Sterigenics: Illinois A/G's lawsuit asks court to 'rewrite' federal rules, based on 'indisputably flawed report'

By Jonathan Bilyk | Dec 14, 2018

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Saying the legal action asks a state court to substitute its own judgment for federal law and environmental rules, Sterigenics, the owner of a facility in suburban Willowbrook targeted by trial lawyers, politicians and a group of area residents for its use of ethylene oxide, has asked a federal judge to take jurisdiction over a lawsuit brought against them by state prosecutors.

Earlier this fall, the offices of Illinois Attorney General Lisa Madigan and DuPage County State’s Attorney Robert Berlin filed suit against Sterigenics in DuPage County Circuit Court. The lawsuit accuses Sterigenics of creating a public health hazard by emitting thousands of pounds per year of ethylene oxide gas (EO.)

Sterigenics has said the EO is essential to its method of sterilizing surgical instruments, such as hypodermic needles and other medical tools, as alternative sterilization methods using heat and radiation can weaken the materials and compromise their effectiveness. This, Sterigenics says, can place patients at greater risk of injury and infection.

Sterigenics claims more than half of all medical devices and 90 percent of surgical kits used in operating rooms in the U.S. are sterilized using EO. Without EO, Sterigenics says, infection risks in American hospitals “would soar.”


Attorney General Lisa Madigan  

However, this summer, Sterigenics’ facility in Willowbrook came under a storm of scrutiny following the release of a report from the federal Agency for Toxic Substances and Disease Registry, which claimed to show a sharply elevated cancer risk for people in and around Willowbrook stemming from EO emissions. The ATSDR report relied on air quality data and modeling conducted by the EPA in May.

The report’s release generated public and political outcry. Trial lawyers filed dozens of lawsuits. Politicians, including Illinois senators Dick Durbin and Tammy Duckworth and U.S. Reps. Bill Foster and Brad Schneider, all Democrats, demanded tighter regulations on the use of EO.

Amid the outcry, the Illinois Environmental Protection Agency referred the matter to the Illinois Attorney General’s office for enforcement. Madigan’s and Berlin’s offices then responded with the lawsuit, filed Oct. 30. The village of Willowrook joined the action against Sterigenics on Nov. 30.

The lawsuit does not accuse Sterigenics of violating either the federal Clean Air Act, or its EPA operating permit, which has held since the 1980s and was most recently renewed in 2015.

According to the lawsuit, Sterigenics over the past 25 years emitted on average about 18 percent of the amount of EO the state of Illinois had given it permission to emit.

However, the lawsuit said the company should still be punished for creating a “public nuisance” and “public health hazard” by emitting EO at all.

The state lawsuit essentially asks the court to bar Sterigenics from continuing to use EO in its sterilization operations.

The lawsuit extensively cites the ATSDR’s August report. However, in November, nearly a month after the state lawsuit was filed, the U.S. EPA announced the data it supplied the ATSDR was flawed, as it counted a different chemical as EO, elevating the EO count reported to the ATSDR.

On Dec. 5, Sterigenics moved to transfer the case from DuPage County court in Wheaton to federal court in Chicago. In its motion, Sterigenics said the case was best left to the federal courts, as the lawsuit comes as a “direct challenge” to federal EO regulations under the Clean Air Act and the authority of the U.S. EPA to set and enforce those standards.

“Plaintiff asks the court to ignore these uniform federal standards and to impose new and different standards primarily based on the ATSDR report, which USEPA itself now admits is based on inaccurate data,” Sterigenics wrote. “Thus, not only does Plaintiff ask the State court to rewrite a federal regulation, it seeks to do that based on a demonstrably and indisputably flawed report generated by one federal agency – ATSDR -  at the behest of another federal agency - USEPA.”

Further, Sterigenics said the lawsuit would undercut the U.S. EPA’s ongoing work to monitor Sterigenics’ emissions and decide whether further action is required.

“… Not only does USEPA have the resources to provide Plaintiff’s requested relief, USEPA is already in the process of providing the exact relief requested by Plaintiff (the state of Illinois),” Sterigenics said in its motion.

Sterigenics said federal jurisdiction in the case is also demonstrated by the move by senators Durbin and Duckworth and U.S. Reps. Foster and Schneider to introduce legislation setting new standards for EO use in medical sterilization and pressing the EPA to “convene an interagency taskforce to immediately begin investigating alternatives to ethylene oxide.” This Sterigenics said, drives “home the point that this is inherently a federal issue with respect to which the State of Illinois has neither a particular interest in nor the power to resolve.”

Sterigenics said any action against its sterilization methods also could cross into federal regulations for medical product sterilization set by the U.S. Food and Drug Administration (FDA).

“… There are no FDA approved alternative sterilization procedures for these products,” Sterigenics wrote. “Thus, to the extent that a State court resolution limits or completely halts the use of ethylene oxidation sterilization, it is effectively halting the flow of certain medical products.

“Even if another sterilization method is employed, these devices would be illegal under federal law and could not be sold in the State. If such a scenario were to occur, the State would be utterly incapable of handling the resulting chaos.”

Neither Madigan’s nor Berlin’s office has yet to respond to Sterigenics’ motion in federal court.

Sterigenics is represented by attorneys with the firm of Sidley Austin LLP, of Chicago.

 

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Circuit Court of Dupage County DuPage County State's Attorney's Office Illinois Attorney General Illinois Environmental Protection Agency Sidley Austin LLP State of Illinois Sterigenics International Sterigenics Willowbrook U.S. District Court for the Northern District of Illinois

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