The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) just announced this afternoon that McNees Meats and Wholesale LLC, a North Branch, Michigan company, is expanding its August 9, 2011 Class I recall to include approximately 2,200 pounds of ground beef product that may be contaminated with E. coli O157:NM (non-motile). Through an epidemiologic investigation, investigators have determined that there is a link between the company’s ground beef products produced on July 15 and July 21 and a number of illnesses in Michigan.

The company’s products have already sickened 5 who the Michigan Departments of Community Health (MDCH) and Agriculture and Rural Development (MDARD) have reported are confirmed Shiga-toxin producing E. coli cases. In addition, the latest reports indicate that there are also 4 probable cases in Lapeer, Genesee, Isabella, and Sanilac counties. According to MDCH and MDARD, illness onset dates range between July 18 and July 25, 2011. Those affected range in age from 15-88. A total of 6 have been hospitalized.

The additional products that are now subject to recall include:

  • 1 and 10-lb. clear packages of “McNees Ground Beef Bulk.”
  • 1 to1.5-lb., approximate weight clear plastic bags of “McNees Ground beef patties.”
  • 1-lb. packages of “McNees Ground Round.”
  • 1 and 2-lb packages of “McNees Ground Beef Bulk” sold in red and white plastic bags.

Each clear plastic bag and retail package bears the establishment number “EST. 33971” within the USDA mark of inspection. The products subject to recall were produced on July 7, July 15, July 21, July 28 and Aug. 4, 2011, and sold to retail establishments and restaurants in Armada, Lapeer and North Branch, Michigan. The products were also sold directly to consumers from a retail establishment owned by McNees Meats and Wholesale, LLC. When available, the retail distribution list(s) will be posted on FSIS’ website at www.fsis.usda.gov/FSIS_Recalls/Open_Federal_Cases/index.asp.

E. coli O157: NM is a potentially deadly bacterium that can cause bloody diarrhea, dehydration, and in the most severe cases, kidney failure. The very young, seniors and persons with weak immune systems are the most susceptible to foodborne illness. E. coli O157: NM differs from E. Coli O157:H7 in that it lacks the flagellar H antigen, making it non-motile (NM).

Seattle Times staff reporter, Maureen O’ Hagen,  writes in today’s paper about the role our firm, Marler Clark, played in the recent WinCo Foods meat recall related to potential E. coli O157:H7 contamination. Positive E. coli O157:H7 test results revealed in a study that Marler Clark has commissioned revealed the contamination:

The E. coli came to light not because of testing by the government or by WinCo or its suppliers. Instead, it was because a Seattle lawyer is conducting a private study, testing ground beef from retailers all over the country.

"I’ve spent about a half-million dollars on this project," attorney Bill Marler said. Clients represented by Marler’s firm have won more than $500 million in settlements from companies whose food sickened them.

Marler set out, in 2008, to prove a point: that certain pathogens could be in your burgers because of a loophole in government regulations.

Most of the time, when you hear about E. coli, it’s a strain known as O157:H7. Under government regulations, O157 is an "adulterant" in ground beef, which means processors have to test for it. If the meat tests positive, it can’t be sold.

But there are other potentially harmful strains of E. coli, too — O26, O111, O103 — and they can cause illness just as serious as O157, including diarrhea, kidney failure, and even death. (Cooking meat well-done should kill the pathogens.)

For a number of reasons, however, these bugs aren’t labeled as "adulterants" under government regulations so processors don’t have to test for them. The bottom line is, since processors aren’t testing for them, you could be eating them.

Last October, Marler petitioned the government to include these bugs in its list of "adulterants." If he succeeds, beef processors will have to conduct additional testing. But if pathogens do slip through and people get sick, it also could make it easier for Marler to sue.

Waiting for a decision, he took an unprecedented step: private testing.

"This is clearly something the government should be doing," he said. "This is stuff, frankly, I think retail stores should be doing. They’re the ones that could put the pressure on the manufacturers."

He hired a well-regarded local scientist to test grocery-store ground beef around the country. So far, they’ve tested 4,700 samples and found about 1.9 percent contain the non-O157 E. coli strains they were looking for, Marler said.

To him, that argues for regulation.

Periodically, he’d also been testing for the more well-known E. coli O157. That’s when Marler said they found two contaminated packages at a WinCo store in Modesto, Calif. Because O157 is regulated, they felt they should report it to WinCo.

"It was a call out of the blue from a lab that we hadn’t hired and wasn’t connected with a government study," said Michael Read of WinCo. The company voluntarily recalled all ground beef sold over a 13-day period, ending April 9.

WinCo has stores in six Western states, including Washington. No human illness has been linked to the recalled ground beef.

Meanwhile, Marler has been hammering government regulators, and is impatient for a decision.

J. Glenn Morris, director of the Emerging Pathogens Institute at the University of Florida, says that while Marler has a valid point — government should address this issue — it’s not quite so simple. Not all of these non-0157 E. coli bacteria carry the genes that make them harmful to humans, he said.

"This is, in part, why the regulatory process has been going somewhat slowly," he said. "Because there are uncertainties."

 

In 1996, the USDA’s Food Safety and Inspection Service established the HACCP (hazard analysis and critical control points) rule to verify that establishments have consistent process control for preventing, eliminating, or reducing the contamination of raw meat and poultry products with disease-causing bacteria like Salmonella, E. coli O157:H7, and campylobacter.  The rule, in part, sets performance standards for foodborne pathogens that slaughter establishments, and establishments that produce raw ground products, need to meet.  

The FSIS recently released its 2009 progress report for Salmonella, specifically, on raw meat and poultry products:

In calendar year 2009, FSIS analyzed 29,116 verification samples across eight meat and poultry product classes with the following percent positive rate of Salmonella per product class: broilers (7.2%), market hog (2.3%), cow/bull (0.6%), steer/heifer (0.2%), ground beef (1.9%), ground chicken (18.2%), ground turkey (10.7%) and turkey (3.8%).

Sounds like a lot of salmonella, particularly on broilers, ground chicken, and ground turkey.  As for broilers, the 7.2% contamination rate is actually a reduction, down from 7.3%, 8.5%, and 11.4% in 2008, 2007, and 2006, respectively.  Ditto for ground chicken and ground turkey, though the percentage of those raw products that are contaminated remains quite high.  The figure below tracks the incidence of salmonella in raw product over the course of the last decade.

 

 

The Associated Press and New York Times just reported on the impetus behind the testing that caused WinCo to issue its large-scale meat recall:  us.  The positive tests were generated during a study that Marler Clark had comissioned on the presence of E. coli in retail beef samples.  The Times reports:

A ground beef recall that has expanded to WinCo Foods stores in six Western states was prompted by a law firm’s investigation of contaminated beef products.

Saying the meat could be contaminated with E. coli, California officials issued the recall Sunday for WinCo Foods fresh ground beef that was packaged in Styrofoam trays at the stores and marked with sale dates from March 28 to April 9. The warning covers about 70 stores in California, Idaho, Nevada, Oregon, Utah and Washington.

The announcement expanded a voluntary recall last week at one store in Modesto, Calif. California officials say an additional sample from that store tested positive for E. coli Friday, prompting the expanded recall. No illnesses have been reported.

The supermarket chain learned about the bacterial contamination from an independent lab that was conducting a nationwide survey of ground beef for Marler Clark, a Seattle law firm specializing in food-borne illness cases.

The ground beef likely came from one of two national beef companies that supply many grocery stores, said Michael Read, WinCo Foods vice president of public and legal affairs.

WinCo has no reason to believe any ground beef that was sold was contaminated, he said. Read had no estimate of how many pounds of ground beef could be affected, but he noted that much of the meat has probably already been consumed and no illnesses have been reported.

”That’s the truly nice thing,” he said. ”We’ve recalled all ground beef from all stores, even though there’s only a suggestion that there’s a problem with one store, but we want to do everything possible to protect the public.”

Read said WinCo is cooperating with the investigation by California and federal officials. 

Bill Marler represented more than 100 victims in the 1993 Jack in the Box E. coli outbreak that killed four children. He commended WinCo Foods for issuing the recall, given that the information came from a private study.

”They certainly could have pushed back and said, ‘What is this, it’s a lawyer doing testing in a lab in Seattle,” he said. ”They could have taken the much less pro-consumer point of view, because obviously this is not something a company wants to do. Under the circumstances, I certainly appreciate what they did.”

Marler Clark filed a lawsuit today on behalf of Alice Smith against Fairbank Farms in Federal District Court in Maine.   Ms. Smith, 88 years old, was hospitalized for weeks with an E. coli O157:H7 infection after consuming ground beef contaminated with the bacteria produced by Fairbank.

In late October 2009, Fairbank Farms recalled 545,699 pounds of ground beef contaminated with toxic E. coli O157:H7. A joint investigation between the Centers for Disease Control (CDC), the Food Safety and Inspection Service (FSIS), and several state health departments determined that the contaminated meat was responsible for 2 deaths and at least 25 E. coli illnesses in 10 states, most of them in New England.

Ms. Smith was hospitalized for several weeks, during which time she suffered from renal failure.  She has not returned to her prior state of health.  

Marler Clark previously filed lawsuits in Maine and Massachusetts on behalf of other victims of the Fairbank Farm outbreak.

West Missouri Beef, LLC has voluntarily recalled 14,000 pounds of boneless beef products due to potential contamination by E. coli O157:H7.  USDA’s Food Safety and Inspection Service (FSIS) announced the Class I recall in a press release last night.  It is the third Class I recall this year, and the fifth since November, adding up to 1,636,000 pounds of beef products that have been recalled due to potential E. coli O157:H7 contamination in the last 3+ months.

What is a Class I recall?

A Class I recall, according to FDA definitions, should occur when "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."  Class II and III recalls are appropriate only when there is a significantly lesser, or remote, risk of adverse health consequences, or when the health consequences are minor.  Due to its lethal capacity, E. coli O157:H7 is a bacteria that always requires a Class I recall.

What is E. coli O157:H7?

Escherichia coli (E. coli) are members of a large group of bacterial germs that inhabit the intestinal tract of humans and other warm blooded animals (mammals, birds). Newborns have a sterile alimentary tract which within two days becomes colonized with E. coli.

More than 700 serotypes of E. coli have been identified. The different E. coli serotypes are distinguished by their “O” and “H” antigens on their bodies and flagella, respectively. The E. coli serotypes that are responsible for the numerous reports of contaminated foods and beverages are those that produce Shiga toxin (Stx), so called because the toxin is virtually identical to that produced by another bacteria known as Shigella dysenteria type 1 (that also causes bloody diarrhea and hemolytic uremic syndrome [HUS] in emerging countries like Bangladesh) (Griffin & Tauxe, 1991, p. 60, 73). The best known and most notorious Stx-producing E. coli is E. coli O157:H7. It is important to remember that most kinds of E. coli bacteria do not cause disease in humans, indeed, some are beneficial, and some cause infections other than gastrointestinal infections, such urinary tract infections. This section deals specifically with Stx-producing E. coli, including specifically E. coli O157:H7.

Shiga toxin is one of the most potent toxins known to man, so much so that the Centers for Disease Control and Prevention (CDC) lists it as a potential bioterrorist agent (CDC, n.d.). It seems likely that DNA from Shiga toxin-producing Shigella bacteria was transferred by a bacteriophage (a virus that infects bacteria) to otherwise harmless E. coli bacteria, thereby providing them with the genetic material to produce Shiga toxin.

Although E. coli O157:H7 is responsible for the majority of human illnesses attributed to E. coli, there are additional Stx-producing E. coli (e.g., E. coli O121:H19) that can also cause hemorrhagic colitis and post-diarrheal hemolytic uremic syndrome (D+HUS). HUS is a syndrome that is defined by the trilogy of hemolytic anemia (destruction of red blood cells), thrombocytopenia (low platelet count), and acute kidney failure.

Stx-producing E. coli organisms have several characteristics that make them so dangerous. They are hardy organisms that can survive several weeks on surfaces such as counter tops, and up to a year in some materials like compost. They have a very low infectious dose meaning that only a relatively small number of bacteria, less than 50, are needed “to set-up housekeeping” in a victim’s intestinal tract and cause infection.

The Centers for Disease Control and Prevention (CDC) estimates that every year at least 2000 Americans are hospitalized, and about 60 die as a direct result of E. coli infections and its complications. A recent study estimated the annual cost of E. coli O157:H7 illnesses to be $405 million (in 2003 dollars) which included $370 million for premature deaths, $30 million for medical care, and $5 million for lost productivity (Frenzen, Drake, and Angulo, 2005).
 

Continue Reading Class I Beef Recall due to E. coli Contamination

Counting Friday’s sausage recall by Daniele International, Inc., food companies have recalled at least 2,880,000 pounds of meat products since November 2009 due to contamination by E. coli or Salmonella. 

Friday’s recall:  (from FSIS press release)

Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is recalling approximately 1,240,000 pounds of ready-to-eat (RTE) varieties of Italian sausage products, including salami/salame, in commerce and potentially available to customers in retail locations because they may be contaminated with Salmonella, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The Daniele Inc. sausage outbreak, due to contamination by Salmonella Montevideo, has caused at least 184 illnesses in residents of 38 states. 

On January 18, 2010, the USDA’s food inspection branch (FSIS) announced the recall of 846,000 pounds of ground beef products produced by a California company called Huntington Meat Packing, Inc., due to potential contamination by E. coli O157:H7.

On January 11, 2010, Adams Farm Slaughterhouse, LLC., an Athol, Mass., establishment, recalled approximately 2,574 pounds of beef products that was potentially contaminated with E. coli O157:H7.  The beef was the cause of infection in at least one Massachusetts resident. 

On December 24, 2009 (The Christmas Eve sneak), an Oklahoma company called National Steak and Poultry recalled 248,000 pounds of tenderized beef products due to contamination by E. coli O157:H7.  The outbreak is known to have sickened at least 21 people in 16 states.  Last week, Marler Clark filed the first lawsuit arising from the outbreak on behalf of a Utah resident.

And in November 2009, A New York company called Fairbank Farms recalled 545,699 pounds of ground beef due to E. coli O157:H7 contamination. The outbreak caused resulted in 26 E. coli O157:H7 illnesses, nineteen hospitalizations, and five who developed hemolytic uremic syndrome (HUS). 

 

 

Fox 6 News in Milwaukee reported today that the state of Wisconsin, with the aid of local health authorities, is investigating 6 E. coli O157:H7 illnesses in Belgium, Wisconsin.  Wisconsin has been hit hard by E. coli before.  Why is it that some states–Minnesota, Utah, and a list of 3 or 4 others–seem to be involved in many major E. coli O157:H7 outbreaks?

Forty-nine Wisconsin residents were sickened in the infamous spinach E. coli O157:H7 (and other serotypes) outbreak in August/September 2006.  (Actually, it was a call from the mother, in the second week of September, of TWO kids infected in the outbreak that helped us figure out exactly what was happening), as were multiple Minnesota residents.  In the Cargill E. coli O157:H7 outbreak in 2007, many Minnesota residents were sickened including Stephanie Smith.  And in the JBS E. coli O157:H7 outbreak in summer 2009, at least six Wisconsin residents were infected, including Joshua Rosploch, who developed HUS.  This is just a short list, but these several states (most prominently Wisconsin and Minnesota) truly have been at the epicenter of surveillance and detection of multiple major national outbreaks. 

Why?  Unlucky distribution of the implicated products?  Wisconsin and Minnesota residents eat more beef and bad produce? 

Many would say that the real reason doesn’t have anything to do with plain old nebulous bad luck.  Instead, it happens because these states have surveillance, microbiological, and sanitation personnel who are among the most talented anywhere.  It is not mere coincidence that these states figure prominently in many outbreaks of foodborne disease.  

FSIS reported today that Huntington Meat Packing Inc., a Montebello, Calif. establishment, is recalling approximately 864,000 pounds of beef products that may be contaminated with E. coli O157:H7.  Although the recall is Class I–i.e. associated with a very high risk to consumer health–there are no illnesses currently known to be associated with the potentially contaminated meat.  The recalled ground beef was produced between January 5, 2010, and January 15, 2010, and was shipped to distribution centers, restaurants, and hotels within the State of California.

The following products, consisting of all ground beef products produced by the plant from January 5, 2010 to January 15, 2010, are subject to recall:

40 lb. boxes of “Huntington Meats Ground Beef”
40 lb. boxes of “ HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING”
40 lb. boxes of “BEEF BURRITO FILLING MIX”
10 lb. boxes of “IMPERIAL MEAT CO. GROUND BEEF PATTY”
20 lb. boxes of “IMPERIAL MEAT CO. GROUND BEEF PATTY”
10 lb. boxes of “El Rancho MEAT & PROVISION ALL BEEF PATTIES”

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a label.

Interestingly, though, these are not the only products subject to the large recall.  FSIS investigation at Huntington Meat Packing, Inc., must have turned up some serious violations because the company is also recalling meat produced in 2008.  FSIS determined that the 2008 meat was adulterated because the ground beef products produced from February 19, 2008 to May 15, 2008 may have been contaminated with E. coli O157:H7.

As a result, the following products produced from February 19, 2008 to May 15, 2008, are subject to recall:

40 lb. boxes of “Huntington Meats Ground Beef”
40 lb. boxes of “ HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING”
40 lb. boxes of “BEEF BURRITO FILLING MIX”
10 lb. boxes of “IMPERIAL MEAT CO. GROUND BEEF PATTY”
20 lb. boxes of “IMPERIAL MEAT CO. GROUND BEEF PATTY”
10 lb. boxes of “El Rancho MEAT & PROVISION ALL BEEF PATTIES”

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a label.

So how does the principle of strict liability–i.e. liability without regard to fault–which is applicable in foodborne illness cases, apply to bottles of Tylenol that make people sick?  The answer:  very well.

For some background, Johnson & Johnson today expanded its recall of various Tylenol products, which, like many food items, are regulated by the FDA, due to potential contamination with a substance that produces a chemical odor that has made a bunch of people ill with gastrointestinal symptoms.  (see primer on strict liability). 

Despite some differences in the way the fifty states apply the doctrine, strict liability holds manufacturers of defective products liable to people injured by the product defect.  It’s pretty simply applied in food cases.  A beef company that produces ground beef, or any meat, contaminated with E. coli O157:H7 is liable to the people who become ill because contaminated ground beef is defective.  Similarly, a restaurant that serves a meal that became contaminated with Salmonella because an infected foodworker prepared it is liable to the customer who then contracts the disease.  In both situations, it does not matter whether the defendant (i.e. the beef producer and the restaurant) was negligent.  Simply making and selling contaminated food makes the defendant liable. 

Tylenol, whether the bottle it is sold in or the indvidual pills themselves, that is contaminated with a substance that makes people ill is also defective.  Johnson and Johnson is strictly liable to the people who have become ill, as would be the company that made the pallets that were contaminated with the substance that has made people sick.  Both produced a defective product in the eyes of the law.

This concept sounds offensive to some people. But when you pause for a moment to think where the safety of our food and pharmaceutical supply might be without the media attention that these recalls and outbreaks have gotten, and without lawsuits that put the immense costs of illnesses and medical treatment squarely back in the food producer’s hands, the concept begins to seem a little less grim.