In a previous blog post I shared the current information on Pharmakon, an Indiana 503B Outsourcing Facility that released sub/super potent drugs. This facility closed in 2016 after the third FDA investigation which was prompted by an adverse event report concerning the administration of superpotent morphine sulfate (2,460 times potency) to three infants.
You may recall that Caprice Bearden Pharmakon’s Director of Compliance pleaded guilty Nov 22, 2017 to one count of conspiracy and nine misdemeanor counts related to the sale of adulterated drugs. As reported in the Indianapolis Business Journal, the case against Paul Elmer is set to go to trial today (April 1, 2019), before Judge James R. Sweeney in Indianapolis.
This should prove interesting as:
Prosecutors plan to introduce dozens of exhibits, including the warning email sent by Wang, according to a trial brief they recently filed that summarizes the government’s evidence and includes examples of documents and testimony.
They also plan to call “multiple employees” who will offer firsthand observations and statements from Elmer, including some workers who heard him and other company officials talking about potency failures on multiple occasions, according to the government’s trial summary.
A key witness will be the company’s former compliance officer, Caprice Bearden, who pleaded guilty in 2017 to one count of conspiracy to defraud the United States and nine misdemeanor counts related to the sale of adulterated drugs.
Based on the document trail, eye-witness accounts from employees, and having the Director of Compliance as a key witness this should be an open/shut case but one never knows.