B. Braun Medical faces a class action lawsuit over ethylene oxide emissions into a Pennsylvania community, which may have caused area residents to face a long-term cancer risk from unknowingly inhaling the toxic gas.
The complaint (PDF) was filed by Adam Akarsoy in March in the U.S. District Court for the Eastern District of Pennsylvania, seeking class action status to pursue damages for similarly situated individuals who were impacted by ethylene oxide exposure caused by Braun’s medical manufacturing and sterilization plant in Allentown, Pennsylvania.
According to the lawsuit, the plant was prone to release of large amounts of ethylene oxide, which is used in the medical device sterilization process, sometimes reaching as high as 8,960 pounds in a single year.
Ethylene oxide is a highly carcinogenic compound, but it is used to sterilize 50% of medical devices that require sterilization, according to the FDA. It is useful for sterilizing devices made of some polymers, metals, glass, or made with multiple layers with hard-to-reach crevices.
“As a result (of the ethylene oxide exposure), and unbeknownst to them, individuals living and working near the B. Braun facility face some of the highest long-term cancer risks in the United States,” the lawsuit states. “These individuals have been unknowingly inhaling ethylene oxide on a routine and continuous basis for decades. Now they are at an increased risk of developing a variety of cancers, reproductive issues, birth defects and other life-altering health effects from their exposure to ethylene oxide.”
The class action lawsuit indicates ethylene oxide has been linked to an increased risk of Hodgkin’s lymphoma, pediatric lymphoma, breast cancer, prostate cancer, pancreatic cancer, ovarian cancer and bladder cancer.
The U.S. Environmental Protection Agency (EPA) indicates that exposure also carries a higher risk for children, due to its ability to damage human DNA.
According to the EPA’s Toxic Release Inventory (TRI) the Allentown facility has emitted an average of nearly 5,000 pounds of the gas over the last 10 years, reaching a peak of 8,960 pounds in 2009; levels the lawsuit claims pose a health risk to individuals living in the area.
The lawsuit calls for compensatory damages and for Braun to pay for medical monitoring for those who were exposed.
Ethylene Oxide Gas Leaks
The Braun Allentown plant is one of several nationwide linked to high, potentially dangerous, ethylene oxide gas emissions.
In March 2019, the FDA warned that the Sterigenics plant in Willowbrook, Illinois was being shut down due to ethylene oxide leaks. Another facility in Michigan was also closed down for similar reasons. In August 2019, Georgia health officials determined similar leaks were occurring at a Sterigenics facility outside of Atlanta. That facility has been shut down to address the problem.
At about the same time the Georgia investigation was launched, at least 32 complaints were filed in Cook County Circuit Court, in Chicago, alleging cancer caused by the release of ethylene oxide into the air near the Sterigenics Willowbrook facility in Illinois. The cases joined 11 other previously filed claims.
The closures have raised concerns from the FDA about potential shortages of adequate medical device sterilization.
The FDA is calling on device manufacturers and health care providers to warn the agency on potential shortages before they happen. The agency can be notified by users, patients, manufacturers, or anyone within the supply chain of a problem through its device shortages mailbox.