PharmaTech, a Florida-based pharmaceutical company, announced in July that it would be voluntarily recalling several lots of their docusate sodium solutions, known as Diocto Liquid. The recall came after the company discovered that the lots had been contaminated with Burkholderia cepacia. The bacteria have caused infections in people in outbreaks in five states. In August the company expanded the recall further in response to even more outbreaks.
- cepacia Outbreaks
The latest outbreak has affected several states and has been connected to several liquid medications with different brand names, but all manufactured by PharmaTech. B. cepacia is a type of bacterium that can cause serious infections, most often pneumonia. The people most vulnerable to infection during one of these outbreaks are hospitalized patients with compromised immune systems. Many are patients on ventilators or with lung conditions.
The bacteria also have the potential to cause other types of infections like respiratory tract infections or infections around catheters. Nearly all cases of infections occur in hospitals and healthy, non-hospitalized people are rarely at risk for an infection by B. cepacia. Anyone with a compromised immune system may be affected, but those most at risk include people with weakened immune systems and lung conditions.
The First PharmaTech Recall
The drug implicated in the outbreaks of B. cepacia is called docusate sodium, is a liquid laxative and stool softener used to treat constipation. It is often used for children with hard stools and for patients taking opiates that have caused constipation as a side effect. In the latter case it is typically used along with another stimulant laxative.
PharmaTech makes docusate sodium and the product goes to several different distributors under different brand names. Some of the distributors include Rugby, Bayshore, Centurion, Metron, Major, and Virtus. Because the medication is distributed to so many different locations, the contaminated lots were able to cause outbreaks of infection in multiple states.
PharmaTech issued a voluntary recall of its products once the information about the outbreaks came to light. The first recall of docusate sodium was for lots distributed by Rugby in Livonia, Michigan, which distributed a brand called Diocto Liquid. The recall was announced in July of 2016 and included several lots of unexpired product. For this first recall PharmaTech and Rugby worked together to notify any customers they could contact about the risks of infection.
By mid-August the recall had been expanded as announced by the U.S. Food and Drug Administration (FDA) and PharmaTech. The recall was extended to include the other distributors of the docusate sodium liquid. The recall even extended to other manufacturers of liquid docusate products, including a company in India, Laxachem Organics. As of August 19 the FDA and the Centers for Disease Control and Prevention were still investigating the outbreaks to determine if further recalls would be needed.
Potential for Lawsuits
Any drug recall means that there is a potential for affected consumers, patients, and their families to file lawsuits. Manufacturers of medical products like PharmaTech have a responsibility to provide consumers with safe products. When manufacturing processes lead to mistakes like contamination with a potentially deadly bacteria patients suffer and some may even die. Those patients that are most vulnerable are especially likely to file lawsuits.
The B. cepacia bacteria have the potential to cause infections in patients who have been hospitalized for lung conditions and those who have weakened immune systems. These patients rely on medications and expect that they will be safe and uncontaminated. If they struggle with infection from a contaminated product they may have enough evidence to make a case against the manufacturer for liability.