Round 2: Open letter to the leadership at FDA – Please know that these are the people you were bound to protect

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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