Confidential Ethylene Oxide Settlement Reached To Resolve Lawsuits Over Emissions at Pennsylvania Facility

Manufacturer claims it has resolved the majority of the litigation, but has not released any details on the ethylene oxide lawsuit settlement agreement.

The German drug company B. Braun indicates it has reached an ethylene oxide lawsuit settlement with plaintiffs in the vicinity of a medical device manufacturing facility in Lehigh County, Pennsylvania, which they say leaked and exposed nearby residents to toxic, cancer-causing air pollution.

Ethylene oxide is a gas used in the sterilization process of some hard-to-clean medical devices, such as those made of metal or glass, or which have multiple layers and small crevices. However, inhalation of the gas can cause lung, throat, eye and nose irritation, and has been linked to increased cancer risks and may cause brain and nervous system damage.

Concerns about environmental risks associated with exposure to the gas began to emerge after a series of ethylene oxide leaks in 2019, at facilities operated in Illinois, Michigan and Georgia by Sterigenics, another medical sterilization company. Those facilities were shut down temporarily to address the leaks, but multiple lawsuits were subsequently filed over health risks from exposure to the toxic gas. Last November, the medical device sterilization company Steris also announced it is currently facing hundreds of ethylene oxide exposure lawsuits in the U.S.

B. Braun has also faced dozens of similar claims over the last five years by local Pennsylvania residents, who say ethylene oxide emissions from a different facility in Lehigh County exposed them to a risk of cancer. However, on Monday the company announced it had reached a settlement agreement to resolve the majority of those claims.

According to B. Braun officials, the details of the settlement are confidential and represent no admission of wrongdoing. The company also indicates it will continue to defend itself against the remaining, unresolved, claims.

In a statement on its website, B. Braun claims that it has addressed the issues at the Lehigh County facility in recent years.

“As a result of voluntary steps we have taken beyond what is required by regulation, emissions of EtO from our Allentown facility have significantly declined in recent years,” according to the statement. “For example, in 2020 we voluntarily installed a new emission control system that has demonstrated during third-party testing an EtO destruction and removal efficiency of more than 99.9% for the main sterilization process.”

New Ethylene Oxide Safety Standards

Recent years have seen several high-profile ethylene oxide leaks from sterilization facilities throughout the U.S., leading to widespread exposure to the chemical for those working or living nearby.

In 2023, Sterigenics settled similar claims brought following leaks at facilities in Illinois, Georgia and Michigan. Plaintiffs indicated they developed breast cancer, non-Hodgkin’s lymphoma and other ailments, resulting in a $408 million settlement agreement.

To address growing concerns, the U.S. Environmental Protection Agency issued new ethylene oxide standards in March 2024 for the 90 commercial sterilization facilities in the U.S. The new rules:

• Establish standards for unregulated emissions and chamber exhaust vents
• Strengthen standards for sterilization chamber vents and aeration room vents
• Require continuous air emissions monitoring and quarterly reporting for commercial sterilization plants
• Ensure sterilizers are subject to emission standards during startup, shutdown and malfunction

Since there are safer alternatives available to clean medical equipment, experts have also been calling for the healthcare industry to move away from the use of ethylene oxide.  However, it is still used to sterilize about half of the medical equipment made in the U.S.