FORT LAUDERDALE, Fla. – The former CEO of Pharmatech, LLC, a drug and supplement manufacturer that was based in Davie, pleaded guilty to multiple charges related to a bacterial outbreak stemming from contaminated liquid laxatives.
The outbreak led to at least one wrongful death lawsuit.
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On Thursday, Raidel Figueroa pleaded guilty in Fort Lauderdale federal court to charges of conspiring to defraud the Food & Drug Administration, falsifying records in an FDA investigation, obstructing proceedings before the FDA, and distributing adulterated drugs, according to a U.S. Department of Justice news release.
Pharmatech manufactured Diocto Liquid, a drug used to treat constipation. The news release said the FDA began an inspection at Pharmatech as part of an investigation into an outbreak of Burkholderia cepacia (B. cepacia) infections.
In 2017, the family of Alivia Singleton sued Pharmatech in federal court. They said the 9-month-old baby died after developing a B. cepacia infection after taking Diocto Liquid while in a Pittsburgh children’s hospital.
B. cepacia is a group of often-drug-resistant bacteria typically found in soil and water that can be harmful to people who are immunocompromised or have lung issues.
According to the release, in August 2016, the FDA notified Figueroa that a sample it had taken from Pharmatech’s water system tested positive for B. cepacia. Figueroa advised the FDA that Pharmatech was re-engineering its purified water system to prevent future contaminations.
In March 2017, prosecutors said Figeuroa lied after investigators asked him to disclose all products that Pharmatech had manufactured after manufacturing resumed.
“Figueroa lied to the FDA investigators by, among other things, knowingly excluding Diocto Liquid from its products list (even though Pharmatech shipped over 7,000 units of the drug earlier that month) and by falsely stating to the FDA that Pharmatech’s new water system had met ‘acceptance criteria,’ which was not true,” the release said.
In July 2017, the FDA became aware of a B. cepacia outbreak at two children’s hospitals and it investigated and collected bottles of Diocto Liquid from those hospitals. The samples were from the March 2017 lot Pharmatech Figueroa omitted to investigators at the time, prosecutors said.
“Several of the bottles contained total aerobic microbial counts and total yeast and mold counts in excess of acceptable limits and some of the bottles also tested positive for the presence of B. cepacia,” the news release said.
Figueroa, who signed a plea agreement, could face more than three decades in prison if the sentences were to run consecutively, though prosecutors are recommending a lesser sentence.