The former compliance officer of a defunct Noblesville drug company has been sentenced to five months in prison after pleading guilty to multiple criminal charges related to sale of pharmaceuticals that were as much as 25 times more potent than they should have been.
Caprice R. Bearden, 63, of Carmel, was sentenced Monday by Judge James R. Sweeney II in U.S. District Court in Indianapolis. She also was fined $1,000, sentenced to 40 hours of community service and three years of supervised release.
Bearden had worked at Pharmakon Pharmaceuticals, a company that manufactured large batches of drugs for hospitals. The company closed its doors in 2016 after the government began investigating complaints.
Pharmakon compounded drugs—including morphine and fentanyl—at its Noblesville facility and sent them to hospitals all over the country, including Community Health Network in Indiana and Walter Reed National Military Medical Center in Washington, D.C. Many of its hospital customers used the drugs to treat infants, the elderly and veterans. Compounding drugs is a highly technical practice in which a pharmacist mixes ingredients to produce medicines.
Prosecutors said that from July 2013 through February 2016, Bearden received about 70 potency-test failure notices from companies used by Pharmakon, indicating that drugs such as morphine sulfate and fentanyl were either under- or over-potent.
The indictment said Bearden discussed the out-of-specification test results with CEO Paul Elmer, a licensed pharmacist, and Elmer determined that Pharmakon should not contact any clients–including hospitals–who received the drugs, nor conduct product recalls before FDA intervention. Prosecutors said the motivation was to prevent a loss of revenue.
In one case in 2016, Pharmakon distributed an opiate painkiller called morphine sulfate at a potency level of 2,460 percent to two hospitals in Indiana and Illinois. Three infants from the Indiana hospital later received the medicine, and one had such a severe reaction that it was taken by emergency helicopter to Riley Hospital for Children.
Elmer, 66, of Fishers, was convicted earlier this month by a federal jury of nine counts of adulterating compounded drugs and one count of conspiracy. He was found not guilty of an additional count of obstruction of justice. He is awaiting sentencing.
Bearden, who pleaded guilty in November, testified against him, as did several other employees and outside vendors.
Elmer founded Pharmakon in 2003 in Indianapolis, moved it to Carmel in 2008 and then to Noblesville in 2014. It received more than $500,000 in tax breaks and other incentives from state and local governments. Pharmakon closed its doors in 2016.