Whistleblower Rewarded for Reporting Possibly Tainted Drug Products

Mary Jane Wilmoth

Published On: March 28th, 2017

Drug manufacturer Baxter Healthcare Corporation (Baxter) agreed to pay $18.158 million to the United State to resolve its criminal and civil liability arising from its failure to follow current Good Manufacturing Practices (cGMP) when manufacturing sterile drug products in North Carolina.

The federal government alleged that, between July 2011 and November 2012, Baxter introduced into interstate commerce drugs that were adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA) because Baxter did not follow cGMP when making those products. At North Cove, Baxter manufactured large-volume sterile intravenous (IV) solutions in a clean room that had high-efficiency particulate absorption (HEPA) filters installed in the ceiling. Air was pushed into the clean room through the HEPA filters. During that time, a Baxter employee reported the presence of mold on the HEPA filters to plant management. However, Baxter continued to manufacture IV solutions in that clean room for months while the filters the employee had identified as moldy remained in place. Subsequent testing of the filters following an unannounced U.S. Food and Drug Administration (FDA) inspection revealed several mold species on the filters. There was no evidence of impact on the IV solutions from the mold found on the filters. Baxter is alleged to have violated the False Claims Act by submitting false claims to the Department of Veterans Affairs based upon Baxter’s failure to follow cGMPs.

The False Claims Act settlement resolves a lawsuit filed by Christopher Wall, an employee of Baxter. The False Claims Act permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government’s recovery. Mr. Wall will receive $431,535.99 from the proceeds of the civil settlement.