Noblesville pharmaceutical company sold drugs that sickened babies, feds allege

Executives at a Noblesville pharmaceuticals company did not recall a painkiller that was 25 times stronger than its label said it was until after it caused three infants to become ill, a federal indictment alleges.

"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.

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The babies suffered "serious adverse events," according to the Food and Drug Administration. One infant 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. Her defense attorney, Jennifer Lukemeyer, did not return a request for comment on Bearden's behalf. 

Elmer's defense attorney, Josh Moudy, said he believes there will be a satisfactory resolution after the attorneys get through the discovery process.

"We are trusting in the process," Moudy said.

A representative answering the phone at a number listed for Pharmakon said the company has closed.

Pharmakon would send out its drugs for testing to make sure the labeled strength matched its actual strength, but the indictment alleges that Elmer and Bearden would ship the drugs to health care providers before receiving the results. 

From 2013 to 2016 Bearden was notified of about 70 test results that indicated Pharmakon drugs were either stronger, or weaker, than labeled, the indictment says. 

Pharmakon, though, did not notify the FDA, or the health care providers, about the problems with the potency of the drugs, the indictment says, and even lied to FDA investigators during a 2014 inspection. During that inspection, the indictment says, Bearden told officials that Pharmakon had never received test results outside of the targeted potency range. 

Less than a month later, in March of 2014, an Indiana hospital worker noticed that a drug the hospital used for sedation was twice as strong as the label indicated — after the hospital had given the drug to 13 infants in the neonatal intensive care unit. 

The hospital worker notified the FDA, the indictment says, which investigated and found that Elmer and Bearden learned about the double-strength drug two months before the hospital administered it to infants but did nothing. 

Pharmakon only recalled the drug after the FDA's investigation, the indictment says. 

The FDA sent the company an official warning letter in 2015 that said Pharmakon's practices put patients at risk.

But in February of 2016, the indictment alleges, Pharmakon distributed a painkiller to hospitals in Indiana and Illinois that was 25 times more powerful than its label said. The indictment accuses Bearden and Elmer of concealing the misrepresented strength of their drugs until the result was nearly catastrophic.

"They lied about it. They hid those results," Minkler said. "Had they told the FDA, those drugs would have been taken off the market immediately and those infants, their lives would not have been put at risk."

Three babies were given the painkiller and became sick, the indictment says. Pharmakon then recalled the drug. No infants died after taking the mislabeled drugs, officials said Thursday.

"Elmer determined that Pharmakon should not contact any individuals and entities — including physicians and hospitals — who received the drugs," the indictment says, "because the health care providers had likely already used the drugs, and because notification would lead to the loss of customers, and therefore, a loss of profit."

Editor's note: An earlier version of this article incorrectly stated that the infant rushed to a children's hospital by helicopter was a newborn. IndyStar regrets the error.

IndyStar reporter Vic Ryckaert contributed to this story. Call IndyStar reporter Madeline Buckley at (317) 444-6083 or email her at madeline.buckley@indystar.com.