Dive Brief:

• Ethylene oxide emissions from medical supply manufacturer Medline Industries and chemical producer Vantage Specialty Chemicals subjected local residents to elevated cancer risks, resulting in cancers developing in four patients, according to lawsuits filed Wednesday in the Circuit Court of Cook County, Illinois.
• The law firms representing the individuals said they believe the lawsuits are the first filed against Vantage and Medline. Commercial sterilizer Sterigenics, which was forced to shut down a Willowbrook medical device sterilizing plant in February, is defending itself against at least 32 lawsuits in the same state court over similar claims.  
• This week, the White House Office of Management and Budget concluded its review of a proposed rule that aims to address air pollution emissions from the ethylene production process. An Environmental Protection Agency spokesperson said the publication of the rule may take a few weeks. The rule is separate from additional forthcoming regulations on ethylene oxide emissions from commercial sterilizers under development.

Dive Insight:

The lawsuits claim Vantage and Medline knowingly emitted high levels of ethylene oxide at "as much as five times the level of acceptable risk," resulting in cases of breast cancer and leukemia among residents living nearby the facilities.

"Individuals living and working near the Medline and Vantage facilities face some of the highest long-term cancer risks in the United States," the lawsuits state. "These individuals have been inhaling ethylene oxide on a routine and continuous basis for decades. Now they are suffering from a variety of cancers, miscarriages, birth defects, and other life-altering health effects from continuous exposure to ethylene oxide."

The medical device industry has been lobbying the federal government to maintain access to ethylene oxide, a carcinogenic gas used to sterilize over half of medical devices. The EPA is in the process of proposing regulations on ethylene production and on commercial sterilizers using ethylene oxide.

The lawsuits cite an EPA frequently asked questions website that states the agency "believes the largest sources of ethylene oxide emissions in Lake County are Medline, a commercial sterilizer located in Waukegan, and Vantage, a chemical production facility in Gurnee."

In 2017, Medline reported it released 2,863 pounds of ethylene oxide emissions, according to EPA. In February, the company received a permit from the Illinois EPA to construct various improved emission controls at its commercial sterilization facility.

Vantage emitted 1,547 pounds of ethylene oxide emissions in 2017 from controlled emission stacks and fugitive sources. The company has installed additional pollution controls and committed to ambient air monitoring around its plant, according to a May update by EPA.

Medline said it plans to fight the four lawsuits. Vantage did not respond to questions in time for publication.

"We have always operated in compliance with all laws and regulations, have always operated at or below our permitted levels, and plan to defend any suits vigorously," Medline told MedTech Dive in a statement.

The four individuals are represented by Chicago law firms Edelson PC and Tomasik Kotin Kasserman, which anticipate additional similar lawsuits will be filed.