Purchases of cancer treatment drugs allegedly made by East Tennessee Hematology, Oncology and Internal Medicine from foreign sources were one focus of testimony Monday at the trials of Dr. Anindya Sen and his wife, Patricia Posey Sen.
U.S. Food and Drug Administration (FDA) investigator Robert West identified each of the drugs as it was introduced into evidence by Assistant U.S. Attorney M. Neil Smith.
Sen, 65, is the only doctor at the Greeneville and Johnson City clinics. Patricia Sen is office manager. The government alleges the medical practice administered to patients some drugs from foreign sources that are not approved by the FDA.
Evidence showed that the drugs allegedly obtained from Clinical Care, a Canada-based company, were routinely less expensive than FDA-approved drugs the practice purchased from a U.S. company.
Assistant U.S. Attorney Smith showed West invoices froma Japanese company called Meiko America that owns a warehouse in Illinois. The invoices indicated that some of the alleged unapproved medications shipped to the Sen practice were received from Canada and elsewhere.
Smith and West detailed the paper trail of invoices and other documents the government maintains show that non-approved drugs were knowingly ordered and used at the Sen practice.
The Sens have maintained their innocence since a first grand jury indictment in June.
Another company, this one based in the United Kingdom, called River East Supplies Ltd., also allegedly shipped unapproved or misbranded drugs to the practice, according to prosecution testimony.
Some of the drugs were shipped directly to the Sens’ Greeneville clinic, West testified.
Prosecution evidence introduced included documents from the U.S. Postal Service and its British equivalent that showed medications had been mailed to the Sen practice.
On cross-examination, defense lawyer Daniel Warlick asked some pointed questions regarding interviews West had with Patricia Sen at the Greeneville practice in April 2012.
If Patricia Sen lied about buying foreign drugs or foreign-labeled drugs, “She would have to have known what they were,” Warlick said.
Earlier trial testimony established that Patricia Sen had no formal medical training.
“I think she knew exactly what I was talking about when I talked to her,” West told Warlick.
Several questions by Warlick to West focused on interviews about buying “foreign drugs and foreign-labeled drugs.”
The charges against the Sens stemmed from a broader investigation that focused on smaller, independent “mom and pop” clinics and not larger hospital groups, Warlick said.
West agreed with that characterization. He said all the invoices received by the practice were from Clinical Care and not Meiko America or one of its subsidiaries.
Through his line of questioning, Warlick suggested that Patricia Sen was not aware the practice was receiving misbranded or non-approved drugs.
“She couldn’t lie about it if she didn’t know about it,” he said.
“I believe she knew exactly what I was talking about,” West responded.
Warlick asked if the prosecution had any witnesses who would testify that Patricia Sen was the one who opened the packages that arrived at the clinic, or put the drugs in the system that dispensed them to nurses.
“No,” West said.
Warlick asked West if he knew if medications like the ones used at the Sen clinic could have “dual labeling” in English and another language. He cited federal regulations that allowed the practice.
West said it was his “opinion” that dual labeling was not allowed.
Warlick cited an excerpt from an interview between West and Patricia Sen where the investigator said Sen was being untruthful when denying the clinic’s use of unapproved drugs.
“It’s an interviewing technique,” West said. “I think I had sufficient facts to know what was going on.”
Heather Sheppard, another prosecution witness and a registered nurse at Cahaba Government Benefits Administrators (GBA), a private company that works with Medicare and Medicaid recipients in Tennessee and two other states, reviewed Medicare reimbursement forms from the Sen practice and explained how claims are paid out to a medical practice.
The provider receives 106 percent of the purchase price of drugs from companies.
The unapproved drugs can be purchased at about 80 percent of the cost of FDA-approved drugs, Smith said earlier in the trial.
The Sens’ 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, then billed Medicare, Blue Cross/Blue Shield and other providers about $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 in his opening statement.
On cross-examination, Anindya Sen defense lawyer Edward M. Yarbrough asked Sheppard if companies such as Cahaba GBA pay out billing claims even if there are errors that are “innocently” included.
“We rely on the integrity of the provider for an accurate and true claim,” Sheppard said. “We process a claim based on what is provided to us.”
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.