Another 200 plaintiffs have come forward to present claims over health problems caused by gas leaks from medical device sterilization plants near Atlanta, including cases of cancer and other serious injuries.
At least six new lawsuits have been filed in Georgia state court, according to a local media reports, indicating that injuries were caused by releases of ethylene oxide gas from both a Sterigenics’ Atlanta facility, and from a Becton, Dickinson Bard plant in Covington, Georgia.
The complaints come on the heels of more than 700 similar claims filed in recent weeks in Cook County Circuit Court in Illinois, over similar problems at other Sterigenics plants, including allegations that toxic gas leaked from the sterilization facilities and impacted surrounding neighborhoods.
In March 2019, the FDA warned that the Sterigenics plant in Willowbrook, Illinois was being shut down due to ethylene oxide leaks. Another facility in Michigan was also closed down for similar reasons. In August 2019, Georgia health officials determined similar leaks were occurring at a Sterigenics facility outside of Atlanta. That facility was shut down temporarily to address the problem, but has partially reopened.
Ethylene oxide is a highly carcinogenic compound used to sterilize some medical devices, including those made of some polymers, metals, glass or made with multiple layers with hard-to-reach crevices. However, exposure to ethylene oxide has been linked to serious and potentially life-threatening injuries.
In addition to these latest lawsuits, Sterigenics also faces a lawsuit filed in May by more than 50 individuals who say they suffered ethylene oxide exposure to its products at a medical warehouse in Georgia. Two months before that, a class action lawsuit was filed in Pennsylvania on behalf of residents living near B. Braun Medical’s Allentown medical device manufacturing and sterilization plant in Allentown.
Sterigenics officials say their facility was not responsible for causing the illnesses alleged in the lawsuits, and BD Bard claims air sampling in the Atlanta area shows similar exposures to ethylene oxide gas as those who live in areas without sterilization facilities.
The Sterigenics leaks in Georgia were only discovered after a newspaper investigation tipped off state regulators. And critics have accused Sterigenics of knowing about the leaks and trying to hide them.
Last year, the FDA raised concerns that the leaks and plant closures would result in a shortage of certain sterilized medical devices.
The FDA is calling on device manufacturers and health care providers to warn the agency on potential shortages before they happen. The agency can be notified by users, patients, manufacturers, or anyone within the supply chain of a problem through its device shortages mailbox.