Dive Brief:

• The New Mexico Attorney General is suing medical device sterilization company Sterigenics for emitting the carcinogenic gas ethylene oxide in excess of permissible limits.

• The suit alleges Sterigenics' plant in Santa Teresa, New Mexico has harmed the environment and potentially threatened human health by emitting high amounts of ethylene oxide since 1989. Sterigenics’ sites in Georgia and Illinois were the focus of emission concerns in 2019.

• A spokesperson for Sterigenics parent company Sotera Health called the claims baseless and said it would vigorously defend itself against the lawsuit. Law firms submitted hundreds of cases against Sterigenics last year and some observers expect the Biden administration to give momentum to the efforts. 

Dive Insight:

Sterigenics sells sterilization services for the medical device, pharmaceutical, commercial and food industries. The work went largely unnoticed until early 2019, when they closed a facility in response to an order from the Illinois Environmental Protection Agency. 

Later that year, the Georgia Environmental Protection Division began measuring levels of ethylene oxide around sterilization plants run by BD and Sterigenics in Atlanta. Sterigenics closed the facility within weeks of that action. AdvaMed maintains the use of ethylene oxide is necessary, giving limited alternatives. 

The effect of the closures rippled through the medical device industry, with Teleflex linking it to an $8.7 million financial hit and companies including Medtronic and Boston Scientific also reporting lost revenues. Since then, the focus has moved to the courts as individuals and now the state of New Mexico have taken action against Sterigenics.

The New Mexico suit accuses Sterigenics of causing "substantial unreported, uncontrolled releases" of ethylene oxide into the atmosphere. Specifically, the suit alleges ethylene oxide levels inside the facility were often elevated due to "lax oversight" practices such as leaving sterilization chamber doors ajar when not in use. Sterigenics allegedly lowered ethylene oxide levels inside the facility by leaving shipping bays and large doors “open for hours, or entire days.”

The recent actions against companies that work with ethylene oxide are underpinned by the actions of the U.S. EPA, which published an assessment of the risks posed by the substance in 2016. EPA did the work toward the end of the Obama administration. In the Trump years, EPA delayed a regulation that could restrict ethylene oxide emissions. EPA may change under President Biden.

Writing in The National Law Review last month, lawyers from environmental specialist Beveridge & Diamond said the election of Joe Biden could increase enforcement risk for emitters of ethylene oxide. The warning is based on a belief the Biden administration could back EPA to take a harder line as part of its focus on environmental justice. 

While the gas is regulated by the EPA, FDA held an advisory panel on the issue late in 2019 and warned shutdowns threatened capacity that could lead to shortages of medical devices that did not have facilities to be sterilized.​

This story has been updated with Sterigenics comment.