Ethylene Oxide & Medical Device Sterilization: A Litigation Overview

Last year, Berkley Life Sciences’ Blog featured an important post on Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain. That article highlighted potential supply chain constraints caused in-part by sterilization facility shutdowns and regulatory requirements to install or upgrade emission control equipment. What that post did not address—and what this article will explore—is the nationwide litigation that has impacted the sterile medical device industry over the past five years. 

Background: Regulatory Actions and Litigation

Litigation involving alleged exposure to ethylene oxide (EtO) used by medical device sterilizers can be traced to a series of regulatory actions taken by the U.S. Environmental Protection Agency (“EPA”) and state agencies. In 2016, the EPA issued an Integrated Risk Information System (“IRIS”) in which it reassessed the cancer potency of EtO resulting in a risk value more than 50-fold more potent than before. The same year, the EPA reclassified EtO’s carcinogenicity classification from “probably carcinogenic to humans” to “carcinogenic to humans, by inhalation.” In August 2018, the EPA released updated data from the 2014 National Air Toxics Assessment (“NATA”), which implemented a low-risk value for EtO. Consequently, the NATA identified (for the first time) several areas across the United States where elevated cancer risks occurred nearby commercial sterilization facilities using EtO. Notably, EPA’s NATA is a screening tool used by state air agencies to identify which pollutants, emissions sources, and places should be further studied to understand any possible risks to public health. As the EPA itself cautions, NATA results should be used “cautiously” and “[o]ften, more localized studies are needed to better characterize local-level risk.” And in fact, this is what many state air agencies did—they began coordinating with sterilizers in their respective states to better understand the potential risk associated with the EtO emissions. 

As swiftly as the state agencies acted, so did the plaintiffs’ attorneys. Since 2020, litigation brought on behalf of individuals who lived or worked near sterilization facilities has been initiated across the country, including in Illinois, Georgia, Colorado, Pennsylvania, Tennessee, Arkansas, California, and Puerto Rico. More than 1,000 cases are pending in various state courts, drawing attention from regulators, legislators, and the public.

Understanding Ethylene Oxide

EtO is a naturally occurring and organic compound with which everyone comes into contact in their daily lives. It is produced endogenously in the human body as a byproduct of ethylene metabolism. EtO is also emitted to the atmosphere from vehicle exhaust, natural gas combustion, home furnaces, gas grills, and household cleaners. Industrially, EtO is used in the manufacture of ethylene glycol (antifreeze), polyester, detergents, polyurethane foam, solvents, medicine, adhesives, and other products. A relatively small percentage of the overall industrial usage of EtO is for sterilization of medical devices. 

Ethylene Oxide & Medical Device Sterilization

Mechanistically, EtO disrupts the metabolism of bacteria, fungus, and other organisms. It is this unique characteristic that renders EtO so effective when used to sterilize medical devices. The FDA strictly regulates EtO sterilization to ensure it achieves required sterility levels without adversely affecting the device’s performance, safety, or effectiveness. To that end, the FDA reviews sterilization modalities for every device, and a manufacturer cannot change its sterilization modality without FDA approval. Approximately 50% of all sterile medical devices in the United States are sterilized with EtO. For many medical devices, sterilization with EtO is the only modality that effectively sterilizes without damaging the device.

Ethylene Oxide Litigation Landscape

To date, six EtO lawsuits have been tried to verdict. 

Three cases have resulted in defense verdicts:

• Glass v. B. Braun Med. Inc. (PA)

• Fornek v. Sterigenics U.S., LLC (IL)

• Isaacks v. Terumo BCT Sterilization Services, Inc. (CO)

Two cases resulted in mistrials:

• Knobbe v. Isomedix Operations, Inc. (IL)

• Walker v. Becton, Dickinson and Co. (GA)

One case, Kamuda et al. v. Sterigenics U.S., LLC (IL), resulted in a verdict for the plaintiff.

Plaintiff Litigation Themes

Plaintiffs—typically residents or workers near sterilization facilities—allege that prolonged exposure to EtO emissions causes breast and blood cancers such as non-Hodgkin’s lymphoma, leukemia, and multiple myeloma. 

Key arguments include:

• No “safe” level of EtO exposure.

• Emission controls are inadequate, even if compliant.

• Failure to warn the community about EtO use and emissions, regardless of legal duty.

Plaintiffs across these cases often rely on a consistent group of experts to support claims of causation and standard of care. 

Defense Themes & Strategies

Defense themes vary but generally focus on three key areas.

1. Causation:

   Cancer is common in our population and often has no defined cause. Compounding that challenge in cases alleging EtO exposure is the scientific uncertainty with respect to dose. A plaintiff must demonstrate that EtO exposure levels were hazardous to human beings generally and capable of causing their specific injuries. This is often challenged at the summary judgment stage and through expert testimony. 

2. Regulatory vs. Legal Standards:

   Plaintiffs and their experts rely heavily on regulatory classifications. Ensuring that the judge and jury understand the distinction between legal causation and regulatory risk assessments is critical. Specifically, regulatory bodies that assess risks do so for the purpose of setting exposure standards to guide both agency and company actions and are often based on conservative assumptions and lower standards of proof. Courts have recognized that regulatory findings do not equate to legal causation and often cannot withstand the rigors of the rules of evidence. 

3. Safe Use of EtO:

   Defendants emphasize that EtO can be used safely and that safe exposure levels do exist. Emphasizing the many innocuous alternative sources of EtO we all interact with regularly and highlighting endogenous EtO helps contextualize the chemical’s presence. 

    

Legislative Activity

At least one state has passed a law protecting businesses utilizing EtO as a sterilant for medical devices from litigation. Utah Code § 78B-3-1201 et seq. creates a general bar on EtO exposure claims filed against those “engaged in business in the healthcare industry”, subject to limited exceptions. It remains to be seen whether other states will follow suit. 

Looking Ahead

While litigation has largely focused on commercial sterilizers and EtO producers, recent media reports raise questions about potential risks associated with warehouses where medical products sterilized with ethylene oxide are stored. This media scrutiny may lead to expanded litigation, including claims against medical device manufacturers that simply warehouse their EtO sterilized products, regardless of whether any sterilization occurs on-site. 

Medical device manufacturers that use EtO, whether or not sterilization occurs in-house or at a contract sterilizer, may face increased legal exposure. While these cases are certainly defensible on scientific and regulatory grounds, they are often complex and costly, nonetheless. It is important to engage experienced legal counsel specializing in this nuanced field early to assess potential litigation risks and prepare effective defense strategies.

Authored by Lori G. Cohen (Vice Chair), Sean P. Jessee (Shareholder), Sydney Fairchild Williamson (Shareholder), and Rachel Kagan (Associate) of Greenberg Traurig, LLP’s Pharmaceutical, Medical Device & Health Care Litigation Group.

Greenberg Traurig, LLP’s Pharmaceutical, Medical Device & Health Care Litigation Practice is a premier life sciences litigation team, involved in pharmaceutical and medical device industries’ top mass torts and class actions. As national, regional, trial, and settlement counsel for industry leaders, GT’s team routinely tries cases involving cutting-edge medical and scientific issues. Distinguished by its depth of experience and thorough understanding of the industry, this nationwide team of 130+ litigators deliver top-of-class client service. GT has assembled a cross-functional litigation team that meets the unique needs of environmental toxic tort cases that implicate the life science industry such as medical device sterilization with ethylene oxide. www.gtlaw.com