If your company utilized ethylene oxide (EO), you have likely been following the EPA news. In recent years, a noticeable rise has occurred in plaintiff cases targeting companies that emit ethylene oxide, with some of this increase related to a published EPA 2016 study. Many companies have already had to incorporate expensive equipment to monitor EO emissions, and others have been shut down entirely. Protecting your company is your highest priority. It is ours also. Let the West Virginia toxic tort attorneys at Orndorff Mowen PLLC handle your ethylene oxide litigation.
Toxic Tort Law
Toxic tort law deals with alleged exposure to harmful substances, with that exposure resulting in some form of injury to an individual. Normally falling under product liability, these cases are also akin to personal injury claims and will need thorough review by an experienced tort law lawyer.
In a toxic tort case, the plaintiff must prove that your company caused their exposure to a toxic chemical or substance and, as a result, is responsible for any health effects or sustained injuries.
In order to be awarded damages in such a case, the plaintiff must be able to show the following:
- Plaintiff was indeed exposed to a toxic substance.
- Your company is responsible for that exposure.
- Plaintiff suffered an injury or suffers currently from the toxic exposure.
- That toxic exposure proximately caused the plaintiff’s injury.
What a Defendant Should Prepare Against
To prepare for cases involving ethylene oxide toxic tort claims, your company, as the defendant, must understand how the plaintiff will attempt to prove their claim. These theories of liability include but are not limited to strict liability, negligence, product liability, or intentional tort.
Under strict liability, the plaintiff does not need to show that your actions were negligent, only that a defect existed, an injury occurred, and the defect is what led to that injury. Your company will potentially be at risk for being held strictly liable for toxic exposure if it involves what is referred to as “abnormally dangerous activities.” Such activities are defined as those not common and which present a foreseeable and preventive risk of causing physical harm.
To prepare against such a strict liability claim, you must be able to show that generally safe circumstances result from reasonable care and present evidence that you exercised such reasonable care.
The plaintiff will attempt to prove that your company was, in some way, negligent. Such a claim can center around negligent conduct or negligence in investigating or warning about the harmful attributes of a particular chemical like ethylene oxide.
For negligence, the plaintiff will need to prove the following:
- The existence of a duty of care;
- There was a violation of this duty of care;
- This violated duty of care proximately led to the plaintiff’s exposure and resulting injury; and
- The plaintiff has sustained serious injuries, or death, as a result of the exposure.
Product liability cases fall under three distinctive categories:
- Defective manufacturing
- Flawed design
- Failure to warn
To prepare for these types of claims, you will need to collect thorough evidence to prove otherwise and will need a legal strategy that puts the efforts onto the plaintiff to provide adequate proof that you were in the wrong.
To prepare ahead of time, however, start now if you haven’t already by providing proper instructions, documentation, or warnings concerning ethylene oxide exposure.
Under intentional tort, the plaintiff is claiming that your company deliberately and willfully misrepresented the dangers of the toxic chemical or substance or committed fraud. For example, you provided marketing materials that were misleading in some way so as to conceal certain risks, or you were knowledgeable about the potential toxicity of the substance or chemical but failed to warn.
In such cases, the plaintiff will attempt to prove that your company had a duty to disclose or warn of the hazards involved.
What is Ethylene Oxide, and Why Does It Put Companies At Risk?
Ethylene Oxide is essentially a flammable, colorless gas that is invisible to the naked eye. Once it reaches room temperature, this gas can quickly dissolve in water or other solvents that are water-based.
In the air, this gas can last a half-life of between 69 and 149 total days, while once dissolved in natural, deionized, or sterile water, it has a half-life of 12-14 days. The gas can also dissolve in waters of increased salinity, and this will decrease that half-life.
While ethylene oxide is predominantly used in the production of other chemicals, like ethylene glycol, a smaller percentage may be used by companies during their sterilization processes, such as for food, cosmetics, or medical equipment.
If your company emits any ethylene oxide, even the smallest amount, you could risk unwanted attention due to new scrutiny surrounding this chemical. Plaintiffs have increasingly filed cases against companies as knowledge of this chemical becomes more readily available. While individual cases are becoming more common, so too are attempts at certifying class actions.
Understanding the Side Effects of Ethylene Oxide
Understanding the side effects of ethylene oxide exposure is important for your company. You need to know what may be claimed as an injury in a case made against you. It will also alert you to the dangers associated with exposure to this gas and prompt you to seek solutions for monitoring it in your own environment and also for providing warnings and directions to both employees and customers alike.
The exposure to ethylene oxide by the general population primarily occurs through inhalation, especially in areas where the gas is used or produced. Yet, the general population also risks exposure via first or secondhand smoke, as it exists in small percentages there also.
Ethylene oxide occupational exposure can potentially occur in ethylene oxide sterilization facilities, fumigation plants, ethylene glycol production facilities, and hospitals.
Acute exposure to this gas can result in any of the following human health side effects:
- Nausea or vomiting
- Excessive thirst
- Shortness of breath
- Respiratory irritation
- Lung injury
- Cyanosis, a blueish skin discoloration
- Eye irritation
There are also chronic effects of ethylene oxide alleged to lead to cancer, neurotoxicity, and reproductive issues.
The U.S. EPA has found ethylene oxide to be a carcinogen. This finding is based on its own guidelines and risk assessment as well as that of the National Toxicology Program and the International Agency for Research on Cancer (IARC) Working Group. In addition, other entities, including the National Institute for Occupational Safety and Health (NIOSH), support the finding that ethylene oxide exposure increases cancer incidence risk.
The carcinogenicity of ethylene oxide is considered genotoxic, meaning it has the ability to damage genetic information within a cell and cause mutations, which, in turn, lead to cancer.
To calculate the potential risks for cancer from inhalation exposure to ethylene oxide, the EPA utilizes what is referred to as the inhalation unit risk (IUR) value for ethylene oxide. Available data indicate that long-term exposure to elevated concentrations of ethylene oxide increases the risk of certain types of cancer, including myeloma, lymphocyte leukemia, non-Hodgkin lymphoma, and breast cancer.
This characterization of ethylene oxide as a carcinogenic requires that you remain diligent in your care and warnings involving any amount of exposure.
What Tests Are Used to Measure Ethylene Oxide?
While the 2016 study by the US Environmental Protection Agency, which caused the rise in litigation against several companies that emit ethylene oxide, is important, the knowledge and regulation of ethylene oxide are not new. The first recommendation for a limit to occupational exposure occurred in 1977 by the Occupational Safety and Health Administration. In 1990, an amendment to the already established Clean Air Act included measures to regulate the gas as a hazardous air pollutant.
The EPA, in 1994, published the very first National Emissions Standards for Hazardous Air Pollutants (NESHAP) concerning ethylene oxide and included commercial sterilization. Going forward, other industries became applicable as well. One of the EPA’s jobs is to review NESHAP every eight years and make revisions if necessary.
Diagnosing Ethylene Oxide Toxicity in Patients
When it comes to diagnosing ethylene oxide toxicity in a patient, the process is clinically based, focusing on exposure history, symptoms, and physical findings. Specific lab tests are not used as they cannot provide definitive data that any abnormalities come from just occupational ethylene oxide exposure.
According to the CDC’s available data, more than 95% of the population in the US have some detectable levels of ethylene oxide hemoglobin adducts in their blood. These adducts are biomarkers of exposure from all sources — environmental, occupational, or naturally produced within the body.
Measuring Ethylene Oxide Emissions
As for the measuring of ethylene oxide emissions, the EPA released its own screening tool in 2018 to assist both local and state agencies in identifying sources to study further. This tool is based on its 2014 Air Toxics Assessment (NATA) and incorporates the findings of the 2016 IRIS Assessment for ethylene oxide. Ethylene oxide is now classified as a cancer risk driver, and as such, census tracts are being identified as having increased risks of toxic ethylene oxide emissions.
More recently, in 2022, the EPA released the 2017 Air Toxics Screening Assessment (AirToxScreen). This serves as a public mapping tool users can query by location, faculty, and specific air emissions to identify those census tracts with a potential elevated cancer risk due to the existence of ethylene oxide and other toxic chemicals.
Why Your Company Should Care
Ethylene oxide case trends have increased since the 2016 publication of the EPA study, putting all companies on notice that they could be next. Your company needs to take notice of this and prepare in the best ways possible. Why? Consider the following.
- Regulations, both federal and state, will likely continue to increase. As such, your company will need to monitor these changes and respond.
- Companies that did not have issues in the past will unknowingly be suspect to litigation going forward. This risk is rising due to the outreach by the EPA and the increase of litigation surrounding the exposure to ethylene oxide.
- Finally, occupational exposure to ethylene oxide can be hazardous and increase health risks to both your workers and the general population, resulting not only in missed work and higher health care insurance costs but also putting you at higher risk for personal injury claims against your company.
The ethylene oxide landscape is changing quickly. Ensuring your company understands how it is changing can help to predict where it will go and how you need to prepare.
The EPA’s 2023 Announcement Regarding Ethylene Oxide Emissions
On April 11, 2023, the US Environmental Protection Agency proposed new requirements for ethylene oxide emissions from commercial sterilizers. While the proposal is still in the public comments stage, if it is implemented, it will reduce ethylene oxide emissions from commercial sterilizers by 80%, lowering the risk to communities nearby.
As such, commercial sterilizers will need to incorporate more control practices, procedures, and technologies to reduce ethylene oxide emissions. In addition, they will need to conduct continual monitoring to make sure such equipment continues to operate effectively. Data will need to be submitted electronically to the EPA two times each year.
EPA Targeting NESHAP for Commercial Ethylene Oxide
As a follow-up to the EPA’s 2023 measure, NESHAP will likely soon start to target the following.
Commercial Hospital Ethylene Oxide sterilizers
While the majority of commercial sterilization or fumigation sources that use ethylene oxide are subject to the NESHAP regulation, currently, commercial hospital ethylene oxide sterilizers are not. However, the EPA is moving toward a regulatory review process for hospital ethylene oxide sterilization, which currently falls under a different regulation.
Group 1 Polymers and Resins
Group 1 polymers and resins also currently fall under a separate NESHAP regulation, and it may change as they are also being targeted by the EPA. A regulatory review is scheduled to be completed sometime in 2024.
Polyether Polyols Production
A separate National Emission Standards for Hazardous Air Pollutant Emissions for Polyether Polyols Production is up for regulatory review as well. The completion of this specific review is expected to occur in 2024.
Is Your Company At Risk of an Ethylene Oxide Class Action?
With the release of the 2016 EPA study concerning ethylene oxide emissions and exposure, more companies than ever may be at risk for litigation, which can mean an ethylene oxide class action. Is your company included in this risk? If so, contact the tort law attorneys of Orndorff Mowen PLLC to discuss your concerns. We serve clients throughout West Virginia and nationwide and are here to help protect your company. Call our office today at 866-481-2765 or submit to our website’s online contact form to schedule a consultation with our legal team.