Colorado jury rules Terumo isn’t liable for cancer allegedly related to toxic chemical releases in Lakewood

Terumo Blood and Cell Technologies of Lakewood was found not negligent Friday by a Jefferson County jury for alleged releases of toxic ethylene oxide into surrounding neighborhoods from its sterilization process, after four women sued the company for liability in their cancer cases. 

The plaintiffs, part of a large group of negligence and liability cases against Terumo and other companies who use ethylene oxide, claimed the Lakewood plant should have done more to stop chemical emissions into neighborhoods. They sought damages in state district court over their extensive medical costs, as well as physical impairment and disfigurement. 

EPA updates in 2018 and 2022 on potential cancer risks from ethylene oxide releases had riled Lakewood residents and prompted new reviews by Colorado’s health department. 

“We are pleased that the jury ruled in our favor after carefully considering the facts and the science,” a company statement said at the conclusion of the weekslong trial dominated by detailed testimony from competing scientific experts. “We care deeply about the Lakewood community, where many of our employees live and raise families, and are committed to meeting or exceeding all relevant health and safety standards in our sterilization of lifesaving medical devices.”

Plaintiffs’ attorney Kurt Zaner said, “While the plaintiffs are disappointed in the result today, we appreciate the jury’s service. We will continue to fight on behalf of the residents of Lakewood and all of our plaintiffs as we look forward to the next trial and another chance at holding Terumo accountable.” 

Liability cases have been building for years aimed at companies that use ethylene oxide, or EtO, in sterilization and other industrial processes. Some courts have consolidated individual civil complaints against companies like Terumo, which have facilities near residential neighborhoods, schools and other high-traffic areas. 

The complaints against Terumo took on added momentum when the EPA put out plume maps and information stating that some neighborhoods within a certain distance of EtO emissions could see higher than the natural background level of cancer cases over long periods of time. 

In 2018, the EPA released an update to its national database of toxic chemical releases, focusing on 26 manufacturers around the nation using EtO at levels the agency said could pose added cancer risks to neighbors. Terumo’s large Lakewood plant was one of those facilities. 

The Colorado Department of Public Health and Environment set up temporary air monitoring outside the Terumo buildings after the EPA reports. The state’s measurements confirmed the EPA findings that there could be an elevated risk of developing cancer. But the state also conducted an epidemiological study of actual cancer cases in surrounding ZIP codes. They later announced there was no perceptible increase in cancer cases over the number expected in an average neighborhood.

“The plaintiffs, who allege between 15 and 53 years of exposure to ambient EtO from the facility, (were) altogether asking for more than $217 million in damages for their physical impairment, $7.5 million for past and future medical expenses, plus additional punitive damages for Terumo’s allegedly willful conduct,” according to Law360. 

Terumo has maintained throughout the disputes, and in expert testimony during the civil cases, that it has always updated equipment and monitored EtO releases to stay within regulations. Another update of its Lakewood equipment in 2018 further reduced any EtO released after the chemical is used in sterilization bays to purify equipment before shipping. 

Sterilization with EtO “is the most regulated part of a highly regulated company within a highly regulated industry,” a Lakewood Terumo executive said, in a 2023 interview. 

Zaner and the team of lawyers his firm has worked with on multiple civil cases have said merely meeting the minimum regulation is not enough to escape liability in chemical contamination suits. 

The companies preceding Terumo at the Lakewood sterilization facility, and Terumo with additions  in the 2000s, should not have placed a toxic chemical source in a fast-growing suburb full of houses, day care centers and schools, Zaner said in 2023. 

Excess short-term exposure to EtO can cause breathing problems and other acute health issues. Longer term, the EPA says, “scientific evidence in humans indicates that exposure to EtO for many years increases the risk of cancers of the white blood cells, including non-Hodgkin lymphoma, myeloma, and lymphocytic [also known as lymphoblastic] leukemia. Studies also show that long-term exposure to EtO increases the risk of breast cancer in women.”

In 2022, a Chicago-area jury awarded $363 million to plaintiffs suing over emissions from a medical equipment sterilization plant using ethylene oxide, the first major judgment in the growing body of challenges to the sterilization chemical. Faced with hundreds more suits, Sterigenics in January agreed to pay out $408 million to all the plaintiffs in the Illinois cases.

Terumo’s Lakewood sterilization operation handles products made in blood collections. Before shipping, boxes of Terumo’s finished equipment are loaded into sterilization chambers. 

An injection of ethylene oxide gas permeates the shipping boxes and packaging materials as the medical equipment sits on large pallets. EtO sterilizes the equipment over hours, and the boxes sit inside the sealed bays for hours longer while the gas dissipates. Terumo has various scrubbing systems meant to filter out EtO before it leaves the plant. 

A vacuum system pulls the spent gas to an internal scrubbing system, Terumo said. The boxes of products continue to emit leftover gases for some hours, and Terumo washes the bay with clean air that is also sent to scrubbers. When employees finally open the chambers to remove products for shipping, the vacuum pulls any remaining traces of air away from the open end and sends it through vents to filters. In media tours of the plant, Terumo has noted that EtO traces are so low at that point, the employees aren’t required by OSHA to wear ventilators or masks.

About half of medical devices that must be sterile are treated with EtO, the Food and Drug Administration says. The gas is one of the few methods that penetrate all packaging and will not damage delicate plastics or glass materials. 

The EPA in 2024 issued a rule further cutting allowed exposure to EtO, backed by Colorado officials who said they welcomed the federal action on the highly toxic substance. 

Four facilities in Colorado, including Terumo’s large sterilizing operations, must meet the new rules requiring 90% cuts to emissions of EtO from previous regulations, the Colorado Department of Public Health and Environment said last year.