Lawsuits & Litigation – Food Safety Website https://www.storkxx.com Breaking news for everyone's consumption Mon, 03 Aug 2020 23:57:32 +0000 en-US hourly 1 https://wordpress.org/?v=5.3.4&lxb_maple_bar_source=lxb_maple_bar_source https://www.storkxx.com/files/2018/05/cropped-siteicon-32x32.png Lawsuits & Litigation – Food Safety Website https://www.storkxx.com 32 32 San Diego man files suit against fresh produce company in Salmonella outbreak https://www.storkxx.com/2020/08/san-diego-man-files-suit-against-fresh-produce-company-in-salmonella-outbreak/ https://www.storkxx.com/2020/08/san-diego-man-files-suit-against-fresh-produce-company-in-salmonella-outbreak/#respond Mon, 03 Aug 2020 23:42:13 +0000 https://www.storkxx.com/?p=196260 Continue Reading]]> A California man is seeking damages from Thomson International Inc. contending he was poisoned with Salmonella from the company’s onions. He is part of a multi-national outbreak that has sickened more than 500.

Keith Robert Willis, 58, bought and ate the implicated onions in June and fell ill on July 1, according to a civil complaint filed against the produce company in the Superior Court of California in San Diego. The San Diego health department confirmed Willis was part of the Salmonella Newport outbreak that has sickened 396 in the United States and 114 in Canada.

Willis seeks damages “in an amount that is fair and reasonable, for his costs incurred, and for any other relief to which he may be entitled. . .” according to the lawsuit. Willis suffered classic food poisoning symptoms and is still on antibiotics for his infection.

The red onions in question, plus yellow, white and sweet onions, have been recalled in Canada and the United States. They were distributed to all 50 U.S. states and are packaged under a variety of brands and sold at many retailers, including Walmart, Kroger and Food Lion.

Public health officials in both countries say traceback investigations showed a link between Thomson International’s red onions and the Salmonella Newport outbreak. The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are working with the Public Health Agency of Canada and the Canadian Food Inspection Agency on the outbreak investigation.

“Building on this information, and on epidemiologic information on the U.S.  outbreak from CDC, the FDA’s traceback investigation was able to identify Thomson International Inc. as a likely source of contaminated red onions in the U.S. 

Thomson International, Inc. of Bakersfield, California is recalling red, Yellow, white, and sweet yellow onions shipped from May 1, 2020, through the present,” according to the civil complaint.

Among the counts cited in the complaint are strict liability, breach of warranty and negligence. 

“The defendant had a duty to properly supervise, train, and monitor its respective employees, and to ensure that its respective employees complied with all applicable statutes, laws, regulations, safety codes, and provisions pertaining to the manufacture, distribution, storage, and sale of similar food products. The defendant breached this duty and was therefore negligent,” according to the lawsuit.

Willis is represented by the Ventura, CA, law firm of Murphy and Murphy with co-counsel Marler Clark LLP of Seattle.

About Salmonella infections
Food contaminated with Salmonella bacteria does not usually look, smell, or taste spoiled. Anyone can become sick with a Salmonella infection. Infants, children, seniors, and people with weakened immune systems are at higher risk of serious illness because their immune systems are fragile, according to the CDC.

Anyone who has eaten any of the recalled onions and developed symptoms of Salmonella infection should seek medical attention. Sick people should tell their doctors about the possible exposure to Salmonella bacteria because special tests are necessary to diagnose salmonellosis. Salmonella infection symptoms can mimic other illnesses, frequently leading to misdiagnosis.

Symptoms of Salmonella infection can include diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating contaminated food. Otherwise, healthy adults are usually sick for four to seven days. In some cases, however, diarrhea may be so severe that patients require hospitalization.

Older adults, children, pregnant women, and people with weakened immune systems, such as cancer patients, are more likely to develop a severe illness and serious, sometimes life-threatening conditions.

Editor’s note: Bill Marler is publisher of Food Safety Website.

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Panera named in civil suits involving E. coli infections and romaine https://www.storkxx.com/2020/06/panera-named-in-civil-suits-involving-e-coli-infections-and-romaine/ https://www.storkxx.com/2020/06/panera-named-in-civil-suits-involving-e-coli-infections-and-romaine/#respond Tue, 16 Jun 2020 04:02:28 +0000 https://www.storkxx.com/?p=195059 Continue Reading]]> Civil lawsuits have been filed in the Circuit Court of St. Louis (MO) County on behalf of Stephanie Ingberg and in the U.S. District Court, Eastern District of New York, on behalf of Brianna Ruocchio, a minor, in relation to an E. coli outbreak associated with Romaine lettuce.

Both plaintiffs became ill with E. coli O157:H7 infections after eating romaine lettuce at Panera Bread locations. Ingberg and Ruocchio are represented by Marler Clark LLP, the Food Safety Law Firm based in Seattle, Gregory Aleshire of Aleshire, Robb & Rapp, a Springfield, MO, law firm, and Paul Nunes of Heisman, Nunes & Hull, a New York law firm.

The patients named in the lawsuits were part of a 2018 romaine lettuce outbreak that infected 240 people with E. coli O157:H7. It involved 37 states and Canada. Illnesses started on dates ranging from March 13, 2018, to Aug. 22, 2018. Of the 201 people with information available, 104 were hospitalized, including 28 people, including Ingberg and Ruocchio. Five people died.

A week after eating the salad, and following an emergency airlift to a medical facility, and three weeks of hospitalization, Ingberg suffered life-threatening HUS that included acute renal failure, pneumonia, anemia, thrombocytopenia, sepsis with multisystem organ failure, tonic/clonic seizures, brain injury, and severe caloric malnutrition. She continues to have regular outpatient hemodialysis, pulmonary, neurology, nephrology, and physical therapy and is at high risk of future medical complications.

Four days after eating salad, Ruocchio began experiencing symptoms of an E. coli infection, which included diarrhea, vomiting and nausea. Ruocchio was hospitalized and developed severe HUS as manifested by the need for dialysis which lasted several weeks; she remains at risk for future health complications.

Disclosure: Bill Marler, founding member of Marler Clark LLP, is publisher of Food Safety Website.

(To sign up for a free subscription to Food Safety Website, click here.)

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Letter From The Editor: Truth is, Blue Bell sure made lot’s of news for case about concealment https://www.storkxx.com/2020/05/letter-from-the-editor-truth-is-blue-bell-sure-made-lots-of-news-for-case-about-concealment/ https://www.storkxx.com/2020/05/letter-from-the-editor-truth-is-blue-bell-sure-made-lots-of-news-for-case-about-concealment/#respond Mon, 04 May 2020 04:05:42 +0000 https://www.storkxx.com/?p=194012 Continue Reading]]> Opinion

Not since the defunct Peanut Corporation of America’s CEO Stewart Parnell was convicted six years ago has an American food industry executive been in as much possible criminal jeopardy as former Blue Bell Creamery CEO Paul W. Kruse is now.

Most media outlets in the United States, including Food Safety Website, over the weekend, reported on the filing of these criminal charges, most leading with the fact that Kruse is accused of conspiracy with other “known and unknown” Blue Bell employees in order to obtain “money from customers.”

While that charge may sound relatively close to the job description of a corporate executive in America, the added detail that makes it an alleged criminal conspiracy is the accusation that Kruse’s true goal was to conceal potential or confirmed listeria from “certain Blue Bell customers.”

Blue Bell went through a battle with Listeria, that most stubborn of pathogens with its all-to-common 30 percent fatality rate. Such battles often end with burning the company to the ground and rebuilding from the ground up. That’s essentially what Blue Bell did in recalling all its product from the market, shutting down all of its production, and furloughing almost all of its employees. It’s far from my first candidate for being a conspiracy of concealment.   

Then there was the fact that for almost the first time in history, science connected this unusual outbreak to five-year-old illnesses by linking them to listeria strains found at two of the Blue Bell production facilities. Until then, science found current illnesses involved an outbreak and identified others as they occurred.  

This fact alone made writing about Blue Bell like trying to drink from a fire hose for science and food safety writers. When Kruse retired two years ago, it was on a high note of recovery of the century-old family-owned business.

Blue Bell, as a company, has pleaded guilty to two misdemeanor counts of shipping products across state lines that were involved in the 2015 outbreak and it agreed to pay $19.35 million in civil charges. The company also has signed a secret plea agreement with the government that might not be favorable to Kruse. At this point, he is not charged with any interstate shipping of adulterated products.

Kruse has not yet appeared in U.S. District Court in Austin, TX, but when he does, he is expected to plead not guilty to one count of conspiracy and six counts of wire fraud. He could be sentenced to as much as 20 years in prison and $250 in fines on each count up to $1 million.

Parnell, too, was charged with multiple counts of fraud and those convictions added significantly to his sentence of 28-year prison sentence. But a side-by-side comparison of the wire fraud charges against Parnell and those just lodged against Kruse show more differences than similarities. 

Wire fraud charges against Parnell were for emails he wrote, which overall had to do with forgery of the Certificates of Analysis (COA)  that PCA customers had requested. To his peanut broker brother Michael, he wrote” “please notice the lot numbers don’t match… if YOU want to change them, then please do…”

Parnell ordered the product shipped to customers that had tested positive for Salmonella. A shipment that had not tested within an acceptable microbiological range was approved, and the  Parnell email approved the shipment because he said the customer did not ask for a COA — or there was the email involving the use of peanut past that Parnell said: “tasted like shit.”

The emails for Counts 2 through 7 in the Kruse case are different.  He did not write or respond in any of the six “wire transmissions.”  A statement he made was reportedly quoted in two of the six.

Dated from Feb. 19, 2015, to April 7, 2015, five of the six emails are from Blue Bell sales employees and one is from a “quality” employee. All six were basically responding to various levels of customers about why Blue Bell ice cream was being removed from shelves.

Two February emails, one to a school district and the other to a restaurant chain, responded with a Kruse statement that ice cream was being removed over malfunctioning equipment. The prosecution says, “the actual reason” was certain Blue Bell products had tested positive for Listeria monocytogenes.

In two others, emails do not disclose the fact that the product was removed for Listeria contamination, according to the charges.

In one April email exchange, a sales employee did not disclose that when Blue Bell’s Broken Arrow, OK, production was shutdown the CDC had also recommended not eating ice cream made at the facility based on additional positive Listeria tests.

And in another email exchange, between a Blue Bell quality employee and an Arkansas retail chain, the government says conditions at the creamery were “misrepresented” and Listeria test results were not disclosed.

The bottom line?   Parnell’s fraud was clear to the jury from the get-go.  The Blue Bell emails might not say that to a jury.

April 7 was the last date on the six emails that carry a wire fraud count.  Here’s what Food Safety Website was reporting that is contemporaneous around those dates.

This is also about the time that the federal Centers for Disease Control and Prevention (CDC) began calling Blue Bell “a complex multistate outbreak investigation of listeriosis occurring over several years.” It was where whole genome sequencing (WGS) for one of the first times is used to pull up pulsed-field gel electrophoresis (PFGE) DNA fingerprints from history. 

The South Carolina Department of Health and Environmental Control first isolated Listeria from Blue Bell brand single-serving ice cream produced in Brenham, TX, in February 2015. Whole genome sequencing or WGS linked the Listeria to multiple strains that infected ten people from 2010 to 2014 in four states Arizona 1; Kansas 5, Oklahoma 1; and Texas 3.   

As the fast-moving investigation carried into March, Kansas health officials were able to determine that all five who were sickened in that state were hospitalized for different and unrelated problems “before developing invasive listeriosis.” In other words, their infections were likely acquired in the Kansas hospital. And four of five had PFSE patterns consistent with the ice cream tests in Texas and South Carolina. Three died.

  • On March 13, Blue Bell announced removing its “Scoops” ice cream product and others made on the same production line at Brenham, TX, and shutting down that production line.
  • On March 22, Kansas reports finding Listeria in previously unopened single-serve Blue Bell brand chocolate ice cream collected from the Kansas hospital. It was produced at Blue Bell in Broken Arrow, OK, and matches previous tests.
  • On March 23, Bell Blue announces recall of the 3-ounce ice cream cups produced at Broken Arrow, OK.
  •  On April 3, 2015, Blue Bell Creameries voluntarily suspended operations at its Broken Arrow plant to thoroughly inspect the facility due to a 3-ounce institutional/food service chocolate cup that tested positive for Listeria monocytogenes and was immediately withdrawn from all outlets. That product was only available to Blue Bell’s foodservice and institutional accounts and was recalled along with 3-ounce vanilla and strawberry institutional/food service cups. 
  • On April 4, 2015, out of an abundance of caution, Blue Bell began working with retail outlets to remove all products produced in Broken Arrow from their service area. These products are identified with a code date ending in O, P, Q, R, S, or T located on the bottom of the carton, and they are a part of the voluntary market withdrawal. 
  • On April 7, 2015, the U.S. Food and Drug Administration notified Blue Bell that the Banana Pudding Ice Cream pint tested positive for Listeria monocytogenes. This pint was produced in the Broken Arrow plant on Feb. 12, 2015. Subsequently, Blue Bell is recalling all products made on that one particular production line from Feb. 12, 2015, to March 27, 2015. These products were produced on that same line and have a code date ending in either S or T. Recalled products produced in Oklahoma are identified by the code date on the bottom of the carton. 
  • On April 8, 2015, CDC reported that whole-genome sequencing (WGS) confirmed that three of the four isolates from people in Texas were nearly identical to Listeria strains isolated from product produced by Blue Bell in Oklahoma. 
  • On April 20, 2015, Blue Bell voluntarily recalled all products on the market made at any of its facilities including ice cream, frozen yogurt, sherbet, and frozen snacks. The complete shutdown came after Chocolate Chip Cookie Dough Ice Cream in half gallons tested positive for Listeria.

(To sign up for a free subscription to Food Safety Website, click here.)

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Beach Beat: The faces behind the petition https://www.storkxx.com/2020/01/beach-beat-the-faces-behind-the-petition/ https://www.storkxx.com/2020/01/beach-beat-the-faces-behind-the-petition/#respond Mon, 20 Jan 2020 19:18:44 +0000 https://www.storkxx.com/?p=191793 Continue Reading]]> Opinion

If you haven’t heard, a Seattle attorney is petitioning the USDA to make it illegal to sell meat and poultry that is contaminated with Salmonella. 

Yep, as of right now — and who knows how much longer — it is perfectly legal to sell you hamburger, whole hogs, turkey legs, chicken strips, and any other meat or poultry product if it is contaminated with this infectious bacteria. Even if they know a product is contaminated with Salmonella, producers from single-family farms to the world’s largest meat manufacturers are allowed to sell it.

Today I will share some of the petition, a legal document, focusing on the human suffering it represents through the stories of five victims. You can read the full petition and all of the 62-pages of legalese, but if you want to zero in on what Salmonella infections do to people, keep reading through a bit of background here and you will find the faces behind the petition.

To borrow an expression from the previous century: 

If  you’re not outraged, you’re not paying attention. 

The bottom line is that the government hasn’t declared Salmonella to be an “adulterant” in meat and poultry, so it’s considered an OK ingredient. Tongue in cheek use of ingredient there, in case you missed the implied emoticon.

Full disclosure here, the Seattle attorney who is handling the USDA petition for three consumer groups and five victims of Salmonella poisoning is the publisher of Food Safety Website. His name is Bill Marler and you can read about him in this profile the Washington Post published yesterday under the headline “He helped make burgers safer. Now he’s fighting food poisoning again.”

The plaintiffs on the petition are victims Rick Schiller, Steven Romes, and the Porter Family. The consumer advocacy groups petitioning for the change are Food & Water Watch, the Consumer Federation of America, and Consumer Reports. Specifically, the petition asks the USDA’s Food Safety and Inspection Service to declare the following outbreak serotypes of Salmonella as adulterants in meat and poultry products:

Salmonella Agona, Anatum, Berta, Blockely, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,[5],12: I :-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, Stanley, Thompson, Typhi, and Typhimurium


The faces behind the petition

Rick Schiller, Salmonella Heidelberg, 2013
Rick Schiller was one of the hundreds of people sickened in March 2013 in a Salmonella Heidelberg outbreak linked to poultry distributed by Foster Farms. The outbreak spanned more than a year and sickened 634 people in 29 states and Puerto Rico. At least 240 victims were hospitalized, according to the Centers for Disease Control and Prevention.

On Sept. 27, 2013, Rick was diagnosed with gastroenteritis, yet did not seek medical treatment as he was convinced that he was suffering from a mild case of food poisoning. Rick could not have been more wrong.

On Saturday night, Sept. 28, 2013, Rick went to bed early, hoping to feel better in the morning. When he woke up the next day, his right knee was painful, reddened, and warm to the touch. 

On Sunday night, Rick went to bed with his right leg propped up and an ice pack on his knee. In the middle of the night, he was awakened by a sharp pain. When he pulled back the covers, he was startled by the sight of his own body— his right leg was dark purple and swollen to about three times its normal size. Rick’s fiancé immediately dialed for an ambulance, but Rick thought it would be faster to have her drive him to the emergency room. However, this was no easy feat. Rick recalls the agonizing experience:

“I couldn’t get my leg into the car because it wouldn’t bend. I leaned over into the driver seat and (my fiancé) had to force my leg into the car. It was excruciating. At the hospital, it took five people to help get me out of the car and into the ER. As soon as I got in there, they pumped me full of morphine for the pain, then they put Novocaine in my leg and attempted to tap the knee.

The first needle they stuck in didn’t work, so they got out a bigger one. They pulled on the syringe and meat- like stuff came out. It was excruciating, even on the morphine.”

Rick was in so much pain that he felt like he might die. After being admitted to the hospital, Rick took out his cell phone, snapped a photograph of himself, and proceeded to draft a Last Will and Testament on his phone.

During his time at the Kaiser San Jose Medical Center, Rick developed a very high fever. He recalls an unpleasant memory of being covered head-to-toe with ice packs. He continued to have pain all over the right side of his body. Both his right leg and right arm were painful. His right eye would crust up and his right ear had intermittently muffled sound.

The following day, doctors ran blood work and performed an arthrocentesis, a duplex Doppler sonography, and an MRCP (magnetic resonance cholangiopancreatography) on Rick. 

On Oct. 2, he was diagnosed with colitis — localized Salmonella infection — and arthritis of the right knee, and he was discharged from the hospital.

On Oct. 15, Rick returned to the Kaiser Medical Center for a follow-up. He was seen by Orod Khaghani, MD, who informed him that his gastroenteritis and Salmonella colitis were resolved; however, Rick was diagnosed with reactive arthritis. 

A few days later, Pradipta Ghosh, MD, performed X-rays on Rick’s lower extremities and diagnosed him with bone spurring and mild joint space loss, consistent with mild osteoarthritis.

Four months after his Salmonella infection, Rick returned to Dr. Khaghani, unfortunately having relapsed with lower left quadrant abdominal pain. He also complained of decreased appetite and loose stools. Dr. Khaghani confirmed his initial diagnosis of reactive arthritis and informed Rick that he was suffering from diverticulitis of the colon. At this point, Rick’s medical bills and estimated wage loss totaled nearly $15,000.

Rick’s reactive arthritis remains symptomatic to this day. He feels as if his “entire right side is now weaker than (his]) left.” He constantly worries about his health and feels as if he never fully recovered from his systemic illness. He notices generalized fatigue and is no longer able to do the handyman work that he once enjoyed.

According to the Centers for Disease Control and Prevention, the multistate outbreak Rick was involved in lasted from March 1, 2013, to July 11, 2014. The USDA’s Food Safety and Inspection Service (FSIS) was first notified of the Salmonella outbreak as early as June 2013. 

By September 2013, FSIS officials had determined that Foster Farms’ chicken was behind the outbreak, yet they were powerless and unable to force a recall of the tainted poultry until July 2014. 

The FSIS did not request a recall because “despite its efforts to identify the product causing the illness, no data were available that enabled its investigators to pinpoint the types of contaminated chicken products — for example, chicken breasts, whole chickens, or ground chicken — or production dates or lots.” 

In September of 2013, during a USDA-FSIS in-facility testing for Salmonella at three Foster Farms production plants in California and Washington, FSIS determined that sanitary conditions at the facilities were so poor that they posed a “serious ongoing threat to public health.”

Steven Romes, Salmonella Newport, 2018
In 2018, Steven Romes, of Gilbert, AZ, was a healthy and athletic husband, father, and insurance underwriter. On Sept. 3 of that year, he consumed medium-to-well done hamburgers as part of a Labor Day family cookout. 

Two days later, Steven fell violently ill with painful diarrhea, fever, and stomach cramps. Over the next few days, Steven’s symptoms worsened. He was unable to consume any solids and was forced to lay on his bathroom floor because he did not have the strength to crawl back into bed after severe bouts of diarrhea and vomiting. 

On Sept. 8, 2018, after his diarrhea progressed to bloody stools, Steven was rushed to the emergency room where urine tests revealed he was suffering from acute kidney injury. He was admitted to the hospital and his illness was determined to be one of many illnesses in a nationwide outbreak of Salmonella Newport linked by public health officials to the various ground and non-intact beef products. The manufacturer was the U.S. unit of JBS, the world’s largest meatpacker. 

The outbreak spurred one of the largest-ever recalls of ground beef — more than 12 million pounds of ground beef, the meat of an estimated 13,000 animals, was recalled. The recall affected nearly 50 different JBS product lines. 

There were 255 cases of Salmonella confirmed across 32 states. Twenty-nine percent of patients for whom information was available were hospitalized; 6 percent were admitted to intensive care units, and two died, according to the CDC.

Fourteen months before the recall the decades-old JBS beef plant in Tolleson, AZ, which was at the center of the outbreak, had received numerous complaints of “egregious” livestock conditions. Despite the conditions, JBS was allowed to continue producing meat for human consumption.

After a colonoscopy and three-day in-patient stay at the Dignity Health Mercy Gilbert Medical Center, Steven was finally discharged from the hospital. Unfortunately, his normal bowel habits and appetite never returned, and he was diagnosed with Irritable Bowel Syndrome. Today, Steven can only tolerate bland foods and he still occasionally suffers from stomach cramps and diarrhea.

The Porter Family, Salmonella I 4,[5],12: I -, 2015
On the afternoon of June 28, 2015, Rose and Roger Porter hosted a going away party at their home in Rainier, WA. The Porters planned on moving to Costa Rica and wanted to celebrate with their family and friends one last time.

On June 27, Rose Porter picked up a whole hog from Stewart’s Meats in McKenna, WA. The next day, Rose cooked the pig just the way she was told to by Stewart’s. Hours later, the Porters’ home was filled with friends and family, many of whom were about to become seriously ill with Salmonella poisoning. It all seemed so easy and matter of fact in retrospect, as Rose recalls:

“When (the whole roasted hog)was done, I served it up. After everyone left, I cleaned everything up and threw out any food that was leftover. We packed everything up and went to bed. The next day, I woke up with explosive diarrhea. I had a very busy day because we were packing up to move to Costa Rica. I had to get out of our house because we had renters coming in. I had to find a hotel and I was dealing with my daughter not feeling well at all. She went with me for the day because she wanted to sleep in a bed at a hotel. I had to stop every half hour to use the bathroom. Diarrhea kept up.”

Once Rose and Mikayla arrived at the hotel, all Mikayla could do was lie down. She fell asleep at 6 p.m. By 2:30 a.m. she was up and vomiting. Mikayla woke her mom up and, at 4:30 a.m. on June 30, they both headed to Providence St. Peter Hospital in Olympia, WA. Joseph Pellicer, MD, was on duty in the emergency hospital and listed Mikayla’s chief complaints as “abdominal pain, emesis, diarrhea, and fever.” 

Rose explained that Mikayla had been sick since the morning before with severe diarrhea. By the evening, Rose stated that Mikayla “felt like she was on fire.” Mikayla also described having shaking chills with fever and Rose told Dr. Pellicer that she was having similar symptoms. Mikayla was miserable, wracked with body aches and pain that radiated up into both of her shoulders.

Dr. Pellicer did an exam and found Mikayla was tachycardic with a heart rate of 125 and a diffusely tender abdomen. The doctor also observed that Mikayla was dehydrated with turbid urine, ketonuria, proteinuria, and dry mucous membranes. 

Despite these clinical symptoms, no cultures were sent to the lab and no stool sample was collected. Dr. Pellicer diagnosed Mikayla with “acute gastroenteritis.” Just after 8 a.m., he discharged Mikayla from the ER with a prescription for an antiemetic drug and clearance to travel to Costa Rica.

On July 2, 2015, the Porters landed in Costa Rica. Mikayla was still suffering from frequent bouts of diarrhea. Upon logging in to a social media website, Rose discovered that a party attendee’s daughter was being hospitalized for Salmonella poisoning. Rose decided to take her daughter to the local ER — Beach Side Emergency Clinic in Santa Cruz Guanacaste. Andrea Messeguer, MD, the medical director of the clinic, evaluated Mikayla and noted that she was lethargic with persistent abdominal pain in the periumbilical area. Because Mikayla was currently afebrile and able to orally hydrate, Dr. Messeguer told Rose she could watch her daughter at home.

Over the next day, Mikayla did little but drink ice water, sleep, and go to the bathroom. Unfortunately, things soon took a turn for the worse. Rose recalls:

“She started crying in the bathroom that she could not bear the stomach pains anymore and needed to go back to the doctor. She told me that she had blood coming out of her butt, that it had been that way for a while, and that she didn’t know what to do. The amount of time between her going to the bathroom went from every 20 to 30 minutes to every five to 10 minutes. She was screaming in pain in the bathroom. She said that she felt like someone was stabbing her over and over again in the stomach.”

On July 3, Rose took Mikayla back to see Dr. Messeguer at the urgent clinic and told the doctor that there was now mucus and blood in her daughter’s stools. Dr. Messeguer examined Mikayla and performed a stool smear and culture. While at the clinic, Mikayla’s diarrhea decreased in frequency and she was still holding down fluids, so the doctor diagnosed her with “bacterial gastroenteritis” until proven otherwise and sent her home.

It was not long before it was clear that Mikayla’s condition was deteriorating. By the morning of July 4, her stools were entirely bloody. Rose, once again, rushed her back to the urgent care clinic. Upon their arrival, Dr. Messeguer asked to speak to Rose privately. She informed her that Mikayla was losing a lot of blood and may need a blood transfusion. However, the clinic did not have the equipment or resources necessary to perform the procedure. 

Dr. Messeguer told Rose that her daughter could die on the four to five-hour drive to Hospital CIMA San Jose, and therefore, Mikayla would need to be airlifted there.

Rose and Mikayla were both transported by helicopter to Hospital CIMA San Jose in Costa Rica. According to a memorandum written by Luis Picado, MD, Mikayla presented with a high-grade fever, bloody stools, general malaise, and moderate dehydration. He wrote: “On admission, she presented with clear signs of bacterial gastroenteritis and required intravenous rehydration and parenteral antibiotics to control the infection. Stool studies were positive for Salmonella.”

Rose does not require a formal medical record to recall how things went for her daughter over the next several days. The memory is still fresh in her mind:

“For the next three days, I sat back and watched as my daughter cried in pain. I changed her bloody sheets when she couldn’t make it to the bathroom. I didn’t sleep for the first couple of nights because I was so scared that she wouldn’t wake up. (She) couldn’t process food or water. The doctor told me that the bacteria had gotten into her system and shut it down completely. When she ate or drank, it would go straight through her. She wasn’t getting any nutrition or hydration.

“The good news is that she is out of the hospital now. We have cut all pork out of our diets and are fearful of chicken and eggs. I have dealt with a husband over in Afghanistan and this was still the scariest thing I have ever been through.

I can’t say that I know what it is like to have a child die, but I do know what it is like to see a child on their deathbed.

“I have spent the last couple of months going over every detail that has happened over those two weeks. I felt totally responsible when this happened. I had to question all of my decisions as a mother. I felt like I poisoned my own child and everyone else that ate at my house. I lost friends from all of this. It was weeks later that I found out that, in the end, it wasn’t my fault.”

During the time of Mikayla’s illness, Rose and Roger had their own Salmonella illnesses to contend with. On the helicopter ride to the hospital in San Jose, Rose’s blood pressure plummeted, and she lost consciousness. Roger had gastroenteritis with uncontrollable diarrhea for several days. Rose and Roger still suffer from periodic bouts of severe diarrhea.

The Porters were three of 152 diagnosed victims of a nationwide outbreak of multidrug-resistant Salmonella I 4,[5],12:i:-. Stewart Meats’ distributor of whole hogs was Kapowsin Meats. 

Laboratory testing of environmental samples at Kapowsin Meats by the Washington State Department of Health confirmed the presence of Salmonella I 4,[5],12:i:- in the facility. As a result of the investigation, Kapowsin Meats voluntarily recalled more than half a million pounds of pork products.

No wonder the petition requests an expedited hearing, calling the situation with Salmonella contamination “an imminent threat to public health necessitating prompt agency action.”

(To sign up for a free subscription to Food Safety Website, click here.)

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Ranchers ask federal court to block RFID traceability tags for cattle, bison https://www.storkxx.com/2019/10/ranchers-ask-federal-court-to-block-rfid-traceability-tags-for-cattle-bison/ https://www.storkxx.com/2019/10/ranchers-ask-federal-court-to-block-rfid-traceability-tags-for-cattle-bison/#respond Wed, 16 Oct 2019 04:05:03 +0000 https://www.storkxx.com/?p=188893 Continue Reading]]> For the cause of traceability, radio frequency identification (RFID) ear tags will be required in American beef cattle, dairy cows, and bison by Jan. 1, 2023.

Unless, of course, a Montana-based cattle ranchers’ organization can persuade a federal judge in Wyoming to call a halt to the RFID mandate handed down by USDA’s Animal and Plant Health Inspection Service (APHIS). Traceability is increasingly in the food safety spotlight because of its crucial role in contamination and outbreak investigations.

The Billings, MT-based Ranchers Cattlemen Action Legal Fund United Stockgrowers of America on Oct. 4 sued USDA on the issue in U.S. District Court for Wyoming in Casper. The government has not yet even acknowledged the lawsuit exists.

The ranchers’ organization, usually just called R-CALF for short, wants U.S. District Judge Nancy D. Freudenthal to declare the government’s RFID plan for cattle as “arbitrary, capricious, an abuse of discretion and unlawful. . .” The cattle ranchers contend the USDA is acting beyond the scope of its legal authority.

Freudenthal joined the federal court in 2010 after an appointment by President Barack Obama. She served as the court’s chief judge from 2011 to 2018. Wyoming’s chief federal magistrate, Kelly H Rankin, is also on the RFID case.

R-CALF’s 48-page complaint is the work product of attorney Harriet M. Hageman, senior litigation counsel for Washington D.C.-based New Civil Liberties Alliance. She is a member of the Wyoming Bar Association.

In addition to the 20-year old R-CALF, the other plaintiffs in the case are Tracy and Donna Hunt, who run cow-calf operators in northeastern Wyoming outside of Newcastle, and South Dakota ranchers Kenny and Roxy Fox. Both couples are R-CALF members.

The Hunt ranch uses brands, metal ear tags, and tattoos to identify their cattle. The Fox ranch uses brands to identify and trace its cattle as the family-owned operation has done for generations.  

The RFID planned rolled out earlier this year mandates the use of RFID technology to identify cattle and bison that are moved across state lines for sale. APHIS adopted a 2013 final rule that appears to provide much more flexibility. 

 At that time, ear tags, tattoos, and metal ear tags — so long as acceptable to state brand boards and breed associations — were acceptable. That flexibility extended to livestock moved in interstate commerce so long as it was moved directly to a slaughter facility. 

Wyoming does not have any production-scale slaughter operations.

The 2013 rule’s “maximum flexibility” was intended to mesh with the states, Tribal governments, and producer practices. It’s “low cost” technology was also cited as an advantage.

The USDA contends that depending on the quantity purchased, tags can range in cost from $1.50 to $2.00 each. Price, however, is likely to be part of the legal dispute.

Technology experts say most companies selling RFID tags do not quote prices because there are too many factors to consider, such as the number ordered, amount of memory, and the tag’s packaging. A single active tag might fetch $25 but could today cost $100 or more depending on the packing, battery life, and sensors. They acknowledge RFID tag prices for livestock will come down dramatically once they are in greater demand.

No changes are yet proposed for identification tags for pigs, goats, sheep or other animals, but more mandates could emerge by late 2020.

Beef, dairy, or bison required to have an official identification after the deadline will need to have an Electronic ID — which can be called, EID, RFID, or Electronic tag — instead of the previous metal tags. Only the type of tag is changing, no other parts of the animal identification rule are changing. EID Tags have a 15-digit identifying number that can be read if no RFID scanner is available.

The USDA will also discontinue providing free metal tags and beginning Jan. 1, 2021, the department will no longer approve the production of metal ear tags.

Approved vendor tags will be available for purchase on a state-by-state basis as authorized by each state’s animal health official through Dec. 31, 2020.

Metal ear tags won’t be honored as official identification. RFID tags must be used as official identification for any newly tagged animals.

Animals without an RFID tag but that have a metal tag before Jan. 1, 2021, will not need an RFID tag until Jan 1, 2023. On that date all beef cattle, dairy cows, and bison will be required to have an official ID and will have to have an RFID tag. Other methods will no longer be accepted as a form of USDA official identification for any cattle after that deadline.

The ranchers’ complaint says USDA has no legal authority to require individual RFID ear tags on the cattle, dairy and bison herds.

Government attorneys have not yet responded to the lawsuit, which relies heavily on the federal Administrative Procedures Act for its claims.

Plaintiffs say they are “primarily concerned with the 2013 Final Rule as it relates to the identification and interstate movement and sale of cattle.” They say that the 2013 Final Rule even prohibits state and tribal governments from requiring RFID ear tags.

The R-CALF organization also contends the USDA rolled out the 2019 plan without a notice and comment process or publishing it in the Federal Register.

“The 2019 Plan requirements are in fact intended to repeal and replace critically important aspects of the 2013 Final Rule, including in relation to approved livestock identification methods as well as the type of livestock covered,” the ranchers’ complaint says.

(To sign up for a free subscription to Food Safety Website, click here.)

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Publisher’s Platform: FSIS knows your chicken is tainted, says it’s OK to sell, but tells you not to wash it https://www.storkxx.com/2019/08/publishers-platform-fsis-knows-your-chicken-is-tainted-says-its-ok-to-sell-but-tells-you-not-to-wash-it/ https://www.storkxx.com/2019/08/publishers-platform-fsis-knows-your-chicken-is-tainted-says-its-ok-to-sell-but-tells-you-not-to-wash-it/#respond Wed, 21 Aug 2019 21:07:37 +0000 https://www.storkxx.com/?p=187349 Continue Reading]]> By warning you not to wash chicken (or other poultry), FSIS correctly recognizes the risk of cross-contamination in your kitchen and the risk that it poses to you and your family – especially children and the elderly.  But, why does it continue to allow companies to knowingly sell us Salmonella-tainted poultry?

Personally, as I said to the Los Angeles Times some time ago, “I think that anything that can poison or kill a person should be listed as an adulterant [in food].”

Ignoring Salmonella in meat makes little, if any, sense. Even after the Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella “not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat ‘inspected and passed’, ” our government’s failure to confront the reality of Salmonella, especially antibiotic-resistant Salmonella, is inexcusable.

The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it:

The E. coli strain that killed Brianna and made the others sick is a “deleterious substance which may render [meat] injurious to health.” There is no dispute about this. Thus, under the first part of 21 U.S.C. § 601(m)(1), meat that either “bears or contains” E. coli O157:H7 (the “deleterious substance”) is “adulterated.” That E. coli O157:H7 contamination can be rendered non-“injurious to health” by cooking thoroughly, as discussed below, does not negate this; Congress used the phrase “may render,” not “in every circumstance renders.” Moreover, if the E. coli bacteria is not considered to be “an added substance,” because it comes from some of the animals themselves and is not either applied or supplied during the slaughtering process (although we do not decide this), it cannot be said that the E. coli strain “does not ordinarily render [the meat on or in which it appears] injurious to health.” Accordingly, meat contaminated by E. coli O157:H7 is also “adulterated” under the second part of § 601(m)(1).

Now, why would Salmonella be different? According to the CDC, it is estimated that 1.4 million cases of salmonellosis occur each year in the United States. Of those cases, 95 percent are related to foodborne causes. Approximately 220 of each 1,000 cases result in hospitalization, and 8 of every 1,000 cases result in death. About 500 to 1,000 deaths – 31 percent of all food-related deaths – are caused by Salmonella infections each year.

So, where do we stand with the existing USDA/FSIS law on adulteration?  Here is the law:

21 U.S.C. § 601(m)(4) – SUBCHAPTER I – INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING – CHAPTER 12 – MEAT INSPECTION – TITLE 21—FOOD AND DRUGS

(m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthyputrid, or decomposed substance or is for any other reason unsound, unhealthfulunwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; …

Hmmm.

It is hard to read the above and not think that the words in bold equate to all E. coli and Salmonella — frankly, all pathogens in food. I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens, like Salmonella) in them, should be considered adulterated too?  But, hey, that is just me. Another odd governmental fact is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not. FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is: 

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance … that is unsafe within the meaning of section 406;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health …

It would be interesting, and perhaps entertaining, to have House and Senate hearings focusing on what should and should not be considered adulterants in our food. I can see panels of scientists from various fields, FDA, USDA and FSIS officials, beef and produce industry representatives, and consumers discussing this. I would pay to watch it.

(To sign up for a free subscription to Food Safety Website, click here.)

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The Blue Bell ice cream Listeria outbreak and its fallout https://www.storkxx.com/2019/08/the-blue-bell-ice-cream-listeria-outbreak-and-its-fallout/ https://www.storkxx.com/2019/08/the-blue-bell-ice-cream-listeria-outbreak-and-its-fallout/#respond Thu, 01 Aug 2019 14:57:47 +0000 https://www.storkxx.com/?p=186846 Continue Reading]]> Opinion

Authors: Angela Spivey, Andrew Phillips, and Alan Pryor 

It may come off as a truism that food safety is the “most central consumer safety and legal compliance issue” facing a food and beverage company. Yet the Delaware Supreme Court’s decision in Marchand v. Barnhill—a shareholder derivative suit that catalogs the fallout from the 2015 Blue Bell listeria outbreak—serves as a reminder of the importance of food safety and reporting controls up to even the highest levels of corporate governance.

We break down the Delaware Supreme Court’s analysis and offer insights into best board practices in a post-Marchand world.

The Blue Bell Listeria outbreak and fallout
In early 2015, Blue Bell Creameries, one of the country’s largest ice cream manufacturers, suffered a listeria outbreak. Ultimately, three people died, and the CDC formally recognized at least 10 related illnesses—although many more were suspected or alleged. The outbreak led to a recall of all Blue Bell products, a shutdown of production at all of its plants, and a layoff of over a third of its workforce. With its operations shuttered, Blue Bell also suffered a liquidity crisis that forced it to accept a dilutive private equity investment. 

Not surprisingly, voluminous litigation followed, including Marchand. In Marchand, a Blue Bell shareholder sued Blue Bell’s management and board of directors derivatively. As for the board, the Marchand complaint alleged that the board members “utterly failed to adopt or implement any [food safety] reporting and compliance systems” and therefore breached their duty of loyalty under In re Caremark International Inc. Derivative Litigation. Specifically, “by failing to implement any system to monitor the company’s food safety compliance programs,” Blue Bell’s board was unaware of any “red or yellow flags about the growing food safety issues” at Blue Bell’s plants until it was too late.

Director liability under Caremark
Under Caremark, a director must make a good-faith effort to oversee the company’s operations. Failing to do so breaches the duty of loyalty and exposes a director to liability. In other words, for a plaintiff to prevail on a Caremark claim, the plaintiff must show that a fiduciary acted in bad faith—“the state of mind traditionally used to define the mindset of a disloyal director.”

Caremark claims are difficult to plead and successfully prosecute because the law gives substantial deference to directors in the monitoring and operating of a business. To establish bad faith under Caremark, a plaintiff must allege particularized facts that the directors (1) failed to implement any reporting or information system or controls; or (2) having implemented such a system or controls, consciously failed to monitor or oversee its operations. In short, under Caremark “the board must make a good faith effort—i.e., try—to put in place a reasonable board-level system of monitoring and reporting.”

The Delaware Chancery Court’s dismissal
Discounting the allegations that Blue Bell’s board had no supervisory structure in place to oversee “health, safety, and sanitation controls and compliance,” the chancery court concluded that the plaintiff failed to meet this exacting standard. The court noted that Blue Bell operated in an industry highly regulated by the FDA, that Blue Bell had food safety controls and policies in place throughout the company, and that the CEO and VP of operations regularly reported on operational issues and facility audits to the board. Reframing the issue, the court concluded that “[w]hat Plaintiff really attempts to challenge is not the existence of monitoring and reporting controls, but the effectiveness of monitoring and reporting controls in particular instances,” which “[i]s not a valid theory under … Caremark.” 

For food companies, food safety is a board-level issue

On appeal, the Delaware Supreme Court sharply disagreed with the chancery court’s reasoning. Crediting the plaintiff with conducting a proper investigation that included a Section 220 request for Blue Bell’s books and records, the Delaware Supreme Court concluded that the complaint supported a Caremark claim. The court specifically emphasized the complaint’s allegations that:

    • There was no board committee that addressed food safety.
    • There were no regular board-level “process[es] or protocols that required management to keep the board apprised of food safety compliance practices, risks, or reports.”
    • There was no schedule for the board to consider any food safety risks, on a regular basis or otherwise.
    • “During a key period leading up to the deaths of three customers, management received reports” from various third-party auditors and regulatory officials containing “what could be considered red, or at least yellow, flags” regarding potential food safety issues—including positive tests that listeria was present at certain plants—but the board meeting minutes “revealed no evidence that these were disclosed to the board.”
    • The board meeting minutes were bereft of “any suggestion that there was any regular discussion of food safety issues.”

Given these allegations, the Delaware Supreme Court found that the complaint supported a reasonable inference that Blue Bell did not have board-level controls over one of the “most central issues at the company: whether it is ensuring that the only product it makes—ice cream—is safe to eat.” Accordingly, it reversed the trial court’s dismissal.

With this ruling, the court rejected the board’s arguments that it satisfied its oversight obligations because Blue Bell operates in an industry tightly regulated by the FDA and implemented policies, procedures, and audits consistent with those regulations. As the court explained, that “Blue Bell nominally complied with FDA regulations does not imply that the board implemented a system to monitor food safety at the board level.” At best, Blue Bell’s compliance with these requirements showed only that management—not the board—was nominally following certain standard requirements of state and federal law. The “mundane reality” that Blue Bell operates in a highly regulated industry did not bar a claim “that the directors’ lack of attentiveness rose to the level of bad faith indifference required to state a Caremark claim.”

A Checklist for mitigating risk
Marchand serves notice to the food industry: food safety is mission-critical and must have board-level visibility and attention. But Caremark claims remain difficult to plead and prosecute, and the Marchand Court offers a blueprint for food and beverage industry boards to avoid exposure under Caremark:

  1. Form a board committee addressing food safety.
  2. Adopt processes and protocols requiring management to keep the board apprised of food safety compliance practices, risks, or reports.
  3. Establish a regular schedule (quarterly or biannually) for the board to consider food safety compliance and risks.
  4. Approve resolutions requiring full disclosure by management to the board of all material food safety threats.
  5. Implement an anonymous food safety reporting system with board visibility to reports raising significant food safety concerns.
  6. Document board food safety compliance discussions, committee meetings, and board efforts in board resolutions and board meeting minutes.

With Caremark’s bottom line requirement that the “the board must make a good faith effort—i.e., try—to put in place a reasonable board-level system of monitoring and reporting,” the Marchand Court may very well have affirmed the dismissal had the board undertaken any of these steps. Nevertheless, we recommend implementing a robust compliance strategy that addresses at least these items. Corporate boards and in-house counsel should treat Marchand as a cautionary tale.

(To sign up for a free subscription to Food Safety Website, click here.)

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Pet food firm sues FDA; wants some Salmonella to be allowed https://www.storkxx.com/2019/07/pet-food-firm-sues-fda-wants-some-salmonella-to-be-allowed/ https://www.storkxx.com/2019/07/pet-food-firm-sues-fda-wants-some-salmonella-to-be-allowed/#respond Mon, 29 Jul 2019 04:05:31 +0000 https://www.storkxx.com/?p=186711 Continue Reading]]> A company that markets raw meat and poultry as pet food is suing the FDA saying the agency’s intolerance of Salmonella contamination violates the U.S. Constitution and is a bunch of “gobbledygook.”

Lystn LLC, doing business as Answers Pet Food, filed the federal lawsuit earlier this month in U.S. District Court in Colorado. It names the U.S. Food and Drug Administration, numerous Colorado officials and agencies, and the Association of American Feed Control Officials (AAFCO) as defendants. In keeping with standard public policy, the state and federal agencies do not comment on pending litigation.

In a 34-page complaint, the company refers to FDA policy and safety guidance as “gobbledygook” and makes a vague reference to “punitive inspections.”

The company’s complaint cites the adage “absolute power corrupts absolutely” in its description of the FDA’s zero-tolerance policy for Salmonella in pet foods. The company also contends it’s OK to have “detectable levels” of Salmonella because it is not always harmful to humans or pets.

Answers Pet Food owners contend people should be able to feed their pets such food if they so choose. The company also says an FDA warning about Salmonella in its pet food was libelous. The agency issued the warning after the company refused to issue a recall.

“The FDA’s and participating states’ noncompliance with federal law, while at the same time illegally enforcing the disfavored, nonbinding zero-tolerance guidance deprives the people of the freedom of food choice for their pets,” according to the Answers Pet Food complaint.

“The FDA, AAFCO, and the participating states are arbitrarily and capriciously deciding what pet owners can and should feed their pets while disseminating misinformation harmful to Plaintiff’s Answers Pet Food brand and proprietary processes as though it were scientific fact.”

Guidance from the FDA recommends ways for pet food companies to control pathogens in their products. Companies that do not wish to follow the guidance can opt for other processes if they are reviewed and determined to be equivalent.

Under federal law, the FDA considers a pet food to be adulterated — and therefore unfit for sale — when it is contaminated with any Salmonella “and will not subsequently undergo a commercial heat step or other commercial processes that will kill the Salmonella.”

Officials with Answers Pet Food say they’ve got a system that mostly kills Salmonella.

“. . . instead of using high heat, high pressure, or irradiation — all processes that denature proteins to control bacteria — (Answers Pet Food) uses an alternative approach that satisfies the requirements of the applicable statutes and regulations through fermentation, Hurdle Technology, and other proprietary processes to control bacteria in its product. This includes inoculating the product with Lactic Acid Bacteria (LAB) to a level that potential pathogens such as Salmonella are either eliminated, reduced, and/or have their growth inhibited by this bacterial competition,” according to the complaint.

The complaint also states that the Answers brand food carries a warning label that states:

“WARNING: NOT FOR HUMAN CONSUMPTION. THIS PRODUCT HAS NOT BEEN PASTEURIZED AND MAY CONTAIN HARMFUL BACTERIA.”

The pet food company’s complaint was filed seven months after the FDA’s January public warning about “A+ ANSWERS Straight Beef Formula for Dogs.” The warning was prompted by laboratory findings in Nebraska.

Specifically, the company is asking the federal court to:

  1. Require all previous claims and references of Plaintiff distributing an adulterated product in which the FDA failed to conduct, follow, and comply with all the requirements, criteria and procedures of the Food, Drug and Cosmetic Act and resulting inspection reports, the Reportable Food Registry listing(s), and any other federal report or record initiated from pursuit of enforcement of the zero-tolerance Compliance Policy Guide be expunged from all federal and state records; 
  2. GRANT Declaratory Judgment that Plaintiff was denied due process rights and FURTHER GRANT an injunction for the FDA and AAFCO’s several participating member states to cease and desist from continued application and enforcement of Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals , as well as suspend any pending related enforcement actions specific to the application of this Compliance Policy Guide; 
  3. PROHIBIT Defendants from reintroducing similar Compliance Policy Guides that do not strictly follow the Food, Drug and Cosmetic Act or attempt to circumvent the Administrative Procedures Act; 
  4. PROHIBIT Defendants from creating artificial, false, and misleading appearances with respect to raw pet food products, safety, security, commodity, and currency (including removal of such from existing federal government websites and other means of publications); and/or 
  5. Award Plaintiff such other and further relief as this Honorable Court deems necessary and proper. 

(To sign up for a free subscription to Food Safety Website, click here.)

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Tyson lost $2.5 million because, they say, FSIS failed to properly inspect hogs https://www.storkxx.com/2019/05/tyson-lost-2-5-million-because-they-say-fsis-failed-to-properly-inspect-hogs/ https://www.storkxx.com/2019/05/tyson-lost-2-5-million-because-they-say-fsis-failed-to-properly-inspect-hogs/#respond Fri, 17 May 2019 04:05:28 +0000 https://www.storkxx.com/?p=184128 Continue Reading]]> Dr. Yolanda Thomspon was the USDA inspector on duty for the Food Safety and Inspection Service (FSIS) at the Tyson Fresh Meats Inc. plant in Storm Lake, IA, on March 26, 2018.

Her actions that day are alleged to have cost Tyson Fresh Meats and Tyson Foods Inc. $1.85 million. Tyson has sued the United States for almost $2.5 million.

Tyson’s lawsuit against the federal government, filled in U.S. District Court for Northern Iowa, may open a window to view FSIS practices. The agency’s meat and poultry inspectors are assigned to more than 6,200 processing and slaughter plants located throughout the nation.

According to documents Tyson filed with the court, the Tyson Storm Lake facility slaughtered 4,622 hogs on March 26, 2018. Thompson was the FSIS inspector on duty and was responsible for pre-slaughter inspections, referred to in federal statutes as ante-mortem inspections

The Tyson complaint says Thomson presented Tyson Storm Lake management with signed inspection pen cards certifying that the more than 4,600 hogs had been inspected and were eligible to bear the USDA mark of inspection.

“Unbeknownst to Tyson Storm Lake management, Dr. Thompson conducted negligent ante-mortem inspections of the hogs prior to slaughter,” according to the complaint. “Video footage obtained later revealed that Dr. Thompson never entered the pre-slaughter holding area to perform an in-person visual inspection of the hogs as required to satisfy her duties as both (1) an employee and agent of the defendant and (2) a reasonable person taking on the duty to conduct inspections for the protection of others. Instead, Dr. Thompson remained in her vehicle, signing the inspection cards without entering the holding area to examine the hogs.

“Tyson Storm Lake management was unaware that Dr. Thompson was negligent in conducting the ante-mortem inspections until the following day, March 27, 2018, when they were informed by FSIS personnel that the hogs at issue had not received proper ante-mortem inspections.”

Such inspections are important from a food safety perspective and are required by federal law.

Rosaland Koob, Tyson’s Sioux City attorney, said the management at the Storm Lake plant took immediate steps to mitigate the damages.

“Unfortunately, by this time, the negligently inspected hog carcasses had been intermingled into a larger group of approximately 8,000 hog carcasses and, consequently, the negligently inspected hog carcasses could no longer be positively identified,” the complaint explains. “On March 30, 2018, USDA, acting through supervisors of the Des Moines Field Office, concluded that it was not possible to clearly identify whether the animals were subject to any health conditions that would have necessitated condemnation of the negligently inspected carcasses. This left Tyson with no choice but to destroy the negligently inspected carcasses and those with which they had been commingled, salvaging portions of the product for non-food related purposes at a greatly reduced rate.”

Tyson’s says it has a claim that totals $2,480,961 because of “the USDA-FSIS inspector’s negligence.” Most of that sum is from the loss of the condemned pork, but Tyson’s complaint says the company incurred costs for loss of sales to third parties, freight and storage, emergency overtime, and expenses from losing the regular use of its plant.

Tyson’s claims USDA-FSIS personnel were aware of the deficiencies in the quality, scope, and integrity of Dr. Thompson’s inspection practices. Other USDA employees on site told Tyson employees about Thompson’s “bad habits related to her inspection practices.”

The company’s complaint also says USDA-FSIS knew of Thompson’s physical limitations and difficulty walking.

“Dr. Thompson’s normal inspection site was the turkey processing plant, a plant that is much smaller in size than the pork processing plant,” Tyson says.

“In addition, the way in which the animals are kept in the pork processing plant requires an inspector to navigate the holding pens. If the USDA and/or FSIS personnel adequately trained and supervised Dr. Thompson, or otherwise addressed Dr. Thompson’s deficient inspection practices and her health issues, the damage to Tyson could have been avoided”

The USDA and FSIS have not yet responded to the complaint, which was filed May 14,

The four-count complaint says the U.S. government is guilty of negligence, negligent inspection, negligent retention, and negligent supervision. It says Thompson “failed to act as a reasonable person when she performed the ante-mortem inspections.”

Tyson says under Iowa law, the federal government has the same liability for the damages it causes as a private party does. It says the “duty to inspect” is an operational task and not something that was done at FSIS’s discretion.

The USDA-FSIS failed to recognize that Thompson was unfit to perform inspections as necessary, the plaintiffs contend. They did not recognize her “mobility and performance” issues.

(To sign up for a free subscription to Food Safety Website, click here.)

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Four sentenced in France for roles in horse meat scandal https://www.storkxx.com/2019/04/four-sentenced-in-france-for-roles-in-horse-meat-scandal/ https://www.storkxx.com/2019/04/four-sentenced-in-france-for-roles-in-horse-meat-scandal/#respond Fri, 19 Apr 2019 04:04:13 +0000 https://www.storkxx.com/?p=183092 Continue Reading]]> The former director of a French meat processor has been sentenced to six months in jail for his role in the 2013 horse meat scandal.

Jacques Poujol, ex-director at Spanghero, was found guilty of fraud by a French court and given 24 months with 18 of these suspended. The court ordered €100,000 ($112,000) that was found at his home to be confiscated.

He will also not be able to engage in professional activity related to the meat sector for two years.

Patrice Monguillon, manager of the Spanghero factory in France, received a one-year suspended sentence.

Foodwatch France said the penalties were not dissuasive enough because Spanghero’s turnover between February and December 2012 was €1.9 million ($2.1 million) for its horse meat trading. The consumer organization added that six years after the scandal in Europe similar incidents could happen again citing the example of illegal use of fipronil that affected egg products in 2017.

The horse meat scandal involved food products across Europe being labeled as beef when they contained horse. The scheme was profit driven. It was identified by Irish food inspectors who revealed in mid-January 2013 that they had found horse meat in frozen beef burgers.

Also, beef lasagna supplied by Comigel-Tavola Luxembourg was found to contain between 80 percent to 100 percent horse meat. And, horse meat labeled as beef was sold to Tavola, a subsidiary of Comigel, which sold frozen meals to companies across Europe.

Johannès Fasen, a Dutch trader, was sentenced to two years in prison and banned from working in the French meat industry. Hendricus Windmeijer, who worked with Fasen, received a one-year suspended sentence.

 

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