Marler Blog - Providing commentary on food poisoning outbreaks & litigation

The demographics associated with this monumental outbreak, due in significant part to the propensity of Listeriosis to affect the elderly, have given us the opportunity to explore history. As you know, several of our clients were decorated for extraordinary actions in World War II. The story of Isaak Margolin, however—at least the story before the Listeriosis illness that almost claimed this warrior—emerges from a vastly different historical lens.

Isaak Margolin is living history. Born February 18, 1915, to a Jewish family in Lithuania, Isaak’s family emigrated to Kiev, Ukraine when he was three years old, soon after the Russian Revolution. As did many during this time, Isaak’s family wanted to escape the disintegrating social and cultural structure of his homeland, which had merged with the Soviet Republic after the Revolution. Kiev became Isaak’s home until the late 1970s.

The notion of “home” for a young man in Eastern Europe in the 20s, 30s, and 40s, was different than today. Isaak did what he could to survive in an increasingly turbulent, and ultimately violent society. In the 20s, he went to Moscow, Russia, where he participated in the construction of the city’s underground railway. Later, before World War II, he would travel to Russia’s far east, along the border with China, to build another rail line.

When he returned to Kiev, Ukraine’s formal name had been changed to “Ukrainian Socialist Soviet Republic,” and the country was on a war footing. Isaak ultimately fought for the famous Ukrainian General Sydir Artemovych Kovpak as part of the Soviet partisan forces. As the Nazi Wehrmacht advanced into Soviet territory, Isaak tried to convince his entire family—including his wife Faina and daughter Maya—to escape through the Ural Mountains to the security of the Far East. Some of the family would not leave, believing the Nazis to be incapable of the atrocities that were being reported. But Faina, Maya, and Faina’s mother escaped on the last train carrying refugees out of Kiev, and remained in a village in Eastern Russia throughout the war. They struggled to survive.

Isaak remained in Kiev to fight, and to defend the factory at which he had formerly worked as a mechanic, and other important installations. Nazi forces ultimately surrounded the city, and Isaak escaped into surrounding forests, where he continued to serve under General Kovpak and fought a guerilla war. He was ultimately injured, taken prisoner by the Nazis, and escaped a concentration camp to return to the army and continue the fight.

Though Kiev was liberated earlier, Isaak did not see his family again until after the war ended. After they were reunited, Isaak and his family remained in Kiev until 1979. Isaak and Faina had another child; a son named Yakov. Isaak eventually became disillusioned with the oppressive Soviet communist regime, and finally received political asylum and emigrated to Denver, Colorado around 1979.

In Denver, where Isaak has remained since immigrating, he has enjoyed an extended and growing family. He is pictured below with a great-grandson. In all, Isaak has four grandchildren and nine great grandchildren.

Before Isaak’s Listeriosis illness, he was completely independent, despite being 97 years old. He exercised at a local gym nearly every day. Things changed drastically, however, after he ate a cantaloupe that had been purchased from M&I International Market in Denver in August 2011.

The onset of Isaak’s symptoms began around August 28 with a low-grade fever and diarrhea. The bouts of diarrhea soon became dark and bloody, and increased to the point that by August 31, they were occurring 10 to 12 times daily. Isaak also felt very weak and depleted, having been unable to eat or drink much at all since the illness began.

On August 31, Isaak saw his primary physician, Irina Pines, MD, at Webb Family and Internal Medicine. He described to Dr. Pines a several-day history of fever and bloody diarrhea. Dr. Pines described Isaak as being dehydrated and thought that his illness was a viral syndrome due to food poisoning. She advised that he be seen at the Rose Medical Center emergency department the same day. Transport occurred by ambulance.

At the ER, Isaak saw David Moon, MD, describing a course similar to the one he related to Dr. Pines. Dr. Moon obtained blood, urine and stool samples for study, and began Isaak on intravenous fluids for rehydration, as well as Tylenol for fever and pain. CBC showed that Isaak had an elevated BUN and creatinine, and that he was deficient in potassium and sodium. He also had low platelets, and protein was present in the urine. A portable chest x-ray showed a slightly prominent cardiac silhouette, which was thought to be “likely technically related” to the illness process. Isaak received supplemental oxygen via nasal cannula during his stay in the ER, and was ultimately discharged home after a few hours, stating that he felt much better. Dr. Moon advised that he be seen in follow up with Dr. Pines.

Isaak stayed at home, mostly resting, for the next two days. The pace of his diarrhea had slackened some, but he continued to have difficulty staying hydrated, and continued to feel weak and generally ill. Having endured much worse before, however, he resolved to simply do what he could to make himself comfortable until the illness resolved of its own accord. Isaak did not yet know, of course, that he was suffering from a life-threatening bacterial infection that was actively killing dozens across the United States.

On September 2, the blood sample taken at the ER on August 31 showed gram-positive rods, and then Listeria monocytogenes. A physician at Rose Medical Center called Isaak’s family immediately and requested that he be brought back to the ER for inpatient care and treatment. Isaak arrived shortly thereafter with family members.

On arrival at Rose Medical Center, Isaak saw Laurn Sarnat, MD, who noted an intractable, low grade fever, mild dizziness, a multi-day history of dark-colored diarrhea, a sore throat, and left-sided chest discomfort. He was started on supplemental oxygen and intravenous fluids. Given the positive test for Listeria from the sample on August 31, Dr. Sarnat began ampicillin therapy intravenously. Dr. Sarnat also ordered an echocardiogram to rule out endocarditis, as well as an MRI of the brain. Tylenol was given for control of Isaak’s ongoing pain and fever. Dr. Sarnat’s diagnoses were acute Listeria bacteremia and febrile gastroenteritis.

The echocardiogram was done the next day, September 3, showing (1) mild concentric left ventricular hypertrophy, (2) mild left atrial enlargement, (3) mildly sclerotic aortic valve, (4) moderate mitral and tricuspid regurgitation, (5) severe pulmonary hypertension, and (6) grade 1 diastolic dysfunction. The brain MRI was done on September 2, and showed small vessel ischemic change but no acute disease. After the MRI, Dr. Hammer, who consulted from infectious disease, noted that he anticipated that the ampicillin therapy would continue for 3 weeks, “which is presumptive for meningoencephalitis.”

Over the next several days, Isaak continued to be hypokalemic, and developed hypophosphatemia, though this resolved sooner. After several days’ hospitalization, by September 5, though the hypokalemia continued, Isaak was not having any more diarrhea or fever. Nevertheless, ampicillin therapy continued, as it would for several more weeks.

Ultimately, Isaak’s family decided not to have the physicians at Rose Medical Center perform a lumbar puncture. Isaak’s physicians had told them that the results likely would not dictate any different course of treatment, since Isaak had already tested positive for Listeria. But in order to effectively address that infection, physicians indicated that Isaak would need to have a peripherally inserted central catheter (PICC line) installed to facilitate continuous ampicillin therapy. The procedure occurred, and fortunately was uneventful, on September 6. Afterward, ultrasound showed good placement in the left basilic vein, with the tip lodged securely in the superior vena cava.

Isaak was upset to learn that he could not be discharged home, which is where he badly wanted to go by the end of his hospitalization at Rose Medical Center. Instead, in order to ensure that his Listeria infection resolved with appropriate ampicillin therapy, he was transferred on September 8 to Shalom Park, a convalescent care center for elderly people.

During his stay at Shalom Park, Isaak progressed well, though it was a difficult time for him. He has always been very social and highly independent, despite his old age, and to be reliant on others for his care caused him to become depressed. Jake Berzon, Isaak’s grandson, states:

After spending more than a week at the hospital with Listeria, Isaak had to spend another three plus weeks in rehabilitation at a nursing home, surrounded by people, many of whom he had been acquainted with before, but all of whom are now completely disabled physically, mentally and most often both – a most depressing experience for anybody, but especially for an optimist like Isaak. Isaak persevered yet again, came through the full cycle of rehabilitation at the nursing home and returned to his home.

On September 26, the PICC line was finally removed. Again the procedure was uneventful. Isaak was asking to be discharged home on September 27, and so, after nurses spoke with Mike Todd, MD, who had overseen Isaak’s care at Shalom Park, he was discharged.

In the weeks that followed, Isaak did his best to regain the functionality and independence that he had enjoyed prior to his Listeriosis illness. He never has. Again, Jake Berzon:

He is still not fully recovered from the disease, his two children, who themselves are not in the best of health are also getting up there in age, are not able to help as much as they would like to, the four grandchildren try to help as much as they can, as well, but all live far away and all are raising little kids, under 5 years of age. To sum it all up, Isaak is a fighter and his children and grandchildren never had any doubt that he would live a full 120 years and see his great grandchildren as adults. After Listeria, unfortunately, we just cannot believe that any longer.

As of May 11, at least 15 people in nine states and one person in Canada had been confirmed infected with Salmonella from contact with the contaminated dry dog food or from contact with a pet that had eaten the tainted product, according to the Centers for Disease Control and Prevention (CDC). 

The Form 483 report, posted by the FDA late Tuesday afternoon, was the result of a week-long inspection that began April 12 after an outbreak of human Salmonella Infantis infection was traced to contaminated pet food manufactured at the Diamond Pet Foods plant in Gaston, S.C.

The report states that Diamond was using cardboard and duct tape on some of its equipment and that there were damaged paddles on the conveyor. The inspectors also noted that some surfaces at the facility were encrusted with food residues.

FDA inspectors specifically listed these four observations:

OBSERVATION 1

All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.

Specifically, no microbiological analysis is conducted or there is no assurance that incoming animal fat will not introduce pathogens into their production and cause contamination of finished product. Also, the firm's current sampling procedure for animal digest does (sic) preclude potential for adulteration after sampling and during storage in warehouse. On 4/13/12, an employee was observed touching in-line fat filter and oil with bare hands.

OBSERVATION 2

Failure to provide hand washing and hand sanitizing facilities at each location in the plant where needed.

Specifically, there are no facilities for hand washing or hand sanitizing in the production areas where there is direct contact with exposed finished feed/food.

OBSERVATION 3

Failure to maintain equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.

Specifically, paddles in conveyor (South or Middle conveyor leading to the screeners going to packaging) were observed to have gouges and cuts, which exhibited feed residues. The damage to the paddles may allow for harborage areas for microorganisms and are difficult to clean and sanitize.

OBSERVATION 4

Failure to maintain equipment so as to facilitate cleaning of the equipment.

Specifically, firm utilizes cardboard, duct tape, and other non cleanable surfaces on equipment. These materials were observed to have residues adhering. The foam gaskets around access doors to the bucket elevators were observed in deteriorating condition and exhibited an accumulation of feed residues and dust.

Diamond Pet Foods recalled nine brands of dry pet foods manufactured at its Gaston plant between Dec. 9, 2011 and April 7, 2012. Several other companies whose food was also produced in the facility have joined the recall. See eFoodAlert for the most up-to-date information on the recall and product distribution.

A total of 258 persons infected with the outbreak strains of Salmonella Bareilly (247 persons) or Salmonella Nchanga (11 persons) have been reported from 24 states and the District of Columbia. 32 ill persons have been hospitalized, and no deaths have been reported. Collaborative investigation efforts of state, local, and federal public health agencies indicate that a frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation is the likely source of this outbreak.

FDA 483 Inspection Report (download PDF):

Mr. Dominic Sebastian, Managing Director, Moon Fishery (India) Pvt. Ltd., 11/722/D, Chemical Industrial Estate, Aroor, Alleppy 688534 Kerala India

Observation No. 1

Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.

Specifically, your HACCP plan for raw tuna does not list critical control points at the following process step to control the hazards of Clostridium botulinum, histamine and allergens.

A. There is no Critical Control Point listed on your HACCP plan for the process of cutting, scraping, and vacuum packaging performed in your processing room, kept at a temperature of REDACTED C to control the hazard of pathogen growth and histamine formation.

B. There is no Critical Control Point listed on your HACCP plan for Clostridium botulinum and allergen labeling applied to the primary packaging.

C. There is no Critic al Control Point listed on your HACCP plan for metal detection.

D. In your HACCP plan for receiving tuna, the only critical limit listed is temperature, with no critical limit listed for vessel monitoring and histamine testing records to show that tuna was not temperature abused on the harvesting vessel.

Observation No. 2:

You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice condition and cleanliness of food contact surfaces maintenance of hand washing, hand sanitizing and toilet facilities, and protection of food, food packaging material, and food contact surfaces from adulteration.

A. You are not monitoring the safety of water as evidenced by:

1. Tanks used for storage of process waters have apparent visible debris, filth and microbiological contamination. Sand and activated carbon filter units used in manufacturing of water are not sanitized, and ventilation for tanks is not filtered to protect against contamination. There is no laboratory analysis for water used in ice manufacturing at the REDACTED facility to show the water used to make ice is potable. Ice manufacturing lacks sanitary controls: ice manufacturing equipment at the Moon Fishery facility is located outside and is susceptible to adulteration from pests and the environment. Apparent bird feces were observed on the ice manufacturing equipment at Moon Fishery; insects and filth were observed in and on the equipment. Ice manufacturing equipment at your REDACTED facility is rusty and situated so that the ice cannot be protected against adulteration, as the ice manufacturing process is constructed into the flooring of the ice facility. Tuna processed at your facility, which is consumed raw or cooked, comes in direct contact with water and ice.

B. You are not monitoring the condition or cleanliness of food contact surfaces as evidenced by:

1. Some of the floor and wall tiles in the tuna processing area are broken and cracked, not allowing for proper cleaning.

2. After cleaning, the ceiling directly above the in-process tuna line was observed to have visible product residue.

3. After cleaning, product residues and rust were observed on knives and utensil storage boxes. These knives are used to cut raw tuna.

C. You are not monitoring protection from adulterants as evidenced:

1. Peeling paint was observed directly above the in-process tuna line.

D. You are not monitoring hand washing, hand sanitizing and toilet facilities as evidenced by:

1. There was no hand drying devices available in the employee rest rooms on the first floor.

Moon Fishery (India) Pvt. Ltd., the Manufacturer of the Yellow Fin Tuna Nakaochi Scrape that was recently recalled by a U.S. Distributor, is also recalling its 22 pound cases of "Tuna Strips" Product of India AA or AAA GRADE because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. Consumers should take precautions when choosing to eat raw seafood and be sure that the raw tuna they decide to consume is not from the implicated lots. If in doubt, don't eat it.

Moon India became aware of the problem after the FDA sampled tuna strips from a lot not yet in distribution. However as a cautionary measure Moon India agreed to recall tuna strips that were already distributed, none of which is from the suspect lot sampled by FDA. Distribution of these AA or AAA Grade Tuna Strips Product of India is limited to 4 wholesalers: one in Georgia, one in Massachusetts, one in New Jersey and one in New York.

The wholesalers may have broken the shipments into smaller lots for further distribution. The frozen raw yellow fin tuna product was originally packaged in white boxes with black writing naming the importer as Moon Marine USA Corporation, a separate and independent company, and identifying the contents as Tuna Strips AA or AAA, Product of India. The boxes contain several vacuum-wrapped packages with no further labeling.

Distribution of the product has been suspended while FDA and the company continue their investigation as to the scope of the problem.

Product sellers, including distributors and restaurants, should consult their suppliers to determine whether the Tuna Strips from India in their possession originated from Moon India. The product may not be accompanied by lot numbers or labeling information.

CDC collaborated with public health officials in multiple states and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella Enteritidis infections which was associated with eating food from a Mexican-style fast food restaurant chain, Restaurant Chain A. Investigative efforts were unable to identify a specific food associated with illness, but data indicate that contamination likely occurred before the product reached Restaurant Chain A locations.

A widely distributed contaminated food product might cause illnesses in a specific region and across the United States. As of January 19, 2012, a total of 68 individuals infected with the outbreak strain of Salmonella Enteritidis have been reported from 10 states. The number of ill persons identified in each state with the outbreak strain was as follows: Texas (43), Oklahoma (16), Kansas (2), Iowa (1), Michigan (1), Missouri (1), Nebraska (1), New Mexico (1), Ohio (1), and Tennessee (1).