Steris this week announced that its jury trial against its subsidiary Isomedix Operations ended in a mistrial.
The trial began on Dec. 4, 2024, and involved a plaintiff’s claim that ethylene oxide emissions from a sterilization facility in Waukegan, Illinois, caused personal injury. The facility was owned and operated by Isomedix from 2005 to 2008.
The court declared a mistrial at the plaintiff’s request during jury deliberations. The plaintiff requested a mistrial when one of the jurors was dismissed. Steris said the court will schedule the case for a later re-trial.
Isomedix plans to continue to defend against the allegations regarding its ethylene oxide operations and emissions from the Waukegan facility.
The risks of EtO sterilization
Ethylene oxide (EtO) is a common commercial sterilizer used to clean medical devices. For some devices, it is the only sterilization option. For many years, the FDA sought safer ways to use EtO and alternative ways to sterilize medical devices in an effort to reduce EtO emissions.
The EPA in 2022 updated the Clean Air Act’s National Emission Standards for Hazardous Air Pollutants (NESHAP) to reflect EtO’s risk and mitigating technologies. At the time, the agency identified nearly two dozen U.S. cities where commercial sterilizers contribute to elevated cancer risk for residents in surrounding communities, particularly blood cancers and breast cancer.
The CDC also listed the toxicity profile of EtO as a far-reaching health threat. The CDC’s systematic review of non-cancer hazards includes presumed respiratory, neurotoxicity, genotoxicity, reproductive toxicity and developmental toxicity and suspected hematological and endocrine health effects. The agency relied on numerous animal and human studies of inhalation and oral consumption of EtO to reach its conclusions.
