A new cancer threat is quietly emerging in and around sterilization facilities across the country. In efforts to prevent contamination in medical equipment and food products, communities are now being exposed to an invisible danger: ethylene oxide. This colorless, odorless gas has long been used to sterilize essential items and manufacture chemicals like antifreeze, but its risks are far from hidden. The U.S. Environmental Protection Agency has classified ethylene oxide as a human carcinogen since 2016, and federal health agencies have warned of its dangers for decades.
Human exposure to EtO typically occurs through inhalation or ingestion and can stem from occupational, consumer, or environmental sources. At manufacturing plants, the gas can easily seep through unsealed cracks in buildings and infiltrate the surrounding air.
Despite its known health risks, many sterilization facilities across the U.S. continue to operate near residential areas—often without informing the public. In many cases, communities have unknowingly been exposed to dangerous levels of EtO for decades. The Napoli Shkolnik law firm is leading legal efforts nationwide to secure compensation and justice for communities impacted by EtO. “The sterilization companies and related defendants are putting some of the most obstinate defenses I’ve seen in 38 years of litigation: fortunately, Napoli Shkolnik has the team to take on every fight,” said John Fonda, Attorney at Napoli Shkolnik.
In late 2022, the EPA began publicly identifying the highest-risk sterilization facilities. Among them is Sterilization Services of Tennessee, located in South Memphis. The facility has released levels of EtO twenty times higher than the EPA’s maximum acceptable risk level—reaching up to 100 times that level during the 1980s. These emissions continue to pose a serious public health threat.
Operating since 1976, the facility sits within five miles of more than 100,000 residents and hundreds of schools and childcare centers—most of which are lower-income, predominantly Black communities. Exposure to EtO has been linked to increased rates of certain cancers (including breast cancer, lymphoma, multiple myeloma, and leukemia), fertility issues, birth injuries, and other long-term health problems.
On February 2, 2024, Napoli Shkolnik, along with co-counsel Wampler, Carroll, Wilson & Sanderson, PLLC, filed an Amended Complaint in a class action lawsuit in Shelby County, Tennessee. The updated filing includes a Medical Monitoring Claim, potentially setting a precedent under Tennessee law, that would provide cancer screening and preventive care to thousands of residents in South Memphis. Judge Higgins recently issued an order denying these same defendant’s preliminary motions to dismiss in a similar case.
In Puerto Rico, progress is also being made. A recent court recommendation advances Napoli Shkolnik’s case Pérez-Maceira et al. v. Customed, Inc., et al., which alleges that sterilization facilities operated by Customed, Medtronic, and Steri-Tech released unsafe levels of EtO in Salinas, Añasco, Fajardo, and Villalba. In 2022, the EPA flagged these facilities for exceeding federal cancer risk thresholds. If the magistrate judge’s recommendation is adopted, it would allow the case to proceed and support the creation of a medical monitoring fund for early detection and treatment. Napoli Shkolnik is pursuing claims in other EPA recognized high risk locations in Erie Pennsylvania and Linden New Jersey and is investigating claims in Sandy, Utah, Taunton, Massachusetts, and Jessup, Hanover, and Salisbury, Maryland
“People in these communities have been breathing in a toxic chemical for years without ever being told what they were exposed to. It’s a pattern that’s all too familiar—where industrial pollution goes unchecked and communities are left to suffer. This recommendation moves us one step closer to accountability, care, and lasting protections for those who’ve been put at risk.” said Paul Napoli, Partner at Napoli Shkolnik
The work on EtO is just beginning. The EPA maintains an interactive map showing facilities across the country that have reported EtO emissions. While not all sites are represented due to federal reporting thresholds, the map offers a powerful look at the scope and scale of EtO pollution nationwide. The map can be viewed here: https://www.epa.gov/trinationalanalysis/ethylene-oxide.