Food Poison Journal - Food poisoning outbreaks and litigation: surveillance and analysis

According to Katie Mulvaney at the Providence Rhode Island Journal, meat producer Daniele International has filed suit against the spice companies who supplied the Salmonella-contaminated pepper that led to Daniele's recall of nearly 1.2 million pounds of meat and $1.5 million in refunds to customers.

Daniele filed suit Tuesday against Wholesome Spice and Seasonings Inc. and the Mincing Trading Corp. in U.S. District Court, saying it had incurred and expects to incur in the future substantial losses and expenses because it used their contaminated pepper to coat some of its gourmet meats.

The company accuses the spice manufacturers of negligence and breach of contract. According to the suit, the company was forced to recall 1.2 million pounds of its meat and refund $1.5 million to customers.

"The hallmarks of success in the specialty food industry are quality and reputation," the suit says.

Founded in 1945, Daniele produced cured meat products, including salami, prosciutto and pancetta that it sold to delis and supermarkets in the United States, Latin American and countries in Asia.

Daniele in 2009 purchased 50,000 pounds of pepper from Wholesome Spice and 40,000 pounds from Mincing, the suit says.

Beginning in July, public health officials nationwide observed a spike in people reporting poisoning symptoms resembling salmonella. During the six-month outbreak, the United States Centers for Disease Control identified at least 252 people in 44 states who were infected, the suit says.

Based on the CDC findings, Daniele recalled ready-to-eat pepper coated salami and other pepper-coated products in January. The Rhode Island Department of Health and other health officials linked the outbreak to black pepper used by Daniele. The U.S. Food and Drug Administration found that the contaminated black pepper and crushed red pepper had been produced by Wholesome and Mincing. The companies recalled the pepper.

Kristen Hansen, community columnist with the Milwaukee Journal Sentinel posted today on the raw milk debate that is brewing in Wisconsin over the state's upcoming vote on Senate Bill 434:

There is a trend toward healthy eating and natural foods in this country, and that is a good thing. Even though some labels of "organic" only mean "twice the price," we seem to be headed in the right direction. I am a particular fan of farmers markets for locally grown produce.

The quest for natural foods, however, can go too far. Raw milk is a perfect example. The Centers for Disease Control and Prevention is unequivocal in its findings that raw milk is dangerous and does not give benefits beyond those of pasteurized milk. The CDC lists 10 scary and unpronounceable bacteria found in raw milk, even if it comes from healthy animals. E. coli and salmonella are just the tip of the iceberg.

Remember the salmonella-tainted spinach of last year? The contaminated peanut butter? Here in the Milwaukee area, a child died of E. coli after eating contaminated food at a buffet restaurant. All of these outbreaks were from the same bacteria found in raw milk. Whole Foods has discontinued sales of raw milk following the hospitalization for renal failure of a previously healthy 7-year-old girl and 27-year-old woman in 2008. Both illnesses were traced to E. coli from raw milk purchased at Whole Foods.

And before you tell me that E. coli is commonly found in meat and produce, remember this: You can kill the bacteria by cooking the meat and washing the produce. You can't cook or wash milk.

Oh, wait - you can. It's called pasteurization, and it is considered one of the breakthrough scientific discoveries of the last century. Pasteurization is the only way to kill disease-causing bacteria while maintaining the healthful qualities of milk.

There are people who believe, based on isolated, anecdotal "evidence," that raw milk cures everything from autism to high blood pressure. But there is a huge difference between correlation and causation. That a child's autism symptoms decreased after drinking raw milk means absolutely nothing. You have to conduct real medical trials, where all other variables are removed to see if the raw milk can indeed be credited, and the Food and Drug Administration will not approve those trials because they are too dangerous.

Think about that. We're talking about legalizing sale of a product that is considered by the FDA to be too dangerous for medical trials. So dangerous that the very bill that would legalize its sale in Wisconsin, Senate Bill 434, exempts the sellers from liability for death or injury. Bill Keene, senior epidemiologist with the Oregon Division of Public Health, actually said, "I think after a few dead kids, people will lose their enthusiasm for raw milk." Who wants to volunteer their kids for this experiment?

It remains a fact that people do get very ill and die from drinking raw milk and that the same benefits can be obtained from drinking pasteurized milk. Raw milk is just not worth the risk.

As I post this latest article, I do realize that Food Poison Journal appears this week to be more like Raw Milk Journal. Believe it or not, we do make a genuine effort to post on a variety of foodborne illness-related subjects. With that in mind, I was tempted to refrain from posting another article on the subject today.  But with news emerging this week of yet another outbreak associated with raw milk consumption (this time Campylobacter from a Michigan farm), and Wall Street Journal writer Laura Landro's excellent article today on the contentious raw milk debate, I had to post just one more.

Advocates of fresh-from-the-farm unprocessed foods tout "raw" milk as the ultimate health food, claiming it is rich in disease-fighting nutrients and healthy enzymes that are lost in pasteurization. But public health officials are unequivocal that the risks of fresh milk far outweigh any benefits, and that pasteurization—heating milk at temperatures high enough to kill harmful bacteria—is the only way to ensure its safety.

Now amid new reports of illnesses linked to raw milk the Centers for Disease Control and Prevention and the Food and Drug Administration are stepping up efforts to warn consumers of the dangers, and urging states to strengthen their regulations to minimize the hazards of raw milk. The FDA is also reviewing its policy covering hard cheeses made from raw milk, which are currently approved for sale if aged 60 days. A federal microbiology advisory committee has raised questions about whether that is sufficient to kill pathogens, as long believed.

On Friday, the FDA reported 12 new cases of illness in the Midwest linked to raw milk from a dairy contaminated with a dangerous bacterium, campylobacter. "Raw milk is inherently dangerous and should not be consumed by anyone, at any time, for any reason," says John Sheehan, director of the FDA's division of plant- and dairy-food safety.

For the full article, click here.

I really was not going to jump too much further into the Wisconsin Raw Milk debate until I read this quote the other morning: "We just don't see that as an issue.” That’s what Kathy Kramer, nutritionist and office manager at the Weston A. Price Foundation in Washington, D.C., told Mike Nichols of the Wisconsin Journal Sentinel Online when he asked, what if people get sick from drinking raw or unpasteurized milk?  

Over the last years I have tried to bring some level of rationality to the debate over the consumption of raw milk. I first published on my blog a summary of the findings of a review of peer-reviewed literature on the topic of the "pros" of the consumption of raw milk. I then posted about the "cons."

Until the proponents admit that the outbreaks are more than FDA conspiracies against them and learn something, they can never take the high moral ground that they desire.  The fact is that Raw Milk produced by your favorite local farmer or hamburger or cookie dough made by some faceless mega-corporation, can sicken or kill your child if it is contaminated with a food borne pathogen like E. coli O157:H7, Campylobacter, Listeria or Salmonella. 

I would ask the proponents – small dairy farmers trying to make a buck, retailers trying to make even more, the Weston A. Price Foundation, people who believe that drinking raw milk cures everything from asthma, autism, eczema, and erectile dysfunction, to policy makers considering allowing the sales of raw milk – PLEASE read the above links, "Comparing the Food Safety Record of Pasteurized and Raw Milk Products," and read what happened in the following outbreaks to consumers. 

Organic Pastures - On September 18, 2006, the California Department of Health Services (CDHS) opened an investigation of a possible outbreak of E. coli O157:H7 infections after receiving reports of two patients who had been hospitalized with HUS. See CDHS and CDC Reports. One was culture confirmed as infected with E. coli O157:H7. Interviews revealed that both patients had consumed unpasteurized cow milk sold by Organic Pastures in the week prior to the onset of illness. In the following days, four additional cases of E. coli O157:H7 were identified. All of the additional cases had consumed raw milk or raw cow product sold by Organic Pastures. Isolates of the E. coli O157:H7 cultured from the five culture-positive patients had indistinguishable “genetic fingerprints” as determined by pulsed-field gel electrophoresis (PFGE) testing. These PFGE patterns were new to the national PulseNet database. In other words, the pattern associated with all of these children was unique, and had not been seen before in conjunction with any other outbreaks of E. coli O157:H7.  

CDHS conducted an epidemiological and environmental investigation of the cluster of illnesses. A review of 50 consecutive E. coli O157:H7 cases reported to CDHS from October 2004 to June 2006 revealed that 46 of 47 cases asked about raw milk consumption reported consuming no raw milk. In contrast, five of the six patients in the cluster being investigated reported definite consumption of Organic Pastures raw dairy products. The sixth denied consuming the raw milk, but his family routinely consumed Organic Pastures raw milk during the suspected time frame. 

The California Department of Food and Agriculture conducted an environmental investigation. As part of the investigation, fecal samples were collected from dairy cows at Organic Pastures. E. coli O157:H7 was isolated from five of the samples, although the PFGE patterns differed from the pattern associated with the outbreak. Testing of Organic Pastures product revealed abnormally high aerobic plate counts and fecal coliform counts. CDHS ultimately concluded: “the source of infection for these children was likely raw milk products produced by the dairy.” 

Chris Martin, then age seven, developed an E. coli O157:H7 infection in September 2006 following consumption of raw milk. He was hospitalized beginning on September 8, suffering from severe gastrointestinal symptoms, including bloody diarrhea. Shortly thereafter, he developed hemolytic uremic syndrome (HUS). In an effort to properly treat his rapidly deteriorating condition, Chris was moved to multiple medical facilities, twice by life-flight. His HUS was remarkably severe, marked by prolonged renal failure, pancreatitis, and severe cardiac involvement. He required 18 days of renal replacement therapy. On two occasions his cardiac problems became so severe that he was placed on a ventilator. At several junctures, the possibility that he might not survive was very real. Ultimately he was hospitalized through November 2, after incurring over $550,000 in medical bills. Renal experts have opined that Chris is likely to develop severe renal complications in the future. These complications include end stage renal disease (ESRD) and kidney transplant.

Alexandre Eco Farms Dairy - On October 2, 2008, the California Department of Public Health (CDPH) issued a report linking an outbreak of Campylobacter illnesses to unpasteurized milk from Alexandre Eco Farms Dairy. The report was the result of an investigation commenced on July 14, 2008, when Dr. Thomas Martinelli, the County Health Officer for Del Norte County, California reported four cases of laboratory confirmed Campylobacter infections and five additional cases of diarrhea in Del Norte County residents. Eight of the original nine sick individuals were members of the Alexandre Eco Farms “cow-leasing” program. Eight of these individuals had consumed milk produced on the farm. The ninth sick individual worked with cattle on the Alexandre EcoDairy Farms. One of the eight individuals who was sick, Mari Tardiff, had already been hospitalized with GBS, following the onset of acute gastroenteritis after consumption of the milk. 

As part of the investigation, health department officials retrieved a refrigerated carton of partially consumed Alexandre EcoDairy Farms milk from Mari Tardiff’s home. Mari had consumed a portion of the milk before her illness. The specimen tested positive for Campylobacter jejuni DNA using a test called polymerase chain reaction (PCR). Testing indicated that multiple strains of Campylobacter jejuni were present in the milk. Del Norte County officials eventually identified 16 cases of Campylobacter jejuni associated with the outbreak. Fifteen of those were persons who consumed milk from Alexandre EcoDairy Farms. The 16th case was the farm employee. CDPH and Del Norte county officials concluded that “the available epidemiologic and laboratory data support the conclusion that this cluster of acute diarrheal illness in Del Norte County was an outbreak of C. jejuni infections caused by consumption of unpasteurized milk from [Alexandre EcoDairy Farms.]” 

There was a causal link between the Alexandre EcoDairy Farms milk and Mari’s illness. This link cannot be seriously questioned. This causal link was so clear, and Mari’s injuries so remarkable, that the physicians that treated her are publishing a report on her case entitled, “Investigation of the First Case of Guillain-Barre Syndrome Associated with Consumption of Unpasteurized Milk – California, 2008.” Amy K. Earon, T. Martinelli, W. Miller, C. Parker, R. Mandrell, D. Vugia. The authors explained the laboratory methods used in investigating Mari’s illness: 

We reviewed the patient’s medical record and interviewed her husband to assess her symptoms and exposures. We used polymerase chain reaction (PCR) and multilocus sequence typing (MLST) to test a six-week old unpasteurized milk sample, obtained from the cow leasing-program and partially consumed by the patient, for genes encoding the bacterial membrane component lipooligosaccharide (LOS) in GBS-associated Campylobacter jenuni. 

In addition to the DNA testing, the authors also tested Mari’s blood for anti-bodies to GBS. The authors then explained that the PCR and MLST testing of the milk detected Campylobacter jejuni gene. In addition, the blood test was positive for anti-bodies that indicated the presence of GBS. The authors concluded: “Combined laboratory and epidemiologic evidence established the first reported association between GBS and unpasteurized milk consumption.” See Article. 

This conclusion echoes the conclusions reached by investigating officials with Del Norte County and the State of California, as noted above: “the available epidemiologic and laboratory data support the conclusion that this cluster of acute diarrheal illness in Del Norte County was an outbreak of C. jejuni infections caused by consumption of unpasteurized milk from [Alexandre EcoDairy Farms.]” See CDPH Report. 

Mari Tardiff was one of those sickened in the 2008 outbreak of campylobacter connected to raw milk sold by Alexandre EcoDairy Farm. As a result of her campylobacter infection, Mari developedGuillain Barré syndrome, or GBS, a potentially fatal inflammatory disorder. GBS is an infrequent, but well-known risk of campylobacter infection. By the time she was hospitalized in mid June, Mari was essentially paralyzed. On June 15, Mari was intubated and placed on mechanical ventilation. For weeks on end, Mari’s condition remained unchanged. She was heavily sedated, unable to move, and entirely dependent on mechanical ventilation for survival. In August, there were indications of slight improvement, and the very slow process of weaning Mari off mechanical ventilation began. At the outset, it was not clear that the process was successful. Through incredible effort on Mari’s part, she was fully weaned off mechanical ventilation by August 20, and discharged to a rehabilitation facility. She spent more than two months at the rehabilitation facility diligently attempting to re-acquire the ability to speak, breathe, and move her arms and legs on her own. She was discharged home on November 1, still in need of essentially 24-hour care. Since that time, she has worked every day toward achieving her goal, as yet unreached, of walking again. Medical expenses to date exceed $1,000,000. 

Herb Depot - On May 12, 2008 the Lawrence County Health Department (LCHD) was notified of a case of HUS in a child with a history of bloody diarrhea. The health care provider reported that the child had consumed unpasteurized goat’s milk obtained from a local store, the Herb Depot, in Barry County, Missouri. The milk had been purchased on April 29, 2008. It was quickly learned that an additional Barry County child that had cultured positive for E. coli O157:H7 had also consumed unpasteurized goat’s milk from the same store. As a result, the LCHD contacted the Missouri Department of Health and Senior Services (DHSS) who began a full epidemiological and environmental investigation of the illnesses. The investigation revealed that the milk consumed by both ill children had been produced at Autumn Olive Farms. 

At the conclusion of its investigation, the DHSS ultimately announced that there were four cases of E. coli O157:H7 associated with the outbreak. Of these, three were laboratory confirmed, and one was identified as a probable case. Each of these individuals resided in different counties in Southwest Missouri, and were not known to have any relation to each other. Nonetheless, each shared a common exposure to milk from Autumn Olive Farms. In addition, the three culture-confirmed cases shared a common, indistinguishable genetic strain of E. coli O157:H7. The strain was identified as a unique subtype of E. coli O157:H7, never before reported in Missouri. Each of the four cases had consumed milk from Autumn Olive Farms within 3-4 days of onset of illness. The DHSS reported: “no other plausible sources of exposure common to all four cases were identified [other than the milk.]” The final outbreak report ultimately concluded: “the epidemiological findings strongly suggest the unpasteurized goat’s milk from Farm A [Autumn Olive] was the likely source of infection for each of the cases associated with this outbreak.” See MDOH Report. 

Larry Pedersen had just turned one year old when he developed an E. coli O157:H7 in May 2008. When his diarrhea turned bloody, his parents took him for medical treatment. He was admitted to the hospital on May 8. Shortly thereafter, Larry developed hemolytic uremic syndrome (HUS) and was transferred to a specialty care facility. As is typical of HUS, Larry was then suffering from acute renal failure. He was started on dialysis, which was necessary at that point for his survival. He required 15 days of dialysis before his kidneys recovered enough to function on their own. Larry was discharged on May 29, to continue recovery and treatment on an outpatient basis. The medical bills associated with his care approached $90,000. As the result of damage to his kidneys suffered during his bout with HUS, Larry is at significant risk for severe renal complications in the future. These complications include end stage renal disease (ESRD) and kidney transplant. 

Nicole Riggs developed an E. coli O157:H7 infection in May 2008 from consumption of raw goat’s milk. She was nine years old at the time. Nicole suffered from symptoms typical of E. coli O157:H7 infections – bloody diarrhea, cramping, and nausea – that quickly intensified and led to her hospitalization on May 8, 2008. Once hospitalized, Nicole developed renal failure, anemia, and thrombocytopenia (low platelet count) indicating that she was developing HUS. She was transferred to a Children’s hospital and started on dialysis in order to save her life. She received dialysis for 18 days. Nicole’s renal function slowly returned to the point that she was deemed healthy enough for discharge on June 1. After discharge, she remained under the care of a nephrologist. In addition, damage suffered during her HUS has required that her gall bladder be removed. Medical costs to this point exceed $180,000. As the result of damage to her kidneys suffered during her bout with HUS, Nicole is at significant risk for severe renal complications in the future. 

Raw Milk - Real Risks

Sue Wallis, a Wyoming Republican legislator, recently introduced a bill called the Wyoming Food Freedom Act, which, in Wallis's words, "seeks to clarify the fundamental right of Wyoming citizens to eat whatever they want to eat."

Ron Paul, libertarian-minded republican congressman from Texas undoubtedly would have supported Mrs. Wallis's bill, had he been a Wyoming legislator.  He didn't say as much, but he did recently introduce a bill into the federal Congress, HR 778, that sought "To authorize the interstate traffic of unpasteurized milk and milk products that are packaged for direct human consumption," seeking to override the current prohibition against the interstate sale and shipment of raw milk.  Congressman Paul stated, in support of the bill,

 "I urge my colleagues to join me in promoting consumers' rights, the original intent of the Constitution, and federalism by cosponsoring my legislation to allow the interstate shipment of unpasteurized milk and milk products for human consumption."

The bill was referred to committee after introduction, where it did not get a second sponsor and thus died a timely death.

There is, in fact and law, no "fundamental right to eat whatever we want," and no indication in the federal Constitution that the founders intended such a right to be implicit in the Bill of Rights.  In fact, these legislative attempts are a little ironic, considering that their sponsors, Mrs. Wallis and Mr. Paul, are undoubtedly strict constructionists when it comes to constitutional interpretation.  Indeed, the only inference as to the founders' intent that can fairly be drawn from the Constitution is that Congress is well within its rights to outlaw the interstate sale and shipment of raw milk. 

The decidedly moralistic, and sometimes even religious, undertones with which the arguments over the exploding raw milk war are framed are insensible and largely irrelevant.  There is no legal support for them, much as there is no legal impediment to the several states and Congress's legal authority to regulate raw milk. 

It is astonishing that proponents of raw milk are willing to put their livelihoods, financial well-being, and potentially even their personal freedom at stake over this cause. Setting aside the risk that the raw milk poses to consumers, the other shoe will drop at some point, and the states and federal government will begin enforcing, not just with civil penalties but also with criminal prosecution, those who elect to break the law by selling raw milk in states that prohibit it and distribute raw milk across state lines, which is forbidden by the federal government.  

The current campylobacter outbreak linked to Forest Grove Dairy in Middlebury, Indiana may be an example of circumstances that could support criminal prosecution.  As AnnArbor.com reports, the Dairy received a warning letter from the Food and Drug Adminstration in 2007 warning it of violations of federal code. The letter on the FDA's site references 21 CFR 1240.61 on the mandatory pasteurization of milk delivered into interstate commerce.  Though it is heavily redacted, the letter reads as follows: 

"The regulation prohibits the delivery into interstate commerce of [redacted] and [redacted] in final package form for direct human consumption unless they have been pasteurized. The [redacted] and [redacted] you produce in [redacted] and distribute to [redacted] and [redacted] for further distribution to their [redacted] is in final package form for direct human consumption."

Despite the redactions, it is clear that the FDA explicitly warned the Dairy that it was violating federal law in producing and selling raw milk for consumption by citizens of other states.  Further, the milk was distributed under the guise of a cow-share agreement, which is arguably in violation of state law on the distribution and sale of raw milk. 

The raw milk debate is certainly not going away anytime soon.  Although it is likely to fall on deaf ears, maybe the right approach would be to allow consumer health and safety to drive laws on the subject, rather than arguments about fundamental freedoms, God's will, and Constitutional rights that do not exist.