Drug maker sued over contaminated laxative slapped with new FDA warning
A Florida drug manufacturer at the center of a wrongful death lawsuit involving the parents of a Hampton infant is under fire again by the Food and Drug Administration.
PharmaTech LLC of Davie, Fla., is being sued in federal court in Pittsburgh by Jocelyn and Lamont Singleton in connection with the May 4, 2016, death of their daughter, Alivia Singleton, who was three months shy of her first birthday.
The lawsuit contends Alivia contracted a bacterial infection after being given a liquid laxative, while hospitalized, made by PharmaTech. The laxative, known as “Diocto Liquid,” was contaminated with Burkholderia cepacia, a rare form of bacteria, according to the lawsuit.
On Friday, the FDA issued an advisory regarding PharmaTech products after a multistate outbreak of Burkholderia cepacia bacterial infections traced to liquid drug products. The infections afflicted at least eight patients in California and Maryland, the FDA said in a news release.
“FDA reminds health care professionals and patients not to use any liquid product manufactured by PharmaTech’s Davie, Florida, facility,” the news release said.
PharmaTech vacated its Davie building in June, a town spokesman told the Tribune-Review this week. Its website is down and a former phone number is disconnected.
In June 2016, a month after Alivia died, the FDA and the Centers for Disease Control and Prevention reported an investigation of multistate outbreaks of Burkholderia cepacia, or B. cepacia infections.
A month later, PharmaTech voluntarily recalled all of its Dicoto Liquid products. The FDA confirmed the laxative was contaminated with B. cepacia linked to infections in five states, including Pennsylvania.
PharmaTech contends that the Pittsburgh lawsuit should be dismissed because it “lacks specificity.”
Attorney Brendan Lupetin, who represents the Singleton family, said his claims are legitimate.
Ben Schmitt is a Tribune-Review staff writer.