Blue Bell Outbreak Shows Increased Legal Risks for Companies

According to the criminal complaint (called an “information”), Kruse, as of at least 2010, knew that Blue Bell was not following appropriate practices to ensure sanitary conditions at its manufacturing facilities. During the outbreak period, Blue Bell coliform levels were, on occasion, too high to count. Blue Bell laboratory technicians referred to these results as “TMTC” (too many to count) and shipped the products despite the high coliform counts. In early 2011, following customer complaints about the coliform levels, a Blue Bell quality control employee created a program to periodically test high coliform Blue Bell product for the presence of Listeria. In April 2011, Kruse ordered the employee to halt the program. After Kruse issued the order, two products tested presumptively positive for Listeria. Based on Kruse’s order, an employee destroyed the testing records and the presumptively positive product was shipped to customers.

In February 2015, South Carolina health officials, during routine sampling, isolated Listeria from multiple Blue Bell products. In turn, Texas health officials went to Blue Bell’s Brenham, Texas, facility and conducted additional sampling, which led to the discovery of seven different Listeria strains. At least one of the positives came from product that had been produced on the same production line as the South Carolina positives.

In March 2015, two people in a Kansas hospital were infected with a matching strain of Listeria. When the Blue Bell and South Carolina isolates were uploaded to PulseNet, investigators discovered that three additional cases, which were from the same hospital but were infected with different strains, were a match. In total, four of the five hospital patients had strains that matched the Blue Bell ice cream tested by South Carolina and Texas. Moreover, all four had consumed milkshakes made with Blue Bell ice cream while they were in the hospital.

Upon notification of the positives, Kruse purportedly told FDA that Blue Bell would be recalling all implicated products. Instead of recalling the products, however, he is accused of directing employees to surreptitiously remove the implicated products from stores during their regularly scheduled deliveries. Prosecutors claim that Kruse also ordered employees not to disclose the reason for the withdrawal to customers, and that he directed executives to forbid employees from disclosing information about Blue Bell’s Listeria contamination to customers. In addition, Kruse allegedly: 1) concealed the potential presence of Listeria by asserting the withdrawal was due to a manufacturing irregularity; 2) refused to notify the public about the Listeria contamination; and, 3) oversaw the issuance of a statement claiming all potentially contaminated products had been withdrawn even as they were still available in stores.

Eventually, Blue Bell did initiate a recall, which ultimately included eight million gallons of ice cream. In the aftermath of the outbreak, more than 1,400 workers were laid off and another 1,400 were furloughed. To be sure, the Blue Bell outbreak involved more than minor oversights and bad luck, and if the allegations levied by the federal government prove to be true, Blue Bell’s conduct was egregious and inexcusable.

Even absent the alleged criminal conduct, there are numerous aspects of this outbreak that should be gravely concerning to food industry executives. One is that an outbreak could last for five years. The first known illness was in January 2010. It was followed by two additional illnesses in 2011, one in 2012, three in 2014, and one in 2015. That pathogens could continue to periodically contaminate products for such a long period of time creates enormous potential risk to food companies. From a legal standpoint, it should serve as a warning that ignoring potential microbiological problems can be far more costly than the interventions and actions required to adequately address such problems.