View this article online: https://www.insurancejournal.com/news/southcentral/2020/09/23/583734.htm
Texas-based Blue Bell Creameries L.P. has been ordered to pay $17.25 million in criminal penalties for shipments of contaminated ice cream products linked to a 2015 listeriosis outbreak, according to the U.S. Justice Department.
Blue Bell pleaded guilty in May 2020 to two misdemeanor counts of distributing adulterated ice cream products. Imposed last week by U.S. District Judge Robert Pitman in Austin, Texas, the sentence was consistent with the terms of a plea agreement previously filed in the case.
The $17.25 million fine and forfeiture amount is the largest-ever criminal penalty following a conviction in a food safety case. Blue Bell, headquartered in Brenham, Texas, had originally agreed to pay $19.35 million and plead guilty to charges of shipping the contaminated product, according to an April 2020 Justice Department announcement.
The plea agreement and criminal information filed against Blue Bell allege 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 samples of two ice cream products from the company’s Brenham factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems. Blue Bell directed its delivery route drivers to remove 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 state-led testing confirmed Listeria in a third product. Blue Bell again chose not to issue any formal notification to customers regarding the positive tests. Blue Bell’s customers included military installations.
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 severe illness caused by ingestion of Listeria-contaminated food.
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.
According to the plea agreement with the company, 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 water dripping into product mix during the manufacturing process.
Blue Bell temporarily closed all of 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.
Judge Pittman in July 2020 dismissed charges against former Blue Bell Creameries President Paul Kruse, who U.S. prosecutors had said concealed from customers what the company knew about contaminated ice cream linked to a 2015 listeria outbreak, according to Reuters.
Pitman dismissed the case against Kruse after the Justice Department conceded he did not waive his right to be indicted by a grand jury, which prosecutors did not seek due to COVID-19.
Trial Attorneys Patrick Hearn and Matt Lash of the Civil Division’s Consumer Protection Branch prosecuted the case with assistance from 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.
Source: U.S. Justice Department
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