Background

Ethylene Oxide (EtO) is a reactive chemical widely used as a sterilizing agent for medical equipment that cannot otherwise be sterilized by heat/steam. EtO may also be used as a component for producing other chemicals, including glycol and polyglycol ethers, emulsifiers, detergents, and solvents. Allegations that exposure to EO may increase the risk of certain cancers has resulted in litigation in Illinois, Georgia, and New Mexico against companies that own and operate sterilizations facilities that utilize EtO. The claimants are nearby residents of these plants who allege that their cancers were caused by EtO emissions.

EtO Litigation

The first ethylene oxide trial went to verdict in September 2022, and a Cook County (Illinois) jury awarded $363 million to a plaintiff who alleged that she developed breast cancer as a result of ethylene oxide emissions from the Sterigenics Willowbrook plant. This was the Kamuda case and was the first ethylene oxide personal injury case to go to trial. It was followed by a second trial involving the same defendant and in the same court though with a different type of cancer at issue. That trial, Fornek, resulted in a defense verdict.

In January 2023, Sterigenics, the defendant in the three trials noted above and in another 870 or so cases arising from the Willowbrook plant, announced a settlement of its pending cases in the amount of $408 million. The cases were pending in state and federal court in Illinois. The settlement was recently agreed to by all but three of the plaintiffs.

In October 2023, Sterigenics settled 79 claims for $35 million. The claims arose from claimants alleging cancer as a result of their proximity to a plant in Smyrna, Georgia that utilizes EtO. Other claims are still pending in that jurisdiction.

California Litigation

The EtO litigation has recently branched west to California. On March 18, 2024, a 49 page Complaint was filed in Superior Court, County of Los Angeles, on behalf of approximately 15 plaintiffs who live or lived near the Sterigenics sterilization facility in Vernon, California (actually two adjacent facilities). The Complaint alleges that the plaintiffs developed various types of cancer due to their proximity to the facility. Notably, the Complaint in the California action makes numerous references to the Willowbook settlement.

Although the California litigation is in its infancy, we expect that other suits will be filed or that this Complaint will be amended to include additional plaintiffs. The potential pool of plaintiffs is vast given the high population density surrounding the Vernon facility, and we anticipate that this litigation will receive a fair amount of media attention, which in turn will likely entice community members to join the suit.

Analysis

We had previously opined after the Illinois settlement that the EtO litigation would expand both with respect to the number of plaintiffs as well as the number of jurisdictions. Although it took some time for this to happen, this new suit in California evidences that the litigation will continue to grow. The settlement numbers in the Illinois and Georgia litigation served as invitations to potential plaintiffs in other jurisdictions.

We anticipate that the EtO litigation will spread across the country, particularly in light of the EPA’s new regulations which significantly tighten permissible levels of EtO emissions by sterilization plants (more on this in a separate posting).

What Measures Can Your Company Take To Minimize Risk?

What measures should companies take to minimize the risk of being sued by private parties or by regulatory agencies? For one, retaining an expert to review whether the facility is emitting EtO unknowingly (or in excess of allowable regulatory levels) is recommended. If a problem is identified, consider purchasing (or upgrading) equipment that will bring the facility into compliance. Be proactive with respect to potential litigation. Is your facility in a community that is concerned with environmental justice? Are you in compliance with all state and federal regulations, particularly the new EPA rules? The best litigation strategy is to ensure you avoid litigation in the first place.