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
- 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.
- 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 no precedent for liability for alleged personal injury or property damage related to low-level EO emissions from facilities consistently operating under governmental permits.
- 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.