FORT LAUDERDALE, Fla. — The former CEO of a Davie-based drug manufacturer accused of selling tainted stool softeners that sickened dozens and killed three infants has pleaded guilty to four felonies after reaching a plea agreement with federal prosecutors.
Raidel Figueroa, who founded and co-owned the company PharmaTech, turned himself into authorities in April after a grand jury indicted him on nine criminal charges. He entered his guilty pleas Thursday in U.S. District Court in Fort Lauderdale.
Figueroa pleaded guilty to distributing tainted drugs across interstate lines, conspiring to defraud the U.S. Food and Drug Administration, distributing falsifying records in an FDA investigation and obstructing proceedings before the FDA.
According to court filings in the case, PharmaTech manufactured and distributed liquid docusate, a drug used to treat constipation, in 2016 and 2017. The drug was distributed under various brand names, including Diocto Liquid.
In July 2016, the plant was inspected by the FDA after Diocto Liquid was traced to an outbreak of a bacterial infection known as Burkholderia cepacia that sickened 63 people in 45 states.
Also known as b. cepacia, the bacteria can cause serious serious respiratory infections and other types of infections to people with health problems like weak immune systems or chronic lung diseases.
The FDA informed PharmaTech that it found the bacteria in PharmaTech’s water purification system as well as in more than 10 lots of the liquid docusate. In response, Figueroa told the FDA that PharmaTech was modifying its water purification system to prevent future contamination.
During another FDA inspection of the plant in March 2017, Figueroa lied by failing to disclose that it had resumed manufacturing the liquid docusate and by stating that the company’s new water system had met “acceptance criteria,” court records state.
“Figueroa knew that a water sample taken on Feb. 15, 2017 from the water system tested presumptive positive for the presence of (Burkholderia) cepacia,” according to a fact sheet filed in court by prosecutors.
Another outbreak of Burkholderia cepacia was investigated in July 2017, this time among children who were patients at Stanford Children’s Health Lucile Packard Children’s Hospital in Palo Alto, California and Johns Hopkins Children’s Center in Baltimore.
Bottles of Diocto Liquid recovered from the hospitals were imprinted with lot numbers proving that they were distributed by PharmaTech in March 2017 — the same lot that Figueroa failed to disclose to the FDA.
Several of the bottles tested positive for the presence of the bacteria, and several contained total aerobic microbial counts and total yeast and mold counts that exceeded acceptable limits, according to prosecutors.
Numerous lawsuits have been filed against PharmaTech and several of its affiliates, including three by parents of infants who died after allegedly being given the stool sampler while hospitalized.
Two of the lawsuits have been settled while a third is pending in Broward County Circuit Court.
Figueroa is scheduled to be sentenced on Aug. 31. According to the plea agreement, he faces up to 20 years in prison and fines of more than $750,000.
