A suburban Chicago based sterilizer of medical devices and personal protective equipment has gone to court in Georgia against county officials who have refused to allow them to fully operate an Atlanta-area sterilization facility, even in the face of threatened federal action out of concerns the county is impeding the nation’s response to the COVID-19 pandemic.
On March 30, Sterigenics, based in Oak Brook, filed a complaint in federal court in Atlanta, asking a judge to order Cobb County to allow them to return their facility to full operations, in part to help the country respond to COVID-19.
In the complaint, Sterigenics asserts county officials have concocted illegal and unconstitutional reasons to keep them from resuming fully their work of sterilizing medical equipment at the Cobb County sterilization facility, “depriving health care providers and patients of essential medical products that are in critical need,” the complaint said.
The complaint said the county’s continued resistance to allowing Sterigenics to reopen has nothing to do with their stated reasons, related to fire and building codes. Rather, the complaint accused the county officials of attempting to use their power to enforce “unfounded environmental claims the County has no authority to regulate.”
The complaint particularly accuses Cobb County of buckling to the demands of local activists, with a stated goal of shutting down the Sterigenics facility and all other medical device sterilization plants that use the chemical known as ethylene oxide to sterilize health care equipment. The complaint said the county then essentially fabricated reasons to block Sterigenics from reopening its facility, until federal authorities began pressing for the plant to reopen to produce medical equipment in high demand from U.S. hospitals and first responders treating those infected with the novel coronavirus that causes COVID-19.
The activists, known as “Stop Sterigenics,” along with a group of trial lawyers, have targeted sterilization facilities using ethylene oxide (EtO) since 2018. They have particularly taken aim at Sterigenics facilities in Illinois, in the western Chicago suburb of Willowbrook, and at Cobb County, in Georgia.
At one point in 2019, the activists succeeded in pressuring officials in both states to close both plants. Other sterilization plants operated by medical device makers Medline in Illinois and Becton Dickinson in Georgia were also closed for a period of time, as state officials evaluated their emissions or supervised the installation of emissions control equipment.
Activists have demanded the closures, citing concerns, based on a risk assessment from the federal Agency for Toxic Substances and Disease Registry, that EtO emissions exposure increases the risk of cancer and other maladies in those located near sterilization facilities.
Sterigenics has disputed those conclusions, and repeatedly noted its plants never violated state or federal EtO emissions levels.
However, the U.S. Food and Drug Administration and those in health care have expressed concern over the effects of the closures on the availability of key medical devices, such as catheters, IV tubes, pacemakers, syringes, and personal protective equipment (PPE), like gowns and masks, among many others. Many of these devices cannot be sterilized in any other way, or they could suffer damage which would render them useless or even dangerous to patients, the FDA and medical device makers warned. As recently as fall of 2019, the FDA expressed concern over shortages of medical equipment as a result of the sterilization plant closures.
In a statement accompanying its lawsuit, Sterigenics said those fears have been borne out, as hospitals scramble for equipment needed to respond to the COVID-19 pandemic.
On March 19, the FDA sent a letter to Georgia Gov. Brian Kemp, asking the state of Georgia and Cobb County officials to allow Sterigenics’ Cobb County plant to reopen. The letter was first obtained and published by the Cook County Record.
Sterigenics has said its facility can produce up to 1 million pieces of equipment per day, if it were fully operational.
On March 25, Cobb County granted permission for Sterigenics to reopen, but only to sterilize PPE, noting that is what was specifically referenced by the FDA in its request.
Sterigenics has said that permission was inadequate.
And on March 26, Cobb County released excerpts from an email, purportedly forwarded by Gov. Kemp’s office, from U.S. Health and Human Services Secretary Alex Azar, expressing anger at Cobb County’s decision to only allow Sterigenics to partially resume operations. The message further threatened more federal action “at the highest level” should the county continue to oppose the FDA’s request and hamper the national COVID-19 response.
The county, however, refused to relent, sparking Sterigenics’ lawsuit.
In the complaint, Sterigenics asserts the county had been working with Sterigenics until activists intervened in 2019. At that point, Sterigenics said, the county began indicating it would keep Sterigenics’ Georgia facility closed until the company met the terms of the county’s “certificate of occupancy.” The county further revoked a building permit Sterigenics held.
Sterigenics said it agreed to submit to a third-party review from a firm known as Q-Dot Engineering, of York, Pa. The firm and its consultant, James Munger, a certified fire protection specialist, was selected by Cobb County.
However, the complaint said, when Ferguson presented a draft report backing Sterigenics in the dispute, Sterigenics asserts Cobb County rejected the report and demanded a different engineer at Q-Dot, identified as Patsy Warnick, “write a different report based on instructions they gave her.”
“Defendants (Cobb County) were trying to obtain a report that would support (its) unlawful closure of the Facility,” Sterigenics wrote in its complaint.
Sterigenics said the new report was written without the company’s knowledge. The report “contained erroneous findings and recommendations based on (Cobb County’s) improper instructions,” and was written without a site visits from Warnick.
“Those erroneous recommendations required the Facility to operate at less than half of its normal operating capacity and to undergo renovations that would take time substantial time before Sterigenics could resume its operations,” the complaint said.
Sterigenics said it then provided more information and materials to Warnick, who also toured the facility.
Sterigenics asserts Warnick’s report, issued March 23 “confirmed” Sterigenics’ position in the dispute with the county and indicated “there was no reason to preclude Sterigenics from resuming its normal sterilization operations at the Facility.”
However, Sterigenics said the county officials continue to prevent Sterigenics from resuming its normal operations.
The report also notes the county’s alleged illegal decision to block Sterigenics from resuming operations comes amid the COVID-19 pandemic, and comes despite the federal government’s decision to designate medical device sterilization services as a “’scarce material’ ‘needed to respond to the spread of COVID-19.’”
“However, rather than allow Sterigenics to reopen the Facility to provide essential sterilizations of medical products for patient treatments, (Cobb County officials) continue their lawless closure of the Facility,” the complaint said.
“Even during this pandemic, the County would not intervene to allow the Facility to fully operate.”
While the county is allowing Sterigenics to produce PPE, the complaint said PPE is only about 20% of what Sterigenics sterilizes at the Georgia facility. The plant also produces equipment needed to treat a range of other “COVID-19 complications” including pneumonia, cardiac injury, arrhythmia, septic shock, liver disfunction, acute kidney injury and multi-organ failure.”
The county, the complaint said, is “preventing millions of essential and lifesaving medical products that would be sterilized at the Facility from reaching healthcare providers for use in patient care.”
Sterigenics is represented in the action by attorneys from the firm of Alston & Bird, of Atlanta.
The lawsuit does not address Sterigenics’ Illinois plant, which has been closed since February 2019, when Gov. JB Pritzker’s Illinois Environmental Protection Agency ordered it closed. Sterigenics announced last September it would no longer seek to reopen the Willowbrook plant. A spokesman for Pritzker’s administration said the state had not received any requests to reopen the Illinois facility.
Sterigenics has also declined to publicly discuss whether they would ever seek to reopen the Illinois plant.
Medline’s sterilization facility in Waukegan was cleared by state officials to reopen last Friday, after tests confirmed the facility’s $10 million emissions control systems satisfy state EtO emissions rules.