Lawsuits pile up against CMO tied to Burkholderia cepacia outbreak

A South Florida contract manufacturer that the FDA said was tied to an outbreak of deadly Burkholderia cepacia has had seven lawsuits filed against it on behalf of patients who were infected by the bacterial virus, including three infants who died after taking a stool softener.

According to the Sun Sentinel, the lawsuits were filed against PharmaTech LLC, as well as principals and distributors of the company, which may now be defunct. It vacated its manufacturing plant in Davie, Florida, 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, which they said was contaminated. The company had produced 10 contaminated lots of constipation drug docusate sodium.

In an update last fall, the FDA said that the bacteria had been found in several bottles of Rugby Diocto (docusate sodium) made by the company. It 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.

In addition to the company, his most recent lawsuit names as co-defendants its CEO Raidel Figueroa; distributors The Harvard Drug Group and Bayshore Pharmaceuticals; and Florida Ultrapure Water, a Fort Myers-based company the suit says supplied the water purification system used to manufacture the contaminated medicine.