Medical device sterilizer Sterigenics has secured a path to reopening its plant in suburban Willowbrook, which has remained shuttered since February when state regulators under Illinois Gov. JB Pritzker ordered it closed over pollution concerns, even though the plant never violated the terms of its state operating permit.
On July 17, Sterigenics and Illinois Attorney General Kwame Raoul announced the state and the company had reached an agreement to end a months-long court fight over the alleged pollution and resulting state action, which the company said represents an attempt by the governor and state officials to sidestep the law for political gain.
The proposed agreement, spelled out in a so-called consent order, was filed in DuPage County Circuit Court. DuPage County Judge Paul Fullerton is expected to consider the consent order at a hearing on July 24.
Sterigenics President Philip Macnabb
| Sterigenics
In a press release, Sterigenics said the agreement would “enable the company’s Willowbrook sterilization facility to resume operations and continue sterilization of life saving medical devices for patients and hospitals in Illinois and across the country.”
In a separate release, Raoul said the terms of the agreement “surpasses the emissions limits contained in Illinois law” and would subject Sterigenics to “the strictest capture and control requirements in the nation.”
“The proposed consent order … will enable the state to act quickly to hold Sterigenics accountable for violating Illinois’ emissions limits,” Raoul said.
Despite that accusation, the state did not introduce evidence in court that Sterigenics violated the terms of its operating permit, which was issued by the Illinois Environmental Protection Agency and authorized the company to use and emit the chemical compound ethylene oxide in its sterilization procedures.
Sterigenics noted the agreement imposes no penalties on the company for any alleged violations, and contains “no finding of liability or fault by either side.”
Sterigenics and the attorney general’s office have been locked in a legal battle since last October, when former Attorney General Lisa Madigan and DuPage County State’s Attorney Robert Berlin filed suit in DuPage County court against the company, asking a judge to essentially prohibit Sterigenics from using EO in its operations.
The state actions relied heavily on data and reports issued by the U.S. EPA and the federal Agency for Toxic Substances and Disease Registry, which claimed to show a sharply elevated cancer risk for people in and around Willowbrook. An ATSDR report linked that elevated risk to EO emissions from the Sterigenics plant.
Sterigenics has contested the report’s conclusions, but the report generated a large amount of attention in news reports and a large public outcry, which placed heavy political pressure to act on Pritzker. The Democrat had turned the controversy over the plant into a campaign issue in his race against Republican Gov. Bruce Rauner in the fall of 2018.
Shortly after becoming governor, in mid-February, Pritzker’s IEPA slapped a so-called “seal order” on Sterigenics, ordering them to stop using EO, effectively closing the plant.
Sterigenics has said the EO is essential to its method of sterilizing surgical instruments, such as hypodermic needles and surgical kits. The medical device industry and the U.S. Food and Drug Administration have also expressed concern over the shutdown, noting alternative sterilization methods using heat and radiation can weaken device materials and compromise their effectiveness. The industry warned the closing of sterilization plants would lead to shortages of key devices and raise infection risks in American hospitals.
Sterigenics challenged the seal order in court, calling them “baseless and wrongful” in court filings. The company asserted the state overstepped its authority in shutting down a facility that never violated the terms of its state operating permit and the shutdown order represented a thinly veiled attempt to circumvent federal emissions controls.
In June, Pritzker signed into law strict new emissions standards and regulations for EO use in Illinois.
Despite the shutdown order and the new law, the attorney general’s office continued with its lawsuit against Sterigenics. While conceding the company never exceeded the emissions limits imposed under its permit, the state attorneys argued the company still violated state rules and state law by creating a “public nuisance” by emitting EO at all.
Most recently, Sterigenics and the state have sparred in court over the state’s seeming reluctance to grant Sterigenics access to a number of key documents or to allow the company to question IEPA Director John Kim and others in depositions under oath.
Sterigenics accused the state of slow-walking its document and deposition requests, saying the state is “afraid the truth will come out” regarding the state’s actions and the legal basis for them.
The new agreement, however, would end the litigation, the two sides said.
The two sides stressed Sterigenics would not be allowed to resume operations until it “installs new emissions capture and control systems, which must be approved by the IEPA.”
The company has applied for a permit from the IEPA allowing it to construct and install new emissions control systems.
The agreement also requires Sterigenics to pay $300,000 into a fund to pay for “environmental projects in the village of Willowbrook or neighboring DuPage County communities,” which must be completed within a year.
“We are pleased to have reached this agreement, which creates a path for our Willowbrook facility to resume its safe operation and includes no finding of wrongdoing on the company’s part nor the imposition of any financial penalties,” said Sterigenics President Philip Macnabb in the company’s release.
“The state government has gone to great lengths to set new standards for the protection of the public that are more stringent than any other location in the country. While our Willowbrook operations have consistently complied with and outperformed the state’s requirements, we have repeatedly stated our support for evolving regulations and our commitment to enhancing our operations in the interest of protecting public health. We remain committed to abiding by the new regulations established by the state.
"By resolving this matter, we are one major step closer to resuming the critical work of sterilizing vital medical products and devices in Willowbrook for patients in Illinois and beyond," Macnabb said in the release.
Sterigenics has been represented in the court actions by attorneys Maja C. Eaton, Gerard D. Kelly and others with the firm of Sidley Austin LLP, of Chicago.