The former compliance director of now-defunct Pharmakon Pharmaceuticals Inc. in Noblesville has pleaded guilty to multiple federal charges. The Office of United States Attorney for the Southern District of Indiana Josh Minkler says Caprice Bearden will be sentenced at a later date for alleged crimes that include introducing adulterated drugs into interstate commerce and conspiracy to defraud the U.S. The combined charges could carry a maximum prison sentence of 14 years and hundreds of thousands of dollars in fines.
Minkler says "this defendant distributed serious drugs to hospitals in Indiana and around the country, knowing that the drugs were significantly under or over the strength they were supposed to be. She put greed and the reputation of her company ahead of the health and safety of our most vulnerable patient populations."
The federal charges, which were announced in June, allege that other companies claim some 70 potency tests between July 2013 and February 2016 indicated certain drugs were either under or over-potent under Bearden’s watch. Early last year, Pharmakon is alleged to have distributed over-potent morphine sulfate to hospitals in Indiana and Illinois. Three infants, including one that had to be airlifted for medical care, received the drugs that tested to be nearly 25 times label strength.
U.S. Food and Drug Administration Commissioner Scott Gottlieb says "this is an egregious example of how harmful conduct can result in risk to patients. The disregard for the law resulted in the injury of infants from poorly compounded, super potent morphine products. We will not tolerate substandard practices, like failing to meet federal manufacturing standards like those found at Pharmakon, that put patients at risk and will aggressively pursue individuals that put profit ahead of patient safety."
Owner Paul Elmer was also indicted earlier this year on federal charges on related allegations. You can connect to more about Bearden’s guilty pleas by clicking here.