Ethylene oxide (EO) remains one of the most widely used and effective sterilization methods in the healthcare and life sciences industries. For many complex and radiation-sensitive medical devices—such as catheters, prefilled syringes, and implantable electronics—EO’s ability to sterilize at low temperatures and penetrate deep into packaging makes it difficult to replace.
Despite the rise of alternative modalities such as vaporized hydrogen peroxide, nitrogen dioxide, and electron beam irradiation, EO continues to account for nearly 50% of all single-use medical device sterilization in the United States.
However, while EO’s performance profile is unmatched for certain applications, its use has also drawn significant scrutiny due to concerns about its carcinogenicity and community exposure risks. Over the last five years, this scrutiny has evolved from regulatory pressure into an expansive wave of litigation—culminating in some of the largest toxic tort settlements in the country.
| Case Name | Start | End | Status |
|---|---|---|---|
| Susan Kamuda v. Sterigenics U.S., LLC; Sotera Health | Jan 1, 2018 | Sep 19, 2022 | Settled / Verdict – Plaintiff |
| Consolidated Willowbrook Claims v. Sterigenics U.S., LLC; Sotera Health | Jan 1, 2018 | Jun 1, 2023 | Settled / Verdict – Plaintiff |
| Willowbrook area families v. Sterigenics LLC, GTCR LLC | Sep 20, 2018 | Jun 1, 2023 | Settled / Verdict – Plaintiff |
| State of Illinois (AG & DuPage Co.) | Oct 30, 2018 | Jul 17, 2019 | Settled / Verdict – Plaintiff |
| Multiple PA Residents v. B. Braun Medical Inc. | Jan 1, 2019 | Feb 18, 2025 | Settled / Verdict – Plaintiff |
| Margaret Fornek v. Sterigenics U.S., LLC; Sotera Health | Jan 1, 2019 | Nov 18, 2022 | Verdict – Defendant |
| Hinsdale S. High School Teachers v. Sterigenics U.S., LLC | Dec 27, 2019 | Jun 1, 2023 | Settled / Verdict – Plaintiff |
| Quinn Buczek et al. v. Sterigenics U.S., LLC; Sotera Health | Jan 1, 2020 | Oct 1, 2023 | Settled / Verdict – Plaintiff |
| State of New Mexico (AG Hector Balderas) v. Sterigenics U.S., LLC | Dec 22, 2020 | Ongoing | Pending |
| Christopher Glass et al. v. B. Braun Medical Inc. | Jan 1, 2021 | Dec 1, 2024 | Verdict – Defendant |
| Augusta Residents v. Kendall Patient Recovery (Cardinal Health) | Jul 1, 2021 | Ongoing | Pending |
| Covington Residents v. Becton Dickinson (BD); CR Bard Inc. | Jul 19, 2021 | Ongoing | Pending |
| Lisa Isaacks et al. v. Terumo BCT Inc. | Jan 1, 2022 | Mar 14, 2025 | Verdict – Defendant |
| Lake County/Waukegan area residents v. Medline / Steris | Jan 1, 2022 | Mar 1, 2025 | Settled / Verdict – Plaintiff |
| Franklin, NJ area residents v. Cosmed NJ | Jan 1, 2023 | Ongoing | Pending |
| 15 California Residents v. Sterigenics U.S. | Q2 2024 | Ongoing | Pending |
A Modality Under Fire
Ethylene oxide has been a cornerstone of sterile supply chains for decades, but its classification as a human carcinogen by the U.S. Environmental Protection Agency (EPA) in 2016 would help lay the groundwork for future lawsuits. Although EO is tightly controlled within modern facilities, accidental emissions, legacy equipment, and uncontrolled off-gassing have led to measurable concentrations being found in surrounding communities. These emissions have sparked concern, particularly near densely populated urban sterilization facilities.
To their credit, many of the major sterilization providers have made substantial investments to reduce EO emissions through scrubber upgrades, improved leak detection, and tighter controls on cycle venting. The industry has also responded constructively to EPA and FDA regulatory actions, and most operators today maintain EO emissions well below current permit thresholds. Yet this technical progress has not immunized them from legal exposure—especially for operations predating these improvements.
The Litigation Landscape: Hundreds of Lawsuits, Billions at Stake
The past seven years have seen an explosion of personal injury and class action lawsuits against sterilization companies, primarily alleging that long-term exposure to EO emissions caused cancer or other health conditions in nearby residents. The largest and most publicized litigation has centered on the now-closed EO facility in Willowbrook, Illinois.
By 2023, that single site alone had generated nearly 900 lawsuits, ultimately resulting in a $408 million settlement. The first individual plaintiff trial, Kamuda v. Sterigenics, ended in a landmark $363 million jury verdict, setting the tone for others. Similar waves of litigation have followed in Georgia (Smyrna and Covington), Pennsylvania (Allentown), Colorado (Lakewood), New Mexico (Santa Teresa), and most recently, California (Vernon/Maywood).
While many of these cases remain pending, several have been resolved either through jury verdicts or settlements. A group of 79 Georgia plaintiffs settled for $35 million in 2023, while others have seen mixed results—some defense wins (e.g., Margaret Fornek v. Sterigenics, Christopher Glass v. B. Braun), and others still headed to trial.
As of 2025, well over 1,500 individual plaintiffs have filed suit against sterilization providers across the U.S., with many cases consolidated into state court mass torts. The scale and persistence of this litigation have created a chilling effect for some operators and led others to proactively reduce or relocate EO operations.
Outlook: Will Litigation Subside?
The litigation surge will eventually peak. Most of the largest known community exposure sites (Willowbrook, Smyrna, Covington, Allentown, Waukegan) have already generated their expected waves of litigation, with many cases either resolved or well into discovery. In these jurisdictions, the combination of settlements, facility closures, and upgrades appears to have stemmed the tide of new filings.
Furthermore, a growing number of juries have ruled in favor of defendants. In 2024 and 2025, defense verdicts were returned in trials against B. Braun and Terumo BCT, suggesting that plaintiffs will face increasing hurdles in proving causation and liability—especially where emissions were within regulatory limits.
That said, litigation may persist in newly scrutinized regions. The Sterigenics site in Vernon, California, only recently became the subject of civil action, with a wave of ~25 lawsuits filed in 2024. Franklin, New Jersey (home to Cosmed Group’s facility), has also seen its first wave of plaintiffs (already causing this facility to seek bankruptcy protection from mounting legal costs). Yet these cases currently number in the dozens—not hundreds—and are unlikely to rival the magnitude of Willowbrook or Smyrna.
Where Manufacturers Go from Here
As EO litigation accelerates, the risks for manufacturers are no longer theoretical. Transitioning to cleaner, more defensible sterilization methods like E-Beam is not just about sustainability; it’s about survival. If you’re exploring your options, schedule a 1:1 call with our team to talk through what that transition could look like.
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