within her scope of job responsibility to do so.
She testified about an email inquiry to Clinical Care requested by Patricia Sen about a particular drug.
Patricia Sen didn't order the drug after being told in the email by a Clinical Care representative that it wasn't FDA-approved, Seabolt told Yarbrough.
Earlier, Smith asked Seabolt if she recalled any other time Sen asked her to inquire if a drug was FDA-approved.
"No," she replied.
The last shipment from Clinical Care, on March 8, 2012, was not paid for because it was sent back to the company, Seabolt testified.
Smith said Tuesday in his opening statement that early March 2012 was when the government began its case against another clinic in Johnson City for buying misbranded drugs and administering them to patients, then billing Medicaid as if FDA approved drugs were used.
The case spurred news reports that may have prompted Patricia Sen to stop purchasing drugs from Clinical Care, Smith suggested.
Daniel D. Warlick, who represents Patricia Sen, also cross-examined Seabolt.
Seabolt told Warlick that clinic patients held Anindya Sen in high regard and testified that no one was ever turned away, regardless of insurance or income.
"You know anybody over there who tried to shortchange a patient in any way?" Warlick asked.
"No," Seabolt said.
Drugs the government alleges were misbranded and administered to patients at the practice include Aloxi, Altuzan, Avastin, Bonviva, Mabthera, Neupogen and Venofer.
MEDICAL ASSISTANT TESTIFIES
Tracy Nicole Gregg, a medical assistant at the Sen practice, testified her job duties include unpacking packages received from Clinical Care and other pharmaceutical companies.
Patricia Sen was in charge of the office, Gregg told Smith.
In 2009, practice employees were told that a "generic medication" was going to be introduced there.
The packages containing the drugs were from a company in the United Kingdom, Gregg said.
One of the first shipments that arrived in 2009 "wasn't in English on the boxes," Gregg told Smith.
Gregg told Smith that she unpacked Altuzan and put it in a medicine locker where an approved medication with a similar name was kept.
Seabolt also identified one document from another provider of drugs to the Sen clinic from a company in the United Kingdom.
The government alleges that the Sens administered unapproved drugs to patients that are from countries such as India and Turkey.
A U.S. mail document in prosecution evidence that Seabolt examined during her testimony showed that drugs had been returned to the United Kingdom company about the same time the practice stopped doing business with Clinical Care.