The agreement includes penalties and forfeitures of some $16 million and another $2.2 million to settle a civil qui tam lawsuit with the U.S. Justice Dept. Whistleblower Christopher Wall, who filed the False Claims suit, is due to receive about $432,000 from the case, according to the Justice Dept.
Federal prosecutors alleged that manager’s at Baxter’s North Cove plant in Marion, N.C., ignored warnings about mold found in the filters above the clean room where the sterile products were made from July 2011 to November 2012. There was no evidence that the mold contaminated the IV solutions.
Baxter spokeswoman Deborah Spak told Reuters that the North Cove plant’s handling of the mold issue “was not consistent with Baxter’s standards” and resulted in changes at the company.
“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,” Spak said in prepared remarks.
Last October, Baxter recalled filters used to remove bacteria and other microscopic matter from water-based IV solutions, due to the presence of particulate matter and the potential absence of filter layers.
In 2014 the Chicago-area company recalled 2 lots of its peritoneal dialysis solution over concerns that the product may have been contaminated during the manufacturing process.