CMO tied to Burkholderia cepacia outbreak faces lawsuits
Seven lawsuits have been filed against PharmaTech LLC, a contract manufacturing organisation based in South Florida (US) identified by the FDA to be linked to an outbreak of deadly Burkholderia cepacia, the Sun Sentinel has reported.
The lawsuits have been filed on behalf of patients who were infected by the bacterial virus, including three infants who died after taking a stool softener.
PharmaTech LLC might be defunct, as it vacated its manufacturing plant in June 2017, the newspaper said.
In 2016, the company recalled about 30 products after the CDC and FDA tracked an outbreak to the company’s water system due to contamination reports indicating the company had produced 10 contaminated lots of its constipation drug docusate sodium.
The FDA said that 63 confirmed cases of infection and 45 suspected cases in 12 states had been confirmed since the outbreak began in 2016.
Howard Grossman, a Boca Raton lawyer who is co-counsel in a couple of the lawsuits, told the newspaper there were indications that the company had reopened elsewhere in Florida but he hadn’t confirmed that yet.
