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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…

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.

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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.

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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.

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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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Dems seek to force EPA action on ethylene oxide monitoring

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

Democrats in both houses of Congress have introduced legislation that would force the U.S. Environmental Protection Agency to better monitor emissions of ethylene oxide (EtO) from plants that manufacture the toxic gas or use it to sterilize medical devices.

The Public Health Air Quality Act of 2020, sponsored by Sen. Tammy Duckworth (Ill.) and Rep. Lisa Blunt Rochester (Del.), would require immediate EPA action to monitor emissions at “facilities contributing to high local cancer rates and other health threats from dangerous pollutants.” The list includes eight medtech sterilization plants included among 25 EPA-designated, EtO-using or -producing facilities:

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