An Indiana-based pharmaceuticals company decided not to recall a painkiller given to newborns even though the drug was 25 stronger than advertised on its label, sickening three infants.
Two top executives at Pharmakon Pharmaceuticals Inc. were indicted by a federal grand jury on charges of engaging in commerce with adulterated drugs, reported the Indianapolis Star.
The company's CEO, Paul Elmer, and chief compliance officer, Caprice Bearden, made decisions "motivated by nothing else but greed," according to U.S. Attorney Josh Minkler.
"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," Minkler said Thursday, after the indictment was unsealed.
Bearden has notified the court she intends to plead guilty to all charges, the U.S. attorney said, and a company representative told the Star that Pharmakon had closed.
The indictment alleges that Pharmakon routinely sent drugs to hospitals without waiting for test results to confirm the potency matched their label.
Prosecutors accused the two executives of keeping the drugs on the market -- rather than risk customers by ordering a recall -- even when their strength was substantially different than advertised.
Bearden was notified between 2013 and 2016 of about 70 test results that were much higher or weaker than labeled but did not notify the FDA or health care providers, according to the indictment.
Prosecutors also accused Bearden of lying to FDA officials in 2014 about receiving test results that showed a painkiller was twice as strong than labeled, and the product was administered to at least 13 newborn babies until a hospital worker noticed the problem nearly a month later.
Pharmakon recalled the drug only after the FDA opened an investigation and issued a warning letter in 2015.
The company distributed a painkiller in February 2016 in Indiana and Illinois that was 25 times stronger than advertised, and three newborn babies given the medicine suffered "serious adverse events," and one had to be airlifted to a children's hospital.
"They lied about it. They hid those results," Minkler said. "Had they told the FDA, those drugs would have been taken of the market immediately and those infants, their lives would not have been put at risk."