In February of 2019, less than six months after the public health threat became known to residents in Willowbrook about a highly carcinogenic odorless, colorless gas called ethylene oxide (EtO) had blanked communities, Illinois Governor J.B. Pritzker took decisive action to close the offending plant in DuPage County, Sterigenics, and order more air testing.

On October 25, 2019, the Food and Drug Administration (FDA) issued a warning concerning the availability of medical equipment in response to the Sterigienics shut down in Illinois. In this rare statement, FDA Commissioner Sharpless warns of supply chain issues that may result because of these closures but does admit, “Although medical devices can be sterilized by several methods, ethylene oxide is the most common method of sterilization of medical devices…” noting that roughly half of all devices are sterilized using this chemical.

This was not the first time the FDA bent to the will of corporate lobbyists. Again, Chicago Tribune reporter Michael Hawthorne predicted this move in his October 2018 article by highlighting past actions. Hawthorne wrote:

“Ethylene oxide has been on the federal list of carcinogens since 1985. In December 2016, the U.S. EPA released a long-delayed reassessment that officially added the agency to a list of other national and international organizations declaring the chemical poses significant cancer risks for people.

“Every time federal or state regulators attempt to protect Americans from ethylene oxide, industry groups stoke the public’s fear of hospital infections.”

By November 2019, the FDA began working in earnest with medical device manufacturers to host innovation and supply chain discussions to identify safer sterilization processes across the industry because public outcry across the country continued unabated. The industry itself was beginning to grapple with making changes to appease public sentiment while balancing business needs for process improvements that had not been explored since 2004 when the EPA elevated EtO to a known carcinogen with elevated risks, primarily for employees at the sterilization companies. This was a full fifteen years after cancer and extreme health risks were reported to the industry and state agencies by the EPA.

The reason for this alarm across the FDA can be attributed to the millions spent by medical device manufacturers and industry lobby groups. Brenda Goodman writing for WebMD reported in September 2019, “Federal lobbying disclosures show medical device makers and sterilizers have spent more than $1 million over the past 12 months lobbying Congress and the EPA on ethylene oxide issues.”

This money was to garner support from the FDA and officials in the Trump administration to slow the curb on toxic chemical usage. Included in this effort was curtailing the database used to report medical device failures that resulted in injury or death. This system was intended to be an early warning for oversight and trigger product recall alerts as well as warn physicians who are obligated to protect their patients.

Along with the FDA, industrial manufacturing lobbies were gearing up for a fight. The closure of Sterigenics was challenged in Illinois courts while medical product titans began quietly pouring money into campaign coffers. Some of the largest companies in the country call Chicago home. Two of these are Abbott Labs and their subsidiary, Abbvie.

Abbott occupies a complex in Abbott Park, IL with reported revenue of $30 billion, and a complete medical equipment manufacturing facility using EtO as part of that process. Abbot donated sizable amounts to legislators across Illinois, including contributions to Rep Mayfield in August 2019 for a cumulative value of more than $16,000 since her tenure began. This single PAC has been generous to the tune of more than $740,000 since its inception in 2006, spreading that wealth among Illinois lawmakers on both sides of the aisle.

In 2019, the same year Waukegan families were still fighting for relief, Abbott was featured in an investigation of companies taking advantage of a tax loopholes using Ireland’s ‘Double Tax’ that allowed them to use subsidiaries to avoid paying tax on €5.6 billion ($6.1 billion), at the same time netting €50 billion ($54 billion) from The International Development Association grants using Irish-registered companies in Bermuda. Abbott had not reported excessive air emissions nor detrimental hazards for employees. That is until one employee had her own blood levels tested as part of a community study investigating to EtO released by Medline in Waukegan.

The CDC funded a study at the University of Illinois, Chicago to determine whether elevated EtO levels would be detected in Lake County residents who had been exposed to the Medline and Vantage EtO leaks. They put out a call and residents like Teuta Boci Tanaka responded.

Tanaka, or Tea as she is known to fellow StopETO group members, is a senior researcher at Abbott Labs with extensive professional experience with antimicrobial biologics and co–authored several papers on analysis of biologic sterilization and antimicrobial research.

She seemed like a prime candidate to join the CDC study except researchers have not confirmed if they were aware of her employment at Abbot and her work in sterilization modalities.

Web MD published an overview of the findings of this test in December 2019, noting that of the 93 residents who participated in the study, all lived close to either Medline or Vantage facilities. The results were to be used to petition for additional funds for and controlled and in-depth study. Authors wrote of Tea:

“Tea Tanaka, one of the founders of the grassroots community group Stop EtO in Lake County, says her own level came back on the high end of the spectrum: 58.2. She lives about 4 miles from both facilities, but she works 2 miles south of Medline, an area which is often downwind of the plant. She thinks most of her exposure happens at work. Her husband, who works from home, had an average level: 26…”

“She says she and her husband have discussed moving.”

Abbott Park is just under two miles away to the West of Medline. Her husband’s test results were not nearly as high, the article points out, and clarifies that he works from home, which is five miles from Vantage and seven miles from Medline. She may have inadvertently proven that her own employer was posing a risk to employee’s health or that risk was exceedingly compounded by Abbott’s proximity to Medline. A spokesperson for Abbot has not confirmed if the facility provides testing of employees as part of their safety procedures.

In a Chicago Tribune article published on these same results, Tanaka was described as helping lead the push to get lawmakers to use the same authority exercised by Governor Pritzker to shut down the Sterigenics facility in DuPage County. This group, StopETO, has been effective in raising the issue locally and keeping the public informed of the risks as well as providing avenues for redress. In a community like Waukegan where median incomes fall around $48,000, the outlay of funds for civil lawsuits added to extensive medical bills, presents yet another significant challenge to residents still struggling through this issue. Meanwhile, in Willowbrook, IL, the number of civil cases grew to more than 70 individual claims against Sterigenics.

While Lake County communities focused on Vantage and Medline, Abbott was not waiting for Illinois legislators to finally enact restrictions. Instead, they had joined Sterigenics and others in accepting grants from the FDA to study alternatives to EtO usage. At the same time, Abbott and other healthcare and Pharma PACs were pouring money into candidate committees.