Marler Blog - Providing commentary on food poisoning outbreaks & litigation

If you did not have health insurance, wouldn’t you try to figure out a way to get it? Wouldn’t you try to figure out how to fix medicare and medicaid costs long-term?

Perhaps the House and Senate should live without insurance for a while? Perhaps then they would do something.

I have spent the last few days face to face with health care in the United States. See, my dad (80) is dying of mesothelioma (he acquired asbestos working for Johns Manville while working his way through college in the early 50’s) and he underwent surgery yesterday, nearly dying on the operating table. Late today I left him joking with the nurses in a private room (arranged because the Hospital is asking me to serve on the Foundation Board) after spending the night in ICU.

My dad is dying. My dad is scared - as is my mom. But, he is getting extraordinary care because he has great insurance and a rich son. He is not thinking about paying for his health care while he struggles with death. My mom is not worried about going bankrupt because of my dad’s bills as she realizes the 57 years of life with her husband is ending.

My dad will hopefully go home soon to die on his farm. He will have everything he needs – all paid for by insurance.

Like my dad and mom, Congress has good health insurance. House and Senate members are allowed to purchase private health insurance (paid for by taxpayers) offered through the Federal Employees Health Benefits Program (FEHBP). According to the Congressional Research Service, the FEHBP offers about 300 different private health care plans, including five government-wide, fee-for-service plans and many regional health maintenance organization (HMO) plans, plus high-deductible, tax-advantaged plans. All plans cover hospital, surgical and physician services, and mental health services, prescription drugs and "catastrophic" coverage against very large medical expenses. There are no waiting periods for coverage when new employees are hired, and there are no exclusions for preexisting conditions. In addition, members of Congress also qualify for some medical benefits that ordinary federal workers do not. They (but not their families) are eligible to receive limited medical services from the Office of the Attending Physician of the U.S. Capitol. House and Senate members (but not their families) also are eligible to receive care at military hospitals.

So, what if the House and Senate were facing what my dad and mom are facing, but doing it without insurance?  That is a far too easy of an answer.

Bryan Gentry of the Lynchburg News & Advance covered a recent hearing of the Bankruptcy Court overseeing the Peanut Corporation of America (PCA) bankruptcy. Mr. Gentry noted that “[m]ore than a year after a nationwide salmonella outbreak, victims and surviving relatives have not received any money in insurance policies held by [PCA] that a bankruptcy court judge said they should share.”

The good news is that is going to be changing soon. Within the next week, $12,000,000 will be divided between 123 people (or families) who filed claims with the bankruptcy court. In my opinion, $12,000,0000 is about $8,000,000 - $10,000,0000 short of what the actual value of the claims are. The differential will necessarily need to be picked up by re-manufacturers such as Kellogg or King Nut.

One year ago, the CDC announced that over 700 people were sickened and nine died as a result of PCA Salmonella-tainted peanut butter.

In reading the February 20th Food Safety News story, “Ten Years of Bribery and Bad Tomatoes” and today’s New York Times story, “Bribes Let Tomato Vendor Sell Tainted Food,” (thanks for pic) I was struck by the thought that the safety of our food ultimately rests on the belief – albeit and apparently mistaken - that the folks selling us food would never sell it to us if it was full of moldy tomatoes or full of Salmonella, E. coli, etc (a.k.a., full of shit).

Despite what seems like daily food recalls and weekly foodborne illness outbreaks, we still - as does the President, Congress, the FDA and FSIS – believe that growers, shippers, manufacturers and retailers are not really out to poison us.

Not to sound paranoid, but don’t you think our beliefs are a bit misplaced? For god’s sake, the CDC says 76,000,000 people are sickened, 325,000 are hospitalized and 5,000 die every year in the U.S.A., because the food they ate was tainted with some pathogen - bacteria or virus. You would think that if we had a nearly 1 or of 4 chances of being sickened by the food we eat yearly, we would have quickly lost trust in our food supply.

Frankly, many of us have.

The tale of tomato bribery and corruption outlined in the articles are shocking, but they are really no more or less shocking than Peanut Corporation of America (PCA) poisoning 700 and killing nine fellow citizens by selling Salmonella-tainted peanut butter and covering up the test results? And, we are still waiting for the criminal prosecution of the president of PCA, Stewart Parnell - we likely will continue to wait.

Also, how different really is the Cargill E. coli outbreak of 2007 that paralyzed 20-year-old dancer, Stephanie Smith, or the 2009 Valley Meats E. coli outbreak of 2009 that eventually lead to the death of 7-year-old Abby Fenstermaker? What about the Nebraska Beef E. coli outbreak in 2006 that killed Caroline Hawkinson at a church supper? What about another Nebraska Beef E. coli outbreak in 2008 that burned through South Georgia nearly taking the life of Evelyn Stewart and several others? And, what about Linda Rivera, who has been hospitalized since May 2009 after eating E. coli-tainted cookie dough?

Those are just the tip of a very nasty food poisoning iceberg, and only a few years snapshot of the outbreaks that stretch back into my legal life. Perhaps there were no bribes; perhaps there were no falsified test results, but there were warnings ignored, shortcuts taken, investments not made, and customers’ safety ultimately ignored. Why? Because, we let them.

The thing about food - unlike most other products – is that, like water and air – we need food to survive. That leaves us with very little leverage in a complex, over fed (in some countries) and under fed (in many others), and over populated world, where we are more and more disconnected to food. Today we rely of a long chain of distribution to feed us. We trust the chain to feed us and not poison us. We trust that it is in the chains’ economic self-interest to not kill us off. We trust the Government to watch our backs. Why? Because, we have to.

Many try to break the chain of growers, shippers, manufacturers and retailers and go “locavore” – to buy food within 100 miles of home (forget bananas in Minneapolis in the winter).

Some have moved so far away from what most American’s recognize as our food chain, as to go from organic, to natural, and then to raw. Word to the wise – not all of the 76,000,000 sickened eat CAFO raised, mass-produced, mega-corporate food. Sometimes local, raw milk, sprout or leafy green farmer Bob - much like (pick a nasty corporation) - does a very efficient job of poisoning his customers.

Yes, on average I think growing your own is safer than leaving it up to Wal-Mart or McDonald’s to decide what to sell you. But, with a world population moving rapidly past six billion, I am not sure we can solely rely on Bob or my tomatoes and zucchini to feed the world.

So, what’s the solution? Yes, I support more inspection, enforcement, criminal prosecution, and, my personal favorite - suing the hell out of companies who poison people. But, all of that will not catch as many problems than if everyone in the food chain – short or long – would simply take a deep breath and ask, “would I feed this to my kid?”

According to the CDC, 238 individuals infected with the outbreak strain of Salmonella Montevideo, which displays either of two closely related pulsed-field gel electrophoresis (PFGE) patterns, have been reported from 44 states and District of Columbia since July 1, 2009. The number of ill persons identified in each state with this strain is as follows: AK (1), AL (2), AZ (7), CA (30), CO (5), CT (5), DC (1), DE (3), FL (3), GA (3), IA (1), ID (4), IL (17), IN (4), KS (4), LA (1), MA (13), MD (1), ME (1), MI (4), MN (5), MO (2), MS (1), NC (11), ND (1), NE (3), NH (2), NJ (8), NM (2), NY (18), OH (9), OK (1), OR (9), PA (7), RI (2), SC (1), SD (3), TN (5), TX (7), UT (9), VA (1), WA (17), WI (1), WV (1), and WY (2).

Salmonella Senftenberg, a different serotype of Salmonella, has been found in food samples from retail and a patient household during this outbreak investigation. PulseNet identified 6 persons who had illness caused by Salmonella Senftenberg with matching PFGE patterns between July 1, 2009 and today. Public health officials have interviewed 5 of the 6 ill persons with this strain of Salmonella Senftenberg and determined that one consumed a recalled salami product during the week before their illness began. These six cases are not included in the overall CDC case count reported above.

Good News, FSIS is paying attention, as is the industry, or at least its minions.  I would not vote against FSIS doing right by the consuming public (click on below to download letter and attachments):

I have the honor to co-present with defense counsel, Alan M Maxwell, at this week's GMA Litigation Conference in Austin, Texas - (click on image below) - I am also going to hand out Food Safety News thermometers.

Stephanie Smith turned 23 years old today. She was born on February 20, 1987 in St. Cloud, Minnesota. Stephanie was a dancer. She lost the ability to walk in 2007 as a result of the most severe E. coli O157:H7-induced HUS illness I have ever seen in someone who survived. One day, she will lose her kidneys as well.

The food that caused Stephanie’s devastating HUS illness was a hamburger made by Cargill, one of the world’s biggest food producers. The contaminated ground beef patty was one of many from a heavily contaminated batch, which caused a major national outbreak and many other awful injuries. But Stephanie Smith’s illness was singular. What happened to her is what happens when everything goes wrong - a massive infectious load of E. coli O157:H7, and a rapidly progressing disease causing irreversible kidney and brain damage.

The first sign of illness occurred on Thursday, September 27, 2007, when Stephanie developed a fever, diarrhea, and chills. Unconcerned at first, Stephanie noticed blood in her diarrhea the next morning. She was hospitalized that afternoon at St. Cloud Hospital in St. Cloud, Minnesota. Nobody knew it yet, but the toxins being released by the E. coli O157:H7 bacteria that Stephanie had ingested were actively causing a cascading series of reactions in her bloodstream that would change her life’s trajectory completely.

Over the next several days, the toxic reaction in Stephanie’s bloodstream would begin causing microscopic clots in her organs, primarily the brain and kidneys. In the early morning hours of October 2, a lab technician drawing blood noticed some unusual spastic movements in Stephanie’s arms and legs. A nurse was summoned, and she observed Stephanie staring vacantly into space, and unable to speak in complete sentences. A doctor arrived within minutes later, by which point Stephanie’s body had begun to shake and jerk in the throes of a severe seizure.

Rushed to intensive care, the clots in Stephanie’s brain and kidneys continued to build and multiply. Her body eventually began to swell due to her inability to pass fluids and waste through her failing kidneys. Doctors ordered that Stephanie be immediately prepared for dialysis and plasma exchange, readying her for the impending total failure of her kidneys, which occurred on October 4. Dialysis began the same day, and would continue for weeks.

Meanwhile, Stephanie remained lethargic and only minimally responsive, alternating between states of confusion and disorientation. The seizure activity that had begun on October 2 had continued without stop, causing her neurologist to begin anti-convulsant therapy. On October 4, Stephanie began to seize so badly that she had to be sedated completely, intubated, and placed on mechanical ventilator to breathe. Her major body systems were shutting down, and the chances of simple survival were growing slim.

And then, at around 4:00 PM, on October 6, Stephanie suffered a grand mal seizure that lasted for over an hour, despite repeated administration of anticonvulsant medications. Afterward, the neurologist advised Stephanie’s mother, Sharon, that seizures as persistent and strong as Stephanie’s frequently caused major brain damage. Further, the anti-convulsants that her daughter was currently on only suppressed the seizure activity by about ten percent. The neurologist thus believed that Stephanie needed to be placed in a drug-induced coma with continuous brain monitoring. Sharon gave her tearful consent, and Stephanie was loaded with pentobarbital, a barbiturate, in an effort to finally end the relentless seizures.

At this point, as Stephanie’s body appeared to calm, Sharon hoped beyond hope that her daughter had found some peace at last. Nevertheless, continued monitoring of her brain function showed that Stephanie had reached “status epilepticus,” meaning that she was suffering from continuous epileptic seizures without intervals of consciousness. In fact, Stephanie’s condition had deteriorated so rapidly and so completely that the doctors at St. Cloud Hospital felt ill-prepared to handle her continuing care. She was rushed to the Mayo Clinic in Rochester, Minnesota.

Over the course of the next two months, Stephanie would suffer from a variety of severe complications. These included such things as metabolic acidosis and alkalosis, episodes of oxygen desaturation, and development of a significant ileus—paralyzation of the gastrointestinal tract resulting in a failure to clear pathogens and wastes. In addition, Stephanie’s body continued to swell, ultimately reaching a weight 50 pounds more than her weight at admission. She also battled infections, an airway blockage, and a tongue so grossly swollen that it eventually protruded from her mouth.

Quite clearly, however, Stephanie’s primary problems during her hospitalization at Mayo Clinic remained kidney failure and status epilepticus. Her kidneys were non-functional, producing very little, if any, urine, from October 3 through October 24. During this time period, she received constant hemodialysis and received all nutrition through a tube. She also received numerous blood transfusions due to the destruction of her red blood cells and platelets.

Neurologically, Stephanie could not breathe on her own, and she remained in a drug-induced coma and ventilator dependent during the months of October, November, and into December. Through all of this, Stephanie’s family stood vigil, hoping and praying for any sign that she might regain consciousness. But there continued to be no sign at all that she ever would.

And then, on November 12, Stephanie’s neurologist noticed that she was “awake” enough to be triggering the ventilator. But it was not until December 2 that Stephanie began to open her eyes spontaneously. Though the initial progress was short-lived—seizures actually resumed afterward—it was progress nonetheless. If nothing else, it gave doctors, nurses, and family alike hope that Stephanie would make a recovery. The extent of that recovery, however, remained a deeply foreboding and uncertain subject.

Imaging studies of Stephanie’s brain did not paint a bright picture. An MRI on December 3 showed injury to the white matter in Stephanie’s brain. And a nerve conduction study done eight days later showed extensive damage to Stephanie’s central nervous system.

The extent of Stephanie’s brain injury would not be known for weeks, until she became well enough again to be able to try and move. When it came, the answer was among the most devastating of all possible scenarios. Stephanie was unable to move her legs and had lost all sensation in her bowels and bladder.

The tests of will that Stephanie survived over the course of the next six months strain comprehension. Early in the process, it was evident that the brain injury had cruelly left her with the ability to realize the limitations she would face for the rest of her life. The resulting psychological struggle was monumental, pitting the will to live against the viscous reality that she could no longer walk, would lose her kidneys and never have children. But Stephanie chose to survive. She returned home for the first time on June 18, 2008, to a totally unfamiliar world.

Stephanie Smith has not rested for a moment since the date that she regained consciousness, choosing tireless rehabilitation over the painful reality of her doctors’ words. In what will ultimately be a futile effort, she continues to try to regain and relearn the functionality that was once second nature. She has received intensive inpatient therapy in many specialty centers across the country. Her primary treatment goal remains, and always will be, to learn to walk again and to have a family.

By this juncture, some have certainly wondered whether death would have been fairer for Stephanie. Her injuries are truly the kind that are uncomfortable to be too close to for the simple fact that it is hard to know what to say to somebody so damaged. It is difficult to imagine a crueler fate, particularly for somebody so young and formerly so vibrant. Indeed, Stephanie’s injuries have changed everything about every day that she lives on this earth. The costs associated with her future medical care are staggering—in the tens of millions of dollars. 

I will offer only one personal anecdote to help understand both Stephanie's spirit and plight. It occurred at meeting with Cargill on December 2, and I will forever remember it. As we were wrapping up two days of unsuccessful negotiations, Stephanie wanted to meet with Cargill’s representatives. She wanted to tell them what their product had done to her life. But when the time came to meet them face-to-face, Stephanie had become physically ill (the combination of necessary medications frequently makes her nauseated). She vomited just before our meeting began—multiple times. I requested of the Cargill representatives a few extra minutes, and helped to clean Stephanie, myself, and the conference room floor and chair. Now Stephanie wanted to meet the Cargill representatives even more, and since she appeared composed in spite of it all, I decided not to stand in her way. But, what neither of us knew at that moment was that, not only had she vomited, Stephanie had also lost control of her bowels and bladder as well. I did not realize what had happened until the Cargill representatives were in the room. There was no question they got a first-hand sense for what Stephanie’s life has become. 

Happy Birthday Stephanie.

The 2007 Cargill E. coli O157:H7 Outbreak and its Genesis

On October 3, 2009, the New York Times published an article on Stephanie Smith’s injuries and the contaminated, recalled Cargill meat that caused them—specifically, a hamburger patty that Stephanie’s aunts had purchased at a local Sam’s Club store. See Michael Moss, "E. coli Path Shows Flaws in Beef Inspection," New York Times, at A 1. The underlying facts in the story are highly relevant to this case. First, they establish that Cargill will not be able to successfully shed any responsibility for Stephanie’s injuries because it cannot show which component part of the recalled ground beef patties was originally contaminated, or where the contaminated component part came from. And second, although Cargill is strictly liable to Stephanie Smith, the facts show that Cargill was negligent, driven purely by financial gain, in its acquisition of meat and the production of ground beef products.

The facility where Cargill produced the recalled hamburger patties (USDA # 924A) is a grinding operation. At this location (Butler, Wisconsin), Cargill receives a variety of beef products (including meat trimmed from larger cuts, called “trimmings”) from a number of sources across the country, and even internationally, and then grinds the products together to produce ground beef patties. According to the New York Times story:

[C]onfidential grinding logs and other Cargill records show that the hamburgers were made from a mix of slaughterhouse trimmings and a mash-like product derived from scraps that were ground together at a plant in Wisconsin. The ingredients came from slaughterhouses in Nebraska, Texas and Uruguay, and from a South Dakota company that processes fatty trimmings and treats them with ammonia to kill bacteria.

The story also notes that “[u]sing a combination of sources—a practice followed by most large producers of fresh and packaged hamburger—allowed Cargill to spend about 25 percent less than it would have for cuts of whole meat.”

The source-material that has drawn the most interest—and, for a majority of people, also inspired the most disgust—is the so-called “fine lean textured beef” supplied by Beef Products, Inc. (“BPI”). This product was the subject of a follow-up story by Michael Moss in the New York Times, titled: "Safety of Beef Processing Method Is Questioned." (Dec. 30, 2009).

This raw material, which Cargill used to make it patties more profitable, is made “from beef that included fatty trimmings the industry once relegated to pet food and cooking oil. The trimmings were particularly susceptible to contamination.”

Despite Cargill’s occasional insistence that it could identify the source of the E. coli-contaminated raw materials, the USDA concluded that such an identification was not possible given the state of records related to the manufacture of the implicated patties.

And, predictably, each of the potential suppliers of contaminated raw materials denies that their product was the source of the E. coli O157:H7 that so seriously injured Stephanie and others.

Commenting on this issue of relative responsibility, and the New York Times article on Stephanie Smith, an article in the Lincoln Star Journal observed:

Smith was victimized by ground meat that was tainted - nobody knows where or when in the processing chain - sold at a Sam's Club and packed at a Cargill meat plant in Wisconsin, supplied in part with meat trimmings from Greater Omaha Packing Co.

At a plant the size of four football fields at 30th and L in Omaha, the company slaughters and processes 2,600 cattle daily, the Times reported.

Others in the Cargill supply chain were slaughterhouses in Texas and Uruguay, and Beef Products Inc., a South Dakota company with a plant in South Sioux City, Neb.

Using a combination of sources of meat and trimmings allowed Cargill to spend about 25 percent less than it would have otherwise, according to the Times.

In a response to questions from the Journal Star, Angelo Fili, executive vice president of Greater Omaha Packing, expressed sympathy for victims of tainted food. But he also said the Times story was biased and unfair because it neglected to report that Greater Omaha's product has never been recalled, and its contribution to the Cargill product that crippled Smith had been cleared by a lab.

"Copies of the Certificate of Analysis test results of Greater Omaha's product used by Cargill are available at our Website: www.greateromaha.com," Fili said in an e-mail. "All product tests were performed by IEH Laboratories, the same lab that the New York Times used for their E. coli tests as referenced in the article.

See Richard Piersol, "Beef Industry under fire after N.Y. Times article," Lincoln Journal Star, October 17, 2009.

The investigation triggered by the 2007 Cargill outbreak prompted the USDA to further scrutinize the plant where Cargill had manufactured the contaminated patties. As noted in the Moss article:

In the weeks before Ms. Smith’s patty was made, federal inspectors had repeatedly found that Cargill was violating its own safety procedures in handling ground beef, but they imposed no fines or sanctions, records show. After the outbreak, the department threatened to withhold the seal of approval that declares “U.S. Inspected and Passed by the Department of Agriculture.”

In the end, though, the agency accepted Cargill’s proposal to increase its scrutiny of suppliers. Records show that Cargill and the USDA reached this accord early last year after contentious negotiations. When Cargill defended its safety system and initially resisted making some changes, an agency official wrote back: “How is food safety not the ultimate issue?”

The sum total of all these circumstances will be brought to bear on Cargill, and Cargill alone, in trial of this case. Cargill will not prove who it received the contaminated trimmings from. Had it been able to do so, it would have done exactly that long before resolving the cases of many other outbreak victims represented by this firm, and long before its association with Stephanie Smith’s devastating injuries was broadcast to the entire world. Ultimately, the effort to cast blame elsewhere will only succeed in causing a scrutiny of its business operations that Cargill can ill-afford.

549.20 PUNITIVE DAMAGES MINNESOTA

Subdivision 1. Standard.

(a) Punitive damages shall be allowed in civil actions only upon clear and convincing evidence that the acts of the defendant show deliberate disregard for the rights or safety of others.

(b) A defendant has acted with deliberate disregard for the rights or safety of others if the defendant has knowledge of facts or intentionally disregards facts that create a high probability of injury to the rights or safety of others and:

(1) Deliberately proceeds to act in conscious or intentional disregard of the high degree of probability of injury to the rights or safety of others; or

(2) Deliberately proceeds to act with indifference to the high probability of injury to the rights or safety of others. …

Subd. 3. Factors.

Any award of punitive damages shall be measured by those factors which justly bear upon the purpose of punitive damages, including the seriousness of hazard to the public arising from the defendant's misconduct, the profitability of the misconduct to the defendant, the duration of the misconduct and any concealment of it, the degree of the defendant's awareness of the hazard and of its excessiveness, the attitude and conduct of the defendant upon discovery of the misconduct, the number and level of employees involved in causing or concealing the misconduct, the financial condition of the defendant, and the total effect of other punishment likely to be imposed upon the defendant as a result of the misconduct, including compensatory and punitive damage awards to the plaintiff and other similarly situated persons, and the severity of any criminal penalty to which the defendant may be subject.

Your thoughts?

References

As this more recent Salmonella Black and Red Pepper outbreaks twists slowly in the wind, I spent some of today re-reading the FDA Establishment Inspection Report on U.F. Union International Food Co., Inc. White Pepper Salmonella Outbreak 2009.  Harris Freeman appears to be the importer of the raw white pepper. The report is a bit long, and much of the really good stuff has been redacted (why? - who the hell knows).  Still, it is worthwhile reading and asking yourself, what did the pepper industry learn in the last year?  You guessed it - not much.

In so many ways, January 20, 2009 ushered in a new era in American politics (my wife and kids stood in the cold and were seated just below the President).  A charismatic leader with an agenda of hope and change took the reins in a time of great trouble on many fronts in this country.  Many hoped for change in how things were run in Washington, and by extension, in government agencies.   Those of us in food safety hoped those changes would begin to reverse the upward trend of contaminated meat production, recalls, and related illnesses and deaths.

Although no one can argue that President Obama has not had a lot on his plate (to put it mildly), however, American dinner plates have not yet been the beneficiaries of an agenda of change. First, the position of Under Secretary for Food Safety at FSIS (Food Safety and Inspection Service, the agency responsible for ensuring the safety of our meat supply) went unfilled for more than a year. There is now a nominee, Dr. Elisabeth Hagen, who, if confirmed, will be faced with a staggering number of meat recalls since the new administration came to Washington.

Meat is recalled for many reasons, but let’s take a look at only Antibiotic-resistant Salmonella and E. coli O157:H7 recalls, both of which carry a Class I rating - meaning that consuming it could cause “serious adverse health consequences, or death” (quoting USDA there, parent agency of the FSIS). Things were quiet for the first few months of the President's term - until May 4, 2009 - when Alex and George Wholesale started things off with a recall of 4,663 pounds of E. coli contaminated meat. Bob’s Food City followed with 375 pounds (E. coli), and then Valley Meats recalled 95,898 pounds (E. coli). That was just May.

Recalls by SP provisions, Snow Creek Meat Processing, International Meat Company, JBS Swift Beef Company, E.S. Miller Packing Company, King Soopers, Inc., Beef Packers, Inc., Sterling Pacific Meat Company, Marcacci Meats, San Diego Meat Company, South Shore Meats, Fairbank Farms, Fairbury Steaks, Beef Packers Inc (again) Harrington and Sons, and National Steak and Poultry rounded out the year for a grand total of 2,681,548 pounds of tainted meats.

2010 has been anything but quiet, with 7,176,563 pounds of recalls to date from Adams Farm, Huntington Meat Packing, Daniele International, West Missouri Beef Company, and Huntington Meat Packing again—the second time as a result of a criminal investigation.

If you have your calculator handy, you’ll already know that almost ten million pounds of potentially deadly meat has been recalled since President Obama took office (see attached spreadsheet). 

Dr. Hagen, you have a difficult road ahead, but I’ll be on that road with you, hoping - and working - for change.  By the way Dr. Hagen, here is my suggested To Do List for you - "IF (now when) there was an USDA Undersecretary for Food Safety this is what they should be doing."

According to a FSIS release late yesterday, Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is expanding its January 23 recall to include approximately 115,000 pounds of salami/salame products that may be contaminated with Salmonella, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The recall is being expanded as a result of a confirmed finding of Salmonella in an unopened salami product tested by FSIS, and by ingredient testing performed by the company. The product was sampled during the course of an ongoing investigation of a multi-state outbreak of Salmonella serotype Montevideo illnesses. These products were not subject to recall previously because they are not sausage products that contain black pepper on the external surface, or packaged with such products. Based on preliminary testing results, the company believes that crushed red pepper may be a possible source of Salmonella contamination.

The products subject to recall include:

* 8-ounce packages of “DANIELE HOT SALAME PANINO WITH FRESH MOZZARELLA.”
* 8-ounce packages of “BOAR’S HEAD SALAME PANINO, SALAME ROLLED IN MOZZARELLA CHEESE.”
* 8-ounce packages of “DANIELE ITALIAN STYLE SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE.”
* Random weight packages of “DANIELE ITALIAN STYLE SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE.”
* 8-ounce packages of “DIETZ & WATSON ARTISAN COLLECTION HOT SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE.”
* 8-ounce packages of “DANIELE SALAME PANINO WITH FRESH MOZZARELLA AND BASIL.”
* 1-pound 8-ounce variety packages of “DANIELE CAPOCOLLO PANINO WITH FRESH MOZZARELLA AND BASIL; PRESIDENT’S PROSCIUTTO PANINO WITH FRESH MOZZARELLA AND BASIL; HOT SALAME PANINO WITH FRESH MOZZARELLA,” with UPC Code 736436709582.

Each package bears a label with establishment number “EST. 459” inside the USDA mark of inspection. The above products are sold individually packed, except as noted above. The products subject to recall have sell-by dates ranging from February 3, 2010, through May 26, 2010, and were distributed to retail establishments nationwide.

As of yesterday as well, the CDC reports that a total of 230 individuals infected with the outbreak strain of Salmonella Montevideo, which displays either of two closely related PFGE patterns, (although we know that there is at least one other strain - Senftenberg) have been reported from 44 states and District of Columbia since July 1, 2009. The number of ill persons identified in each state with this strain is as follows: AK (1), AL (2), AZ (7), CA (30), CO (5), CT (5), DC (1), DE (3), FL (3), GA (3), IA (1), ID (2), IL (15), IN (3), KS (4), LA (1), MA (13), MD (1), ME (1), MI (4), MN (5), MO (2), MS (1), NC (10), ND (1), NE (1), NH (2), NJ (8), NM (2), NY (18), OH (9), OK (1), OR (9), PA (7), RI (2), SC (1), SD (3), TN (5), TX (7), UT (9), VA (1), WA (17), WI (1), WV (1), and WY (2).

We have known for some time now that Daniele Inc.'s recalled salami products, and black pepper sold by Overseas Spice Company and Wholesome Spice, were contaminated with more than one strain of Salmonella. We have also known for some time that the strains involved, or at least two of them, are Montevideo and Senftenberg. But who knew that some of the recalled, contaminated Salami products were contaminated with BOTH strains of Salmonella?

CDC reports 230 individuals infected with the outbreak strain of Salmonella Montevideo, which displays either of two closely related PFGE patterns, have been reported from 44 states and District of Columbia since July 1, 2009. The number of ill persons identified in each state with this strain is as follows: AK (1), AL (2), AZ (7), CA (30), CO (5), CT (5), DC (1), DE (3), FL (3), GA (3), IA (1), ID (2), IL (15), IN (3), KS (4), LA (1), MA (13), MD (1), ME (1), MI (4), MN (5), MO (2), MS (1), NC (10), ND (1), NE (1), NH (2), NJ (8), NM (2), NY (18), OH (9), OK (1), OR (9), PA (7), RI (2), SC (1), SD (3), TN (5), TX (7), UT (9), VA (1), WA (17), WI (1), WV (1), and WY (2).

Recall Release CLASS I RECALL
FSIS-RC-004-2010 HEALTH RISK: HIGH

Editor's Note: This recall release is being reissued to expand the January 18 recall to include approximately 4.9 million additional pounds of beef and veal products, and to correct net weights from 40 lbs. to 50 lbs. in five instances in the earlier release.

Huntington Meat Packing Inc., a Montebello, Calif., establishment, is expanding its recall of January 18 to include approximately 4.9 million additional pounds of beef and veal products that were not produced in accordance with the company's food safety plan. The products are adulterated because the company made the products under insanitary conditions failing to take the steps it had determined were necessary to produce safe products, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. FSIS has received no reports of illnesses associated with consumption of these products. Individuals concerned about an illness should contact a physician.

The recall was expanded based on evidence collected in an ongoing criminal investigation being conducted by the Office of the Inspector General (OIG) with assistance from FSIS. This evidence shows that the products subject to this recall expansion were produced in a manner that did not follow the establishment's Hazard Analysis and Critical Control Points (HACCP) plan. A HACCP plan describes the process controls an establishment must take to prevent food safety hazards and create a safe and wholesome product. The investigation has uncovered evidence to show that the food safety records of the establishment cannot be relied upon to document compliance with the requirements. Therefore, FSIS must consider the products to be adulterated and has acted to remove the products from commerce.

The following beef and veal products, produced by the plant from January 22, 2009, to January 4, 2010, are subject to recall:

10 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
10 lb. boxes of "El Rancho MEAT & PROVISION ALL BEEF PATTIES"
20 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
50 lb. boxes of "HUNTINGTON MEATS GROUND BEEF"
50 lb. boxes of " HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING"
50 lb. boxes of "BEEF BURRITO FILLING MIX"
50 lb. boxes of "HUNTINGTON MEAT PKG. INC. DICED BEEF"
50 lb. boxes of "HUNTINGTON MEAT PKG. INC. SLICED BEEF"
10 lb. boxes of "Huntington Meat VEAL PATTY"
10 lb. boxes of "Imperial Meat VEAL PATTY"
10 lb. boxes of "El Rancho VEAL PATTY"
20 lb. boxes of "Huntington Meat VEAL PATTY"
20 lb. boxes of "Imperial Meat VEAL PATTY"
20 lb. boxes of "El Rancho VEAL PATTY"

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a label. The products were produced between January 22, 2009, and January 4, 2010, and were shipped to distribution centers, restaurants, and hotels within the State of California.

Yesterday Safe Tables Our Priority (STOP) published a Press Release urging FSIS to declare "disease-causing E. coli's other than O157:H7 as adulterants in beef and begin testing for them." Over at Fanatic Cook, they are doing a series on Shiga Toxin E. coli.

In October we filed with FSIS, "Petition for an Interpretive Rule Declaring all enterohemorrhagic Shiga Toxin-producing Serotypes of Escherichia coli (E. coli), Including Non-O157 Serotypes, to be Adulterants Within the Meaning of 21 U.S.C. § 601(m)(1)."  We are studying FSIS's response and will respond shortly.  Here is the FSIS's response (click on image to download):

MeatPoultry.com, February 2, 2010 by Steve Bjerklie

One of the meat industry’s most respected yet sharpest and, arguably, its most litigious, critics says he is “hopeful” about the nomination of Dr. Elisabeth Hagen to the crucial post of undersecretary of agriculture for food safety.

“I am very hopeful she will do the kind of job that needs to be done,” attorney Bill Marler told MEATPOULTRY.com. “Like a lot of people, I am certainly looking forward to working with her.”

Marler and his firm, Marler Clark in Seattle, Wash., have successfully sued the industry dozens of times in food-safety and, in particular, E. coli cases. He first made his name in food-safety litigation by successfully negotiating a huge settlement with the Jack in the Box chain following the outbreak of E. coli traced to Jack in the Box outlets in 1993. Since then he has been at the forefront of virtually every case involving E. coli adulteration of U.S. food.

Dr. Hagen, who had been teaching and practicing medicine as an infectious disease specialist before joining USDA in 2006 and eventually becoming the Department’s chief medical officer, is the first medical doctor to be nominated for an executive-level food-safety position at USDA. “I think having a medical doctor in this position makes a lot of sense,” said Marler, who added that he doesn’t know Dr. Hagen personally. “The clear mission of FSIS is a public-health mission.” He said he thinks career-level employees at FSIS, who are crucial in implementing effective regulations, “will give her their full support.”

The previous undersecretary for food safety, Dr. Richard Raymond, has become a vocal critic of certain USDA policies, and has been especially critical of the long time it has taken the Obama Administration to name a new undersecretary. “I think that toward the end of his term, Richard was beginning to understand the job and what really needs to be done,” said Marler. “Since he left office he’s been very outspoken – surprisingly outspoken, in fact – about it.”

As reported this week by the Washington Post, Dr. Hagen is the Administration’s third choice for the USDA position. Dr. Michael Doyle had been the first choice, “but the day before the announcement was to be made in May, his nomination collapsed. The White House wanted Doyle to divest his financial interest in a patented microbial wash for meat that he had developed. Doyle offered to defer his interests until his government service was completed but the Administration refused,” the Post reported. A second choice, according to the newspaper, was Carolyn Smith DeWaal, the director of food safety at the Center for Science in the Public Interest, who is often considered the industry’s best-informed critic. But she was ruled out because she’s a registered lobbyist, violating the Administration’s policy against hiring lobbyists for policy-making positions.

Marler’s own name had appeared on several speculative lists for the job. “I don’t know who was first, second, third, fourth, fifth or sixth choice,” he told MEATPOULTRY.com. “The bottom line is Dr. Hagen is the president’s pick.”

CORRECTION TO THIS ARTICLE

The article said the administration decided against nominating Caroline Smith DeWaal for the post in August because of its policy against hiring registered lobbyists. Although that was the administration's reasoning, and she was registered as a lobbyist at the time, her employer later acknowledged that the listing was incorrect. The Center for Science in the Public Interest, where she is director of food safety, had a policy of registering all of its officials who spend time on Capitol Hill as lobbyists. After she had been passed over for the Agriculture Department job, the organization amended its filings to reflect the fact that she was not a lobbyist. The article also incorrectly referred to DeWaal as Dewaal. And in one instance it referred to her nomination; she was never nominated.

For readers here, and those who saw the Washington Post article, who have followed Linda and her family's struggle with E. coli O157:H7, the report that I received late yesterday from her brother-in-law is heartbreaking.  It seemed only a few days ago that there was talk about her leaving the hospital (where she has been since May 2009) and starting rehabilitation.  There was hope that both her ventilator tube and feeding tube were being removed.  There was a dream that she might one day go home.  Now this:

2-4-2010

I was on the phone with Richard this morning. Linda has developed a condition called “ascites”. Ascites is when the liver weeps out fluid from itself and the fluid builds up within the abdominal cavity. The fluid buildup can get to the point where the person appears similar to a woman who is pregnant. Linda had around 7 liters of fluid in her belly. The doctors “tapped” out the fluid and sent it for analysis.

Why Linda has this fluid buildup is not certain but, very likely, represents progression of her liver problems to cirrhosis. Other possibilities not related to the liver are possible but cirrhosis leads with the highest possibility. Due to this buildup, they decided not to surgically close the tracheotomy (the breathing opening in her throat). Fluid buildup in the belly interferes with breathing mechanics because the fluid interferes with the diaphragm, the anatomic structure that allows us to breathe in and out. Also, this fluid oftentimes leaks into the cavity surrounding the lungs, which can interfere with her ability to obtain oxygen within her lungs. Rather than risk taking out the tracheostomy device and closing the tracheotomy opening, only to have to potentially put down another breathing tube due to respiratory failure, they have elected to keep the opening for as long as this threat remains.

This is a setback, possibly reflecting onset of end stage liver disease. Please keep Linda and Richard in your thoughts and prayers. It has been a roller coaster ride for sure.

A roller coaster ride for sure. 

West Missouri Beef, LLC, a Rockville, Mo., establishment, is recalling approximately 14,000 pounds of fresh boneless beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced.

The following products are subject to recall:

* One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as "75 1-M," produced on October 26, 2009.
* One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as "90 3-D," produced on November 25, 2009.
* One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as "90 5-D," produced on November 27, 2009.
* Combo bins containing approximately 2,000 pounds of fresh boneless beef identified as "90 2-P," "90 2-R" or "90 2-V," produced on December 8, 2009.
* One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as "90 3-E," produced on January 13, 2010.

Each container is marked with the establishment number "EST. 5821" inside the USDA mark of inspection. The fresh boneless beef products were distributed to wholesalers in the Chicago, Ill., area.

The China Daily reported a few days ago that the government has launched a “10 day crackdown on latest milk scare.” And, for good reason – apparently, they need “to track and destroy melamine-tainted milk products nationwide as a 2008 contamination scandal continued to haunt the country.”

According to the paper:

… “[t]he National Food Safety Rectification Office led by Health Minister Chen Zhu ordered the move following reports that leftovers from the melamine-laced milk powder that had killed six children and sickened 300,000 in 2008 resurfaced on the market, mostly in the form of processed food like ice cream and condensed milk.”

... In late January, three domestic companies were found selling melamine-tainted milk products that health authorities said were leftovers from the 2008 tainted milk powder. The products found have been pulled off shelves and executives of the companies involved have been set for prosecution.

You might recall that a few high-ranking government employees and businesspeople have been either executed or sentenced to long prison terms due to food safety scandals. Thus far those criminal sanctions alone have not deterred bad behavior. Perhaps the US needs to export a trial lawyer (back) to China?

According to the Atlanta Journal Constitution and AP, over 100 victims of last year's nationwide salmonella outbreak will split $12 million as part of a bankruptcy settlement with the insurer of the company linked to the illnesses.

The attorney for the bankruptcy trustee, Atlanta attorney Alan Maxwell said Monday the money comes from an insurance policy that Lynchburg, Va.-based Peanut Corp. of America had with Hartford Financial Services Group Inc. The settlement could be doled out to more than 100 victims or their survivors who filed a claim.

Lawsuits against Kellogg Co. and King Nut Co. are still pending.

The outbreak was traced to the company's plants in Georgia and Texas. It sickened about 700 people and was linked to at least nine deaths. Peanut Corp. has since filed for bankruptcy and authorities have allegedly launched a criminal investigation.

I have the honor to speak, along with Alan Maxwell, at GMA's Food Claims and Litigation Conference about "Recent and Emerging Tends," in Austin, Texas on February 23.  Click on below to see the outline Alan and I put together: