Steris said this month that its Isomedix subsidiary reached a deal with confidential settlements to resolve personal injury claims from people who said they were harmed by a ethylene oxide (EtO) sterilization facility in Illinois.
Isomedix will pay up to $48.15 million to settle the claims, according to a securities filing, which said “the settlement agreements are expected to resolve substantially all of the claims for personal injury related to ethylene oxide (“EO”) that are currently pending in the Circuit Court of Cook County, Illinois.”
Steris said it plans to record a charge for the settlement for fiscal 2025 (which ends March 31), and that the charge won’t be included in the company’s adjusted earnings measures for fiscal 2025.
The company said the deals are not “an admission of liability or that emissions from the Waukegan, Illinois facility ever posed a safety hazard to the people who live or work in the surrounding areas.”
Previously: EPA flags high-cancer-risk EtO sterilization facilities across the country
The first case went before a jury last year in a trial that started in December and ended in January with a mistrial. (The Cook County Record has more details about that first case.)
Isomedix could walk away from the deal “if certain agreed terms are not fulfilled, including if a substantial majority of plaintiffs in such cases do not agree to settle or are disqualified under the applicable terms or the resulting settlements are ultimately not approved by the court.”
“In the event it exercises its walkaway rights, Isomedix is prepared to continue to defend itself in the litigation and reserves all legal and factual defenses against such claims,” Steris continued in the filing. “… Isomedix anticipates dismissal of all pending EO-related claims brought by the covered plaintiffs upon completion of the claims administration process and approval by the court.”
Steris did not say how many lawsuits the settlements cover. In November, the medical device company — which provides contract sterilization for medical device manufacturers through its Applied Sterilization Technologies (AST) unit and makes sterile products for hospitals — disclosed hundreds of EtO lawsuits.
Steris operated the sterilization plant from January 2005 to September 2008 under the Isomedix brand. Steris purchased Isomedix in 1997; it is now a part of AST.
Steris is the world’s 15th-largest medical device company, according to Medical Design & Outsourcing‘s 2024 Medtech Big 100 ranking by revenue.
EtO is used on about 20 billion medical devices each year (approximately half of all sterile medical devices) and alternative methods are not yet sufficient for existing demand.
Rather than banning EtO due to its health risks, the Environmental Protection Agency has increased regulation of the chemical while the medtech industry and FDA work on improving sterilization safety.
Last year, the FDA’s sterilization innovation partnership with device manufacturers and commercial sterilizers led to the addition of vaporized hydrogen peroxide (VHP) as an Established Category A sterilization method for medical devices.
Read more: Taking medical device sterilization in-house with vaporized hydrogen peroxide (VHP)
