An Indiana pharmaceutical company sold the wrong prescription medication to hospitals who then distributed the drugs to infants. The company and the families affected by the mistake are currently going through a lawsuit.
Executives at Pharmakon, a pharmaceutical company in Indianapolis, Ind., did not recall a painkiller after knowing it was much stronger than its label suggested. This decision led three newborns to fall ill.
“This case is about the defendant’s’ disregard for the wellbeing of patients including the most vulnerable among us, newborn infants in a neonatal unit” (Star, 2017, n.p.), said U.S. Attorney, Josh Minkler during a news conference. Minkler also added that the two executives of the company, one of them being the CEO and the other being the compliance officer, “made decisions motivated by nothing else but greed” (Star, 2017, n.p.).
The company regularly sent drugs to hospitals without waiting for their labels to display proper potency information. Even after receiving the correct information Pharmakon protected themselves instead of doing a recall on the drugs.
According to the Food and Drug Administration, the infants affected by Pharmkon’s decision to refrain from recalling their medications suffered “serious adverse events” (Star, 2017, n.p.). One of the three babies was immediately rushed to a children’s hospital by helicopter.
“Pharmakon would send out its drugs for testing to make sure the labeled strength matched its actual strength, but the indictment alleges that [Paul J. Elmer, president and owner of Pharmakon, and Caprice R. Bearden, director of compliance] would ship the drugs to health care providers before receiving the results” (Star, 2017, n.p.).
“From 2013 to 2016 Bearden was notified of about 70 test results that indicated Pharmakon drugs were either stronger, or weaker, than labeled” (Star, 2017, n.p.). Throughout this time the company did not notify the FDA or other health care providers about any of the problems. They also lied to FDA investigators during drug inspections (Star, 2017).
“Paul J. Elmer…and Caprice R. Bearden… are facing federal charges of engaging in commerce with adulterated drugs in an indictment unsealed on Thursday” (Star, 2017, n.p.).
Bearden supposedly notified the court that she plans on pleading guilty to all charges. A request for comment had been put out for the defense attorneys representing both Elmer and Bearden. A representative from the company has stated that Pharmakon has closed.
Luckily, none of the infants died due to the company’s greed.
For more information on this topic please read “Pharmaceutical company sold drugs.”
Star, M. B. (2017, June 22). Pharmaceutical company sold drugs that sickened babies, feds allege. Retrieved July 08, 2017, from https://www.usatoday.com/story/news/nation-now/2017/06/22/indiana-company-sold-drugs-sickened-babies-feds-allege/420086001/