Ethylene Oxide (EtO) has long been used to sterilize medical equipment that cannot be treated by other methods. EtO is also used to sterilize certain commodities to prevent serious food-based illnesses such as Salmonella and E. coli. As government agencies continue to focus on regulations for the emission of EtO, Sidley is dedicated to assisting clients with compliance and analysis by monitoring the evolving state, federal, and international guidelines, as well as litigation trends. Harnessing the firm’s global reach, our product liability and environmental teams coordinate to create strategies for long-term business planning and compliance, providing counsel for the defense of EtO-related litigation.
At the Forefront of EtO Litigation
Sidley has the distinction of being the first and only firm to handle an EtO-related case through trial to a successful defense verdict. We have amassed more than five years of experience in EtO litigation and stand apart from other firms in that we draw on a dedicated core team of both environmental regulatory and product liability practices working in collaboration to defend tort matters. We proactively assess the landscape, analyze, and understand developing regulations and science, and adapt strategies and compliance plans accordingly. Our deep bench includes team members who have held senior positions as government officials, including at the Environmental Protection Agency (EPA).
Our firm’s leading product liability and mass torts practice has played key roles in many of the most significant product liability litigations. With substantial experience in handling lawsuits filed in state and federal courts nationwide, as well as in federal multidistrict litigation (MDL) proceedings, we defend our clients against personal injury, property damage, environmental remediation, class action, and any other claims arising out of the use or emission of EtO.
How We Add Value
We understand all facets of the EtO regulatory process, having worked on matters that involve operations both before and after the establishment of the National Emission Standards for Hazardous Air Pollutants (NESHAP). We are familiar with the history of the NESHAP for EtO and the Miscellaneous Organic NESHAP (“MON”), as well as ongoing proposals for new rules. Drawing upon the experience of Sidley’s multidisciplinary litigation, regulatory, and enforcement practices, as well as the knowledge of our colleagues with scientific and medical backgrounds, we offer an unparalleled ability to manage all aspects of EtO litigation.
Sidley has the experience to assist clients in:
- Guiding the Way Through the Regulatory Framework: We provide counsel on the lifecycle of the regulatory process relating to EtO sterilization, including pre- and post-NESHAP periods; federal, state, and local permitting or zoning laws; TRI reporting; and NATA. We also have insight and understanding of OSHA’s role in regulating workplace exposure to EtO, including the action level, time-weighted averages (“TWA”), and short-term exposure limits (“STEL”).
- Understanding the Benefits of EtO Sterilization: We understand why EtO sterilization is necessary, including how EtO is often the only sterilization modality available, the FDA’s validation role, applicable ISO standards, biological indicator testing, why manufacturers use EtO sterilization, and more.
- Decoding the EtO Sterilization and Emissions Process: We understand the process of EtO sterilization, including pre-conditioning, chamber cycles (e.g., sterilant injection, dwell time, vacuum levels, gas washes), reduction of residuals in aeration rooms, as well as the use of various control devices, from acid scrubbers to dry bed technology, water scrubbers, abators, and catalytic oxidizers.
- Calculating Emissions: We understand the methods and mass balance approaches that have been used by various constituents to quantify and calculate emissions relating to EtO sterilization, including from vacuum pumps, aeration rooms, and other sources, as well as the process of monitoring EtO within facilities.
- Providing Scientific Detail and Background: We have deep knowledge of the science, including the EPA’s Integrated Risk Information System (IRIS) assessment, risk assessments, air modeling, and ecological studies of communities surrounding EtO facilities, as well as medical literature in the areas of epidemiology, toxicology, pathology, biology, and oncology.
As a result of this deep knowledge and experience, Sidley can hit the ground running in any EtO sterilization litigation. Companies do not need to educate us on their business or the regulatory history and framework for EtO sterilization. We already have a high level of trial readiness on these subjects, which we leverage to best position companies facing EtO litigation or to obtain creative settlements when settlement is of interest.
Accolades
Recognized as an Elite Nationwide Practice for Product Liability & Mass Torts
— Chambers USA 2023
Tier 1 in Product Liability and Mass Tort Litigation/Class Actions – Defendants
— U.S. News – Best Lawyers® “Best Law Firms” Survey 2023
Tier 1 in Product Liability and Recall (Nationwide and California)
— Benchmark Litigation 2023
Tier 1 in Product Liability and Finalist for “Product Liability Firm of the Year”
— LMG Life Sciences 2022
Named a BTI “Litigation Standout” for Product Liability Litigation
— BTI Litigation Outlook 2022
Ranked in Environmental (Nationwide)
— Chambers USA 2023
Band 1 in Environmental (DC)
— Chambers USA 2023
Tier 1 in Environmental Law and Environmental Litigation
— U.S. News – Best Lawyers® “Best Law Firms” 2023
“Law Firm of the Year” in Environmental Law
— U.S. News – Best Lawyers® “Best Law Firms” 2023
