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

___________

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
. CrossRefexternal icon PubMedexternal icon

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

From September 2021 to February 2022, the CDC received reports of Cronobacter bacteria cases in infants in Minnesota, Ohio and Texas that resulted in four illnesses with two deaths.  These illnesses were ultimately linked by the CDC and FDA to the consumption of powdered infant formula produced by Abbott in its Sturgis, Michigan facility.  A worldwide recall of formula produced in the plant has left store shelves bare and parents scrambling for safe alternatives to feed their babies.

According to the CDC, Cronobacter  can cause severe, life-threatening infections or meningitis. Although Cronobacter infections are rare, they can be deadly in newborns in the first days or weeks of life with a mortality rate between fifty and eighty percent.  Only a handful of Cronobacter infections are reported yearly but given only the state of Minnesota requires labs to report positive tests, it is unclear how many illnesses are missed.

So, how did Abbott and the FDA find themselves facing some grieving and many other thousands of scared and angry parents?  It is a history of warning signs ignored.

In September 2019, the last time the FDA inspected the facility, the FDA cited Abbott for failing to test an adequate amount of formula to assure that it met “the required microbiological quality standards.”

In September 2021, after two years with no onsite inspection, the FDA returned to Abbott and found several concerning practices that likely lead to formula contamination, specifically, Abbott failed to “maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.”

In October, 2021, the FDA was warned in a confidential whistle blower document by a former Abbott employee who worked at the Sturgis facility, that Abbott was falsifying records, releasing untested formula into the market and failing to adequately clean the plant.  This waring appears to have been ignored by senior FDA officials.

In its March 2022 recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the plant in non-product contact areas, ”but denied having found the bacterium in finished product. This would appear to be in direct contradiction to the FDA’s revelation that the company had recorded the destruction of product in the past due to the presence of Cronobacter.  Specifically, “a review of the firm’s internal records also indicates environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.”

Abbott and the FDA seem 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.  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 has not been 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.

Instead, the FDA facing formula shortages, abdicates its responsibility to protect the public by letting parent know they are on their own with this thin gruel of a 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.”

So, what can parents do to protect their children if Abbott and the FDA will not?

First, clearly, you must consider powdered formula as likely contaminated. So, for those that use powered infant formula sanitize all feeding equipment and use boiling water in formula preparation.  Second, contact your Congressmember and Senators and tell them their oversight of the FDA is unacceptable.  Tell them that parents of babies should not be the last line of defense to fix the failure of Abbott and the FDA to assure babies do not die from infant formula.

All of the children have been younger than 10 years old, with the average age being 2 years old.

None of the affected children had received COVID vaccines and none were infected with coronavirus at the time they were infected with hepatitis.

The CDC is investigating a cluster of hepatitis illnesses among children in 25 states. The outbreak is thought to be part of an international situation that has seen more than 200 children sickened according to the WHO.

In the United States there have been 109 patients identified since October 2021, according to CDC Deputy Director for Infectious Diseases Dr. Jay Butler. During a conference call with media on Friday afternoon he said 90 percent of the children were hospitalized and 14 required liver transplants. Five children have died. All of the children have been younger than 10 years old, with the average age being 2 years old.

None of the affected children had received COVID vaccines and none were infected with coronavirus at the time they were infected with hepatitis.

Half of the sick children in the United States have been infected with adenovirus 41, which is part of a group of viruses known for causing respiratory symptoms. Butler said public health officials are trying to figure out if there is a link between the hepatitis infections and the adenovirus infections, but there is no conclusive information yet. All of the sick children were otherwise healthy before becoming sick with hepatitis.

According to Sante Publique reports, as of 04/25/2022, 55 confirmed cases have been identified, of which 53 are linked to STEC O26 strains, and 2 to STEC O103 strains. Earlier reports on 04/13/2022, indicated that another 26 other cases of HUS and STEC infections notified to Public Health France with investigations are ongoing. The 54 sick children are aged from 1 to 17 years with a median age of 7 years; 24 (44%) are female; 47 (87%) presented with HUS, 7 (13%) with STEC gastroenteritis. Two children died. The adult did not present with HUS.  In France, STEC surveillance is based only on HUS in children younger than 15, so it only catches the most severe cases of E. coli infection – LINK The epidemiological, microbiological and traceability investigations carried out since that date have confirmed a link between the occurrence of these grouped cases and the consumption of frozen pizzas from the Nestlé Buitoni brand Fraîch’Up contaminated with STEC bacteria.

My French is a bit rusty, so I missed the article on the former employee with a lot of very nasty photos.  Here is the translation and the photos.

RMC has obtained images of the Buitoni factory in Caudry (Nord) where the pizzas of the “Fraich’Up” range are produced, accused by the health authorities of being the cause of the poisoning with the bacteria E.Coli of dozens of children and the death of two of them.

Health authorities confirmed on Wednesday the link between Buitoni pizzas and the serious food poisoning of dozens of children, contaminated by the E.Coli bacteria.

It is in the Caudry factory, in the North, that the offending pizzas, those of the Fraich’Up range from Buitoni , are produced . Contaminations which shock but do not surprise a former employee, who left about a year ago, after 18 months at the Caudry factory, and who transmitted images of catastrophic hygiene conditions to RMC.

“We think it’s sanitized, everything is regulated. It’s supposed to be perfect but it’s not the reality, a lot of things are being hidden from us. I thought it was going to be fixed but there was no no change”, testifies this former employee , who had alerted his management and an independent media, ” Mr Mondialisation “.

“For 18 months, I talked about it and I was often told that ‘yes’, I was right and that precisely, they were seeing that and that it was going to change, but basically nothing was moving forward” , explains the former employee of Buitoni to RMC.

“When you see mushrooms on the wall, you know it’s not okay,” he says. “The paint on the metal bars was peeling off. There were bits of food that remained in some places for several days, several weeks,” laments the former Buitoni employee.

“In sauce recovery bins, you could find cigarette butts. Where the flour is sent on the carpets, so that the dough does not stick, there were mealworms. Most people did not wash not the hands, even coming back from the toilets. There was a cross contamination which was clear, it even surprises me that there was no accident before”, describes the former employee.

Ouch!

Yesterday was my birthday (65) and I missed this posted by Sandra Eskin, USDA Deputy Under Secretary for Food Safety in Health and Safety:

Food Safety is About People

When the U.S. Department of Agriculture (USDA) announced a new effort to reduce Salmonella in poultry, we led with the numbers. The number of illnesses due to Salmonella has not decreased over the last two decades. Year after year, people have become ill with Salmonella infections at roughly the same rate. Each case of foodborne illness represents someone whose life was impacted. And among the most vulnerable — children, the elderly, and those with underlying health issues — those impacts can be serious, leading to physical, emotional, and financial harm. These are the people who are always top of mind for me and who motivate me to come to work each day.

The lack of progress toward our national public health goal for Salmonella illness reduction is a call to action. USDA’s Food Safety and Inspection Service (FSIS), which is responsible for ensuring the safety of meat, poultry, and egg products, tests raw poultry products for Salmonella as part of its ongoing monitoring program. FSIS testing data indicate that Salmonella contamination on poultry has been going down, but we have not seen a corresponding reduction in human illness. This tells us that we need to do something different to drive down human illness.

My experience in building coalitions as a consumer advocate has taught me that to reach our public health goal, it will take the combined efforts of innovative and committed people. I’m proud to say that many of those most eager to tackle this problem can be found within FSIS. I’ve also reached out to industry, consumer advocates, and academics to hear their ideas about how FSIS can reduce Salmonella illnesses attributable to poultry consumption. We’ve seen great enthusiasm for this initiative and broad support from a wide range of stakeholders who want to help get us there.

We’ve already had insightful discussions with external stakeholders and within the agency as we gather information to help guide our new strategy. We’ve been learning about the experiences, science, and research on Salmonella in poultry to help us put forward the best proposals for a more effective approach to reduce Salmonella illnesses. Learn more about FSIS efforts to reduce Salmonella in poultry.

Although, I appreciate the Secretary’s focus on consumers, I might direct the Secretary, Congress and the Industry to this:

Publisher’s Platform: Hey Chicken Little, the sky will not fall if Salmonella is deemed an adulterant

If Salmonella is deemed an adulterant – at least those that sicken and kill us – the sky will not fall – history as a guide.

On Jan. 19, 2020, we filed a petition with USDA’s Food Safety and Inspection Service (FSIS), on behalf of Rick Schiller, Steven Romes, the Porter family, Food & Water Watch, Consumer Federation of America, and Consumer Reports. 20-01-marler-011920 The petition asked FSIS to declare the following Salmonella “outbreak serotypes” as per se contaminants (adulterants) in meat and poultry products:

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

I said at the time, reducing salmonellosis from meat and poultry “demands bold action” beyond that yet taken by FSIS. Salmonella is a leading cause of foodborne illness in the United States, causing 1.35 million illnesses, 26,500 hospitalizations, 130 outbreaks, and 420 deaths each year.

Presently, government regulators are somewhat silent with what they intend to do.  The poultry industry, as expected, sees any additional regulation as unnecessary, burdensome and costly.

This is nothing new.   Here is a historical piece written by Helena Bottemiller, then at Food Safety News:

It was Sept. 29, 1994. Mike Taylor took the podium in San Francisco at the American Meat Institute’s annual convention to make his first, and most significant, speechas the top food safety official at the U.S. Department of Agriculture.

“I am here to talk about change,” began Taylor, who had just become administrator for the USDA’s Food Safety Inspection Service, as he looked out over his all-industry audience. “Change in what the public expects when it comes to food safety, change in how we at the Food Safety and Inspection Service (FSIS) are approaching our job, and change in the demands being placed on all those who produce, process and market meat and poultry for American consumers.”

Taylor explained his belief that the meat industry had an opportunity to move beyond the politics of food safety and find real solutions on the heels of the massive E. coli O157:H7 outbreak in the Pacific Northwest.

“You know from your daily experience that improving food safety serves us all.”

And then, Taylor uttered a few lines the industry may not have wanted to hear:

“In one critical respect, our inspection program at FSIS does not currently meet the public expectation. There is a gap in our system…”

“The fact is we do not deal directly enough and scientifically enough with the microbial pathogens that can make people sick,” he continued, before outlining some sweeping public health goals. And then he got very specific.

“To clarify an important legal point, we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act,” he added, explaining that he wanted to make USDA’s E. coli policy “crystal clear.”

“We are prepared to use the Act’s enforcement tools, as necessary, to exclude adulterated products from commerce.”

In September 2011, FSIS banned the “the Big Six” as reported by Helena Bottemiller, still then at Food Safety News:

Six dangerous strains of E. coli — dubbed “the Big Six” — will soon be banned from the beef supply, U.S. Department of Agriculture officials said Monday.

“This is one of the biggest steps forward in the protection of the beef supply in some time,” Under Secretary for Food Safety at USDA, Dr. Elisabeth Hagen, told the New York Times. “We’re doing this to prevent illness and to save lives.”

The proposal, which will be outlined in more detail by top USDA officials Tuesday morning, will declare six additional strains of Shiga toxin-producing E. coli (STECs), beyond well-known E. coli O157:H7, as adulterants in beef, making product contaminated with these pathogens illegal to sell in commerce. USDA’s Food Safety and Inspection Service will soon test ground beef, beef trim that goes into ground beef, and machine-tenderized steaks for these pathogens.

E. coli O157:H7 has been illegal in beef products since 1994, a policy that was put in place in response to the historic outbreak that sickened hundreds and killed four children in the Pacific Northwest. The new policy, which will extend to E coli O26, O45, O103, O111, O121, and O145, is expected to kick in in March.

The meat industry did not react warmly to the announcement, while consumer groups unanimously praised the move.

“USDA’s announcement today that it will soon be ‘illegal’ to have six strains of naturally occurring non-O157 E. coli in ground beef is premised upon the notion that the government can make products safe by banning a pathogen,” said James H. Hodges, executive vice president of the American Meat Institute, the group representing the vast majority of the meat industry. “That view is not supported by science.”

AMI believes the interventions currently used to eliminate E. coli O157:H7 will work for the non-O157 strains and slammed USDA for adding costs that it said will eventually be passed along to consumers.

 “USDA will spend millions of dollars testing for these strains instead of using those limited resources toward preventive strategies that are far more effective in ensuring food safety,” added Hodges, in a statement to reporters. “Imposing this new regulatory program on ground beef will cost tens of millions of federal and industry dollars – costs that likely will be borne by taxpayers and consumers.  It is neither likely to yield a significant public health benefit nor is it good public policy.”

Food safety advocates, many of whom have been lobbying USDA to take action on non-O157 E. coli strains for years, lauded the announcement and argued that the policy may well help the meat industry by preventing costly recalls.

“This is a huge step,” said Dr. Barbara Kowalcyk, CEO of the Center for Food Borne Illness Research and Prevention, who became a tireless advocate after her son lost his life from an E.coli O157:H7-contaminated hamburger. “We think this is going to have a significant impact on public health — fewer recalls, fewer illnesses, fewer deaths.”

Kowalcyk believes the policy is actually a bargain, when you weigh the costs and benefits. USDA estimates that the new rule could cost the meat industry as much as $10 million annually, not just for testing but also for cooking meat that tests positive before it hits store shelves.

“The average cost of a recall is $4-5 million plus the loss in consumer confidence,” added Kowalyck. “Preventing just two recalls could make up for the cost. And that’s not even taking into account the human costs.”

According to the Centers for Disease Control and Prevention, the six strains addressed under the new regulation cause approximately 113,000 illnesses and 300 hospitalizations annually in the United States.

Nancy Donley, co-founder of STOP Foodborne Illness, whose son died in 1993 from an E. coli O157:H7 infection, was also very pleased with the announcement.

“All of us at STOP Foodborne Illness are absolutely thrilled to have the big six declared adulterants,” said Donley in an email. “It’s something that we have been advocating for years now.  We’re pleased to see the USDA act progressively in putting forward an initiative that should greatly enhance public health and safety rather than waiting for another major foodborne illness outbreak to spur them to action.”

USDA’s announcement comes two years after Bill Marler, managing partner at Marler Clark, the nation’s leading food safety law firm (and publisher of Food Safety News), petitioned the department to declare all non-O157 STECs as adulterants. Petition(with Attachments)

“I’m really pleased,” said Marler. “This is going to go a long way towards making our food supply safer.”
 
Congresswoman Rosa DeLauro (D-CT), a staunch supporter of tougher food safety laws, echoed the praise, saying she was “thrilled” by the decision.
 
“It is a critical step forward in bettering our food safety system,” said DeLauro in a statement. “When a similar action was taken on E. coli O157:H7, its prevalence decreased by nearly fourfold, and I hope to see a similar result with these six strains. I applaud this new rule, and hope to continue enhancing the USDA’s ability to protect American consumers from unsafe food.”

If Salmonella is deemed an adulterant – at least those that sicken and kill us – the sky will not fall – history as a guide.

From the Jack in the Box E. coli outbreak in 1993 to the ConAgra E. coli outbreak in 2002, about 90% of my law firm revenue was E. coli O157:H7 cases linked to hamburger.  Deeming E. coli O157:H7 an adulterant did not change things overnight, but the government, industry and consumers over that decade worked hard to “Put me out of Business, Please.”

Today, and for the last 20 years, E. coli cases – O157 and/or “the Big Six”- linked to hamburger has been a small and diminishing factor in my practice.  It works – ask my accountant.

Let this sink in: The CDC estimates 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States.  It is not that I do not think a Conference on Hunger, Nutrition, and Health is important and necessary, but could ya throw a bone to those sickened by foodborne illnesses?

Tom Vilsack and HHS Secretary Xavier Becerra on the White House Conference on Hunger, Nutrition, and Health

This conference marks the first of its kind in more than 50 years. The last time the White House held a conference on these issues was in 1969

Today, the White House announced its commitment to end hunger, improve nutrition and physical activity, reduce diet-related diseases, and close disparity gaps by 2030. As part of this commitment, the White House will hold a conference this fall to catalyze the public and private sectors around a coordinated, whole-of-government strategy to accelerate progress and drive significant change.

U.S. Department of Agriculture Secretary Tom Vilsack released the following statement:

“For our country and our children to reach their highest potential, we must not only keep food on the table, but also aim for everyone to enjoy nutritious and affordable food that contributes to their overall health. The Biden-Harris Administration is committed to tackling both food and nutrition insecurity in order to prevent the diet-related diseases that plague our country, address health disparities in underserved communities, and give all Americans a chance for a healthy future,” said Secretary Vilsack. “The White House Conference on Hunger, Nutrition, and Health will help drive the transformative solutions we seek to enact in the Biden-Harris Administration through a whole-of-government effort and alongside public and private stakeholders. The U.S. Department of Agriculture is proud to be a partner as we work together toward the admirable goal of ending hunger and increasing healthy eating by 2030.”

U.S. Department of Health and Human Services Secretary Xavier Becerra released the following statement:

“Tackling food insecurity is key to boosting our nation’s health. Our understanding of science and social determinants that affect nutrition and physical activity has evolved in the past five decades, and it is high time we prioritize nutrition more for the sake of saving lives. As we prepare to gather for this conference, HHS—in partnership with federal agencies—continues to make new discoveries tied to healthy eating and physical activity, and advance guidance and policy to reduce Type 2 diabetes, obesity, and hypertension. Strengthening access to affordable and healthy food cuts down on chronic disease and helps us advance health equity for all Americans.”

Over at iwaspoisoned.com, they continue to follow the “Magically Suspicious” illnesses that may be linked to General Mills Lucky Charms cereal.  The site states:

Starting in late 2021 Lucky Charms food poisoning reports started to trend on iwaspoisoned.com. Now there are reports of over 6,400 sick. and the FDA has initiated an investigation.  We recommend anyone who fell ill after eating Lucky Charms, to report it, and to keep left over product for testing. We will communicate procedures for testing to everyone  who reports their case.

General Mills seems suspiciously silent about Lucky Charms except for press releases on “The Story of Lucky: Cereal’s most recognized leprechaun takes readers on journey of discovery with new book, ‘The Magic Inside’” and “Lucky Charms inspires new family traditions for St. Patrick’s Day.

The FDA approached the issue a bit more obliquely, noting that there has not been found a pathogen or cause of the illness (now numbering 529 adverse event reports’) linked to “Dry Cereal.”

I guess I will stick with what I said to the Guardian last week:

William Marler, a lawyer who has been at the center of food safety battles for decades, isn’t convinced that the cereal is to blame for the reported illnesses. “Correlation is not necessarily causation,” he wrote in an email to the Guardian, echoing comments by colleagues elsewhere.

He noted the common experience of Googling a handful of symptoms and learning that the itch on your arm is almost definitely proof of a fatal illness. Something similar may be happening here, Marler suggests.

“People try to connect the dots between something that’s happening and something that’s known, but the connection may not necessarily be accurate,” he said in a phone interview.

“There are hundreds of thousands of people today in the United States that are having vomiting and diarrhea, from a bunch of different causes. And it also may be happening that some of those thousandsof people also happen to eat Lucky Charms. And now they’re seeing it in the news and they’re going: ‘Hey, wait a second. I had diarrhea a week ago, and I ate Lucky Charms. Therefore, it had to be the Lucky Charms.’”

In some cases, many of the complainants may be right about the link between their symptoms and a particular food product – while many others are wrong about the same thing. He describes a 2007 case in which several hundred people got sick from salmonella detected in Peter Pan peanut butter jars. “But we got 5,000 phone calls … And the vast majority of them were people who go, ‘Well, no, I didn’t have any medical treatment,’” he said.

“You knew that there was a clear outbreak link to a product. But then you still had thousands of people presuming that they got sick from eating the product. And they probably did not.”

That’s not at all to suggest that people are making up their symptoms or trying to “game the system” – just that it’s very challenging to ascertain the source. “That’s why foodborne illness cases are sometimes really, really difficult to figure out,” he said. Without “solid epidemiological evidence – you have stool culture, you have purchase history, you have the product testing positive, you have, unfortunately, lots of people getting sick, so you can tell the common denominator of what it is – it’s kind of hard to put it together.”

And of course, some people posting online about a connection between their symptoms and a source are absolutely right, and social media such as iwaspoisoned.com can be a useful tool for getting to the root of a problem. Marler once got a call from a customer saying she’d gotten salmonella from a Los Angeles restaurant and posted about it on Yelp – where dozens of others had said the same thing on the same day. “Ultimately, the Yelp review was correct,” he said. “It was an early warning system for getting the health department to act.”

As for the Lucky Charms, Marler says he’d like to see some more hard evidence – testing of products, clear diagnoses of customers’ illnesses – to learn more.

I’ll still go with “Magically Suspicious.

“In the United States, Escherichia coli O157:H7 causes ≈73,000 infections and 60 deaths annually (1). Infection progresses to hemolytic uremic syndrome (HUS) in 2% to 15% of cases (2).”

UPDATE: In France, STEC surveillance is based only on HUS in children younger than 15, so it only catches the most severe cases of E. coli infection – LINK

According to Sante Publique reports, as of 04/25/2022, 55 confirmed cases have been identified, of which 53 are linked to STEC O26 strains, and 2 to STEC O103 strains. Earlier reports on 04/13/2022, indicated that another 26 other cases of HUS and STEC infections notified to Public Health France with investigations are ongoing. The 54 sick children are aged from 1 to 17 years with a median age of 7 years; 24 (44%) are female; 47 (87%) presented with HUS, 7 (13%) with STEC gastroenteritis. Two children died. The adult did not present with HUS.

The epidemiological, microbiological and traceability investigations carried out since that date have confirmed a link between the occurrence of these grouped cases and the consumption of frozen pizzas from the Nestlé Buitoni brand Fraîch’Up contaminated with STEC bacteria.

There is something wrong with the Santa Publique E. coli numbers.  Given that there are now at least 47 with hemolytic uremic syndrome (HUS), you would expect to see that the total number of ill would be closer to 500.  It appears that Santa Publique is counting the HUS cases primarily, leaving the STEC gastroenteritis cases relatively uncounted.  There should not be a 87% HUS to 14% STEC gastroenteritis ration – it should at the minimum be reversed, as cited above and as shown in the below E. coli flour outbreaks in the US.

These 55 cases occurred in 54 children and 1 adult, who presented symptoms between 18/01/2022 (week 3) and 25/03/2022 (week 12). The epidemic peak is in week 7 (14/02 to 20/02) and week 9 (28/02 to 06/03), with 10 cases each of these weeks. These 55 cases occurred in 12 regions of metropolitan France: Hauts-de-France (12 cases), Ile-de-France (9 cases), New Aquitaine (8 cases), Pays de la Loire (7 cases), Brittany ( 6 cases), Grand Est (3 cases), Auvergne-Rhône-Alpes (2 cases), Occitanie (2 cases), Provence-Alpes-Côte d’Azur (2 cases), Center Val-de-Loire (2 cases) , Bourgogne Franche-Comté (1 case) and Normandy (1 case).

So, why is flour the likely vector of this E. coli Outbreak?

According to the CDC, flour doesn’t look like a raw food, but most flour is raw. That means it hasn’t been treated to kill germs that cause food poisoning, such as E. coli. These harmful germs can contaminate grain while it’s still in the field or flour while it’s being made. Steps like grinding grain and bleaching flour don’t kill harmful germs—and these germs can end up in flour or baking mixes you buy at the store. You can get sick if you eat unbaked dough or batter made with flour containing germs.

We have seen these flour E. coli Outbreaks several times over the last “Baker’s Dozen” years.

Nestle Toll House Cookie Dough: As of Tuesday, June 30, 2009, 72 persons infected with a strain of E. coli O157:H7 with a particular DNA fingerprint have been reported from 30 states. Of these, 51 have been confirmed by an advanced DNA test as having the outbreak strain; these confirmatory test results are pending on the others. The number of ill persons identified in each state is as follows: Arizona (2), California (3), Colorado (6), Connecticut (1), Delaware (1), Georgia (1), Iowa (2), Illinois (5), Kentucky (2), Massachusetts (4), Maryland (2), Maine (3), Minnesota (6), Missouri (1), Montana (1), North Carolina (2), New Hampshire (2), New Jersey (1), Nevada (2), New York (1), Ohio (3), Oklahoma (1), Oregon (1), Pennsylvania (2), South Carolina (1), Texas (3), Utah (4), Virginia (2), Washington (6), and Wisconsin (1). Ill persons range in age from 2 to 65 years; however, 65% are less than 19 years old; 71% are female. Thirty-four persons have been hospitalized, 10 developed hemolytic uremic syndrome (HUS); none have died. Reports of these infections increased above the expected baseline in May and continue into June.

Flour: As of September 5, 2016, 63 people infected with the outbreak strains of STEC O121 or STEC O26 were reported from 24 states: Alabama (1), Arkansas (1), Arizona (3), California (3), Colorado (4), Iowa (2), Illinois (4), Indiana (1), Massachusetts (3), Maryland (1), Michigan (4),  Minnesota (7), Missouri (1), Montana (2), Nebraska (1), New York (4), Oklahoma (3), Oregon (1), Pennsylvania (2),  Tennessee (1), Texas (2), Virginia (3), Washington (5) and Wisconsin (4). Illnesses started on dates ranging from December 21, 2015 to September 5, 2016. Ill people range in age from 1 year to 95, with a median age of 18. Seventy-six percent of ill people were female. Seventeen ill people were hospitalized. One person developed hemolytic uremic syndrome, a type of kidney failure, and no deaths were reported.

All Purpose Flour: As of July 11, 2019, a total of 21 people infected with the outbreak strain of E. coli O26 were reported from 9 states: California (1), Connecticut (1), Massachusetts (2), Missouri (1), New Jersey (1), New York (7), Ohio (5), Pennsylvania (2) and Rhode Island (1).Illnesses started on dates ranging from December 11, 2018 to May 21, 2019. Ill people range in age from 7 to 86 years, with a median age of 24. Seventy-one percent of ill people were female. Of 20 people with information available, 3 (15%) were hospitalized. No deaths were reported.

Cake Mix: As of July 27, 2021, 16 people infected with the outbreak strain of E. coli O121 have been reported from 12 states: Illinois (2), Indiana (1), Iowa (2), Massachusetts (1), Michigan (1), Nebraska (2), Ohio (2), Oregon (1), South Carolina (1), Utah (1),  Virginia (1) and Washington (1). Illnesses started on dates ranging from February 26, 2021 to June 21, 2021. Sick people range in age from 2 to 73 years, with a median age of 13, and 100% are female. Of 16 people with information available, 7 have been hospitalized. One person has developed a type of kidney failure called hemolytic uremic syndrome (HUS), and no deaths have been reported.

 

 

1. Mead PS, Slutsker L, Dietz V, McCaig LF, Bresee JS, Shapiro C, et al. Food-related illness in the United States. Emerg Infect Dis. 1999;5:607–25. 10.3201/eid0505.990502.
2. Dundas S, Todd WT, Stewart AI, Murdoc PS, Chaudhuri AKR, Hutchinson SJ. The central Scotland Escherichia coli O157:H7 outbreak: risk factors for hemolytic uremic syndrome and death among hospitalized patients. Clin Infect Dis. 2001;33:923–31. 10.1086/322598.

And, there have been more outbreaks and recalls.

The E. coli lawyers of Marler Clark have represented thousands of victims of E. coli and other foodborne illness infections and have recovered over $800 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our E. coli lawyers have litigated E. coli and HUS cases stemming from outbreaks traced to ground beef, raw milk, lettuce, spinach, sprouts, and other food products.  The law firm has brought E. coli lawsuits against such companies as Jack in the Box, Dole, ConAgra, Cargill, and Jimmy John’s.  We have proudly represented such victims as Brianne KinerStephanie Smith and Linda Rivera.

If you or a family member became ill with an E. coli infection or HUS after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark E. coli attorneys for a free case evaluation.

Additional Resources:

According to Sante Publique reports, as of 04/27/2022: 59 cases of salmonellosis with a strain belonging to the epidemic, Salmonella Typhimurium, have been identified by the National Reference Center (CNR) for salmonella at the Institute Pasteur in France.

The 59 cases are spread over 11 regions (Ile-de-France (11 cases), Grand-Est (10 cases), Provence-Alpes-Côte d’Azur (9 cases), Auvergne-Rhône-Alpes (7 cases), Hauts-de-France (6 cases), Bourgogne-Franche-Comté (4 cases), Normandy (4 cases), New Aquitaine (3 cases), Brittany (2 cases), Occitanie (2 cases), and Corsica (1 case), with a median age of 3 years, and concern 29 boys and 30 girls.

Forty-two cases were able to be questioned by Public Health France. All the cases report, before the onset of their symptoms (which occurred between 20/01 and 31/03/2022), the consumption of Kinder brand chocolates. Seventeen people were hospitalized for their salmonellosis, all since discharged. No deaths were reported.

Kinder Egg products and Schoko-Bons should not be eaten.

As a result of the continued investigation into an outbreak of salmonella cases linked to Kinder products, Ferrero has extended its recall to include all Kinder products manufactured at their Arlon site in Belgium between June and the present date.

These include Kinder Surprise, Kinder Mini Eggs, Kinder Surprise 100g and Kinder Schokobons.

The new update means all the products in the recall notice, regardless of best-before date, should not be eaten. The previous recall only covered products with best-before dates up to 7 October 2022.

Kinder product recall items

As of 04/22/22, According to EU health officials: The outbreak is characterized by an unusually high proportion of children being hospitalized, some with severe clinical symptoms such as bloody diarrhea. Based on interviews with patients and initial analytical epidemiological studies, specific chocolate products (Kinder) have been identified as the likely route of infection. Affected cases have been identified through advanced molecular typing techniques. As this method of testing is not routinely performed in all countries, some cases may be undetected.

Kinder chocolate product recalls have been launched globally and examples of these can be found on several countries web sites including Belgium, France, Germany, Ireland, Luxembourg, Netherlands, Norway, and the UK. The recalls aim to prevent the consumption of products potentially contaminated with Salmonella. Further investigations are being conducted by public health and food safety authorities in countries where cases are reported, to identify the cause and the extent of the contamination, and to ensure contaminated products are not put on the market.

There has been 1 case reported in the United Sates to date.

According to Sante Publique reports, as of 04/27/2022: 59 cases of salmonellosis with a strain belonging to the epidemic, Salmonella Typhimurium, have been identified by the National Reference Center (CNR) for salmonella at the Institute Pasteur in France.

The 59 cases are spread over 11 regions (Ile-de-France (11 cases), Grand-Est (10 cases), Provence-Alpes-Côte d’Azur (9 cases), Auvergne-Rhône-Alpes (7 cases), Hauts-de-France (6 cases), Bourgogne-Franche-Comté (4 cases), Normandy (4 cases), New Aquitaine (3 cases), Brittany (2 cases), Occitanie (2 cases), and Corsica (1 case), with a median age of 3 years, and concern 29 boys and 30 girls.

Forty-two cases were able to be questioned by Public Health France. All the cases report, before the onset of their symptoms (which occurred between 20/01 and 31/03/2022), the consumption of Kinder brand chocolates. Seventeen people were hospitalized for their salmonellosis, all since discharged. No deaths were reported.

According to the World Health Organization (WHO), as of 25 April 2022, a total of 151 genetically related cases of S. Typhimurium suspected to be linked to the consumption of the implicated chocolate products have been reported from 11 countries (Figure 1): Belgium (26 cases), France (25 cases), Germany (10 cases), Ireland (15 cases), Luxembourg (1 case), the Netherlands (2 cases), Norway (1 case), Spain (1 case), Sweden (4 cases), the United Kingdom (65 cases) and the United States of America (1 case).

Salmonella:  Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Salmonella outbreaks. The Salmonella lawyers of Marler Clark have represented thousands of victims of Salmonella and other foodborne illness outbreaks and have recovered over $800 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Salmonella lawyers have litigated Salmonella cases stemming from outbreaks traced to a variety of foods, such as cantaloupe, tomatoes, ground turkey, salami, sprouts, cereal, peanut butter, and food served in restaurants.  The law firm has brought Salmonella lawsuits against such companies as Cargill, ConAgra, Peanut Corporation of America, Sheetz, Taco Bell, Subway and Wal-Mart.

If you or a family member became ill with a Salmonella infection, including Reactive Arthritis or Irritable bowel syndrome (IBS), after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Salmonella attorneys for a free case evaluation.

Additional Resources: