BRENHAM, TX – According to the Justice Department in an announcement Thursday, a federal court in Texas sentenced the ice cream manufacturer Blue Bell Creameries L.P. to pay over $19 million in criminal penalties for shipments of contaminated products that were linked to a 2015 listeriosis outbreak.
In a plea agreement with federal prosecutors, Blue Bell Creameries has plead guilty to two counts of the offense of distributing contaminated ice cream products and has been ordered to pay criminal fines of $ 17.25 million. Blue Bell also agreed to pay $ 2.1 million in order to settle multiple civil claims for unsanitary ice cream products being sold to federal facilities.
Blue Bell ice cream has been linked to 10 cases of listeria in four states, including three deaths in Kansas since the outbreak in 2015. The listeria could have possibly spread through a drainage system at an Oklahoma plant, Blue Bell told federal inspectors during the investigation.
Former Blue Bell CEO Paul Kruse has been charged with seven crimes, including conspiracy and attempted wire fraud, for allegedly telling Blue Bell employees to withdraw the products potentially contaminated store freezers without informing retailers or consumers of the reason for the withdrawal.
Blue Bell previously pleaded guilty in May 2020 to two misdemeanor counts of distributing adulterated ice cream products. The sentence, which was imposed by U.S. District Judge Robert Pitman in Austin, Texas, was consistent with the terms of a plea agreement that was previously filed in the case. A $17.25 million fine and forfeiture amount is the largest-ever criminal penalty following a conviction in a food safety case.
“American consumers must be able to trust that the foods they purchase are safe to eat,” said Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division.
“The sentence imposed today sends a clear message to food manufacturers that the Department of Justice will take appropriate actions when contaminated food products endanger consumers.”
“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 Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration. “Americans expect and deserve the highest standards of food safety and integrity. 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.”
Michael Mentavlos, the Special Agent-in-Charge of the DCIS Southwest Field Office said, “The results of this investigation reflect the determination of the Defense Criminal Investigative Service to hold companies that sell food products to the military accountable and ensure they comply with food safety laws." “The health and safety of our service members and their dependents is of paramount importance.”
The plea agreement and criminal action filed against Blue Bell allege that the company knowingly distributed numerous ice cream products that were manufactured under unsanitary conditions and contaminated with Listeria monocytogenes, which is a serious violation of the Food, Drug and Cosmetic Act.
According to the plea agreement, Texas state officials notified Blue Bell back in February of 2015 that samples of two ice cream products from the company’s Brenham, Texas factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illnesses or even death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems.
Blue Bell immediately directed its delivery drivers to remove all remaining stock of the two products from store shelves, but the company did not recall the products or issue any formal communication to inform the public or its customers about the potential Listeria contamination.
Two weeks after receiving notification of the first positive Listeria tests, Texas state officials notified Blue Bell that an additional state-led testing confirmed Listeria in a third product. Blue Bell once more chose not to issue any public notifications to customers regarding the positive tests, included several military installations.
In March of 2015, tests conducted by the FDA and CDC linked the strain of Listeria from one of the Blue Bell ice cream products to a strain that sickened five patients at a Kansas hospital with listeriosis, the severe illness caused by ingestion of Listeria-contaminated food.
The FDA, CDC, and Blue Bell all issued public recall notifications on March 13, 2015. Follow up tests confirmed Listeria contamination in a product made at another Blue Bell facility in Broken Arrow, Oklahoma, which led to a second recall announcement from the company on March 23, 2015.
According to the plea agreement with Blue Bell, FDA inspections in March and April of 2015 revealed multiple 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 water dripping into product mixtures during the manufacturing process.
Blue Bell temporarily closed all of its plants in late April of 2015 in order to clean and update the facilities. Since re-opening their facilities in late 2015, Blue Bell has taken several significant steps to enhance sanitation processes and even added a program which tests products for Listeria prior to shipment.
Trial Attorneys Patrick Hearn and Matt Lash of the Civil Division’s Consumer Protection Branch prosecuted the case along with the assistance of Shannon Singleton and Michael Varrone of the FDA’s Office of Chief Counsel. The criminal investigation was conducted by the FDA’s Office of Criminal Investigations and the Department of Defense Criminal Investigative Service.
For more information about the enforcement efforts of the Consumer Protection Branch visit its website at http://www.justice.gov/civil/consum….