Ethylene Oxide Investigation

You could recover compensation if you developed cancer while living or working near a sterilization facility or other type of industrial facility that used ethylene oxide (EtO) in its sterilization or manufacturing processes.

According to the Environmental Protection Agency (EPA), around 100 U.S. sterilization facilities exposed residents within the vicinity to dangerous levels of a carcinogenic chemical called ethylene oxide. It is a common substance used for sterilizing medical equipment and in the manufacturing of numerous consumer products.

Those diagnosed with breast cancer, blood cancer, and other medical conditions from EtO emission exposure can hold these negligent companies liable for the harm they caused. Call Paul LLP Trial Attorneys at (816) 984-8100 today for a free consultation to learn more.

Update (March 14, 2024): The EPA has announced a final rule to limit ethylene oxide emissions to reduce cancer risk. Learn more: https://www.epa.gov/newsreleases/epa-announces-final-rule-slash-toxic-emissions-ethylene-oxide-and-reduce-cancer-risk

An Overview of Ethylene Oxide

Ethylene oxide is a flammable, colorless, and typically odorous chemical. Its primary use is for commercial sterilization and manufacturing, including:

• Sterilizing spices, medical equipment, and other products unable to undergo sterilization by steam
• Manufacturing products and chemicals, such as antifreeze and plastic bottles

EtO is an EPA-registered antimicrobial pesticide used to treat nearly half of all medical devices in the country annually. Although it serves a vital function for various companies, taking the necessary steps to avoid harmful exposure is critical. Community residents and workers who suffer exposure can develop cancer and other health problems from EtO emissions. 

Link Between Cancer and Ethylene Oxide Exposure

The EPA released a Draft Risk Assessment in November 2020 during an ethylene oxide registration review. The process involves reviewing registered pesticides every 15 years to evaluate the performance of their intended functions compared to the risks they pose to the environment and human health.

During the assessment, the EPA discovered inhaling EtO over multiple decades can cause a risk of cancer. Additional findings included:

• Long-term exposure causes myeloma, non-Hodgkin lymphoma, lymphocytic leukemia, and other cancers of the white blood cells
• Long-term exposure can also cause breast cancer
• Chronic EtO exposure can cause neurological symptoms, such as impaired hand-eye coordination and memory loss
• It is a belief that children are more susceptible to EtO than adults, and exposure is more likely to cause cancer later in life

The EPA concluded that products made, sterilized, or used with EtO do not cause concern for risk of exposure or exposure to water or soil. The primary issue is the presence of harmful chemicals in the air, especially near commercial facilities using EtO to sterilize products such as medical equipment.

Sterilization Facilities with Dangerous Levels of EtO

The EPA performed a risk assessment for the communities near the commercial sterilization facilities operating in the United States in July 2022. The agency focused on the risk of cancer associated with breathing in emissions from the contaminated area during the residents’ lifetimes.

The results identified 23 facilities with emissions contributing to excess cancer risk among nearby residents. The EPA explained the risk as elevated or exceeding 100 additional cancer cases per one million exposed people.

The sterilization facilities and locations with the highest exposure risks include:

• Professional Contract Sterilization, Inc. in Taunton, MA
• BD Medical in Sandy, UT
• Elite Spice, Inc. in Hanover, MD
• Customed, Inc. in Farjado, PR
• International Sterilization Laboratory in Groveland, FL
• Medtronic PR Operation Co. in Villalba, PR
• Cosmed Group Inc. (dba Cosmed of NJ) in Franklin, NJ
• Cosmed Group LLC/Erie in Erie, PA
• Midwest Sterilization Corporation in Laredo, TX
• Terumo BCT Sterilization Service, Inc. in Lakewood, CO
• Trinity Sterile, Inc. in Salisbury, MD
• Steritec, Inc. in Athens, TX
• Pharmaceutical Systems in Columbus, NE
• Sterilization Services in Memphis, TN
• Midwest Sterilization Corporation in Jackson, MO
• Edwards Lifesciences in Añasco, PR
• Elite Spice, Inc. in Jessup, MD
• ETO Sterilization-Plant #2 (Cosmed) in Linden, NJ
• Sterilization Services of Virginia in Henrico, VA
• LEMCO Ardmore in Ardmore, OK
• American Contract Systems Inc. in Zelienople, PA
• DeRoyal Industries in New Tazewell, TN
• Steri-Tech, Inc. in Salinas, PR

You can review the complete list of ethylene oxide commercial sterilization facilities on the EPA website. There are approximately 100 facilities on the list in 32 states and Puerto Rico. Some companies operate in multiple locations, such as:

• Midwest Sterilization – 2 facilities
• Becton Dickinson – 3 facilities
• 3M – 2 facilities
• Sterigenics – 7 facilities
• Medtronic – 5 facilities
• Jackson Laboratory – 3 facilities
• Jude Medical – 2 facilities
• Cosmed Group – 3 facilities
• Steris – 5 facilities
• Isomedix Operations – 3 facilities
• Boston Scientific – 3 facilities
• American Contract Systems – 2 facilities
• Elite Spice – 3 facilities
• Sterilization Services – 2 facilities

Regulatory Actions Against Sterilization Facilities

Various sterilization facilities included in the risk assessment have faced civil and regulatory cases related to the use and impact of EtO on the environment and human health.

For example, Cosmed agreed to a $1.5 million settlement in 2005 after allegations that it violated the Clean Air Act. The legal action alleged the company didn’t submit required reports to the EPA, failed to measure EtO emissions, and didn’t install pollution control equipment promptly at its facilities in Grand Prairie, TX, Baltimore, MD, Coventry, RI, Waukegan, IL, San Diego, CA, and South Plainfield, NJ between 1998 and 2003.

Facilities that shut down after the FDA reported dangerous EtO emissions include:

• Medline Industries in Waukegan, IL
• Becton Dickinson and Company in Covington, GA
• Sterigenics in Willowbrook, IL, and Atlanta, GA

Facilities with high-profile actions and civil lawsuits against them include:

• Sterigenics – A woman filed a lawsuit against the sterilization facility after claiming to develop breast cancer from exposure while living nearby in Willowbrook, IL. A jury awarded her $363 million in compensation. After the EPA discovered residents within 1.5 miles of the facility were ten times likelier to develop cancer, over 700 additional people filed a lawsuit against Sterigenics.
• Benton Dickinson and Sterigenics – Multiple individuals in Georgia filed a series of lawsuits against Benton Dickinson and Sterigenics in Georgia in 2020. They claimed their breast cancer or blood cancer diagnoses were due to exposure to EtO emissions from the sterilization plants.
• Terumo BCT Facility – In Lakewood, CO, in 2022, the sterilization facility faced at least twelve lawsuits. A twelve-plaintiff trial is supposed to begin in July 2023 over claims of harmful exposure to EtO emissions.
• Braun Med, Inc. – Almost three dozen people filed a lawsuit against the sterilization plant in February 2022. They claimed they developed leukemia and other types of cancer after working at or living near the facility located in Allentown, PA.
• Kendall Patient Recovery – More than two dozen individuals sued Kendall Patient Recovery, located in Augusta, GA, in 2021. The plaintiffs claimed to suffer miscarriages and develop different types of cancer from working or living within five miles of the sterilization plant.
• Baxter International – In Arkansas, individuals claiming to suffer exposure to EtO emissions from a sterilization facility in Mountain Home, AR, filed a lawsuit against Baxter Healthcare Corp. The company reached a confidential settlement with the plaintiffs in 2021.

Cancers Caused by EtO Exposure

According to the EPA, inhaling EtO over prolonged periods can increase the risk of numerous kinds of cancers, including:

• Breast cancer
• Lymphocytic leukemia
• Ovarian cancer
• Cancers of the pancreas
• Kidney cancer
• Stomach cancer
• Brain cancer
• Non-Hodgkin lymphoma
• Bladder cancer
• Myeloma
• Lung cancer
• Other lymph and blood cancers

EtO exposure can also lead to medical conditions, such as:

• Eye damage
• Memory loss
• Nausea and headaches
• Nerve damage
• Impaired hand-eye coordination
• Miscarriages and reproductive issues
• Cognitive and neurological impairment

Positive Changes to Reduce the Risk of EtO Exposure

Although research on EtO and the dangers of exposure is ongoing, the EPA concluded that EtO is carcinogenic to humans if inhaled. Multiple regulators made significant discoveries during studies and other assessments of the dangerous chemical, including:

• In 2018, EPA scientists found the substance is likely to cause cancer in individuals living near specific kinds of facilities during an initial analysis
• The EPA identified sterilization facilities and communities with the highest cancer risk for residents in July 2022

These findings and the increasing number of lawsuits against sterilization facilities led to the implementation of new reporting programs and regulations to lower emissions and reduce EtO exposure. Scientists and regulators are also reviewing potential alternative methods for sterilizing products like medical devices.

Eligibility to File a Lawsuit for EtO Exposure

You might be able to file a lawsuit against a sterilization facility if you:

• Lived or worked near a sterilization facility or other industrial facility that used EtO; and
• Received a cancer diagnosis or developed another medical condition related to EtO exposure.

Compensation in an Ethylene Oxide Lawsuit

The value of your case will depend on numerous factors. If you pursue a successful lawsuit against a sterilization facility, the compensation you receive might cover your losses, such as:

• Diagnostic testing, prescriptions, and other medical expenses
• Pain and suffering
• Mental anguish
• Lost wages
• Lost earning capacity
• Out-of-pocket costs

Seek Justice with Help from Paul LLP Trial Attorneys

You deserve the chance to hold the negligent facility accountable for your suffering. Let Paul LLP Trial Attorneys help you fight for the justice and compensation you deserve.

Call us at (816) 984-8100 for your free consultation if you have developed cancer or another health problem from EtO exposure.