Sterigenics Faces 600 New Ethylene Oxide Lawsuits Filed In Recent Days

More than 600 new lawsuits were filed against Sterigenics last week, each involving claims that the defunct Willowbrook, Illinois ethylene oxide plant released emissions caused area residents to suffer serious health problems.

The recent batch of lawsuits, filed last week in Cook County Circuit Court, brings the total number of claims against the company to more than 700 cases. Each of the lawsuits name Sterigenics and its former parent company, Griffith Foods, as defendants. Sterigenics is now owned by Sotera, which is also named as a defendant in the lawsuits.

In recent years, Sterigenics has experienced a number of problems with ethylene oxide, including claims that the highly toxic gas leaked from 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.

Sterigenics officials have said the plant is not responsible for the illnesses alleged in the ethylene oxide lawsuits, according to statements sent to the media.

In addition to the Illinois 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.

Last year, the FDA raised concerns that the leaks and plant closures would result in a shortage of certain sterilized medical devices.

The FDA warning appears to be aimed in part at state regulators, indicating the agency is concerned that additional closures of the few facilities left in the country may exacerbate the problem. It also calls on manufacturers to notify the FDA if there is a problem before it gets out of hand, suggesting the agency may be able to assist.

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.

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.