Medical device sterilizer Sterigenics will not find any relief from federal courts, after a federal judge ruled its dispute over Gov. JB Pritzker’s order closing Sterigenics’ Willowbrook facility belongs in state court.
On May 3, Judge Ruben Castillo, chief judge of the U.S. District Court for the Northern District of Illinois, granted the state of Illinois’ request to dismiss the lawsuit brought by Sterigenics against the state over the so-called “seal order” issued by Gov. Pritzker’s Illinois Environmental Protection Agency, ordering them to stop using the sterilizing compound known as ethylene oxide (EO).
Without the ability to use the chemical, the Willowbrook plant has been closed since February.
Sterigenics responded to Pritzker’s action with a lawsuit in Chicago federal court, asserting state officials overstepped their bounds by trespassing on the regulatory authority of the U.S. Environmental Protection Agency and violated Sterigenics’ rights to due process by acting without notice, citing an allegedly nonexistent emergency to justify their action.
The state, however, argued the lawsuit doesn’t belong in federal court. The state argued the law to which the IEPA pointed to justify its seal order gives those affected by such orders the right to appeal the order to the Illinois Pollution Control Board – whose members are appointed by the governor – or county circuit courts.
Further, the state asserted the U.S. Constitution’s 11th Amendment should bar the federal courts from intervening in a dispute with state officials over their actions, purportedly under state law.
Judge Castillo sided entirely with the state, saying Sterigenics needs to look to the state courts for any remedy to the state’s alleged overreach.
“… Plaintiff (Sterigenics) alleges it complies with all regulatory requirements, but Defendants (Illinois state officials) nonetheless issued a seal order requiring Plaintiff to seal all ethylene oxide containers at the Willowbrook facility,” U.S. District Chief Judge Ruben Castillo wrote. “Thus, Plaintiff’s suit implicates state, not federal, law.”
Castillo dismissed the lawsuit, but without prejudice, meaning Sterigenics can still sue the state in county circuit court, if it wishes.
Sterigenics’ lawsuit was just one part of a broader legal and regulatory conflict between the state and the company.
Last fall, the Illinois Attorney General’s Office and DuPage County State’s Attorney Robert Berlin filed suit in DuPage County Circuit Court against Sterigenics, asking a judge to essentially prohibit Sterigenics from using EO gas in its sterilization operations.
Sterigenics has said the EO is essential to its method of sterilizing surgical instruments, such as hypodermic needles, and medical devices, including implants. Sterigenics asserts alternative sterilization methods using heat and radiation can weaken the materials and compromise their effectiveness. This, Sterigenics said, can place patients at greater risk of injury and infection.
Sterigenics claims more than half of all medical devices and 90 percent of surgical kits used in operating rooms in the U.S. are sterilized using EO. Without EO, Sterigenics says, infection risks in American hospitals “would soar.”
Sterigenics has asserted the state’s actions, including its lawsuit and the IEPA’s seal order, represent a thinly veiled attempt by state officials to sidestep federal law, which generally governs the use of substances like ethylene oxide.
The state actions relied heavily on data and reports issued by the U.S. EPA and the Agency for Toxic Substances and Disease Registry, which claimed to show a sharply elevated cancer risk for people in and around Willowbrook. An ATSDR report linked that elevated risk to EO emissions from Sterigenics.
That report has generated public and political controversy, resulting in immense political pressure on Pritzker to find some way to act against Sterigenics, and ultimately leading to the seal order.
Judge Castillo’s ruling largely echoed the ruling from another federal judge, who rejected Sterigenics’ attempt to take the state’s lawsuit to federal court.
In his May 3 order, Castillo agreed with the Illinois Attorney General’s Office, finding Sterigenics’ lawsuit was barred by the 11th Amendment and finding the state has not yet violated the company’s due process rights.
Castillo said the current lawsuit is distinguishable from a seemingly similar case, Simpson v Brown County, which was cited by Sterigenics to support its position.
“This case … does not involve Plaintiff’s license to operate but a seal order that Plaintiff alleges is a circumvention of ‘regulatory and judicial processes’ and an ‘extra-legal attempt to accomplish instantaneously what [Defendants] cannot lawfully do without proper notice and process,’” Castillo wrote. “Simpson, therefore, is not analogous because the plaintiff there alleged an established state procedure and broad delegation of power that led to the plaintiffs’ loss of a property interest.
“There are no such allegations here and instead only allegations of state officials acting outside of their authority and in violation of state law.”
Sterigenics has been represented in the case by attorneys with the firm of Sidley Austin LLP, of Chicago.