Blue Bell Ice Cream Listeria Outbreak Lawsuit - Multistate (2015)
In March 2015, the Centers for Disease Control and Prevention (CDC) announced that it had confirmed an outbreak of Listeria monocytogenes infections spanning several years. Using PulseNet to identify the infections associated with the outbreak, the CDC initially reported that five patients had been infected with one of four outbreak-related strains of Listeria (as determined by Pulsed Field Gel Electrophoresis (PFGE) analysis). All five patients had developed invasive listeriosis after being hospitalized – a fact that strongly suggested the infections had been acquired in the hospital. Whole-genome sequencing (WGS) showed that isolates from four of the five patients were closely related. Illness-onset dates ranged from January 2014 through January 2015. Of those patients for whom information was available on the foods eaten in the month before illness onset, all four had consumed milkshakes while hospitalized. The milkshakes had been made with a single-serving Blue Bell brand ice cream product called “Scoops”.
In a separate (non-outbreak-related) investigation, the South Carolina Department of Health and Environmental Control (SCDHE) isolated Listeria from Country Cookie chocolate-chip cookie and ice cream sandwiches and Great Divide Bars, both Blue Bell single-serving ice cream products. The products had been collected as part of an inspection of a distribution center.
In response to findings in South Carolina, the Texas Department of State Health Services collected product samples from the Blue Bell Creameries production-facility in Brenham, Texas. Testing of these samples yielded Listeria from the same two kinds of products tested in South Carolina, and also from “Scoops” single-serving ice cream products. These three products were all made on the same production line. Meanwhile, the Kansas Department of Agriculture laboratory isolated Listeria from an unopened, single-serving cup of Blue Bell chocolate ice cream, a product made for use in institutional food-service operations, like the hospital. Indeed, the ice cream from which the Listeria had been isolated was obtained from the hospital associated with the outbreak. Listeria was isolated in samples of the same product collected from the Blue Bell production facility located in Broken Arrow, Oklahoma. Three strains of Listeria isolated from the ice cream samples had PFGE patterns that were indistinguishable from those strains of Listeria isolated from samples collected from four infected Kansas patients. In a follow-up investigation of the Oklahoma facility, the FDA isolated Listeria from a one-pint container of Blue Bell banana pudding ice cream.
As the investigation of the Blue Bell outbreak continued to unfold, a further search of the PulseNet database identified two other clusters of patients infected with several strains of Listeria that were indistinguishable from strains isolated in Blue Bell products. Three patients from Texas had suffered infections with illness-onsets occurring between 2011 through 2014. All developed listeriosis after being hospitalized for other health-related reasons. Information was available for one patient who reported consuming ice cream in the hospital before developing listeriosis. TDSHS later confirmed that the hospital had received Blue Bell ice cream cups during the time the patient was hospitalized. Whole-genome sequences of the Listeria strains that had infected the three Texas patients were revealed to be nearly identical to Listeria strains isolated from ice cream produced at the Blue Bell facility in Oklahoma. Then, on April 21, CDC reported that whole-genome sequencing confirmed that two more patients – one in Arizona, and one in Oklahoma—had been part of the outbreak, bringing the total outbreak case-count to ten confirmed cases.
On June 10, 2015, after completing its investigation, the CDC declared the outbreak to be over. In its final assessment of the outbreak, it was reported that ten patients infected with several outbreak-strains of Listeria monocytogenes were residents of four states: Arizona (1 case), Kansas (5 cases), Oklahoma (1 case), and Texas (3 cases). Illness-onset dates ranged from January 2010 through January 2015. All ten patients had been hospitalized, with three deaths from Kansas.
On March 23, 2015, in the midst of the ongoing outbreak investigation, Blue Bell Ice Cream of Brenham, Texas announced a recall of the three-ounce ice cream cups that had been marketed to institutional and commercial foodservice operations. On April 3, Blue Bell voluntarily suspended operations at its Oklahoma production facility. Four days later, on April 7, Blue Bell announced an expansion of the product recall to include banana pudding ice cream produced between February 12 and March 27, 2015 at the Oklahoma facility. Then, on April 20, Blue Bell expanded its recall again, this time including all Blue Bell products including frozen yogurt, sherbets, and frozen snacks.
FDA investigators conducted on-site inspections at Blue Bell facilities located in Alabama, Texas, and Oklahoma. At each facility, investigators observed “failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms.” Some of the FDA’s documented observations at each facility are as follows.
Products manufactured between 8/29/14 and 1/21/15 were sampled by the firm and found positive for Listeria monocytogenes. Environmental swabs of samples collected inside the drain of the freezer tunnel and at the outside drain of the freezer tunnel were positive for Listeria in February 2015. After reportedly cleaning and sanitizing, Listeria positive swabs were found on food contact surfaces. FDA investigators concluded that the “procedures used for cleaning and sanitizing the equipment has not been shown to provide adequate cleaning and sanitizing treatment.” On March 17, 2015, FDA investigators observed condensate drip falling onto molds which were filled with berry ice cream. Condensate was dripping directly into pints of mint chocolate ice cream and half gallons of Cookies ‘n Cream. In April 2015 FDA investigators observed condensate drip on top of boxes of ice cream sandwich lids. During inspections in March and April investigators observed failure to clean food contact surfaces and failure to maintain buildings in repair sufficiently to prevent food contamination.
Broken Arrow, Oklahoma
Both Banana Pudding Ice Cream produced in February 2015 and chocolate ice cream produced in April 2015 were positive for Listeria monocytogenes. FDA investigators found that the plan for sampling for environmental pathogens on surfaces at the facility failed to include sampling of food contact surfaces and that there was no plan for preventative action if contamination was found. Investigators determined that the daily total coliform sampling on finished product was inadequate.The procedure for cleaning and sanitizing equipment and utensils was inadequate. FDA investigators noted that in spite of cleaning and sanitizing treatments, the facility continued to have positive environmental test results for Listeria. Twelve observations were listed on FDA Forms 483 as in need of corrective action.
Inspections were conducted in April 2015. FDA investigators noted that the sampling program employed by the facility failed to sample food contact surfaces and that there was no preventative action in the event of contamination. Equipment and utensils were designed such that proper cleaning could not be performed. Employees did not wash and sanitize hands. The drop ceiling was damaged and in poor repair. Tiles appeared to be stained and broken throughout the mixing room.
In response to the failures found at each facility, Blue Bell entered into consent agreements with the public health and agriculture agencies in Texas, Oklahoma, and Alabama, agreeing to take a number of specific steps and actions before bringing Blue Bell ice cream products back to market. According to Blue Bell, the agreed upon “actions include rigorous facility cleaning and sanitizing, revised testing protocols, revised production policies and procedures designed to prevent future contamination and upgraded employee training initiatives.”
Marler Clark represented 21 individuals affected by the Listeria outbreak, achieving settlements covering medical costs, pain and suffering, emotional distress, and loss of consortium.