On Thursday, December 12, 2013 a federal jury concluded deliberations on U.S.A. vs. Dr. Anindya Kumar Sen and Patricia Posey Sen. Dr. Sen is an oncologist practicing in Greeneville and Johnson City, Tennessee. Patricia Posey Sen is his wife, who manages Sen’s medical practice, East Tennessee Cancer and Blood Center (ETCBC). The doctor, his wife and the corporation were initially indicted in June 2013 on 38 counts related to the purchase and administration of non FDA-approved prescription chemotherapy drugs. They pleaded not guilty to the charges reports the Greeneville Sun. After 13 hours of deliberation, they were convicted by a U.S. District Court jury of 29 misdemeanor counts of causing the introduction into interstate commerce of misbranded drugs. Patricia Sen was acquitted of all felony charges against her. The jury concluded that Posey Sen received black market drugs at the practice, but that she could not be convicted of fraud because she did not know the drugs were non-FDA approved. According to the Greeneville Sun, the Sens will appeal the misdemeanor convictions. Sentencing is scheduled for April 30, 2014.
In the run-up to the trial, the prosecution and defense teams tussled over the admissibility of evidence and the standing of the case. The court granted the government’s motion to suppress inadvertent security recordings of agents’ interviews with practice staff in April 2012 and the defense team’s motion to suppress allegedly misbranded drugs seized by FDA special agents without a warrant during the same period, reported the Greeneville Sun.1 It also dismissed defense efforts to throw out the case on the grounds of vindictive or selective prosecution and prosecutorial misconduct.2 For its part, the government issued three superseding indictments between June and November.
At the start of the trial on December 3, ETCBC had been dropped from the prosecution. Dr. Sen’s charges had been reduced to 29 misdemeanor counts of introducing misbranded drugs into interstate commerce. Prosecution had shifted the bulk of its charges to Patricia Posey Sen, who was in charge of ordering medicines at the practice. She faced 29 counts of introducing misbranded drugs at the felony level, six for receiving merchandise imported contrary to law, 44 for defrauding health care benefit programs, and two for making false statements to agents during the investigation. The final two charges were added after Posey Sen lied about purchasing foreign drugs to FDA Special Agent Robert West, who led the investigation, reported the Greeneville Sun.
During the trial, which happened, between December 3 and December 10 the government called the Sens’ employees, the FDA agents who investigated the case, an FDA expert in misbranded drugs, staff from the company that processed the Sen’s claims to benefits programs and an FBI forensic accountant to substantiate its case that the Sens knowingly ordered unapproved foreign drugs for their own profit. The prosecution alleged that between April 2009 and March 2012 Patricia Posey Sen (with the knowledge of Dr. Sen) ordered $3 million in illegally imported drugs from a Canadian supplier called Clinical Care and a British company called River East Supplies, Ltd. Among these were versions of Altuzan, Avastin, Bonviva, MabThera, Nupogen and Venofer offered for less than their FDA-approved counterparts, but the medicines could not be guaranteed to be safe or effective because they lacked a secure chain of custody. The Sens submitted reimbursement statements that totalled $3.2 million for these medicines, falsely claiming that they had administered the FDA approved ones. According to the testimony of LeAnn Lanz, an FBI forensic accountant, illegally imported medicines comprised about 30% of the practices’ prescription costs during the period, reported the Greeneville Sun.
According to the Greenville Sun, ETCBC’s staff testified about administering medications with labels in languages other than English and about delays in receiving drugs shipped from the United Kingdom. The government’s trial brief states that nurses became concerned about the practice’s use of Altuzan in February 2012, when the FDA announced that counterfeit Avastin had been found in the United States. They discovered that their own stock of Altuzan matched the recalled lot numbers and delayed a patients’ treatment until they received a safe replacement supply of the drug. The brief claims that Posey Sen did not dispose of the drugs until the first week of March, when she became aware of the FDA’s investigation of McCleod Blood and Cancer Center in Johnson City. Upon hearing about the case, the brief states, she had staff return the offending medicines to the United Kingdom.3
The United States’ case against the Sens’ rested on proving that Patricia Posey Sen deliberately conspired to defraud the government. US Attorney M. Neil Smith addressed the defense’s suggestion that Posey Sen didn’t know enough about sourcing chemotherapy drugs to be culpable: “You can’t not know something you just have to know.” In his final argument, Dr. Sen’s lawyer, Edward Yarborough, questioned the legitimacy of classifying FDA-approved drugs manufactured overseas as different from drugs manufactured abroad for different markets. He also suggested the government had no proof that Dr. Sen was involved in the false billing scheme. Posey Sen’s lawyer, Daniel Warlick, claimed that the government had not proven its case and that it was inappropriately targeting “mom and pop stores” rather than the illegal distributors selling the drugs, reported the Greeneville Sun.
Update, December 2014:
According to the Wall Street Journal, the Justice Department withdrew its case against Dr. Anindya Kumar Sen and Patricia Posey Sen on December 15, 2014.
The Sens were convicted of 29 misdemeanors relating to the sale of non-FDA approved oncology drugs in December 2013 and were sentenced to pay a fine of $300,000, with Posey Sen serving two days in prison, last June. An appeal filed in September questioned (1) whether the Sens could be convicted for what their defense characterized as the “innocent and unknowing receipt of misbranded drugs by individuals who simply ordered them from a distributor,” (2) whether the unlicensed distributor’s invoices could legally be considered business records and (3) whether the court’s sentences were excessive. The defense argued that section 331 of the Food, Drug and Cosmetic Act, which addresses prohibited acts such as the sale of misbranded or adulterated drugs into the United States drug supply, applied to distributors and manufacturers, not medical professionals who might purchase discounted, non-FDA approved medicines.
The Justice Department’s filing stated simply that “upon further review, and in the exercise of discretion, the Department of Justice has determined not to proceed further with the prosecution of the defendants under 21 U.S.C. § 331(a).”
1) Dennis H. Inman, United State Magistrate Judge, “Report and Recommendation” [on “a joint motion to suppress evidence”], Case 2:13-cr-00056-JRG-DHI Document 90, Filed 11/18/13.
2) Dennis H.Inman, United States Magistrate Judge, “Report and Recommendation” [on “a joint motion to dismiss the Second Superseding Indictment for vindictive prosecution, prosecutorial misconduct, and selective prosecution”], Case 2:13-cr-00056-JRG-DHI Document 92 Filed 11/19/13.
3) M. Neil Smith, Assistant U.S. Attorney, United States Trial Brief, Case 2:13-cr-00056-JRG-DHI Document 98 Filed 11/20/13.