This story is jointly reported by Brenda Goodman of WebMD and Andy Miller of Georgia Health News
May 20, 2020 -- One of Alexandria Pittman’s jobs at ConMed in Lithia Springs, GA, just west of Atlanta, had her working near a dock where trucks would unload boxes of newly sterilized medical supplies.
Those supplies had been sterilized with a toxic gas called ethylene oxide at the Sterigenics facility in Cobb County, about 12 miles to the northeast.
A lawsuit filed in Cobb County on Wednesday on behalf of Pittman and 52 other ConMed employees argues that those medical products were not properly aired out before being ferried to the ConMed warehouse. As a result, the supplies released unsafe levels of ethylene oxide into the air at the warehouse — exposing workers to a known carcinogen for years. The suit names ConMed and Sterigencs and several supervisors and managers at both companies as defendants.
In September 2019, OSHA — the Occupational Safety and Health Administration — cited ConMed for serious violations of worker safety. In a Notification of Penalty letter, the federal agency says the company exposed workers to concentrations of ethylene oxide above permissible limits. The company was fined more than $13,000 for the violation. ConMed reached a settlement with OSHA in early May. The terms of the agreement were not immediately available.
In 2016, the EPA completed nearly two decades of scientific review on ethylene oxide, concluding that studies in workers had shown the chemical 30 times more potent a carcinogen than previously known. The agency reset a key risk value for determining unsafe exposures in outdoor air.
OSHA sets the safe levels for workers exposed to ethylene oxide on the job. Those levels were last updated in 2000. They are far higher than the new safe limits set by the EPA.
“This is in the neighborhood of a thousand times higher than the community exposure,” said Peter Orris, MD, Chief of Occupational & Environmental Medicine at the University of Illinois Health System in Chicago.
“This would appear to be substantial overexposure,” said Orris, who reviewed the OSHA documents for this story.
Pittman says neither she nor her coworkers were warned that exposure to ethylene oxide could cause cancer or a host of other health problems.
According to OSHA, harms to workers who are exposed to the chemical can include difficulty breathing, nausea, blurred vision, miscarriages, nerve damage, muscle weakness, impaired thinking and memory.
Pittman, who worked at ConMed for nearly 3 years from 2016 to 2019, remembers having skin rashes. Her throat would swell up, and her eyes were often irritated.
“I used eyedrops a lot,” says Pittman, 49, who lives in Atlanta.
In December, Pittman was diagnosed with multiple myeloma, a type of cancer that affects white blood cells.
While it is very difficult to determine whether a chemical exposure has caused any one individual’s cancer, exposure to ethylene oxide has been linked to the development of breast and blood cancers, including multiple myeloma.
“Multiple myeloma, there’s no cure for that,” Pittman said.
The lawsuit says that in some cases the exposures continued for nearly 10 years without a warning to employees that they could be working with a hazardous chemical.
“The lawsuit filed today seeks to hold Sterigenics and ConMed liable to the 53 injured victims for exposing them to large quantities of ethylene oxide gas over a long period of time without their knowledge or consent and concealing the existence and danger of ethylene oxide,” says attorney Eric Hertz, who is lead counsel for the plaintiffs.
“Workers who serve as key links in the chain to getting much needed sterilized medical equipment to hospitals and patients must not be sacrificed in the process,” Hertz says.
ConMed did not respond to requests to comment.
In a statement issued in response to the lawsuit, Sterigenics and its parent company Sotera Health, pushed back against the claims.
“Sterigenics and its employees did not cause any injury to the plaintiffs. The allegations asserted in this lawsuit against Sotera Health, Sterigenics and Sterigenics’ employees are baseless, and we will vigorously defend against them,” the company said in an emailed statement.Warehouses have recently become a focus of concern over ethylene oxide emissions.
In December, the Georgia Environmental Protection Division served the company BD with a Notice of Violation for operating a warehouse in Covington, east of Atlanta, without an air pollution permit. Tests conducted by the company at the warehouse, which had no air pollution control equipment, showed that products off-gassing in the warehouse were releasing some 5,600 pounds of ethylene oxide into the air a year. The company was eventually fined by the state and required to apply for a pollution permit for the warehouse.
In comments submitted to the EPA, state officials wrote “Georgia EPD encourages EPA to consider the impacts of offsite off-gassing and the storage of products sterilized using ethylene oxide in any revisions,” to the national emission standards for the chemical, which are under review at the agency.
BD says that its warehouse emissions of ethylene oxide have been significantly reduced.
Kevin Chambers, a spokesperson for the Georgia Environmental Protection Division, said the agency was not aware of the ConMed warehouse and would be looking into it.
In Georgia, facilities with the potential to release more than 2 tons of the hazardous air pollutant are required to have a permit.
“To our knowledge, the Cobb County Sterigenics facility does not store sterilized materials in offsite warehouses in Georgia,” Chambers said.
Sterigenics drew the ire of Cobb County residents and local and state officials in 2019, after WebMD and Georgia Health News revealed that the sterilization facility was releasing ethylene oxide into the air in neighborhoods around the plant at levels above new EPA safety standards.
The company said its emissions have been within legal limits.
Sterigenics entered into a consent order with the state while it upgraded its pollution controls and shut down in order to install new equipment.
Cobb County officials prevented the facility from reopening. saying that the building violated fire and building codes.
The plant remained closed until last month, after the company sued county officials.
On April 1, a federal judge allowed Sterigenics to temporarily resume full operations, and days later, a consent order let the company continue normal sterilization at the plant until the legal dispute was settled.
“The claims [in the lawsuit] do not relate to Sterigenics’ state-of-the-art emissions controls at its Atlanta facility. They also do not concern its dispute with Cobb County and its officials or Sterigenics’ right to continue its operations under the court-approved Consent Order,” the company said in an emailed statement.