October 27, 2020

Volume X, Number 301

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October 27, 2020

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October 26, 2020

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Blue Bell Fined Record $17.25 Million in Post-Conviction Criminal Penalties for Listeria Outbreak

As previously reported on this blog, a multi-state listeriosis outbreak in 2015 linked to Blue Bell Creameries LP’s ice cream products contaminated with Listeria monocytogenes led to recalls, state regulatory enforcement actions (discussed here), civil litigation (including shareholder lawsuits), and criminal prosecution of the company and its former president. According to the Centers for Disease Control and Prevention, at least 10 people were sickened with listeriosis and hospitalized in Arizona, Kansas, Oklahoma, and Texas, and three people in Kansas died.

Pursuant to a plea agreement filed in federal court in Austin, Texas, in May 2020, the company pled guilty to two misdemeanor counts under the Federal Food, Drug, and Cosmetic Act of distributing adulterated ice cream products through interstate commerce. After conviction, Blue Bell was recently sentenced to pay $17.25 million in criminal penalties ($9.35 million in criminal fines and $7.9 million in forfeiture). According to the U.S. Department of Justice (DOJ), this represents the largest-ever criminal penalty following a conviction in a food safety case.

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. According to DOJ, the combined total of $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 largest to date is a $25 million fine paid by Chipotle Mexican Grill Inc. in connection with a three-year deferred prosecution agreement to avoid conviction through implementation of an improved food safety program). According to the U.S. Department of Justice’s (DOJ) press release announcing the Blue Bell plea agreement, since reopening 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 federal action in the same court, Blue Bell’s former president, Paul Kruse, was charged with seven felony counts (including attempt and conspiracy to commit mail fraud, wire fraud, and attempted wire fraud) for his alleged efforts to conceal from customers what the company knew about the listeria contamination. Among other allegations, Kruse allegedly directed Blue Bell employees to remove potentially contaminated products from store freezers without notifying retailers or consumers about the real reason, directed employees to tell customers who inquired that there was an unspecified issue with a manufacturing machine instead of informing them that samples of the products had tested positive for listeria, and directed employees to conceal and destroy evidence. In July 2020, the court dismissed the felony charges for lack of subject-matter jurisdiction, after Kruse successfully argued that while prosecutors had filed an information to charge him, they had failed to properly secure the required indictment or, in the alternative, a waiver of the right of indictment.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 262
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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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