Trial Magazine

Before August 2018, a visit to Willowbrook, Ill., meant entering a picturesque, leafy-green, all-American suburb. Noticeably absent from the quiet community are looming smokestacks and billowing plumes of pollution—very few structures extend above the Willowbrook tree line besides the town’s water tower and the stadium lights around the local high school football field.

However, the tranquil nature of this town changed after the U.S. Department of Health and Human Services Agency for Toxic Substances and Disease Registry (ATSDR) issued a warning to residents that they were being and had been exposed to elevated levels of ethylene oxide (EtO): a “known” human carcinogen¹ and, as a result, had an elevated cancer risk.² Within a few weeks, U.S. EPA officials found themselves interrogated in town halls, and within months, the U.S. EPA created a dedicated web page for the community and had committed to ongoing air monitoring.³ More town hall meetings and webinars were hosted to continue to explain the findings and attempt to calm the smoldering public outrage.⁴

The U.S. EPA’s data revealed that out of over 75,000 census tracts around the country, Willowbrook fell within the top 20 for cancer risks due to exposure to airborne toxins, the largest component being EtO.⁵ The culprit was a company that had used EtO for nearly 35 years to sterilize medical equipment but allowed the chemical to be released into the neighboring community.

The company’s predecessor had pioneered and patented the use of EtO, an invisible flammable gas, to sterilize food and spice products⁶ and then expanded their operations to sterilize medical equipment.⁷ The predecessor moved its medical sterilization operation to a discreet warehouse that an executive’s family member owned in Willowbrook in the mid-1980s, eventually spinning off that part of the company and rebranding it—and the company did so without warning the community residents about the risks involved in the use of EtO at the site.⁸ For the next 35 years, the company owned and operated facilities emitting over 1 million pounds of EtO into Willowbrook and surrounding communities’ air.⁹

In February 2019, after the ATSDR warning letter and the public backlash, the Illinois EPA shuttered the company’s facilities.¹⁰ But the damage had been done. An Illinois Department of Public Health (IDPH) investigation revealed statistically significant elevations in certain blood cancers for adults (Hodgkin lymphoma and non-Hodgkin lymphoma, especially in females), even higher elevations in blood cancers (all lymphomas) for children, as well as increases in breast cancers.¹¹

Cancer clusters, such as the one in Willowbrook, occur when a statistically abnormal number of people are unexpectedly diagnosed with one of the most devastating illnesses imaginable. Many times, this occurs without an explanation—though it also may be a predictable consequence of environmental tragedies, such as the recent Norfolk Southern train derailment that occurred in East Palestine, Ohio, in February.¹²

Cancer cluster cases, like any form of environmental litigation, require a significant amount of time, research, and resources to effectively investigate and litigate. Here are some tips for seeking justice for your clients diagnosed with cancer due to the negligent or purposeful actions of polluters.

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Your first step in a cancer cluster case is identifying potential culprits: the company and chemical.

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Investigation

Not every case will have the smoking gun ecological study like the one from the IDPH in Willowbrook. Even fewer will have the federal ATSDR focus on your client’s community specifically. More likely a client, or group of clients, will approach your firm about suspicions concerning their cancer and who or what may be causing it.

Chemical and company. Your first step in a cancer cluster case is identifying potential culprits: the company and chemical. Databases on the U.S. EPA’s website show companies in any geographical area in the country using chemicals deemed hazardous air pollutants (HAPs) and volatile organic chemicals (VOCs), many of which are probable or known carcinogens.¹³ These mappings can help narrow down potential responsible parties. From there, analyze the types of chemicals those companies are emitting or releasing and make a preliminary determination as to what cancers may be related—specifically those of your potential clients.

Monographs through the World Health Organization’s International Agency for Research on Cancer (IARC) and chemical summary reports from the U.S. EPA and National Toxicology Program (NTP) detail types of cancer associated with exposure based on scientific studies and literature.¹⁴ If the cancers in question are not found in these high-level summaries, your expert witnesses may have a difficult task ahead of them. They will have to do a deeper dive into the scientific literature and studies for answers to the causation question.

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It’s impossible to litigate a cancer cluster case without a team of experts to find and prove both exposure and causation.

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Building your team of experts. Consult and retain expert witnesses early for preliminary investigation. It is impossible to litigate a cancer cluster case without a team of experts to find and prove both exposure and causation.

Once you have a hypothesis for exposure (inhalation, consumption, dermal exposure), focus your inquiry on general and specific causation. General causation seeks to answer whether the chemical can cause the cancer in question (Can EtO cause breast cancer?).¹⁵ Specific causation proceeds to answer whether the chemical did cause a particular person’s cancer (Did EtO cause my client’s breast cancer?).

Consult experts in the fields of epidemiology, toxicology, and oncology. Any one of these experts may help answer causation questions and each will approach it from a unique angle while you build a well-rounded basis to determine whether to proceed with the case. These experts will also identify what additional information they need related to your client’s exposures.

Epidemiologists often start by looking at the broad overviews laid out by IARC, the U.S. EPA, and the NTP. They may then delve deeper by looking at large-scale population or worker studies before employing statistical modeling to determine whether a cluster exists. Statistical data from cancer registries or ecological studies, such as the one in Willowbrook, can be used to determine whether the clustering of cancers is abnormal or significant. These overviews and studies can help show general causation and should be examined at the outset of any investigation. If the chemical is not capable of causing the cancer in question, the case is likely at an end.

Toxicologists may look at similar data, but they typically rely more on cellular and animal studies to analyze the way the chemical affects living organisms to determine whether a plausible mechanism exists for the cancer to occur after chemical exposure. They also may compare the dose of exposure in various studies to the exposure a potential plaintiff may have received to establish whether the amount of exposure was sufficient to cause the cancer. Toxicologists’ opinions can trend between the two causation questions.

Finally, an oncologist can assess your client’s medical records and medical history. They should be familiar with the various risk factors otherwise associated with the cancer and can help answer whether the chemical was a cause or contributor to a specific plaintiff’s disease.¹⁶ Oncologists can also help you understand your client’s treatment and prognosis, which should serve as the primary basis for damages in these cases.

Once some of these preliminary questions are answered, your causation experts should work with your exposure experts to determine the amount of the chemical your client may have encountered from the companies in question and find comparisons in the scientific literature. These exposure experts may vary—airborne exposures may require a meteorologist, while groundwater contaminations may require a hydrologist or a geologist.

Getting answers through FOIA. Even before a lawsuit is filed and while experts are being consulted, consider sending Freedom of Information Act (FOIA) requests to government entities for information relating to the potential defendants’ operations. Ask for site inspection reports and for citations for violations of regulations, rules, or ordinances. Also request data on the company’s operations and the chemical in question. For instance, the U.S. EPA has strict reporting requirements for HAPs and VOCs, which are publicly available online, but FOIA requests may help uncover even more.¹⁷

Provide these figures and data to your exposure experts and standard of care/liability experts for their opinions. After all, you must answer the question of negligence or recklessness before you even reach causation. Ask experts:

• Did the companies employ reasonable technologies to capture or control their releases?
• Did the companies handle the carcinogenic chemical reasonably and with proper regard for its dangerous qualities?

Once more robust discovery is obtained, those experts can compare the information gathered through FOIA to the company’s internal data for emissions or releases to reach conclusions about the defendant’s recordkeeping practices and, ultimately, whether the company complied with regulatory requirements. The slightest inconsistencies or deviations from their legal obligations can raise a scepter of impropriety and be used heavily against a corporate polluter in front of a jury. In the Willowbrook litigation, for example, such an analysis determined that actual emissions vastly exceeded reported emissions, helping craft the case message that the company was not honest with regulators.

Finally, FOIA requests should include requests for communications between the company and government officials and agencies. Due in large part to understaffing and lack of resources, regulators often rely on representations from the company to determine compliance and, as a result, enforcement. But even when regulators catch a company “in the act,” subsequent communications can reveal leniency and even attempts by the company to influence regulators or collateral attacks on the regulations themselves.

This was especially prominent in the Willowbrook litigation. As both the U.S. EPA and Illinois EPA were clamping down on EtO emissions, the defendant companies and their lobbyists’ communication to elected and appointed officials increased tremendously. Trade groups lobbied for “the EPA’s rigorous, peer-reviewed evaluation” of EtO to be thrown out “in favor of industry-funded research rejected by two panels of independent scientists.”¹⁸ Eventually, the U.S. EPA’s Office of Inspector General determined that agency officials had delayed communication to Willowbrook community residents, which they found impacted the region’s ability to address EtO emissions in a timely manner.¹⁹

Discovery

Once a lawsuit is filed, and the merits are at issue, use traditional discovery to the greatest extent possible. Consult with your engineering and standard of care experts about critical documents to request, such as communications relating to the chemical in question, communications relating to inspections, citations from government agencies, and facility diagrams.

Your expert witnesses likely need very specific documents to reach their opinions. For example, they may need schematics of the piping, ducting, or equipment; maps of the facilities or information relating to certain repairs; or detailed hourly reports to detect the efficiency—or inefficiency—of the equipment meant to control toxic releases. They should be considering the information the company had in making their decisions on how to operate.

Internal company documents relating to local communities are also critical. Request environmental impact reports, hazard assessments, risk analyses, and warnings. You may receive a treasure trove of documents that reveal the company conducted tests and determined a risk to the local population. Alternatively, you may learn the assessments were in compliance and deemed safe or that the community had notice the whole time—making your case a bit more difficult. If you encounter a company that admits they have no such reports, assessments, or analyses and never provided any kind of warning, this admission could pave the way for a count for willful and wanton conduct (that they were aware of the dangers but were indifferent to them) and, eventually, punitive damages.²⁰

Many companies hold internal meetings to educate workers on the toxic chemicals they use and to provide safe handling instructions. In fact, if the chemical is a known or probable human carcinogen, companies are likely required to do so by OSHA.²¹ Request minutes from those meetings, presentations, slideshows, and informational handouts.

Another tool that should never be underestimated is the subpoena—some of the most helpful documents may be obtained from private third parties. Potential targets are manufacturers of the chemical at issue and the broader array of companies using the chemical.

In Willowbrook, for example, the company had purchased millions of pounds of EtO from another company that shipped it to them. Chemical manufacturers and distributors usually must provide a Material Safety Data Sheet (MSDS) to end users that has up-to-date information on the chemical. If not produced by your defendant in discovery, these documents can show the company acquired knowledge of the chemical’s dangers over the years and failed to act reasonably within the standard of care.

Beyond that, defendants may be part of industry trade groups that include other companies using the chemical in question. Communications, agendas, minutes, and other records of those meetings could reveal concerted industrywide efforts among the members. These documents are unlikely to be handed over without a fight—but they might be some of the most important in the case. They may demonstrate an industry standard or custom that the defendant companies adhered to or deviated from. They also may show the companies collectively lobbied for looser regulations or may demonstrate an industrywide movement to suppress dangers from regulators and the public or fund science that supports a distortion of the truth.

In light of such disasters as the East Palestine derailment—as well as the ongoing use of EtO by sterilization plants around the country,²² the widespread use of PFAS, and more—you should be well-versed in the requirements to prove a case arising from cancer clusters. As public awareness of certain chemicals’ cancer risks grows, so too will the need to assist those afflicted. Be prepared to act quickly, ask the right questions, and consult the right experts to achieve justice.

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Bryce Hensley is a senior attorney at Romanucci & Blandin in Chicago and can be reached at bhensley@rblaw.net.

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Notes

1. U.S. EPA, Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Dec. 2016), https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1025tr.pdf; U.S. EPA, Frequent Questions: Basic Information About Ethylene Oxide, https://tinyurl.com/qvwkf3v. The U.S. EPA changed EtO’s classification from a “probable” carcinogen to a “known” carcinogen in 2016, finding it was “30 times more likely to cause certain cancers than scientists had once known.” The International Agency for Research on Cancer also has classified EtO as “carcinogenic to humans”: http://www.inchem.org/documents/iarc/vol60/m60-02.html. See also U.S. EPA, Ethylene Oxide—Updates, https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/ethylene-oxide-updates.
2. U.S. Dep’t Health & Hum. Servs., Agency for Toxic Substances & Disease Registry, Letter Health Consultation, “Evaluation of Potential Health Impacts From Ethylene Oxide Emissions” (Aug. 21, 2018), https://www.atsdr.cdc.gov/HAC/pha/sterigenic/Sterigenics_International_Inc-508.pdf. For more, see Alyssa E. Lambert, Poison in the Air, Trial, May 2020, at 48.
3. U.S. EPA, EPA in Illinois, Sterigenics Willowbrook Facility (Aug. 3, 2022), https://www.epa.gov/il/sterigenics-willowbrook-facility.
4. U.S. EPA, EPA in Illinois, Sterigenics Willowbrook Facility: Community Meeting Presentations (Aug. 25, 2022), https://www.epa.gov/il/sterigenics-willowbrook-facility-community-meeting-presentations.
5. U.S. EPA, National Air Toxics Assessment, 2014 NATA: Assessment Results (Feb. 13, 2023), https://www.epa.gov/national-air-toxics-assessment/2014-nata-assessment-results#nationwide. (The 2018 report release was actually its 2014 data.) The other top risk areas were almost exclusively communities in “Cancer Alley,” the notorious region of Louisiana and Texas littered with industrial giants dumping and spewing tons of toxic chemicals into the water and air of impoverished and marginalized communities.
6. U.S. Patent No. 2,189,947 (filed Feb. 13, 1940).
7. Griffith Foods, Griffith Foods Statement on Sterigenics (Aug. 21, 2020), https://griffithfoods.b-cdn.net/wp-content/uploads/2020/08/Griffith-Foods-Statement-on-Sterigenics.pdf.
8. This is based on admissions and deposition testimony in the author’s cases.
9. This amount is based on data gained from discovery and our expert’s work in the litigation. Inventories of facility emissions can be accessed through the U.S. EPA’s Toxic Release Inventory (TRI) by searching through Form R documentation at https://enviro.epa.gov/facts/tri/form_r_search.html?, or through various other search modalities on the U.S. EPA website at https://www.epa.gov/enviro/tri-search.
10. EPA in Illinois, supra note 3.
11. Ill. Dep’t of Public Health, Div. of Epidemiological Studies, Cancer Incidence Assessment Near Sterigenics in Willowbrook, IL, 1995-2015 (Mar. 29, 2019), https://dph.illinois.gov/content/dam/soi/en/web/idph/files/publications/sterigenicswillowbrookcancer-investigation-final-0.pdf.
12. Tom Perkins, Levels of Carcinogenic Chemical Near Ohio Derailment Site Far Above Safe Limit, The Guardian (Mar. 17, 2023), https://www.theguardian.com/us-news/2023/mar/17/norfolk-southern-derailment-east-palestine-ohio-carcinogenic-chemical-levels.
13. U.S. EPA, Initial List of Hazardous Air Pollutants With Modifications (Dec. 19, 2022), https://www.epa.gov/haps/initial-list-hazardous-air-pollutants-modifications#mods.
14. Historical IARC monographs, for example, can be found on their website at https://monographs.iarc.who.int/monographs-available/. See also Nat’l Toxicology Program, 15th Report on Carcinogens (Dec. 21, 2021), https://ntp.niehs.nih.gov/whatwestudy/assessments/cancer/roc/index.html; U.S. EPA, TRI National Analysis: Chemical Profiles (Mar. 16, 2023), https://www.epa.gov/trinationalanalysis/chemical-profiles.
15. For more, see Tara Tabatabaie, Decoding General Causation Data, Trial, April 2019, at 28.
16. A lawyer should research the potential jurisdiction’s causation instruction early on to guide their expert witnesses on the ultimate questions they will have to answer. In Illinois, a plaintiff does not need to show that the chemical in question was the cause or an overwhelming cause. Rather, they must show that it was a cause. See Ill. Pattern Jury Instr. Civ. 15.01 (2022).
17. See U.S. EPA, Hazardous Air Pollutants: Sources and Exposure (Nov. 1, 2022), https://www.epa.gov/haps/hazardous-air-pollutants-sources-and-exposure.
18. Michael Hawthorne, Amid Chemical Industry Lobbying, Trump EPA Reconsiders Risk of Cancer-causing Ethylene Oxide, Chicago Tribune (Dec. 20, 2019), https://tinyurl.com/2vc4xwf4.
19. U.S. EPA, Off. of Inspector Gen., EPA Delayed Risk Communication and Issued Instructions Hindering Region 5’s Ability to Address Ethylene Oxide Emissions (Apr. 15, 2021), https://www.epa.gov/sites/default/files/2021-04/documents/_epaoig_20210415-21-p-0123.pdf. In addition, discovery obtained during litigation revealed that the defendant companies were meeting and communicating with these very same officials during this time.
20. In Illinois, unlike many states, punitive damages cannot be requested in an initial complaint; rather, a plaintiff must make a showing by clear and convincing evidence of a defendant’s evil motive or reckless and outrageous indifference to a highly unreasonable risk of harm and with a conscious indifference to the rights and safety of others. See 735 Ill. Comp. Stat. Ann. 5/2-1115.05 (West 1995); cf. In California, plaintiffs may include punitive damages in their initial pleading but need only allege the ultimate facts of a defendant’s oppression, fraud, or malice. Doe v. Uber Techs., Inc., 184 F. Supp. 3d 774, 790 (N.D. Cal. May 4, 2016) (see also Cal. Civ. Code §3294 (West 1992)).
21. See, e.g., U.S. Dep’t of Labor, OSHA, Ethylene Oxide, https://www.osha.gov/ethylene-oxide/standards.
22. Progress is being made as the U.S. EPA recently proposed more stringent standards for EtO emissions from commercial sterilization facilities in an effort to reduce nearby residents’ maximum individual cancer risk from the emissions to 100-in-1 million or lower. See National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, 88 Fed. Reg. 22,790 (Apr. 13, 2023).