A settlement has been reached to resolve False Claims Act allegations against Baxter Healthcare Corporation.
Baxter Healthcare Corporation has agreed to pay $18.158 million to resolve a False Claims Act suit and bypass criminal charges in North Carolina federal court relating to alleged violations of maintenance regulations for sterile drug products.
According to the department of Justice, between July 2011 and November 2012, Baxter Healthcare manufactured sterile intravenous solutions in a clean room at a North Carolina facility where air filters in the ceiling had mold. Allegedly, a Baxter employee informed management about the mold but the company did not take action and kept producing the drugs in that clean room for months while the filters the employee had identified as moldy remained in place. An unannounced inspection by the U.S. Food and Drug Administration found mold on the filters. There was no evidence the IV solutions were affected.
In a deferred prosecution agreement, Baxter admitted to distributing drug products that were adulterated in violation of the Federal Food, Drug, and Cosmetic Act, paying $16 million in penalties and forfeiture and $2.2 million to settle a related False Claims Act civil suit brought in 2013 by a Baxter whistleblower employee.
“Following current Good Manufacturing Practices is essential to ensure the safety and efficacy of our drugs,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “Today’s settlement shows that the government will continue to hold companies accountable for failing to fulfill this critically important responsibility.”
The lawsuit was brought by Baxter employee Christopher Wall, who will get $431,535.99 from the proceeds of the civil settlement.
