HANOVER TWP., Pa. — A German medical and pharmaceutical device company with a commercial sterilization facility in Lehigh County has settled “the majority” of claims that emissions from the company’s facilities caused cancer.
“We would like to announce that we have reached an agreement to resolve the majority of the ethylene oxide claims pending against B. Braun in the U.S.” Alli Longenhagen, director of corporate communications, said in a Monday email.
“While the terms of this resolution remain confidential, we are pleased with the outcome of this litigation.
"This settlement is not the admission of any wrongdoing, and we will continue to vigorously defend any remaining litigation.”
There have been dozens of claims brought against B. Braun in the past half-decade, alleging the ethylene oxide emissions from company facilities contributed to cancer cases in nearby residents.
However, the company late last year realized its first win in a Philadelphia court after a jury found the company not liable when an employee was diagnosed with leukemia.
Asked how many claims have been resolved through the settlement agreement, and how many are still outstanding, Longenhagen said, “All details relating to the settlement are confidential.”
“Creating a safe environment for all our employees and for the communities in which we operate is our utmost priority."Alli Longenhagen, director of corporate communications
“B. Braun is committed to safety, quality and environmental responsibility,” Longenhagen said in the emailed statement.
“The company continues to comply with all applicable regulations and industry standards regarding ethylene oxide use and emissions.
“Creating a safe environment for all our employees and for the communities in which we operate is our utmost priority.
"Our dedication to safety and sustainability is evident in every product we produce, and every patient touched by our medical devices.”
What is EtO?
B. Braun facilities sterilize medical equipment using ethylene oxide, or EtO. The company has multiple locations throughout the Lehigh Valley.
EtO is a flammable, colorless gas at room temperature with a faint fruit-like odor at high concentrations, according to the state Department of Health.
People who live or work near facilities that emit it may be exposed by breathing contaminated air.
“Long-term exposure to low levels of EtO may damage the nervous system and can cause reproductive effects, genetic changes and blood cancers such as non-Hodgkin lymphoma, myeloma, leukemia and breast cancer in women,” according to the DOH.
“Short-term exposure to low levels of EtO may not harm human health; however, exposure to high levels may cause eye/skin/respiratory irritation, headache and nausea.”
According to the U.S. Environmental Protection Agency, EtO does not pose a risk from standard consumer use of a product sterilized with the chemical.
In May 2022, the DOH published a “Community Cancer Incidence Data Review,” after the agency was prompted to investigate claims of EtO emissions causing higher incidence of cancer near B. Braun facilities.
Officials concluded cancer rates “are not consistent with cancer patterns often associated with environmental exposure” and, without real-time air monitoring data, “PA DOH cannot determine the levels of EtO that people inhaled or are inhaling and the associated human health risks.”
That July, the EPA identified three commercial sterilization facilities in Pennsylvania known to emit EtO in ambient air, including B. Braun, 901 Marcon Blvd.
However, only the other two facilities, Cosmed Group LLC, in Erie, and American Contract Systems, in Zelienople, Butler County, were found to pose elevated cancer risks.
That December, during an EPA online town hall, agency officials said new equipment installed voluntarily by B. Braun in 2019 and 2020 has lowered risk, including a new control system that has resulted in a 90% reduction in EtO emissions from 2018 to 2021.
In March of last year, the EPA finalized its amendments to the air toxics standards for ethylene oxide commercial sterilization facilities, mandating controls to reduce emissions more than 90%.
“We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution — including the health of children, who are particularly vulnerable to carcinogens early in life,” EPA Administrator Michael S. Regan said in a news release at the time of the announcement.
“We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”
In a request for comment, LehighValleyNews.com asked Longenhagen if B. Braun is performing ambient air monitoring near its township facility.
In her response, Longenhagen pointed to a B. Braun webpage with information on EtO titled, “Get the Facts: Protecting Lives Here and Across the Country.”
The webpage does not appear to have any data, recent or historical, on ambient air monitoring.
A win for B. Braun
The most recent court win marks the first for the company in an EtO case.
The civil suit, filed May 2021 by Christopher and Emily Glass, of Kunkletown, Monroe County, in the Philadelphia Court of Common Pleas, alleged Christopher developed leukemia from exposure to ethylene oxide allegedly emitted from B. Braun’s township facility, where he worked for seven years.
After a five-week-long trial, a jury found B. Braun not liable for an employee’s cancer diagnosis.
“We are extremely gratified to have obtained this important victory on behalf of B. Braun, a company that manufactures life-saving medical devices,” Jennifer Adams, an attorney for B. Braun, in a December news release.
LehighValleyNews.com has reached out to an attorney with Kline & Specter, a Philadelphia-based firm, representing Glass in the case.
Court filings show a nearing settlement in that case, with a hearing scheduled for 3 p.m. April 4.
