September 19, 2021

Volume XI, Number 262

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Blue Bell Pleads Guilty to Distributing Adulterated Ice Cream and Former President Faces Charges of Criminal Conspiracy to Conceal Listeria Contamination

A multi-state listeriosis outbreak linked to consumption of Blue Bell Creameries’ ice cream products in 2015 lead to state regulatory enforcement actions (discussed here) and multiple civil lawsuits.  As our readers may recall, Blue Bell did not recall any products that had tested positive for Listeria monocytogenes until after hospitalizations and deaths had occurred.  FDA later published inspectional observations for Blue Bell production facilities indicating the company was aware of food safety violations in facilities dating back to 2007 and positive tests for Listeria monocytogenes in one plant as far back as 2013.  Thus, criminal charges may have been expected to follow.

According to its May 1, 2020 Press Release, the U.S. Department of Justice filed a plea agreement in a Texas federal court whereby Blue Bell has plead guilty to two misdemeanor counts of distributing adulterated ice cream products and has agreed to pay a criminal fine and forfeiture of $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 federal action, Blue Bell’s former president, Paul Kruse, was charged with seven felony counts for his alleged efforts to conceal from customers what the company knew about the listeria contamination.  Kruse allegedly directed other Blue Bell employees to remove potentially contaminated products from store freezers without notifying retailers or consumers about the real reason and directed employees to tell customers who asked that there had been an unspecified issue with a manufacturing machine instead of that samples of the products had tested positive for listeria.

© 2021 Keller and Heckman LLPNational Law Review, Volume X, Number 125
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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