Following the tragedy of the PCA Salmonella peanut outbreak in 2008-2009, that sickened over 700 and killed nine, Dr. Stephen Sundlof of the Food and Drug Administration told lawmakers that agency inspectors will start to routinely collect samples for bacterial testing whenever they go into a peanut butter manufacturing facility.

“We are changing that now as a result of this (outbreak),” Sundlof, head of the FDA’s food safety center, told the House Energy and Commerce investigations subcommittee. The panel is looking for ways to prevent another outbreak like the one that has sickened some 600 people and is being linked to nine deaths. More than 1,900 products have been recalled.

Peanut butter may also be singled out for special attention. Sundlof said the government is weighing whether to designate it as a high-risk food. That means producers would be required to follow written food safety plans to prevent contamination.

Also in 2009, the US Food and Drug Administration (FDA) issued two sets of recommendations for reducing the risk of Salmonella contamination in peanut products, one aimed at the food industry and the other at food service establishments and retail stores.

The FDA’s action follows a 2-month investigation of a nationwide Salmonella Typhimurium outbreak linked to peanut butter, peanut paste, and other items made by Peanut Corporation of America (PCA) that has sickened 683 people in 46 states and has led to the recall of more than 2,833 products. The FDA published the documents on its Web site.

In its guidance for the food industry, the FDA said the document isn’t a set of guidelines, but rather its current thinking on addressing the risk of Salmonella contamination in foods that contain peanut products. It pointed out that Salmonella can become heat resistant as the water activity of a food becomes lower, conditions found in peanut butter and peanut paste.

The effectiveness of processing methods to reduce Salmonella in food products may depend on if and how much an ingredient with low water activity is rehydrated. Processing methods are more effective at killing the pathogen when the peanut ingredient is completely mixed into a high–water activity food, given time to fully rehydrate, and heated or acidified adequately. However, the pathogen may remain when lumps or swirls of peanut butter remain in the food product.

The FDA recommends that food manufacturers obtain peanut products only from suppliers that have validated procedures to reduce Salmonella contamination.

In instances when manufacturers must use raw shelled or blanched peanuts or when Salmonella concerns have been raised about a particular lot or lots of peanut ingredients, the FDA recommends that manufacturers:

  • Ensure that their own manufacturing processes adequately reduce Salmonella contamination
  • Adjust processing conditions to account for the food’s specific characteristics
  • Keep in mind that the most reliable way to gauge if a manufacturing process reduces Salmonella in a peanut-containing food is to conduct microbiological challenge studies
  • Avoid depending on negative tests by themselves in finished products to measure the efficacy of processes that reduce Salmonella

Following the passage of the Food Safety Modernization Act (FSMA) in 2011, the FSMA requires FDA to designate high-risk foods for which the proposed additional recordkeeping requirements “are appropriate and necessary to protect the known safety risks of a particular food, including the history and severity of the public health.” The high-risk food designation must be based on the following factors:

  • Foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention (CDC)
  • The likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce the food
  • The point in the manufacturing process of the food where contamination is most likely to occur
  • The likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination
  • The likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food
  • The likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

Did that ever happen?

Tonight the FDA, along with CDC and state and local partners, are investigating a multistate outbreak of Salmonella Senftenberg infections linked to certain Jif peanut butter products produced at the J.M. Smucker Company facility in Lexington, Kentucky. Total Illnesses: 14, Hospitalizations: 2, Last Illness Onset: May 1, 2022. States with Cases: Arkansas (1), Georgia (2), Illinois (1), Massachusetts (1), Missouri (1), Ohio (1), North Carolina (1), New York (1), South Carolina (1), Texas (2), Virginia (1), and Washington (1). CDC’s review of epidemiological information indicates that five out of five people reported consuming peanut butter and four of the five people specifically reported consuming different varieties of Jif brand peanut butter prior to becoming ill. FDA conducted Whole Genome Sequencing (WGS) analysis on an environmental sample collected at the Lexington, KY, J.M. Smucker Company facility in 2010. The analysis shows that this 2010 environmental sample matches the strain causing illnesses in this current outbreak. Epidemiologic evidence indicates that Jif brand peanut butter produced in the J.M. Smucker Company facility located in Lexington, KY, is the likely cause of illnesses in this outbreak. J.M. Smucker Company has voluntarily recalled certain Jif brand peanut butter products that have the lot code numbers between 1274425 – 2140425 manufactured in Lexington, KY.

I bit(e), or spread, of history:

In 1996, 15 people were sickened after eating peanut butter that was contaminated with S enterica serovar Mbandaka, according to a 1998 report published in the Australia and New Zealand Journal of Public Health. Investigators traced the contamination source to roasted peanuts.

In November 2006, public health officials detected a substantial increase in reports of Salmonella Tennessee isolates. In February 2007, a multistate, case-control study linked the consumption of either Peter Pan or Great Value Peanut Butter brands with infection. 715 people were sickened with 129 hospitalized.  Subsequently the same strain of Salmonella Tennessee was isolated from unopened jars of peanut butter and from environmental samples collected from the processing plant. The product was recalled, and new illness reports declined. Unsanitary conditions at the Sylvester, Georgia, processing plant were known about since 2004. On April 5, 2007, ConAgra announced inadvertent moisture from a leaking roof and sprinkler system could have promoted bacteria growth in the plant. Great Value brand was sold at Walmart stores.

Beginning in November 2008, CDC PulseNet staff noted a small and highly dispersed, multistate cluster of Salmonella Typhimurium isolates. The outbreak consisted of two pulsed field gel electrophoresis (PFGE) defined clusters of illness. The first cluster displayed a unique primary enzyme (XbaI) restriction pattern and an uncommon secondary enzyme (BlnI) pattern. The second cluster had two closely related XbaI patterns that were very similar to the first cluster and a BlnI pattern that was indistinguishable from the first cluster. Illnesses continued to be revealed through April 2009, when the last CDC report on the outbreak was published. A total of 714 were sickened, with 171 hospitalized and at least nine deaths. Peanut butter and peanut butter containing products produced by the Peanut Corporation of America plant in Blakely, Georgia, were implicated. King Nut brand peanut butter was sold to institutional settings. Peanut paste was sold to many food companies for use as an ingredient. Implicated peanut products were sold widely throughout the USA, 23 countries and non-U.S. territories.

On September 22, 2012, the CDC announced a multistate outbreak of Salmonella serotype Bredeney linked to Trader Joe’s Valencia Creamy Salted Peanut Butter. Collaborative efforts by local, state and federal public health and regulatory officials traced the product to Sunland, Inc. a Portales, New Mexico company. Sunland issued a recall of multiple nut butters and products made with nut butters. When the outbreak was declared over, a total of 42 people infected with the outbreak strain of Salmonella serotype Bredeney had been reported by 20 states. Among persons for whom information was available, illness onset dates ranged from June 14, 2012 to September 21, 2012. Ill persons ranged in age from less than 1 year to 79 years, with a median age of 7 years. Sixty-one percent of ill persons were children less than 10 years old. Among 36 persons with available information, 10(28%) patients had been hospitalized. The FDA confirmed that environmental samples collected at the Sunland facility had an DNA fingerprint that was indistinguishable to the DNA fingerprint found in outbreak associated patients.

On August 21, 2014, the CDC announced a multistate outbreak of Salmonella Braenderup involving 6 people residing in Connecticut (1), Iowa (1), New Mexico (1), Tennessee (1), and Texas (2). Almond and peanut butter manufactured by nSpired Natural Foods, Inc. was named as the likely source of this outbreak. The outbreak was declared over on October 16, 2014. Illness onset dates range from January 22, 2014 to May 16, 2014. Among 5 ill persons with available information, one person reported being hospitalized. During inspections at the nSpired Natural Food facility in Ashland, Oregon, between January 2014 and August 2014, the FDA isolated Salmonella Braenderup from environmental samples. A search of the PulseNet database linked ill patients to the environmental isolates taken from the nSpired production plant. On August 19, 2014 nSpired Natural Foods issued a voluntary recall of certain lots of almond and peanut butters because of potential contamination with Salmonella. The recalled brands include Arrowhead Mills, MaraNatha, and specific private label almond and peanut butters.

On December 2, 2015 JEM Raw Chocolate LLC (JEM Raw) of Bend, Oregon announced a recall of its full line of all nut butter spreads due to possible contamination with Salmonella. Health authorities at the FDA, Oregon Health Authority, Oregon Department of Agriculture and the CDC had linked illnesses in 13 persons who consumed nut spreads. Dates of onset ranged from July 18, 2015 to November 22, 2015. Cases were reported from California, Colorado, Georgia, Hawaii, Idaho, Illinois, Maine, North Carolina, New Jersey and Oregon.

In March 2017, the Centers for Disease Control and Prevention (CDC) and several state health departments attributed a multistate outbreak of Shiga toxin-producing Escherichia coli O157:H7 to I.M. Healthy brand SoyNut Butter manufactured by Dixie Dew and sold at retail on online outlets. Outbreak investigators collected open containers of SoyNut Butter from the homes of sick people, and unopened containers from retail locations. Containers of SoyNut Butter from lots #243162 and 244161 tested positive for E. coli. Whole genome sequencing revealed that the same strain of E. coli was found in clinical isolates from sick people and containers of I.M. Healthy SoyNut Butter. Epidemiologic investigation determined that 32 people ill with this strain of E. coli had been infected by eating or attending a facility that served I.M. Healthy SoyNut Butter. This included residents of Arizona (4), California (5), Florida (2), Illinois (1), Massachusetts (1), Maryland (1), Missouri (1), New Jersey (1), Oregon (11), Virginia (2), Washington (2), and Wisconsin (1).

References:

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-peanut-butter-may-2022

https://pubmed.ncbi.nlm.nih.gov/9744205/

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5621a1.htm

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm58e0129a1.htm

https://www.cdc.gov/salmonella/bredeney-09-12/

https://www.cdc.gov/salmonella/braenderup-08-14/

https://www.cdc.gov/salmonella/paratyphi-b-12-15/

https://www.cdc.gov/ecoli/2017/o157h7-03-17/index.html

In 30 years of practice, I have on numerous occasions offered to FDA leadership the opportunity to meet directly with the people who consumed food that was tainted under the FDA’s watch.  I have always thought that if they only had the chance to meet the victims and their families, they would understand just how important their jobs really are. Regardless of administration, I have yet to have a taker.

Lucas Parker, 2-year-old Canadian boy with possible pre-existing autism spectrum disorder exposed to Romaine lettuce contaminated with E. coli O157:H7 on a family road trip to Disneyland from British Columbia.

Onset of pain and bloody diarrhea on 10/18/18 causing family to head home. Made it as far as Olympia, WA ER where Lucas presented with bloody diarrhea, vomiting, nausea, and pain, diagnosed as a gastrointestinal infection and dehydration. Continued their way home but condition deteriorated the following day with Lucas becoming only minimally responsive with high fever, high blood pressure, increasing diarrhea, and dehydration. Admitted to B.C. hospital. When his kidneys began to fail and his lab work showed red blood cell destruction, he was diagnosed with HUS. Transferred to tertiary care children’s hospital on 10/21/18.

Developed seizure activity with severe decline in his neurological functioning and started on anti-convulsant medication. Intubated for head imaging and surgery. Catheter surgically inserted in abdomen for peritoneal dialysis. On 10/25 Shiga toxin 2 confirmed in the lab. More seizures on 10/28 despite medication. Labile blood pressures increased white cell count, and recurrent high blood sugars concerning for sepsis. Remained on mechanical ventilation. More seizure activity on 10/28 worrisome for brain injury with ongoing kidney failure and hemolysis (red blood cell destruction).

Kidney function began to return after 13 days but prognosis was poor given evidence of worsening brain damage. Extubated on 16th hospital day but still on dialysis for fluid removal. At high risk for aspiration due to lack of consistent gag/cough reflex. Surgery on 11/16 to remove peritoneal dialysis catheter and implant a feeding tube. Transferred to rehab facility on 11/18 bedbound in fixed, supine position, with limited visual and neurological function.

Went into respiratory distress after inadvertent drug overdose and readmitted to hospital were treated for complications of HUS including stroke, severe neurological deficit, dystonia and autonomic dysregulation (slow heart rate, high blood pressure, irregular breathing). Head imaging confirmed further brain damage. Experienced intermittent drops in his oxygen saturation levels with possible additional seizure activity and apnea (episodes of cessation of breathing). By 12/03 he was intermittently hypotensive and experiencing recurrent vomiting.

Condition stabilized and returned to rehab on 12/11/18 for multidisciplinary therapy to try to maximize function. He was assessed at a “near coma” level of consciousness with severe cognitive impairment and severe cortical visual impairment. Unable to sit, stand or maintain his head/neck/trunk position independently, with spasticity in his arms and legs, consistent with quadriplegia. He had no meaningful vocalizations and was receiving nutrition through a feeding tube.

Prognosis includes ESRD (end stage renal disease), diabetes, lifelong monitoring of his renal status, multiple kidney transplants, and prolonged periods of dialysis. Neurological deficits unlike to improve over lifetime and is at risk for hip dislocation and scoliosis due to spasticity.

Medical Bills……………………………………………$593,230.38

In 30 years of practice, I have on numerous occasions offered to FDA leadership the opportunity to meet directly with the people who consumed food that was tainted under the FDA’s watch.  I have always thought that if they only had the chance to meet the victims and their families, they would understand just how important their jobs really are. Regardless of administration, I have yet to have a taker.

Sandra Antle, 75-year-old married, very active mother and grandmother, with remote history of chronic lymphocytic leukemia, otherwise in very good health before falling ill.

Onset of fatigue and diarrhea on 09/06/11, progressing over next several days, leading to ER visit on 09/09. Tentative diagnosis was a urinary tract infection and enteric infection with C. diff. She was admitted and started on antibiotics. The following day blood cultures confirmed Listeria and antibiotic coverage was expanded. She went into respiratory distress with high blood pressure and she was rushed to the ICU where she was intubated for mechanical ventilation. A central catheter was placed in her neck for medication and blood draws.

She developed pulmonary edema (fluid in the lungs) and signs of heart failure. The bacteria was confirmed in her bloodstream, including her spinal fluid and brain. Brain imaging confirmed fluid buildup, resulting in extreme somnolence and unresponsiveness. On 09/13 surgery was performed to drill a hole in her skull to drain off some of the fluid that was putting pressure on her brain.

She continued to deteriorate, however, and remained intubated and increasingly unresponsive. On 09/18 the family, after consultation with Sandy’s doctors whose advised that she was showing no indication of any brain activity and her prognosis—a vegetative state—was bleak, decided to disconnect life support. Sandy died on 09/18, just more than one week after first becoming sick.

Medical Bills……………………………………………$200,810.15

Craig Baldwin, 65-year-old widower and aeronautical engineer, with two adult children, on autoimmune medication for a history of pemphigus (an autoimmune dermatological condition), otherwise in good health before becoming infected.

Onset of fatigue and tremulousness on 09/07/11, increasing over the next two weeks to include total body fatigue and dyscoordination, leading to an ER visit on 09/22. No diagnosis was made and Craig was sent home, where he rapidly deteriorated. Admitted to the hospital the following day at which time brain and neck imaging showed multiple lesions. Craig became acutely weak and disoriented with slurred speech. His mental function began to decline with short term memory loss, speech disorder, right facial droop, and right sided weakness. Diagnostic workup continued and he was started on antibiotics for empiric infection.

On 9/24 the lab confirmed Listeria and antibiotic therapy was adjusted. Craig’s condition worsened with loss of right sided function. Brain imaging showed new bleeding in the brain consistent with abscesses from Listeria. Surgery was performed to obtain a biopsy of brain tissue which resulted positive for Listeria. There were signs of acute kidney injury. With antibiotic therapy, his brain infection and cognitive function began to improve.

After 29 days in the hospital, Craig was transferred to the rehab unit on 10/07 for intensive therapy to restore strength and conditioning. He was evaluated for his persistent cognitive deficits and attendant anxiety and depression about his physical and mental deficits. After 1 and ½ months of therapy, he was discharged home on 11/15 with need for full time assistance in mobility, activities of daily living, and cognitive and emotional support, along with regular outpatient therapy. He received daily speech, physical and occupational therapy through the end of 01/12. He was left with permanent physical and cognitive deficits.

Medical Bills……………………………………………$607,379.46

Will Burkes, Sr., 72-year-old married man employed as a mechanic’s assistant who was receiving chemotherapy for colorectal cancer when he became infected.

Symptoms began on 09/07/11 with high fever, severe headache, confusion, and slurred speech. He was admitted to the ICU for evaluation and management with antibiotics for probably bacterial meningitis. He was intubated for mechanical ventilation for airway protection and respiratory failure. On 09/09 labs resulted positive for Listeria and antibiotics were adjusted.

Testing indicated acute heart attack and rhythm changes. He developed atrial fibrillation (ineffective heartbeat that can lead to blood clots) and further workup confirmed impaired heart function and probable congestive heart failure. Diuretics were prescribed to try to relieve some of the fluid buildup in Will’s lungs. Will was able to be extubated on 09/13. He was put on medication for high blood pressure.

Will underwent cardiac catheterization on 09/16 to assess the patency of his coronary arteries and the function of the left side of his heart. He began to show signs of stabilization despite ongoing diarrhea and pulmonary insufficiency.

On 9/21 Will underwent abdominal surgery because of concern that a portion of his colon was ischemic (lacking sufficient blood supply) but surgical findings were negative and the impression was pneumatosis (gas within the wall of the intestine). During this entire time, Will was unable to eat because of high risk of aspiration, and was getting nutrition through a feeding tube. He completed antibiotic therapy which seemed to have successfully treated his infection. He was discharged to a skilled nursing facility on 10/6 after one month in the hospital.

At the nursing facility, he worked with physical, occupational and speech therapy to restore his strength and stamina and was gradually advanced from tube to oral feedings. He was discharged after six weeks of care. He continued to be treated on an outpatient basis for gastrointestinal issues, dizziness, word finding difficulty, and slurred speech, and he remained at risk of aspiration due to ongoing difficulties with swallowing.

Medical Bills……………………………………………$407,287.22

George Drinkwater, 81-year-old married, retired school board member and school bus driver with four adult sons, eight grandchildren, and 14 great grandchildren. Prior medical history of myelodysplastic syndrome (pre-leukemia), coronary artery disease, orthopedic issues, and gastrointestinal bleeding, all under control by his physicians. https://vimeo.com/71609746

Symptoms came on in the middle of the night on 09/09/11. He collapsed when trying to get out of bed and began vomiting uncontrollably. He became incontinent of bowel and bladder during the ambulance ride to the ER. In the ER he was found to have a fever and was diagnosed with pneumonia and gastroenteritis and admitted for treatment. His fever continued, despite medication, along with severe headaches and diarrhea. By 09/12 he began vomiting again and his condition deteriorated significantly.

George was transferred by airlift to a higher level tertiary care facility on 09/13. His heart was in atrial fibrillation (ineffective rhythm creating risk of blood clot), and he became incoherent with no control over his extremities, all consistent with sepsis (inflammatory response to overwhelming infection) and encephalitis (brain inflammation). Brain imaging was negative and a spinal fluid sample was obtained. He stopped breathing and a code team responded to resuscitate him. The family decided, after discussion with his care team, that George would not want to be intubated or undergo CPR in the event of another arrest and a DNR (do not resuscitate) order was put in place.

His course continued to deteriorate, and he died on 09/14, after five days in the hospital.

Medical Bills……………………………………………$103,316.16

Rene Gaxiola, 63-year-old married Apostolic Church bishop and church pastor with one son, suffering from terminal brain cancer in home hospice care at the time he became infected.

Symptoms began on the morning of 09/07/11 with fever and unresponsiveness. The hospice nurse arrived and found his fever to be very high with elevated blood pressure. Medics were called and by the time they arrived, Rene was only semi-conscious, his heart rate was rapid, and he was unable to speak.

Rene was transported to the ER and found to be “essentially unresponsive” by neurological examination. His temperature was over 106°F. While workup was taking place to try to determine the etiology of his symptoms, Rene was started on antibiotics and admitted. Given his underlying terminal cancer diagnosis, DNR status, and progressively deteriorating condition, however, Rene’s family and caregivers decided to transfer him to inpatient hospice for comfort care only.

Rene continued to decline at hospice and on 09/10 he was noted to be “actively dying.” He died on the evening of 09/10, after three days in the hospital.

Medical Bills……………………………………………$23,105.35

William Pumphery, 84-year-old married father and grandfather, retired from a career in the Air Force, with a history of chronic lymphocytic leukemia, and coronary artery disease in stable condition before he became ill.

Symptoms began in early 09/11 with lethargy, weakness, mental status changes, and loss of balance leading to three falls. He became acutely ill on 09/07 with fever, shaking, jerking and unresponsiveness. He was rushed to the ER where he was admitted with fever and weakness, and started on empiric antibiotics. Over the next couple of days, he showed signs of improvement but on 09/10 his blood cultures resulted positive for Listeria, indicative of septicemia (blood poisoning by bacteria). He developed acute on chronic kidney insufficiency. Bill’s mental status changes were concerning for meningoencephalitis (inflammation of the brain) and he had generalized bruising all over his extremities.

While Bill was improved enough by 09/13 to transfer out of the ICU to transitional care, on 09/15 he became more confused and weaker, and was unable to even lift himself out of a chair. His wife, despite being advised by his doctors that he would not likely survive a code, declined to change his status to DNR (do not resuscitate). Over the next week, labs confirmed that he was in progressive kidney failure and by 09/20 his doctors decided to start him on dialysis. By 09/22, Bill was barely oriented to his surroundings and his kidneys were producing no urine at all.

Bill’s blood pressure began to fall and he was bleeding around his catheter insertion site. He received blood products to try to stabilize him hemodynamically, but it was clear that his condition was dire and his prognosis was poor. His wife asked that he be kept alive until their children could arrive from out of the country to say goodbye. On 09/24, Bill was intubated for mechanical ventilation and put on multiple medications to try to raise his blood pressure. Later that day, the family agreed to comfort care measures only, and Bill died that afternoon. He spent 17 days in the hospital.

Medical Bills……………………………………………$102,851.21

John Riffle, 95-year-old married, former Army intelligence officer, farmer and cattle breeder. When he became infected, John was on dialysis for end stage renal disease and he had heart and lung issues. He was mentally intact, however, and completely independent in his daily activities.

John’s symptoms came on in late September 2011. He was seen in the ER on 09/30 for shortness of breath and he was medicated for a presumed urinary tract infection. At a doctor’s visit on 10/11 John was found to have fluid in one of his lungs, thought to be from the infection in his urinary tract. The following day, however, he became weaker and shorter of breath, and he returned to the ER, where blood cultures resulted positive for Listeria. John was admitted for treatment of rapid heartbeat and low blood pressure, consistent with sepsis (inflammatory response to overwhelming infection). With initiation of IV antibiotics, John made some initial improvement, despite development of a painful, itchy rash on his back.

On 10/25, the day John was to be discharged home, he went into respiratory distress. Chest x-rays confirmed pneumonia. Dialysis continued for John’s failing kidneys and to try to relieve some of the fluid buildup in his lungs. On 10/31, after 20 days in the hospital, John’s condition suddenly deteriorated. He became progressively unresponsive and he died on 11/1.

Medical Bills……………………………………………$10,335.62

Paul Schwartz, 92-year-old former life insurance agent, married father of five, grandfather of nine, and great grandfather of ten. Paul had pre-existing age-related medical conditions including high blood pressure, heart disease, degenerative joint disease, and glaucoma but was active and independent. Before falling ill, he was also the primary caregiver for his wife who was suffering from Alzheimer’s disease.

Paul began to feel weak, especially in his legs, on 09/13/11 followed by confusion and loss of appetite. He was seen in the ER on 09/16 but no diagnosis was made. After he returned home, he began to experience increasing abdominal pain and mental status changes, and returned to the hospital where he was admitted for treatment of acute kidney injury attributed to a viral infection. On 09/22 blood cultures confirmed Listeria. He was treated with antibiotics for sepsis (inflammatory response to overwhelming infection) and meningoencephalitis (inflammation of the brain). Over the next several weeks, his medical condition began to stabilize, but he became more agitated and delirious, remaining mostly non-communicative. Given his disorientation and confusion, he was unable to participate in therapy to restore his strength and conditioning.

After five weeks in the hospital, on 10/21 Paul was discharged to a skilled nursing facility. He continued to decline, with hypoxic respiratory distress and atrial fibrillation (irregular heartbeat which can result in blood clots). He fell on 11/04,  developed a bladder infection, and required full assistance for all activities of daily life. He was given supplemental oxygen to compensate for his respiratory distress. His mental status continued to deteriorate, he became agitated at times, and was found several times in a kneeling/praying position on the floor next to his bed. He was too confused and disoriented to be able to participate in therapy.

On 12/18 he was again found on the floor, but this time he was completely unresponsive with no detectable blood pressure or oxygen saturation. He was taking only three breaths per minute. The family decided that they did not want him transferred back to the hospital and comfort measure were provided. Paul died later that day.

Medical Bills……………………………………………$181,384.65

Chris Wallace, 51-year-old fabric business owner with prior history of rheumatoid arthritis on immunosuppressants, and high blood pressure, who was otherwise independent and active before becoming ill.

Chris first began experiencing symptoms in early September 2011 with nausea, vomiting, diarrhea, and fever. On 09/07 he became very confused and disoriented with worsening gastrointestinal symptoms. His partner took him to the ER, where he was started on empiric antibiotics and admitted for presumed meningitis/encephalitis (inflammation of the brain). While waiting for the results of lab studies, his doctors suspected a possible stroke. Chris was so confused he pulled out his lines and catheter, so his wrists were tied to his bed frame. His fever gradually subsided and his condition stabilized, his confusion seemed better, but he was markedly weak.  All of his blood cultures had been negative.

On 09/15 he was transferred to an inpatient rehab facility for therapy. Within a few days, Chris was rushed back to the hospital for falling blood pressure, increased short term memory loss, and lethargy. More blood and spinal fluid were drawn for testing. Brain imaging studies showed increased lesions, inconsistent with stroke or bleeding. Antibiotic coverage was adjusted, given widespread news of a community outbreak of Listeria, but still without lab confirmation in Chris’s case, likely attributable to the fact that he had been receiving antimicrobial therapy when the specimens were obtained. Chris was treated for an enteric infection with C. diff.

Although Chris remained stable during this hospitalization. He was discharged to home on 10/3 on outpatient penicillin infusion for six weeks and orders to follow up with multiple specialists. After discharge, Chris continued to struggle with the effects of permanent brain injury and memory loss, and was dependent upon his partner for all of his daily needs.

Medical Bills……………………………………………$269,189.44

Clarence Wells, 87-year-old widower and former Pentagon lithographer, with two children, four grandchildren, and two great grandchildren, independent in most all of his daily living activities, residing with his daughter and her family.

Clarence became ill in late August 2011. He was seen in the ER on 08/25 in critical condition with a history of bloody stools for several days, swelling, and signs of poor blood perfusion. He was transferred by ambulance  to a tertiary care ICU with diagnoses of congestive heart failure, respiratory distress, kidney insufficiency, anemia, electrolyte imbalances, and risk for bleeding. After several days of treatment in the ICU, his condition seemed to stabilize, and he began therapy to try to restore some of his strength and conditioning.

Clarence’s condition took a turn for the worse on 08/31 with a rapid heartbeat, fever, difficulty breathing, and mental status changes, consistent with sepsis (inflammatory response to overwhelming infection). He was confused with a slight facial droop. By the early evening, his pulse was undetectable, and his pupils were dilated and non-reactive to light. After six days in the hospital, he passed away that night.

Medical Bills……………………………………………$30,381.99

Florence Wilcox, 96-year-old widow with two sons and eight grandchildren, generally in good health with age-related medical issues including high blood pressure, acid reflux, and bladder issues. She lived independently and actively before becoming ill.

Florence’s symptoms began in early September 2011. On 09/08 Florence was having bloody diarrhea, was weak and dehydrated, and she was running a fever. She called for an ambulance and medics rushed her to the ER. At the hospital her temperature was recorded at 104.9°F, she was started on empiric antibiotics, with a diagnosis of sepsis (inflammatory reaction to overwhelming infection). Her condition worsened and she became unresponsive. She was airlifted to a tertiary care facility for specialty care.

Florence was admitted to the ICU with diagnoses of encephalopathy (brain swelling), sepsis, and altered mental status. Concern arose that she had suffered a stroke because of absent reflexes in her arms and legs. Her heart was in atrial fibrillation (irregular heartbeat concerning for clots). Imaging showed fluid buildup in her lungs and she was having difficulty breathing. By 09/11 she was completely unresponsive. A feeding tube was inserted into her esophagus to maintain nutrition. A spinal fluid sample was drawn for analysis which tested positive for Listeria.

Over the next few days, EEG testing revealed general cerebral slowing with possible epilepsy and Florence was started on prophylactic antiepileptic medication. Doctors advised Florence’s son that his mother was dying and, given her advanced age and the extent of her brain injury, any attempts to resuscitate her would likely be followed by further deterioration and more medical emergencies that would ultimately take her life. After one week in the hospital, on 09/15 she suffered a systolic arrest and she died.

Medical Bills……………………………………………$180,248.54

According to the CDC and FDA, at least 4 kids were sickened and of those two died, from drinking Abbott infant formula.  Abbott denies the connection.  However, the resulting investigation and inspection (and whistleblower documents) uncovered enough problems in the Abbott facility to shutter it causing havoc with supplies of infant formula.  The facility is now set to reopen, but not before the U.S. Attorney sued Abbott and several employees. In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.

Abbott is essentially confessing to the violations in the below consent decree. Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

Here are the key documents:

Here is the 2021 inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

Here is the 2022 inspection report at the plant – Updated Final Applied_Unapplied Redactions Abbott Nutrition Sturgis FEI 1815692 FDA 483 1-31022 to 3-16-22 – ISSUED_Redacted

Here is the complaint – abbott_complaint_0

Here is the consent decree – abbott_proposed_consent_decree_0

Please read the above and ask the question: is this how infant formula should have been manufactured?

So, what gives the government the right to charge a company and certain employees with either a felony or a misdemeanor?

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “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.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.

Here are the highlights of the Consent Decree:

  • Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility
  • Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law.
  • It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected.
  • The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs. 

The U.S. Food and Drug Administration is announcing important updates on its ongoing work to increase the supply and availability of infant formula in the U.S. On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan infant formula production facility, and Abbott voluntarily ceased production at this facility as well as initiated a voluntary recall of certain products.

Today, a proposed consent decree of permanent injunction between the FDA and Abbott Nutrition, as well as three Abbott principals, was filed in the U.S. District Court for the Western District of Michigan. Under the proposed consent decree, which is subject to court approval and entry, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility. The proposed consent decree obliges Abbott to take actions that are expected to ultimately result in an increase of infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility. When the company decides to restart production at this facility, it must conform with the provisions of the proposed consent decree and meet FDA food safety standards. If contamination is identified, the company must notify the FDA, identify the source of the problem and conduct a root-cause investigation before resuming production.

In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements. On Jan. 31, the FDA commenced a for-cause inspection and identified Cronobacter sakazakii, a bacterium that can potentially cause severe foodborne illness primarily in infants, in the facility and observed significant operational deficiencies. While the agency’s inspection was ongoing, Abbott Nutrition voluntarily recalled certain powdered infant formula products and voluntarily shut down its facility to implement corrective actions that address issues raised by the FDA.

Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

Here is Abbott’s position:

After a thorough investigation by FDA, Centers for Disease Control and Prevention (CDC) and Abbott, and review of all available data, there is no conclusive evidence to link Abbott’s formulas to these infant illnesses. Specifically:

  • CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
  • Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
  • All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.
  • The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.
  • Genetic sequencing on the two available samples from ill infants did not match the strains of Cronobactersakazakii found in our plant. Samples from ill infants did not match each other, which means there was no connection between the two cases.
  • In all four cases, the state, FDA and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
  • Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
  • The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

This week the CDC declared an outbreak of Cronobacter infections over after the FDA received four complaints of Cronobacter infections in infants beginning on September 20, 2021, through January 11, 2022. Two of the babies died. Parents of all four infants reported having fed their children formula produced by Abbott Nutrition before they became ill. Although five strains of Cronobacter were found in the production plant, none of them was an exact match for the patient samples. The CDC worked with the FDA and state health departments to investigate the outbreak and the plant remains closed while the investigation continues.

A worldwide recall of formula from this plant has caused empty store shelves and desperation from worried parents looking for safe product to feed their children.  Infant formula has now become a political football between politicians and caused finger pointing between Abbott and the FDA as to who is causing the formula shortage.

Seven months after FDA received the first report of an infant infected with Cronobacter and nearly five months after the agency initiated its in-depth inspection of Abbott Nutrition’s production facility, several questions to the FDA and public health officials remain:

  • In view of what the FDA learned in September 2021 regarding Cronobacter-positive environmental and finished product samples at the Abbott facility, why did it take more than four months for the agency to initiate another inspection after receiving the first of the illness reports?
  • Why did the FDA inspectors not respond more forcefully to those Cronobacter-positive results when writing up the list of Inspectional Observations at the completion of their September 2021 inspection?
  • As Cronobacter (unlike Salmonella) is not a “reportable” disease in most states, how many additional cases of Cronobacter in infants have gone unreported?
  • Why did it take until February 17, 2022, before the public was made aware of the situation?

Congress is set to hopefully get responses from the FDA to these questions in a hearing scheduled for May 25th.

However, let’s not lose sight of the fact that the Cronobacter outbreak, subsequent recall and now formula shortage, would not have occurred but for Abbott failing to produce the formula in a manner that would assure the most vulnerable would not be sickened or die.  Looking at the facts surrounding this outbreak illuminate a complete lack of a culture of producing safe food.

Between September 1, 2019, and September 20, 2021, Abbott received seventeen consumer complaints regarding multiple Similac powdered formula products. Fifteen of the complaints related to infants testing positive for Salmonellaafter consuming a Similac product. One complaint cited an infant who was diagnosed with Cronobacter, and one was as the result of an infant death from an unspecified cause. This information is contained in the September 20-24, 2021, Establishment Inspection Report (EIR) from the FDA in response to a Freedom of Information Act request. APPLIED – FOI II – BR Abbott Nutrition- FEI# 1815692 9-2021 EIR.

In response to the Cronobacter complaint, the company reviewed its batch records and its finished product microbiological testing records. The complaint was reviewed by an internal Abbott Nutrition Medical Team. The firm closed the complaint after determining that all batch records were acceptable, that there were no other consumer complaints, and that microbiological testing was negative for Cronobacter. The infant death complaint triggered a batch record review for three lots of Similac Alimentum. After completing the review and determining that no other complaints or medical concerns had been identified for the products, the company closed the complaint.

The fifteen Salmonella complaints involved infants who had been fed one or more batches of Similac Alimentum, Similac ProAdvance, Similac Spit-Up, Similac Total Comfort, Similac Advance, Similac Pro Sensitive or Elecare for Infants. All fifteen of the infants tested positive for Salmonella. Once again, the batch record reviews came back acceptable, and finished product testing results were negative for Salmonella. A finished product sample of one of the implicated batches (Similac Advance lot #472005) was obtained by Abbott Nutrition from the consumer. The sample was subjected to a visual exam, and the container was examined in the packaging lab. The company did not conduct any microbiological tests on this sample.

Abbott Nutrition’s ‘Standard Operating Procedure for Handling Complaints’ specifies that “…any chemical or microbial testing of an unopened customer sample requires the approval of the AN Vice President Quality or delegate.” The EIR does not state whether approval was sought to carry out microbiological tests on the sample.

In addition to the consumer complaints, the EIR also reveals that the company had found Cronobacter in two batches of finished product. The first of these positive results was recorded for Similac Alimentum (Batch 697464), produced on September 25, 2019, just one day after the completion of the FDA’s September 2019 inspection of Abbott’s production facility. The root cause of the contamination was determined to be environmental. The company implemented correction actions and destroyed the contaminated batch. The specific root cause for the second positive result, this time in Similac Spit-Up (Batch 732675), produced on June 22, 2020, was never found, according to the EIR. Several deficiencies were noted during the root cause investigation, corrective actions were implemented, and the batch was destroyed.

In addition to the two instances of Cronobacter in finished products, Abbott also found Cronobacter in five environmental samples between January 2019 and August 2021. There were no Salmonella-positive environmental samples.

In its February 17, 2022, recall notice, Abbott acknowledged “…evidence of Cronobacter sakazakii in the plant in non-product contact areas.” Yet the FDA investigation recovered Cronobacter from at least one swab of what appears to be a contact surface, as described in the 1/31/2022-3/18/2022 Inspectional Observations report (FDA Form 483). Ultimately, the FDA found that Abbott failed to “maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.”

And there was more; information in a confidential whistle blower document was provided to the FDA in October 2021, by a former employee who worked in the production plant. Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

The whistle blower document outlines many problems at the Abbott production facility in Sturgis, Michigan, including the following:

  1. The Falsification of Records – On multiple occasions, and in various ways, records have been knowingly falsified. In most but not all the situations, information of a material nature was not disclosed. This included testing seals on empty cans; signing verifications without adequate knowledge; understating or inaccurately describing events to limit or avoid oversight; issuing certifications of projection pages bereft of pertinent data; shipping packages with fill weights lower than represented on the labels; failing to maintain accurate maintenance records; and prematurely removing holds in the absence of all requisite approvals.
  2. Releasing Untested Infant Formula – The Sturgis site performed a time code removal after the discovery of microorganisms (“micros”) in a batch of infant formula. The remaining portion of the batch outside the time code removal was released without additional testing. On another occasion product was not re-called from the market even after management became aware of a nonconformity (“NC”).
  3. The 2019 FDA Audit – Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to keep the auditors from learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site.
  4. Clean-in-Place Staffing and Practices – The Sturgis site has continued to permit lax practices associated with clean-in-place (“CIP”) procedures. The Sturgis site failed and continues to fail to have staff in place with sufficient training and experience to review CIP charts. Nor are CIP charts regularly reviewed prior to the release of a batch. CIP checklists do not require signatures of those performing the tasks and are not otherwise subject to audit by QS staff.
  5. Failure to Take Corrective Measures – The Sturgis site has repeatedly failed to undertake reasonable measures to reduce natural or unavoidable defects to the level feasible as mandated by the current Good Manufacturing Practices (“cGMPs”). Deficient testing procedures known to be prone to causing mistakes to have not been corrected. The Sturgis site continues to rely on staff with insufficient training and experience to interact with third-party labs (“TPL”).
  6. Lack of Traceability – The Sturgis site has ongoing problems associated with the traceability of its products. The automatic labeler frequently failed to work properly and led to significant difficulties in retracing product. QS staff never knew with certainty if an affected pallet was retrieved.

Abbott seems to have forgotten that the product that was being produced was more than a canned commodity but was a life-saving formula to be ingested by the most vulnerable. This is the type of food that requires the highest of standards and mandates the closest of inspections.  Yes, babies’ lives depended and depend on it. Abbott will likely face both civil and criminal liability for producing a food product that was tainted and sickened and killed children.  Abbott is ultimately responsible for the Cronobacter outbreak and for the contraction of the supply of infant formula.

But additional questions need to be raised to public health officials and FDA regulators.

Public health, specifically, the CDC, needs to reconsider making Cronobacter a nationwide reportable disease, so no illnesses are missing, and outbreaks figured out sooner so the product can be taken off the market in days instead of months.

The FDA leadership needs to be held to account for inadequate inspections and failing to act on the whistle blower warnings.  The FDA has essentially been silent on what it failed to do, but more importantly, what it plans to do to prevent the next Cronobacter outbreak and the resulting shock to the supply of infant formula.  Parents should not be left with this FDA warning:

Those seeking access [to the formula] should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances.

Abbott and the FDA need to do better.  Congress needs to put politics aside and ask the questions to find solutions, so this type of event does not happen again.

Two recalls from two farms in two weeks.

April 29, 2022: New York State Department of Agriculture and Markets Commissioner Richard A. Ball today warned consumers not to consume unpasteurized raw milk from Thomas Miller DBA Miller Dairy Farm due to possible Listeria monocytogenes contamination. Thomas Miller DBA Miller Dairy Farm is located at 51 Transport Lane, Pine Island, New York 10969 in Orange County. To date, no illnesses have been reported to the Department associated with this product.

A sample of the milk collected by an inspector from the Department was discovered to be contaminated with Listeria monocytogenes. On April 21, 2022 the producer was notified of a preliminary positive test result. Further laboratory testing, completed on April 29, 2022, confirmed the presence of Listeria monocytogenes in the raw milk sample. The producer is now prohibited from selling raw milk until subsequent sampling indicates that the product is free of harmful bacteria.

May 13, 2022: New York State Department of Agriculture and Markets Commissioner Richard A. Ball today warned consumers not to consume unpasteurized raw milk from Hawthorne Valley Association, Inc. due to possible Listeria monocytogenes contamination. Hawthorne Valley Association, Inc. is located at 327 Rt 21C, Ghent, New York 12075 in Columbia County. To date, no illnesses have been reported to the Department associated with this product.

A sample of the milk collected by an inspector from the Department was discovered to be contaminated with Listeria monocytogenes. On May 5, 2022 the producer was notified of a preliminary positive test result. Further laboratory testing, completed on May 12, 2022, confirmed the presence of Listeria monocytogenes in the raw milk sample. The producer is now prohibited from selling raw milk until subsequent sampling indicates that the product is free of harmful bacteria.

In 30 years of practice, I have on numerous occasions offered to FDA leadership the opportunity to meet directly with the people who consumed food that was tainted under the FDA’s watch.  I have always thought that if they only had the chance to meet the victims and their families, they would understand just how important their jobs really are. Regardless of administration, I have yet to have a taker.

Linda Rivera, 57-year-old married mother and stepmother of six adult children, in excellent health prior to illness.

Onset of symptoms on 05/03/09 with nausea, vomiting, bloody diarrhea, and painful cramping. Symptoms worsened over next two days and seen in ER on 05/05 where she was treated for probable acute gastroenteritis. Rushed back to hospital that night after dramatic decline in condition. Tentatively diagnosed with acute colitis. By 05/07 labs showed hallmark red blood cell destruction consistent with HUS. Kidneys started to fail, and labs confirmed E. coli. Underwent surgery to remove a portion of ischemic colon and create a colostomy. Remained intubated for ten days postop due to respiratory distress. Started on daily apheresis and dialysis to help relieve her fluid buildup resulting from her failing kidneys.

Exhibited confusion, inability to follow commands, and express words although brain imaging showed no signs of damage. Discharged to rehab facility on 05/27 but was rushed back to hospital on 5/30 because of respiratory distress and signs of fluid overload. Re-started on aggressive dialysis. Because of persistent vomiting and concern that she had torn her esophagus, underwent an endoscopic procedure which revealed a hiatal hernia and extensive stomach inflammation requiring placement of a suction tube to remove excess stomach acid. Was stable enough for transfer back to rehab on 06/15.

Remained in rehab facility for 30 days with some improvement, then transferred to another facility on 07/17 because of chronic nausea, vomiting and failure to thrive with acute weakness and deconditioning. Developed chest pain and elevated heart rate requiring treatment with nitroglycerin, and ultimately readmitted to acute care hospital on 07/24 for evaluation of heart symptoms. Discovered to have gallbladder damage requiring an open surgical procedure to remove it and a stone in her bile duct.

Was discharged home for one day before she again collapsed and was back and forth in the ER over the next several days because of postoperative pain. Was readmitted for 10 days then sent back to rehab facility with diagnoses of erosive esophagitis, urinary tract infection, respiratory insufficiency, kidney insufficiency, malnutrition, deconditioning and cognitive dysfunction. Developed a fever on 09/11 and returned to acute care hospital with sepsis and pneumonia, requiring intubation and mechanical ventilation.  Tracheostomy performed on 09/22 to replace the endotracheal breathing tube. Transferred back to rehab on 09/25 on the ventilator, unresponsive with signs of liver failure and on a feeding tube. Transferred to multidisciplinary rehab facility after several months.

Experienced multiple setbacks requiring readmission over the next several months, with some signs of slow improvement. By 04/12/10 she was still in rehab for intensive rehabilitation despite ongoing cognitive and physical limitations and pain. She was briefly hospitalized during this time for evaluation of possible bowel obstruction. Overall, suffered multi-organ failure (bowel, kidney, brain, lung, gallbladder, and pancreas).

Prognosis includes end stage renal failure with anemia, bone loss, high blood pressure requiring palliative care or dialysis, because she is not a candidate for transplant. In terms of her gastrointestinal disease, she will likely face complications related to her colostomy include bowel obstruction, infection, chronic bile duct blockage, ascites (free fluid in the abdomen), abnormal electrolytes, and post-infectious diarrhea, pain, nausea, vomiting and dyspepsia (heart burn). She has cirrhosis in connection with liver damage, she has dental damage and infections, contractures to her hands, and ongoing cognitive dysfunction.

Medical Bills……………………………………………$5,537,755.03

Richard Miller, 57-year-old married railroad superintendent in previously good health who became ill two weeks after eating food contaminated with Hepatitis A.

Onset of symptoms on 11/03/03. Seen in ER with low blood pressure, dehydration, elevated liver enzymes, and sweating—all suspicious for hepatitis A. Condition worsened to the point that he was physically and mentally incapacitated. Rushed back to ER with nausea, dark urine, jaundice (yellow tint to skin and eyes).  Lab confirmed hep A. Liver function began to deteriorate with lethargy, pain, disorientation, confusion, in fulminant liver failure. Medically paralyzed and intubated to manage his breathing and erratic behavior.

Liver transplant performed on 11/08/03 with postop brain swelling, body temperature dysregulation. On 11/16/03 developed impending respiratory failure from pneumonia/pulmonary fluid. Gradual recovery began two weeks post-implant and started on intensive rehab program. Sustained nerve damage in his left arm and vocal cords because of surgery positioning and intubation, respectively.

Discharged on 12/03/03 on anti-rejection medication, with regular outpatient follow up in transplant clinic. Spent a total of 27 days in hospital.

Developed nerve damage and pain in legs and underwent surgery to repair vocal cord damage. Required psychiatric care and medication for disability related depression and suffered cognitive/social dysfunction because of prolonged deprivation of oxygen to the brain. Left with debilitating pain in left arm and legs.  Will likely required another organ transplant in his lifetime.

Medical Bills……………………………………………$662,659.00

Ashley Armstrong, 2-year-old with no prior medical history before becoming ill.

Symptoms began on 09/08/06 with diarrhea and lethargy which persisted for several days, then turning to bloody stool. Seen twice by family doctor who on 09/12 referred her to hospital for further evaluation and treatment of dehydration. Condition quickly deteriorated to include vomiting and signs of acute kidney failure consistent with HUS. Transferred to tertiary children’s hospital for specialty care where lab confirmed E. coli O157:H7 and diagnosed with pancreatitis, HUS (hemolytic uremic syndrome) with red blood cells destruction, and rapidly deteriorating kidney function.

Peritoneal dialysis catheter placed on 09/14 and central line placed for medication and IV access. Dialysis continued around the clock and blood pressure began to increase. Her liver and spleen became enlarged, and she developed an infection in her dialysis catheter. After 18 days she began to show some signs of urine output and she was transferred out of the PICU to the general pediatric floor on 10/05. She was started on Epogen to stimulate the growth of new red blood cells.

By 12/13 she was doing well enough to reduce dialysis to 1 x per day over the course of 8 hours with once weekly Epogen injection. Completed dialysis therapy later that month and catheter was pulled on 01/24/07. Blood pressure remained labile. Hospitalized for 38 days. Will need medical management for the rest of her life and will need regular blood draws to monitor her kidney and red blood cell status.

Prognosis includes probable decline in kidney function during puberty with ESRD, inadequate growth requiring daily growth hormone therapy, long term dialysis, first kidney transplant in 3-10 years with life-long anti-rejection medication. Additional transplants anticipated after 15 years but could be more frequent due to transplant failure as a result of her type O blood antibodies. Probable ancillary complications include short stature, weak bones, high blood pressure, premature heart disease, life-threatening infections, and cancer.

Medical Bills……………………………………………$199,706.26

Suzanne Bandy, 57-year-old married woman, in excellent health before becoming ill.

Diarrhea and abdominal cramping began on 09/05/06. On 09/08 referred to ER for labs and stool culture by her regular MD after developing mucousy/bloody diarrhea. Hospitalized for two days for workup and started on empiric antibiotics. Discharged home after negative stool culture despite low platelet count with diagnosis of infectious colitis v. inflammatory bowel disease. While home, became weaker, lethargic, confused, uncoordinated with persistent bloody diarrhea, nausea and cramping.

Returned to hospital on 09/16 after voiding bloody urine. Labs concerning for HUS (red blood cell destruction and kidney failure). Transferred to tertiary care facility for specialty care, including plasmapheresis and dialysis. Remained hospitalized through 10/31 where she underwent plasmapheresis (total of 38 sessions). Was medicated with steroids, IV immunoglobulin, and Vincristine. A feeding tube was placed for nutrition.

Evaluated by psychiatry service and prescribed medication to treat depression. Experienced a grand mal seizure and placed on anti-convulsant medication, then developed facial tremors and weakness. Kidney function continued to decline along with increasing hemolysis (red blood cell destruction) and received her first blood transfusion.

Experienced two more seizures. Started on dialysis (total of 12 sessions) and blood pressure rose to dangerous levels (e.g., 200/104) with profound weakness and fatigue. Doctors struggled to manage kidney function, anemia and hypertension. Developed shortness of breath, dry mouth, visual disturbances, tremors, anxiety, and word finding difficulty with global cognitive deficits. Her extremities became increasingly swollen, and she developed numbness and tingling in her arm.

She improved sufficiently to be able to be discharged on 10/31, with dialysis catheter and a PICC (permanent IV line) in place for outpatient dialysis and administration of multiple medications, respectively. Spent 49 days in hospital.

Continued to suffer from and be treated for the debilitating effects of HUS, including kidney failure, high blood pressure, weakness, fatigue, nausea, flank pain, urinary frequency, and swelling. Diagnosed with chronic kidney disease.

Prognosis of increased risk of ESRD (end stage renal disease) within 5-10 years, cardiovascular disease, stroke, and heart failure.  Neuropsychological evaluation revealed diminished cognitive function related to HUS encephalopathy (brain swelling), unlikely to improve with the passage of time.

Medical Bills……………………………………………$454,971.47

Colleen Kortendick, 19-year-old college freshman who was in the process of moving into her dorm when she became ill. 

Onset of extreme fatigue and body pain on 08/27/06, progressing over next several days to stomach pain, diarrhea, bloody stools, and inability to urinate. Admitted to hospital with dehydration, elevated heart rate, low grade fever, copious diarrhea, abdominal cramping, frequent nausea, and vomiting. Labs confirmed acute kidney failure and hemolysis (red blood cell destruction) consistent with severe HUS, and liver compromise.

A catheter placed in neck to begin dialysis. Lab confirmed E. coli O157:H7 in her stool sample. Became increasingly anemic, requiring a blood transfusion.  Some overall improvement in her condition with repeated dialysis and supportive therapy. With gradual return of kidney function over the next week, was discharged on 09/15, after 14 days inpatient, with a tunneled central venous catheter for outpatient dialysis. Received outpatient dialysis through 09/27/06. Catheter removed on 10/05/06. Sustained permanent and irreversible kidney injury as a result of E. coli induced HUS.

Prognosis includes end stage renal disease (ESRD) in her lifetime with the probable need for prolonged dialysis, multiple kidney transplantations and anti-rejection medication.

Medical Bills……………………………………………$81,334.54

Victoria Covington, 61-year-old single, retired music professor, wheelchair bound from arthritis but living independently before becoming ill. 

Onset of severe digestive tract infection shortly after eating spinach. E. coli O157:H7 confirmed at emergency room visit on 09/03/06. Admitted for critical care treatment on 09/04/06 where she remained through 12/20/06. Suffered severe complications from infection including HUS (red blood cell destruction and kidney failure), shock, malnutrition, fluid in the lungs and respiratory failure, convulsions, urinary obstruction and infection, seizures, muscular, and neurological damage. Underwent tracheostomy for respiratory support, and dialysis for kidney failure. Spent 49 days in hospital.

Transferred to a skilled nursing facility from 12/20/06 to 04/21/07. After discharge moved into an apartment with her sister with 24 hour a day nursing care to assist with her persistent weakness, incontinence, nutrition, and all other personal and comfort needs. Confined to a bed as a result of the E. coli infection with only brief periods of sitting for the remainder of her life, with concern for recurring kidney failure.

Medical Bills……………………………………………$700,000.00

June Dunning, 86-year-old widow living with daughter and son in law, in good health, active, and independent in all daily activities. 

On 09/02/06 she experienced sudden onset of frequent, uncontrollable bloody diarrhea, and abdominal pain. Immediately admitted to hospital for treatment with fluids and IV antibiotics. By the next day was confused and disoriented, with persistent bloody diarrhea. Developed a fever, and her kidneys began to fail. Underwent surgery to remove a portion of her colon because of infarction due to toxicity. Heart rate and blood pressure were unstable postoperatively and kidneys continued to fail. Intubated and placed on a ventilator because of respiratory distress.

On 06/06/06 labs confirmed E. coli O157:7.  She was comatose, and HUS was destroying her red blood cells. On 06/07 she suffered two grand mal seizures and was placed on anti-seizure medication. Received a total of five units of transfused blood for worsening anemia. Over the course of the next several days she remained comatose, with ongoing multiple organ failure. She died on 06/13/06, after 11 days in the hospital.

Medical Bills……………………………………………$39,853.64

Regan Erickson, 4-year-old boy with no prior medical problems before becoming ill. 

Seen at urgent care on 09/04/06 for stomach pain and bloody diarrhea and immediately transferred to emergency room for evaluation of suspected bacterial enteric infection. Rapidly deteriorated and admitted with bloody diarrhea turning mucousy, with nausea, retching, vomiting and seriously impaired urine output. Experienced rectal prolapse (slippage of the rectum out of the anus). E. coli O157:H7 confirmed on 09/06 with concern for impending HUS—red blood cell destruction and failing kidneys. Transferred to a tertiary care children’s hospital for higher level specialty care.

By 09/08 in complete HUS kidney failure and catheter placed for peritoneal dialysis on 24-hour cycles. Nausea, low blood pressure, fever, and bloody diarrhea continued with worsening anemia. Was transfused blood. Was irritable, uncooperative, and uncommunicative due to unrelenting pain.

With supportive therapy and dialysis (22 days) by 09/25 began to show some improvement.  Started on medication for labile hypertension. Dialysis catheter removed on 09/29. Discharged on 09/30 after 26 days in hospital, with diagnoses of HUS, pancreatitis, rectal prolapse, acute renal failure, anemia, emesis, electrolyte imbalances and reactive airway disease.

Received ongoing outpatient nephrology care and evaluation of persistent rectal prolapse that had Regan back in diapers. Several attempts were made to reduce the prolapse non-surgically but all failed. Developed subsequent C. difficile enteric infection resulting in recurrent diarrhea and repeated rectal prolapses due to diarrhea and straining with defecation. He remained on blood pressure medication.

Developed PTSD and his frustration and anxiety began manifesting in emotional and behavioral problems, and along with his prolapse, set him back emotionally, developmentally, and socially, with oppositional behavior, anger, anxiety, aggression, and bowel and bladder incontinence.

Prognosis includes chronic renal failure due to permanent kidney damage leading to end stage renal disease (ESRD) by age 21, with a future of long-term dialysis and at least two kidney transplants with lifelong anti-rejection medication.

Medical Bills……………………………………………$126,738.02

Betty Howard, 83-year-old widow living with her son. Active and independent before infection, despite several age-related medical problems including high blood pressure, high cholesterol, and heart disease. 

First seen in the emergency room on 09/07/06 for a three-day history of frequent, watery, bloody diarrhea. Was admitted for treatment of presumed bacterial infection with IV antibiotics, in the setting of ongoing bloody diarrhea, nausea, declining platelets (loss of clotting factors–one of the hallmark features of HUS) and CT evidence of possible bowel ischemia.

E. coli O157:H7 confirmed on 09/10 and antibiotics stopped. Ongoing falling platelet count, hypertension, diarrhea, and abdominal pain. Signs of congestive heart failure on 09/13. Gradual improvement over the next several days and transferred to skilled nursing facility on 09/22 in severely weakened condition. Transferred to rehab facility closer to home on 09/27 where she remained through 10/18/06. Received regular therapy to try to restore strength and function but was hampered by somnolence from pain medication, weakness, malnutrition, and dehydration. Fell from bed on 10/08 and injured elbow. Persistent drowsiness and lethargy with low oxygenation levels, so transferred back to hospital on 10/17. Evaluation confirmed pneumonia, new-onset atrial fibrillation (irregular heart rate), heart muscle damage, urinary tract infection, blood clots in both legs, and lab confirmed C. difficile infection, worrisome for new strains of toxins, which responded to a change in antibiotics. Released back to rehab facility on 10/27.

Remained lethargic with periods of confusion, with assistance needed for all activities of daily living. By 11/02 she developed difficulty swallowing and she was short of breath with poor oxygenation levels. Labs worrisome for possible over-anticoagulation, combined with increased lethargy and weakness, and returned to hospital. Found to be in respiratory distress with mild congestive heart failure and acute kidney insufficiency, likely due to sepsis. Treated supportively with fluids, oxygen, and continuation of antibiotics for the C. diff infection with improvement and return to rehab on 11/06/06.

Further decline in strength and endurance due to illness and immobility with bowel and bladder incontinence and bed sores. In face of overwhelming physical decline and limitations, began to struggle cognitively and emotionally, with significant mood and behavior issues. Returned to the hospital on 12/31 in severe respiratory distress. Workup revealed pneumonia and family opted for no advanced life support measures beyond supportive measures. Improved enough for return to rehab facility on 01/06/07 where she became increasingly weaker, disoriented, anorexic. Stool testing confirmed recurrent C. diff. infection.

Despite increasing supplemental oxygen, her respiratory distress persisted, and she was transferred back to the hospital again on 01/26/07. This time she was unable to be resuscitated and she died in the ED. Hospitalized for 24 days.

Medical Bills……………………………………………$185.535.04

Ashlee Mattson, 23-year-old single, female nursing student with no prior health problems.

Onset of symptoms on 08/29/06 with nausea, diarrhea, cramping, becoming more severe over the course of the next two days, with new symptoms of vomiting, significant abdominal pain, and bloody stool. Seen at ER on 09/03 and received aggressive fluid hydration with transient improvement in symptoms. Stool sample obtained. Differential diagnosis: invasive enteritis v. inflammatory bowel disease pending results of stool analysis.  Sent home after several hours.

Symptoms worsened, with onset of low-grade fever and weakness.  Readmitted to hospital on 09/05. Blood studies evidenced hemolysis (low clotting factors and anemia) and kidney failure, consistent with HUS. Central line placed for anticipated plasmapheresis. Became increasingly swollen from fluid retention due to kidney failure, lethargic, uncommunicative, anorexic.  On 09/08 had first session of hemodialysis. Despite ongoing dialysis and blood transfusions, HUS worsened, and became confused, at times unarousable, hallucinating, with garbled speech, and falling oxygenation levels.

Because of escalating respiratory distress due to kidney failure, fluid overload and risk of multi-organ failure, was transferred to more advanced tertiary care facility on 09/14. Plasmapheresis increased to twice daily. Second dialysis catheter placed because of clotting in the original.

By 09/19 started to show some improvement in labs and by 09/23 her symptoms of nausea, vomiting, and diarrhea decreased, and her kidney function appeared to be returning. Discharged home on 09/26 with careful monitoring by nephrology and hematology.

Returned to hospital the next morning because of recurrent symptoms and found to be hypertensive with worsening anemia. Readmitted for fluids and blood transfusions. On 9/27 developed focal neurological problems with numbness, tingling of the tongue and left side of face, mildly slurred speech, and right-hand weakness, with spike in blood pressure. Condition stabilized and discharged home again on 9/30 after 17 days inpatient and a total of nine blood transfusions and 17 plasma exchanges. Spent 27 days in hospital.

Outpatient care included management of high blood pressure, and monitoring of kidney function which continued to be abnormal.

Prognosis includes gradual further loss of kidney function and ESRD (end stage renal disease) which will require dialysis and several kidney transplants over course of lifetime. Pregnancies ill-advised due to risk of toxicity from

preeclampsia, and at risk for hypertension, cardiac disease, failing bone health, cancer, life threatening infections, fatigue, weakness, and early mortality.

Medical Bills……………………………………………$207,840.16

Chloe Palmer, 6-year-old with no medical problems before becoming ill.

Symptoms began on 09/06/06 with crampy abdominal pain, loose watery stools, and low-grade fever, progressing to bloody stools. Continued deterioration and family MD prescribed a powerful anti-inflammatory used to treat ulcerative colitis.

Seen at ER on 09/09 for fluid hydration and released to home. Symptoms worsened that night with non-stop bloody diarrhea, pain, lethargy.  Returned to hospital on 09/10. Labs confirmed hemolysis (red blood cell destruction) consistent with HUS and acute kidney failure. Airlifted to tertiary children’s hospital for specialty care.

Developed high blood pressure and rapid heart rate, with fever, confusion, increasing lethargy. Catheter placed emergently for peritoneal dialysis and supplemental oxygen started for respiratory distress due to kidney failure and buildup of fluid in the lungs. Started on blood pressure medication for labile hypertension.  Intubated on 09/13 for respiratory support.  Required sedation in order to tolerate being on the ventilator. Dialysis continued for 13 days to deal with failing kidneys. On 9/24 developed leg pain, clots were found in her right leg, started on anti-coagulation therapy.

By 09/30 was beginning to show signs of improvement and on 10/04 her peritoneal catheter for dialysis was removed. Discharged home on 10/06 with orders for close follow up outpatient care after 27 days in hospital.

At high risk of ESRD (end stage renal disease) within 10-15 years with need for multiple kidney transplants, along with diabetes and pancreatic complications, heart disease, further blood clots and pregnancy complications. Will require lifelong anti-rejections medication with side effects of Cushingoid features, weight gain, emotional lability, cataracts, softening of bones, bone pain, hypertension, and acne.

Medical Bills……………………………………………$164,903.02

Donna Roy, 74-year-old retired, married woman. Active with no significant prior medical problems other than high blood pressure and hypothyroidism. 

Symptoms began on 08/27/06 with diarrhea which soon became bloody and increased in frequency.  Condition worsened and admitted to hospital on 08/31 with evidence of kidney failure. Progressive worsening with shortness of breath, EKG abnormalities, disorientation with mental status changes with a seizure on 09/03, after which her condition was so ominous that she was given last rites. Became so delirious that she pulled out her urinary catheter and tried to disconnect all of her other monitors, requiring medication with anti-psychotic drugs. Developed congestive heart failure and kidney function continued to decline with ongoing electrolyte imbalances. She received several blood transfusions and was otherwise managed supportively.

After more than 2 weeks she began to slowly stabilize, and she was discharged home on 09/26 after 27 days in hospital.

She continued to be treated outpatient for heart and lung complications, profound weakness and deconditioning, cognitive dysfunction (difficulty with memory, attention, problem solving and general intelligence), difficulty resuming a regular diet, and persistent gastrointestinal problems including diarrhea

and cramping. Prognosis includes early mortality due to heart disease and stroke, and possible end stage renal disease (ESRD) if her blood pressure is not well  managed and her health is not carefully monitored.

Medical Bills……………………………………………$103,001.33

Ruby Trautz, 81-year-old single, retired nurse living with daughter and son in law. Prior history of COPD and rheumatoid arthritis, but self-sufficient, active, and able to care for herself and help with grandchildren. 

Onset of symptoms on 08/26/06 with nausea, vomiting, abdominal pain, and diarrhea. Developed ominous bloody diarrhea the next day and admitted to hospital for treatment of dehydration, pain, vomiting, bleeding, and possible bowel obstruction.

Condition worsened, GI bleeding increased, she became anemic and received two blood transfusions. Kidneys began to fail as a result of HUS. Started on IV antibiotics before any stool cultures were obtained and tested for pathogens. Developed respiratory distress and abdominal pain/bloating. Central catheter placed in jugular vein for administration of drugs because she was unable to swallow liquid or medication.

Quickly developed an abnormal heartbeat, became obtunded, disoriented, and unresponsive. Despite supportive therapy, continued to deteriorate, with progressive heart, lung, and kidney failure. Developed seizure activity and became unresponsive.

Died on 08/31/06 after five days in hospital.

Medical Bills……………………………………………$86,694.00

Michael Hauser, 68-year-old married, retired podiatrist recovering from prior multiple myeloma treatment. https://vimeo.com/71908869 (VIDEO)

Onset of symptoms on 09/11/11 with rapid deterioration. Admitted to ICU for treatment of bacterial meningitis (brain swelling), seizures, severe sepsis/bacteremia (life-threatening response to infection), and coma. Intubated, tracheotomy performed.

Transferred to long term critical care facility on 09/29/11 where he remained through 10/15/11.

Condition worsened and readmitted to acute care ICU, where he was treated for continued brain swelling, respiratory distress requiring intubation, seizures, anemia/thrombocytopenia (red blood cell destruction), bed sores,  spinal cord compression, blood clots, urinary tract infection, and paralysis in the legs.  Underwent surgery to relieve brain swelling and spinal cord surgery to relieve spinal cord impingement.

Taken off ventilator for discharge back to long term acute care facility on 11/10/11 for treatment of chronic respiratory failure with intermittent re-intubations, septic shock, seizures, diminished mental status, aspiration pneumonia, acute kidney injury. Spent 44 days in hospital.

Transferred to rehab facility on 12/11/11 for almost two months. Released home severely debilitated, functionally paralyzed, with altered mental status, and swallow disorder. Choked on 02/17/12 and was re-hospitalized, intubated, diagnosed with SIRS (full body inflammation in response to infection), placed on DNR status. Died on 02/21/12, 5 months after becoming ill.

Medical Bills……………………………………………$1,569,826.70

Marie Jones, 89-year-old widow in exceptionally good health prior to becoming ill

Became ill on 09/09/11 with worsening weakness, anorexia, nausea, high fever, and altered mental status. Admitted to the hospital on 9/12 in atrial fibrillation (irregular heartbeat) and respiratory distress, confused and unresponsive.  Diagnosed with pulmonary embolism, and anemia. Spinal fluid culture confirmed Listeria and started on IV antibiotics. Hemodynamic instability with low blood pressure and rapid heart rate. Remained unresponsive. Developed a GI bleed and signs of kidney failure. Placed on a ventilator and given dire prognosis, the family decided to suspend all but comfort treatment. Marie died on 09/23/11 after 11 days in hospital.

Medical Bills……………………………………………$97,397.65

Charles Palmer, 70-year-old married, retired Marine with no significant medical problems prior to illness. 

Onset of symptoms on 08/30/11, hospitalized the next day with meningitis symptoms (headache, altered mental status, fever, lethargy, high white blood cells). Culture confirmed Listeria. Developed bloody diarrhea, abdominal pain, persistent confusion/disorientation. Imaging showed a rectosigmoid mass which was removed and found to be cancerous, and colostomy performed. Kidney mass also discovered. Treated with IV antibiotics and supportive therapy.

Developed kidney failure, shortness of breath, and complications with colostomy which required additional surgery. Discharged after 35 days on 10/03/11 in severely deconditioned state with assistance of home nursing care.

Medical Bills……………………………………………$268,797.19

Herbert Stevens, 84-year-old married, retired hydrologist with pre-existing history of heart, lung, kidney, neuro disease. Was living independently at home with wife prior to illness. 

Onset of symptoms on 08/24/11. Admitted to hospital for treatment of sepsis, pneumonia, red blood cell destruction, and exacerbation of underlying conditions. Culture confirmed Listeria. Treated with IV antibiotics and supportive therapy.

Discharged to skilled nursing facility in profoundly debilitated condition on 08/30/11 through 09/08/11. Developed extensive sores on his legs due to swelling and antibiotic induced rash, gastrointestinal bleeding due to anticoagulation therapy, and malnutrition. After one week, continued to deteriorate and was readmitted to acute hospital for management of extensive skin blistering/rash, anemia, bloody stools, and exacerbation of heart and lung complications. Spent 17 days in hospital.

Released to skilled rehab facility on 09/19/11 for therapy to try to return home. After one month of intensive therapy was strong enough for discharge home with multiple home assistive devices and strong family support. Continued to be seen outpatient for ongoing, complex medical issues.

Medical Bills……………………………………………$143,368.60

Hepatitis A viruses, illustration. Hepatitis A is transmitted through infected food or drink. Symptoms include influenza-like symptoms of fever and sickness, along with jaundice.

According to the CDC, the hepatitis a virus (HAV) is transmitted via the fecal-oral route, usually from direct person-to-person contact or consumption of contaminated food or water (33). Children were a key source of HAV transmission before HepA vaccination was available and recommended routinely for children because the majority of children infected with HAV have asymptomatic or unrecognized infections and can shed the virus in their feces for months (34,35). Transmission currently occurs primarily among susceptible adults.

Common-source outbreaks and sporadic cases also occur from exposure to food or water with fecal contamination. Uncooked foods have been recognized as a source of outbreaks (36). Cooked foods also can transmit HAV if the heat level used in preparation is inadequate to inactivate the virus or if food is contaminated after cooking, which can occur during outbreaks associated with infected food handlers (36). Waterborne outbreaks of hepatitis A are infrequent in developed countries with well-maintained sanitation and water supplies (37). Depending on conditions, HAV can be stable in the environment for months (33,38). HAV also is stable when frozen (10,3941). Heating foods at temperatures >185°F (>85°C) for 1 minute or disinfecting surfaces with a 1:100 dilution of sodium hypochlorite (i.e., household bleach) in tap water inactivates HAV (42).

HAV vaccination is not specifically recommended for persons who handle food in the absence of other risk factors. Foodborne hepatitis A outbreaks occur relatively infrequently in the United States; however, recent outbreaks of hepatitis A related to pomegranate arils (the fruit-coated seeds) imported from Turkey, frozen scallops imported from the Philippines, and frozen strawberries imported from Egypt demonstrated the risk for outbreaks related to foods imported from HAV-endemic areas (10,11,169). Contamination of food with HAV can happen at any point: growing, harvesting, processing, handling, or after cooking. Food handlers are not at increased risk for hepatitis A because of their occupation (36). Transmission of HAV from infected food handlers to susceptible consumers or restaurant patrons in the workplace is rare (36,170,171). Transmission among food handlers has not been common since the adoption of the universal childhood HepA vaccination recommendation in 2006, despite costly and resource-intensive investigations of HAV infections among food handlers. One study found that in >90% of case investigations of infected food handlers, only the food handler was infected, with no secondary cases (172). A survey of state health departments experiencing person-to-person hepatitis A outbreaks during 2016–2019 demonstrated that among almost 23,000 hepatitis A outbreak cases reported from states, <4% occurred among food handlers; secondary infections among patrons accounted for 0.2% of outbreak cases (173). The risk for secondary infection from hepatitis A–infected food handlers to food establishment patrons in these person-to-person hepatitis A outbreaks was <1% (173).

However, as a lawyer, I have seen first-hand the impacts on consumers exposed to HAV positive food service workers.  Here are a few examples of cases involving ill workers and the impact on customers and restaurants:

  • McDonalds in Skagit County in 1998 was implicated in a cluster of Hepatitis A illnesses linked to an exposure by a Hepatitis A positive assistant manager.
  • In 1999 nearly 40 became ill after being exposed to a Hepatitis A positive working at two Subway locations in the Seattle area.  Several of the patrons were hospitalized with one young boy suffering acute liver failure requiring a liver transplant.
  • A Carl’s Jr. was hit in Spokane in 2000 with a Hepatitis A cluster that sickened over a dozen after being exposed to an ill worker.
  • In 2001 a Massachusetts D’Angelo’s Hepatitis A ill employee was linked to several customers who became ill after being exposed to contaminated food served at the restaurant.
  • A Hepatitis A positive employee at Maple Lawn Dairy in New York sickened at least six customers in 2004, including one patron who suffered acute liver failure and died.
  • In 2009, public health officials in the Quad-City region of Illinois identified at least 32 confirmed cases of hepatitis A among residents of Rock Island, Henry, Mercer, Warren, and Woodford Counties. People became ill after eating food purchased from the Milan McDonald’s restaurant and then developing a Hepatitis A infection.
  • In 2017 Bartaco in New York at least 5 people sickened with Hepatitis A many of who were hospitalized with hundreds of thousands in medical bills and wage loss.
  • In 2017 a McDonald’s in Waterloo, New York was linked to the death of one woman who was exposed to a hepatitis A ill worker.
  • In 2019 the New Jersey Department of Health announced that 23 people contacted hepatitis A after being exposed to an ill worker at the Mendham Golf & Tennis Club.
  • And in 2021 52 were sickened, with over 30 hospitalized, including 2 with liver transplants and 4 deaths linked to an HAV ill worker at Famous Anthony’s restaurants in Roanoke, Virginia.

Real people, not statistics.  See more at https://marlerclark.com/food-litigation/hepatitis-a-outbreak-litigation

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10. Collier MG, Khudyakov YE, Selvage D, et al. Hepatitis A Outbreak Investigation Team. Outbreak of hepatitis A in the USA associated with frozen pomegranate arils imported from Turkey: an epidemiological case study. Lancet Infect Dis 2014;14:976–81. CrossRefexternal iconPubMedexternal icon

11. Viray MA, Hofmeister MG, Johnston DI, et al. Public health investigation and response to a hepatitis A outbreak from imported scallops consumed raw—Hawaii, 2016. Epidemiol Infect 2018;147:1–8.

33. Tassopoulos NC, Papaevangelou GJ, Ticehurst JR, Purcell RH. Fecal excretion of Greek strains of hepatitis A virus in patients with hepatitis A and in experimentally infected chimpanzees. J Infect Dis 1986;154:231–7. CrossRefexternal icon PubMedexternal icon

34. Smith PF, Grabau JC, Werzberger A, et al. The role of young children in a community-wide outbreak of hepatitis A. Epidemiol Infect 1997;118:243–52. CrossRefexternal icon PubMedexternal icon

35. Staes CJ, Schlenker TL, Risk I, et al. Sources of infection among persons with acute hepatitis A and no identified risk factors during a sustained community-wide outbreak. Pediatrics 2000;106:e54
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36. Fiore AE. Hepatitis A transmitted by food. Clin Infect Dis 2004;38:705–15. CrossRefexternal icon PubMedexternal icon

37. Barrett CE, Pape BJ, Benedict KM, et al. Impact of public health interventions on drinking water-associated outbreaks of hepatitis A—United States, 1971–2017. MMWR Morb Mortal Wkly Rep 2019;68:766–70. CrossRefexternal icon PubMedexternal icon

38. McCaustland KA, Bond WW, Bradley DW, Ebert JW, Maynard JE. Survival of hepatitis A virus in feces after drying and storage for 1 month. J Clin Microbiol 1982;16:957–8. CrossRefexternal icon PubMedexternal icon

39. Niu MT, Polish LB, Robertson BH, et al. Multistate outbreak of hepatitis A associated with frozen strawberries. J Infect Dis 1992;166:518–24. CrossRefexternal icon PubMedexternal icon

40. Nordic Outbreak Investigation Team. Joint analysis by the Nordic countries of a hepatitis A outbreak, October 2012 to June 2013: frozen strawberries suspected. Euro Surveill 2013;18:20520. CrossRefexternal icon PubMedexternal icon

41. Reid TM, Robinson HG. Frozen raspberries and hepatitis A. Epidemiol Infect 1987;98:109–12. CrossRefexternal icon PubMedexternal icon

42. Favero MSBW. Disinfection and sterilization. In: Zuckerman AJ TH, ed. Viral hepatitis, scientific basis and clinical management. New York: Churchill Livingstone; 1993. pp. 565–75.

169. CDC. 2016—Multistate outbreak of hepatitis A linked to frozen strawberries (final update). Atlanta, GA: US Department of Health and Human Services, CDC; 2016. https://www.cdc.gov/hepatitis/outbreaks/2016/hav-strawberries.htm

170. Ridpath A, Reddy V, Layton M, et al. Hepatitis A cases among food handlers: a local health department response—New York City, 2013. J Public Health Manag Pract 2017;23:571–6. CrossRefexternal icon PubMedexternal icon

171. Sharapov UM, Kentenyants K, Groeger J, Roberts H, Holmberg SD, Collier MG. Hepatitis A infections among food handlers in the United States, 1993–2011. Public Health Rep 2016;131:26–9. CrossRefexternal icon PubMedexternal icon

172. Morey RJ, Collier MG, Nelson NP. The financial burden of public health responses to hepatitis A cases among food handlers, 2012–2014. Public Health Rep 2017;132:443–7. CrossRefexternal icon PubMedexternal icon

173. Hofmeister MG, Foster MA, Montgomery MP, Gupta N. Notes from the field: assessing the role of food handlers in hepatitis A virus transmission—multiple states, 2016–2019. MMWR Morb Mortal Wkly Rep 2020;69:636–7. CrossRefexternal icon PubMedexternal icon