The Summer 2008 E. coli O157:H7 Outbreak linked to Nebraska Beef and Whole Foods - A story of companies out of control leaving victims in its wake.
On June 30, 2008, Nebraska Beef, Ltd., an Omaha-area beef processor, recalled approximately 531,707 pounds of ground beef products because the meat was potentially contaminated by E. coli O157:H7.
On June 24, 2008, the CDC announced an outbreak of E. coli O157:H7 illnesses among 24 residents of Michigan and Ohio. The next day, the CDC announced that the number of outbreak linked cases had grown to 32, and that ground beef sold at Kroger stores, the Cincinnati based grocery chain, was the likely outbreak vehicle. That afternoon, Kroger recalled all varieties and weights of ground beef products bearing a Kroger label sold between May 21 and June 8 at Michigan and Central and Northwestern Ohio Kroger retail establishments. By June 26, the outbreak had claimed 33 victims; and by June 30, the CDC counted 35 confirmed cases linked to ground beef sold by Kroger, with 19 people hospitalized and 1 known case of hemolytic uremic syndrome.
But Kroger did not produce the meat from which the contaminated ground beef implicated in this developing outbreak was made. Investigation by health officials in Michigan and Ohio, in collaboration with officials at the CDC and FSIS, showed that the contaminated Kroger beef had actually been produced by an Omaha, Nebraska beef processor called Nebraska Beef, Ltd. On the basis of these investigative findings, Nebraska Beef recalled approximately 531,707 pounds of beef products on June 30, 2008.
The outbreak linked to Nebraska Beef’s products would continue to grow through the end of June and into July. On July 1, the CDC announced that 38 people had now been infected in Ohio and Michigan; on July 3, the number rose to 41. That day, Nebraska Beef expanded its recall “to include all beef manufacturing trimmings and other products intended for use in raw ground beef produced between May 16 and June 26.” The massive recall now totaled an estimated 5.3 million pounds of beef. In an FSIS press release the same day, it was reported:
FSIS has concluded that the production practices employed by Nebraska Beef, Ltd. are insufficient to effectively control E. coli O157:H7 in their beef products that are intended for grinding. The products subject to recall may have been produced under insanitary conditions.
Meanwhile, further epidemiological investigation revealed that the outbreak had spread beyond the states of Michigan and Ohio. On July 15, the CDC announced that New York, Indiana, and Kentucky had reported outbreak cases as well—i.e. individuals with a stool sample that was positive for a strain of E. coli O157:H7 that was indistinguishable from the patterns detected in recalled beef products and in other already-recognized outbreak cases. The next day, the CDC reported that the State of Georgia had a case too, bringing the total to 45 victims nationally.
But Nebraska Beef’s contaminated beef products had spread even further than that into the stream of commerce, and unfortunately into the homes of consumers. On August 8, 2008, Nebraska Beef announced yet another massive recall. This time, the troubled company recalled approximately 1.2 million pounds of primal cuts, subprimal cuts and boxed beef due to potential E. coli O157:H7 contamination.
This latter recall also occurred in the wake of a large-scale investigation into a multi-state outbreak of E. coli O157:H7 illnesses with exposures to ground beef products from a variety of retail outlets. At least 31 people in 12 states and Canada had been infected. The investigation ultimately showed that, through a middleman called Coleman Natural Meats, Nebraska Beef had supplied the implicated retail outlets, including certain Whole Foods and Dorothy Lanes locations.
The total amount of beef products recalled by Nebraska Beef from June to August 2008 was 6,660,000 pounds. The contaminated beef subject to Nebraska Beef’s various recalls ultimately caused at least 80 illnesses in 16 states and Canada.
Eula Bentley-Tobias
Eula Plum Bentley-Tobias is a two-and-a-half-year-old, free spirited little girl who lives in Charlottesville, Virginia with her parents, Jonah and Lisa. At the time of her illness, Eula was just twenty-one months old, and the Tobias family was living in New York City.
Prior to her HUS illness, Eula was an extremely healthy child. In fact, after her birth, she had never even been to a hospital, she was not on any medications, and she had no known allergies or other health problems whatsoever. Moreover, she had met all of her major developmental milestones, both psychosocial and physical, including babbling at six months, speaking her first word (“dada”) at eight months, and walking at twelve months. Without a doubt, Eula was an entirely healthy toddler with no congenital impediment to leading a productive, normal life.
On July 2, 2008, Eula and her parents traveled to Charlottesville, Virginia for the Fourth of July holiday. They stayed at Jonah’s mother and father’s home. While there, Jonah’s mother purchased ground beef on two occasions from the local Whole Foods store. The first package of ground beef was actually returned to the store because, when Lisa took it from the refrigerator to prepare hamburgers, she noticed that the meat appeared grayish in color. Whole Foods willingly allowed Jonah’s mother to exchange the discolored meat for a new package of fresh ground beef the morning of July 4. That afternoon, Lisa prepared hamburgers for many members of the family, including Jonah. Eula did not consume any of the ground beef.
Eula began to suffer from a low-grade fever on July 7 or 8. No other symptoms of illness manifested until approximately one week later, when Eula began to complain that her “tummy hurt.” Onset of diarrhea occurred around the same time, quickly increasing in intensity and frequency over the next twenty-four hours. Eula saw her pediatrician, Mark Levin, MD, on July 17, who noted significant abdominal pain and guarding. Dr. Levin’s differential diagnosis included gastroenteritis and intussusception, which is a potentially fatal condition characterized by the enfolding of the large and small bowel. He recommended that Jonah and Lisa take Eula immediately to the emergency department at Beth Israel Hospital for further diagnostic tests.
Jonah and Lisa were ill prepared for what they would witness over the course of the next month, much less the medical reality that would confront their then-only child by the time she was finally discharged from the hospital on August 16. During her three-day-stay at Beth Israel, Eula’s kidneys would shut down, becoming clogged with cellular debris produced by the hemolyzing effect of the shiga toxins circulating in her bloodstream. She would also become badly anemic and suffer from a precipitous decline in platelets, signaling the onset of hemolytic uremic syndrome, a potentially fatal condition triggered by E. coli O157:H7 bacteria.
Unable to produce urine, yet requiring intravenous fluids due to the dehydration caused by her continuing, grossly bloody diarrhea, Eula’s entire body, even her eyelids, swelled to the point that her frightened parents could hardly recognize the form that their daughter had taken. And toward the end of her short stay at Beth Israel, before being transferred to New York Presbyterian Hospital’s pediatric intensive care ward, Eula’s body began to experience metabolic changes that would ultimately cause insulin-dependent diabetes. By July 20, 2008, Eula’s condition had deteriorated to the point that her team of doctors at Beth Israel agreed that she should be transferred to New York Presbyterian for potentially life-saving kidney dialysis and other care.
Eula’s body continued its rapid descent toward catastrophic, total failure at New York Presbyterian. After being directly admitted to the intensive care unit, blood tests confirmed that her kidneys had shut down completely, and that she had experienced a critical drop in red blood cells and platelets. The first of many blood transfusions occurred in the early morning hours of July 21. Over the next ten days, Eula would be repeatedly transfused with red blood cells.
On July 22, swollen and failing, Eula became much more irritable and fussy; too much so, in fact, for the change to be simply a consequence of her very ill condition. She began to speak incoherently, losing entirely the relatively advanced verbal structure that she had developed over the course of her first twenty-one months of life. In an email written to family and friends, Eula’s mother said, “She is slowly slipping away from us mentally, becoming less and less responsive.”
The changes became more pronounced that evening. Then, at midnight on July 22, Eula’s pediatric critical care specialist noticed certain behaviors, including agitation and a pronounced, left-sided gaze, that he believed to be a seizure. An EEG done later detected a seizure lasting eighteen minutes in the right hemisphere of Eula’s brain. Doctors immediately loaded her with Dilantin, an anti-seizure medication that caused Eula to become only minimally responsive. And then, four days later, she suffered a grand mal seizure lasting over an hour. During the seizure, Jonah and Lisa Tobias were rushed out of the room, and watched through a window in the door as doctors compressed Eula’s chest to ensure that her heart continued to beat. Ultimately, Eula would remain only minimally responsive into the month of August, when the anti-seizure medications could be safely withdrawn.
Meanwhile, Eula continued to suffer from total kidney failure, and metabolic changes that lead to respiratory failure, alternating low and high blood pressures, liver and pancreas disease, and, ultimately, insulin-dependent diabetes mellitus. Peritoneal dialysis began on July 25, having to take over the job of Eula’s failing kidneys and rid her body of the harmful toxins and wastes that were building up due to her inability to produce any urine. Eula remained sedated, and breathing through a mechanical ventilator, through the end of July.
Eula ultimately remained on dialysis through August 11, by which point her kidneys had been irreversibly and severely damaged. By the time of discharge from New York Presbyterian Hospital on August 16, she had regained most of her mental function, and doctors were optimistic that, despite the severity of her neurological involvement, she had not sustained any organic brain damage. Nevertheless, due to the severity of her kidney injury and her ongoing diabetes mellitus, Eula remained on a variety of medications after discharge from the hospital, including Enalapril, Nystatin, Dilantin, Erythropoietin, and Lantus.
Since discharge, Eula’s recovery has been gradual and, sadly, incomplete. Her kidneys have not regained the functional capacity that they had before she became infected by E. coli O157:H7 in July 2008; and they never will. Eula remains on multiple medications to support her damaged kidneys and prolong their life, but she will require medical monitoring for the rest of her life, and at some point will likely require kidney transplantation and further dialysis for survival.
Nebraska Beef’s Six-Plus Years of Serious Food Safety Violations
Nebraska Beef and its meat-processing plant not only has a long history of safety and health violations, it has repeatedly been the target of USDA efforts to shut it down, including this year. This sordid history is summarized in a recent front-page, investigative news article that was published in the Washington Post, which stated:
Nebraska Beef has a contentious history with the USDA. Over the past six years, federal meat inspectors have repeatedly written it up for sanitation violations, and the company has fought back in court.
From September 2002 to February 2003, USDA shut down the plant three times for problems such as feces on carcasses, water dripping off pipes onto meat, paint peeling onto equipment and plugged-up meat wash sinks, according to agency records.
After the third suspension, Nebraska Beef took USDA to court, arguing that another shutdown would put the company out of business. A judge agreed and temporarily blocked the department. The USDA and the company then settled out of court and inspections resumed. However, when federal meat inspectors found more violations, Nebraska Beef sued the department and the inspectors individually, accusing them of bias. The suit was later dismissed.
In 2004 and early 2005, Nebraska Beef ran afoul of new regulations aimed at keeping animal parts that may be infected with bovine spongiform encephalopathy, or mad cow disease, out of the meat supply. Meat processors are required to remove certain high-risk parts, such as brains and spinal cords. Between July 2004 and February 2005, federal meat inspectors wrote up Nebraska Beef at least five times for not removing spinal cords and heads, according to USDA records obtained by Food and Water Watch, a Washington advocacy group. The company corrected the problems.
In August 2006, federal meat inspectors threatened to suspend operations at the packing house for not following requirements for controlling E. coli. The company corrected the problem a week later, USDA records show.
The hundreds of safety and sanitation violations from April 2002 through February 2003 include dozens of instances of documented fecal contamination—the major source of E. coli O157:H7—on beef carcasses and other cut meat items, like chuck rolls. There were also repeated instances where failures were identified in the plant’s E. coli testing program. And nearly every violation for that time period involved the plant’s failure “to prevent insanitary conditions or the adulteration of product.”
Ultimately, it was the regrettable history of food safety violations, and the threat the plant and its meat products posed to the public health, that prompted the USDA to conduct a “comprehensive public health assessment…during the week of September 2, 2002.” According to the legal brief later filed by the USDA in its attempt to shut down Nebraska Beef’s plant and operations:
That assessment was conducted because Nebraska Beef was one of the few suppliers of meat products used to prepare ground beef which was identified to contain E. coli O157:H7. The evidence…will show that Nebraska Beef provided a large amount of the meat products used to prepare the contaminated ground beef.
Accordingly, USDA argued that the Court should not prevent it from shutting the plant down, explaining:
FSIS has determined after extensive oversight that Nebraska Beef’s HACCP system is not working, and that its products are being produced under insanitary conditions that may make them unsafe for human consumption….Anyone who might handle or consume Plaintiffs’ [Nebraska Beef] products is therefore being exposed to greater than normal risk.
There is ample evidence that Nebraska Beef continued to run its meat-processing plant in a way that put the public at a “greater than normal risk” when consuming its products. This risk was because the plant’s HACCP and other safety systems—e.g., Standard Sanitation Operation Procedures (SSOP’s) and E. coli testing program—were insufficient or simply not working. The earlier E. coli outbreak caused by Nebraska Beef meat that occurred during the summer of 2006 is but one piece of such evidence. Indeed, in a striking replay of what had occurred in 2003, the USDA once more tried to shut down Nebraska Beef’s plant. Specifically:
On August 3, 2006, the Food Safety and Inspection Service (FSIS) issued establishment 19336, Nebraska Beef, a Notice of Intended Enforcement (NOIE). This decision was based on the finding noted during the Comprehensive Food Safety Assessment performed at [its] establishment from July 10, 2006 through August 3, 2006.
Not coincidentally, this time period was the one leading up to and including the same time period as the first Nebraska Beef E. coli Outbreak.
The NOIE Letter that FSIS sent to Nebraska Beef on August 3, 2006 is replete with examples of unsafe and insanitary practices and conditions at the plant in the months—if not years—leading up to the Longville E. coli outbreak. FSIS notes numerous noncompliances, including: the insufficiency and failure of its E. coli testing program; the failure to maintain or implement SSOP’s in compliance with regulatory requirements; and HACCP system that was inadequate because it “allowed adulterated product to be produced,” and failed to meet numerous other regulatory requirements.
Another Outbreak, and FSIS Attempt to Shut Nebraska Beef Down
Since the Longville E. coli outbreak, Nebraska Beef has been involved in another E. coli O157:H7 outbreak linked by FSIS, CDC, and other public health officials to contaminated meat products like those implicated in the present case—i.e., 60-pound boxes of Nebraska Beef chuck rolls. See, e.g. FSIS Recall No. 022-2008, dated June 30, 2008. According to FSIS:
[it] has concluded that the production practices employed by Nebraska Beef, Ltd. are insufficient to effectively control E. coli O157:H7 in their beef products that are intended for grinding. The products subject to recall [including chuck rolls] may have been produced under insanitary conditions.
See, e.g. FSIS Recall No. 022-2008, dated June 30, 2008. The cited practices and conditions have also been explicitly linked to insufficiencies that were subject to FSIS Noncompliance Reports as far as April 25, 2002 involving, among other things, insanitary practices in the fabrication area—i.e., the part of the plant where carcasses are turned into primal and subprimals. The Nebraska Beef plant has been operating with a broken safety system for over six years, and all aspects of its plant and operations are evidence of Nebraska Beef’s long history of continuing negligence—indeed, negligence so severe that it appears consciously indifferent to the safety and well-being of the consuming public, including the plaintiffs in this present action.
Unfortunately, not many ordinary consumers know of the systemic problems at Nebraska Beef, and those who are unaware have regrettably placed their faith in this company who so woodenly adheres to its intransigent, dilapidated, and mostly non-existent, food safety practices. The world would certainly be a better place if Nebraska Beef simply vanished as a link in our country’s food chain.
Perhaps more reprehensible than Nebraska Beef, however, are the companies that continue to buy or use Nebraska Beef’s products. These companies, which include many otherwise respectable organizations like Kroger and Whole Foods, simply have no excuse for what transpired in summer 2008. These companies have actual knowledge of the USDA’s repeated efforts to shut Nebraska Beef down.
I would hope these national grocery chains could find better suppliers...if not than the USDA and the FSIS and the FDA are about effective as the SEC.
The American people need a HACCP on their Congressmen and Senators
Now that a Corporation has been given the right to fund elections the fox is not only in the hen house they also own the farmers.
From Monsanto to the USDA the term from field to fork has a whole new meaning.More like from Pork to Court.