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…

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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…

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FDA reports sterilization challenge progress as EPA takes aim at EtO emissions

Ethylene oxide (EtO) gas can penetrate paper and cardboard, doesn’t discolor or harm plastics used in many devices, and can sterilize truckloads of devices at one time. [Photo courtesy of the FDA]

The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities.

The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage and develop new sterilization methods.

Those innovation challenges are making “encouraging progress,” FDA said, with some facilities cutting EtO emissions by an estimated 20% to 35%.

“In general, manufacturers are targeting an ethylene oxide cycle concentration that is 11-66% less than the typical ethylene oxide concentration range,” the FDA said in a news…

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

This map of Richmond, Virginia, shows the EPA’s estimated cancer risk for the area surrounding Sterilization Services of Virginia’s EtO plant. [Image courtesy of the EPA]

The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities.

EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices —  and in some cases it’s the only option. The FDA is seeking safer ways to use EtO and alternative means of sterilization in an effort to reduce EtO emissions due to its cancer risk, particularly blood cancers and breast cancer.

“Exposure over the course of a lifetime (24 hours a day for 70 years) to EtO at concentrations expected to be found near some commercial sterilizers can increase a person’s risk of developing cance…

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Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia

(Image from the U.S. Occupational Safety and Health Administration)

Nearly two dozen people who have lived in the Augusta, Ga. area are suing Cardinal Health subsidiary Kendall Patient Recovery U.S. over ethylene oxide emissions from a medical device sterilization plant in the city.

The people suing KPR U.S. in U.S. District Court in Southern Georgia lived and worked within miles of the Augusta facility over the decades and claim that they never had any notice that they were inhaling air that was potentially endangering their health. Industrial users of EtO, according to the plaintiffs’ lawyers, knew of EtO’s potential dangers by the early 1980s. (The EPA classified ethylene oxide as a human carcinogen in December 2016.)

The people suing KPR U.S. suffered a host of cancers.

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

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Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia

[Image from U.S. Occupational Health and Safety Administration]

Nearly two dozen people who have lived in the Augusta, Ga. area are suing Cardinal Health subsidiary Kendall Patient Recovery U.S. over ethylene oxide emissions from a medical device sterilization plant in the city.

The people suing KPR U.S. in U.S. District Court in Southern Georgia lived and worked within miles of the Augusta facility over the decades and claim that they never had any notice that they were inhaling air that was potentially endangering their health. Industrial users of EtO, according to the plaintiffs’ lawyers, knew of EtO’s potential dangers by the early 1980s. (The EPA classified ethylene oxide as a human carcinogen in December 2016.)

The people suing KPR U.S. suffered a host of cancers, including breast cancer, B-cell lymphoma, ovarian cancer and colon cancer — as well as miscarriages. In a separately filed l…

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Italian sterilization plants falsified records for years, FDA says

Device sterilized by ethylene oxide (EtO) (Image from the FDA)

An Italian medtech sterilization company falsified records of a variety of FDA-regulated products since 2016, the agency said today.

The company, Steril Milano, falsified graphs and parameters of sterilization certificates for devices processed at its Reggiolo and Monza ethylene oxide (EtO) plants, the FDA said.

Steril Milano on March 9, 2021, announced the temporary closure of the Monza and Reggiolo sites for further investigations following a review of operating procedures. The company said that it has taken steps to strengthen the quality control processes at its Biassonno site. Steril Milano’s certifying body has suspended the certification for its Italian sites, the company added.

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

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Medline, Sterigenics failed to report EtO emissions to EPA, report says

Ethylene oxide (Image from Sterigenics)

Two companies that use ethylene oxide (EtO) to sterilize medical devices failed to report emissions of the toxic gas to the U.S. Environmental Protection Agency, according to a report by the Chicago Tribune.

Medline Industries and Sterigenics, both headquartered in Illinois, have also operated medtech sterilization operations in the state. Medline continues to do so, and Sterigenics decided in September 2019 not to reopen its EtO plant in Willowbrook, Ill., following a state-ordered closure in February of that year.

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

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New ethylene oxide regulations now expected in 2022

(Image from the U.S. Occupational Safety and Health Administration)

The EPA now estimates that it will issue propose new regulations for medical device sterilizers’ emissions of ethylene oxide (EtO) in 2022.

The agency issued an advance notice of proposed rulemaking for the commercial sterilizers in December 2019 but has not produced the proposal.

Now the EPA’s inspector general wants the agency to conduct a new residual risk and technology review for commercial and industrial sites that use or produce EtO, particularly because some of these facilities are located in areas populated by people of color or low income.

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

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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).

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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.

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Sterigenics sues Ga. county officials over EtO-related property tax devaluations

Sterigenics has filed a lawsuit against the members of a Georgia county tax board, claiming that the board’s decision to lower valuations on properties near the company’s medical device sterilization plant has harmed its reputation.

The federal lawsuit, filed in Atlanta, also claims that the members of the Cobb County Board of Tax Assessors unfairly and arbitrarily pinned their April 15, 2020, tax valuation decision on Sterigenics’ use of ethylene oxide (EtO) to sterilize medical devices at the plant. The county lowered assessments by 10% on properties within 2 miles of the plant, citing “environmental air quality concern surrounding the Sterigenics plant,” the complaint says.

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