MARION, N.C. -- Baxter Healthcare Corporation will pay more than $18 million to settle civil and criminal liabilities, after the United States Justice Department claims the company ignored mold in air filters at a plant in Marion, North Carolina - where sterile intravenous (IV) solutions are made.
The U.S. Justice Department made the announcement Thursday. In a release, the department said a former Baxter employee, Christopher Wall, initially raised the concerns about the mold, telling managers, but nothing was done.
The IV solutions and bags in question were made between July 2011 and November 2012, the department’s release said.
One former Baxter employee said Friday that he worked at the North Cove facility in the 1970s and was shocked to hear about the massive settlement.
"I’m not informed on it that much, as well as the fact that surely with a multi-million dollar corporation, if you can’t fix a mold issue, you need to shut the doors anyway," said Keith McCall.
Another former employee, Jordan Wilson, said he left Baxter in November 2015 and said while he never experienced moldy air filters while he was there, other issues arose that were never fixed.
“All the problems never really got fixed. It was always put off until a later date,” said Wilson, saying that he witnessed standing water on the floor multiple times. “They just wanted you to push out bags as fast as you could, as many as you can, without getting them fined. All they cared about was numbers, numbers, numbers, they didn't care about the employees, they didn't really care about the product too much.”
One former Baxter worker, who wanted to remain anonymous, said she believes the company is dedicated to quality products that are safe for patients, but adds that there definitely was a lack of proper management at the plant several years ago.
“We are supposed to be saving people and that puts people in high danger,” she said. “It’s hard to believe that they would let something go that long considering they make such a big deal with their workers saying, ‘Hey, we need to do exactly what we need to do to make these products safe,' they stress it!”
Baxter International’s full statement to Time Warner Cable News is below:
“The government’s investigation stemmed from questions about the handling of maintenance concerns in 2011-2012 on an IV solution production line at Baxter’s North Cove manufacturing facility in Marion, North Carolina.
While the handling of these concerns was not consistent with Baxter’s standards, there has been no evidence that products manufactured on this line during the time period were impacted. Manufacturing processes at the facility include extensive sterilization, monitoring and testing procedures, and during the relevant time frame there were no “out of limit” results. Our extensive monitoring systems also revealed no increases in complaints or patient adverse events associated with the products made on these lines during this time period.
We took a number of actions to address these issues, including terminating several members of the facility’s management team and enhancing the training and compliance processes for employees throughout the facility. We also undertook a number of actions to remediate the line and ensure continued compliance with quality standards, including physical changes to the line and implementing enhanced measures for inspections and environmental monitoring. And we’ve made a number of organizational and operational changes since 2012 that have served to elevate and enhance our quality systems, measurement and documentation, and operational oversight, in order to ensure we have the structure and processes in place to consistently deliver the high quality products our patients need and our customers expect.
Patient safety and product quality are the cornerstones of our work at Baxter. Healthcare providers and patients rely on our products to support them in critical situations. That is an important responsibility, and one that requires us to maintain the highest standards for ourselves, our products and our processes.
We have cooperated fully and responsively with the FDA, Department of Justice and others to drive toward resolution of this matter.”
The U.S. Attorney for the Western District of North Carolina, Jill Westmoreland Rose said in response to the Baxter settlement:
“The Baxter case is significant because we need to be able to trust that health care companies implement effective quality control procedures for the production of drugs and that they enforce those procedures. In this case, the repeated alarm bells raised by employees were mishandled by multiple managers and supervisors, who, quite frankly, ‘dropped the ball.’ We conducted a thorough investigation of the facts and public safety and, as a result, we required Baxter to implement significant remedial and compliance measures.”
The employee who blew the whistle on the moldy filters at Baxter, Christopher Wall, will receive more than $431,000 from the civil settlement for his role in the matter.