MARION, N.C. — A health care company has agreed to pay more than $18 million after a whistleblower raised alarms about mold near a production line for sterile IV bags.
U.S. Justice Department officials announced the developments with Baxter Healthcare Corp. late Thursday. The company will pay the $18 million to resolve civil and criminal matters after issues with mold in part of its Marion, North Carolina plant in 2011 and 2012.
During the time in question, justice officials said the plant produced 60 percent of IV bags in the United States.
Chris Wall, a longtime HVAC technician at the company's North Cove plant in Marion, spurred the investigation into Baxter after noticing mold on air filters near a production line where IV bags were filled. Wall spotted mold on air filters for a room where sterile IV bags were filled.
Tony Scheer, one of two attorneys representing Wall, told Eyewitness News that Wall tried to get managers at Baxter to stop the production line. When they didn't, he went to the Federal Drug Administration, Scheer said.
"It's truly unfortunate that a group of managers at that plant ignored the best efforts of Mr. Wall and some others at the plant to get them to stop it," Scheer said.
Production in that room continued until an unannounced FDA inspection in 2012, according to the U.S. Attorney's Office.
Scheer and Tommy Odom, another attorney for Wall, helped Wall file a civil lawsuit against the company in 2013. The matter remained sealed until Thursday.
"[Wall] was concerned because of the potential of people being injured because of these drugs being manufactured in non-sterile conditions," Odom told Eyewitness News.
In addition to the civil matter, federal prosecutors filed a criminal complaint against Baxter Thursday. Baxter agreed to defer prosecution and pay an $8 million penalty and $8 million forfeiture to resolve the matter.
Court records allege as early as 2006, HVAC technicians were instructed by Baxter officials to stop using the word "mold" on paperwork and write "stained" or "discolored" instead. Federal officials scolded the company over its management of the issue.
"Despite notification by an employee of potential contamination concerns, Baxter was poorly focused on instituting sufficient safety standards for their products," said U.S. Attorney Jill Westmoreland Rose, for the Western District of North Carolina.
In a statement Thursday to Eyewitness News, a Baxter spokesperson said the company had made changes since concerns first arose.
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Cox Media Group