Texas-based ice cream manufacturer Blue Bell Creameries has agreed to plead guilty to charges and pay millions in fines for shipping contaminated products linked to a 2015 listeriosis outbreak that hospitalized 10 people, three of which died. The company’s former president was also charged in connection with a scheme to cover up the incident, the Department of Justice (DOJ) announced.

In a plea agreement filed with a criminal information in federal court in Austin, Texas, 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.

In a related case, Blue Bell’s former president, Paul Kruse, also was charged with seven felony counts related to his alleged efforts to conceal from customers what the company knew about the listeria contamination.

“American consumers rely on food manufacturers to take necessary steps to provide products that are safe to eat,” said assistant attorney general Jody Hunt of DOJ’s Civil Division.  “The Department of Justice will take appropriate action where food manufacturers ignore poor factory conditions or fail to abide by required recall procedures when problems are discovered.”

The plea agreement and criminal information filed May 1 against Blue Bell in the U.S. District Court for the Western District of Texas alleged that the company distributed ice cream products that were manufactured under insanitary conditions and contaminated with Listeria monocytogenes, in violation of the 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, a dangerous pathogen that can lead to serious illness or death in vulnerable populations. While Blue Bell directed its delivery route drivers to remove remaining stock of the two products from store shelves, it did not recall the products or issue any formal communication to inform customers about the potential listeria contamination, the DOJ said. 

“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 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, Oklahoma, which led to a second recall announcement on March 23, 2015.

“The health of American consumers and the safety of our food are too important to be thwarted by the criminal acts of any individual or company,” said Judith McMeekin, Ph.D., associate commissioner for regulatory affairs at the FDA.  “Americans expect and deserve the highest standards of food safety and integrity and we will continue to pursue and bring to justice those who put the public health at risk by distributing contaminated foods in the U.S. marketplace.”  

Since re-opening the facilities involved in the incident, Blue Bell has taken significant steps to enhance sanitation processes and enact a program to test products for listeria prior to shipment.