Food Poisoning Lawyer & Attorney : Marler Clark : Food Poison Journal

In 2000, the drinking water in the Ontario town of Walkerton was contaminated with E. coli O157:H7 and campylobacter.  7 people died, and roughly 2,300 suffered illness as a result.   The large number of people involved in the outbreak has provided doctors and scientists an opportunity to look at the long term impacts of foodborne illness. 

According to this report, studies on Walkerton survivors are now revealing genetic risk factors associated with the likelihood of developing post-infectious irritable bowel syndrome:

Of the 2,300 people who were sickened, 36 per cent developed post-infectious irritable bowel syndrome or PI-IBS.

Patients suffer from chronic abdominal pain and discomfort, bloating, and defecation problems that develop suddenly after an episode of acute gastroenteritis or inflammation of the stomach and intestines. Doctors diagnose PI-IBS after ruling out structural and biochemical abnormalities and other known disorders like Crohn's disease or ulcerative colitis.

The study, which linked three particular genes to an increased risk of post-infectious irritable bowel syndrome, will be published in the March edition journal Gastroenterology.

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We hear about them so often these days--recalls of all kinds of products, from foods, to medications, to kids toys--that "recall" has become a working concept in everybody's vocabulary.  But what is a recall?  Who has the legal obligation to announce them?  And what legal ramifications are there ot being involved in one?  

First, despite not having the legal authority to actually recall products, the FDA and USDA are frequently involved.  In fact, the USDA's Food Safety and Inspection Service (the agency arm responsible for ensuring the safety of meat, poultry, and eggs) sets the standards for when, and what kind of, a recall is required.  

The FSIS defines three kinds of recall actions that can fairly be included under the same umbrella.  A "Class I recall" should occur in "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."  (Editor's note: "should" is italicized because sometimes food product manufacturers do not issue class I recalls even when circumstances require it.)  Under this definition, a Class I recall should occur any time a food product is known or suspected to be contaminated with any foodborne pathogen, whether bacterial or viral.  The reason:  bacteria and viruses make people sick, and as a result, food contaminated by them will make people sick.

A "Class II recall" should occur in "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."  This is a little less clear than the definition of a Class I recall, but I certainly believe that the consequences of foodborne disease are simply too extreme for food companies to play fast and loose under these definitions.  A Class I recall should occur every time a food manufacturer knows, or has reason to know, that a product it has produced is or may be contaminated with a foodborne pathogen.  Every time.

Finally, a "market withdrawal"

occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

A "market withdrawal" has no place in the world of food contamination.  Again, salmonella and e. coli and campylobacter and hepatitis and every other foodborne pathogen are simply too dangerous for companies to try to avoid their obligations by calling what should be a recall a "market withdrawal"--something done purely to avoid the media ramifications of saying that you're product has been recalled.  This has been done before under circumstances where a Class I recall was surely warranted. 

Who has the legal obligation to recall a food product when it is known or suspected to be contaminated with something that will make people sick?  The unfortunate answer is that its not the USDA or FDA.  Nor is it any other state or federal regulatory body.  The answer is that the company who produced the contaminated product is the only entity with the legal authority to recall a product.  The CDC can announce that the product has caused an outbreak, but the company itself is the only entity that can truly and effectively act. 

A recall is a firm’s action to remove product from commerce (e.g., by manufacturers, distributors, or importers) to protect the public from consuming adulterated or misbranded products. Although it is a firm’s decision to recall product, the Food Safety and Inspection Service (FSIS) coordinates with the firm to ensure it has properly identified and removed recalled product from commerce by verifying the effectiveness of the firm’s recall activities. FSIS also notifies the public about product recalls.

See http://www.fsis.usda.gov/Search/Search_Results/Index.asp?q=%22market+withdrawal%22&mode=simple&num=10&as_occt=any&site=FSIS

Finally, with regard to the legal ramifications of announcing a recall, again the real threat comes from the private sector.  Penalties and fines are not necessarily assessed simply because a recall happens.  Often, it is only private citizens who have been injured by the contaminated product that take legal action against a company that has recalled its product. 

Aside from lawsuits (which are an insufficient check, by themselves, on food safety because they are largely reactive rather than preventative) FSIS may issue public health alerts or perform product detentions and seizures, to mitigate the risk to the public when firms have inadequately removed recalled product from commerce. The Agency will investigate if it appears that a firm’s recall strategy or execution of that strategy is ineffective and, based on its findings, FSIS may seek enforcement action against the recalling firm or its consignees.

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Trent Rowe reported yesterday on TheLedger.com about the disturbing prevalence of campylobacter on chicken purchased at retail. 

Most of the chickens we buy in supermarkets are contaminated with Salmonella and/or Campylobacter bacteria. They make us sick.

Consumer Reports checked 382 chickens from 100 stores around the country and found the bacteria in about two-thirds of the birds.

Only 34 percent of the birds had neither bugs.

Figures from the Centers for Disease Control and prevention show that the bacteria from food sources infect 3.4 million Americans a year, resulting in 25,500 hospital cases and 500 deaths.

 

Unfortunately, odds are, the uncooked chicken you've got in your refrigerator or freezer at home is contaminated with something that can make you very sick, or kill you if you're a particularly susceptible person.  But it doesn't have to be this way.  Campylobacter and chicken, just like E. coli O157 and beef, is not a bacteria found in the animal's muscle tissues.  Chickens and cows alike harbor the bugs that can make us sick in their gastrointestinal tract.  So, just like E. coli and beef, the problem boils down to food manufacturers keeping feces off of edible meats. 

This is exactly what the Food Safety and Inspection Service (FSIS), which is the branch of USDA responsible for meat, eggs, and poultry, is trying to achieve with its newly adopted performance standards in chickens and turkeys.  Even though we won't get to zero, it seems like the industry should be able to lower the contamination level from "most of the birds you buy are contaminated." 

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Consumer Reports has unveiled the results of a study that provide a frightening look at commercially sold uncooked chicken in the U.S. - two thirds of the chicken tested was positive for either Salmonella, Campylobacter, or both. 

The consumer organization tested 382 chickens from 100 different stores in 22 states.  Here are a few of their findings:

• Campylobacter was in 62 percent of the chickens, salmonella was in 14 percent, and both bacteria were in 9 percent.

• Store-brand organic chickens had no salmonella at all, showing that it's possible for chicken to arrive in stores without that bacterium riding along...57 percent of those birds harbored campylobacter.

• The cleanest name-brand chickens were Perdue's: 56 percent were free of both pathogens.

• Most contaminated were Tyson and Foster Farms chickens. More than 80 percent tested positive for one or both pathogens.

• Among all brands and types of broilers tested, 68 percent of the salmonella and 60 percent of the campylobacter organisms we analyzed showed resistance to one or more antibiotics.

No doubt that some confronted with these findings will dismiss it - "everyone knows that you have to cook chicken before you eat it."  Such an attitude understates the problem associated with these eye-opening findings.   

First, the risks of cross-contamination in the home are not often fully appreciated.   Any contact between these raw products and other surfaces - knives, hands, counter tops- that will then come in contact with ready-to-eat foods, puts consumers at risk.

Second, the severity of the risk is likely under-appreciated.  The bacterial pathogens on these chickens can cause severe illnesses.  The 2008-2009 Salmonella outbreak associated with PCA peanut butter killed nine people.   Campylobacter infections are a known cause of Guillain-Barre Syndrome (GBS).  GBS  is a disorder in which the body's immune system attacks part of the peripheral nervous system. It often leads to paralysis, and can be fatal. 

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Walworth County (WI) and Zinninker Farm have reached a settlment regarding potential fines following an outbreak of campylobacter jejuni linked to raw milk sold by the farm.  The Janesville Gazette reports:

The district attorney’s office filed 24 citations against Zinniker Farm, N7399 Bowers Road, charging the sale of non-compliance milk. The citations carry a total maximum penalty of $24,000.  As part of the agreement, the Zinnikers admitted the violations but the case will be held open and they will not be fined.  If Mark and Petra Zinniker were again caught selling raw milk, they would be fined the maximum—$24,000—and would lose their license to sell milk.

The Zinnikers apparently sold some or all of the milk using a "cow-share" program.  In such programs consumers theoretically purchase a portion of the cow (which they don't receive) but not the milk (which they do.)  As is true in many states, Wisconsin officials do not recognize these programs as effective measures to circumvent state raw milk regulations. 

Our office recently resolved a claim by a woman who developed Guillain-Barre Syndrome resulting from a campylobacter infection acquired from raw milk.  This raw milk, too, was purchased through a cow-share program.   Ms. Tardiff was hospitalized for months, and remains in a remarkable and valiant struggle to regain her former health. 

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Some interesting quotes and figures from Bill Chirdon, director of Pennsylvania Department of Agriculture's Bureau of Food Safety regarding the sale of raw milk, as reported in the American Agriculturalist.    Chirdon warned potential sellers to closely examine the decision, addressing the sellers liability for sales of contaminated product:

It's an enormous risk....There are times when insurance companies don't even know producers are marketing raw milk. Producers need multi-million-dollar coverage, and it's very expensive.

Bill Marler recently took an in depth look at the risks involved in retailing raw milk, here. Chirdon also had some compelling statistics on bacterial testing of raw milk in Pennsylvania.   According to Chirdon, in 2007, 8.4% of (Pennsylvania) raw milk tested positive for pathogenic bacteria.  He reports a decrease in positive results this year, at less than 2%, and touts this as improvement.  No doubt 2% is less than 8%, but to have 1 in 50 samples of a food product testing positive for pathogenic bacteria ought to be giving consumers, retailers, and insurers reason to rethink their choice. 

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It is a wonder that Campylobacter doesn't get more attention as a public health scourge.  It has long ruled the international kingdom of diarrhea as the most prevalent foodborne disease worldwide--the United States too--yet the average person walking down the street has probably never heard of it.  Nonetheless, Campylobacter continues to cause more illnesses than any of its bacterial brethren. 

Campylobacter, like E. coli, is a family of bacteria; and there are multiple strains of it that can make you sick.  Campylobacter jejuni is the most common.  The illnesses that Campylobacter infections cause are called Campylobacteriosis.  The CDC receives about 10,000 reports a year, but it is estimated that between two and four million people are infected annually.  The effects of Campylobacteriosis, like pretty much any foodborne pathogen, can run the gamut from several days of "flu-like" symptoms to, in extreme cases, death.  CDC monitoring shows that approximately 124 people die every year from Campylobacteriosis.  Moreover, recent studies have shown that infection by certain bacteria, including Campylobacter, significantly increases a victim's risk of developing ongoing, or permanent gastrointestinal problems, including post-infectious Irritable Bowel Syndrome, or even Irritable Bowel Disease (including Crohns).  Finally, It is conservatively estimated that Campylobacteriosis illnesses cost $1 billion annually for medical care, lost wages, and other productivity losses.

Food is, of course, the most common vehicle for the spread of Campylobacter, and chicken is the most common food implicated.  But an important fact to understand is that, even in chickens, Campylobacter is not a muscle-born bug--i.e. the bacteria lives in the intestines of chicken.  Thus, contamination of chicken meat results, ultimately, from contact with chicken feces. 

Soberingly, a study done in 1998 identified Campylobacter in 63% of more than 1000 chickens obtained in grocery stores, and other studies have documented Campylobacter contamination on up to 88 percent of chicken carcasses.  Lots of other studies have been done, but even studies showing relatively "low" levels of contamination of raw chicken were in the 30%, 40%, or 50% range.  Thus, good food-handling practices are critical when handling raw chicken. 

But at this level of contamination, which really should come as no shock when you consider the conditions in which chickens are raised and slaughtered, its not realistic to believe that good food-handling practices alone are sufficient to prevent infections and outbreaks from happening on a broad basis.  It takes only 500 Campylobacter bacteria to cause illness in a human being, and millions of the bacteria fit on the head of a pin.  A single basically unnoticeable drop of chicken juice on a child's plate, or in an old folks' home, might kill somebody.  More, or better, controls in food processing are obviously needed.

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Researchers at Bristol University recently presented new findings regarding Campylobacter contamination in poultry populations.  Professor Tom Humphrey from the University’s Department of Clinical Veterinary Science, led a new study showing that Campylobacter levels increase in the gut of chickens and other farm animals when they are transported. According to a Bristol University press release:

Research in many countries has shown that after transport, levels of bacteria like Campylobacter are higher in the gut of food animals than on the farm. Work at Bristol has demonstrated that this may be associated with the release of the stress hormone noradrenalin. This hormone makes Campylobacter grow more quickly, become highly motile and invasive, leading to an increase in its ability to cause disease - its virulence.

A further finding in the studies at Bristol is that Campylobacter can interact with other organisms in the gut of food animals. When this happens it can become even more infective. The results of this study provide vital information to enable the control of infection in the production environment, making chicken safer and decreasing cases of food poisoning.

Infection caused by Campylobacter bacteria is called campylobacteriosis and is usually caused by consuming unpasteurized milk, raw or undercooked meat or poultry, or other contaminated foods and water, and contact with feces from infected animals.

Symptoms of Campylobacter infection, which usually occur within 2 to 10 days after the bacteria are ingested, include fever, abdominal cramps, and diarrhea (often bloody). In some cases, physicians prescribe antibiotics when diarrhea is severe. The illness can last about a week.

Complications can include meningitis, urinary tract infections, and possibly reactive arthritis (rare and almost always short-term), and rarely, Guillain-Barre syndrome, an unusual type of paralysis. While most people who contract campylobacteriosis recover completely within 2 to 5 days, some Campylobacter infections can be fatal, resulting in an estimated 124 deaths each year.

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We sometimes hear food poisoning dismissed (usually by those who are being blamed with causing it, not those suffering from it) as "just a little diarrhea."  Here is yet more evidence that such a characterization has no basis in reality.  Web MD is reporting today that Salmonella and Campylobacter infections triple the risk of Inflammatory Bowel Disease for at least 15 years.  Web MD is reporting the results of a study conducted by Henrik Nielsen, MD, of Denmark.

According to the report, Inflammatory Bowel Disease "typically refers to Chron's disease and ulcerative colitis."  Both of these disorders can cause chronic bloody diarrhea and abdominal pain. 

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The bacteria were found in a routine testing sample taken Dec. 11, the department said.

Local health departments are reviewing Campylobacter illness reports that may be related to the milk, the news release said. Symptoms of the illness usually occur two to five days after ingestion and generally last for seven to 10 days.

The milk was sold in half-gallon plastic containers at the Pleasant Valley farm store and at Barganica, Community Food Co-op and Terra Organica in Bellingham; Skagit Valley Co-op in Mount Vernon; Arlington Health, Petosa's, Manna Mills, Tru Health and Bob's Corn Patch in Snohomish County; and Spuds in Seattle, the news release said.

Four Whatcom County residents and one Skagit County resident tested positive for the same campylobacter jejuni strain that was found in a routine sample of raw milk from Pleasant Valley Dairy. The dairy pulled that batch of milk from the shelves and has resumed its distribution of raw milk.

The dairy has changed its testing procedures to reduce the risk of releasing contaminated milk, the health department said.

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Milk typically comes out of the cow (or goat or human) without any dangerous bacteria. But think of where most milking occurs—all sorts of unsanitary things may be occurring. Milk is a particularly dangerous food precisely because it is so nutritious; a miniscule amount of contaminating bacteria can multiply in the welcoming environment, greatly increasing the chance of someone becoming ill from ingesting it. Pasteurization works by killing any of the bacteria that find their way into the milk, before they can divide and make you sick later. This little step of heating dairy before storage and transport has been one of the most effective public-health inventions of all time.

There are no health benefits in drinking raw milk—the nutrients easily survive the heating.

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Tracking Down the Culprits

When stomach symptoms occur, people tend to attribute the cause to a “bug” rather than food. Clues suggesting a possible foodborne pathogen include severe symptoms and having more than one person is affected – especially if the symptoms occur in several families. A physician may contact the local health department to determine if other cases have been reported. In addition, stool samples may be sent to a lab for testing.

It can take quite a bit of detective work to track down a source of foodborne illness. Not everyone who eats a contaminated food product gets sick (typically the very young, very old, patients with chronic medical conditions and those with weak immune systems are most susceptible). The severity of symptoms may also vary.

Health officials gather data on patient characteristics, how long they have been sick and places they may have visited days before the onset of illness. Hopefully, common traits will begin to emerge, such as “everyone ate at the same restaurant” or “ate the same food.” Suspect food items may be tested for the presence of bacteria or toxins. As more clues emerge, experts may be able to narrow down or pinpoint the source of the problem. In some cases (as with the peanut butter/salmonella link recently), an investigation may lead to an extensive recall of a particular food item.

The E. coli Reference Center at Penn State University is the nation’s largest repository for E. coli strains, holding more than 70,000 strains collected over the last 40 years. The bacteria are frozen to enable researchers to study and track changes or genetic mutations that may make the illness more difficult to treat. Older samples are stored at room temperature in “slants,” or test tubes containing a solid growth medium to preserve the culture. The lab can also test a current sample for the bacteria and look for genes associated with those causing the most serious illness.

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The Utah county Health Department announced that all milk samples from the Payson dairy farm at the center of a controversy over whether its raw milk products were contaminated with Campylobacter tested negative for the bacterium. From a story in the Deseret Morning News:

"It's very possible that an earlier batch had been contaminated and all the traces worked their way out of the system," said Lance Madigan, Utah County Health Department spokesman.

A spokesman for the Utah Department of Agriculture and Food confirmed that the contamination could have happened at the dairy at an earlier date.

"We were testing to check the current batch of milk," said UDAF spokesman Larry Lewis. "This doesn't speak to the milk that may have contributed to the illness of these people, which would have been produced weeks before."

Utah County Health Department officials issued a health advisory Wednesday after receiving multiple reports of campylobacteriosis, a disease caused by ingesting bacteria commonly found in unpasteurized milk products and improperly prepared chicken.

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Consumer Reports has run extensive tests for bacteria and found 83 percent of the chicken tested harbored the kinds of bacteria that are the leading causes of food poisoning.

Leighton Kunkle has nerve damage in his hands and feet from Guillain-Barré syndrome, a side effect of food poisoning caused by the bacteria campylobacter. He believes he got sick from eating undercooked chicken in a restaurant.

Consumer Reports tested chicken purchased nationwide to see if it contained the bacteria campylobacter or salmonella -- the two leading bacterial causes of food poisoning. According to government figures, they sicken close to 3.5 million Americans a year and kill more than 700.

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Science Daily reports that in spite of our long and painful relationship with Campylobacter jejuni, we are just starting to answer basic questions about the bug that is the leading cause of bacterial food-borne illness in the United States, and one of the most common causes of diarrhea worldwide. The Centers for Disease Control estimate that "campylobacterioisis" strikes 2.4 million Americans a year.

While most sufferers recover after a few unpleasant days, it can be life threatening to those with compromised immune systems. A rare but serious complication of C. jejuni infection is the triggering of the autoimmune disorder, Guillain-Barré paralysis.

Yale researchers now have some answers to one of the most basic puzzles surrounding C. jejuni infections. How could such a large bacteria gain access to human intestinal epithelial cells that do not normally take up particles of such size" And once inside, how does C. jejuni disappear off the conventional endocytic road map" 

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Ruth Heide of The Valley Courier (Colorado)reports that for some San Luis Valley residents this year, a trip to the doctor may have been preceded by a trip to the kitchen or outdoor grill. The Valley averages 3-6 cases of Campylobacter per year, and it looks like this year will be no exception, according to Dr. William Brinton, regional epidemiologist for the San Luis Valley.

Campylobacter is an illness that must be reported to the Colorado Department of Health. Brinton said the San Luis Valley has had four cases of the food-born illness this year, some of them occurring this summer when risks are higher because bacteria grows more readily in warmer temperatures and because of the conditions sometimes associated with outdoor cooking.

Campylobacter almost always is a food born illness and is not easy to pass from human to human, Brinton explained, “so when we see a case, usually it is from contaminated food or dairy.” It is commonly contracted from chicken although sometimes is contracted from dairy products or meats such as pork or beef.

Brinton added Campylobacter is the most common cause of illness from food reported in Colorado. Symptoms include diarrhea, fever and vomiting. People generally become sick within 2-5 days after they have eaten contaminated food, and the illness may last several days, up to a week or longer, Brinton said.

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