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New ethylene oxide rules could trigger sterilization consolidation — and new options

Firefighters training on a simulated ethylene oxide leak [Photo via Adobe Stock]

The largest commercial sterilizers will likely absorb the costs of new ethylene oxide (EtO) regulations — and could consolidate smaller competitors, according to a new analysis from Moody’s Investors Services.

Tighter controls on EtO emissions would increase capital spending and operating costs for all commercial sterilizers who use the toxic gas, which is the most commonly used method for eliminating infection-causing microbes from medical devices.

“Large companies have enough liquidity to fund the significant increase in spending without incremental debt,” Moody’s said in a subscribers-only report this week. “But the higher costs and compliance requirements could make the business less attractive for some small companies.”

The largest commercial sterilizers can absorb the cost of new…

Sterigenics to pay $408M to settle Illinois ethylene oxide lawsuits

Sterigenics’ parent company Sotera Health announced that it has agreed to settle more than 870 ethylene oxide lawsuits in Illinois.

The agreements, announced yesterday evening, have Sterigenics paying $408 million to settle the claims filed in the Circuit Court of Cook County and U.S. District Court in northern Illinois.

Sotera Health saw its stock more than double in value today on the settlement news, with SHC shares up 104% to $17.60$ apiece on the Nasdaq.

The settlement comes about four months after a Cook County jury awarded $363 million in a lawsuit that blamed Sterigenics EtO emissions from its now-shuttered Willowbrook facility for a woman’s breast cancer and her son’s non-Hodgkin’s lymphoma. The verdict in September 2022 shook the medtech space, which relies on EtO as a major sterilization method for manufactured medical devices. Analysts even wondered whether ethylene oxide liabilities would impact financial results for Sterigenics compet…

Sterigenics to pay $408M to settle Illinois ethylene oxide lawsuits

Sterigenics’ parent company Sotera Health announced that it has agreed to settle more than 870 ethylene oxide lawsuits in Illinois.

The agreements, announced yesterday evening, have Sterigenics paying $408 million to settle the claims filed in the Circuit Court of Cook County and U.S. District Court in northern Illinois.

Sotera Health saw its stock more than double in value today on the settlement news, with SHC shares up 104% to $17.60$ apiece on the Nasdaq.

The settlement comes about four months after a Cook County jury awarded $363 million in a lawsuit that blamed Sterigenics EtO emissions from its now-shuttered Willowbrook facility for a woman’s breast cancer and her son’s non-Hodgkin’s lymphoma. The verdict in September 2022 shook the medtech space, which relies on EtO as a major sterilization method for manufactured medical devices. Analysts even wondered whether ethylene oxide liabilities would impact financial results for Sterigenics compet…

Steris stock downgraded as analysts expect lawyers to seek more ethylene oxide lawsuits

Steris (NYSE: STE) stock was downgraded today by Needham from buy to hold following the $363 million jury verdict against its primary competitor, Sterigenics, over ethylene oxide (EtO) emissions.

Needham analysts said they expect attorneys to target communities near EtO facilities with ads to find people willing to file more lawsuits against sterilization plant operators past and present.

RELATED: EPA flags high-cancer-risk EtO sterilization facilities across the country

The analysts believe Steris can manage any EtO legal liabilities due to the company’s size, diversification and balance sheet, but said investors are looking forward to Steris estimating and reserving cash for potential liabilities.

“Since breast and blood cancers are relatively common, we worry that attorneys could have success in finding additional people willing to file more lawsuits,” the analysts wrote. “We expect the risk of lawsuits and any n…

Jury awards $363M verdict in Sterigenics ethylene oxide lawsuit

Illinois officials halted operations at the Sterigenics facility in Willowbrook, Illinois, after analysis of ethylene oxide (EtO) emissions found potential cancer risks for neighbors. [Image courtesy of the EPA Air and Radiation Division, Region 5]

An Illinois jury has awarded $363 million in an ethylene oxide lawsuit that blamed a Sterigenics sterilization facility’s emissions of ethylene oxide for a woman’s breast cancer and her son’s non-Hodgkin’s lymphoma.

It’s the first verdict in hundreds of lawsuits against Oak Brook, Illinois-based Sterigenics, which permanently closed the Willowbrook, Illinois facility in 2019 after state officials halted operations due to high emissions of ethylene oxide (EtO).

PREVIOUSLY: Sterigenics failed to report EtO emissions to EPA, report says

The verdict included $38 million in compensatory damages and $325 million in punitive damag…

Sotera Health launches educational series covering sterilization, lab testing and more

Sotera Health (Nasdaq: SHC) has launched the Sotera Health Academy to help companies get their products to market faster while navigating regulatory risk.

The Broadview Heights, Ohio-based parent company of Sterigenics, Nordion and Nelson Labs said the program offers more than 100 hours of curated content covering introductory sterilization, lab testing topics and advanced, in-depth learning, plus more than 150 webinars, whitepapers, and e-books from more than 75 industry experts.

Sotera Health’s recent acquisition of Regulatory Compliance Associates (RCA) means more content is on the way, the company said.

“From product conception to commercialization, each stage in the lifecycle of a medical device, pharmaceutical, or commercial product poses unique challenges for manufacturers, especially when patient safety is paramount,” Nelson Labs Chairperson Jeffery Nelson said yesterday in a news release. “The free educational resources contained in t…

Sotera Health buys BioScience Laboratories to boost Nelson Labs business

Sotera Health (NASDAQ:SHC) recently announced that it has acquired Bozeman, Mont.–based BioScience Laboratories in a deal that will expand the U.S.-based antimicrobial and antiviral testing capabilities of Sotera Health’s Nelson Labs business.

The financial terms of the deal were not disclosed in the March 10 announcement. BioScience Laboratories provides topical antimicrobial product testing in the consumer, pharmaceutical, and medical device industries — with a 22,000 ft2 laboratory in Bozeman that includes a new biosafety level 3 (BSL-3) virology lab.

Get the full story on our sister site Medical Design & Outsourcing.

Sotera Health buys BioScience Laboratories to boost Nelson Labs business

Sotera Health (NASDAQ:SHC) recently announced that it has acquired Bozeman, Mont.–based BioScience Laboratories in a deal that will expand the U.S.-based antimicrobial and antiviral testing capabilities of Sotera Health’s Nelson Labs business.

The financial terms of the deal were not disclosed in the March 10 announcement. BioScience Laboratories provides topical antimicrobial product testing in the consumer, pharmaceutical, and medical device industries — with a 22,000 ft2 laboratory in Bozeman that includes a new biosafety level 3 (BSL-3) virology lab.

“BioScience Laboratories is premier provider of antimicrobial testing services; known for its testing of consumer hand sanitizers, pre-operating hand-wash, and hard surface disinfectants. It is also recognized for its strong relationships with its customers and regulators,” Sotera Health CEO Michael B. Petras Jr. said in a news release.

“This acquisition will expand and further strengthen our anti…

New Mexico AG sues Sterigenics over ethylene oxide emissions

The attorney general of New Mexico has filed a lawsuit against Sterigenics and associated companies claiming a company medtech sterilization plant in Santa Teresa, N.M. has harmed air quality and “materially contributed” to nearby residents’ health risks.

In the claim filed Dec. 22, 2020, attorney general Hector Balderas alleges that Sterigenics has caused “substantial unreported, uncontrolled releases” of the medical device sterilant ethylene oxide (EtO).

Get the full story on our sister site, Medical Design & Outsourcing.

600 new ethylene oxide lawsuits filed against Sterigenics in Illinois

Ethylene oxide (Image from Sterigenics)

More than 600 lawsuits were filed last week against Sterigenics, claiming that emissions from the company’s now-shuttered Willowbrook, Ill., ethylene oxide (EtO) plant caused health problems in people who lived or worked nearby.

The filings bring the total of personal-injury lawsuits against the Oak Park, Ill.-based company to more than 700, according to one of more than a dozen Chicago-area law firms that have filed lawsuits against Sterigenics; its parent company, Sotera Health; previous parent company Griffith Foods; current investor, private equity firm GTCR; and two managers.

Get the full story on our sister site, Medical Design & Outsourcing.

Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure

Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas.

The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple deaths, cancer, tumors, respiratory, pulmonary, epidermal, hematological, cardiological, neurological and other serious medical conditions. The U.S. Environmental Protection Agency considers EtO a human carcinogen, and news of its use has sparked an outcry among residents and workers in neighborhoods surrounding EtO plants in Illinois, Michigan and Georgia.

Get the full story on our sister site, Medical Design & Outsourcing.