Sterigenics

History

2023: Payment of $408 million for harmful plant emissions that led to breast cancer

On June 22, 2023, Sterigenics and its parent, Sotera Health, announced a payment of $408 million to settle approximately 880 claims related to carcinogenic gas emissions at a facility in Willowbrook, Illinois.

Sterigenics, which specializes in sterilizing medical equipment and devices, used ethylene oxide at its plant, which has disinfecting properties. At the same time, this gas is a slow acting strong poison for warm-blooded animals and humans, exhibiting carcinogenic, mutagenic, irritating and narcotic effects.

Sterigenics and its parent, Sotera Health, reported paying $408 million to settle approximately 880 claims

The Sterigenics plant in Willowbrook was closed at the request of the Illinois Environmental Protection Agency in early 2019. And in September 2022, the first of 882 cases involving ethylene oxide emissions went to trial. In it, Illinois resident Susan Kamuda claimed that Sterigenics emissions led to her developing breast cancer and her son developing non-Hodgkin's lymphoma. The Cook County jury found the woman's claims justified and awarded her $363 million in compensation from Sterigenics.

Initially, the company announced that it plans to appeal the court order, but subsequently decided not to risk large amounts when considering individual cases and entered into a settlement agreement for $408 million. It covers 879 of the said 882 cases.

We are pleased that 99.7% of eligible applicants participate in the settlements. The agreements explicitly state that the payments should not be considered a recognition of liability, and Sterigenics states that its activities in Willowbrook do not pose a threat to the safety of the surrounding community. We will continue to operate all our facilities in accordance with established rules and industry practices, the company said in a notice.[1]

2019: Medical Equipment Sterilization Plant Closure

In April 2019, there was an acute shortage of medical equipment due to the sudden closure of the Sterigenics sterilization plant. The facility was halted in February, with the Food and Drug Administration (FDA) reporting in March that more than 100 medical device manufacturers were facing shortages. Then the regulator called on companies to take the necessary measures.

Sterigenics-owned medical equipment sterilization facility whose closure caused an acute shortage in the market

The Sterigenics plant was closed due to a lawsuit by the Illinois Environmental Protection Agency: it required the factory to stop emitting ethylene oxide, a carcinogenic gas used for sterilization.

Officials at Cardinal Health and Guerbet sent letters of apology to customers. The letter from Cardinal Health (USA, Ohio) indicates that the Kendall Accu-Trace intrauterine catheter, a device for controlling uterine contractions during childbirth, will practically disappear from the market until early August 2019. Guerbet (France) said in a letter that there may be a shortage of disposable automatic syringes used with Optistar, Optivantage and Illumena contrast injection systems on the market.

The American company Teleflex Medical, which sterilized up to seven million devices a year at the Sterigenics plant, also suffered. After the closure of the plant, Teleflex began to select alternative options for customers, but even with suitable replacement products, their timely delivery will depend on existing stocks. In the event that no suitable substitutes are found, Teleflex products will not enter the market until the company finds alternative means of sterilization.

The company also partnered with Sterigenics to sterilize devices used in minimally invasive surgery, according to a Medtronic spokesperson. However, the company believes that this is a temporary problem that will affect its revenues in the field of surgical innovation only in the fourth quarter of 2019 and the first quarter of 2020. Medtronic has already developed a plan to fill the shortfall.^[2]

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