INDIANAPOLIS — Executives at a Noblesville, Ind., pharmaceuticals company did not recall a painkiller that was 25 times stronger than its label said it was, a federal indictment alleges, which caused three newborns to become ill.
“This case is about the defendants’ disregard for the well-being of patients including the most vulnerable among us, newborn infants in a neonatal unit,” U.S. Attorney Josh Minkler said at a news conference Thursday.
Minkler said two executives at Pharmakon Pharmaceuticals Inc., one the CEO and the other the compliance officer, made decisions “motivated by nothing else but greed.”
The company routinely sent drugs to hospitals without waiting for test results that would confirm that the potency of the drugs matched what the label said, the indictment says.
And when the company received results that showed the strength was often nearly double what the label said, the indictment alleges, the company protected its profits rather than recalling the drugs.
These profits, the indictment says, came at the expense of the health of three infants.
The babies suffered “serious adverse events,” according to the Food and Drug Administration. One newborn was rushed to a children’s hospital by helicopter.
Paul J. Elmer, president and owner of Pharmakon, and Caprice R. Bearden, director of compliance, are facing federal charges of engaging in commerce with adulterated drugs in an indictment unsealed on Thursday.
Bearden, Minkler said, has notified the court that she intends to plead guilty to all charges.
IndyStar has requested comment from the defense attorneys representing Elmer and Bearden. A representative answering the phone at a number…