A federal court in Texas has sentenced Blue Bell Creameries to pay $17.5 million in criminal penalties in association with the deadly 2015 Listeria monocytogenes outbreak that killed three people who lived in Kansas. The company allegedly shipped contaminated product to hospitals where patients who were already susceptible to infection ate the ice cream in milkshakes and ice cream cups.
In May 2020, Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream products. The $17.25 million fine and forfeiture is the largest ever criminal penalty in a food safety case.
Judy McMeekin, Pharm.D., Associated Commissioner for Regulatory Affairs in the FDA, said in a statement, “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. 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.”
The government alleged that the company distributed products that were made under insanity conditions and contaminated with Listeria monocytogenes bacteira, in violation of the Food, Drug, and Cosmetic Act. Texas officials told Blue Bell in February 2015 that samples of two ice cream products from the company’s factory in Brenham, Texas, texted positive for the pathogen. Blue Bell told its delivery route drivers to remove any remaining stock of those two products from store shelves, but did not recall the ice cream and did not tell customers about the contamination.
Two weeks after that first notification, Blue Bell was sold that state testing found Listeria in a third product. Again, the government asserted that the company did not tell its customers about this problem, including military installations.
In March 2015, tests conducted by the FDA linked the strain of Listeria in one of the Blue Bell products to a strain that sickened five patients at a Kansas hospital. A public recall was finally issued on March 13, 2015. After Listeria was found at another Blue Bell plant in Broken Arrow, Oklahoma, a second call was issued on March 23, 2015.
The Department of Justice started investigating the company in December 2015. They were trying to discover what officials knew about the contamination and when they knew it.
FDA inspections in March and April 2015 found serious sanitation issues at both plants, including insanitary water dripping directly into the product mix during manufacturing. Blue Bell temporarily closed all facilities in April 2015 to clean and update. Blue Bell has taken “significant steps to enhance sanitation processes and enact a program to test products for Listeria prior to shipment,” according to the report.
