PharmaTech faces a growing number of lawsuits over an outbreak of Burkholderia cepacia infeactions, which have been traced back to the water system at the drug maker’s Florida manufacturing plant.
According to a recent report by Fierce Pharma, at least seven product liability lawsuits have been filed against PharmaTech as a result of infections stemming from a 2016 and 2017 outbreak, which sickened at least 63 people in 12 states. The lawsuits include three wrongful death claims by the parents of infants who died after allegedly taking the company’s Rugby Diocto stool softener.
In August 2017, the FDA issued an advisory warning the public not to use any liquid forms of drugs manufactured by PharmaTech.
The FDA updated the warning in October 2017, warning that some B. cepacia outbreaks had been linked directly to Rugby Diocto manufactured in Florida. The Fierce Pharma reports that PharmaTech abandoned its Davie, Florida manufacturing plant in June 2017.
The warning was initiated after Rugby Laboratories of Livonia, Michigan voluntarily announced a recall of certain Diocto Liquid and Diocto Syrup products, which were manufactured by PharmaTech. This action was taken after several consumer reports indicated patients became ill with B. cepacia infections shortly after use.
PharmaTech, in conjunction with officials from the FDA, performed routine testing on multiple lots of the liquid docusate products and found several strains of the infection within the products. Further investigations discovered the liquid medications had become contaminated by the local water system used to manufacture the medications, which was tested and found to contain similar strains of B. cepacia.
B. cepacia bacterium is an organism that is typically found in aquatic environments and can cause mild to severe infections in patients depending on the state of the individual’s health. Healthy individuals are typically not impacted by the bacterium, however, individuals with weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be at increased risk levels requiring hospitalizations and immediate medical care.
Symptoms of Burkholderia cepacia infection are similar to the symptoms you would experience with many other common bacteria’s, causing symptoms including cough,congestion, difficulty breathing and fever. In severe cases, individuals may develop cepacia syndrome, which can lead to very severe symptoms including high fevers.
Docusate products are generally used as for stool softeners and constipation relief medications, and are often sold in either liquid gel capsule forms or as a syrup for easy consumption. The products are an over-the-counter drug and can be purchased at local pharmacies or grocery stores.