Open letter to the leadership at FDA – Please know that these are the people you are bound to protect

Richard Miller, 57-year-old married railroad superintendent in previously good health who became ill two weeks after eating food contaminated with Hepatitis A. https://vimeo.com/39019505 (VIDEO)

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. https://vimeo.com/37687417(VIDEO)

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. https://vimeo.com/37691923 (VIDEO)

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.  https://vimeo.com/39005733 (VIDEO)

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.  https://vimeo.com/39018970 (VIDEO)

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. https://vimeo.com/39005733 (VIDEO)

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. https://vimeo.com/39002646 (VIDEO)

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. https://vimeo.com/39002646 (VIDEO)

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. https://vimeo.com/44839343 (VIDEO)

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 too 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. https://vimeo.com/39002646 (VIDEO)

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. https://vimeo.com/39002646 (VIDEO)

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.  https://vimeo.com/39016978 (VIDEO)

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

William Beach, 87-year-old married, retired truck driver living independently with typical age-related medical issues. https://vimeo.com/39016978 (VIDEO)

Collapsed at home on 09/01/11, unresponsive, short of breath. Taken by ambulance to hospital in apparent severe sepsis, with respiratory failure, and brain swelling due to infection. Began to bleed uncontrollably from nose and mouth and died just before midnight.

Medical Bills……………………………………………$27,505.33

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. https://vimeo.com/39016978 (VIDEO)

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. https://vimeo.com/37695630 (VIDEO)

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. https://vimeo.com/71908653 (VIDEO)

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

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. (Insert Video)

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 16^th 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

Linda Rivera, 57-year-old married mother and stepmother of six adult children, in excellent health prior to illness. https://vimeo.com/39009586 (VIDEO)

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

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.