Sterigenics shutdown crimps supply of medical devices, as courts mull next steps, procedural motions

By Cook County Record | Apr 16, 2019

As state and federal courts grapple with the legal questions of what comes next, a state-imposed shutdown of a Willowbrook medical device sterilization facility has begun to have ripple effects for health care facilities and patients far from the suburbs of Chicago.

On April 12, the U.S. Food and Drug Administration announced a maker of tracheostomy tubes, which are essential breathing devices for many patients, has informed government regulators of a shortage of the tubes.

The FDA said Minneapolis-based Smiths Medical said it was experiencing a “temporary shortage” of its Bivona tracheostomy tubes, in large part due to the state of Illinois’ decision to order the Sterigenics facility in Willowbrook closed.

The tubes were among the array of medical devices routinely sterilized by Sterigenics at the Willowbrook plant.

The Sterigenics facility has remained shut down since it was hit by a seal order issued by the Illinois Environmental Protection Agency under Gov. JB Pritzker in February, because the state said the facility’s emissions of ethylene oxide (EO) gas posed an emergency health risk to the surrounding communities.

That shutdown order had come amid a growing public clamor for Pritzker to take action after he was inaugurated in February. Public concern had centered on an alleged link between elevated EO emissions from the Sterigenics facility and incidences of cancer in those living nearby. The outcry began in the summer of 2018 following the release of a report from the federal Agency for Toxic Substances and Disease Registry claiming an increased risk of cancer for those living near the Sterigenics facility. 

Sterigenics has contested those findings, asserting they were based on flawed data supplied by the U.S. Environmental Protection Agency.

In late March, the Illinois Department of Public Health issued a report it claimed indicated “some cancers were elevated in populations living near the Sterigenics facility in Willowbrook.” The IDPH report, which was based on cancer registry data, concluded “many apparent differences and inconsistencies, however, existed between genders, across study areas, and among cancer sites.”

“Further studies, preferably with larger populations and multiple facilities, are strongly recommended to confirm this assessment’s findings,” the IDPH said.

In response, Sterigenics noted three of the cancers most commonly associated with high exposure to EO – which Sterigenics called “lymphohematopoietic cancers” – were not associated with the elevated cancer risk in and around Willowbrook.

Further, Sterigenics noted “several of the cancers noted in the report have no previous association with EO and incidence rates related to those cancers should be ‘viewed with an abundance of caution.’”

“The misinformation regarding EO and Sterigenices has unnecessarily caused fears among the Willowbrook community and resulted in a shutdown of our Willowbrook facility, causing serious negative consequences for the patients who rely on the critical medical products and devices sterilized there,” Sterigenics said in its march 29 statement.

At about the same time, the FDA issued an advisory warning health care professionals, hospitals and the public of likely shortages of medical devices sterilized by Sterigenics in Willowbrook using EO.

The FDA said shortages could get worse as states, including Illinois and Michigan, move to further shut down other EO-reliant sterilization facilities and restrict the use of EO altogether.

On April 12, the FDA said it was “working to quickly and proactively secure alternative locations and methods for the sterilization of devices that were previously processed at the Willowbrook facility.”

The FDA said it would also regularly share “updates on potential impacts to medical devices once sterilized at these facilities.”

In its April 12 advisory, the FDA noted the shortage of Bivona tracheostomy tubes would be particularly difficult for children, as they are particularly reliant on the “flexible silicone material which makes them easier to insert in … pediatric patients.”

“We recognize the challenges this shortage imposes for these pediatric patients who need access to new tubes now, and are working to limit the impact to patients as much as possible by helping the company quickly move their sterilization to another facility,” the FDA said.

The FDA did not indicate in the statement which facility would accommodate the demand for the tubes.

For now, the fate of the Willowbrook Sterigenics facility remains up in the air, as Sterigenics and Illinois state officials await pending court proceedings.

In DuPage County, a judge is being asked to decide on the state’s request for a court order keeping the Sterigenics facility closed. In that lawsuit, the Illinois Attorney General’s Office, on behalf of the IEPA, and the DuPage County State’s Attorney have accused Sterigenices of violating Illinois law by emitting EO.

To date, the state has not presented evidence showing the facility has operated outside the emissions range allowed under its operating permit.

Rather, the state argues Sterigenics should be punished for creating a “public nuisance” and “public health hazard” by emitting EO at all.

Sterigenics has argued the state’s arguments amount to an attempt to illegally sidestep federal emissions regulations and even the state’s own laws and rules, because the matter has become politically expedient.

Appearances are scheduled in that case for later this week in Wheaton.

Since February, Sterigenics and Illinois Attorney General Kwame Raoul have sparred in federal court in Chicago over the company’s lawsuit, asking a federal judge to undo the IEPA and Pritzker’s emergency so-called “seal order,” barring the company from using its EO gas supplies and effectively closing the Willowbrook facility.

A judge has yet to rule on the state’s motion to dismiss that lawsuit. However, the judge has repeatedly denied Sterigenics’ attempt to secure an injunction allowing them to reopen the plant.

Sterigenics has also asked U.S. District Judge Ruben Castillo to order the state to take part in a settlement conference, a move the state has also opposed.

The Attorney General has argued the matter doesn’t belong in federal court, and Sterigenics should take its appeal of the IEPA order through state proceedings, either before the Illinois Pollution Control Board or in DuPage County Circuit Court.

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Circuit Court of Dupage County Illinois Attorney General Illinois Department of Public Health Illinois Environmental Protection Agency Sterigenics U.S. District Court for the Northern District of Illinois US Food & Drug Administration

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