Docs: Pharmacy ignored test results; infant received drug treatment with 25x strength
NOBLESVILLE, Ind. (WISH) — The owner and director of compliance at a Noblesville pharmacy face federal charges related to the potency of drugs.
64-year-old Paul Elmer of Fishers and 62-year-old Caprice Bearden of Carmel are both charged in the case.
Elmer is the owner and president of Pharmakon Pharmaceuticals and Bearden was director of compliance for the company. Pharmakon compounded drugs at its Noblesville facility.
The pair face 10 federal charges. The pair were indicted on charges of one count of conspiracy to defraud the United States, three counts of distributing an adulterated drug in interstate commerce and six counts of adulterating drugs while held for sale after shipment of a drug component in interstate commerce.
Court documents state that the company received 70 potency test failure notices for their drugs, which were found to be either underpotent or overpotent. Drugs tested included morphine sulfate and fentanyl. Investigators believe Elmer ignored the test results after being told by Bearden.
The test notices were received between July 2013 and February 2016.
Investigators said that three infants in Indiana hospitals received morphine sulfate treatments that were nearly 25 times the strength as indicated on the label. One of the infants had to be transported to a children’s hospital by helicopter.
Elmer was arrested Wednesday and has pleaded not guilty. Bearden has been issued a summons to appear in court.
Trial is set for Aug. 21.
“These defendants put greed and the reputation of their company ahead of the health and safety of our most innocent victims,” said U.S. Attorney Josh Minkler. “Their actions put lives in danger and they will be held accountable.”Read the full indictment below: