By Jonathan Bilyk | Nov 29, 2018

Saying plaintiffs are asking the courts to essentially rewrite federal environmental laws and regulatory rules based on a single report issued by a federal agency relying on faulty data, medical device sterilizer Sterigenics has asked a federal judge to corral a stampede of lawsuits that have hit the courts in recent weeks amid a blizzard of media reports asserting the company’s use of a key sterilizing agent at its facility in suburban Willowbrook could cause cancer.

This week, attorneys for Sterigenics filed a brief in the U.S. District Court for the Northern District of Illinois asking a judge to send a group of virtually identical lawsuits to one judge for consideration and proceedings, rather than spread among several different federal district court judges and in state courts in Cook and DuPage counties.

Patrick Salvi | Salvi Schostok Pritchard

The lawsuits have landed in federal court this fall as Sterigenics mounts a reply to the litigation that followed in the wake of news reports centering on the release of a report from the federal Agency for Toxic Substances and Disease Registry, which purported to show an elevated cancer risk for people living around Sterigenics’ Willowbrook facility as a result of the company’s use of a compound known as ethylene oxide (EO).

In court documents, Sterigenics said EO is essential for the sterilization procedures it performs on surgical instruments, such as scalpels, hypodermic needles and other medical tools, as alternative sterilization methods using heat and radiation can weaken the materials and potentially compromise their effectiveness. Sterigenics says 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.

Sterigenices reported its Willowbrook facility sterilizes “1,000 cardiac devices used in heart surgery, 1,000 knee implants, 1,500 surgical procedure kits, 16,000 catheters, 11,000 syringes … and thousands of diabetes monitoring and care kits, renal care products, neurosurgical devices and respiratory care products” each day.

“Without ethylene oxide for sterilization, infection risks would soar dramatically in hospitals and operating rooms,” Sterigenics wrote. “For heat- and irradiation-sensitive devices, no currently available sterilization method exists that has been accepted and approved as a practical replacement for ethylene oxide.”

Following the ATSDR report, dozens of lawsuits have been filed in Cook and DuPage counties by trial lawyers, asserting the company should be made to pay for what they say is decades of emitting EO into the atmosphere in amounts that federal officials said placed the surrounding area at an elevated cancer risk.

Law firms bringing the complaints have included the Chicago firms of Salvi Schostok and Pritchard; Power Rogers & Smith; the Dolan Law Offices; Romanucci & Blandin; and Hart McLaughlin & Eldridge.

The lawsuits all center on the cancer risk reported in the ATSDR’s August report, which relied on air quality data and modeling conducted by the EPA in May.

However, in its court filings, Sterigenics noted representatives of the U.S. Environmental Protection Agency sought to clarify the underlying air quality data that forms the basis of the ATSDR’s report saying its data indicates “the air concentrations of ethylene oxide are not high enough to cause immediate harm to health for the people in and around Willowbrook.” Such risk assessments, EPA officials said, is “based on ‘someone who is continuously exposed to EO for 24 hours per day over 70 years.’”

Sterigenics’ emissions and the ATSDR report became a significant issue in the 2018 elections, as Democrats in particular pounced on the issue, using it to attack Republican incumbents, including Gov. Bruce Rauner and U.S. Rep. Peter Roskam.

Outgoing Illinois Atty. Gen. Lisa Madigan, a Democrat, also joined with Republican DuPage County State’s Attorney Robert Berlin to file a lawsuit asking the state to order Sterigenics’ Willowbrook plant closed.

However, just before Thanksgiving, the U.S. EPA announced the data it supplied the ATSDR was flawed, as it counted a different chemical, identified as trans-2-butene, as EO, elevating the EO count reported to the ATSDR.

The company also released the results of what it called a third-party analysis of air quality in the Chicago area, which shows a significant background presence of EO consistently in the atmosphere from a variety of sources, including some naturally occurring, and all at levels above the exposure risk level identified by the ATSDR.

The company said its test results were  “free of the methodological flaws and interference from other compounds” that had been present in the EPA’s test results and which were relied upon by the ATSDR.

Sterigenics did not reference those new test results in its court filings.

But the company continued to assert the ATSDR report was “flawed,” as the “collected samples” it relied upon “are not a valid representation of ethylene oxide concentrations in Willowbrook.”

While casting aspersions on the report underlying their lawsuits, Sterigenics has also argued the lawsuits further overreach by “fraudulently” naming as defendants an Illinois-based firm, identified as GTCR LLC, an investment capital group which is an owner of Sterigenics and has a “presence on the Sterigenics’  board of directors.”

“There are four companies separating GTCR’s partial and indirect ownership interest from Sterigenics U.S. LLC. Sterigenics, meanwhile, allegedly owns several facilities across different countries, one of which is the Willowbrook facility,” Sterigenics wrote in its filing.

“As is evidenced by this corporate structure, GTCR does not direct or authorize the manner in which Sterigenics U.S., LLC operates, let alone direct or authorize the activities at the Willowbrook.”

The complaints also name two managers at the Sterigenics plant as defendants.

Sterigenics has argued GTCR and the managers were included in the lawsuits simply to allow the plaintiffs to prevent Sterigenics from removing the cases to federal court.

Sterigenics asked the federal judge to “ignore” their presence in the case when determining whether the case should remain in federal court.

Plaintiffs have responded to Sterigenics’ assertions with motions of their own, asking the federal judges hearing their cases to send their cases back to the county courts where they were filed. They have asserted the cases belong in state courts, not federal, as the lawsuits allege charges under state law, not federal.

The lawsuits, for instance, do not assert Sterigenics violated federal environmental or emissions laws. Rather, the lawsuits essentially assert Sterigenics created a public nuisance and health hazard by emitting EO, a state law claim.

Sterigenics, however, argued the lawsuits present a “direct challenge” to acceptable EO levels established under the federal Clean Air Act and “the Illinois EPA’s implementation of those standards.”

“Plaintiffs ask the state court to ignore these uniform federal standards and impose new and different standards” based on the EPA’s report, Sterigenics said.

“Thus, not only do Plaintiffs ask the state court to rewrite a federal regulation, they seek to do that based on a report generated by one federal agency—ATSDR—at the behest of another federal agency—USEPA,” Sterigenics wrote.

In response, in a motion to remand filed Nov. 28, attorney Patrick Salvi, of the Salvi Schostok firm, on behalf of plaintiffs Susan and Ed Kamuda, reiterated assertions the lawsuits only address clean air regulations “tangentially.” Instead, he said, “the causes of action in Plaintiffs’ Complaint, such as negligence, nuisance, trespass, and willful and wanton conduct, are plainly state law and common law claims.”

“The mere fact that Plaintiffs’ injuries were caused via transmission through the air does not necessarily mean that Plaintiffs’ Complaint raises disputed issues of federal law,” Salvi wrote.

However, in its most recent filing on Nov. 26, Sterigenics indicated it intends to seek to remove more cases from county courts and send them to federal court. And from there, Sterigenics would like all of the cases to be reassigned to one judge for one set of proceedings, which it says will help to conserve judicial resources and increase efficiency.

Following a hearing Thursday, that request and the motions to remand remain pending.

Sterigenics is represented in the action by attorneys Maja C. Eaton, Gerard D. Kelly, Elizabeth M. Chiarello, Michael L. Lisak and Stephanie C. Stern, of the firm of Sidley Austin LLP, of Chicago.

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Organizations in this Story

Agency for Toxic Substances and Disease Registry (ATSDR) Dolan Law Offices Hart McLaughlin & Eldridge, LLC Power, Rogers and Smith, PC. Romanucci & Blandin Salvi, Schostok, & Pritchard, PC. Sidley Austin LLP Sterigenics International U.S Environmental Protection Agency

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