An Indiana pharmacy's owner, as well as its director of compliance, is facing criminal charges related to distributing over- and under-potent drugs. Apart from distributing products with potencies that are inconsistent with their labelling, the two also allegedly attempted to cover up their tracks despite their knowledge of the mistake.
Adulterated Drugs
On Thursday, June 22, the United States Department of Justice announced that Paul J. Elmer, owner of Pharmakon Pharmaceuticals Inc., and Caprice R. Bearden, the pharmacy's director of compliance, are being charged with a 10-count indictment.
The charges are in relation to allegedly fraudulent actions by the two regarding their company's sale of painkillers that were either over- or under-potent when compared to their labelling, an action that placed many lives in danger.
In fact, on more than one occasion, Pharmakon allegedly distributed batches of adulterated morphine sulfate, an opioid typically used for pain relief, that were administered to infants. For instance, a batch that was 25 times more potent than indicated in its labelling was distributed to a hospital in Indiana and in Illinois. Three infants at the hospital in Indiana were given the over-potent drug, one of whom had to be flown via emergency helicopter to a children's hospital.
Fraudulent Efforts
According to the indictment, between July 2013 and February 2016, Bearden received about 70 potency test failure notices indicating that some of their products' potencies, such as morphine sulfate and fentanyl, were inconsistent with the labelling. Bearden evidently discussed the matter with Elmer, who then decided not to contact any of the hospitals who received the adulterated medication or contact the Food and Drug Administration (FDA) to conduct a recall.
What's more, in 2014 and 2016, Bearden allegedly lied to the FDA about receiving any of the potency results, something that Elmer did not correct even when he learned of Bearden's lies shortly after. In fact, Elmer also allegedly told at least one Pharmakon employee to backdate the batch records of compounded drugs.
In addition to these reports of fraudulent actions, Elmer and Bearden allegedly failed to investigate on the root cause of their products' drug potency failures and carried on with the distribution them despite having knowledge of the products being over- or under-potent.
Because of these offenses, Elmer and Bearden are facing a 10-count indictment, which includes three counts of distributing an adulterated drug, one count of conspiracy to defraud the United States, and six counts of adulterating drugs.
The conspiracy charges could lead to a maximum sentence of five years and a fine of $250,000, while each count of adulterating drugs and distributing said adulterated drugs carries a maximum of one year in prison and a fine of $100,000.
"These defendants put greed and the reputation of their company ahead of the health and safety of our most innocent victims," said Southern District of Indiana U.S. Attorney Josh Minkler.
Elmer, who was arrested yesterday, pleaded not guilty to the charges.
