Sterigenics court fight worries health care sector over short-, long-term impacts of effort to restrict EO use

By Jonathan Bilyk | May 9, 2019

IEPA Headquarters, Springfield, Ill.   Cook County Record

As the court fight continues over the fate of Sterigenics’ medical device sterilization plant in Willowbrook, the company and others are working to draw attention to the health care side effects of this and possible further moves by Illinois state officials and lawmakers to further restrict access to the sterilizing agent ethylene oxide.

This week, after getting rebuffed in federal court in Chicago, Sterigenics asked a judge in DuPage County Circuit Court in suburban Wheaton to lift the order slapped on it by the Illinois Environmental Protection Agency, under Illinois Gov. JB Pritzker, effectively shuttering the Willowbrook facility.

In the complaint, which is similar to the legal action Sterigenics filed in Chicago federal court in February, Sterigenics continues to assert Pritzker’s IEPA broke the law and violated their constitutional rights by imposing a so-called “seal order,” which forbids them from using their stores of ethylene oxide gas, which is essential to the sterilization operations they perform at the plant.

The company says it sterilizes a wide array of surgical equipment and medical devices at its plant.

in the complaint filed by its lawyers with the firm of Sidley Austin LLP, of Chicago, Sterigenics stressed again their operations remained in compliance with the operating permits issued to them by the IEPA, yet the state still shut them down anyway.

“Instead of attempting to revoke, alter, modify or terminate the operating permits IEPA issued to Sterigenics or to revise applicable regulations, defendants summarily issued the Seal Order,” Sterigenics said in its complaint. “The Seal Order is an extra-legal attempt to accomplish instantaneously by fiat what IEPA cannot lawfully do without proper notice and process.”

The company further asserted IEPA issued the Feb. 15 seal order mere hours after IEPA officials had met with Sterigenics representatives, and allegedly never mentioned the possibility of such a seal order.

The seal order was issued days after Pritzker had been inaugurated as Illinois governor, ostensibly in response to what the state characterized as elevated levels of ethylene oxide (EO) emissions in the community, allegedly from the Sterigenics plant.

Sterigenics had come under a storm of criticism from the community and then from politicians over alleged emissions from the plant, many of whom appealed personally to Pritzker to act. The controversy ramped up in the fall of 2018, after the federal Agency for Toxic Substances and Disease Registry released a report purporting to show an elevated cancer risk for those living in surrounding communities. 

In its complaint, Sterigenics asserted “ATSDR’s methods were unreliable and were highly biased toward a nonsensical worst-case scenario.”

Yet Sterigenics said the IEPA relied on that report, as well as air quality testing conducted by the village of Willowbrook, to justify the seal order.

In its May 6 complaint, Sterigenics also questioned the data supplied by the village of Willowbrook, saying the village has steadfastly refused to share the data with Sterigenics or prove the data was not corrupted or manipulated.

Sterigenics had asked a federal court to step in, but a judge in that matter ruled last week the case belongs in state courts.

THE REAL 'ENDANGERMENT?'

Sterigenics' May 6 complaint also focused on the effects the shutdown has had on health care in the U.S. to date.

Sterigenics said its “customers are deeply concerned about their ongoing ability to supply hospitals and other healthcare providers with vital tools and devices.”

It pointed to public and investor statements provided by health care manufacturers and product suppliers, including Teleflex, Boston Scientific and Medtronic, noting concerns the state-ordered shutdown has pinched available sterilization capacity for their products and others.

Sterigenics noted the U.S. Food and Drug Administration has said the shutdown effects more than 100 medical device and supplies manufacturers and “hundreds of devices,” and the impact of the shutdown have only begun to ripple across the health care sector and filter down to the hospitals and, ultimately, patients.

“It is the Seal Order itself, and not the ethylene oxide containers at Sterigenics’ Willowbrook facility, that represents an ‘imminent and substantial endangerment to the public health or welfare or the environment’ in the State of Illinois,” Sterigenics said.

However, the concerns expressed in Sterigenics’ complaint are shared broadly across the medical device manufacturing and distribution industry, said Greg Crist, spokesman for AdvaMed, the Advanced Medical Technology Association.

Crist stressed AdvaMed recognizes the concerns surrounding emissions of ethylene oxide, and is not contesting any air quality measurements.

But he said AdvaMed is talking with federal and state officials throughout the country in the wake of the actions taken by the state against Sterigenics, asking them to consider the possible unintended consequences of decisions to further restrict the use of EO in sterilization operations.

He said AdvaMed estimates 20-50 billion medical devices and supplies are sterilized with EO every year. To put the numbers in context, he said a typical surgical patient comes into contact with 55 different medical devices in the operating room, before the surgery even begins. A patient undergoing a routine physical exam can come into contact with 17 sterilized devices.

He said 56% of all medical devices in the U.S. are sterilized using EO, including 80% of all pre-prepped surgical tray kits. He said EO sterilization is also critical for complicated devices like pacemakers, which require a sterilization method that can reach every “nook and cranny” of the device, without damaging or weakening its key components.

At this point, Crist said, “there is nothing that could replace (EO) right now.”

“This is an emotionally-charged issue,” said Crist. “But we want people to be aware of how any decision regarding ethylene oxide is going to impact our health care ecosystem.”

Crist noted manufacturers and the FDA have taken steps in response to the IEPA seal order that are typically reserved for a supply interruption caused by a natural disaster, such as a hurricane. And he noted the Sterigenics Willowbrook plant is just one of nine facilities Sterigenics operates in eight states.

However, he noted the industry cannot simply pivot on a dime in response to rapidly-taken state enforcement actions. He said medical device and supply makers must certify to the FDA how they are going to sterilize their products. Any changes to that plan must also be recertified and validated by the FDA.

To further complicate the situation, Crist said Advamed estimates commercial sterilizers, like Sterignics, operate at 90% capacity to hit their desired profit margins. He said this means, if plants like Sterigenics Willowbrook are closed and remain closed, other sterilizers may not be able to rapidly absorb the additional demand for product sterilization, setting the stage for supply shortages.

He said those concerns have particularly come to the fore as the Illinois General Assembly considers measures to ban the use of EO in Illinois altogether or measures are introduced to require significantly stricter emissions standards, which could push sterilizers who rely on EO out of business.

For instance, Illinois lawmakers have now begun to push the IEPA to similarly scrutinize the use of EO at two other Illinois medical device sterilization plants in Lake County, operated by Medline and Vantage.

Crist said Sterigenics, Medline and Vantage are not AdvaMed members.

“There are real concerns around the supply chain and inventories,” Crist said.

A spokesperson for the FDA pointed The Cook County Record to the agency’s past statements concerning the effects of the Sterigenics Willowbrook shutdown and the agency’s actions in response.

DEAL CLOSE?

As the court fight between Sterigenics and the Illinois state government drags on, rumors have swirled in recent days concerning a potential deal to resolve the seal order and allow Sterigenics to resume its operations in Willowbrook.

A spokeswoman for IEPA declined to confirm whether such talks may be occurring, saying the seal order remains in place and IEPA is working with Illinois Attorney General Kwame Raoul on court litigation, and with state lawmakers on new legislation to address EO use.

“The administration remains completely committed to the safety of the people of Willowbrook and Illinois,” the IEPA said in a prepared statement. “The Illinois EPA took action to seal the Sterigenics facility in Willowbrook and is working closely with the governor’s office and the General Assembly to create the strongest possible legislation to keeps residents safe.”

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Advamed Illinois Attorney General Illinois Environmental Protection Agency Illinois General Assembly Illinois Governor J.B. Pritzker Sidley Austin LLP State of Illinois Sterigenics US Food and Drug Administration

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