In 2018, ethylene oxide sterilization became the subject of regulatory and media scrutiny due to the release of a controversial and highly conservative EPA risk assessment as well as a significant misunderstanding of the facts. As a result, medical supply sterilization companies have been subjected to hundreds of personal injury claims and related tort lawsuits citing alleged injury due to long term, low-level environmental exposure from emissions from sterilization facilities. The litigation consists of individual claims, rather than class actions. Sterigenics has and will continue to vigorously defend against these claims. Sterigenics operates safely and in compliance with regulatory requirements and continues to invest in voluntary emission controls to perform better than even the strictest of regulations, as it continues to fulfill its critical role in healthcare.
Important points for investors and other interested parties to consider relating to Sterigenics' EO litigation
- On November 18, 2022 the Fornek trial concluded and the jury found Sterigenics US, LLC and Sotera Health LLC not liable for damages. The jury’s verdict in this matter reflects the careful consideration and understanding of the science and other evidence presented at trial. Sterigenics remains committed to our mission of Safeguarding Global Health. As we have consistently done throughout our history, we will continue to operate in compliance with applicable rules and regulations to ensure the safety of our employees, the communities in which we operate and patients around the world.
- Griffith Foods International Inc., the other defendant in the Fornek trial, is unrelated to Sotera Health and Sterigenics. In 1999, Griffith sold its sterilization operations (then known as Griffith Micro Science), including the Willowbrook facility, to a company that later became Sterigenics.
- As disclosed in Sotera Heath Company’s SEC filings, we expect future trials in the IL EO litigation. The third and fourth trials are scheduled to begin in Cook County, IL in January 2023 and April 2023 respectively.
- You can find more information on EO and matters related to EO litigation generally on the Company website at https://investors.soterahealth.com/ethylene-oxide-eo-overview
The second individual trial began in Cook County, IL on October 6, 2022 and is underway. Subsequent individual trials are currently scheduled to begin in January 2023 and April 2023. At a recent hearing, the court indicated that the claims of small groups of plaintiffs should be tried jointly, starting in late May 2023. The parties have been instructed to confer to identify plaintiffs whose claims could be tried jointly because the details of their individual claims are similar. We expect to know more in mid-November about whether joint trials are possible and when they will be scheduled. Even if joint trials proceed, they will remain individual actions, not class actions.
On September 19, 2022, the jury in the Kamuda case delivered a verdict in favor of the plaintiff. We do not believe the jury verdict reflects the evidence presented in court. Sterigenics is evaluating the verdict and plans to challenge this decision through all appropriate process, including appeals. We will continue to vigorously defend against allegations about our ethylene oxide operations and emissions. We remain committed to our mission of Safeguarding Global Health. As we have consistently done throughout our history, we will continue to operate in compliance with applicable rules and regulations to ensure the safety of our employees, the communities in which we operate and patients around the world.
- Griffith Foods International Inc., the other defendant in the Kamuda trial, is unrelated to Sotera Health and Sterigenics. In 1999, Griffith sold its sterilization operations (then known as Griffith Micro Science), including the Willowbrook facility, to a company that later became Sterigenics.
- You can find more information on EO and matters related to EO litigation generally on the Company website at https://investors.soterahealth.com/ethylene-oxide-eo-overview.
- No generally accepted science demonstrates that low-level EO exposure from Sterigenics' facilities cause medical conditions.
- EO is a naturally occurring substance, unlike many other chemicals at issue in other environmental litigation.
- EO consistently occurs in the environment from natural/everyday human activity, often at levels above those to which the general public is exposed to long-term from the Sterigenics facilities.
- The EPA and others now acknowledge background levels of EO, contrary to the view the EPA took for some time after it published the IRIS EO assessment.
- A recent meta-analysis of studies regarding cancer risks among workers exposed to EO concluded that the most recent and informative studies on the topic “do not support the conclusion that exposure to EO is associated with an increased risk of lymphohematopoietic cancers (LHC) or breast cancer.”
- Another study reevaluated historical exposures to EO among sterilization workers in the National Institute of Occupational Safety and Health (NIOSH) study cohort that was relied upon by the EPA in its 2016 IRIS risk assessment. The review found that the trend in EO exposures during the study period was opposite to the trend indicated in the NIOSH study “suggesting that the US EPA’s exclusive reliance on the NIOSH cohort to estimate EO cancer risk should be re-examined.”
- Sterigenics consistently complies with environmental permits issued specifically for each of its sterilization facilities.
- Sterigenics disclosed its EO emissions for decades in federal and state filings, even when others in the industry did not.
- Sterigenics has implemented leading safety practices and continues to work with regulators and others to enhance the safety of EO sterilization.
- Pending claims are individual claims; results in one trial will relate to the individual claimants involved – Sterigenics will defend remaining claims as they go to trial over time.
- Although some pending claims are consolidated for efficiency in pre-trial proceedings, any trials are expected to address individual plaintiff claims, not claims of large classes of people.
- Each case has its own unique circumstances and as such the first case should not be considered representative of the other cases to follow.
- The Plaintiffs’ bar seeks to create a new kind of mass tort relating to this ubiquitous, naturally occurring substance emitted at permitted facilities.
- There is little precedent for liability for alleged personal injury or property damage related to low-level EO emissions from facilities consistently operating under governmental permits. The Kamuda verdict is unusual in this regard.
- Plaintiffs are represented by motivated attorneys across multiple jurisdictions, who will disagree with the evidence the Company presents and who will present differing evidence and allegations, including government reports suggesting long-term health risk at EO sterilization facilities.
- The cases are pending in multiple state court systems with varying procedures and law.
- Many cases are likely to be resolved in jury trials with associated uncertainty.
- Investors should review the latest Sotera Health Company Annual Report on Form 10-K and the latest Sotera Health Company Quarterly Report on Form 10-Q including the section titled “Cautionary Note Regarding Forward-Looking Statements” in each, for a detailed discussion of Risk Factors and litigation affecting the Company.