If cookie dough adulterated with E. coli O157:H7 was so rare, how could consumers have been at fault for the E. coli outbreak linked to Nestles Cookie Dough?
A logical disconnection (Non sequitur, if you will) is an argument in which its conclusion does not follow from its premises.
In March 2009 there was an E. coli O157:H7 outbreak associated with Nestle Cookie Dough involving 77 confirmed E coli infections in 30 states, including 35 hospitalizations and 10 cases of hemolytic uremic syndrome. I represented several of the survivors from that outbreak.
In a medical journal article published online on December 8, 2011,1 the authors concluded that raw flour used to make the cookie dough was the “prime suspect” in the outbreak although there was no conclusive evidence that the flour was, in fact, adulterated. The authors concluded:
This is the first reported STEC outbreak associated with consuming ready-to-bake commercial prepackaged cookie dough. Despite instructions to bake brand A cookie dough before eating, case patients consumed the product uncooked. Manufacturers should consider formulating ready-to-bake commercial prepackaged cookie dough to be as safe as a ready-to-eat product. More effective consumer education about the risks of eating unbaked cookie dough is needed. (emphasis added)
Within a few months of the outbreak (by July 1, 2009 according to press reports), FDA investigators were focusing on flour as the source of the E. coli O157:H7. However, officials and food safety pundits stressed how novel it was for an E. coli O157:H7 outbreak to be associated with either raw flour or cookie dough. Evidently it was so novel that most cookie dough producers were not treating their flour to kill off the deadly pathogen (and presumably were not testing for it either).
There appears to be a logical disconnection here. If cookie dough adulterated with E. coli O157:H7 was so rare that even producers did nothing to prevent it, how can it be suggested that consumers (who are known to eat raw cookie dough) are implicitly at fault because they failed to take precautions against the E. coli O157:H7 threat?
I can already hear the response: Everyone knows cookie dough contains raw eggs and everyone knows raw eggs carry Salmonella, so if consumers used common sense and refrained from eating cookie dough to avoid salmonellosis, they could have also avoided E. coli O157:H7 poisoning.
But you know what? Most consumers are not food safety experts. They may not know about the dangers associated with raw cookie dough and certainly could not know it was capable of harboring deadly E. coli O157:H7. They also don’t know that the infective dose of E. coli O157:H7 is so incredibly low (which means that you don’t even have to eat raw cookie dough to become poisoned by it).
I agree that consumers need to take reasonable precautions. But if producers – especially multi-national companies like Nestle – don’t consider a danger or prevent it from occurring, it’s illogical and unfair to blame consumers for not doing so.
Food is a product and therefore subject to product liability law and the requirements of safe product design. Those requirements establish a three-tier safe design process: design out the defect; if you cannot design out the defect, add guards that prevent contact with the danger; and if you cannot design out or guard against the danger, then (and only then) are you allowed to warn users to avoid the danger (and when you do issue warnings, they have to be explicit).
In this case, as in so many others involving unsafe food products, producers don’t design out the dangers; they simply bypass the principles of safe design and jump to innocuous and ill-conceived warnings that do not convey sufficient information to constitute an effective warning (Why? Because if the warnings were truly effective, people would not buy the product).
1. Karen Neil, et al., A Novel Vehicle for Transmission of Escherichia coli O157:H7 to Humans: Multistate Outbreak of E. coli O157:H7 Infections Associated With Consumption of Ready-to-Bake Commercial Prepackaged Cookie Dough—United States, 2009 , Clin Infect Dis. (2011) doi: 10.1093/cid/cir831. First published online: December 8, 2011.
Food Safety Lawyer Fred Pritzker to Bourdain: Love Your Show But Medium Rare Hamburger Is Dangerous
I live in Minnesota. That means that for four or five months of the year, my exercise regimen is relegated to the basement of our St. Paul home.
Since using an elliptical trainer or riding an exercise bicycle is mind-numbingly dull, I distract myself with television. One of my favorite work-out programs is Anthony Bourdain’s “No Reservations” (and his new show, “The Layover”). I like Bourdain because he’s wry, mordant and cynical: the perfect companion for a visit to places I may never see on my own.
I also like the fact that he’s a dick. His persona is that of a self-absorbed and highly opinionated guy – traits you probably don’t want in your father or best friend but quite enjoyable as a travel guide (provided you have separate rooms and a lot of time apart).
Bourdain is also the quintessential (and disdainful) foodie. In a recent episode, “The Layover: New York,” Bourdain samples some of New York’s best burgers, including the $26 offering at Minetta Tavern (a blend of inexpressibly choice cuts of cow capable of exciting the salivary glands of any carnivore, me included).
Bourdain, of course, orders his burger medium rare and eats it with a verbal dollop of sanctimony about the virtues of less-cooked food. On some level, I think “good for him.” If he drinks too much or has no antipathy toward pathogenetic microorganisms, who am I to judge?
And yet…I wonder if Bourdain has ever cared about someone dying from foodborne illness or watched a child undergoing dialysis? I doubt it. The pleasure of food well-eaten pales in comparison to a young life lost to foodborne illness.
We tout the virtue of personal freedom and rebel against the sanctimonies of dictated behaviors. That tension will always exist and the line separating the extremes is, by necessity, ever shifting. But Bourdain is still a dick, albeit an entertaining one, and hamburger, even the priciest, is still a danger at less than 160°.
Consumers Need to be Warned about the Dangers of Raw Milk
One of the troubling issues about the sale of raw milk is that consumers are not adequately warned about the risks. I represent people sickened by raw milk due to contamination with Campylobacter jejuni, E. coli O157:H7 and other dangerous pathogens. Raw milk can cause kidney failure, paralysis and death. I know because I have stood by the bedsides of people who innocently drank raw milk and ended up hooked up to life support fighting for their lives.
I don’t frankly care if raw milk advocates drink it at their peril. But I do care, passionately, when they harm people who are simply curious about raw milk, don’t realize their milk and dairy products are unpasteurized, are too young to protect themselves, or didn’t even consume any raw milk products (but were infected by someone who did). Since it is impossible to indulge the former and protect the latter, raw milk will remain a public health hazard. It is therefore, critical that sellers of raw milk be required by law to post information about the risks of consuming raw milk, including the risks of kidney failure, paralysis and death. This warning should be posted on every bottle of raw milk sold and on every raw milk product.
In addition, before raw milk can be distributed, sold, or in any way provided to a consumer (this includes consumers who buy a “share” in a cow), the following information from the Centers for Disease Control and Prevention (CDC) should have to be provided to the consumer:
Raw (Unpasteurized) Milk
Raw milk can carry harmful germs that can make you very sick or kill you. If you’re thinking about drinking raw milk because you believe it has health benefits, consider other options.
Trying to decide about raw milk?
Developing a healthy lifestyle is a process with many decisions and steps. One step you might be thinking about is adding raw milk to your diet. Raw milk is milk that has not been pasteurized to kill harmful germs. Germs include bacteria, viruses, and parasites. It’s important to understand the risks of drinking raw milk, especially because you may be hearing claims about the supposed “benefits” of raw milk.
Raw milk contains bacteria, and some of them can be harmful. So, if you’re thinking about consuming raw milk because you believe that it is a good source of beneficial bacteria, you need to know that it isn’t and you may instead get sick from the harmful bacteria. If you think that certain types of bacteria may be beneficial to your health, consider getting them from foods that don’t involve such a high risk. For example, so-called probiotic bacteria are sometimes added to pasteurized fermented foods, such as yogurt and kefir.
Milk and products made from milk need minimal processing, called pasteurization, which can be done by heating the milk briefly (for example, heating it to 161°F for about 20 seconds). When milk is pasteurized, some bacteria remain in it, but the disease-causing ones are killed. Harmful germs usually don’t change the look, taste, or smell of milk, so only when milk has been pasteurized can you be confident that these germs are not present. To ensure that milk is safe, processors rapidly cool it after pasteurization, practice sanitary handling, and store milk in clean, closed containers at 45°F or below.
Remember, you can’t look at, smell, or taste a bottle of raw milk and tell if it’s safe to drink. Make the best decision for the health of your family. If you want to keep milk in your family’s diet, protect them by not giving them raw milk. Even healthy adults can get sick from drinking raw milk. If you’re thinking about drinking raw milk because you believe it has health benefits, consider other options.
Who is at greatest risk of getting sick from drinking raw milk?
The risk of getting sick from drinking raw milk is greater for infants and young children, the elderly, pregnant women, and people with weakened immune systems, such as people with cancer, an organ transplant, or HIV/AIDS, than it is for healthy school-aged children and adults. But, it is important to remember that healthy people of any age can get very sick or even die if they drink raw milk contaminated with harmful germs.
What are the risks associated with drinking raw milk?
Raw milk can carry harmful bacteria and other germs that can make you very sick or kill you. While it is possible to get foodborne illnesses from many different foods, raw milk is one of the riskiest of all.
Getting sick from raw milk can mean many days of diarrhea, stomach cramping, and vomiting. Less commonly, it can mean kidney failure, paralysis, chronic disorders, and even death.
Many people who chose raw milk thinking they would improve their health instead found themselves (or their loved ones) sick in a hospital for several weeks fighting for their lives from infections caused by germs in raw milk. For example, a person can develop severe or even life-threatening diseases, such as Guillain-Barré syndrome, which can cause paralysis, and hemolytic uremic syndrome, which can result in kidney failure and stroke.
Aren’t raw or natural foods better than processed foods?
Many people believe that foods with no or minimal processing are better for their health. Many people also believe that small, local farms are better sources of healthy food. However, some types of processing are needed to protect health. For example, consumers process raw meat, poultry, and fish for safety by cooking. Similarly, when milk is pasteurized, it is heated just long enough to kill disease-causing germs. Most nutrients remain after milk is pasteurized. There are many local, small farms that offer pasteurized organic milk and cheese products.
I’ve heard that many organic and raw milk producers are creating sanitary and humane conditions for raising animals and producing “safe” raw milk and raw milk products (like cheeses and yogurts). Does this help reduce milk contamination?
Adherence to good hygienic practices during milking can reduce, but not eliminate, the risk of milk contamination. The dairy farm environment is a reservoir for illness-causing germs. No matter what precautions farmers take, and even if their raw milk tests come back negative, they cannot guarantee that their milk, or the products made from their milk, are free of harmful germs.
- Germs such as Escherichia coli O157, Campylobacter, and Salmonella can contaminate milk during the process of milking dairy animals, including cows and goats. Animals that carry these germs are usually healthy.
How does milk get contaminated?
Milk contamination may occur from:
- Cow feces coming into direct contact with the milk
- Infection of the cow’s udder (mastitis)
- Cow diseases (e.g., bovine tuberculosis)
- Bacteria that live on the skin of cows
- Environment (e.g., feces, dirt, processing equipment)
- Insects, rodents, and other animal vectors
- Humans, for example, by cross-contamination from soiled clothing and boots
Pasteurization is the only way to kill many of the bacteria in milk that can make people very sick.
Information about raw milk-related outbreaks
States that allow the legal sale of raw milk for human consumption have more raw milk-related outbreaks of illness than states that do not allow raw milk to be sold legally.
Among dairy product-associated outbreaks reported to CDC between 1973 and 2008 in which the investigators reported whether the product was pasteurized or raw, 82% were due to raw milk or cheese. From 1998 through 2008, 86 outbreaks due to consumption of raw milk or raw milk products were reported to CDC. These resulted in 1,676 illnesses, 191 hospitalizations, and 2 deaths. Most of these illnesses were caused by Escherichia coli O157, Campylobacter, or Salmonella. It is important to note that a substantial proportion of the raw milk-associated disease burden falls on children; among the 86 raw dairy product outbreaks from 1998 to 2008, 79% involved at least one person less than 20 years old.
Reported outbreaks represent the tip of the iceberg. For every outbreak and every illness reported, many others occur, and most illnesses are not part of recognized outbreaks.
Pritzker Calls for Action on New E. coli Research
This is a call to action for the New Year and beyond.
It’s made on behalf of the tens of thousands of people who have already suffered E. coli O157:H7 poisoning and the millions more who will be afflicted by it in the future. It is made because new research convincingly demonstrates that even people with so-called “mild” cases of E. coli O157:H7 – those thought to have made a full recovery – have a dramatically increased lifetime risk of hypertension, kidney impairment and cardiovascular disease. This ground-breaking research shows that E. coli O157:H7 patients require extensive annual medical evaluations and testing to “to prevent or reduce silent progressive vascular injury.”
In response to this research, we are calling for the following:
- We are calling on the United States Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to immediately post this research on its websites and convene an appropriate panel to evaluate these data and implement guidance in light of them.
- We are also calling on food companies responsible for E. coli O157:H7 outbreaks — including past outbreaks — to responsibly notify their customers about these newly identified risks and treatment needs. As the entities that should have prevented these illnesses from occurring in the first place, it is only appropriate that they fully pay for the needed medical care.
The findings of Dr. Clark and his co-authors are contained in the British Medical Journal article published on November 17, 2010 entitled Long term risk for hypertension, renal impairment, and cardiovascular disease after gastroenteritis from drinking water contaminated with Escherichia coli O157:H7: a prospective cohort study. The complete article is available free at http://www.bmj.com/content/341/bmj.c6020.full.pdf.
In summary, people who suffer E. coli O157:H7 poisoning but do not go on to develop the rarer and much more serious complication, hemolytic uremic syndrome (HUS), nevertheless have a 33% greater risk of hypertension and a more than two-fold increase in cardiovascular events as reported as congestive heart failure, heart attack or stroke. They also face more than a three-fold increase in the occurrence of both structural and functional kidney impairment, compared to a non-exposed comparison population.
The study authors recommend that any individual who has suffered gastroenteritis as a result of E..coli O157:H7 exposure should have an annual assessment by a physician and a blood pressure measurement coupled with a urinanalysis, serum creatinine value and micro albumin :creatinine ratio to determine if they have hypertension and/or if they have structural or functional kidney impairment. Certainly any cardiovascular complaints would also be recorded with appropriate risk factor investigation with subsequent modification by exercise, diet and medications. Individuals who had definite E. coli O157 H:7 gastroenteritis, in view of their potential cardiovascular risks, would likely warrant low dose ASA prophylaxis if there are no other contraindications. Those detected with hypertension will require specific anti-hypertensive treatment including a low salt diet, medications and a BP monitor for home recording and long term follow-up to make sure their blood pressure reaches their target (if they have evidence of renal impairment the target is 130/70 and without renal impairment the target would be 130/80).
If any patients have micro albuminuria or proteinuria not previously detected, then the use of an ACE Inhibitor, an ARB or an anti-renin to reduce their protein excretion rate (if it exceeds 0.5Gm on 24hour quantification) with follow-up by annual 24 hour urine protein or a microalbumin: creatinine ratio. Identifying individuals with high blood pressure can prevent many of the future vascular complications and if they already have structural and or functional kidney impairment consideration should be given to initiating an ACE Inhibitor, angiotensin receptor blocker or anti-renin agent to reduce the proteinuria as well as to control their blood pressure.
To contact our law firm for more information, please call 1-888-377-8900 (toll free) or submit our online form.
The High Cost of E. coli and Salmonella Food Poisoning
Americans pay about $3.13 billion a year in costs incurred each year by Salmonella and E. coli O157:H7 alone, according to the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP).
The center is reporting figures gathered by the U.S. Department of Agriculture’s (USDA) Economic Research Service (ERS). As seen in the chart below, the ERS used estimates from the Centers for Disease Control and Prevention (CDC), to come up with cost estimates for both E. coli and Salmonella cases annually. The numbers for Salmonella costs are based on the CDC’s estimate of almost 1.4 million Salmonella cases each year, which includes 415 deaths. The average cost per case is an estimated $1,896.
| Pathogen | CDC estimate of annual number of cases | ERS cost estimate (2009 dollars) |
|---|---|---|
 Campylobacter (foodborne sources) |
2,000,000 | |
| Salmonella (all sources) |
1,397,187 | $2,649,413,401 |
| Shiga toxin-producing E. coli O157 (STEC O157) (all sources) |
73,480 | $478,381,766 |
| Non-O157 shiga toxin-producing E. coli (non-STEC O157) (all sources) |
31,229 | |
| Listeria (all sources) |
2,797 |
The CDC numbers of E coli O157 cases are significantly lower, at 73,480 cases a year with 61 deaths, however the per-case cost of $6,510 is much higher than Salmonella cases.
According to CIDRAP:
“The ERS has posted an online “Foodborne Illness Cost Calculator” that allows Web users to come up with their own estimates of the cost of foodborne illnesses for a state or region or for a given outbreak. The ERS’s estimates, which have been used in cost-benefit and impact analyses, include assumptions about disease incidence, outcome severity, and medical and productivity costs.”
Currently the only pathogens available in the calculator are Salmonella and E. coli O157, however, the ERS is planning on adding Listeria, Campylobacter, and other strains of E. coli (non-0157 shiga toxin-producing E. coli such as ecoli 0111 and E. coli 0145). The types of costs taken into consideration by the USDA’s ERS include:
- Medical costs
- Time missed from work due to illness
- Cost of premature death
However, they do NOT include costs such as:
- Pain and suffering
- Travel
- Child care
A similar report released in March by The Produce Safety Project, an initiative of The Pew Charitable Trusts at Georgetown University, estimated much higher numbers, with a total cost of $152 billion per year for all pathogens, $14.6 billion for Salmonella and $993 million for E. coli 0157.
Fred Pritzker On Newsmakers
