According to the U.S. Department of Justice (DOJ), Texas-based ice cream manufacturer Blue Bell Creameries agreed on May 1 to plead guilty to charges it shipped contaminated products linked to a 2015 listeriosis outbreak. In addition, the company’s former president, Paul Kruse, was charged in connection with a scheme to cover up the incident.
In a plea agreement filed with criminal information in federal court in Austin, Blue Bell agreed to plead guilty to two misdemeanor counts of distributing adulterated ice cream products and pay a criminal fine and forfeiture amount totaling $17.25 million. Blue Bell also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding ice cream products manufactured under insanitary conditions and sold to federal facilities. The total $19.35 million in fine, forfeiture, and civil settlement payments constitutes the second largest-ever amount paid in resolution of a food-safety matter.
The plea agreement and criminal information filed alleges that the company distributed ice cream products that were manufactured under insanitary conditions and contaminated with Listeria monocytogenes, in violation of the U.S. Food, Drug, and Cosmetic Act. According to the plea agreement, Texas state officials notified Blue Bell in February 2015 that two ice cream products from the company’s Brenham, Texas, factory tested positive for Listeria monocytogenes. Blue Bell directed its delivery route drivers to remove the remaining stock of the two products from store shelves, but the company did not recall the products or issue any formal communication to inform customers about the potential Listeria contamination. Two weeks after receiving notification of the first positive Listeria tests, Texas state officials informed Blue Bell that additional testing confirmed Listeria in a third product. Blue Bell again chose not to issue any formal notification to customers regarding the positive tests.
In March 2015, tests conducted by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) linked the strain of Listeria in one of the Blue Bell ice cream products to a strain that sickened five patients at a Kansas hospital with listeriosis. The FDA, CDC, and Blue Bell all issued public recall notifications on March 13, 2015. Subsequent tests confirmed Listeria contamination in a product made at another Blue Bell facility in Broken Arrow, Okla., which led to a second recall announcement on March 23, 2015.
According to the plea agreement with the company, the FDA inspections in March and April 2015 revealed sanitation issues at the Brenham and Broken Arrow facilities, including problems with the hot water supply needed to properly clean equipment and deteriorating factory conditions that could lead to insanitary circumstances. Blue Bell temporarily closed its plants in late April 2015 to clean and update the facilities. Since re-opening its facilities in late 2015, Blue Bell has taken significant steps to enhance sanitation processes and enact a program to test products for Listeria prior to shipment.
In a related case, Kruse was charged with seven felony counts related to his alleged efforts to conceal from customers what the company knew about the Listeria contamination. According to the allegations filed against Kruse, Blue Bell’s former president allegedly orchestrated a scheme to deceive certain Blue Bell customers after he learned that products from the company’s Texas factory tested positive for Listeria monocytogenes. Kruse specifically is asserted to have directed other Blue Bell employees to remove potentially contaminated products from store freezers without notifying retailers or consumers about the real reason for the withdrawal. Kruse also is alleged to have directed employees to tell customers who asked why products were removed that there had been an unspecified issue with a manufacturing machine instead of that samples of the products had tested positive for Listeria.
According to The New York Times, a lawyer for Kruse said that his client was innocent of the charges. No date has been set for Kruse’s initial appearance in court.
“We faced a situation our company had never dealt with before, and our agreement with the government reflects that we should have handled many things differently and better,” Blue Bell said in a statement. “We apologize to everyone who was impacted, including our customers, our employees, and the communities where we live and work.”