What a Court’s Recent Recommendation Signals for EtO Victims

A recent court recommendation marks a major step forward in our efforts to hold polluters accountable in Puerto Rico. A federal magistrate judge has recommended that critical claims move forward in a class action lawsuit on behalf of residents allegedly exposed to harmful levels of ethylene oxide (EtO) from nearby sterilization facilities.

What Is Ethylene Oxide, and Why Are We Taking Action?

EtO is a colorless, odorless gas commonly used to sterilize medical equipment and food products, as well as to manufacture other chemicals. The U.S. Environmental Protection Agency (EPA) classified EtO as a human carcinogen in 2016, linking long-term exposure to increased risk of cancer and other serious health conditions.

Despite these known risks, sterilization facilities across the U.S. have continued operating in or near residential neighborhoods, often without fully informing the public. In many cases, communities have been exposed to this harmful chemical for years without realizing the potential danger.

Case Background

The lawsuit, Pérez-Maceira et al. v. Customed, Inc., et al., alleges that for years, sterilization facilities operated by Customed, Medtronic, and Steri-Tech released dangerous levels of EtO into the air in Salinas, Añasco, Fajardo, and Villalba. In 2022, the EPA confirmed the risk, flagging these sites for emitting EtO at levels far above federal cancer safety thresholds.

As a result of this exposure, residents have developed serious health conditions, including asthma, breast cancer, uterine cancer, thyroid disorders, and high blood pressure. In addition to damages, those affected are calling for the creation of a medical monitoring fund to support early detection and treatment.

If the magistrate judge’s recommendation is adopted, it would allow these claims to proceed and support early medical monitoring efforts for affected residents.

“People in these communities have been breathing in a toxic chemical for years, without ever being told what they were being exposed to. It’s a pattern that’s all too familiar, where industrial pollution goes unaddressed for years, and communities are left to deal with the fallout. This recommendation moves us one step closer to accountability, care, and lasting protections for those who’ve been put at risk.” – Paul Napoli, partner at Napoli Shkolnik

What Comes Next?

The recommendation will now be reviewed by a U.S. district judge. If approved, the case will move into the discovery phase and class certification process, ultimately paving the way for a court-supervised medical monitoring program to help those exposed to EtO receive early diagnoses and critical care.

The judge also recommended dismissing certain claims against Balchem Corporation, Mays Chemical, and Edwards Lifesciences, a decision the legal team plans to formally challenge.

Access the full Report & Recommendation (“R&R”), issued by Magistrate Judge Camille Vélez-Rivé, ここ.

Our Work 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, this map offers a powerful look at the extent of EtO pollution.

“We remain deeply committed to environmental justice in Puerto Rico and will continue working to hold polluters accountable, ensuring that those impacted receive the care, answers, and compensation they deserve. At the same time, this fight is just the beginning. Communities across the country are facing the same risks from EtO exposure, and we’re committed to holding polluters accountable wherever this harm occurs.” – Paul Napoli