Ethylene Oxide Lawsuits: $20M Verdicts Reveal Hidden Industry Risks

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Ethylene Oxide Lawsuits

January 9, 2026 — Ethylene oxide lawsuits have resulted in verdicts exceeding $20 million as communities discover their exposure to this invisible industrial chemical. The legal landscape surrounding this sterilizing agent has dramatically shifted since the EPA’s 2016 reclassification of ethylene oxide as a known human carcinogen.

Consequently, hundreds of toxic tort cases have emerged across the country, with plaintiffs claiming that facilities using this chemical failed to prevent harmful emissions into neighboring areas.

The Schmidt National Law Group is now accepting Ethylene oxide lawsuit cases from any individuals who may have been exposed to this known carcinogen. Use the secure intake form on this page to begin your Ethylene oxide claim, or call us direct at 1-800-631-5656, we expect substantial cash settlements made from these lawsuits.

EtO litigation now represents one of the fastest-growing areas of industrial chemical lawsuits in the United States. Although ethylene oxide plays a critical role in sterilizing approximately 20 billion medical devices annually, ethylene oxide exposure claims continue to mount as evidence links the chemical to cancer, reproductive issues, and genetic damage. Furthermore, recent settlements exceeding $400 million highlight the significant financial risks facing companies involved in these toxic tort cases. This blog post examines the scientific disputes, landmark verdicts, and future litigation risks that have transformed ethylene oxide from an essential industrial tool into a major liability for manufacturers and sterilization facilities nationwide.

Understanding Ethylene Oxide and Its Industrial Use

Ethylene oxide (EtO) serves as a critical industrial chemical with widespread applications across multiple sectors. This colorless, flammable gas possesses unique properties that make it invaluable for certain commercial processes, despite the growing concerns related to ethylene oxide exposure claims and subsequent industrial chemical lawsuits.

Medical Device Sterilization: 20 Billion Units Annually

Medical sterilization represents one of ethylene oxide’s most essential applications. The FDA reports that approximately 50% of all sterile medical devices—about 20 billion units annually—undergo EtO sterilization. This method proves indispensable for items that cannot withstand alternative sterilization methods like steam or radiation.

EtO gas effectively penetrates packaging materials and reaches all surfaces of medical equipment, making it particularly valuable for complex devices. The process operates through strict control of four critical parameters: gas concentration (450-1200 mg/l), temperature (37-63°C), relative humidity (40-80%), and exposure time (1-6 hours).

Devices commonly sterilized with ethylene oxide include:

  • Surgical kits and plastic tubing
  • Catheters and syringes
  • Pacemakers and heart valves
  • Wound dressings and gowns
  • Endoscopes and electrical equipment

Additionally, over 50,000 different types of single-use medical devices are FDA-cleared for EtO sterilization. This widespread application has subsequently placed numerous facilities at the center of toxic tort cases as communities raise concerns about emissions.

Chemical Manufacturing Applications: Ethylene Glycol and Detergents

Beyond medical applications, ethylene oxide primarily serves as a chemical intermediate in manufacturing processes. The largest portion of commercially produced EtO—over 60%—goes toward creating ethylene glycol. This derivative finds extensive use in antifreeze products, polyester fibers, and polyethylene terephthalate (PET) resins used in plastic bottles.

The production process typically involves either direct hydrolysis of ethylene oxide or a two-step process creating ethylene carbonate first. This manufacturing pathway generates several important industrial chemicals:

  • Mono-ethylene glycol (MEG) for antifreeze and textiles
  • Di-ethylene and tri-ethylene glycols for industrial applications
  • Ethylene glycol ethers used in brake fluids and solvents
  • Ethanolamines for detergents and natural gas purification

Notably, ethylene oxide-based surfactants serve as “workhorses” in the cleaning industry. These derivatives appear in numerous household products including laundry detergents, window cleaners, floor polishes, and degreasers. The versatile chemical properties of EtO make it essential for these applications, even as ethylene oxide lawsuits highlight health concerns.

Food Sterilization: Spices, Nuts, and Dried Vegetables

The food industry employs ethylene oxide as an effective fumigant and sterilization agent. According to the American Spice Trade Association, approximately 50% of spices in the United States undergo EtO treatment yearly. This process effectively eliminates microbial contaminants like Salmonella and E. coli without damaging heat-sensitive products.

Products commonly treated with ethylene oxide include:

  • Spices and dried herbs
  • Dried vegetables and fruits
  • Sesame seeds and walnuts
  • Coconut and other nuts

The process works by exposing food to ethylene oxide gas in sealed chambers, where it penetrates packaging to reach all surfaces. Nevertheless, regulatory approaches differ globally. While the EU banned EtO use in food processing in 1991 due to health concerns, countries including the United States, Canada, and India continue this practice.

These widespread industrial applications demonstrate why ethylene oxide remains economically vital despite growing EtO litigation. The chemical’s unique properties and effectiveness in critical applications create a complex challenge for regulators, manufacturers, and communities balancing industrial needs against potential health risks.

Health and Environmental Risks of Ethylene Oxide Exposure

The scientific understanding of ethylene oxide risks has evolved significantly, triggering numerous toxic tort cases across the United States. Behind these ethylene oxide lawsuits lies substantial evidence of serious health and environmental hazards that have alarmed communities near industrial facilities.

Carcinogenic Classification by EPA IRIS (2016)

The watershed moment for EtO litigation came in 2016 when the Environmental Protection Agency’s Integrated Risk Information System (IRIS) assessment formally reclassified ethylene oxide from “probably carcinogenic” to “carcinogenic to humans” by the inhalation route of exposure. This reclassification was based on substantial evidence that long-term exposure increases risk of lymphoid cancers and breast cancer in females. Concurrently, the EPA dramatically lowered its inhalation unit risk value, recognizing EtO’s carcinogenicity at extremely low doses.

The Schmidt National Law Group is now accepting Ethylene oxide lawsuit cases from any individuals who may have been exposed to this known carcinogen. Use the secure intake form on this page to begin your Ethylene oxide claim, or call us direct at 1-800-631-5656, we expect substantial cash settlements made from these lawsuits.

The revised risk assessment increased the cancer potency estimate from 1 in 10,000 to 30 in 10,000 excess cancers per microgram per cubic meter of air. Following this reassessment, the National Air Toxics Assessment identified 18 counties across 12 states where EtO emissions created unacceptable cancer risks exceeding one in ten thousand people.

Importantly, other major health organizations reached similar conclusions. The International Agency for Research on Cancer (IARC) classified EtO as a Group 1 carcinogen in 1994, and the National Toxicology Program within the U.S. Department of Health and Human Services designates it as a known human carcinogen.

DNA Damage and Reproductive Health Concerns

Ethylene oxide’s primary danger stems from its mutagenic properties—it directly damages DNA by forming adducts, particularly N7-(2-hydroxyethyl)guanine (HEG). This mechanism explains why EtO exposure is linked to multiple cancer types, including non-Hodgkin lymphoma, myeloma, lymphocytic leukemia, and breast cancer.

Beyond cancer risks, ethylene oxide exposure claims often involve reproductive health concerns. Studies suggest exposure increases the risk of spontaneous abortion, with dental assistants exposed to EtO showing 2.5 times higher risk of spontaneous abortion. Animal studies provide compelling evidence of ethylene oxide’s reproductive toxicity, demonstrating decreases in reproductive organ weights, germ cell survival, and sperm counts.

Developmental concerns also exist, as animal studies show EtO exposure leads to depressed fetal weight, delayed ossification, and ocular defects. Children may face heightened susceptibility to these toxic effects because EtO’s DNA-damaging properties can disproportionately impact growing bodies.

Airborne Exposure Pathways in Residential Areas

The physical properties of ethylene oxide create significant exposure risks for communities near industrial facilities. This colorless, odorless gas collects at ground level due to its molecular weight, with a half-life of 69 days during summer months and 149 days during winter. Consequently, ambient EtO levels may be higher closer to the ground than at emission stack heights.

Epidemiological surveillance confirms these concerns. Residents living approximately 0.8 kilometers from facilities emitting EtO showed significantly higher HEG adduct levels compared to those living farther away (p<0.001). A 2023 analysis found that over 14 million people live within 5 miles of commercial sterilization facilities, placing them at potential risk.

The risk extends beyond the facilities themselves. After sterilization, ethylene oxide off-gasses from products during transport and storage, turning shipping containers, trucks, and warehouses into potential sources of toxic air pollution. Moreover, EPA considers cancer risk unacceptable when exposure exceeds 0.1 parts per trillion continuously across a lifetime—a level often too small for some instruments to detect.

These environmental pathways have become central to industrial chemical lawsuits as communities discover their long-term exposure to this invisible carcinogen.

Major Ethylene Oxide Lawsuits and the $20M Georgia Verdict

Recent court battles over ethylene oxide emissions have yielded groundbreaking verdicts that define the growing legal landscape surrounding industrial sterilization facilities. These cases highlight the financial and legal consequences facing companies that use this chemical.

Kamuda v. Sterigenics: $363M Award

In September 2022, an Illinois jury awarded Susan Kamuda $363 million in the first ethylene oxide lawsuit to reach trial. The 70-year-old plaintiff developed breast cancer after living several hundred yards from Sterigenics’ Willowbrook facility for over 30 years. The historic verdict included $38 million in compensatory damages and $325 million in punitive damages, establishing a precedent for hundreds of similar cases. Kamuda’s attorneys successfully argued that Sterigenics knew of EtO risks since the 1980s but failed to control emissions or notify the neighboring community.

Sterigenics $408 Million Settlement with 870 Plaintiffs

Initially triggered by the Kamuda verdict, Sterigenics ultimately agreed to a $408 million settlement in January 2023 to resolve 870 pending lawsuits related to its Willowbrook operations.

This agreement required 95-100% of plaintiffs to opt in for the settlement to take effect. Though Sterigenics maintained that its operations posed no safety risk, the company cited “biased media coverage” and the significant costs of defending hundreds of additional lawsuits as factors in its decision to settle.

Walker v. C.R. Bard: $20M Georgia Verdict Overview

In May 2025, a Georgia jury awarded $20 million to Gary Walker, a retired truck driver who developed non-Hodgkin lymphoma after 47 years of exposure to ethylene oxide. As both a driver making regular deliveries to C.R. Bard’s Covington facility and a resident living 1.5 miles away, Walker experienced prolonged exposure to the carcinogenic gas. The jury determined that Bard acted negligently by failing to implement available emissions controls, specifically noting that the facility had no emissions controls until 1990 despite warnings in the 1980s about cancer risks.

Colorado Bellwether Trial: Terumo BCT Defense Win

In contrast to these plaintiff victories, March 2025 saw the first defense win in ethylene oxide litigation. After a six-week trial, Terumo BCT secured a complete defense verdict against four plaintiffs who alleged the company’s Lakewood, Colorado facility caused their cancers. Despite plaintiffs’ request for $444 million in damages, jurors concluded Terumo had not been negligent in handling emissions. This verdict, representing the fifth ethylene oxide case to reach trial nationwide, demonstrated that juries might evaluate facility compliance with regulations as a significant factor in determining liability.

Scientific Disputes and Regulatory Conflicts

At the heart of ethylene oxide lawsuits lies an unprecedented scientific dispute among regulatory agencies that has dramatically influenced toxic tort cases nationwide.

EPA vs TCEQ: 2400x Risk Discrepancy

The core regulatory conflict centers on a stark discrepancy between federal and state risk assessments. In 2020, the Texas Commission on Environmental Quality (TCEQ) concluded that the EPA had overestimated ethylene oxide’s carcinogenic risk by a factor of 2400. This extraordinary difference stems from fundamentally different approaches to modeling cancer risk. Whereas the EPA utilized what critics call an “unconventional supra-linear model” for low-dose exposure, TCEQ advocates for the standard Cox proportional hazards model.

In fact, TCEQ argues that EPA’s assessment contains flawed calculations of p-values and incorrect application of statistical criteria. Furthermore, TCEQ contends that EPA’s model is “over-predictive” of the very lymphoid cancer data driving the agency’s unit risk factor. Yet the EPA has firmly rejected these criticisms, officially declining to use TCEQ’s alternative risk values in its 2022 final rule.

EPA’s 2023 Proposals to Cut Emissions by 80%

Undeterred by ongoing scientific disputes, the EPA issued sweeping regulatory proposals in 2023 based on its 2016 IRIS assessment. These proposals aim to reduce ethylene oxide emissions by approximately 80%, or 19 tons annually. The agency estimates implementation costs at $220 million (2021 dollars).

If finalized, these standards would reduce lifetime cancer risk below EPA’s Clean Air Act benchmark in all affected communities. Alongside these measures, EPA released a revised risk assessment under the Federal Insecticide, Fungicide, and Rodenticide Act, which found ethylene oxide presents up to a 1-in-10 lifetime cancer risk for sterilization facility workers.

Impact of IRIS Assessment on Legal Outcomes

The 2016 IRIS assessment has become pivotal in industrial chemical lawsuits, even without scientific consensus regarding the risks. Plaintiffs in EtO litigation frequently cite this assessment as substantiating environmental justice claims. The assessment has likewise influenced state agencies to implement stricter standards and pursue high-profile enforcement actions, including facility closures.

The legal community recognizes how risk assessments can catalyze toxic tort cases regardless of scientific disputes. For instance, the flood of lawsuits against Sterigenics in Willowbrook, Illinois, followed directly from the application of the 2016 IRIS values in the 2014 National Air Toxics Assessment. As mentioned by one legal observer, “even where there is controversy and disputes relating to the accuracy of EPA and other governmental or regulatory risk assessments, these can be catalysts for toxic tort and class action litigation.”

Industry Impact and Future Litigation Risks

The financial implications of ethylene oxide lawsuits extend far beyond courtroom verdicts, reshaping entire industries and business practices.

Insurance Exposure for Sterilization Facilities

Insurance coverage for EtO claims remains uncertain. Companies facing litigation often attempt to use their pollution liability policies or cite “permitted emissions” exceptions stemming from the 1997 Illinois Supreme Court decision in Koloms. However, a recent Pennsylvania federal court ruled that pollution exclusions in CGL policies barred coverage for EtO liabilities. Currently, insurance outcomes vary dramatically by state law and specific policy language, creating significant financial uncertainty for facilities.

Emerging Class Actions in Tennessee and Delaware

August 2023 saw a new class action filed in Tennessee against Sterilization Services’ Memphis facility, which EPA identified among its 24 most unsafe EtO operations. Meanwhile, Delaware’s Supreme Court recently ruled that individuals must demonstrate physical symptoms before claiming legally recognizable injury from EtO exposure. This contrasts with Maryland, Pennsylvania, and New Jersey, which allow suits based on increased risk of illness without present symptoms.

Alternative Sterilization Methods: Nitric Oxide, CO2, H2O2

Several EtO alternatives show promise as industry adapts:

  • Vaporized hydrogen peroxide (VHP): Recently reclassified by FDA from “novel” to “established” sterilization technique
  • Nitrogen dioxide (NO2): Effective through DNA degradation, operates at ultra-low temperatures of 10°-30°C
  • Supercritical carbon dioxide: Uses pressurized CO2 with peracetic acid

Yet experts acknowledge “it is a unicorn to think we’re going to find a drop-in replacement for ethylene oxide sterilization.”

Summary of Ethylene oxide Litigation

Ethylene oxide litigation has undoubtedly emerged as a watershed moment for industries relying on this essential yet hazardous chemical. Recent verdicts exceeding $20 million highlight the significant financial stakes companies now face when facilities fail to adequately control emissions.

Though ethylene oxide remains critical for sterilizing billions of medical devices annually, its reclassification as a known human carcinogen has fundamentally altered the risk landscape for manufacturers and nearby communities.

Scientific evidence increasingly supports claims that even low-level exposure can cause DNA damage, reproductive issues, and various cancers. Nevertheless, sharp disagreements between regulatory bodies like EPA and TCEQ regarding risk assessment methodologies continue to complicate litigation outcomes. This regulatory uncertainty, coupled with landmark verdicts like the $363 million Kamuda award, leaves companies in a precarious position.

The Schmidt National Law Group is now accepting Ethylene oxide lawsuit cases from any individuals who may have been exposed to this known carcinogen. Use the secure intake form on this page to begin your Ethylene oxide claim, or call us direct at 1-800-631-5656, we expect substantial cash settlements made from these lawsuits.

Key Verdicts and Settlements

Recent court cases have set important precedents:

  • Kamuda v. Sterigenics: An Illinois jury awarded $363 million to a plaintiff who developed breast cancer after living near a Sterigenics facility.
  • Sterigenics Settlement: The company agreed to a $408 million settlement to resolve 870 lawsuits related to its operations.
  • Walker v. C.R. Bard: A Georgia jury awarded $20 million to a retired truck driver who developed non-Hodgkin lymphoma after prolonged exposure to EtO.

Sources:

https://grist.org/accountability/are-you-being-exposed-to-eto/
https://www.tceq.texas.gov/toxicology/ethylene-oxide
https://www.medtechdive.com/news/device-companies-lawsuits-ethylene-oxide-sterigenics/632545/
https://www.ajc.com/news/atlanta-news/20m-verdict-awarded-to-retired-truck-driver-in-landmark-trial/SR3232VTOZD4ZCHNHAYMCK34LM/
https://www.ajicjournal.org/article/S0196-6553(23)00057-3/fulltext
https://www.chemicalsafetyfacts.org/chemicals/ethylene-oxide/
https://www.chemengonline.com/ethylene-glycol-production/?printmode=1
https://www.epa.gov/system/files/documents/2023-04/Fact Sheet Proposal to Address EtO Risks from Commercial Sterilizers.pdf

Ethylene Oxide Lawsuits Claims and Settlements page updated on January 9, 2026.