Steris Faces Lawsuits Over Ethylene Oxide Exposures Linked to Sterilization Facilities

The medical device sterilization company Steris faces hundreds of ethylene oxide exposure lawsuits following leaks involving the toxic gas used at its facilities, primarily involving individuals who lived or worked near a facility in the Chicago suburbs.

In a quarterly filing to the Securities and Exchange Commission (SEC) that was submitted on November 7, Steris indicates it faces about 275 lawsuits due to ethylene oxide leaks from its Lake County, Illinois sterilization facility, where the chemical was used from January 2005 until September 2008.

Area residents and workers are pursuing compensatory and punitive damages for injuries that resulted from exposure to ethylene oxide, which is known to increase the risk of various respiratory problems, as well as cancers and other side effects. The first trial is scheduled to begin this month in Illinois state court.

Ethylene Oxide Concerns

Ethylene oxide is used during the sterilization process for some medical devices, including those made of metals, glass or containing multiple layers and small crevices.

Inhaling the gas can irritate the lungs, throat, eyes and nose. It is also linked to increased breast and lymphoid cancer risks, and research indicates it can cause damage to the brain and nervous system.

There have been several high-profile ethylene oxide leaks at certain sterilization facilities throughout the U.S. in recent years, which have caused widespread exposure to the toxic chemical for individuals living or working near certain facilities. As a result, federal agencies have outlined new regulations that are designed to protect these vulnerable populations.

Since there are safer alternatives available to clean medical equipment, experts have also been calling for the healthcare industry to move away from the use of ethylene oxide.  However, it is still used to sterilize about half of the medical equipment made in the U.S.

“The plaintiffs have filed separate suits in which each alleges that they have been diagnosed with one or more types of cancer, allegedly resulting from exposure to [ethylene oxide] emissions from the facility into the ambient air,” the Steris SEC filing states. “As of September 30, 2024, approximately 275 individual plaintiffs have filed such suits asserting individual personal injury claims and seeking compensatory and, if subsequently permitted by the court, punitive damages.”

Steris indicates that it intends to fight the litigation, but notes that even winning would be potentially costly, and that it has adequately reserved funds to handle expenses associated with defending the claims or potentially reaching settlements with area residents.

“Due to their inherent uncertainty, however, there can be no assurance of the ultimate outcome or effect of current or future litigation, investigations, claims or other proceedings,” the company warned.

New Ethylene Oxide Standards

Following several massive gas leaks at sterilization facilities in recent years, the U.S. Environmental Protection Agency (EPA) finalized new ethylene oxide standards for the medical device sterilization industry in March 2024.

Ethylene Oxide leaks occurred in 2019 at facilities operated by Sterigenics, another medical sterilization company, impacting plants in Illinois, Michigan and Georgia. The facilities were shut down temporarily to address the leaks, but multiple lawsuits were subsequently filed over health risks from exposure to the toxic gas.

Following the leaks, the FDA began hosting a series of town hall meetings to discuss restrictions on ethylene oxide use, alternative sterilization methods, and reducing use of the chemical overall.

The final rule addresses emissions at 90 commercial sterilization facilities owned and operated by 50 companies across the U.S. The rule will:

• Establish standards for unregulated emissions and chamber exhaust vents
• Strengthen standards for sterilization chamber vents and aeration room vents
• Require continuous air emissions monitoring and quarterly reporting for commercial sterilization plants
• Ensure sterilizers are subject to emission standards during startup, shutdown and malfunction

Lawsuits over ethylene oxide leaks at Sterigenics facilities were brought by a number of workers and nearby residents who developed breast cancer, non-Hodgkin’s lymphoma and other health problems due to exposure. The lawsuits resulted in a $408 million settlement last year to resolve claims brought by residents in surrounding communities.