in the circuit court of cook county, illinois county …€¦ · 19 l 9179 angie...
TRANSCRIPT
IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS COUNTY DEPARTMENT, LAW DIVISION
Susan Kamuda and Edward Kamuda et al.,
Plaintiffs,
v. Sterigenics U.S., LLC; Sotera Health, LLC; Bob Novak; Roger Clark; and GTCR, LLC;
Defendants.
No. 18 L 10475 Consolidated for discovery with: 18 L 10744 Teresa Fornek; 18 L 11004 Shawn Fornek; 18 L 11252 Anita Govic; 18 L 11939 Heather Schumacher; 19 L 9163 George Vessol; 19 L 9167 Carol Ray; 19 L 9169 Dawn Paganelli; 19 L 9170 Stephanie Lucak; 19 L 9171 Lisa Besch; 19 L 9173 John Lebel; 19 L 9176 Dorothy Beres; 19 L 9177 Judith Hall; 19 L 9178 Patricia Watt; 19 L 9179 Angie Kostopoulos-Andrews; 19 L 9181 Jana Conev; 19 L 9182 Justin Schoenhardt; 19 L 9189 Gerardo Chacin; 19 L 9190 Sandra Allen; 19 L 9196 Arkadiusz Suska; 19 L 9197 Stacey Guido; 19 L 9198 Susan Schemmer; 19 L 9200 Barbara Carkhuff; 19 L 9202 Shirley Ruck; 19 L 9205 Arthur Schmid; 19 L 9206 Denise Baum; 19 L 9207 Jeanne Hochhalter; 19 L 9213 Lee Schramm; 19 L 9214 Susan Pedersen; 19 L 9215 Kristina Janulis; 19 L 9216 Halina Jajic; 19 L 9362 Robert Stafford; 19 L 9454 Gina LaPapa; 19 L 9508 Ivan Harrison III; 19 L 9528 David Gaddis; 19 L 9732 Helen Ramos; 19 L 11510 Sarah Sophie; 19 L 11682 Anne Cahill; 19 L 13486 Loretta Wawak; 19 L 13488 Candace Owens;
FILED4/28/2020 6:06 PMDOROTHY BROWNCIRCUIT CLERKCOOK COUNTY, IL2018L010475
9159317
19 L 13493 Donna DePaolo Engelsman; 19 L 13517 Laura Carbray; 19 L 13518 Janice Bielaga; 19 L 13522 Laura Duran; 19 L 13537 Jan Cheng; 19 L 13538 Ryan Feeney; 19 L 13539 Ada Garro; 19 L 13540 Rose Marth; 19 L 13541 John Chlada; 19 L 13544 LaTangie Young; 19 L 13545 Rajini Mady; 19 L 13546 Nicolas Brinias; 19 L 13550 Virginia Janis; 19 L 13551 Deborah Faulkner; 19 L 13552 Delores Lombardo; 19 L 13554 Cathy Lou Pearson; 19 L 13562 Karen Kostrzewa; 19 L 13568 Phyllis Martin; 19 L 13575 Pam Paziotopoulous; 19 L 13576 Stan Czyzon; 19 L 13857 Arun Ohri; 19 L 13860 Patricia Vanhal; and 19 L 14265 Mary Eskey
Calendar R Judge Christopher E. Lawler
STERIGENICS U.S., LLC’S MEMORANDUM IN SUPPORT OF ITS MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED MASTER COMPLAINT
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TABLE OF CONTENTS Page
FACTUAL BACKGROUND ......................................................................................................... 2
A. EtO Sterilization is a Critical Component of the Healthcare System. .................... 2
B. The Sterigenics U.S. Willowbrook Facility Was Strictly Regulated. ..................... 4
C. Procedural History of Plaintiffs’ Consolidated Claims. ......................................... 5
LEGAL STANDARD ..................................................................................................................... 6
ARGUMENT .................................................................................................................................. 7
I. PLAINTIFFS FAIL TO STATE A CLAIM FOR PUBLIC NUISANCE (COUNT VII), WHICH IS ALSO BARRED UNDER PRINCIPLES OF RES JUDICATA. ..................... 7
A. Plaintiffs’ Public Nuisance Claim Was Already Litigated, and Therefore is Precluded by Res Judicata. ..................................................................................... 7
B. Sterigenics U.S.’s Lawful, Authorized Conduct Cannot Constitute a Public Nuisance. ............................................................................................................... 10
II. PLAINTIFFS FAIL TO STATE A CLAIM FOR CIVIL BATTERY (COUNT VI) BECAUSE THEY DO NOT PLEAD ANY INTENT TO CONTACT OR HARM THE PLAINTIFFS. ................................................................................................................... 13
III. PLAINTIFFS’ STRICT LIABILITY (ULTRAHAZARDOUS/ABNORMALLY DANGEROUS ACTIVITY) CLAIM (COUNT V) FAILS BECAUSE ETO STERILIZATION CAN BE, AND IS, PERFORMED SAFELY. ................................... 16
A. Plaintiffs Incorrectly Focus on Substances, Not Activities. ................................. 17
B. Plaintiffs Concede that Reasonable Care Can Eliminate the Risks, and the Other Restatement Factors Are Not Met......................................................................... 19
IV. PLAINTIFFS’ GENERIC ALLEGATIONS REGARDING STERIGENICS U.S.’s REGULATED AND LAWFUL ETO STERILIZATION OPERATIONS FAIL TO STATE ANY COGNIZABLE NEGLIGENCE CLAIMS (COUNTS I, II, III). .............. 22
A. Plaintiffs Never Articulate the Duty or Standard of Care Sterigenics U.S. Should Have Satisfied to Prevent Plaintiffs’ Alleged Injuries. ......................................... 23
B. Plaintiffs’ Conclusory Breach Allegations are Entirely Unsupported by Any Well-Pled Factual Allegations. ...................................................................................... 25
C. Plaintiffs’ Allegations Are Equally Insufficient to Allege a Claim for Negligent Training or Negligent Supervision Against Sterigenics U.S. ............................... 27
D. Plaintiffs’ Allegations Are Insufficient to Allege a Failure to Warn Claim Against Sterigenics U.S. ..................................................................................................... 28
V. ILLINOIS DOES NOT RECOGNIZE A STANDALONE CLAIM FOR WILLFUL AND WANTON CONDUCT (COUNT IV). ............................................................................. 30
CONCLUSION ............................................................................................................................. 30
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TABLE OF CASES
Page(s)
A & R Janitorial v. Pepper Constr. Co., 2018 IL 123220 ..........................................................................................................................8
Atalig v. Mobil Oil Mariana Islands, Inc., No. 2012-SCC-0006-CIV, 2013 N. Mar. I. LEXIS 11 (D.N. Mar. I. Oct. 2, 2013) ........................................................................................................................................15
Bakes v. St. Alexius Med. Ctr., 2011 Ill. App (1st) 101646 .......................................................................................................13
Blaue v. Kissinger, No. 03 C 9025, 2006 U.S. Dist. LEXIS 55995 (N.D. Ill. July 24, 2006) ................................29
Cadena v. Chicago Fireworks Mfg. Co., 297 Ill. App. 3d 945 (1998) (overruled on other grounds) ......................................................20
Campos v. BP Prod. N. Am., Inc., No. 13 CV 8376, 2014 U.S. Dist. LEXIS 159242 (N.D. Ill. Nov. 12, 2014) ....................19, 30
Cangemi v. Advocate S. Suburban Hosp., 364 Ill. App. 3d 446 (2006) .....................................................................................................25
Carrizales v. Rheem Mfg. Co., 226 Ill. App. 3d 20 (1st Dist. 1991) .........................................................................................28
Chandler v. Ill. Central R.R. Co., 207 Ill. 2d 331 (2003) ................................................................................................................6
Chaveriat v. Williams Pipe Line Co., No. 94 C 0750, 1994 U.S. Dist. Lexis 15082 (N.D. Ill. Oct. 18, 1994) ......................17, 18, 19
In re Chicago Flood Litig., 176 Ill. 2d 179 (1997) ........................................................................................................16, 17
Chicago v. Beretta U.S.A. Corp., 213 Ill. 2d 351 (2004) ..........................................................................................................6, 13
City of Bloomington, Ind. v. Westinghouse Elec. Corp., 891 F.2d 611 (7th Cir. 1989) .............................................................................................17, 18
Cont’l Bldg. Corp. v. Union Oil Co. of Cal., 152 Ill. App. 3d 513 (1st Dist. 1987) .......................................................................................20
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N. Carolina, ex rel. Cooper v. Tenn. Valley Auth., 615 F.3d 291 (4th Cir. 2010) ...................................................................................................12
Copass v. Ill. Power Co., 211 Ill. App. 3d 205 (4th Dist. 1991) .......................................................................................14
Cusumano v. Mapco Gas Prods., No. 90 C 7161, 1994 U.S. Dist. LEXIS 1502 (N.D. Ill. Feb. 11, 1994) ..................................18
Dunlap Lake Prop. Owners Ass’n, Inc. v. Edwardsville, 22 Ill. App. 2d 95 (4th Dist. 1959) ...........................................................................................12
Dvorak v. Primus Corp., 168 Ill. App. 3d 625 (2d Dist. 1988) ........................................................................................24
Evco Assocs., Inc. v. C.J. Saporito Plating Co., No. 93 C 2038, 1993 U.S. Dist. Lexis 12423 (N.D. Ill. Sept. 7, 1993) ...................................18
Flores v. Santiago, 2013 Ill. App. (1st) 122454 .....................................................................................................13
G.J. Leasing Co. v. Union Elec. Co., 854 F. Supp. 539 (S.D. Ill. 1994), aff’d, 54 F.3d 379 (7th Cir. 1995) ...............................18, 19
Ganton Techs., Inc. v. Quadion Corp., 834 F. Supp. 1018 (N.D. Ill. 1993) ..........................................................................................17
Gilmore v. Stanmar, Inc., 261 Ill. App. 3d 651 (1st Dist. 1994) .................................................................................11, 12
Glowacki v. Moldtronics, Inc., 264 Ill. App. 3d 19 (2d Dist. 1994) ....................................................................................13, 14
Great Am. Ins. Co. of N.Y. v. Heneghan Wrecking & Excavating Co., 2015 Ill. App. (1st) 133376 .....................................................................................................17
Gubala v. CVS Pharm., Inc., No. 14 C 9039, 2016 U.S. Dist. LEXIS 32759 (N.D. Ill. Mar. 15, 2016) .................................2
Hager v. Waste Techs. Indus., No. 2000-CO-45, 2002 Ohio App. LEXIS 3558 (Ct. App. June 27, 2002).............................12
Hanson vs. Hyatt Corp, 196 Ill. App. 3d 618, 623 (5th Dist. 1990) ...............................................................................24
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Indiana Harbor Belt R.R. Co. v. Am. Cyanamid Co., 916 F.2d 1174 (7th Cir. 1990) ...........................................................................................18, 19
Jackson v. Callan Publ’g, Inc., 356 Ill. App. 3d 326 (1st Dist. 2005) ...............................................................................8, 9, 10
Jackson v. S. Holland Dodge, Inc., 197 Ill. 2d 39 (2001) ..............................................................................................................6, 9
Keim v. Kalbfleisch, 57 Ill. App. 3d 621 (5th Dist. 1978) ...........................................................................................8
Knox College v. Celotex Corp., 88 Ill. 2d 407 (1981) ..................................................................................................................6
Kopnick v. JL Woode Mgmt. Co., LLC, 2017 Ill. App. (1st) 152054 .......................................................................................................2
Kozak v. Armstrong World Indus., Inc., 213 Ill. App. 3d 1061 (1991) .............................................................................................25, 28
Krywin v. Chicago Transit Auth., 238 Ill. 2d 215 (2010) ..............................................................................................................30
Marshall v. Burger King Corp., 222 Ill. 2d 422 (2006) ..............................................................................................................23
May Dep’t Stores Co. v. Teamsters Union Local No. 743, 64 Ill. 2d 153 (1976) ..................................................................................................................2
McClenathan v. Rhone-Poulenc, Inc., 926 F. Supp. 1272 (S.D.W. Va. 1996) .....................................................................................15
McNerney v. Allamuradov, 2017 Ill. App. (1st) 153515 (2017) .............................................................................27, 28, 29
Miller v. Civil Constructors, 272 Ill. App. 3d 263 .................................................................................................................20
Nelson v. Chicago Park Dist., 408 Ill. App. 3d 53 (1st Dist. 2011) ...........................................................................................8
Norabuena v. Medtronic, Inc., 2017 Ill. App (1st) 162928 .......................................................................................................29
O’Callaghan v. Satherlie, 2015 Ill. App (1st) 142152 .........................................................................................................2
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Pechan v. DynaPro, Inc., 251 Ill. App. 3d 1072 (2d Dist. 1993) ......................................................................................14
Rabel v. Ill. Wesleyan Univ., 161 Ill. App. 3d 348 (4th Dist. 1987) .............................................................................6, 23, 24
Rein v. David A. Noyes & Co., 172 Ill. 2d 325 (1996) ................................................................................................................8
River Park, Inc. v. Highland Park, 184 Ill. 2d 290 (1998) ................................................................................................................9
Scott v. Continental Can Co., 28 Ill. App. 3d 1004 (1st Dist. 1975) .......................................................................................12
Simpkins v. CSX Transp., Inc., 2012 IL 110662 ........................................................................................................................23
Sorkin v. Blackman, Kallick & Co., 184 Ill. App. 3d 873 (1st Dist. 1989) .......................................................................................30
Sparks v. Starks, 367 Ill. App. 3d 834 (1st Dist. 2006) .......................................................................................30
Teter v. Clemens, 112 Ill. 2d 252 (1986) ................................................................................................................7
Vernon Vill., Inc. v. Gottier, 755 F. Supp. 1142 (D. Conn. 1990) .........................................................................................16
Vill. of Pawnee v. Knostman, 115 Ill. App. 3d 842 (Ill. App. Ct. 1983) .................................................................................25
Young v. Bryco Arms, 213 Ill. 2d 433 (2004) ..............................................................................................................11
Ziarko v. Soo Line R.R., 161 Ill. 2d 267 (1994) ..............................................................................................................30
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Pursuant to 735 ILCS 5/2-615 (“Section 2-615”) and 735 ILCS 5/2-619 (“Section 2-
619”), Defendant Sterigenics U.S., LLC (“Sterigenics U.S.”) moves to dismiss all claims against
it—Counts I through VII—in Plaintiffs’ First Amended Master Complaint (“FAMC”).
INTRODUCTION
The core question in this litigation is whether Plaintiffs should be permitted to hold a
company liable in tort for operating as expressly authorized by state and federal agencies, when
Plaintiffs have not identified any standard of care that the company failed to meet. The answer to
that straightforward question is no, and, as such, Plaintiffs’ claims against Sterigenics U.S.
should be dismissed.
Sterigenics U.S. provides a critical service that has become even more important in recent
months—sterilization of critical medical devices and hospital equipment, including wound
dressings, stents, surgical kits, medical gowns, and ventilators—to ensure that they are free from
dangerous and potentially deadly organisms prior to patient and healthcare use. The Sterigenics
U.S. facility in Willowbrook, Illinois employed one of the most common and effective methods
of sterilization available for medical equipment—ethylene oxide (“EtO”) sterilization. For
decades, the Sterigenics U.S. Willowbrook facility sterilized life-saving medical equipment
subject to strict, extensive, and exacting regulatory oversight by numerous federal and state
agencies. Sterigenics U.S. operated the Willowbrook facility in full compliance with the law,
including regulations and a government permit that required Sterigenics U.S. to capture 99
percent of its EtO emissions from the most significant emissions points. See, e.g., 40 C.F.R. Part
63, Subpart O.
Despite both the state and federal governments’ continuous regulation and authorization
of emissions at the Willowbrook facility, Plaintiffs boldly and baldly allege that the facility’s
operations were somehow tortious. Utterly lacking from Plaintiffs’ FAMC, however, is (1) any
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allegation that Sterigenics U.S. did not operate as expressly sanctioned by the federal and Illinois
governments; and (2) any more stringent standard for EtO emissions with which Sterigenics U.S.
allegedly should have—but failed to—comply. Without any explanation as to how Sterigenics
U.S.’s conduct was tortious in spite of federal and state authorization, Plaintiffs cannot hold
Sterigenics U.S. liable for the lawful operation of the Willowbrook facility, including the
regulated and permitted emission of EtO. Hoping to shroud this fatal flaw, Plaintiffs are asking
this Court to substitute Plaintiffs’ misguided, conclusory, and hindsight-aided judgment (which
defines no standard of care, much less an emissions standard) for that of the Illinois
Environmental Protection Agency (“IEPA”) and the U.S. Environmental Protection Agency
(“USEPA”)—two agencies with expertise regulating the industrial use and emission of a
multitude of chemicals, including EtO, and expressly charged with regulating Sterigenics U.S.’s
use and emissions of EtO to protect human health and the environment. For these reasons and
those stated below, Plaintiffs’ claims against Sterigenics U.S. should be dismissed with
prejudice.
FACTUAL BACKGROUND
A. EtO Sterilization is a Critical Component of the Healthcare System.
Sterilization of medical devices is a critical part of our healthcare system, necessary to
prevent potentially deadly infections.1 Sterigenics U.S. plays a critical role in these life-saving
1 Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility, U.S. FOOD AND DRUG ADMINISTRATION (March 26, 2019), https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-steps-agency-taking-prevent-potential-medical-device. See O’Callaghan v. Satherlie, 2015 Ill. App. (1st) 142152, ¶ 18 (in considering a 2-615 motion to dismiss, the court can consider “matters of which the court is entitled to take judicial notice”) (internal citation omitted). This Court may take judicial notice of the U.S. Food and Drug Administration (“FDA”) website, as well as other government sources cited hereafter, because they are “capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Ill. R. Evid. 201(b); Kopnick v. JL Woode Mgmt. Co., LLC, 2017 Ill. App. (1st) 152054, ¶ 26 (taking judicial notice of municipality’s public website); Gubala v. CVS Pharm., Inc., No. 14 C 9039, 2016 U.S. Dist. LEXIS 32759, at *18, n.10 (N.D. Ill. Mar. 15, 2016) (taking judicial notice of government agency website). The Court may also take judicial notice of court records cited hereafter, as they are
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efforts by providing contract EtO sterilization services for medical device and equipment
manufacturers. EtO is a gas that is used to safely sterilize a wide range of medical devices and
equipment, including wound dressings, stents, surgical kits, masks, medical gowns, and
ventilators. According to the FDA, EtO sterilization “is a well-established and scientifically-
proven method of preventing harmful microorganisms from reproducing and transmitting
infections”2 and is used to sterilize more than 20 billion devices sold in the U.S. every year,
representing half of all medical devices that require sterilization.3 Indeed, EtO is the only
acceptable sterilization method for many delicate, complex, and sophisticated medical devices.4
In short, EtO sterilization “is critical to our health care system and to the continued availability
of safe, effective and high-quality medical devices.”5 The Sterigenics U.S. Willowbrook facility
played a vital role in this effort by performing necessary EtO sterilization of 594 different types
of medical devices, including respiratory care products, surgical kits, catheters, and syringes.6
public documents. See May Dep’t Stores Co. v. Teamsters Union Local No. 743, 64 Ill. 2d 153, 159 (1976). At the Court’s request, Sterigenics U.S. can provide courtesy copies of the cited documents for which it seeks judicial notice. 2 Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility, U.S. FOOD AND DRUG ADMINISTRATION (March 26, 2019), https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-steps-agency-taking-prevent-potential-medical-device.
3 Statement from Acting FDA Commissioner Ned Sharpless, M.D., on concerns with medical device availability due to certain sterilization facility closures, U.S. FOOD AND DRUG ADMINISTRATION (Oct. 25, 2019), https://www.prnewswire.com/news-releases/statement-from-acting-fda-commissioner-ned-sharpless-md-on-concerns-with-medical-device-availability-due-to-certain-sterilization-facility-closures-300945652.html.
4 Id. (referencing surgical kits used in emergency procedures such as emergency C-sections, feeding tube devices used in neonatal intensive care units, cardiac stents, catheters, shunts, and other implantable devices).
5 Supra n.2.
6 Supra n.1.
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B. The Sterigenics U.S. Willowbrook Facility Was Strictly Regulated.
Sterigenics U.S.’s use and emission of EtO was strictly regulated by several federal and
state agencies. As the Illinois Attorney General and DuPage County State’s Attorney both
affirmed, “[t]here is no uncertainty about the fact that for years Sterigenics has operated in
compliance with federal standards.” People of the State of Illinois et al. v. Sterigenics U.S., LLC,
No. 2018 CH 001329 (18th Jud. Cir. Aug. 30, 2019) (Plaintiff’s Response to Villages’
Comments on Consent Order). The USEPA regulates EtO emissions from sterilization facilities
under the federal Clean Air Act, and, pursuant to National Emissions Standards for Hazardous
Air Pollutants (“NESHAP”), requires at least a 99 percent reduction in EtO emissions from the
most significant emission points in a sterilization facility. The Illinois Environmental Protection
Act incorporates NESHAP into state law. 415 ILCS 5/9.1(b).
Federal and state law required Sterigenics U.S. to apply for and obtain permits to ensure
that operations at the Willowbrook facility complied with all federal and state environmental
requirements, including but not limited to NESHAP. 42 U.S.C. § 7661a(a). More specifically,
the IEPA administers this permitting program in Illinois under the Clean Air Act Permit Program
(“CAAPP”). 415 ILCS 5/39.5; see also Illinois Air Plan Approval, 66 Fed. Reg. 62946 (Dec. 4,
2001). IEPA will only issue a CAAPP permit if it determines that the facility complies with all
substantive environmental rules. IEPA also requires the facility to report its emissions annually
to the state. 35 Ill. Admin. Code Part 254. IEPA has continuously issued CAAPP permits for the
Willowbrook facility since the CAAPP program was implemented, and before that, IEPA issued
operating permits for the Willowbrook facility, which also contained various operating
parameters. Most recently, IEPA issued a CAAPP permit to Sterigenics U.S. for the
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Willowbrook facility in 2015, which remains in effect.7 The CAAPP permit includes the EtO-
specific requirements from NESHAP, and it sets limits on precisely how much EtO the facility
may use annually and how much EtO may be emitted.
Sterigenics U.S. is also regulated by the federal Occupational Safety and Health
Administration (“OSHA”), which establishes allowable EtO exposure levels for occupational
health and safety, and the FDA, which reviews medical device premarket submissions to ensure
that sterility procedures and results comply with FDA standards. As part of its review, the FDA
inspects industrial facilities that sterilize medical devices to confirm that validated sterilization
processes meet FDA standards.
Plaintiffs do not allege that Sterigenics U.S.’s operations at the Willowbrook facility ever
failed to meet IEPA, USEPA, OSHA, or FDA standards, choosing instead to wholly ignore these
regulations, requirements, and rules, despite their direct applicability to Plaintiffs’ claims.
C. Procedural History of Plaintiffs’ Consolidated Claims.
Prompted by a report released by the Agency for Toxic Substances and Disease Registry
(“ATSDR”) on August 21, 2018, Plaintiffs’ first complaints were filed in the Circuit Court of
Cook County on September 26, 2018 against Sterigenics U.S., a private equity firm (GTCR
LLC), and two Sterigenics U.S. employees, alleging various health problems as a result of
alleged exposure to EtO emissions from the Willowbrook facility. All cases were subsequently
consolidated before Judge Lawler as Kamuda, et al. v. Sterigenics U.S., LLC, et al., No. 2018 L
010475 for pretrial and discovery purposes. On October 24, 2019, Plaintiffs filed a Master
Complaint adding Sotera Health LLC—the sole member (parent) of Sterigenics U.S.—as an
7 A copy of Sterigenics U.S.’s CAAPP permit is available at IEPA’s website. See June 8, 2015 CAAPP Permit No. 95120085, available at https://www2.illinois.gov/epa/topics/community-relations/sites/sterigenics/Documents/Sterigenics%20CAAPP%20Permit.pdf. This permit remains in effect even though Sterigenics U.S. announced on September 30, 2019 that it would exit its EtO sterilization operations in Willowbrook.
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additional defendant. On November 22, 2019, Defendants filed motions to dismiss. In lieu of
responding to the motions to dismiss, Plaintiffs filed their FAMC on January 31, 2020.
LEGAL STANDARD
A motion to dismiss “under Section 2-615 of the Code (735 ILCS 5/2-615) challenges the
legal sufficiency of the complaint by alleging defects on its face.” Chicago v. Beretta U.S.A.
Corp., 213 Ill. 2d 351, 364 (2004). “Because Illinois is a fact-pleading jurisdiction, a pleading
must be both legally and factually sufficient.” Chandler v. Ill. Central R.R. Co., 207 Ill. 2d 331,
348 (2003). “It must assert a legally recognized cause of action and it must plead facts which
bring the particular case within that cause of action.” Id. (emphasis added). See also Rabel v. Ill.
Wesleyan Univ., 161 Ill. App. 3d 348, 354 (4th Dist. 1987) (“a complaint must allege facts
which, when considered together, establish the cause of action which the plaintiff seeks to
state”). Based on this “heavier burden on the plaintiff, . . . a complaint that would survive a
motion to dismiss in a notice-pleading jurisdiction might not do so in a fact-pleading
jurisdiction.” Beretta, 213 Ill. 2d at 368.
Moreover, “mere conclusions of law, argumentative matter, or conclusions of fact
unsupported by allegations of specific facts upon which such conclusions rest, are irrelevant and
must be disregarded by the trial court in ruling on a motion to dismiss” under Section 2-615.
Rabel, 161 Ill. App. 3d at 354. See also Beretta, 213 Ill. 2d at 368 (in considering a motion to
dismiss, “a court must disregard the conclusions that are pleaded and look only to well-pleaded
facts to determine whether they are sufficient to state a cause of action against the defendant. If
not, the motion must be granted ‘regardless of how many conclusions the count may contain and
regardless of whether or not they inform the defendant in a general way of the nature of the claim
against him.’”) (quoting Knox College v. Celotex Corp., 88 Ill. 2d 407, 426 (1981)); Jackson v. S.
Holland Dodge, Inc., 197 Ill. 2d 39, 52 (2001) (“In opposing a motion for dismissal under
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section 2-615 of the Code of Civil Procedure, a plaintiff cannot rely simply on mere conclusions
of law or fact unsupported by specific factual allegations.”); Teter v. Clemens, 112 Ill. 2d 252,
256 (1986) (“[o]nly well-pleaded facts are admitted by a motion to dismiss”) (emphasis added).
Section 2-619(a) of the Code provides for involuntary dismissal based upon certain
defects or defenses, including if “the cause of action is barred by a prior judgment.” 735 ILCS
5/2-619(a)(4). In considering a Section 2-619 motion to dismiss, the court may look outside a
complaint and consider other facts or legal bases that defeat the cause of action. 735 ILCS 5/2-
619.
ARGUMENT
I. PLAINTIFFS FAIL TO STATE A CLAIM FOR PUBLIC NUISANCE (COUNT VII), WHICH IS ALSO BARRED UNDER PRINCIPLES OF RES JUDICATA.
Plaintiffs’ public nuisance claim fails because: (1) it has been litigated in a prior action
and therefore should be dismissed pursuant to principles of res judicata and Section 2-619(a)(4);
and (2) Plaintiffs fail to allege that Sterigenics U.S.’s conduct, which was strictly regulated and
expressly authorized at both the state and federal levels, nonetheless constituted a public
nuisance, requiring dismissal pursuant to Section 2-615.
A. Plaintiffs’ Public Nuisance Claim Was Already Litigated, and Therefore is Precluded by Res Judicata.8
On October 30, 2018, the People of the State of Illinois ex rel. Attorney General of the
State of Illinois and ex rel. State’s Attorney for DuPage County, Illinois filed a complaint against
Sterigenics U.S. asserting public nuisance based on the allegedly carcinogenic emission of EtO
from the Willowbrook facility. DuPage County Circuit Court, Case No. 2018 CH 001329 (the
8 In support of its arguments under Section 2-619, Sterigenics U.S. submits the Affidavit of Attorney Jana D. Wozniak (“Wozniak Aff.”), filed concurrently at Tab 1. Attached to the Wozniak Affidavit as Exs. A to E thereto are true and correct copies of certain court filings from the State of Illinois case.
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“State of Illinois case”).9 On September 12, 2019, Judge Fullerton dismissed the State of Illinois
case with prejudice pursuant to a September 6, 2019 Consent Order.10
“The doctrine of res judicata provides that a final judgment on the merits rendered by a
court of competent jurisdiction bars any subsequent actions between the same parties or their
privies on the same cause of action.” Rein v. David A. Noyes & Co., 172 Ill. 2d 325, 334 (1996).
Res judicata bars claims that were actually decided as well as those that were not, but could have
been. A & R Janitorial v. Pepper Constr. Co., 2018 IL 123220, ¶ 16. “For res judicata to apply,
three requirements must be met: (1) a final judgment on the merits rendered by a court of
competent jurisdiction, (2) an identity of cause of action, and (3) an identity of parties or their
privies.” Id. All three requirements are met here.
Final Judgment. Judge Fullerton’s order dismissing the State of Illinois case constitutes
a final judgment on the merits. “There is no question that an order dismissing a complaint with
prejudice is a final, appealable order,” id. at ¶ 17, including when dismissal is a result of a
settlement, Nelson v. Chicago Park Dist., 408 Ill. App. 3d 53, 61 (1st Dist. 2011) (order
dismissing case with prejudice pursuant to a settlement “was a final judgment on the merits that
satisfied the first element of res judicata”). See also Keim v. Kalbfleisch, 57 Ill. App. 3d 621, 624
(5th Dist. 1978) (dismissal pursuant to a court-approved settlement is “as conclusive of the rights
of the parties as if the suit had been prosecuted to a final adjudication adverse to the plaintiff”);
Jackson v. Callan Publ’g, Inc., 356 Ill. App. 3d 326, 340 (1st Dist. 2005) (“The modern view
9 Original Complaint ¶ 33, State of Illinois case (Ex. A to Wozniak Aff.). The State of Illinois filed an amended complaint on June 6, 2019, which continued to assert public nuisance based on the EtO emissions from the Sterigenics U.S. Willowbrook facility. See Amended Complaint, pp. 18–19, ¶¶ 61–64 (Ex. B to Wozniak Aff.).
10 September 12, 2019 Order, State of Illinois case (Ex. C to Wozniak Aff.).
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generally recognizes that a valid consent judgment is entitled to a res judicata effect, so as to
preclude relitigation of the same claim or cause of action as was covered by such judgment.”).
Identity of Cause of Action. Under the transactional test adopted by the Illinois Supreme
Court to determine identity of causes of action for res judicata purposes, “the assertion of
different kinds or theories of relief still constitutes a single cause of action if a single group of
operative facts give rise to the assertion of relief.” River Park, Inc. v. Highland Park, 184 Ill. 2d
290, 307 (1998).
Here, both the State of Illinois and Plaintiffs brought lawsuits against Sterigenics U.S.
following and in response to the release of the report by ATSDR. Compare Wozniak Aff. at Ex.
B at ¶¶ 41–46 with FAMC ¶¶ 4, 11. Both the State of Illinois and Plaintiffs support their public
nuisance claim by referencing Article XI of the Illinois Constitution. Compare Wozniak Aff. at
Ex. B at ¶ 59, p. 18 with FAMC ¶ 161. Both the State of Illinois and Plaintiffs allege that EtO
emissions from the Willowbrook facility caused an unreasonable and substantial interference
with a public right. Compare Wozniak Aff. at Ex. B at pp. 18–19, ¶ 62 with FAMC ¶ 162. And
both the State of Illinois and Plaintiffs allege injury based on the assertion that members of the
community were exposed to EtO, an alleged carcinogen. Compare Wozniak Aff. at Ex. B at pp.
18–19, ¶ 62 with FAMC ¶¶ 161, 164. Because the public nuisance claims of both the State of
Illinois and Plaintiffs are predicated on the same Sterigenics U.S. conduct and the same cause of
action, the identity of cause of action requirement for res judicata is satisfied.
Identity of Parties or Privies. Sterigenics U.S. is a named defendant in both the State of
Illinois case and the FAMC, so identity of parties is met as to the defendant. As to the plaintiffs,
“privity may exist where a person is so identified in interest with another that he represents the
same legal right.” Jackson, 356 Ill. App. 3d at 340–41. When addressing privity in Jackson, the
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court held that “[a]lthough plaintiffs were not parties to the settlement agreements in the AG
action . . . plaintiffs’ interests were presumptively represented by the Attorney General.” Id. at
341. Similarly, although Plaintiffs here were not named parties to the State of Illinois’s lawsuit,
their interests were represented by the State of Illinois, which brought its public nuisance count
“pursuant to the power of the Attorney General and State’s Attorney to institute an action on
behalf of the People of the State of Illinois.” See Wozniak Aff. at Ex. B at p. 18, ¶ 61.
In addition to being represented by the Illinois Attorney General, Plaintiffs’ interests
were also represented by the specific villages and cities where their alleged injuries occurred.
The Village of Willowbrook, the City of Darien, the Village of Burr Ridge, and the Village of
Hinsdale (collectively, “Intervenors”) were permitted to intervene in the case to represent their
respective constituents.11 The Intervenors commented on the proposed settlement, providing
their analysis as representatives of the Plaintiffs’ communities.12
Because all three requirements of res judicata are met, Plaintiffs’ public nuisance claim
should be dismissed pursuant to Section 2-619(a)(4).
B. Sterigenics U.S.’s Lawful, Authorized Conduct Cannot Constitute a Public Nuisance.
Plaintiffs seek to hold Sterigenics U.S. liable for the very activity authorized by
Sterigenics U.S.’s permit from IEPA—the “use and emission of EtO from the [Willowbrook]
Facility.” FAMC ¶ 112.13 As a general rule, however, conduct that is expressly authorized by the
11 July 24, 2019 Order, State of Illinois case (Wozniak Aff. at Ex. D).
12 Intervenors’ Comments to Consent Order, id. (Wozniak Aff. at Ex. E).
13 See June 8, 2015 CAAPP Permit No. 95120085 at 1 (“This permit is hereby granted to [Sterigenics U.S., LLC] authorizing operation in accordance with this CAAPP permit.”), available at https://www2.illinois.gov/epa/topics/community-relations/sites/sterigenics/Documents/Sterigenics%20CAAPP%20Permit.pdf; see also CAAPP Permit at 19 (“[M]onthly usage of propylene oxide and ethylene oxide shall not exceed 2,800 lbs and 70,000 lbs respectively.”).
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government cannot be subject to a public nuisance claim. See REST. (2D) TORTS § 821B cmt. f.
Under Illinois law, “when a commercial enterprise is highly regulated by state or federal law”—
as the Sterigenics U.S. Willowbrook facility was—“the operators of the enterprise may not be
held liable in public nuisance for a resulting interference with a public right unless: (1) the
defendant’s conduct is not in compliance with the law; (2) the defendant was otherwise
negligent; or (3) the law permitting the conduct is itself invalid for allowing a nuisance.” Young
v. Bryco Arms, 213 Ill. 2d 433, 443–44 (2004) (emphasis added). Plaintiffs do not allege that
Sterigenics U.S. failed to comply with any rule or regulation; nor do they challenge the statutory
and regulatory schemes that govern EtO use and emissions. Thus, the only theory on which
Plaintiffs could even attempt to proceed is that Sterigenics U.S. was “otherwise negligent.”
In order to fit into the “otherwise negligent” exception, Plaintiffs cannot simply allege
negligence based on a standard of ordinary care. Holding otherwise would allow the “otherwise
negligent” exception to completely swallow the general rule that “conduct that is fully
authorized by statute, ordinance or administrative regulation does not subject the actor to tort
liability,” REST. (2D) TORTS § 821B cmt. f. In order to fit within the “otherwise negligent”
exception, a plaintiff must allege a standard of care based on other authorities, and that other
standard must also be specifically linked to the alleged public nuisance itself. Gilmore v.
Stanmar, Inc., 261 Ill. App. 3d 651, 660–61 (1st Dist. 1994). Only one Illinois court has
permitted Plaintiffs to proceed down this narrow path. In Gilmore, the court concluded that
defendant’s permit did not “automatically destroy” the plaintiffs’ common law nuisance claim,
because other authorities (a statute and common law) established a separate standard of care.
261 Ill. App. 3d at 660–61. Here, in contrast, Plaintiffs do not point to any other authority
establishing a separate standard of care.
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Additionally, the regulations and authorizations in this case are much more specific and
extensive than in Gilmore, where the “permit” at issue was a form allowing canopy placement
and construction. Id. at 654. In contrast to the “form” in Gilmore, the Sterigenics U.S.
Willowbrook facility was governed by numerous exacting environmental authorizations
generated by agencies with extensive technical expertise. These authorizations governed every
aspect of how the Sterigenics U.S. Willowbrook facility controlled EtO emissions, from
mandating certain pollution control equipment testing requirements, to setting record retention
requirements, to limiting both the amount of EtO that could be used and the amount of EtO
emissions the facility was required to capture.14
Courts routinely refuse to supplant specific and exacting standards—like the ones
governing the Sterigenics U.S. Willowbrook facility—with the general and ill-defined public
nuisance tort. See, e.g., Scott v. Continental Can Co., 28 Ill. App. 3d 1004, 1005, 1007 (1st Dist.
1975) (dismissing public nuisance claim because it was undisputed that defendant “had been
issued a permit and was in compliance with the limitations of the Pollution Control Board and
with the provisions of the Environmental Protection Act” and “once regulations are adopted that
apply to the subject air emissions, the applicable regulations become the sole standard against
which the emissions are measured”); Dunlap Lake Prop. Owners Ass’n, Inc. v. Edwardsville, 22
Ill. App. 2d 95, 99 (4th Dist. 1959) (control and abatement of water pollution as a public
nuisance is generally “best left to the specialized agency therewith concerned”).15 To hold
14 Id., generally.
15 Courts in other jurisdictions have reached the same conclusion. See N. Carolina, ex rel. Cooper v. Tenn. Valley Auth., 615 F.3d 291, 309 (4th Cir. 2010) (“‘[c]ourts traditionally have been reluctant to enjoin as a public nuisance activities which have been considered and specifically authorized by the government’”—“especially . . . ‘where the conduct sought to be enjoined implicates the technically complex area of environmental law’”) (internal citations omitted); Hager v. Waste Techs. Indus., No. 2000-CO-45, 2002 Ohio App. LEXIS 3558, at *29 (Ct. App. June 27,
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otherwise would make all companies with authorized emissions subject to liability for public
nuisance and, in the case of EtO emissions, risk the shut-down of a lawful, compliant
sterilization process vital to our healthcare system. Such an enormous change in the law
governing a “highly regulated industry must be the work of the legislature, brought about by the
political process, not the work of the courts.” Beretta, 213 Ill. 2d at 432.
Sterigenics U.S. operated the Willowbrook facility in accordance with express regulatory
requirements regarding EtO use and emissions—the very same use and emissions that Plaintiffs
now attempt to label a public nuisance. The State’s specific authorization of Sterigenics U.S.’s
EtO operations and emission controls—not general public nuisance law—establishes the
standard of care by which Sterigenics U.S.’s operations and emissions must be assessed. Because
Sterigenics U.S. has complied with regulations, Plaintiffs’ attempt to use this Court to conjure
entirely new EtO standards under the guise of public nuisance common law must fail.
II. PLAINTIFFS FAIL TO STATE A CLAIM FOR CIVIL BATTERY (COUNT VI) BECAUSE THEY DO NOT PLEAD ANY INTENT TO CONTACT OR HARM THE PLAINTIFFS.
To maintain a civil battery claim, Plaintiffs must adequately allege that Sterigenics U.S.
“(a) [ ] act[ed] intending to cause a harmful or offensive contact with the person . . . or an
imminent apprehension of such contact, and (b) a harmful [or offensive] contact with the person
of the other directly or indirectly result[ed].” Flores v. Santiago, 2013 Ill. App. (1st) 122454, ¶
14; see also Bakes v. St. Alexius Med. Ctr., 2011 Ill. App. (1st) 101646, ¶ 22 (same), citing
REST. (2D) TORTS § 13. Because Plaintiffs do not allege that Sterigenics U.S. committed an
unlawful act, Sterigenics U.S.’s intent is “material” to the viability of this claim. Glowacki v.
2002) (“[s]ince [defendant’s] waste incineration facility operates under sanction of law, based on that fact alone, it cannot be a common law public nuisance”).
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Moldtronics, Inc., 264 Ill. App. 3d 19, 22 (2d Dist. 1994) (where “the party inflicting the injury
is not doing an unlawful act, the intent to harm is material”).
Plaintiffs’ battery claim is deficient in at least three important respects: First, Plaintiffs do
not allege that Sterigenics U.S. specifically intended to bring EtO into contact with them.
Instead, Plaintiffs allege that Sterigenics U.S. “intended to emit EtO into the air despite its
knowledge that it would contact” those in the area generally. FAMC ¶ 156 (emphasis added).
Notably absent is any specific, factual support for Plaintiffs’ conclusion that Sterigenics U.S.
knew EtO would contact the Plaintiffs in this lawsuit, let alone that Sterigenics U.S. specifically
intended that it do so. EtO sterilization, and the emissions inherent therewith, is a permitted
activity and not a battery because Sterigenics U.S. did not and does not sterilize medical
equipment with EtO with any intent whatsoever to bring EtO into contact with community
members. See Pechan v. DynaPro, Inc., 251 Ill. App. 3d 1072, 1085 (2d Dist. 1993) (“As of this
day and time, smoking remains a permitted activity in our society, although its glory days are
waning. Smoking is a legal activity and not an act of battery because, generally, smokers do not
smoke cigarettes with the intent to touch nonsmokers with secondhand smoke.”).
Second, Plaintiffs fail to allege that Sterigenics U.S. specifically intended to harm them.
Plaintiffs’ vague generalization that Sterigenics U.S. “knew” of the alleged dangers associated
with EtO falls far short of a legally sufficient allegation that Sterigenics U.S. intended to harm
Plaintiffs. FAMC ¶ 153. This deficiency defeats their battery claim. See, e.g., Glowacki, 264 Ill.
App. 3d at 22–23 (affirming lower court’s decision to dismiss plaintiff’s battery claim for
absence of “support for the conclusion that defendants specifically intended to injure plaintiff”);
Copass v. Ill. Power Co., 211 Ill. App. 3d 205, 212–13 (4th Dist. 1991) (battery requires
“specific-intent-to-injure” rather than the lower standard of “substantial certainty that injury
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w[ill] result”). Further, Plaintiffs’ allegation that Sterigenics U.S. “specifically intended” to harm
them cannot be squared with the regulations and permits that required Sterigenics U.S. to capture
99 percent of its emissions from the most significant emissions points. Not only did Sterigenics
U.S. comply with EtO use and emissions requirements, it actually captured (and thereby
prevented the emission of) more EtO than was required under its permit—an action inconsistent
with an intent to harm Plaintiffs.16 Because EtO use and emission levels for Sterigenics U.S.’s
Willowbrook facility were regulated by the government, Plaintiffs’ battery claim essentially
alleges that the government itself, through its regulations and permits, intended to harm
Plaintiffs. Such logical inconsistencies demonstrate the legal insufficiency of Plaintiffs’ battery
claim.
Third, Plaintiffs’ civil battery claim is based solely on allegations of discharge of
regulated and permitted EtO emissions from the Sterigenics U.S. Willowrook facility into the air;
however, this expansion of battery to cover any company that emits or discharges has no
support in Illinois law and has been expressly rejected by other courts. See, e.g., Atalig v.
Mobil Oil Mariana Islands, Inc., No. 2012-SCC-0006-CIV, 2013 N. Mar. I. LEXIS 11, at *34
(D.N. Mar. I. Oct. 2, 2013) (“we conclude that a claim for civil battery cannot lie in the
intentional discharge of harmful substances at a particular individual, group, or entity”);
McClenathan v. Rhone-Poulenc, Inc., 926 F. Supp. 1272, 1276 n.5 (S.D.W. Va. 1996) (“The
Court is not prepared to extend the contours of [battery] to hold the mere presence and resultant
inhalation of chemicals in the air constitutes a ‘harmful or offensive contact’ by the emitter.”);
16 See, e.g., Report of Air Pollution Source Testing of an Ethylene Oxide Emission-Control System Operated by Sterigenics, US, LLC in Willowbrook, Illinois on September 21, 2018, ECSI, Inc. (Oct. 30, 2018) (“The AAT Safe Cell System demonstrated an EtO control efficiency of greater than 99.61 percent. In accordance with various state and federal requirements, this control equipment must have an EtO control efficiency of 99 percent or more.”). A copy of this report is available at IEPA’s website. Available at https://www2.illinois.gov/epa/topics/community-relations/sites/sterigenics/Documents/WBI%20rev1.pdf.
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Vernon Vill., Inc. v. Gottier, 755 F. Supp. 1142, 1156 (D. Conn. 1990) (dismissing battery claim
because “[e]ven if the presence of contaminants in plaintiff’s drinking water could be
characterized as a ‘harmful contact,’ there is no evidence to suggest that defendants intended to
cause this harmful or offensive contact”). Plaintiffs fail to state a claim for civil battery against
Sterigenics U.S. (Count VI) and the claim should be dismissed pursuant to Section 2-615.
III. PLAINTIFFS’ STRICT LIABILITY (ULTRAHAZARDOUS/ABNORMALLY DANGEROUS ACTIVITY) CLAIM (COUNT V) FAILS BECAUSE ETO STERILIZATION CAN BE, AND IS, PERFORMED SAFELY.
Sterigenics U.S.’s permitted use of EtO to sterilize life-saving medical equipment—and
the resulting regulated and permitted EtO emissions from its Willowbrook facility—was not an
ultrahazardous activity.17 Illinois law recognizes the general principle in Section 519 of the
RESTATEMENT (SECOND) OF TORTS that “a defendant who performs an abnormally dangerous or
ultrahazardous activity . . . is subject to liability for harm . . . resulting from the activity, although
the defendant has exercised the utmost care to prevent the harm.” In re Chicago Flood Litig., 176
Ill. 2d 179, 208 (1997). In determining whether an activity is “ultrahazardous,” Illinois courts
consider six factors set forth in Section 520 of the RESTATEMENT (SECOND) OF TORTS:
(a) existence of a high degree of risk of some harm to the person, land or chattels of others; (b) likelihood that the harm that results from it will be great; (c) inability to eliminate the risk by the exercise of reasonable care; (d) extent to which the activity is not a matter of common usage; (e) inappropriateness of the activity to the place where it is carried on; and (f) extent to which its value to the community is outweighed by its dangerous attributes.
In re Chicago Flood Litig., 176 Ill. 2d at 208–09.
While no single factor alone is sufficient to establish an activity is ultrahazardous,
“[u]ltrahazardous activities” are those that are inherently dangerous at all times and cannot be
17 Whether an activity is ultrahazardous and subject to strict liability is a matter of law to be determined by the court. See, e.g., In re Chicago Flood Litig., 176 Ill. 2d 179, 210 (1997).
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rendered safe even with the exercise of care.18 Id. at 208–09. Illinois courts rarely designate
activities as ultrahazardous and routinely decline to extend strict liability to objectively
dangerous activities. See City of Bloomington, Ind. v. Westinghouse Elec. Corp., 891 F.2d 611,
617 (7th Cir. 1989) (manufacture of polychlorinated biphenyls)19; Ganton Techs., Inc. v.
Quadion Corp., 834 F. Supp. 1018, 1020 (N.D. Ill. 1993) (chemical cleanup activities); In re
Chicago Flood, 176 Ill. 2d at 212 (pile driving); Great Am. Ins. Co. of N.Y. v. Heneghan
Wrecking & Excavating Co., 2015 Ill. App. (1st) 133376, ¶ 13 (building demolition). “Whether
an activity is abnormally dangerous presents a question of law in Illinois,” Chaveriat v. Williams
Pipe Line Co., No. 94 C 0750, 1994 U.S. Dist. Lexis 15082, at *14 (N.D. Ill. Oct. 18, 1994), and
“[t]he burden of coming forward with facts sufficient to support a theory of abnormally
dangerous activity rests with the plaintiffs,” id. at *17 (dismissing count for strict liability
brought under abnormally dangerous activity theory).
Here, the relevant question is whether Plaintiffs have alleged sufficient facts to
demonstrate that the highly regulated activity of EtO sterilization at the Sterigenics U.S.
Willowbrook facility—not the use and emission of EtO itself—should be deemed
ultrahazardous. They have not, and the claim should be dismissed pursuant to Section 2-615.
A. Plaintiffs Incorrectly Focus on Substances, Not Activities.
Plaintiffs allege that Sterigenics U.S.’s “use and emission of EtO from the facilities
constitutes an ultra-hazardous activity.” FAMC ¶ 146. In Illinois, however, strict liability
attaches only to abnormally dangerous activities, not abnormally dangerous substances used in
18 The terms “abnormally dangerous” and “ultrahazardous” are used interchangeably by Illinois courts when discussing strict liability. See, e.g., In re Chicago Flood Litig., 176 Ill. 2d 179, 207–09 (1997).
19 This case was decided under Indiana law. However, the court acknowledged that “there is no indication that Indiana law differs” from Illinois law on this issue. Bloomington, 891 F.2d at 616.
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those activities. See G.J. Leasing Co. v. Union Elec. Co., 854 F. Supp. 539, 568 (S.D. Ill.
1994), aff’d, 54 F.3d 379 (7th Cir. 1995); see also Indiana Harbor Belt R.R. Co. v. Am.
Cyanamid Co., 916 F.2d 1174, 1181 (7th Cir. 1990) (applying Illinois law and finding that
“plaintiff overlooks the fact that ultrahazardousness or abnormal dangerousness is, in the
contemplation of the law at least, a property not of substances, but of activities”). “[I]f the rule
were otherwise, virtually any commercial activity involving substances that are dangerous in the
abstract automatically would be deemed as abnormally dangerous. This result would be
intolerable.” G.J. Leasing, 854 F. Supp. at 568 (quoting Bloomington, 891 F.2d at 616).
Sterigenics U.S. is in the EtO sterilization business, not the business of emitting EtO. See
id. at *12–13 (inappropriate to focus on actions taken “as a result of defendant’s operation”).
Thus, the relevant activity in question is EtO sterilization. See Cusumano v. Mapco Gas Prods.,
No. 90 C 7161, 1994 U.S. Dist. LEXIS 1502, at *3 (N.D. Ill. Feb. 11, 1994) (plaintiff’s assertion
“that the activity in question here is the transportation, installation and release of LP gas into an
enclosed space” misidentified the relevant activity because the defendant was “not in the
business of releasing LP gas into enclosed spaces; it is in the business of selling LP gas”). When
viewed through the lens of sterilization activity rather than the chemical substances used, the
FAMC does not contain any allegation that the operation of an EtO sterilization facility is
ultrahazardous. This deficiency alone warrants dismissal of Plaintiffs’ ultrahzardous activity
claim. See Evco Assocs., Inc. v. C.J. Saporito Plating Co., No. 93 C 2038, 1993 U.S. Dist. Lexis
12423, at *13 (N.D. Ill. Sept. 7, 1993) (dismissing plaintiff’s ultrahazardous activity claim
because the complaint only contained allegations regarding defendant’s “use and handling of
plating materials” and did not contain factual allegations regarding electroplating, the actual
relevant activity).
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B. Plaintiffs Concede that Reasonable Care Can Eliminate the Risks, and the Other Restatement Factors Are Not Met.
As the Seventh Circuit explained in the seminal case applying Illinois’ doctrine of strict
liability for ultrahazardous activity, “[t]he baseline common law regime of tort liability is
negligence. When it is a workable regime, because the hazards of an activity can be avoided by
being careful (which is to say, nonnegligent), there is no need to switch to strict liability.”
Indiana Harbor, 916 F.2d at 1177. In other words, where the “activity can be made safer by the
exercise of care,” strict liability does not apply. Campos v. BP Prod. N. Am., Inc., No. 13 CV
8376, 2014 U.S. Dist. LEXIS 159242, at *27 (N.D. Ill. Nov. 12, 2014). Illinois courts frequently
consider the existence of applicable regulations in analyzing whether an allegedly ultrahazardous
activity may be made safe by due care. See Indiana Harbor, 916 F.2d at 1183 (describing
regulations as “relevant to showing that [an activity is] not abnormally dangerous . . . whether or
not the regulations are given preemptive effect”); G.J. Leasing, 854 F. Supp. at 568–69 (citing
NESHAP requirements as evidence that asbestos removal risks could be “eliminated by the
exercise of reasonable care”).
Sterigenics U.S.’s EtO sterilization operations were subject to multiple strict federal and
state safety regulations that were specifically intended to mitigate potential risks associated with
EtO sterilization. See supra pp. 3–5. Indeed, nowhere in the FAMC do Plaintiffs allege that EtO
sterilization cannot be made safe through the exercise of reasonable care. See Chaveriat, 1994
U.S. Dist. LEXIS 15082, at *16 (plaintiffs bear the burden of alleging facts sufficient to support
a theory of strict liability based on an abnormally dangerous activity). To the contrary, Plaintiffs
tacitly concede that EtO sterilization can be performed “safely” (whatever that may mean to
Plaintiffs). See FAMC ¶¶ 128(h), 66 (alleging that Sterigenics U.S. failed to “employ safe
methods to adequately control, reduce, minimize, and/or mitigate EtO emissions” and “failed for
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decades to install available emission control technology to limit emissions of EtO from its
Willowbrook facility”). As such, operations at the Sterigenics U.S. Willowbrook facility are not
appropriately subject to strict liability as a matter of law. Miller v. Civil Constructors, 272 Ill.
App. 3d 263, 270 (“The doctrine of strict or absolute liability is ordinarily reserved for
abnormally dangerous activities for which no degree of care can truly provide safety.”).
The other Restatement factors also weigh against the imposition of strict liability. Under
Section 520(e), Illinois courts look to “the character of the place and its surroundings” when
determining whether an allegedly ultrahazardous activity is inappropriate to the place in which it
occurs. Miller, 272 Ill. App. 3d at 270. Sterigenics U.S.’s EtO sterilization operations were
located in an area zoned for light manufacturing,20 a zone that allows for “[a]ny production,
manufacturing, assembling, processing, cleaning, servicing, testing, repair or storage of
materials, goods or products,” Willowbrook Village Code Section 9-8-1. EtO sterilization
operations have been conducted in this location since 1984, and Plaintiffs do not allege that the
zoning has ever been different. See Cont’l Bldg. Corp. v. Union Oil Co. of Cal., 152 Ill. App. 3d
513, 517–18 (1st Dist. 1987) (oil company’s storage of highly flammable liquid in a warehouse
located in an urban, mixed commercial area did not constitute an abnormally dangerous activity).
Section 502(d) requires analysis of “the extent to which the activity is not a matter of
common usage.” Notably, EtO sterilization is the most common means of sterilizing medical
devices, with half of all medical devices used in the U.S. sterilized with EtO.21 Cadena v.
Chicago Fireworks Mfg. Co., 297 Ill. App. 3d 945, 962 (1998) (“Under factor (d), while
20 Village of Willowbrook Zoning Map (March 11, 2019, valid through December 31, 2019), available at https://www.willowbrookil.org/DocumentCenter/View/1556/2019-Zoning-Map-Color-36x50?bidId=. 21 Supra n.2.
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displaying fireworks is not a common activity undertaken by a large amount of individuals,
certainly many individuals view them and many municipalities display fireworks.”) (overruled
on other grounds).
With respect to he remaining factors—(a) the “degree of risk”; (b) the “likelihood the
harm . . . will be great”; and (f) the “extent to which its value to the community is outweighed by
its dangerous attributes,” Sterigenics U.S.’s operations were regulated and authorized by both the
state and federal governments. In creating these regulations, the federal and state legislatures
weighed the “degree of risk” to the public and the “likelihood” of harm against the “value to the
community,” and ultimately determined that the valuable benefits that EtO sterilizers provided to
the community cannot be ignored. As explained by the FDA, the loss of EtO sterilization for
“life-saving, life-sustaining” medical devices “can be a detriment to public health.”22 Recently,
the FDA stated that “the closure of some commercial sterilizers” has limited “the supply of
critical [personal protective equipment] during the COVID-19 outbreak.”23 Indeed, in discussing
Sterigenics U.S.’s EtO sterilization facility in Georgia, the U.S. Department of Health and
Human Services noted that the facility sterilizes personal protective equipment, as well as “other
items like catheters, syringes, IV sets and ventilator components like tubes, filters, and masks
[that] are critical to helping patients” and the plant’s closure could “jeopardize the nation’s
response to an unprecedented national pandemic.”24
22 Supra, n.3.
23 Letter to Georgia Governor Brian P. Kemp, .S. FOOD AND DRUG ADMINISTRATION (March 19, 2020), https://s3.amazonaws.com/jnswire/jns-media/d7/73/11408978/fda_letter_re_sterigenics.pdf.
24 Chairman Mike Boyce Responds to Reaction Concerning his Limited Emergency Authorization Allowing Sterigenics to Reopen, COBB COUNTY COMMUNICATIONS (March 26, 2020), https://s3.us-west-2.amazonaws.com/cobbcounty.org.if-us-west-2/prod/2020-03/Boyce%20Statement%20Mar%2026.pdf; see also Medical sterilization plants reopen to fight COVID, but feds discussing further steps ‘at highest level’ to boost medical supplies, COOK COUNTY RECORD (March 27, 2020), https://cookcountyrecord.com/stories/528810646-
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Sterigenics U.S.’s life-saving EtO sterilization activities took place in an appropriate,
permitted location; any potential risks could have been, and indeed were, mitigated through the
exercise of reasonable care; and the facility provided a valuable service to the community.
Consequently, this activity was not ultrahazardous, and Plaintiffs’ strict liability claims should be
dismissed.
IV. PLAINTIFFS’ GENERIC ALLEGATIONS REGARDING STERIGENICS U.S.’s REGULATED AND LAWFUL ETO STERILIZATION OPERATIONS FAIL TO STATE ANY COGNIZABLE NEGLIGENCE CLAIMS (COUNTS I, II, III).
Plaintiffs’ claims for negligence (Count I), negligent training (Count II), and negligent
supervision (Count III), should be dismissed under Section 2-615 for failure to state a claim.
First, the FAMC is devoid of any applicable standard establishing Sterigenics U.S.’s duty to
reduce its emissions beyond what was required by federal and state regulations, failing to put
Sterigenics U.S. on notice as to what it should have done to prevent Plaintiffs’ alleged injuries.
Second, Plaintiffs’ allegations of breach are conclusory and unsupported by any specific factual
allegations, and, again, are bereft of any identified standard of care. Third, Plaintiffs similarly
fail to articulate the duty of care to which Sterigenics U.S. purportedly was subject and that it
purportedly breached with respect to training and supervising its employees. Fourth, Plaintiffs’
failure to warn claim is deficient because it does not specify what warning Sterigenics U.S.
should have provided, how Sterigenics U.S. should have known to provide that warning, and
how the lack of warning about regulated and permitted emissions proximately caused Plaintiffs’
alleged injuries.
medical-sterilization-plants-reopen-to-fight-covid-but-feds-discussing-further-steps-at-highest-level-to-boost-medical-supplies.
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A. Plaintiffs Never Articulate the Duty or Standard of Care Sterigenics U.S. Should Have Satisfied to Prevent Plaintiffs’ Alleged Injuries.
Under Illinois law, to adequately plead a claim for negligence, a complaint must contain
well-pled facts to support (1) the existence of a duty owed by the defendant to the plaintiff; (2) a
breach of that duty; and (3) injury proximately caused by that breach. Marshall v. Burger King
Corp., 222 Ill. 2d 422, 429–30 (2006). While all individuals and entities owe a standard of
ordinary care, this obligation does not create a general “duty to the world at large.” Simpkins v.
CSX Transp., Inc., 2012 IL 110662, ¶ 19. Instead, individuals only have a duty to protect others
from a particular harm if the individual’s course of conduct creates a foreseeable risk of that
particular harm. Id. Conversely, “[i]f the injury was not reasonably foreseeable, no duty can
exist.” Id. at 24. In order to adequately plead a cause of action for negligence, “[i]t is not
sufficient that the complaint merely allege a duty, rather the pleader must allege facts from which
the law will raise a duty.” Rabel, 161 Ill. App. 3d at 357. “Whether such a duty exists is a
question of law, the determination of which must be resolved by the court. If no duty exists, it is
axiomatic that no recovery can occur.” Id.
Plaintiffs’ negligence claim fails to articulate an emissions standard that Sterigenics U.S.
should have met—but failed to—in operating the Willowbrook facility. This shortcoming is
particularly glaring given Sterigenics U.S.’s stringent compliance with highly technical and
exacting requirements imposed by USEPA and IEPA regarding EtO use and emissions—two
agencies with expertise and Congress’s authorization to regulate the industrial use and emission
of a multitude of chemicals, including EtO.25 Plaintiffs’ FAMC is silent on what more
Sterigenics U.S. should have done, above and beyond its full compliance with government
25 As noted above, the Illinois Attorney General and DuPage County State’s Attorney both affirmed in the State of Illinois case that “[t]here is no uncertainty about the fact that for years Sterigenics has operated in compliance with federal standards.” (Plaintiff’s Response to Villages’ Comments on Consent Order).
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requirements, to prevent Plaintiffs’ alleged injuries. (Plaintiffs’ vague allegation that Sterigenics
U.S. had a “duty to exercise ordinary care,” FAMC ¶ 126, is woefully deficient in identifying the
contours of the company’s duty and the corresponding standard of care under these
circumstances.) Moreover, notably absent from Plaintiffs’ FAMC is any explanation about how
Sterigenics U.S.’s lawful operation of the Willowbrook facility (and its inherent—and
permitted—EtO emissions), in full compliance with all applicable rules, regulations, and
standards, created a foreseeable risk of harm to Plaintiffs.
Plaintiffs attempt to skirt this failing by simply declaring that Sterigenics U.S.’s
Willowbrook facility emissions were “unsafe,” “massive and unnecessary,” and “excessive and
dangerous.” FAMC ¶¶ 128(a), (b); id. ¶ 6. Not only are such conclusory allegations insufficient
to meet Illinois’ stringent fact-pleading standards, Rabel, 161 Ill. App. 3d at 354, but Plaintiffs’
bald characterizations of Sterigenics U.S.’s permitted emissions levels are meaningless given
that they do not articulate an alternative EtO emission standard, safety standard, or standard of
conduct, or provide any authority, formula, or resource for such a standard to be applied in place
of the existing USEPA and IEPA authority, expertise, and requirements with which Sterigenics
U.S. complied.
Illinois courts routinely dismiss such vague and conclusory allegations of negligence. See
e.g., Dvorak v. Primus Corp., 168 Ill. App. 3d 625, 634 (2d Dist. 1988) (affirming dismissal of
complaint that “summarily state[d] only that [defendant] negligently failed to require [its alleged
agent] to employ specific safety procedures or devices”); Hanson vs. Hyatt Corp, 196 Ill. App.
3d 618, 623 (5th Dist. 1990) (dismissing complaint where plaintiff alleged conclusion but not
underlying factual support and noting “[a] court is bound to consider only those facts well
pleaded”). Further, because Plaintiffs’ allegations are so utterly lacking in detail, they fail to
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“apprise [Sterigenics U.S.] of sufficient facts upon which to base a defense,” as required in order
to state a claim. Kozak v. Armstrong World Indus., Inc., 213 Ill. App. 3d 1061, 1067 (1991).
Plaintiffs’ negligence claim (Count I) must therefore be dismissed.26
B. Plaintiffs’ Conclusory Breach Allegations are Entirely Unsupported by Any Well-Pled Factual Allegations.
General and conclusory allegations of breach are insufficient to support a claim for
negligence. “[A] general statement, without more, cannot stand for the specific breaches of duty
plaintiffs appear to assume [defendant] committed.” Cangemi v. Advocate S. Suburban Hosp.,
364 Ill. App. 3d 446, 459 (2006). Plaintiffs solely rely on general and conclusory allegations in
asserting breach in Count I.
As one example, Plaintiffs allege that Sterigenics U.S. breached some unspecified duty of
care by using EtO in its process “when safer alternatives could accomplish the same or similar
business purpose.” FAMC ¶ 128(c). However, nowhere in the Complaint do Plaintiffs specify
what these safer alternatives are, by what standard they are considered safer, and what it means
to accomplish “the same or similar business purpose.”27 It is also unclear what Plaintiffs are
referencing when they allege that Sterigenics U.S. placed “its own economic interests above the
health and well-being” of the community. Id. ¶ 128(d). The FAMC contains no factual
allegations supporting the idea that Sterigenics U.S. made decisions to advance its own economic
26 In the event the Court does not dismiss Plaintiffs’ negligence claim (Count I) despite Plaintiffs’ failure to plead any duty owed by Sterigenics U.S. to reduce EtO emissions below levels expressly permitted by IEPA and EPA regulations, or the breach of such a duty as discussed in Section IV.B herein—including Plaintiffs’ failure to identify the source of any such additional or different duty, let alone the EtO emissions standards on which they might be based—Sterigenics U.S. requests that Plaintiffs be required to respond to a Demand for a Bill of Particulars, attached as Tab 2, providing sufficient detail about the alleged duty and breach to inform Sterigenics U.S. of the claims it is called upon to defend against. A Bill of Particulars is appropriate “when the complaint [a party] is asked to respond to is wanting in details.” Vill. of Pawnee v. Knostman, 115 Ill. App. 3d 842, 852 (Ill. App. Ct. 1983).
27 See supra at p. 3 and nn. 3 and 4, referring to fact that EtO sterilization is the only available sterilization method for some types of medical devices.
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interests at the expense of the Willowbrook community.28 And while Plaintiffs baldly allege that
Sterigenics U.S. “cut corners” and failed to implement “safety measures,” id. ¶ 66, Plaintiffs fail
to provide any factual support for these allegations, particularly in light of Sterigenics U.S.’s
routine and persistent compliance with all federal and state regulations governing EtO use and
emissions. More importantly, Plaintiffs fail to specify how any alleged “corner cutting” or other
“failures” led to any emissions other than those permitted by the government.
Plaintiffs also allege that Sterigenics U.S. breached its duty by failing to employ “safe
methods” to adequately control the Willowbrook facility’s EtO emissions. Id. ¶ 128(h).
Elsewhere in the FAMC Plaintiffs make similarly conclusory allegations regarding Sterigenics
U.S.’s failure to use “best practices and control technologies,” id. ¶ 3, employ “[e]ffective
technologies,” id. ¶ 54, and “install available emission control technology,” id. ¶ 66. What is
missing from the FAMC is any factual allegation defining what exactly this supposed technology
was, when it became available, and why it was superior to Sterigenics U.S.’s existing, legally-
compliant emissions control technologies and procedures. To be sure, Plaintiffs spend a large
portion of the FAMC claiming without any factual support whatsoever that Sterigenics U.S. was
financially hamstrung such that it was unable to spend money on the “use, addition and/or
maintenance of EtO emission control equipment.” Id. ¶ 106. These broad and generic assertions,
however, offer no clarity as to what emission control technology Sterigenics U.S. should have
been investing in, beyond the emission control equipment already installed that ensured
compliance with regulations.
28 Although Plaintiffs’ FAMC includes numerous, unfounded assertions regarding supposed financial transactions, see FAMC ¶¶ 8, 9, 92–94, 97, 106–108, 110–113, 114(d), 115–117, 122, these allegations are wholly untethered to Plaintiffs’ negligence claims against Sterigenics U.S. or any other cause of action. Allegations regarding corporate transactions in no way support either a duty or a breach. Indeed, Sterigenics U.S. cannot discern from the FAMC how, or even if, the allegations regarding financial transactions relate to the causes of action pled against Sterigenics U.S.
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According to Plaintiffs, Sterigenics U.S. also failed “to adequately study and test the
effect of EtO emissions.” Id. ¶ 128(i), (j). There are no allegations in the FAMC detailing this
supposed obligation to study or test, or Sterigenics U.S.’s alleged breach thereof. It is entirely
unclear from the FAMC what specific studying and testing Plaintiffs allege Sterigenics U.S.
should have done (above and beyond what Sterigenics U.S. did in compliance with its permits
and regulations), or why such studying and testing should have been done in light of Sterigenics
U.S.’s reliance on and compliance with the requirements of USEPA and IEPA, the agencies with
the applicable authority and extensive technical expertise.
Simply put, Plaintiffs’ unsupported and conclusory assertions of breach are insufficient to
support a claim for negligence, and Plaintiffs’ claim (Count I) should be dismissed.
C. Plaintiffs’ Allegations Are Equally Insufficient to Allege a Claim for Negligent Training or Negligent Supervision Against Sterigenics U.S.
The same deficiencies that defeat Plaintiffs’ general negligence claim also run through
Plaintiffs’ negligent training and negligent supervisions claims (Counts II and III). See
McNerney v. Allamuradov, 2017 Ill. App. (1st) 153515, ¶ 61 (2017) (outlining elements of duty,
breach of duty, and proximate cause for negligent supervision or training claims). Plaintiffs fail
to specify the specific duty of care that Sterigenics U.S. should have (but allegedly failed to)
meet in training and supervising its employees. Instead, Plaintiffs allege a breach of a generic
duty to “properly train” and “properly supervise” without ever defining such a duty or alleging
how it was breached. See FAMC ¶ 133 (alleging breach of a duty to “properly train” and follow
“proper procedures,” but failing to allege elsewhere what training protocol, procedures, or
requirements Sterigenics U.S. should have complied with); id. ¶ 138 (alleging breach of a duty to
“properly supervise” and follow “proper procedures,” some of which led to unspecified and
vague “unintended leaks, spills or emissions,” but failing to allege elsewhere what “proper
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procedures” Sterigenics U.S. should have complied with and further failing to specify what
“leaks, spills or emissions” Plaintiffs are referencing). Plaintiffs’ deficient pleading fails to
apprise Sterigenics U.S. of sufficient facts upon which to base its defense and necessitates
dismissal of Plaintiffs’ negligent supervision and negligent training claims. See Kozak, 213 Ill.
App. 3d at 1067.
D. Plaintiffs’ Allegations Are Insufficient to Allege a Failure to Warn Claim Against Sterigenics U.S.
Plaintiffs’ summary allegation in Count I that Sterigenics U.S. breached a duty by
“failing to warn or advise Plaintiff . . . that it was emitting a known carcinogen into the air from
its facility,” id. ¶ 128(e)–(g), also fails because Plaintiffs have not sufficiently alleged what
warning Sterigenics U.S. should have provided to prevent Plaintiffs’ alleged injuries. In Illinois,
“[a] duty to warn of a particular hazard will be imposed only where there is unequal knowledge,
either actual or constructive, and the defendant knows or should know that injury may occur if
no warning is given.” Carrizales v. Rheem Mfg. Co., 226 Ill. App. 3d 20, 25 (1st Dist. 1991). The
Sterigenics U.S. Willowbrook facility operated in accordance with strict regulatory requirements.
Plaintiffs offer no facts to explain how Sterigenics U.S. would know that, despite compliance
with the stringent emission requirements imposed by the USEPA and IEPA—two agencies with
expertise regulating the industrial use and emission of a multitude of chemicals, including EtO—
Plaintiffs’ injuries would “occur if no warning is given.” In fact, Plaintiffs do not even specify
what warning should have been provided that would have prevented their alleged injuries.
Without any allegation as to what Sterigenics U.S. should have been warning Plaintiffs about,
and why, Plaintiffs’ failure to warn claim is deficient.
Additionally, because Plaintiffs do not provide any details about what warning should
have been provided, they also cannot establish proximate cause. To establish proximate cause in
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a failure to warn context, a plaintiff “must demonstrate that an adequate warning would have
been read and heeded, and would have prevented the injuries in question.” Blaue v. Kissinger,
No. 03 C 9025, 2006 U.S. Dist. LEXIS 55995 *16 (N.D. Ill. July 24, 2006). Plaintiffs admit that
Sterigenics U.S. publicly reported its emissions information. FAMC ¶¶ 51, 52. Sterigenics U.S.
reported its emissions information to USEPA, which posted that information on a public
website.29 Plaintiffs allege that the health risks associated with EtO were researched and
published by numerous organizations, including the National Institute for Occupational Safety
and Health, the U.S. Department of Health and Human Services, the World Health Organization,
OSHA, and USEPA. Id. ¶¶ 28–38. Plaintiffs include a table of over two decades of the
Sterigenics U.S.’s Willowbrook facility’s publicly-available emissions data. Id. ¶¶ 51, 52 (Table
1).
Plaintiffs fail to allege what additional information should have been provided to warn
individuals in the Willowbrook area and beyond about the potential risks associated with
regulated and permitted EtO emissions and how this additional information would have altered
their behavior. This deficiency warrants dismissal of Plaintiffs’ failure to warn claim. See
Norabuena v. Medtronic, Inc., 2017 Ill. App. (1st) 162928, ¶ 38 (affirming dismissal of failure
to warn claim where plaintiffs “failed to sufficiently allege facts indicating that [defendant’s]
acts or omissions proximately caused the complained of injuries”).
29 See TRI Explorer: Release Reports, United States Environmental Protection Agency, https://enviro.epa.gov/triexplorer/release_trends?p_view=COYR&trilib=TRIQ1&sort=_VIEW_&sort_fmt=1&state=17&county=17043&chemical=000075218&core_year=&industry=ALL&year=All+years&tab_rpt=1&fld=AIRLBY&fld=E1&fld=E2&fld=E3&fld=E4&fld=E41&fld=E42&fld=E5&fld=E52&fld=E53&fld=E53A&fld=E53B&fld=E54&fld=E51&fld=E51A&fld=E51B&fld=TSFDSP&fld=TSFDSP&fld=m10&fld=m41&fld=m62&fld=potwmetl&fld=m71&fld=m81&fld=m82&fld=m72&fld=m63&fld=m64&fld=m65&fld=m66&fld=m67&fld=m73&fld=m79&fld=m90&fld=m94&fld=m99&fld=RELLBY (last accessed Apr. 27, 2020).
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V. ILLINOIS DOES NOT RECOGNIZE A STANDALONE CLAIM FOR WILLFUL AND WANTON CONDUCT (COUNT IV).
Illinois does not recognize a “separate and independent tort of ‘willful and wanton’
misconduct.” Ziarko v. Soo Line R.R., 161 Ill. 2d 267, 274 (1994); see also Sparks v. Starks, 367
Ill. App. 3d 834, 837 (1st Dist. 2006) (“Illinois courts have consistently held that there is no
separate and independent tort of willful and wanton misconduct.”). Rather, such claims are
properly used to determine the appropriate level of damages only once liability for negligence
has been proven. Krywin v. Chicago Transit Auth., 238 Ill. 2d 215, 235 (2010); see also Ziarko,
161 Ill. 2d 267, 276 (willful and wanton conduct is grounds for punitive and compensatory
damages); Sorkin v. Blackman, Kallick & Co., 184 Ill. App. 3d 873, 879–80 (1st Dist. 1989)
(“Willful and wanton misconduct affects the amount of damages and is not a separate tort.”).
Plaintiffs’ allegation of willful and wanton misconduct as the basis of an independent
cause of action must therefore be dismissed under Illinois law. See, e.g., Campos, 2014 U.S.
Dist. Lexis 159242, at *20 (“[T]o the extent it purports to state a separate cause of action, [the
willful and wanton misconduct claim] is dismissed.”).
CONCLUSION
For the foregoing reasons, all counts of the FAMC against Sterigenics U.S.—Negligence
(Count I), Negligent Training (Count II), Negligent Supervision (Count III), Willful and Wanton
Conduct (Count IV), Ultrahazardous Activity/Strict Liability (Count V), Civil Battery (Count
VI), and Public Nuisance (Count VII)—should be dismissed with prejudice.
Date: April 28, 2020 Respectfully submitted,
By: /s/ Maja C. Eaton Maja C. Eaton, IL Bar No. 6188479 [email protected] Jana D. Wozniak, IL Bar No. 6288881 [email protected]
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Michael L. Lisak, IL Bar No. 6299347 [email protected] SIDLEY AUSTIN LLP One South Dearborn Street Chicago, IL 60603 (312) 853-7000 Firm I.D. Number: 42418 Kimberly Moses, IL Bar No. 0029601 [email protected] Lindsey E. Sacher, IL Bar No. 0087883 [email protected] CALFEE, HALTER & GRISWOLD LLP The Calfee Building 1405 East Sixth Street Cleveland, Ohio 44114-1607 Phone: (216) 622-8200 Fax: (216) 241-0816 Attorneys for Sterigenics U.S., LLC
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CERTIFICATE OF SERVICE
I hereby certify that on April 28, 2020, I caused a copy of Defendant Sterigenics U.S.,
LLC’s Memorandum in Support of Motion to Dismiss Plaintiffs’ Master Complaint to be served
upon counsel of record by service on Lead Counsel Antonio Romanucci and Liaison Counsel
Bryce Hensley via email.
By: /s/ Bojan Manojlovic
SERVICE LIST
Antonio M. Romanucci Bryce T. Hensley ROMANUCCI & BLANDIN, LLC 321 N. Clark Street, Suite 900 Chicago, IL 60654 (312) 458-1000 (312) 458-1004 [email protected] [email protected]
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EXHIBIT A FILE
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IN THE CIRCUIT COURT OF THE EIGHTEENTH JUDICIAL CIRCUITDUPAGl!: COUNTY, ILLINOIS
CHANCERY DIVISION
PEOPLE OF THE STATE OF ILLINOIS,ex rei. LISA MADIGAN, Attorney Generalof the State of Illinois, andex rel. ROBERT BERLIN, State's Attorneyfor DuPage County, Illinois,
Plaintiff,
v.
STERIGENICS U.S., LLC,a Delaware limited liability company,
Defendant.
))))))))))))))
No.
COMPLAINT FOR INJUNCTIVE RELIEF AND CIVIL PENALTIES
Plaintiff, PEOPLE OF THE STATE OF ILLINOIS, ex rel. LISA MADIGAN, Attorney
General ofthe State of Illinois, on her own motion, and ex rei. ROBERT BERLIN, State's Attorney
ofDuPage County, Illinois, on his own motion, complain of the Defendant, STERIGENICS U.S.,
LLC, a Delaware limited liability company ("Sterigenics" or "Defendant"), as follows:
COUNT ICAUSING, THREATENING OR ALLOWING AIR POLLUTION
1. This Count is brought on behalf of the People of the State of Illinois, ex rei. Lisa
Madigan, Attorney General of the State of Illinois, on her own motion, and ex rel. Robert Berlin,
State's Attorney of DuPage County, on his own motion, against the Defendant, pursuant to
Sections 42(d) and (e) of the Illinois Environmental Protection Act ("Act"), 415 ILCS 5/42(d) and
(e) (2016).
2. This Count is brought at the request of the Illinois Environmental Protection
Agency ("Illinois EPA").
I
2018CH001329
TRAN# : 170431095680/( 4394856 )2018CH001329FILEDATE : 10/30/2018Date Submitted : 10/30/2018 12:04 PMDate Accepted : 10/30/2018 01:58 PMROSE,SARAH
St 2-26-19 2005 9am
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3. The Illinois EPA is an administrative agency of the State of Illinois, established by
Section 4 of the Act, 415 ILCS 5/4 (2016), and is charged, inter alia, with the duty of enforcing
the Act.
4. Since at least January 30, 2006, the Defendant has been and is a Delaware limited
liability company duly authorized to transact business in the State of Illinois.
5. Since at least January 30, 2006 to present, on dates better known to the Defendant,
the Defendant has operated an ethylene oxide gas ("EtO") commercial sterilization enterprise.
6. Sterigenics is comprised of two separate buildings located at 7775 South Quincy
Street, Willowbrook, DuPage County, Illinois ("Building 1") and 830 Midway Street,
Willowbrook, DuPage County, Illinois ("Building 2") (together, "Source").
7. In 1984, Griffith Micro Science, Inc. ("Griffith") began operating an "EtO
sterilization business at Building 1 of the Source.
8. In 1999, Ion Beam Applications acquired both Griffith and SteriGenics
International, Inc. SteriGenics Internati.onal, Inc. is the parent company of the Defendant. Between
1999 and 2006, SteriGenics International, Inc. was bought and sold multiple times.
9. On January 30, 2006, the Illinois EPA issued to the Defendant modified Clean Air
Act Permit Program ("CAAPP") Permit No. 95120085 naming the Defendant as operator of the
Source. Since 2006, the Defendant is the permitted operator of the Source.
10. Since 1984, at Building 1, and 1999, at Building 2, an EtO sterilization enterprise
has been operating in Willowbrook.
11. From January 30, 2006 to present, on dates better known to the Defendant, the
Defendant has operated at least fourteen commercial sterilizers at Building 1, and four commercial
sterilizers at Building 2. Individual sterilizers are also known as "chambers".
2
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12. Each commercial sterilizer is comprised of a steam-heated sterilization chamber, a
recirculating vacuum pump chamber evacuation system, a backvent valve, and a fugitive emissions
exhaust hood.
13. During the sterilization process, the Defendant places medical equipment and other
products (together, "products") into individual chambers and EtO is introduced. During this
process, the chambers are sealed. After a certain residence time, the Defendant evacuates EtO from
the chambers. After the gas is pumped out of the chambers, air is introduced into the chambers.
When air is introduced into the chambers, the chamber doors are opened and residual amounts of
EtO are vented through the "backvent valves."
14. Upon completion of the sterilization cycle, EtO and other gases evacuated from the
chambers in Building 1 are pumped to a Chemrox DEOXX packed tower chemical scrubber
("Acid Water Scrubber #1"), while the EtO from the chambers in Building 2 are routed to a two
stage Advanced Air Technologies Safe Cell emission-control system ("Willowbrook II Scrubber")
and dry bed reactor.
15. After products are removed from the commercial sterilizers, they are placed in one
of the Source's aeration rooms where EtO continues to volatilize, or off gas, from the sterilized
products. There are three aeration rooms at Building 1 and two aeration rooms at Building 2.
Emissions from the aeration rooms at Building 1 are captured and treated by a two-stage Advanced
Air Technologies Safe Cell emission-control system ("Acid Water Scrubber #2") and dry bed
reactor, and the emissions from the aeration rooms at Building 2 are captured and treated by' the
Willowbrook II Scrubber and dry bed reactor. The three scrubber systems and two dry bed reactors
at the Source are collectively referred to as "the Scrubbers." The Scrubbers are the sole method
used by the Defendant to control EtO emissions from the Source.
3
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16. As part of its operations at the Source, the Defendant discharges and emits EtO to
the atmosphere.
17. In 1990, EtO was listed as a "hazardous air pollutant" under Section 112 of the
Clean Air Act, 42 U.S.C. § 7412(b)(l) (2016).
18. On June 8,2015, the Illinois EPA issued renewal CAAPP Permit No. 95120085 to
the Defendant ("Operating Permit"). The Operating Permit includes the Clean Air Act National
Emission Standard for Hazardous Air Pollutants ("NESHAP") for EtO emissions from sterilization
facilities. 40 C.F.R. Part 63, Subpart O. The NESHAP requires facilities to control EtO emissions
from the vacuum pump chamber evacuation systems and aeration rooms by at least 99.0%. The
NESHAP does not require that facilities control EtO emissions from the backvent valves.
Therefore, the Operating Permit does not require the Defendant to control EtO emissions from the
backvent valves at the Source.
19. The Operating Permit allows the Defendant to utilize up to 542.1 tons (l,084,200
pounds) of EtO per year in its operations at the Source.
20. Section 3.5.c of the Operating Permit provides as follows:
Annual Emissions Reporting
Pursuant to 35 lAC Part 254, the Source shall submit an Annual Emission Report to the[llIinois EPA], due by May 1 ofthe year following the calendar year in which the emissionstook place. All records and calculations upon which the verified and reported data are basedmust be retained by the source.
21. Between 1984 and 1992, the Source emitted EtO. I Beginning in 1993 and
continuing through 2005, the owner and or operator of the Source reported in its Annual Emission
Reports releasing the following amounts of EtO to the atmosphere:
I Illinois EPA's Part 254 Rules (Annual Emissions Report) were first adopted on May 14, 1993. Hence, calendaryear 1993 is the first Annual Emissions Report available for the Source.
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Year EtO Released (Ibs.)
1993 10,780
1994 9,600
1995 21,320
1996 21,720
1997 30,800
1998 35,400
1999 15,940
2000 10,380
2001 6,146
2002 5,750
2003 5,200
2004 6,200
2005 5,800
22. According to the Defendant's Annual Emission Reports as filed by the Defendant
with the Illinois EPA, the Defendant reported releasing the following amounts of EtO to the
atmosphere during the years 2006 to 2017:
Year EtO Released (lbs.)
2006 4,760
2007 7,340
2008 7,080
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2009 5,600
2010 6,440
2011 6,980
2012 6,980
2013 5,960
2014 5,080
2015 4,600
2016 4,200
2017 4,600
23. On June 26, 2018, Illinois EPA issued the Defendant permit no. 18060020 to duct
the emissions of EtO from the backvent valves of the sterilization chambers to the existing
Scrubbers ("Construction Permit"), Illinois EPA received this construction permit application on
June 11,2018.
24. On information and belief, on or about July 27, 2018, the Defendant completed the
modifications to its air pollution control equipment by ducting the emissions from the backvent
valves at Building 1 to Acid Water Scrubber #2 and the dry bed reactor and the emissions from
the backvent valves at Building 2 to Willowbrook II Scrubber and the dry bed reactor.
25. Prior to modifying its air pollution control equipment to control the emission of
EtO from the backvent valves of the sterilization chambers, the Defendant allowed the
uncontrolled emission of EtO from the backvent valves. As a result, since at least 2006, on a date
better known to the Defendant, until on or about July 27, 2018, the Defendant had allowed the
emission to the environment of 100% oftheEtO that was released through the backvent valves.
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26. The Operating Permit requires that the Defendant meet a control efficiency of.
99.0% of emissions from the vacuum pump chamber evacuation system and aeration rooms. Once
the backvent valves were ducted to the Scrubbers, those emissions also became and are subject to
the 99.0% control efficiency.
27. The Operating Permit allows the Defendant to emit approximately 18.2 tons
(36,400 pounds) of EtO per year.
28. EtO is highly reactive, readily absorbed, and easily distributed in the human body.
EtO is mutagenic and causes chromosome damage in many species, including humans.
29. From 1985 to 2016, the United States Environmental Protection Agency. ("U.S.
EPA") categorized EtO as "probably carcinogenic to humans".
30. In December 2016, U.S. EPA's Integrated Risk Information System ("IRIS")
program released an "Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide" ("2016
IRIS Evaluation"). In the 2016 IRIS Evaluation, U.S. EPA changed EtO's weight of evidence
descriptor from "probably carcinogenic to humans" to "carcinogenic to humans" while increasing
EtO's lifetime inhalation cancer unit risk estimate about 50-fold. The 2016 IRIS Evaluation is
incorporated by reference herein.?
31. In the 2016 IRIS Evaluation, U.S. EPA noted that an increased incidence and
mortality of breast and lymphohematopoietic system cancers have been observed in workers in
EtO sterilizing facilities.
32. In the 2016 IRIS Evaluation, U.S. EPA determined that there is sufficient evidence
to establish a causal relationship between EtO exposure and breast cancer in women.
2 Available at http://ofmpub.epa.gov/eims/eimscomm.getfile?p download id=529970.- -
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33. As a mutagenic carcinogen, EtO causes cancer by damaging DNA in cells which is
then duplicated when the cells divide. Repeated exposure over time to EtO increases the cancer
risk compared to a one-time exposure. This increase occurs because DNA damage may take place
with each and every exposure that is passed on to more cells, increasing the number of mutated
cells, which eventually leads to cancer in some people.
34. The Source is in a densely populated residential, industrial and commercial area,
with 19,271 people living within 1 mile of the Source boundary. The Source is located in an
industrial park that is surrounded by, and in close proximity to, residential neighborhoods, schools,
daycare facilities, businesses, and parks, including but not limited to, the following:
1. Homes (less than 0.25 miles)
11. Schools: Gower Middle (0.42 miles), St. Mark Christian Montessori (0.70 miles),Hinsdale South High School (0.76 miles), Gower West (0.79 miles), KingswoodAcademy (0.87 miles), Kindert.are (1.0 mile), Our Lady of Peace School (1.22miles), Concord Elementary (1.62 miles), Ready Set Grow (1.76 miles), Burr RidgeMiddle School (1:86 miles)
111. Parks and Government Buildings: Willowbrook Police Department and Mayor'sOffice (0.07 miles), Willowbrook Community Park (0.45 miles), Indian PrairieLibrary (0.97 miles), Harvester Park (1.0 mile), Whittaker Park (1.03 miles), BurrRidge Police Department (1.19 miles)
IV. Businesses: Dance Duo Studio (0.1 miles), Dell Rhea's Chicken Basket (0.16miles), Denny's (0.18 miles), Target (0.19 miles), La Quinta Inn (0.29 miles), RedRoof PLUS+ (0.3 miles), Diamond Edge Training (0.3 miles), BIG Gymnastics(0.68 miles), Darien Sportsplex (1.0 mile)
35. According to U.S. EPA's website,' for a single year of exposure to EtO, the cancer
risk is greater for children than for adults. This elevated risk to children exists because EtO can
damage DNA, and children have more years ahead of them to develop the other cancer risk factors
that result in the formation of malignant cells. Additionally, compared to adults, children receive
3 Available at https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/frequent-questions-ethylene-oxide(accessed on October 18,2018).
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larger doses per body weight because they have greater lung surface area and increased lung
volume per body weight, and breathe in more air per body weight.
36. According to 2010 U.S. Census Data, 3,494 children 5 years and younger lived
within 3 miles of the Source in 2010, including 250 that lived within 1 mile.
37. According to the 2014 National Air Toxics Assessment ("NATA") released by U.S.
EPA in August 2018, seven census tracts near the Source are among 109 nationwide that have
cancer risk scores greater than 100 in 1 million, or 1 in 10 thousand, meaning that in those census
tracts hazardous air pollution may cause more than one additional incidence of cancer per 10
thousand people. There are a total of73,057 census tracts in the United States.
38. Between May 16,2018 and May 17,2018, the U.S. EPA collected 39 ambient air
samples at 26 discrete locations near the Source ("May 2018 sampling event"). All of these
samples were collected in proximity to the various public places listed in paragraph 34.
39. U.S. EPA modeled short and long-term ambient EtO concentrations to evaluate the
impact of emissions from the Source using, among other data, the National Emissions Inventory
("NEI") data from 2014. The NEI data includes the actual pounds of EtO emitted by the Source,
as reported by Illinois EPA, which is substantially lower than the amount ofEtO that the Defendant
is allowed to emit under the Operating Permit. As alleged in paragraph 22, the Defendant reported
emitting 5,080 pounds of EtO in 2014, while as alleged in paragraph 27, the Operating Permit
allows the emission of 18.2 tons, or 36,400 pounds, of Eta.
40. In June 2018, U.S. EPA provided the analytical data from the May 2018 sampling
event and the modeled ambient EtO concentrations to the United States Department of Health &
Human Services Agency for Toxic Substances and Disease Registry ("ATSDR"). At the same
time, U.S. EPA: "requested that ATSDR review air measurements of Eta and modeling results of
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EtO emissions from Sterigenics and specifically answer the question: If modeled and measured
ethylene oxide concentrations represent long term conditions, would they pose a public health
problem for people living and working in Willowbrook?"
41. On July 26, 2018, the ATSDR provided to U.S. EPA its answer to the above
question. The letter provides:
It is ATSDR's conclusion that the data U.S. EPA provided suggests that residents andworkers are exposed to elevated airborne EtO concentrations from facility emissions. It isdifficult to assess long-term public health implications from facility emissions becausethere has been no historical air monitoring in the community. ATSDR assumed that thesedata represent long term exposures for area residents and workers. Specifically, ATSDRconcludes the following:
1) If measured and modeled data represent typical EtO ambient concentrations inambient air, an elevated cancer risk exists for residents and off-site workers inthe Willowbrook community surrounding the Sterigenics facility. Theseelevated risks present a public health hazard to these populations.
2) Measured and modeled ethylene oxide concentrations in ambient air indicatethat non-cancer health effects are unlikely for residents and off-site workers inthe Willowbrook community surrounding the Sterigenics facility.
The July 26, 2018 ATSDR letter is attached hereto and .incorporated by reference herein.
42. The ATSDR used the maximum recorded EtO sample taken near a residence close
to the Source to conclude that the lifetime risk for the area surrounding the Source is an additional
64 incidences of cancer per 10,000 people, or 64 times what U.S. EPA considers to be an
acceptable risk.
43. On August 21, 2018, the July 26, 2018 letter from ATSDR to U.S. EPA was
released as a "Letter Health Consultation."
44. ATSDR's conclusion that an elevated cancer risk exists for residents and off-site
workers in the Willowbrook community and that these elevated risks present a "public health
hazard" is based on EtO emissions that are substantially lower than 18:2 tons (36,400 pounds).
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Thus, the Operating Permit allows the "public health hazard" as found by the ATSDR in its report
to continue unabated.
45. As of October 23,2018,28,925 people had signed a petition entitled "Action Alert:
Illinois, Say "No" to toxic air" on the website www.change.org. The petition expresses the public's
overwhelming concerns regarding the impact of Defendant's EtO emissions on the surrounding
community. The concerns include the following:
1., Detrimental health impacts to their children swimming at a pool located across
the street from the Source.
H. The general safety of families in the area.
HI. The mutagenic effects of EtO on children in the area.
IV. Fear that past and current incidents of cancer in the area were caused by the
Source.
v. A desire to have residents' children and grandchildren breathing safe air.
VI. The number of individuals in the community with cancer.
vii. Past exposure to EtO from the Source.
viu. The location of the Source in such a densely populated area.
46. As of October 24, 2018, more than 80 people have contacted the Illinois Attorney
General's Office to express their concerns regarding the Source's EtO emissions.
47. As of October 24, 2018, the Illinois EPA has been contacted more than 100 times
by members of the public to express their concerns regarding the Source's EtO emissions.
48. For those people who have resided near the Source over a period of years, the public
health concerns with EtO are exacerbated due to the increased risk caused by exposure over a
lifetime (see paragraphs 21 and 22, which show the Source's EtO emissions from 1993 to 2017,
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including from 1995 to 1999, when the Source emitted, on average, more than 25,000 pounds of
EtO annually to the environment).
49. Article XI of the Illinois Constitution provides, in pertinent part, as follows:
SECTION 1. PUBLIC POLICY - LEGISLATIVE RESPONSIBILITY,
The public policy ofthe State and the duty ofeach person is to provide and maintaina healthful environment for the benefit of this and future generations. The GeneralAssembly shall provide by law for the implementation and enforcement of thispublic policy.
SECTION 2. RIGHTS OF INDIVIDUALS
Each person has the right to a healthful environment. ...
50. In fulfillment of the Constitutional requirement to protect each person's right to a
healthful environment, the General Assembly adopted the Act. Section 9(a) of the Act, 415 ILCS
5/9(a) (2016), provides as follows:
No person shall:
a) Cause or threaten or allow the discharge or emission of any contaminantinto the environment in any State so as to cause or tend to cause air pollutionin Illinois, either alone or in combination with contaminants from othersources, or so as to violate regulations or standards adopted by the Boardunder this Act.
51. Section 201.141 of the Illinois Pollution Control Board ("Board") Air Pollution
Regulations, 35 Ill. Adm. Code 201.141, provides, in relevant part, as follows:
Prohibition of Air Pollution
No person shall cause or threaten or allow the discharge or emission of anycontaminant into the environment in any State so as, either alone or in combinationwith contaminants from other sources, to cause or tend to cause air pollution inIllinois, or so as to violate the provisions of this Chapter ....
52. Section 3.315 of the Act, 415 ILCS 5/3.315 (2016), provides the following
definition:
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"Person" is any individual, partnership, co-partnership, firm, company, limitedliability company, corporation; association, joint stock company, trust, estate,political subdivision, state agency, or any other legal entity, or their legalrepresentative, agent or assigns.
53. The Defendant, a limited liability company, is a "person" as that term is defined in
Section 3.315 of the Act, 415 ILCS 5/3.31.5 (2016).
54. Section 3.115 of the Act, 415 ILCS 5/3.115 (2016), provides the following
definition:
"Air pollution" is the presence in the atmosphere of one or morecontaminants in sufficient quantities and of such characteristics andduration as to be injurious to human, plant, or animal life, to health, or toproperty, or to unreasonably interfere with the enjoyment oflife or property.
55. Section 3.165 of the Act, 415 ILCS 5/3.165 (2016), provides the following
definition:
"Contaminant" is any solid, liquid, or gaseous matter, any odor, or any formof energy, from whatever source.
56. Section 201.102 of the Board Air Pollution Regulations, 35 Ill. Adm. Code
201.102, provides the following definitions:
"Air Contaminant": Any solid, liquid or gaseous matter, any odor or any form ofenergy that is capable of being released into the atmosphere from an emissionsource.
57. The EtO released from the Facility is a "contaminant" within the meaning of
Section 3.165 of the Act, 415 ILCS 5/3.165 (2016),·and an "air contaminant" within the meaning
of Section 201.102 of the Board Air Pollution Regulations, 35 Ill. Adm. Code 201.102.
58. Beginning on or before January 30, 2006 and continuing to the present, Defendant
has discharged or emitted from the Source into the surrounding area thousands of pounds of EtO,
which, as alleged herein, has caused or threatened injury to persons near the Source and
unreasonably interfered with their enjoyment of life or property.
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The threat to human health is particularly heightened in children, who have an
59. The Defendant's allowable emissions of approximately 18.2 tons (36,400 pounds)
per year of EtO, a known human carcinogen, into the atmosphere near residences and places of
business (a) threaten to injure the health of people living, attending school, recreating, working,
and shopping near the Source, (b) have caused fear in the community due to the threat to public
health, and (c) interfere with the enjoyment and use of their homes and work places, and therefore
constitutes "air pollution" as that term is defined in Section 3.115 of the Act, 415 ILCS 5/3.115
(2016).
60.
increased susceptibility from exposure to a known human carcinogen. The unreasonable
interference with enjoyment of life and property is particularly heightened for parents of children
who live near the Source who are legitimately concerned about the health and welfare of their
children as it relates to exposure to EtO, a known human carcinogen.
61. By causing, threatening, or allowing the discharge or ermssron of EtO, a
contaminant, into the environment so as to cause air pollution, Defendant violated Section 201.141
of the Board Air Pollution Regulations, 35 Ill. Adm. Code 201.141, and Section 9(a) of the Act,
415 ILCS 5/9(a) (2016).
62. Violations of the pertinent environmental statutes and regulations will continue
unless and until this Court grants equitable relief in the form of preliminary and, after trial,
permanent injunctive relief.
WHEREFORE, Plaintiff, PEOPLE OF THE STATE OF ILLINOIS, respectfully requests
this Court to enter a preliminary and, after trial, permanent injunction in favor of Plaintiff and
against Defendant, STERIGENICS U.S., LLC, a Delaware limited liability company, with respect
to Count I:
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1. Finding that the Defendant has violated Section 9(a) of the Act, 415 ILCS 5/9(a)
(2016), and Section 201.141 ofthe Board Air Pollution Regulations, 35111. Adm. Code 201.141;
2. Enjoining the Defendant from any future violations of Section 9(a) ofthe Act, 415
ILCS 5/9(a) (2016), and Section 201.141 of the Board Air Pollution Regulations, 35 Ill. Adm.
Code 201.141;
3. Setting operational limits on the Source, including ordering the Defendant to cease
operations if warranted, or setting EtO emission limits on the Source so as to ensure the protection
of public health and the elimination ofthe threat of air pollution in the surrounding community;
4. Ordering the Defendant to immediately undertake the necessary action that will
result in a final and permanent abatement of violations' of Section 9(a) ofthe Act, 415 ILCS 5/9(a)
(2016), and Section 201.141 of the Board Air Pollution Regulations, 35 Ill. Adm. Code 201.141,
including but not limited to, taking all steps necessary to ensure the protection of public health and
the elimination of the threat of air pollution in the surrounding community, and performing
ambient air monitoring at and around the Source in accordance with an approved sampling plan as
well as conducting an updated cancer risk analysis. The ambient air monitoring and risk
assessment shall be performed by independent contractors approved by the State and pursuant to
plans approved by the State.
5. Assessing a civil penalty against the Defendant of Fifty Thousand Dollars
($50,000.00) for each violation of the Act and pertinent regulations, and an additional civil penalty
ofTen Thousand Dollars ($10,000.00) for each day of violation;
6. Ordering the Defendant to pay all costs including attorney, expert witness and
consultant fees expended by the State in its pursuit of this action pursuant to 415 ILCS 5/42(f)
(2016); and
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7. Granting such other relief as this Court deems appropriate and just.
COUNT IICOMMON LAW PUBLIC NUISANCE
1. This count is brought on behalf of the PEOPLE OF THE STATE OF ILLINOIS,
ex rei. LISA MADIGAN, Attorney General of the State of Illinois, on her own motion, and ex
rei. ROBERT BERLIN, State's Attorney ofDuPage County, Illinois, on his own motion. The
Attorney General is the chieflegal officer of the State ofIllinois having the powers and duties
prescribed by the law, ILL. CONST. Article V, Section 15 (1970). The DuPage County State's
Attorney is an elected county officer having the powers and duties prescribed by the law, ILL.
CONST. Article VI, Section 19 and Article VII, Section 4 (1970). This count is brought pursuant
to the power of the Attorney General and State's Attorney to institute an action on behalf of the
People of the State of Illinois to abate a public nuisance and to protect the health, safety and
welfare of the People of the State of Illinois.
2-59. Plaintiffrealleges and incorporates by reference herein paragraphs 4 through 61
of Count I as paragraphs 2 through 59 of this Count II.
60. The Defendant, by its actions, has caused and continues to cause an unreasonable
and substantial prejudice to the public health and welfare and the environment, to wit, 1)
beginning on or before January 30, 2006 and continuing to the present, the Defendant has
discharged or emitted from the Source into the surrounding area tens of thousands of pounds of
EtO; 2) The Defendant's allowable emissions of approximately 18.2 tons (36,400 pounds) per
year of EtO, a known carcinogen, into the atmosphere near residences and places of business (a)
threaten to injure the health of people living and working near the Source, (b) have caused fear in
the community due to the threat to public health, and (c) interfere with the enjoyment and use of
their homes and work places.
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61. As a consequence of its actions as alleged herein, the Defendant has created and
maintained a public nuisance at common law.
62. Plaintiff is without an adequate remedy at law. Plaintiff will be irreparably
injured, and violations of the applicable and pertinent environmental statutes and regulations will
continue unless and until this court grants equitable relief in the form of preliminary and, after
trial, permanent injunctive relief.
WHEREFORE, Plaintiff, PEOPLE OF THE STATE OF ILLINOIS, respectfully requests
this Court to enter a preliminary and, after trial, permanent injunction in favor of Plaintiff and
against Defendant, STERIGENICS U.S., LLC, a Delaware limited liability company, with respect
to Count II:
1. Finding that the Defendant has created and maintained a common law public
nuisance at and around the Source;
2.· Setting operational limits on the Source, including ordering the Defendant to cease
operations if warranted, or setting EtO emission limits on the Source so as to ensure the protection
of public health and the elimination of the threat of air pollution in the surrounding community,
and abatement of the public nuisance;
3. Enjoining the Defendant from maintaining a common law public nuisance at and
around the Source;
4. Ordering the Defendant to immediately undertake the necessary action that will
result in a final and permanent abatement of the common law public nuisance.
5. Ordering the Defendant to pay all costs including attorney, expert witness and
consultant fees expended by the State in its pursuit of this action; and
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6. Granting such other relief as this Court deems appropriate and just.
Respectfully submitted,
PEOPLE OF THE STATE OF ILLINOISex ref. LISA MADIGAN, Attorney Generalof the State of Illinois
MATTHEW 1. DUNN, ChiefEnvironmental Enforcement!AsbestosLitigation Division
BY:
BY:
Of Counsel:
Daniel I. RottenbergStephen J. SylvesterAssistant Attorneys GeneralEnvironmental Bureau69 West Washington Street, 18th FloorChicago, Illinois 60602(312) 814-3816/[email protected]@atg.state.il.usSecondary: [email protected]
18
~4ht~IZABE WALLACE, ChIef
Environmental BureauAssistant Attorney General
PEOPLE OF THE STATE OF ILLINOISex ref. ROBERT B. BERLIN, State'sAttorney for DuPage County, Illinois
LISA SMITHAssistant State's Attorney
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EXHIBIT B FILE
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1
IN THE CIRCUIT COURT OF THE EIGHTEENTH JUDICIAL CIRCUIT
DUPAGE COUNTY, ILLINOIS
CHANCERY DIVISION
PEOPLE OF THE STATE OF ILLINOIS, )
ex rel. KWAME RAOUL, Attorney General )
of the State of Illinois, and )
ex rel. ROBERT BERLIN, State’s Attorney )
for DuPage County, Illinois, )
)
Plaintiff, )
)
v. ) No. 2018 CH 001329
)
STERIGENICS U.S., LLC, )
a Delaware limited liability company, )
f/k/a SteriGenics International, Inc., )
)
Defendant. )
FIRST AMENDED COMPLAINT
FOR INJUNCTIVE RELIEF AND CIVIL PENALTIES
Plaintiff, PEOPLE OF THE STATE OF ILLINOIS, ex rel. KWAME RAOUL, Attorney
General of the State of Illinois, on his own motion, and ex rel. ROBERT BERLIN, State’s Attorney
of DuPage County, Illinois, on his own motion, complains of Defendant, STERIGENICS U.S.,
LLC, a Delaware limited liability company (f/k/a SteriGenics International, Inc.) (“Sterigenics” or
“Defendant”), as follows:
COUNT I
CAUSING, THREATENING, OR ALLOWING AIR POLLUTION
1. This Count is brought on behalf of the People of the State of Illinois, ex rel. Kwame
Raoul, Attorney General of the State of Illinois, and ex rel. Robert Berlin, State’s Attorney of
DuPage County, on their own motion, against Defendant, pursuant to Sections 42(d) and (e) of the
Illinois Environmental Protection Act (“Act”), 415 ILCS 5/42(d) & (e) (2018).
TRAN# : 170431241179/( 4540581 )2018CH001329FILEDATE : 06/06/2019Date Submitted : 06/06/2019 02:22 PMDate Accepted : 06/06/2019 04:01 PMTEELING,AMY
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2
2. This Count is also brought at the request of the Illinois Environmental Protection
Agency (“Illinois EPA”).
3. Illinois EPA is an administrative agency of the State of Illinois, established by
Section 4 of the Act, 415 ILCS 5/4 (2018), and is charged, inter alia, with the duty of enforcing
the Act.
4. In or about 1984, Griffith Laboratories U.S.A., Inc. began operating a contract
sterilization facility at 7775 South Quincy Street, Willowbrook, DuPage County, Illinois
(“Willowbrook I”).
5. Between 1999 and 2006, two changes of control occurred with respect to
Defendant. In 1999, Ion Beam Applications acquired Griffith Micro Science, Inc. (“Griffith Micro
Science”) and SteriGenics International, Inc., which in 2005 changed its name to Sterigenics U.S.,
LLC. In 2005, a successor to Griffith Micro Science merged into Defendant.
6. Since at least January 30, 2006, Defendant has been and is a Delaware limited
liability company, duly authorized to transact business in the State of Illinois.
A. Background
7. Between 1999 and February 15, 2019, and on dates better known to Defendant,
Defendant (whether named Sterigenics International, Inc. or Sterigenics U.S., LLC) conducted
commercial sterilization operations in Illinois, utilizing ethylene oxide (“EtO”), at Willowbrook I
and 830 Midway Street, Willowbrook, DuPage County (“Willowbrook II” and together with
Willowbrook I, the “Source”).
8. The Source is in a densely populated residential, industrial and commercial area,
with 19,271 people living within 1 mile of the Source boundary. The Source is located in an
industrial park that is surrounded by, and in close proximity to, residential neighborhoods, schools,
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daycare facilities, businesses, and parks, including but not limited to, the following:
a. Homes (less than 0.25 miles);
b. Schools: Gower Middle (0.42 miles), St. Mark Christian Montessori (0.70
miles), Hinsdale South High School (0.76 miles), Gower West (0.79 miles),
Kingswood Academy (0.87 miles), KinderCare (1.0 mile), Our Lady of
Peace School (1.22 miles), Concord Elementary (1.62 miles), Ready Set
Grow (1.76 miles), Burr Ridge Middle School (1.86 miles);
c. Parks and Government Buildings: Willowbrook Police Department and
Mayor’s Office (0.07 miles), Willowbrook Community Park (0.45 miles),
Indian Prairie Library (0.97 miles), Harvester Park (1.0 mile), Whittaker
Park (1.03 miles), Burr Ridge Police Department (1.19 miles); and
d. Businesses: Dance Duo Studio (0.1 miles), Dell Rhea’s Chicken Basket
(0.16 miles), Denny’s (0.18 miles), Target (0.19 miles), WEST Superior
Training (0.19 miles), La Quinta Inn (0.29 miles), Red Roof PLUS+ (0.3
miles), Diamond Edge Training (0.3 miles), BIG Gymnastics (0.68 miles),
Darien Sportsplex (1.0 mile).
9. On February 15, 2019, Illinois EPA issued a “Seal Order” for the Source. A true
and correct copy of the Seal Order is attached hereto as Exhibit 1.
10. Between 1999 and February 15, 2019, and on such dates better known to
Defendant, Defendant operated at least fourteen commercial sterilization chambers at
Willowbrook I and four commercial sterilization chambers at Willowbrook II.
11. Each commercial sterilization chamber at the Source is steam-heated and contains
a recirculating vacuum pump chamber evacuation system, a backvent valve and a fugitive
emissions exhaust hood.
12. During the sterilization process, Defendant places medical equipment and other
products (together, “Products”) into individual chambers, and EtO is introduced. During this
process, the chambers are sealed. After a certain residence time, Defendant evacuates EtO from
the chambers. After the gas is pumped out of the chambers, air is introduced into the chambers.
When air is introduced into the chambers, the chamber doors are opened, and residual amounts of
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EtO are vented through the “backvent valves.”
13. Upon completion of a sterilization cycle in Willowbrook I, EtO and other gases
evacuated from the chambers in Willowbrook I are pumped to a Chemrox DEOXX packed tower
chemical scrubber (“Acid Water Scrubber #1”). Products are then removed from the commercial
sterilization chamber and placed in one of the three aeration rooms at Willowbrook I, where EtO
continues to volatilize, or off-gas, from the sterilized Products. Emissions from the aeration rooms
at Willowbrook I are captured and treated by a two-stage Advanced Air Technologies Safe Cell
emission-control system (“Acid Water Scrubber #2”) and dry bed reactor.
14. Upon completion of a sterilization cycle in Willowbrook II, EtO and other gases
evacuated from the chambers in Willowbrook II are routed to a two-stage Advanced Air
Technologies Safe Cell emission-control system (“Willowbrook II Scrubber”) and dry bed reactor.
Products are then removed from the commercial sterilization chambers and placed in one of the
two aeration rooms at Willowbrook II, where EtO continues to volatilize, or off-gas, from the
sterilized Products. Emissions from the aeration rooms at Willowbrook II are captured and treated
by the Willowbrook II Scrubber and dry bed reactor.
15. The three scrubber systems and two dry bed reactors at the Source are collectively
referred to in this Complaint as “the Scrubbers.” The Scrubbers are the sole method used by
Defendant to control EtO emissions from the Source.
16. Between 1999 and February 15, 2019, and on such dates better known to
Defendant, Defendant discharged and emitted EtO to the atmosphere as part of its operations at
the Source.
17. EtO is a listed “hazardous air pollutant” under Section 112 of the Clean Air Act, 42
U.S.C. § 7412(b)(1).
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B. CAAPP Permit and Construction Permit
18. On January 30, 2006, Illinois EPA issued Clean Air Act Permit Program Permit
No. 95120085 to Defendant, which Illinois EPA renewed on June 8, 2015 (collectively, the
“CAAPP Permit”). The CAAPP Permit refers to Defendant as the “source” throughout. Since
January 30, 2006, Defendant has been, and continues to be, the permitted operator of the Source.
19. The CAAPP Permit includes the Clean Air Act National Emission Standard for
Hazardous Air Pollutants (“NESHAP”) for EtO emissions from sterilization facilities, 40 C.F.R.
Part 63, Subpart O, which requires facilities to control EtO emissions from the vacuum pump
chamber evacuation systems and aeration rooms by at least 99.0%. The NESHAP does not require
that facilities control EtO emissions from the backvent valves.
20. The CAAPP Permit allows Defendant to utilize up to 542.1 tons (1,084,200 pounds)
of EtO per year in its operations at the Source.
21. The CAAPP Permit allows Defendant to emit approximately 18.2 tons (36,400
pounds) of EtO per year.
22. On June 26, 2018, Illinois EPA issued Defendant permit no. 18060020 to duct the
emissions of EtO from the backvent valves of the sterilization chambers to the existing Scrubbers
(“Construction Permit”). Illinois EPA received this construction permit application on June 11,
2018.
23. On or about July 27, 2018, Defendant completed the modifications to its air
pollution control equipment by ducting (a) the emissions from the backvent valves at Willowbrook
I to Acid Water Scrubber #2 and the dry bed reactor, and (b) the emissions from the backvent
valves at Willowbrook II to the Willowbrook II Scrubber and the dry bed reactor.
24. Prior to modifying its air pollution control equipment to control the emissions of
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EtO from the backvent valves of the sterilization chambers, Defendant allowed the uncontrolled
emissions of EtO from the backvent valves.
25. Once the backvent valves were ducted to the Scrubbers, those emissions also
became and are subject to the 99.0% control efficiency.
C. Annual Emissions Reporting
26. Between 1984 and 1992, the predecessor to the Defendant who owned and/or
operated the Source, emitted EtO.
27. Section 3.5.c of the CAAPP Permit provides as follows:
Annual Emissions Reporting
Pursuant to 35 IAC Part 254, the Source shall submit an Annual Emission Report
to the [Illinois EPA], due by May 1 of the year following the calendar year in which
the emissions took place. All records and calculations upon which the verified and
reported data are based must be retained by the source.
28. Beginning in 19931 and continuing through 1998, the owner and/or operator of the
Source reported in its Annual Emission Reports that it released the following amounts of EtO to
the atmosphere:
Year EtO Released (lbs.)
1993 10,780
1994 9,600
1995 21,320
1996 21,720
1997 30,800
1998 35,400
1 Illinois EPA’s Part 254 Rules (Annual Emissions Report) were first adopted on May 14, 1993. Hence,
calendar year 1993 is the first Annual Emissions Report available for the Source.
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29. In the Annual Emission Reports that it submitted to Illinois EPA, Defendant
reported releasing the following amounts of EtO to the atmosphere during the years 1999 to 2018:
Year EtO Released (lbs.)
1999 15,940
2000 10,380
2001 6,146
2002 5,750
2003 5,200
2004 6,200
2005 5,800
2006 4,760
2007 7,340
2008 7,080
2009 5,600
2010 6,440
2011 6,980
2012 6,980
2013 5,960
2014 5,080
2015 4,600
2016 4,200
2017 4,600
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2018 2,840
D. Ethylene Oxide is a Known Human Carcinogen that Presents a Public Health Hazard.
30. EtO is highly reactive, readily absorbed, and easily distributed in the human body.
EtO is mutagenic and causes chromosome damage in many species, including humans.
31. From 1985 to 2016, the United States Environmental Protection Agency (“U.S.
EPA”) categorized EtO as “probably carcinogenic to humans”.
32. In December 2016, U.S. EPA’s Integrated Risk Information System (“IRIS”)
program released an “Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide” (“2016
IRIS Evaluation”). In the 2016 IRIS Evaluation, U.S. EPA changed EtO’s weight of evidence
descriptor from “probably carcinogenic to humans” to “carcinogenic to humans.” In addition, the
U.S. EPA also increased EtO’s adult-based-lifetime inhalation cancer unit risk estimate about 50-
fold in the 2016 IRIS Evaluation. The 2016 IRIS Evaluation is incorporated by reference herein.2
33. In the 2016 IRIS Evaluation, U.S. EPA noted that an increased incidence and
mortality of breast and lymphohematopoietic system cancers have been observed in workers in
EtO sterilizing facilities.
34. In the 2016 IRIS Evaluation, U.S. EPA determined that there is sufficient evidence
to establish a causal relationship between EtO exposure and breast cancer in women.
35. As a mutagenic carcinogen, EtO causes cancer by damaging DNA in cells which is
then replicated when the cells divide. Repeated exposure over time to EtO increases the cancer
risk compared to a one-time exposure. This increase occurs because DNA damage may take place
with each and every exposure that is passed on to more cells, increasing the number of mutated
2 Available at http://ofmpub.epa.gov/eims/eimscomm.getfile?p_download_id=529970 (accessed on May
31, 2019).
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cells, which eventually leads to cancer in some people.
36. According to U.S. EPA’s website:3 (a) for a single year of exposure to EtO, the
cancer risk is greater for children than for adults; (b) this elevated risk to children exists because
EtO can damage DNA, and children have more years ahead of them to develop the other cancer
risk factors that result in the formation of malignant cells, and (c) compared to adults, children
receive larger doses per body weight because they have greater lung surface area and increased
lung volume per body weight, and breathe in more air per body weight.
37. According to 2010 U.S. Census Data, 3,494 children 5 years and younger lived
within 3 miles of the Source in 2010, including 250 that lived within 1 mile.
38. According to the 2014 National Air Toxics Assessment (“NATA”) released by U.S.
EPA in August 2018, seven census tracts near the Source are among 109 nationwide that have
cancer risk scores greater than 100 in 1 million, or 1 in 10 thousand, meaning that in those census
tracts hazardous air pollution may cause more than one additional incidence of cancer per 10
thousand people. There are a total of 73,057 census tracts in the United States.
39. Between May 16, 2018 and May 17, 2018, U.S. EPA collected 39 ambient air
samples at 26 discrete locations near the Source (“May 2018 Sampling Event”). All of these
samples were collected in proximity to the various public places listed in Paragraph 10 supra.
40. U.S. EPA modeled short and long-term ambient EtO concentrations to evaluate the
impact of emissions from the Source using, among other data, the National Emissions Inventory
(“NEI”) data from 2014.
41. In June 2018, U.S. EPA provided the analytical data from the May 2018 Sampling
3 Available at https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/frequent-questions-ethylene-
oxide (accessed on May 31, 2019).
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Event and the modeled ambient EtO concentrations to the United States Department of Health &
Human Services Agency for Toxic Substances and Disease Registry (“ATSDR”). At the same
time, U.S. EPA: “requested that ATSDR review air measurements of EtO and modeling results of
EtO emissions from Sterigenics and specifically answer the question: If modeled and measured
ethylene oxide concentrations represent long term conditions, would they pose a public health
problem for people living and working in Willowbrook?”4
42. In a letter dated July 26, 2018, ATSDR responded to the U.S. EPA’s inquiry (“July
26 Letter”) set forth in Paragraph 41.
43. Thereafter, on August 21, 2018, the July 26 Letter was released to the public as a
“Letter Health Consultation.” A true and correct copy of the Letter Health Consultation is attached
hereto as Exhibit 2 and incorporated by reference herein.
44. In the Letter Health Consultation, the ATSDR provided to U.S. EPA its answer to
the question set forth in Paragraph 41 above:
It is ATSDR’s conclusion that the data U.S. EPA provided suggests that residents
and workers are exposed to elevated airborne EtO concentrations from facility
emissions. It is difficult to assess long-term public health implications from facility
emissions because there has been no historical air monitoring in the community.
ATSDR assumed that these data represent long term exposures for area residents
and workers. Specifically, ATSDR concludes the following:
1) If measured and modeled data represent typical EtO ambient concentrations in
ambient air, an elevated cancer risk exists for residents and off-site workers in
the Willowbrook community surrounding the Sterigenics facility. These
elevated risks present a public health hazard to these populations.
2) Measured and modeled ethylene oxide concentrations in ambient air indicate
that non-cancer health effects are unlikely for residents and off-site workers in
the Willowbrook community surrounding the Sterigenics facility.
45. In its analysis underlying the Letter Health Consultation, ATSDR “used the
4 See Ex. 2, Letter Health Consultation at p. 1.
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maximum recorded EtO sample taken near a residence” close to the Source to conclude that the
lifetime risk for the area surrounding the Source is an additional 64 incidences of cancer per 10,000
people, or 64 times what U.S. EPA considers to be an acceptable risk.
46. ATSDR’s conclusions that (a) an elevated cancer risk exists for residents and off-
Source workers in the Willowbrook community and (b) these elevated risks present a “public
health hazard,” are based on EtO emissions that are substantially lower than 18.2 tons (36,400
pounds)—the maximum emissions level set by the CAAPP Permit Defendant received in 2015,
prior to the 2016 IRIS Evaluation, the May 2018 Sampling Event, and ATSDR’s 2018 analysis
reflected in the Letter Health Consultation.
47. On March 29, 2019, the Illinois Department of Public Health (“IDPH”) released a
“Cancer Incidence Assessment near Sterigenics in Willowbrook, IL, 1995-2015” (“Assessment”).
The Assessment is attached hereto as Exhibit 3 and incorporated by reference herein.
48. In the Assessment, IDPH found “[s]ignificantly elevated Hodgkin’s lymphoma
cases in females” in the area around the Source as compared to county and state5 averages.6 Female
breast cancer was elevated in the area surrounding the Source as compared to the state average.
Female breast cancer was not elevated in the area surrounding the Source as compared to the
county average.
49. On May 29, 2019, U.S. EPA released the results from a risk assessment that used
modeling to determine the cancer risk from the Source after the backvent valves were ducted to
5 In the Assessment, IDPH deemed the term “county” to be DuPage County and the term “state” to be
the five suburban collar counties, including Lake, McHenry, Kane, DuPage, and Will Counties. Assessment
at pp. 11, 29. 6 See infra at pp. 3, 13.
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the Scrubbers.7 The risk assessment found an estimated residential lifetime cancer risk from EtO
emissions from the Source as high as an additional 10 incidences of cancer per 10,000 people, or
10 times what U.S. EPA considers to be acceptable. The risk assessment also found a lifetime
cancer risk for people who work close to the Source from EtO emissions from the Source as high
as an additional 10 incidences of cancer per 10,000 people, or 10 times what U.S. EPA considers
to be acceptable. According to U.S. EPA, these estimated risks “require regulatory action.”
E. Village and U.S. EPA Sampling Near the Source
50. Between November 13, 2018 and March 31, 2019, U.S. EPA conducted ambient
air sampling of EtO concentrations at locations near the Source. A true and correct copy of the
results of such sampling is attached hereto as Exhibit 4.
51. The U.S. EPA’s results set forth in Exhibit 4 include multiple instances whereby
such results were substantially higher than the highest applicable residential and commercial
results which ATSDR utilized in reaching its conclusions that “an elevated cancer risk exists for
residents and off-site workers in the Willowbrook community surrounding the Sterigenics facility
[and that][t]hese elevated cancer risks present a public health hazard to these populations.”8
52. These sample results were higher than those obtained the May 2018 Sampling
Event even though, as set forth in paragraphs 24 and 27 herein, Defendant completed a
construction project to duct the emissions of ethylene oxide from the backvent valves of
Defendant’s sterilization chambers to existing Scrubbers, which Defendant publicly claimed
7 See U.S. EPA Risk Assessment for Sterigenics – Willowbrook
https://www.epa.gov/sites/production/files/2019-05/documents/risk-assessment-results-sterigenics
willowbrook.pdf (accessed on May 31, 2019). 8 See Ex. 2, Letter Health Consultation at 12.
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would reduce its emissions by 90%.9
53. On November 16-17 and February 5-17, 2019, the Village of Willowbrook
(“Village”) conducted ambient air sampling of EtO concentrations at locations near the Source. A
true and correct copy of the results of such sampling is attached hereto as Exhibit 5.
54. The Village’s sampling had multiple results that were many times higher than any
previous results collected.
55. Since Illinois EPA’s issuance of the Seal Order on February 15, 2019, the ambient
air concentrations of EtO at locations near the Source have substantially decreased. See Exhibit 4.
F. Public Concern
56. As of June 3, 2019, Illinois EPA has been contacted more than 200 times by
members of the public to express their concerns regarding the Source’s EtO emissions.
57. As of June 3, 2019, more than 175 people have contacted the Illinois Attorney
General’s Office to express their concerns regarding the Source’s EtO emissions.
58. As of June 3, 2019, 33,336 people had signed a petition entitled “Action Alert:
Illinois, Say ‘No’ to toxic air” on the website www.change.org. The petition expresses the public’s
overwhelming concerns regarding the impact of Defendant’s EtO emissions on the surrounding
community. The concerns include the following:
a. Detrimental health impacts to their children swimming at a pool located
across the street from the Source.
b. The general safety of families in the area.
c. The mutagenic effects of EtO on children in the area.
9 See https://www.sterigenicswillowbrook.com/s/Sterigenics-Response-Letter-to-Mayor-of-Willowbrook-
090318-tm59.pdf (accessed on May 31, 2019).
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d. Fear that past and current incidents of cancer in the area were caused by the
Source.
e. A desire to have residents’ children and grandchildren breathing safe air.
f. The number of individuals in the community with cancer.
g. Past exposure to EtO from the Source.
h. The location of the Source in such a densely populated area.
G. Air Pollution Violations
59. Article XI of the Illinois Constitution provides, in pertinent part, as follows:
SECTION 1. PUBLIC POLICY - LEGISLATIVE RESPONSIBILITY
The public policy of the State and the duty of each person is to provide and maintain
a healthful environment for the benefit of this and future generations. The General
Assembly shall provide by law for the implementation and enforcement of this
public policy.
SECTION 2. RIGHTS OF INDIVIDUALS
Each person has the right to a healthful environment. . . .
60. In fulfillment of the Constitutional requirement to protect each person’s right to a
healthful environment, the General Assembly adopted the Act.
61. Section 9(a) of the Act, 415 ILCS 5/9(a) (2018), provides as follows:
No person shall:
(a) Cause or threaten or allow the discharge or emission of any
contaminant into the environment in any State so as to cause or tend
to cause air pollution in Illinois, either alone or in combination with
contaminants from other sources, or so as to violate regulations or
standards adopted by the Board under this Act.
62. Section 201.141 of the Illinois Pollution Control Board (“Board”) Air Pollution
Regulations, 35 Ill. Adm. Code 201.141, provides, in relevant part, as follows:
Prohibition of Air Pollution
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No person shall cause or threaten or allow the discharge or emission of any
contaminant into the environment in any State so as, either alone or in combination
with contaminants from other sources, to cause or tend to cause air pollution in
Illinois, or so as to violate the provisions of this Chapter . . . .
63. Section 2.7(c) of the CAAPP Permit provides as follows:
Pursuant to Section 39.5(7)(a) of the Act, the issuance of this permit by the IEPA
does not and shall not be construed as barring, diminishing, adjudicating or in any
way affecting any currently pending or future legal, administrative or equitable
rights or claims, actions, suits, causes of action or demands whatsoever, that the
IEPA or the USEPA may have against the applicant including, but not limited to,
any enforcement action authorized pursuant to the provision of applicable federal
and state law.
64. Section 3.315 of the Act, 415 ILCS 5/3.315 (2018), provides the following
definition:
“Person” is any individual, partnership, co-partnership, firm, company, limited
liability company, corporation, association, joint stock company, trust, estate,
political subdivision, state agency, or any other legal entity, or their legal
representative, agent or assigns.
65. Defendant, a limited liability company, is a “person” as that term is defined in
Section 3.315 of the Act, 415 ILCS 5/3.315 (2018).
66. Section 3.115 of the Act, 415 ILCS 5/3.115 (2018), provides the following
definition:
“Air pollution” is the presence in the atmosphere of one or more
contaminants in sufficient quantities and of such characteristics and
duration as to be injurious to human, plant, or animal life, to health, or to
property, or to unreasonably interfere with the enjoyment of life or property.
67. Section 3.165 of the Act, 415 ILCS 5/3.165 (2018), provides the following
definition:
“Contaminant” is any solid, liquid, or gaseous matter, any odor, or any form
of energy, from whatever source.
68. Section 201.102 of the Board Air Pollution Regulations, 35 Ill. Adm. Code
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201.102, provides the following definition:
“Air Contaminant”: Any solid, liquid or gaseous matter, any odor or any form of
energy that is capable of being released into the atmosphere from an emission
source.
69. The EtO released from the Source is a “contaminant” within the meaning of Section
3.165 of the Act, 415 ILCS 5/3.165 (2018), and an “air contaminant” within the meaning of Section
201.102 of the Board Air Pollution Regulations, 35 Ill. Adm. Code 201.102.
70. Between 1999 and February 15, 2019, and on such dates better known to
Defendant, Defendant discharged or emitted from the Source into the surrounding area thousands
of pounds of EtO, which, as alleged herein, has caused or threatened injury to persons near the
Source and unreasonably interfered with their enjoyment of life or property.
71. For those people who have resided near the Source over a period of years, the public
health concerns with EtO are exacerbated due to the increased risk caused by exposure over a
lifetime.
72. The threat to human health is particularly heightened in children, who have an
increased susceptibility from exposure to EtO, a known human carcinogen. The unreasonable
interference with enjoyment of life and property is particularly heightened for parents of children
who live near the Source and are legitimately concerned about the health and welfare of their
children as it relates to exposure to EtO.
73. Defendant’s emissions of EtO, a known human carcinogen, into the atmosphere
near residences and places of business in the Willowbrook community (a) threaten to injure the
health of people living, attending school, recreating, working, and shopping near the Source,
(b) have caused fear in the community due to the threat to public health, and (c) interfere with the
enjoyment and use of their homes and work places, thereby constituting “air pollution” as that term
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is defined in Section 3.115 of the Act, 415 ILCS 5/3.115 (2018).
74. By causing, threatening, or allowing the discharge or emission of EtO, a
contaminant, into the environment so as to cause air pollution, Defendant violated Section 9(a) of
the Act, 415 ILCS 5/9(a) (2018), and Section 201.141 of the Board Air Pollution Regulations, 35
Ill. Adm. Code 201.141.
75. Violations of the pertinent environmental statutes and regulations will continue
unless and until this Court grants equitable relief in the form of preliminary and, after trial,
permanent injunctive relief.
WHEREFORE, Plaintiff, PEOPLE OF THE STATE OF ILLINOIS, respectfully requests
that this Court enter a preliminary and, after trial, permanent injunction in favor of Plaintiff and
against Defendant, STERIGENICS U.S., LLC, a Delaware limited liability company, with respect
to Count I:
A. Finding that Defendant has violated Section 9(a) of the Act, 415 ILCS 5/9(a)
(2018), and Section 201.141 of the Board Air Pollution Regulations, 35 Ill. Adm. Code 201.141;
B. Enjoining Defendant from any future violations of Section 9(a) of the Act, 415
ILCS 5/9(a) (2018), and Section 201.141 of the Board Air Pollution Regulations, 35 Ill. Adm.
Code 201.141;
C. Setting operational limits on the Source, so as to ensure the protection of public
health and the elimination of the threat of air pollution to the surrounding community;
D. Ordering Defendant to immediately undertake the necessary action that will result
in a final and permanent abatement of violations of Section 9(a) of the Act, 415 ILCS 5/9(a) (2018),
and Section 201.141 of the Board Air Pollution Regulations, 35 Ill. Adm. Code 201.141, including
but not limited to, taking all steps necessary to ensure the protection of public health and the
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elimination of the threat of air pollution to the surrounding community, capturing 100% of all EtO
emissions and reducing EtO emissions to the atmosphere from each exhaust point at the Source by
at least 99.9% or to 0.2 parts per million;
E. Assessing a civil penalty against Defendant of Fifty Thousand Dollars ($50,000.00)
for each violation of the Act and pertinent regulations, and an additional civil penalty of Ten
Thousand Dollars ($10,000.00) for each day of violation;
F. Ordering Defendant to pay all costs including attorney, expert witness and
consultant fees expended by the State in its pursuit of this action pursuant to 415 ILCS 5/42(f)
(2018); and
G. Granting such other relief as this Court deems appropriate and just.
COUNT II
COMMON LAW PUBLIC NUISANCE
1-60. Plaintiff realleges and incorporates by reference herein paragraphs 1 through 60
of Count I as paragraphs 1 through 60 of this Count II.
61. The Attorney General is the chief legal officer of the State of Illinois having the
powers and duties prescribed by the law, ILL. CONST. Article V, Section 15 (1970). The DuPage
County State's Attorney is an elected county officer having the powers and duties prescribed by
the law, ILL. CONST. Article VI, Section 19 and Article VII, Section 4 (1970). This count is
brought pursuant to the power of the Attorney General and State's Attorney to institute an action
on behalf of the People of the State of Illinois to abate a public nuisance and to protect the health,
safety and welfare of the People of the State of Illinois.
62. Defendant, by its actions, has caused and continues to cause an unreasonable and
substantial risk to the public health and welfare and the environment, to wit, (a) between 1999 and
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February 15, 2019, and on such other dates better known to Defendant, Defendant discharged or
emitted from the Source into the surrounding area tens of thousands of pounds of EtO; and (b)
Defendant’s emissions of EtO, a known human carcinogen, into the atmosphere near residences
and places of business in the Willowbrook community (i) threaten to injure the health of people
living and working near the Source, (ii) have caused fear in the community due to the threat to
public health, and (iii) interfere with the enjoyment and use of their homes and work places.
63. As a consequence of its actions as alleged herein, Defendant has created and
maintained a public nuisance at common law.
64. Plaintiff is without an adequate remedy at law. Plaintiff will be irreparably injured,
and violations of the applicable and pertinent environmental statutes and regulations will continue
unless and until this Court grants equitable relief in the form of preliminary and, after trial,
permanent injunctive relief.
WHEREFORE, Plaintiff, PEOPLE OF THE STATE OF ILLINOIS, respectfully requests
that this Court enter a preliminary and, after trial, permanent injunction in favor of Plaintiff and
against Defendant, STERIGENICS U.S., LLC, a Delaware limited liability company, with respect
to Count II:
A. Finding that Defendant has created and maintained a common law public nuisance
at and around the Source;
B. Setting operational limits on the Source, so as to ensure the (a) protection of public
health, (b) elimination of the threat of air pollution to the surrounding community, and (c)
abatement of the public nuisance;
C. Enjoining, or continuing to enjoin, Defendant from maintaining a common law
public nuisance at and around the Source;
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D. Ordering Defendant to immediately undertake, or continue to undertake, the
necessary action that will result in a final and permanent abatement of the common law public
nuisance;
E. Ordering Defendant to reimburse the State of Illinois for the costs incurred to abate
the nuisance; and
F. Granting such other relief as this Court deems appropriate and just.
Respectfully submitted,
PEOPLE OF THE STATE OF ILLINOIS
ex rel. KWAME RAOUL, Attorney General
of the State of Illinois
MATTHEW J. DUNN, Chief
Environmental Enforcement/Asbestos
Litigation Division
BY: /s/ Elizabeth Wallace
ELIZABETH WALLACE, Chief
Environmental Bureau
Assistant Attorney General
PEOPLE OF THE STATE OF ILLINOIS
ex rel. ROBERT B. BERLIN, State’s
Attorney for DuPage County, Illinois
BY: /s/ Lisa Smith
LISA SMITH
Assistant State’s Attorney
Of Counsel:
Daniel I. Rottenberg
Stephen J. Sylvester
Assistant Attorneys General
Environmental Bureau
69 West Washington Street, 18th Floor
Chicago, Illinois 60602
(312) 814-3816/2087
Secondary: [email protected]
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EXHIBIT C FILE
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ORDER 201 8cH00r 329-1 088
FILED19 Sep 12 AM 09:45
U,- il/**-a^CLERK OF THE
18TH JUDICIAL CIRCUIT
DUPAGE COUNTY, ILLINOIS
UNITED STATBS OF AMERICASTATE OF ILLINOIS COUNTY OF DU PAGE
IN THE CIRCUIT COURT OF THE EIGHTEBNTH
PEOPLE OF THE STATE OF ]LLINOIS EX RELLISA MADIGAN AND ROBERT BERLIN
-vs-2018CH00r329
CASE NUMBER
STERIGENICS US LLC
ORDER
This matter is dismissed, with prejudice and without costs, pursuant to the consent order of 9/6/19
Case closed
Submitted by: JUDGE PAUL FULLERTON
DuPage Attorney Number:
Attorney for:
Address:
City/StatelZip:
Phone number:
Entered:,6,@4@MR
JUDGE PAUL FULLERTON
Validation ID : DP-09122019-0945-1857 6
Date:0911212019
CHRIS KACHIROUBAS, CLERK OF THE I8TH JUDICIAL CIRCUIT COURT OWHEATON, ILLINOIS 60187 -07 07
Visit http://www.i2file.net/dv to validate this docurrent. Validation ID: DP-09122019-0945-18576
Page I of I
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IN THE CIRCUIT COURT OF THE 18TH JUDICIAL CIRCUIT DU PAGE COUNTY, ILLINOIS
PEOPLE OF THE STATE OF ILLINOIS, ) ex rel. KWAME RAOUL, et al., ) ) Plaintiffs, ) ) Vs. ) No. 2018 CH 001329 ) STERIGENICS U.S., LLC, a Delaware limited ) liability company, ) ) Defendant. ) Honorable Judge Paul M. Fullerton
INTERVENORS’ COMMENTS TO CONSENT ORDER
Intervenors, VILLAGE OF WILLOWBROOK, CITY OF DARIEN, VILLAGE OF
BURR RIDGE, AND VILLAGE OF HINSDALE1 (collectively “Villages” and/or “Intervenors”)
submit their COMMENTS TO CONSENT ORDER, supported by the attached affidavit and
exhibits:
INTRODUCTION
Since the Court’s July 24, 2019 order, the Villages have received approximately forty-
five (45) written comments from their residents regarding the Consent Order, many of which are
incorporated herein. Almost universally, the residents’ comments assert that they object to the
Consent Order due to their fear for their health because of continued and cumulative exposure to
ethylene oxide (“EtO”)2 if Sterigenics were permitted to resume its operations of one
(“Willowbrook I”) of its two Willowbrook sterilization facilities.
1 According to the 2010 U.S. Census, the Village of Willowbrook had 8,540 residents; the City of Darien had 22,086 residents; the Village of Burr Ridge had 10,559 residents; and the Village of Hinsdale had 16,816 residents; total residents for all four municipalities from 2010 U.S. Census were 58,001 residents. 2 Attached hereto as Exhibit 1 is the Affidavit of Attorney Acker. Attached to the Affidavit of Attorney Acker as Affidavit Exhibit A is a document entitled “Letter Health Consultation” – “Evaluation of Potential Health Impacts from Ethylene Oxide Emissions” – Sterigenics International, Inc. – Willowbrook, Illinois, United States Department of Health and Human Services, Agency for Toxic Substances and Disease Registry (“ATSDR”), Division of Community Health Investigations, Atlanta, Georgia 30333 (August 21, 2018) (“ATSDR – Letter Health
Chris Kachiroubase-filed in the 18th Judicial Circuit CourtDuPage CountyENVELOPE: 6309004 2018CH001329FILEDATE: 8/23/2019 2:18 PMDate Submitted: 8/23/2019 2:18 PMDate Accepted: 8/23/2019 2:43 PMKB
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The Villages likewise object to the entry of the Consent Order and echo the concern of
their residents that significant public safety issues are presented by this matter such that this
Court should exercise its discretion and deny the joint motion for entry of the Consent Order.
The Villages believe that prior to the IEPA Director’s issuance of a “seal order” on February 15,
2019, Sterigenics’s operations using and emitting EtO from Willowbrook I caused a public
nuisance that endangered the health, safety and welfare of the Villages’ residents and workers.
Prior to February 15, 2019, Sterigenics regularly and continuously emitted EtO from its facilities,
resulting in significantly elevated ambient air concentrations of EtO to occur in and around the
Villages.3 Because neither Sterigenics nor the IEPA has provided the Villages with an
explanation supported by a root cause analysis as to how the operation of Sterigenics’ facilities
in the Village of Willowbrook prior to February 15, 2019, caused such elevated ambient air
concentrations of EtO to occur, there is a legitimate concern that fundamental facts may not have
been evaluated fully in order to determine with better certainty the nature and extent of
Sterigenics’ EtO emissions. It should not be forgotten that when IEPA took the extraordinary
step on February 15, 2019, to fully stop the emission of EtO from Willowbrook I (and
Sterigenics’ other nearby facility, Willowbrook II), it did so because the levels of EtO “present a
public health hazard to residents and off-site workers in the Willowbrook community.”
(February 15, 2019, seal order.) These hazards still exist and the harm caused by years of
exposure of EtO cannot be undone. Approval of this Consent Order will obfuscate the basis of
Consultation”); see, Affidavit Exhibit A, pp. 2-7, discussing ambient air testing of EtO done by USEPA in May 2018. Also attached to the Affidavit of Acker as Affidavit Exhibit B is a document entitled “Cancer Incidence Assessment near Sterigenics in Willowbrook, IL, 1995-2015” – A publication of the Illinois Department of Public Health (“IDPH”), Division of Epidemiological Studies, Springfield, Illinois 62761 (March 29, 2019) (“IDPH Assessment”); see, Affidavit Exhibit B, pp. 15-23, discussing elevated risk to Villages’ residents and workers of certain cancers. 3 Id., Affidavit Exhibit C is a document entitled “Risk Assessment Report for the Sterigenics Facility in Willowbrook, Illinois” – United States EPA’s Office of Air Quality Planning and Standards, Office of Air and Radiation (“USEPA”) (August 14, 2019) (“USEPA Report”); see, Affidavit Exhibit C, p. 8; Appendix 1, p. 1-8, discussing ambient air testing of EtO done by USEPA for time period between November 2018 and March 2019.
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the seal order – to preclude further harm to human health and the environment what already had
occurred. Without a thorough understanding of the past issues, it is impossible to confirm the
proposed corrections and their ability to meet the new standards of Section 5/9.16.
If the Consent Order is entered as presented, it will allow Sterigenics to undertake
modifications to Willowbrook I using untested and experimental technology for the control of
the emission of EtO in a densely populated area. The Villages have reason to believe that there is
a dangerous probability that a threatened or potential injury to our residents and workers could
occur should the untested and experimental control technologies fail resulting in renewed and
continued exposure to this carcinogen.
The Consent Order (1) does not provide the Village with adequate protections or
safeguards from continued and future exposure to EtO; and (2) does not afford the Villages with
adequate information or notice regarding whether Sterigenics presently and/or in the future
complies with EtO requirements under Illinois law and regulations. The Consent Order should
not be approved.
To the extent this Court considers entry of the Consent Order, the Villages submit the
following comments to the Consent Order.
COMMENTS TO CONSENT ORDER:
I. Admission of Violations, Lack of Fines, Ambient Air Monitoring Plan.
In order to restore public confidence in this matter, Sterigenics should acknowledge that
it committed violations of State law and should not be permitted to deny the same as provided in
Paragraph I.C. Likewise, a court-approved order which imposes no fine or penalty against
Sterigenics for past conduct as provided in Paragraph III.B sends the wrong message to the
public that Sterigenics is not being held accountable for its past conduct. To the extent that
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Sterigenics is required to undertake a “Beneficial Project(s)” in the amount of $300,000 pursuant
to Paragraph III.A., it is presently unclear how such project will benefit the environment of the
Villages.
The provision for ambient air testing provided in Paragraph III.D.3.b. is the one item of the
Consent Order that has the potential to provide the Villages with the benefit of objective,
quantifiable and scientific information as to the quality of the ambient air its residents and
workers are breathing. In addition to the “Air Monitoring Plan” as provided in Paragraph
III.D.3.b., the Villages suggest that Sterigenics be required to pay for ambient air testing to occur
at sites in each of the Villages for a continuous and ongoing period of time, at least for the five-
year period of the Consent Order, and to be performed by a vendor chosen by the Villages, with
periodic reporting to the Court.
The “Air Monitoring Plan4” as provided in Paragraph III.D.3.b. should be prepared by
Sterigenics and submitted to IEPA for approval prior to the entry of the Consent Order so that
the specifics of the “Air Monitoring Plan” are known and made a part of the Consent Order. For
example, although Paragraph III.5. of the Consent Order provides that Sterigenics is to
immediately cease operations in the event the “Stack Testing” (emissions testing of control
system at Willowbrook I) demonstrates that the Required Control Efficiency is not being met,
there is nothing in the Consent Order defining the consequences of elevated concentrations
detected during ambient air testing conducted pursuant the required “Air Monitoring Plan.” The
Consent Order also does not provide a level of EtO detected during ambient air testing that will
be considered safe or acceptable and more importantly, levels that are considered unacceptable
or unsafe. It is essential that the Consent Order give meaning to the ambient air testing by setting
4 Attached to the Affidavit of Attorney Acker as Affidavit Exhibit D is a copy of the Villages’ comments to the IEPA draft construction permit for Sterigenics dated August 15, 2019, see, Sec. 1,ii.c., p. 2, discussing “Ambient Air Monitoring Plan” requirements. The Villages incorporate by reference these comments herein.
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a clear standard as to the acceptable or safe level of EtO detected during the ambient air testing,
and the operational consequences of detecting levels that exceed that defined standard.
The Villages’ request language requiring (i) that ambient air testing take place in appropriate
locations within each of the Villages boundaries, and (ii) that the Villages be provided with the
funding to retain a consultant of their choosing to independently perform air testing and confirm
that Sterigenics is not improperly emitting EtO and the additional capture and control measures
provided in Paragraph III.D.2. are properly operating. As discussed above, although Paragraph
III.5. of the Consent Order provides that Sterigenics is to immediately cease operations in the
event the Stack Testing demonstrates that the Required Control Efficiency is not being met, there
are no similar provisions in the Consent Order as to what happens in the event the permanent
total enclosure (“PTE”) providing negative pressure (so as to prevent fugitive emissions) to
Willowbrook I as provided in Paragraph III.D.2. fails or does not operate properly5.
II. Release of Seal Order, Stack Test, Emergency Temporary Operations.
Although counsel for Plaintiffs and Defendant have orally stated to this Court that
Sterigenics is required to comply with the provisions of the newly enacted “Matt Haller Act”
(415 ILCS 5/9.16) in addition to the Consent Order, the issues raised in the amicus brief filed by
State Senator Curran and State Representatives Durkin and Mazzochi as to the applicability of
Section 5/9.16(g) to the seal order in this case should be specifically addressed in the Consent
Order. Because of the intense public interest in this case, a term should be included that mirrors
the language from Section 5/9.16(g) requiring Sterigenics to provide certification6 by suppliers
5 Id., Affidavit Exhibit D, see, Sec. 6.ii.b.,c., pp. 5-6, discussing Section 5/9.16 requirements for Sterigenics’s permanent total enclosure (“PTE”), and need for clarification in event PTE fails or malfunctions. See, Sec. 7., p. 6, discussing events where the pollution control equipment at Willowbrook I is not operating, when elevated ambient air impacts are observed, or when the facility is not capturing 100% of EtO emissions. The Villages incorporate by reference these comments herein. 6 Id., Affidavit Exhibit D, see, Sec. 2, pp. 2-3, discussing requirement for supplier certifications. The Villages incorporate by reference these comments herein.
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of products to be sterilized/fumigated that EtO is the only available method to completely
sterilize/fumigate such products, and that the IEPA certify7 that Sterigenics facility uses
technology that produces the greatest reduction of EtO emissions. The IEPA’s certification
arising from Section 5/9.16(g) can only be obtained after Sterigenics has completed all of the
construction to its facility as required by the Consent Order and after IEPA has tested the
operation of the facility.
Because Section 5/9.16(g) expressly requires Sterigenics to provide certification from its
suppliers and for the IEPA to provide certification as to the facility’s use of technology that
produces the greatest reduction of EtO emissions before the seal order is lifted, the terms of
Paragraph III.J.1. need to be modified to expressly reflect the provisions of Section 5/9.16(g).
Because the seal order applies to both of Sterigenics’ two facilities (“Willowbrook I” and
“Willowbrook II”), and because Sterigenics has not complied with Section 5/9.16(g) as to
Willowbrook II, the provisions contained in Paragraph III.J.1. releasing the seal order in its
entirety as to both of Sterigenics two facilities, including Willowbrook II, is improper and
contrary to the express provisions of Section 5/9.16(g). Paragraph III.D.9. of the Consent Order
should be modified to include a date by which Sterigenics must file a construction permit
application to the IEPA in order to resume operations of Willowbrook II. If the date is not met,
Willowbrook II cannot resume operations.
The Consent Order also fails to take into account any past and cumulative exposure of the
Villages’ residents to EtO, and instead presupposes a community with zero prior exposure.
Because the seal order was entered to protect the public safety, and because the Consent Order
seeks to release the seal order, the Villages’ submit that this Court should reckon with the fact
7 Id., Affidavit Exhibit D, see, Sec. 1.i.,ii,iii, p. 2, discussing requirement for certification that pollution controls used has greatest reduction in EtO emissions. The Villages incorporate by reference these comments herein.
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that cumulative exposure to EtO is harmful. (See, Affidavit Exhibit B, pp. 15-23) Further, the
Consent Order fails to recognize that based upon Sterigenics self-reporting for 1987-1988 and
1995-2016 (omitting reporting of EtO emissions for ten-years, 1984-1986, 1989-1994 and 2017-
2018) that it has emitted 465,634 pounds of EtO from its Willowbrook I and II facilities. The
Villages submit that this Court should take into account these matters that have been wholly
omitted.
Although Paragraph III.D.2.a. provides that Sterigenics has submitted to the IEPA an air
dispersion modeling demonstrating that the planned modifications at Willowbrook I will be
sufficient to ensure that the maximum long-term average modeled concentrations of EtO will be
at or below a level satisfactory to IEPA, the air dispersion modeling8 submitted by Sterigenics to
IEPA is deficient for several reasons. The air dispersion modeling is deficient because it is based
upon the premise of Sterigenics constructing a new stack at Willowbrook I to a height of 87 feet.
Because the Village of Willowbrook’s ordinances do not allow the construction of a stack at
Willowbrook I to the height of 87 feet as a matter of right9, it is speculative as to whether a stack
will be constructed at Willowbrook I to a height of 87 feet.
Additionally, the air dispersion modeling did not include or account for EtO emissions from
Willowbrook II,10 which may become operational in the immediate future and emit EtO. As
such, the provisions contained in Section III.D.3.a. for the submission of a “Stack Test Protocol”
should be modified to reflect that no construction occur until Sterigenics first obtains necessary
zoning approvals from Willowbrook, and then submits a new air dispersion model to IEPA based
8 Id., Affidavit Exhibit D, see, Sec. 9.i.,ii., pp. 7-9, discussing Sterigenics’s air dispersion modeling submitted to IEPA. The Villages incorporate by reference these comments herein. 9 Id., Affidavit Exhibit D, see, Sec. 9.i.a., p. 7, discussing Sterigenics’s air dispersion modeling submitted to IEPA based upon a stack height of 87’. The Villages incorporate by reference these comments herein. 10 Id., Affidavit Exhibit D, see, Sec. 9.ii.a., p. 8, discussing Sterigenics’s air dispersion modeling submitted to IEPA did not include or account for EtO emissions from Willowbrook II. The Villages incorporate by reference these comments herein.
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upon the actual stack height permitted for Willowbrook I under Village of Willowbrook’s
ordinances and provide for the emissions from Willowbrook II.
Paragraph III.D.7, providing for emergency temporary operations, does not afford any notice
or any protection to the public before allowing Sterigenics to resume operations at Willowbrook
I. As drafted, the State in its sole discretion, may approve temporary, limited operations at
Willowbrook I. The Consent Order should require that the State provide notice to the Villages if
the State obtains information identifying a critical need for sterilization of medical devices
necessary to protect public health prior to approving temporary, limited operations. The Consent
Order should also require prior approval from this Court of any temporary limited operations at
Willowbrook I or II and that Sterigenics be required to post a bond with the Court to secure any
damages that may arise from reopening Willowbrook I or II in advance of meeting all
requirements in the proposed Consent Order, in advance of completing the work proposed by
Sterigenics in its construction application to the IEPA and in advance of meeting the
requirements of the Matt Haller Act including IEPA certifying Sterigenics’ compliance with
Section 5/9.16(g).
III. Best Management Practices, Notice.
Paragraph III.D.6, providing for best management practices (“BMPs”), fails to address
Sterigenics’s outdoor storage of EtO drums prior to use and also fails to address Sterigenics’s
storage and disposal of EtO drums after use. Because Paragraph III.D.2.b. mandates the
installation of additional capture and control measures at Willowbrook I, including total
enclosure providing 100% of all areas containing EtO, the Consent Order should require
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Sterigenics’s storage of EtO11 be in an area that is subject to capture and control measures as
well as BMPs for proper storage and disposal of used EtO drums.
In order to gain and maintain public confidence, the Villages must be given accurate
information regarding IEPA and Sterigenics’s performance of the terms of the Consent Order
and Section 5/9.16, with full transparency and in real time. As such, the Consent Order must
include a clear process for the Villages-or at least the Village of Willowbrook- to receive notice
and real time access to documents, plans and reports submitted pursuant to the Order. For
example, under Paragraph III.D.1, notice should be given by IEPA that Sterigenics has satisfied
the requirements of and obtained written approval from specified in Paragraph III.D.4.(a); notice
should be given of Sterigenics’s submission of its construction completion report to the IEPA
provided in Paragraph III.D.4(a); notice should be given if the negative pressure system fails or
does not operate properly; notice should be given if Sterigenics’s ambient air testing shows
elevated levels of EtO; notice should be given if IEPA is inspecting Sterigenics’s operations;
notice should be given in the event Sterigenics requests the Consent Order to terminate under
Paragraph III.K.1 as well as notice given by the IEPA as to its decision to Sterigenics’s request
to terminate the Consent Order under Paragraph III.K.1. The Consent Order should also require
that the State post publicly all documents, plans and reports submitted pursuant to the Order.
Summary and Conclusion.
This Court should exercise its discretion and deny Plaintiffs’ and Defendant’s joint motion
for entry of Consent Order, because it: (1) does not provide the Villages or their residents and
workers with adequate protections or safeguards from continued and future exposure to EtO
from Sterigenics’ operations; and (2) does not afford the Villages with adequate information or
11 Id., Affidavit Exhibit D, see, Sec. 5., p. 4, discussing Sterigenics’s storage of EtO drums. The Villages incorporate by reference these comments herein.
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notice regarding whether Sterigenics presently and/or in the future complies with EtO
requirements under Illinois law and regulations.
In the alternative, the Court should ask the parties to consider the comments received and
return with a revised proposed Consent Order addressing the Villages’ concerns, summarized as
follows:
Require term in Consent Order for Sterigenics to pay for the Villages’ ambient air testing for period of five years using independent vendors chosen by Villages;
Require term in Consent Order setting ambient air standard; Require term in Consent Order that Sterigenics immediately cease and desist
operations in event ambient air standard exceeded; Require term in Consent Order expressly requiring certifications be provided as stated
in Section 5/9.16(g) and be provided before Sterigenics reopen; Require term in Consent Order requiring air dispersion modeling to be done using
both Sterigenics’ facilities and using stack height allowed by Village of Willowbrook ordinance;
Require term in Consent Order requiring Court approval, posting of bond, and notice to Villages before “emergency temporary operations” may occur;
Require term in Consent Order requiring outdoor storage of EtO be included in area subject to capture and control devices; and
Require term in Consent Order requiring notice be given to the Villages as to documents, plans and reports given to IEPA.
Respectfully submitted,
By: /s/ Andrew Y. Acker
Andrew Y. Acker [email protected] Storino Ramello and Durkin 9501 W. Devon Ave., #800 Rosemont, IL 60018 847-318-9500 Attorney No. 7620 / Attorney for Village of Willowbrook and Village of Burr Ridge John B. Murphey Lance C. Malina [email protected] [email protected] Rosenthal, Murphey, Coblentz and Donahue Klein, Thorpe and Jenkins, Ltd. 30 N. LaSalle St., Suite 1624 20 N. Wacker Dr., Suite 1660 Chicago, IL 60602 Chicago, IL 60606 312-541-1070 312-984-6400 Attorney No. 7615/Attorney City of Darien Attorney No. 44500/Village of Hinsdale
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IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS COUNTY DEPARTMENT, LAW DIVISION
Susan Kamuda and Edward Kamuda,
Plaintiffs,
v. Sterigenics U.S., LLC; Sotera Health, LLC; Bob Novak; Roger Clark; and GTCR, LLC;
Defendants.
No. 18 L 10475 Consolidated for discovery with: 18 L 10744 Teresa Fornek; 18 L 11004 Shawn Fornek; 18 L 11252 Anita Govic; 18 L 11939 Heather Schumacher; 19 L 9163 George Vessol; 19 L 9167 Carol Ray; 19 L 9169 Dawn Paganelli; 19 L 9170 Stephanie Lucak; 19 L 9171 Lisa Besch; 19 L 9173 John Lebel; 19 L 9176 Dorothy Beres; 19 L 9177 Judith Hall; 19 L 9178 Patricia Watt; 19 L 9179 Angie Kostopoulos-Andrews; 19 L 9181 Jana Conev; 19 L 9182 Justin Schoenhardt; 19 L 9189 Gerardo Chacin; 19 L 9190 Sandra Allen; 19 L 9196 Arkadiusz Suska; 19 L 9197 Stacey Guido; 19 L 9198 Susan Schemmer; 19 L 9200 Barbara Carkhuff; 19 L 9202 Shirley Ruck; 19 L 9205 Arthur Schmid; 19 L 9206 Denise Baum; 19 L 9207 Jeanne Hochhalter; 19 L 9213 Lee Schramm; 19 L 9214 Susan Pedersen; 19 L 9215 Kristina Janulis; 19 L 9216 Halina Jajic; 19 L 9362 Robert Stafford; 19 L 9454 Gina LaPapa; 19 L 9508 Ivan Harrison III; 19 L 9528 David Gaddis; 19 L 9732 Helen Ramos; 19 L 11510 Sarah Sophie; 19 L 11682 Anne Cahill; 19 L 13486 Loretta Wawak;
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19 L 13488 Candace Owens; 19 L 13493 Donna DePaolo Engelsman; 19 L 13517 Laura Carbray; 19 L 13518 Janice Bielaga; 19 L 13522 Laura Duran; 19 L 13537 Jan Cheng; 19 L 13538 Ryan Feeney; 19 L 13539 Ada Garro; 19 L 13540 Rose Marth; 19 L 13541 John Chlada; 19 L 13544 LaTangie Young; 19 L 13545 Rajini Mady; 19 L 13546 Nicolas Brinias; 19 L 13550 Virginia Janis; 19 L 13551 Deborah Faulkner; 19 L 13552 Delores Lombardo; 19 L 13554 Cathy Lou Pearson; 19 L 13562 Karen Kostrzewa; 19 L 13568 Phyllis Martin; 19 L 13575 Pam Paziotopoulous; 19 L 13576 Stan Czyzon; 19 L 13857 Arun Ohri; 19 L 13860 Patricia Vanhal; and 19 L 14265 Mary Eskey
Calendar R Judge Christopher E. Lawler
DEMAND FOR A BILL OF PARTICULARS
Pursuant to 735 ILCS 5/2-607, Defendant Sterigenics U.S., LLC (“Sterigenics U.S.”)
hereby states that Plaintiffs’ First Amended Master Complaint (“FAMC”) is wanting in detail in
the following respects and demands a Bill of Particulars with the following details. The section
titles below correspond to the section headers in the FAMC for ease of reference.
I. INTRODUCTION (OF FAMC)
1. With respect to Plaintiffs’ allegation in Paragraph 3 of the FAMC that
“Sterigenics operated for years in Willowbrook without using the best practices and control
technologies available to reduce its emissions,” specify and describe:
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a. The “best practices and control technologies” that were available to reduce
emissions during the time period described in Paragraph 3 of the FAMC;
b. The reference source(s) of these “best practices and control technologies”;
c. When these “best practices and control technologies” first became
available;
d. The standard or authority by which they were deemed “the best”; and
e. Whether such standard or authority changed over time and if so, how and
when.
II. “STERIGENICS’ OPERATIONS AND CONDUCT IN WILLOWBROOK”
2. With respect to Plaintiffs’ allegation in Paragraph 54 of the FAMC that
“[e]ffective technologies to reduce EtO emissions to levels low enough to make the emissions a
‘non-significant contributor’ to cancer risk have been available, cost-effective, and widely
known since the 1980s; and on information and belief, Sterigenics has known it,” specify and
describe:
a. What “effective technologies” Plaintiffs are referencing, the feasibility of
each alleged technology, and the specific date(s) those technologies were
first available;
b. The exact levels of EtO emissions Plaintiffs allege are “low enough to
make the emissions a ‘non-significant contributor’ to cancer risk”;
c. Plaintiffs’ basis for asserting that those levels constitute a “‘non-
significant contributor’ to cancer risk”;
d. Plaintiffs’ definition of a “‘non-significant contributor’ to cancer risk” and
the source of this definition; and
e. The date(s) of Sterigenics U.S.’s alleged knowledge.
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3. With respect to Plaintiffs’ allegation in Paragraph 55 of the FAMC that “there
have been periods during which the Willowbrook facilities had no pollution controls in place,
had inadequate controls in place, and/or had pollution controls in place that failed to work due to
the acts and omissions of the defendants,” specify and describe:
a. All period(s) of time for which Plaintiffs allege that the Willowbrook
facilities had no pollution controls in place;
b. All period(s) of time for which Plaintiffs allege that the Willowbrook
facilities had “inadequate controls” in place;
c. What Plaintiffs consider “inadequate controls” and the reference
standard(s) against which such controls are to be compared;
d. All period(s) of time for which Plaintiffs allege that the Willowbrook
facilities “had pollution controls in place that failed to work due to the acts
and omissions of the defendants”;
e. The “acts and omissions of the defendants” that allegedly caused the
pollution controls to fail to work, the date(s) of the alleged “acts and
omissions,” and the specific individual(s) who conducted each of the
alleged “acts and omissions”; and
f. How the pollution controls “failed to work” and the date(s) of the alleged
failure.
III. “STERIGENICS’ PATTERN OF RECKLESS CONDUCT”
4. With respect to Plaintiffs’ allegation in Paragraph 66 of the FAMC that
“Sterigenics failed for decades to install available emission control technology to limit emissions
of EtO from its Willowbrook facility,” identify the “decades,” describe the “available emission
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control technology” referenced in this paragraph, and identify the date(s) such technology
allegedly first became available.
IV. COUNT I (NEGLIGENCE —STERIGENICS U.S., LLC)
5. With respect to Paragraph 126 of the FAMC, identify the date on which the
alleged duty of care arose, the source of the alleged duty, the scope of the alleged duty, whether
the alleged duty changed over time (and, if so, when and how it changed), and the basis for such
a duty under Illinois law. In specifying the scope of the alleged duty, specify and describe:
a. The EtO emissions standard, safety standard, or standard of conduct that
Plaintiffs allege is applicable to a contract sterilization company operating
under a lawful permit and regulations issued by the Illinois Environmental
Protection Agency;
b. When the EtO emissions standard, safety standard, or standard of conduct
was imposed, and the reference source for same;
c. Whether the alleged duty, EtO emissions standard, safety standard, or
standard of conduct changed over time, and if so, how it changed, and
when the change(s) occurred, including the reference sources for any
change(s);
d. The obligations that the alleged duty or standard imposed on Sterigenics
U.S. in addition or in contrast to any applicable regulatory and permit-
based obligations; and
e. The date(s) on which Sterigenics’ breach of the alleged duty or standard
occurred.
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6. With respect to Plaintiffs’ allegation in Paragraph 128(a) of the FAMC that
Sterigenics U.S. breached a purported duty of care by “expos[ing] Plaintiffs, their decedents, and
others to unsafe levels [of] EtO,” specify and describe:
a. The level of EtO Plaintiffs are referring to as “unsafe” and the basis for the
assertion that this level is “unsafe”;
b. The level(s) of EtO that Plaintiffs deem to be within the standard of care
for a contract sterilization company utilizing EtO, and the reference or
basis for same;
c. Whether the level(s) of EtO that Plaintiffs deem to be within the standard
of care for a contract sterilization company utilizing EtO changed over
time and if so, the date(s) such change(s) occurred, how the standard(s)
changed, and the reference(s) or basis for each standard; and
d. The date(s) of this alleged breach.
7. With respect to Plaintiffs’ allegation in Paragraph 128(b) of the FAMC that
Sterigenics U.S. breached a duty of care by “emitting massive and unnecessary amounts of EtO
into the air,” specify and describe:
a. What quantity of EtO Plaintiffs are referring to as “massive” and
Plaintiffs’ basis for the assertion that this quantity is “massive”;
b. What quantity of EtO Plaintiffs are referring to as “unnecessary” and the
basis for the assertion that this quantity is “unnecessary”;
c. The level(s) of EtO emission that would be deemed to be within the
standard of care for a contract sterilization company utilizing EtO, and the
reference or basis for same;
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d. Whether the level(s) of EtO emission that Plaintiffs deem to be within the
standard of care for a contract sterilization company utilizing EtO changed
over time and if so, the date(s) such change(s) occurred, how the
standard(s) changed, and the reference(s) or basis for each standard; and
e. The date(s) of this alleged breach.
8. With respect to Plaintiffs’ allegation in Paragraph 128(c) of the FAMC that
Sterigenics U.S. breached a purported duty of care by using EtO “when safer alternatives could
accomplish the same or similar business purpose,” specify and describe:
a. The “safer alternatives” to which Plaintiffs are referring;
b. How these alternatives are “safer”;
c. How each alleged “safer alternative[] could accomplish the same or
similar business purpose”;
d. When these “safer alternatives” first became available; and
e. The date(s) of this alleged breach.
9. With respect to Plaintiffs’ allegations in Paragraphs 128(e)–(g) regarding
Sterigenics U.S.’s breach of a duty of care by “failing to warn or advise Plaintiffs,” specify and
describe:
a. The source of the alleged duty to warn and the basis for such duty under
Illinois law;
b. What specific warnings or advice Sterigenics U.S. allegedly failed to
provide, and what form these warnings or advice should have taken;
c. How such warning or advice would have prevented Plaintiffs’ alleged
injuries; and
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d. The date(s) of this alleged breach.
10. With respect to Plaintiffs’ allegation in Paragraph 128(h) that Sterigenics U.S.
breached a duty of care by “failing to employ safe methods,” specify and describe:
a. The “safe methods” referenced and the source of these “safe methods”;
b. When these “safe methods” first became available; and
c. The date(s) of this alleged breach.
11. State the levels Plaintiffs allege constitute “dangerous amounts of EtO,” as this
phrase is used in Paragraphs 6, 129, 134, 139, 144, 151, 159, and 164, and the reference
standards by which “dangerous amounts” were to be compared. For each reference standard,
state when the reference standard was issued or imposed, and the source for same; and whether
the standard changed over time, and if so, the date of each such change, and how it changed.
Date: ________________ Respectfully submitted, By:________________ Maja C. Eaton, IL Bar No. 6188479 [email protected] Jana D. Wozniak, IL Bar No. 6288881 [email protected] Michael L. Lisak, IL Bar No. 6299347 [email protected] SIDLEY AUSTIN LLP One South Dearborn Street Chicago, IL 60603 (312) 853-7000 Firm I.D. Number: 42418 Kimberly Moses, IL Bar No. 0029601 [email protected] Lindsey E. Sacher, IL Bar No. 0087883 [email protected]
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CALFEE, HALTER & GRISWOLD LLP The Calfee Building 1405 East Sixth Street Cleveland, Ohio 44114-1607 Phone: (216) 622-8200 Fax: (216) 241-0816 Attorneys for Sterigenics U.S., LLC
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