A recent surge in reports of illnesses due to the parasite Cyclospora has prompted DSHS to investigate the infections in hopes of determining a common source. DSHS has received reports of 151 Cyclosporiasis cases from around Texas this year.

Cyclosporiasis is an intestinal illness caused by consuming food or water contaminated with the Cyclospora parasite. The major symptom is watery diarrhea lasting a few days to a few months. Additional symptoms may include loss of appetite, fatigue, weight loss, abdominal cramps, bloating, increased gas, nausea, vomiting and a low fever. People who think they may have a Cyclospora infection should contact their health care provider.

DSHS recommends thoroughly washing fresh produce, but that may not entirely eliminate the risk because Cyclospora can be difficult to wash off. Cooking will kill the parasite.

Last year, Texas had 200 cases, some of which were associated with cilantro from the Puebla region in Mexico.

22893783_BG1-300x169What is cyclospora?

Cyclospora is a parasite composed of one cell, too small to be seen without a microscope. The organism was previously thought to be a blue-green alga or a large form of cryptosporidium. Cyclospora cayetanensis is the only species of this organism found in humans. The first known human cases of illness caused by cyclospora infection (that is, cyclosporiasis) were first discovered in 1977. An increase in the number of cases being reported began in the mid-1980s, in part due to the availability of better diagnostic techniques. Over 15,000 cases are estimated to occur in the United States each year. The first recorded cyclospora outbreak in North America occurred in 1990 and was linked to contaminated water. Since then, several cyclosporiasis outbreaks have been reported in the U.S. and Canada, many associated with eating fresh fruits or vegetables. In some developing countries, cyclosporiasis is common among the population and travelers to those areas have become infected as well.

Where does cyclospora come from?

Cyclospora is spread when people ingest water or food contaminated with infected stool. For example, exposure to contaminated water among farm workers may have been the original source of the parasite in raspberry-associated outbreaks in North America.

Cyclospora needs time (one to several weeks) after being passed in a bowel movement to become infectious. Therefore, it is unlikely that cyclospora is passed directly from one person to another. It is not known whether or not animals can be infected and pass infection to people.

What are the typical symptoms of Cyclospora infection?

Cyclospora infects the small intestine (bowel) and usually causes watery diarrhea, bloating, increased gas, stomach cramps, loss of appetite, nausea, low-grade fever, and fatigue. In some cases, vomiting, explosive diarrhea, muscle aches, and substantial weight loss can occur. Some people who are infected with cyclospora do not have any symptoms. Symptoms generally appear about a week after infection. If not treated, the illness may last from a few days up to six weeks. Symptoms may also recur one or more times. In addition, people who have previously been infected with cyclospora can become infected again.

What are the serious and long-term risks of cyclospora infection?

Cyclospora has been associated with a variety of chronic complications such as Guillain-Barre syndrome, reactive arthritis or Reiter’s syndrome, biliary disease, and acalculous cholecystitis. Since cyclospora infections tend to respond to the appropriate treatment, complications are more likely to occur in individuals who are not treated or not treated promptly. Extraintestinal infection also appears to occur more commonly in individuals with a compromised immune system.

How is cyclospora infection detected?

Your health care provider may ask you to submit stool specimen for analysis. Because testing for cyclospora infection can be difficult, you may be asked to submit several stool specimens over several days. Identification of this parasite in stool requires special laboratory tests that are not routinely done. Therefore, your health care provider should specifically request testing for cyclospora if it is suspected. Your health care provider might have your stool checked for other organisms that can cause similar symptoms.

How is cyclospora infection treated?

The recommended treatment for infection with cyclospora is a combination of two antibiotics, trimethoprim-sulfamethoxazole, also known as Bactrim, Septra, or Cotrim. People who have diarrhea should rest and drink plenty of fluids. No alternative drugs have been identified yet for people with cyclospora infection who are unable to take sulfa drugs. Some experimental studies, however, have suggested that ciprofloxacin or nitazoxanide may be effective, although to a lesser degree than trimethoprim-sulfamethoxazole. See your health care provider to discuss alternative treatment options.

How can Cyclospora infection be prevented?

Avoiding water or food that may be contaminated is advisable when traveling. Drinking bottled or boiled water and avoiding fresh ready-to-eat produce should help to reduce the risk of infection in regions with high rates of infection. Improving sanitary conditions in developing regions with poor environmental and economic conditions is likely to help to reduce exposure.

Washing fresh fruits and vegetables at home may help to remove some of the organisms, but cyclospora may remain on produce even after washing.

ucm454508-300x225Maya Overseas Foods Inc. of Maspeth, NY, is recalling approximately 8000 lbs. of Cashew Split because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The Cashew Split was distributed between February 18, 2015 and March 20, 2015 to retailers and restaurants located in New York, New Jersey, Connecticut, Pennsylvania, Massachusetts, and Florida by direct trucking and delivery.

Maya brand Cashew Split was sold uncoded in 7 oz. (UPC 020843230389), 14 oz. (UPC 020843230716), 28 oz. (UPC 020843230327) and 5 lbs. (UPC 020843230303) clear plastic pouches. The Cashew Split was also sold in bulk 50 lbs. tins.

The recall was as the result of routine FDA sampling at our supplier which revealed that the bulk Cashew Split contained the bacteria. The company has ceased the production and distribution of the product as FDA and the supplier continue their investigation as to what caused the problem.

Michael Lee Beachwood is a 60-year-old gentleman who lives in Kihei, Hawaii with his 53-year-old wife, Sheryl (“JJ”) Preston. The two run a successful wedding service in Hawaii, creating custom and Hawaiian themed music productions for weddings on the beach. Their duo name is PrestonBeachwood, and both are singers, composers, and producers.

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Michael has a medical history that was significant only for hyperlipidemia and hearing loss until he developed pain in his low back in December of 2012. The pain persisted, prompting a visit to the emergency room early in 2013. He was given pain medication and seen in follow-up by his PCP, Dr. Sands. They discussed doing a colonoscopy since his brother had died of stage IV colon cancer in 2008. Unfortunately, the colonoscopy revealed a mass in the sigmoid colon that was suspicious for cancer. General surgeon Rebecca Sawai, MD performed a hand-assisted laparoscopic sigmoid colectomy on February 26, 2013, from which the pathology report revealed a 2.5 cm moderately differentiated adenocarcinoma extending through the bowel wall into the subserosa; 5 of the 17 lymph nodes were involved, staging Michael at pT3, pN2a, Mx = IIIB[1]. However, a follow-up PET scan done on April 9, 2013 showed no metastases whatsoever, staging Michael at pT3, pN2a, M0.

After his diagnosis, Michael was referred for oncology follow-up to Ted Keyes, MD at Maui Memorial Medical Center, a part of the Kaiser Medical Foundation. On April 11, 2013, Dr. Keyes discussed the risk of recurrence using the Adjuvant Online program and the rationale for adjuvant chemotherapy, explaining that the most active regimen in decreasing the risk of recurrence is a combination of oxaliplatin and 5-FU/leucovorin (FOLFOX). Michael agreed with the treatment plan, and therapy was planned for every two weeks for 12 cycles. Plans were made to insert the port required for chemotherapy and draw blood for a series of health screens.

Michael was still reeling from the shocking news of his cancer diagnosis, but he and Sheryl felt some small measure of comfort after the news from the PET scan. He and Sheryl prepared for his upcoming chemotherapy and decided they should improve their diet to include more foods that support the immune system. To that end, they shopped at Costco on April 20, 2013, choosing Townsend Farm’s berries, believing berries to be great for building the immune system. They implemented their health promotion plan by preparing and consuming smoothies made from the berries over the next few weeks. Michael made a point of starting this regimen prior to starting chemotherapy.

Michael and Sheryl had no idea that their new “healthy” smoothie routine was about to sabotage the chemotherapy that was intended to improve Michael’s chances of recovery from colon cancer, as the berries they purchased were contaminated by hepatitis A, a fecal pathogen found in the feces of infected animals and people. Michael describes his health prior to becoming infected with hepatitis A:

Before being infected by Thompson Farms/Costco Hep A, I was a very vibrant and healthy person. I had no limitations, could run, snorkel, scuba dive, I could keep up with most people half my age.

After being diagnosed with Colon Cancer, I had laparoscopic surgery, all went well, they got the tumor, just taking a short length of “pipe” as one doctor humorously pointed out, and sewing it back together. I recovered quickly. My Kaiser surgeon, Doctor Sawai, commented that she was very impressed with how in “tone” all my tissues and muscles were. Very strong.

Diagnosis, cancer stage 3, with 5 of 13 lymph nodes infected, but NO OTHER SPOTS OR EVIDENCE OF SPREADING, pet scan showed no other manifestations of cancer. Prognosis: that I was so healthy and vibrant, that I would sail through the 12 chemo sessions that they were recommending, with a 5 to 10 year life expectancy. My oncologist, Dr. Keyes, said that chemo for me would be very mild because of my great health, few side effects would be expected. MOST IMPORTANT: Dr. Keyes warned that all 12 sessions of chemo should commence UNINTERRUPTED, as when chemo at this stage is stopped or interrupted, it gives the remaining floating cells of cancer a chance to ADAPT AND BUILD RESISTANCE to the chemo drugs.

After participating in a teaching session with the chemotherapy staff, Michael presented to the Ambulatory Oncology Clinic on May 8, 2013 for his first infusion of FOLFOX. He was premedicated with oral Zofran, Percocet, and Valium. After his therapy was complete, the chemo nurse reiterated to Michael and Sheryl that he was to be exceedingly careful about infection prevention, since the therapy consisted of highly potent immunosuppressant drugs. Specifically Michael was given a handout, part of which stated:

“To prevent infections:

– Wash your hands often during the day, especially before you eat and after you use the bathroom.

– Stay away from people who have illnesses that you might catch, such as the flu or a cold.

– Try to stay out of crowds.

– Clean cuts and scrapes right away with warm water and soap. Clean them daily until they are healed.

– Keep track of your temperature, if your doctor or other clinician recommends it. You can do this by taking your temperature at regular times and writing it down.”

Michael and Sheryl took these instructions very seriously and thought they were doing a very good job of following them. Therefore, when Michael became very sick after his first treatment, he thought he was just having a very bad reaction to chemotherapy. On May 10, he called Kaiser Oncology to report that he had been having severe nausea for three days. It was so bad, he stated he did not want any more chemo if this was what he had to look forward to every time. Annette de Lima, NP called Michael back and discussed trying another medication to help with anxiety and insomnia, offering him a prescription for lorazepam, a benzodiazepine.

Michael continued to feel poorly despite the lorazepam, however, on May 18, he presented to Maui Memorial Medical Center in the late evening, complaining of both nausea and fever for two days. Marc Emde, MD was on duty in the ER and evaluated Michael. His temperature was not elevated, and he was not vomiting, but Michael felt terrible, and so the doctor hydrated him with IV fluids and medicated him with IV Zofran and lorazepam. Dr. Emde also ordered blood cultures and other labwork. Michael’s white blood cell count was just slightly low at 3.7 (RR 3.8.-11.2), and he had a marginally elevated serum creatinine of 1.31 (RR 0.5-102). His liver transaminases were somewhat elevated with an AST of 85 (RR 0-37) and ALT 136 (RR 7-51). Dr. Emde diagnosed Michael with a low-grade fever and possible neutropenia (low neutrophils, a type of WBC). A chest x-ray ruled out pneumonia. After a period of observation, Dr. Emde discharged Michael with instructions to see his oncologist as scheduled. The blood cultures showed no growth when they were finaled a few days later.

On May 22, Michael returned to the Kaiser Oncology Clinic for his second chemotherapy session. He reported to Annette Tanaka, RN that he continued to have nausea without vomiting, and he was taking oral Zofran every eight hours for nausea. Before beginning the infusion, Michael had his first chemo follow-up with Annette de Lima, NP. They discussed the severe nausea he experienced after the first cycle of chemo and his ER visit. NP de Lima was not alarmed by Michael’s lab values in the ER and advised him to proceed with his second cycle infusion that day.

Michael again experienced severe nausea following the second FOLFOX infusion on the 22nd. On May 31, he telephoned the clinic to report that he had nausea almost all the time, regardless of whether he took Zofran consistently or not. He also reported shortness of breath, weakness/tiredness, and could not get off the couch most of the day. This was making it difficult for him to work, since doing weddings involved long walks across sand. He was managing, but it was difficult. Annette Tanaka, RN returned his call and told Michael that shortness of breath was not a common side effect of chemotherapy, so she thought he should go in to see the internal medicine doctor at Kaiser’s Kihei clinic.

That same afternoon, Michael saw Windred Frazier, MD at Kihei Clinic, who evaluated him for dizziness, shortness of breath, and fever. His temperature was measured at 100.6ºF and he was tachycardic with a pulse of 102. Michael told the doctor that the fevers he had been having were low grade and started about a week earlier. Dr. Frazier spoke with Michael’s oncologist Dr. Keyes, who suggested he order blood cultures to look for signs of infection. Dr. Frazier also ordered a CBC and metabolic panel to recheck Michael’s elevated liver enzymes. A chest x-ray was again normal appearing. Dr. Frazier reassured Michael that this was probably just a virus and not to worry.

Meanwhile, at home Sheryl was not feeling well. She was having unexplained symptoms that were similar to what Michael was having – fatigue, nausea, and joint pain. She chalked it up to some kind of bug or flu. On June 1, Michael emailed his oncologist to ask whether he had been tested for hepatitis A. Michael stated that he had been watching the news on TV and saw that an organic berry mix sold by Costco had been recalled after sickening over 30 people so far with hepatitis A. Alarmed, Michael checked his freezer and discovered that he and Sheryl had been consuming the very same product he saw on the news. Michael now questioned his “unexplained” symptoms, specifically fever, fatigue, nausea, and elevated liver enzymes… “could this be caused by hepatitis A virus??”

Michael recalls this period of time as something out of a nightmare:

After first ingesting the Thompson Farm Berries, my first 2 chemo sessions were normal, however, I began feeling tired, light-headed, weak, dizzy. My oncologist was very perplexed. We continued with #3 of 12 chemo. After which I became very sickened. My PCP doctor, Dr. Sands, became involved, as well, examined me and could not understand my deteriorating health condition. He ordered additional tests, to look at lungs, other areas. Everything there checked out. Blood tests were showing extreme elevation of liver enzymes, extreme decrease of red and white blood cells, which couldn’t be explained by just the chemo.

Weakening further, I was forced to pretty much lay on the couch most of the time. While watching the news, an alert was made about the Thompson Farms/Costco’s HepA outbreak. I paused the DVR with the picture of the berries packaging, checked my freezer, and found them to be the same. WE STILL ARE IN POSSESSION OF THE BERRIES IN QUESTION, IN OUR FREEZER. Ironically, Costco did not send a letter of warning about this for another 2 weeks. Had I not seen the news alert, I would have continued to get more and more sick.

On June 2, Jessie Gordon, DO from Kihei Clinic called Michael and Sheryl at home in follow-up of his visit on the 31st and his phone call of the day before. Michael’s liver enzymes were even higher than they were when checked on May 18th, with an AST of 165 and ALT 310. His white count was low at 1.6 and his platelets were markedly decreased at 66 (RR 130-440). His blood cultures were negative, however. Dr. Gordon discussed the couple’s exposure to hepatitis A from Costco berries and asked that Michael make an appointment with their primary care doctor. Dr. Gordon told Michael to follow-up immediately with his oncologist, but he wanted the hepatitis screening done as soon as he could get his blood drawn.

On June 3, Michael called Dr. Keyes’ office and spoke with Annette Tanaka, RN. They discussed his hepatitis A exposure and the abnormal liver tests. Dr. Keyes ordered Michael’s chemotherapy to be held for at least a week because of his fever and potential hepatitis A infection, and he wanted Michael to get an ultrasound of his liver as soon as they could get it approved.

On June 4, Michael was seen by his PCP, Frederick Sands, MD. They discussed his elevated liver enzymes and Michael’s exposure to hepatitis A from tainted Costco berries. Michael reported that he was having night sweats, soaking the bed for the past four nights. In the office that day, Michael’s temperature was 100.2ºF. Dr. Sands sent Michael over to the hospital for a CT scan and blood work.

Michael presented to Maui Memorial Medical Center’s laboratory for his blood to be drawn. At 5:18 PM, Lee Miyasato, MD performed a CT of Michael’s abdomen and pelvis at Maui Memorial Medical Center. Dr. Miyasato identified an enlarged spleen but no evidence for any liver abscess. Michael’s lymph glands looked stable.

Michael’s blood work showed increasing liver enzymes, with an AST of 662, ALT 505, and total bilirubin 1.2. His white count continued to be suppressed at 1.0, and his platelets were further decreased at 38. When Dr. Sands received lab and CT results, he discussed Michael’s case with Dr. Keyes, who wanted Michael admitted to the hospital immediately for telemetry, IV fluids, Neupogen administration (to increase his white count), fever control, and pain medications. Michael would have serial liver enzyme measurements, along with blood cultures and CBC. They planned to administer broad-spectrum antibiotics to cover for pseudomonas and other organisms. Michael was assigned the diagnoses of “Neutropenia, febrile; Elevated ALT; Leukopenia; and Fever.”

Michael remembers feeling so sick, he can barely recall the events that unfolded while waiting to hear from Dr. Sands about his test results. He reflects back upon it now:

… we drove over to Kaiser and he asked us to stay close by, as the test was being examined. We visited our good friends nearby, and I had to lay down on their couch I was so tired and weak. Less than a hour later, we received a call from Dr. Sands, who instructed me to go directly to emergency admittance at Maui Memorial Hospital, that I had tested positive for HepA, that I was on PRE-ADMITTANCE STATUS, and said, do not let anyone sneeze on me or cough close to me, as it would be LIFE THREATENING.

Hospitalist Eri Shimizu, MD was waiting for Michael in the emergency department when he returned to the hospital. When he got there, Dr. Shimizu described Michael’s condition: “Severe SOB, lightheaded, fever 103; Dr. Sands sent him for decreased WBC.” He turned Michael’s care over to hospitalist Colleen Haynes, MD to formally admit him to the hospital. Dr. Haynes set Michael up on continuous cardiac telemetry and started him on IV fluids.

Just after midnight on June 5, 2013, the laboratory reported that Michael’s hepatitis panel was positive for hepatitis A total antibody, positive hepatitis A IgM by EIA, and his hepatitis B and C were negative. Michael’s official diagnosis became “Acute hepatitis A infection,” in addition to the other admitting diagnoses of neutropenic fever, colon cancer status post two cycles chemotherapy, and thrombocytopenia.

Later on that morning, Dr. Shimizu came in to see Michael and found him resting comfortably. His telemetry showed sinus rhythm with frequent PVC’s, but his shortness of breath had resolved. Michael required no supplemental oxygen. He continued to be febrile and a fever of 101.6ºF was reported to the doctors at 6:30 PM. The following morning of June 6, Michael’s fever was even higher at 102.5ºF. Dr. Shimizu ordered the discontinuation of Tylenol or any other liver toxic agents because of Michael’s elevated liver enzymes. His AST that morning was up to 5291 and his AST was 5782. His platelets had improved to 95, however. The nurses applied cold compresses to make Michael more comfortable. Dr. Haynes ordered IV Zosyn for Michael’s antibiotic prophylaxis after discussing his case with infectious disease.

Michael reflects back on this time:

My life was in danger, any germ, any sneeze or cough on me could kill me at this point. Here is a picture of me in the hospital that evening. My wife, Sheryl, says that my texting to her later that evening was so incoherent, that she returned to the hospital after midnight, after visiting hours, and demanded to be allowed to be present, as she was fearing for my life.

On June 6, Michael underwent an ultrasound of his right upper abdomen that showed no evidence for any portal vein thrombosis and demonstrated normal Dopplers.

On June 7, Michael’s fever had come down to 100.2ºF and his blood cultures remained negative. His liver profile began to improve, and his AST dropped to 3909 and ALT 5307 that morning. His platelets were uptrending and were up to 95, and his white count improved to 3.3.

On June 8, Michael was afebrile and Dr. Shimizu starting planning to discharge him from the hospital. Michael still looked “icteric,” but his liver transaminases had improved further to an AST of 1935 and ALT 3910. In his discharge summary, Dr. Shimizu addressed each of Michael’s presenting problems and diagnoses. For the neutropenic fever, Dr. Shimizu recounted that Michael had received two doses of Zosyn for empiric coverage and he was afebrile at the time of discharge.

Turning to Michael’s hepatitis A infection, Dr. Shimizu commented on his elevated transaminases that were now trending downward. At the time of discharge, Michael’s bilirubin was still up to 6.6, but he saw no obvious obstruction or portal vein thrombosis on ultrasound, and Dr. Shimizu attributed this to the hepatitis A infection. Michael’s clotting studies were watched carefully and Dr. Shimizu described his coagulation labs and fibrinogen levels as “okay.” Dr. Shimizu discharged Michael home with prescriptions for Protonix and Lactulose, an antacid and laxative, respectively. He told Michael to hold his home cholesterol medication until his liver function tests had normalized. He advised him to continue to take Zofran as needed for nausea, but to hold all pain medications to be used sparingly for severe pain only.

On June 10, Michael returned to see Dr. Sands for follow-up of his hospitalization. Michael was still jaundiced from the hepatitis A, but he had not had a recurrence of his fevers. On June 14, Michael’s labwork showed a normal white count of 5.0, platelets 148, and normal coagulation studies. However, his total bilirubin was still quite elevated at 8.1. His liver transaminase AST was 180, which was still elevated but trending downward.

On June 17, Michael returned to the Kaiser Oncology Clinic to see Dr. Keyes. They discussed Michael’s recent hospitalization for neutropenic fever and significant elevation of his transaminase levels, which had now left him quite jaundiced. Michael reported that he had just now begun to recover from this, with his skin color returning and his lab results trending down to normal. He was still feeling very fatigued, however. Michael and Dr. Keyes discussed resuming his chemotherapy, and the doctor explained that Michael was going to need another one to two weeks to continue his recovery before they could consider any such immunosuppressive treatment.

Over the next few weeks, Michael recovered further and had repeat blood work done. In early July, he felt perhaps 80% back to normal in terms of his strength and endurance. Michael was concerned that his liver enzymes worsened on July 12, showing at AST of 307 and ALT 568. On July 15, Dr. Sands communicated with Michael about those results and told him he wanted to recheck his liver function in another week. Dr. Sands informed Michael, “Approximately 85 percent of HAV-infected individuals have full clinical and biochemical recovery within three months, and nearly all have complete recovery by six months. Serum aminotransferase concentrations decrease more rapidly than the serum bilirubin; the latter normalizes in more than 85 percent of individuals by three months.” Therefore, Dr. Sands told Michael it might take up to 6 months to have full recovery from his infection.

On July 17, Michael returned to Kaiser Oncology Clinic to see Dr. Keyes. They also discussed Michael’s abnormal liver function tests. Dr. Keyes agreed that this was a problem, particularly with the 5-fluorouracil part of the FOLFOX regimen, however the oxaliplatin component should not be a problem as it was primarily renally excreted. Michael’s bilirubin continued to come down to 2.0 on July 19, but his AST was still up to 312 and ALT 542. Dr. Keyes thought they should wait another week and retest Michael’s blood.

Michael’s ALT dropped to 180 and bilirubin 1.6 by August 2nd, and Michael was able to resume FOLFOX therapy. He received treatments on July 22 and August 5, 2013. Unfortunately, Michael’s platelets and white count became more of a problem and his chemotherapy had to be cancelled because of levels that were too low. Michael was able to resume chemotherapy on August 26th.

Michael had a very difficult time tolerating chemotherapy on August 26, 2013. He was so sick, he cancelled chemo for September and notified Dr. Keyes of this. Because Michael’s nausea lingered for so long after his last treatment, he felt certain that his hepatitis A infection was related.

On September 23, 2013, Michael returned to see Dr. Keyes. They discussed the extremely difficult time Michael had with his last cycle of FOLFOX adjuvant chemotherapy, with significant fatigue, nausea, and abdominal discomfort. Dr. Keyes wrote in the chart note: “He feels that the hepatitis may still be affecting him, which is likely the case.”

Dr. Keyes was disturbed that Michael had only completed three out of five cycles of chemotherapy. He discussed several options including continuing the FOLFOX at lower dose or switching to Xeloda as an adjuvant regimen. Dr. Keyes commented further: “Given the delay in treatment due to his hepatitis I am uncertain as to whether he would have significant benefit from further adjuvant chemotherapy. He is inclined not to continue with chemotherapy.” He urged Michael to continue adjuvant treatment with Xeloda and wanted him to have another CT scan in December.

Michael was feeling so much better in October that he emailed Dr. Keyes asking when he could get his annual flu shot, and he was also interested in getting immunized against hepatitis B and shingles. Dr. Keyes approved a flu shot and hepatitis B immunization, but he asked him to hold off on shingles because it was a live virus vaccine. He thought six months might be long enough to wait for that.

On November 6, Michael returned to the Kaiser Oncology Clinic and saw Annette de Lima, NP. He was feeling better off chemotherapy. He was advised to returned to the clinic in three months for blood tests, including a CBC, Chem 20, and CEA[2]. Michael’s CEA level was noted to be elevated in January and February 2014, and Dr. Keyes wanted to repeat the test in another two months. He also wanted to get a CT scan of Michael’s brain, chest, and abdomen as soon as possible.

On February 10, 2014, Michael presented to Maui Memorial Medical Center for his CT scans. Bradford Burton, MD performed the exam and identified a 1.4 cm focal hypodensity in the left lobe of his liver, which was new and concerning for a metastatic deposit. His brain, chest, abdomen, and pelvis revealed nothing concerning. After the exam results were called to Dr. Keyes’ office, NP de Lima called Sheryl and advised her that Michael should schedule an oncologist appointment as soon as possible to discuss further testing. Dr. Keyes was no longer with Kaiser, and therefore Michael had to schedule with a different doctor.

On February 12, 2014, Michael went to Maui Memorial Medical Center for an appointment with a new oncologist, Ming Shuo He, MD. Dr. He discussed with Michael that, unfortunately, his restaging CT showed a single liver lesion concerning for metastasis. Michael was asymptomatic at this time. Dr. He reviewed the history of Michael’s cancer treatment, noting that he was unable to complete his adjuvant chemotherapy because of complications from hepatitis A. Dr. He commented that she hoped this recurrence was the result of insufficient treatment and not treatment resistance.

Dr. He advised Michael to have an image-guided biopsy of his liver as soon as possible. Once the pathology was confirmed, she recommended he proceed with chemotherapy (FOLFOX) with careful monitoring. She discussed a future metastatectomy, but she wanted Michael to have to have stable/shrinking disease while on chemotherapy. She planned to monitor his serum CEA throughout treatment. Dr. He spoke with pathologist Dr. Isaacson about sending the tissue from Michael’s upcoming biopsy for KRAS/BRAF testing for tumor mutations.

On February 20, Michael underwent a CT-guided anterior left hepatic nodule biopsy. Samuel Wu, MD performed the procedure and sent multiple samples for pathology assessment. When the results of the biopsy were reported as normal, the pathologist advised PET/CT correlation. However, Michael and Sheryl were ecstatic. Dr. He saw Michael back in the office on February 25 to discuss the pathology report. She advised Michael to be cautiously optimistic and that he would still require close follow-up.

Michael’s next CT scan of his chest and pelvis was done on April 22nd at Maui Memorial Medical Center. Radiologist Peter Abcarian, MD performed the exam, and unfortunately he identified interval enlargement of the left lobe hepatic lesion, along with two additional small 1.2 cm hypodense foci involving the right inferior tip and caudate lobe. Dr. Abcarian was concerned that this represented metastatic disease and advised that Michael undergo another biopsy.

On April 28, Dr. He talked to Michael about his CT results, as well as a new CEA result that was markedly elevated over the last test. She scheduled Michael for a CT-guided needle biopsy, which John T. Watabe, MD performed on May 7. The results were not good. Michael had evidence of metastatic adenocarcinoma.

Dr. He saw Michael and Sheryl together in her office on May 14. Michael stated he was not surprised at the pathology findings, even though he was presently feeling well and was exercising regularly. He was entirely asymptomatic at this point. Dr. He advised Michael and Sheryl that he should begin first-line chemotherapy, and her choice would be FOLFOX plus Avastin. They agreed and his first therapy was set for May, however on May 22nd Michael notified the Oncology Clinic that he wanted to investigate some alternatives before starting new chemotherapy. He requested and received some referral numbers for a naturopathic consultation. Sheryl called the clinic the same day and informed Annette Tanaka, RN that Michael did not want to start the chemo that was scheduled for the 27th. Michael wanted to discuss treatment with an oncologist first, and arranged to speak with Huy V. Nguyen, MD, of Moanalua Clinic Oncology in Honolulu.

On June 4, 2014, Michael traveled to Honolulu for a consultation visit with Dr. Nguyen. Dr. Nguyen reviewed Michael’s oncologic history and CEA results, both of which support the development of metastatic cancer. Michael was now classified as Stage IV sigmoid colon cancer, KRAS and BRAF “wild type.” Michael wanted to know about potential treatment and prognosis. Dr. Nguyen explained that, unfortunately, there were no surgical options available to Michael, as he had bilateral liver involvement. They discussed options for palliative chemotherapy, and Dr. Nguyen agreed with FOLFOX-Avastin. Michael was leaning towards doing chemotherapy, but he wanted a little time to consider that vs. naturopathic options first. Dr. Nguyen agreed to manage Michael’s chemotherapy and they tentatively planned on starting the next week. On June 6th, Sheryl called the office to tell Dr. Nguyen he wanted to detoxify for now and start chemo the next month. Michael still had a chemo port and agreed to return for regular flushes of the port.

On August 13, Michael returned to Maui Memorial Medical Center for a CT scan of his liver. John Sanico, MD performed the exam and identified further interval enlargement of the known hepatic lesions, which he thought were suspicious for progression of metastatic disease.

On August 18, Dr. Nguyen notified his staff that Michael was ready to start chemotherapy. Debra Sawczynec, RN contacted Sheryl, however, who informed her that Michael did not want to start chemotherapy until after September.

On September 2, 2014, Michael returned to the Kaiser Oncology Clinic to start chemotherapy as ordered by Dr. Nguyen. Michael returned to the clinic on the 24th to see Linda Degennaro, NP. They discussed his recent chemo, which he had tolerated well. His latest CEA drawn on September 13 was 44.7, down slightly from that drawn on August 29 but still markedly elevated. Michael was taking a number of naturopathic supplements to support his immune system and was on an alkaline diet. He felt surprisingly well.

Dr. Nguyen wrote on letter in Michael’s behalf on October 2, 2014:

“To Whom It May Concern: I am the treating physician for Michael Beachwood, who requested that I summarize his clinical situation and outline his expected prognosis. Mr. Beachwood underwent sigmoid colectomy on 2/26/13 for a T3N2 stage IIIB colon cancer. He subsequently was treated with adjuvant chemotherapy, but this was complicated by hepatitis A infection and was stopped early.

He remained well until 2/10/2014 when a CT scan showed that he developed a metastatic recurrence of the colon cancer in the L lobe of his liver. Definitive diagnosis was difficult at the time but he eventually had a biopsy of the liver mass, which confirmed metastatic colon cancer. He deferred palliative chemotherapy until 9/2/2014, at which point he started treatment with FOLFOX – bevacizumab.

I have discussed with the patient that he has an incurable cancer, but that treatment with chemotherapy may prolong his life. Without chemotherapy, median survival is typically less than 12 months from time of development of metastatic disease. Multiple clinical trials have demonstrated that treatment with chemotherapy can increase median survival to approximately 20-24 months once a patient develops metastatic disease.”

Michael continued therapy with the addition of oxaliplatin on October 6, but unfortunately he had an adverse reaction to it and it had to be stopped. He resumed therapy on October 14, with the initiation of Leucovorin/5FJ.

On December 1, 2014, Michael had the first good news he had in a long time. He returned to Maui Memorial Medical Center for another CT of his chest, abdomen and pelvis. Earl Nishimura, MD performed the exam and identified an interval decrease in the size of Michael’s liver metastases.

Michael returned to the Kaiser Oncology Clinic on December 28 and saw Ryan Takamori, MD. They discussed his recent imaging results and ongoing treatment plans. With a reduced tumor size and given Michael’s adverse reaction to the most effective chemotherapy, Dr. Takamori told Michael that liver resection was the optimal next step for him. Michael requested that they proceed with this option.

On January 12, 2015, Michael was admitted to Maui Memorial Medical Center, where Dr. Takamori performed an exploratory laparotomy, a resection of segment 3 of the liver, a wedge resection of the right hepatic lobe metastatic lesion, and a caudate lobectomy. The tissues were submitted to pathology, and these were confirmatory of metastatic adenocarcinoma. All three specimens resulted in cancer-free margins.

Over the next few months, Michael went home to recover from surgery. On March 6, he started another course of chemotherapy with FOLFIR/Cetuximab. He developed a severe rash with pruritus and discomfort after cycle 2, which was managed with doxycycline. On April 13, he returned to the Oncology Clinic and saw Ellen Chuang, MD in follow-up. She planned to follow him with monthly CEA checks.

Michael is understandably bitter about his experience of being exposed to hepatitis A at a time of his life when it could not have been more important to avoid infections of any kind. He is quite justified in his belief that, but for his hepatitis A infection, he could have successfully completed a full course of chemotherapy at a time when his tumor was confined and his cancer was at a lesser stage III.

As stated previously, in September, 2013, Dr. Keyes, Michael’s oncologist, discussed with him the extremely difficult time Michael had with his last cycle of FOLFOX adjuvant chemotherapy, with significant fatigue, nausea, and abdominal discomfort. Dr. Keyes wrote in the chart note: “He feels that the hepatitis may still be affecting him, which is likely the case.” Dr. Keyes commented further: “Given the delay in treatment due to his hepatitis I am uncertain as to whether he would have significant benefit from further adjuvant chemotherapy. He is inclined not to continue with chemotherapy.”

Huy Nguyen, MD, is a practicing hematologist and medical oncologist at Kaiser Permanente in Honolulu, HI, and assumed care of Michael from Drs Ming He and Ted Keyes during the period of June 6, 2014 through August 14, 2014. Dr. Nguyen agrees with Dr. Keyes’ assessment that the hepatitis caused a delay in treatment of Michael’s cancer, with devastating effects:

Due to the hepatitis A infection, his liver function remained abnormal even upon hospital discharge. His third cycle of FOLFOX chemotherapy required a dose reduction and was also delayed by 47 days while awaiting sufficient liver recovery to resume chemotherapy. The fourth cycle followed on time, but his fifth cycle of chemo was delayed an additional 7 days. Per Dr Keyes’ assessment, his ability to tolerate chemotherapy was significantly diminished following his hepatitis A infection and further treatment was aborted after the fifth cycle was given on 8/26/13.

In fact, it is Dr. Nguyen’s opinion that Michael had a 75% chance of being cancer free within five years[3], had he received the appropriate treatment that was rendered impossible by the hepatitis infection:

It is my opinion that the hepatitis A infection significantly compromised the treatment of Michael’s colon cancer. For patients such as Michael with stage IIIB colon cancer, the standard of oncologic care is surgical resection followed by 12 cycles (6 months) of post-operative FOLFOX chemotherapy without dose adjustment or interruption if possible. Based on his age, overall health and pathologic stage at the time of diagnosis, appropriate treatment would have given Michael an approximately 75% chance of being disease free at 5 years, which is a medical surrogate for cure in colon cancer.

Michael shares his thoughts about this:

… The Thompson Farms/Costco HepA caused me to have to discontinue Chemo. As such, the cancer was allowed to become resistant to the drugs, and then spread to the one organ that the Thompson Farms/Costco’s HepA weaken the most: my liver. Liver had 4 cancer tumors on it.

The Thompson Farms/Costco’s HepA, has caused my cancer to go from STAGE 3 TO STAGE 4, reducing my life expectancy from 5 to 10 years to 12 to 18 MONTHS!!!!!! Thompson Farms/Costco HepA has taken 8 years life expectancy from me.

AS A RESULT, I have had to take 7 rounds of chemo, in 2014. Side effects, hives, nausea, fatigue, unable to work, wife unable to work, as she is the caregiver and driver for my chemo sessions.

These circumstances of going from a life expectancy of 5-10 years, to 18 months, has caused EXTREME stress and worry for both of us, most notably to Sheryl, who is looking at a bleak future, and still has to carry on the caregiving duties. We are both suffering from PTSD, Sheryl is now in counseling.

Now after surgery, I have to take 24 chemo sessions, as I am still STAGE 4 (and always will be). Here are the side affects: Extreme rash on chest, back and face and head, fatigue, nausea, cracks in heels of feet and on tips of fingers, loss of hair. As of this writing, I am on #10 of 24 chemo sessions.

The causal link between Michael Beachwood’s hepatitis A infection and Townsend Farms Frozen Organic Antioxidant Blend Frozen Berries is clear. On April 20, 2013 Mr. Beachwood purchased two bags of the frozen berry blend at Costco store #119 located in Kahului, Hawaii. He consumed the product in homemade smoothies over the next several weeks.

On May 1, 2013 Michael Beachwood began to experience fatigue, muscle aches and shortness of breath. His symptoms continued and worsened over the next few weeks. A blood specimen collected on June 3 was reactive to IgM hepatitis A antibodies indicating a recent infection with hepatitis A. This finding was reported to the Hawaii Department of Health who interviewed him about his exposures to hepatitis A and consumption of Townsend Farms frozen berries. Genotyping of Mr. Beachwood’s specimen confirmed he was infected with genotype 1B, the Townsend Farms outbreak strain.

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[1]Tumor >50 mm in greatest dimension; Metastases in 4 to 9 axillary lymph nodes; Metastases through mucosa of colon wall. to submucosa, and to 7 or more nearby lymph nodes. Source of data: NIH. (2015, April 2). Colon Cancer Treatment – States of Colon Cancer. Retrieved June 22, 2015, from http://www.cancer.gov/types/colorectal/patient/colon-treatment-pdq#section/_112

[2] CEA (carcinoembryonic antigen) is a tumor marker, especially for cancers of the gastrointestinal tract. When the CEA level is abnormally high before surgery or other treatment, it is expected to fall to normal following successful surgery to remove all of the cancer. A rising CEA level indicates progression or recurrence of the cancer. This must be confirmed , as the CEA test by itself is not specific enough to substantiate a recurrence of a cancer.  Source: Mayo Medical Laboratories Extended Catalog. Retrieved June 22, 2015, http://www.testcatalog.org/show/CEA

[3] There is nothing speculative about Dr. Nyugen’s opinion concerning Michael’s initial survival prospects. There is a wealth of data for colon cancer survival at five years by stage as demonstrated by the many online cancer survival calculators.

Babrber_Foods_Chicken_Kiev_USDA_large-300x237The Minnesota Department of Health and the Minnesota Department of Agriculture, along with CDC and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS), are investigating two outbreaks of Salmonella Enteritidis infections linked to raw, frozen, breaded and pre-browned stuffed chicken entrees.

In one outbreak, four people infected with a strain of Salmonella Enteritidis have been reported from Minnesota. Two of these ill people have been hospitalized. No deaths have been reported.

In the second outbreak, three people infected with a different strain of Salmonella Enteritidis have been reported from Minnesota. Two of these ill people have been hospitalized. No deaths have been reported.

On July 1, 2015, USDA-FSIS issued a public health alert due to concerns about illnesses caused by Salmonella that may be associated with raw, frozen, breaded and pre-browned, stuffed chicken products.

USDA-FSIS advises all consumers to safely prepare and cook these products. Read more on the Advice to Consumers page.

As a result of the first investigation, on July 2, 2015, Barber Foods recalled approximately 58,320 pounds of Chicken Kiev because it may be contaminated with Salmonella Enteritidis.

The product subject to recall includes a 2 lb.-4 oz. box containing six individually pouched pieces of “Barber Foods Premium Entrees Breaded-Boneless Raw Stuffed Chicken Breasts with Rib Meat Kiev” with use by/sell by dates of April 28, 2016, May 20, 2016, and July 21, 2016.

In 2014 Minnesota Public health and agriculture investigators in identified 6 cases of Salmonella Enteriditis linked to consumption of Antioch Farms brand A La Kiev raw stuffed chicken breast. Illness onsets occurred in August and September 2014. The outbreak strain was isolated in packages purchased at grocery stores.

In addition, similar products were linked to Salmonella outbreaks in 2005 S. Heidelberg2005-6 S. Enteritidis and 2006-S. Typhimurium.

3872463819_9ce1f4113cIn September 2014, the Minnesota Department of Health (MDH) investigated a cluster of six patients diagnosed with Salmonella Enteriditis. Four of five case-patients reported eating Chicken Kiev, purchased as a raw, frozen, breaded and pre-browned chicken entree. Illness onset dates ranged from August 17 to September 26. One person was hospitalized. There were no deaths. All six patients were infected with an indistinguishable genetic strain of Salmonella Enteriditis as determined by Pulsed Field Gel Electrophoresis (PFGE). Isolates from all six case-patients were indistinguishable by whole genome sequencing.

Several patients told public health investigators they could not remember the brand name but described the packaging as “red and clear.” Other patients reported the brand as “Antioch Farms”. The Paulson family and another outbreak associated case patient had leftover product which was collected by health officials and tested for Salmonella at the Minnesota Department of Agriculture (MDA) laboratory. Of the home samples collected, 7 of the 11 were confirmed positive for Salmonella. Salmonella serotype Enteriditis was confirmed in 6 of the 7 positive samples. MDH conducted PFGE on isolates cultured from food collected from patients’ homes. Isolates obtained from patients and Antioch Farms brand Chicken Kiev collected at their homes were a 2-enzyme PFGE pattern match.

Minnesota Department of Agriculture (MDA) staff also collected samples of Antioch Farms brand A La Kiev raw stuffed chicken breast from grocery stores for testing at the MDA laboratory. In total 30 samples were collected and tested. Of these, 26 confirmed positive for Salmonella. Nine confirmed positive for Salmonella Enteriditis, and 17 confirmed positive for Salmonella serotype Schwarzengrund.

On October 23, 2014 MDA and MDH issued a joint press release alerting the public of the cases of salmonellosis and their link to Antioch Farms Chicken Kiev.[1] This was followed by a recall announcement by Aspen Foods Division of Koch Meats, a Chicago based establishment. The company recalled 28,980 pounds of chicken products with sell dates of October 1, 2015 and October 7, 2015.[2] These products were shipped to retail stores and distribution centers in Minnesota.

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[1] http://www.health.state.mn.us/news/pressrel/2014/salmonella102314.html

[2] http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2014/recall-073-2014-release

781439300328Well, actually, this in number five.

Minnesota state health and agriculture officials said today that seven recent cases of salmonellosis in Minnesota have been linked to raw, frozen, breaded and pre-browned, stuffed chicken entrees. Investigators from the Minnesota Department of Health (MDH) and the Minnesota Department of Agriculture (MDA) determined that the illnesses occurred in two separate outbreaks, involving two different strains of Salmonella bacteria in products from two distinct, unrelated producers.

In the first outbreak, four illnesses occurring from April 5 through June 8 were linked to Barber Foods Chicken Kiev. This product has a U.S. Department of Agriculture (USDA) stamped code of P-276. This product is sold at many different retailers, including grocery store chains. The four cases in this outbreak ranged in age from 19 to 82 years, all from the metro area, and two were hospitalized.

In the second outbreak, three people got sick from May 9 to June 8 after eating Antioch Farms brand Cordon Bleu raw stuffed chicken breast with a U.S. Department of Agriculture stamped code of P-1358. This product is sold at many different grocery store chains. The three cases were all adults in their 30s and 40s from the metro area, and two were hospitalized.

No deaths have been linked to either outbreak. MDH and MDA are working with USDA’s Food Safety and Inspection Service (FSIS) on the investigation. The investigation is on-going.

With these two outbreaks, there have now been nine outbreaks of salmonellosis in Minnesota linked to these types of products since 1998.

In 2014 Minnesota Public health and agriculture investigators in identified 6 cases of Salmonella Enteriditis linked to consumption of Antioch Farms brand A La Kiev raw stuffed chicken breast. Illness onsets occurred in August and September 2014. The outbreak strain was isolated in packages purchased at grocery stores.

In addition, Plant 1358 Aspen Foods was linked to Salmonella Outbreaks in 2005 S. Heidelberg2005-6 S. Enteritidis and 2006-S. Typhimurium.

Chicken_Cordon_Bleu_I-11-300x249The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns about illnesses caused by Salmonella that may be associated with raw, frozen, breaded and pre-browned, stuffed chicken products. These items may be labeled “chicken cordon bleu” or “chicken Kiev”.

FSIS was notified of, and is investigating with the State of Minnesota, a Salmonella Enteritidis illness cluster on June 23, 2015. FSIS suspects that there is a link between the frozen, raw, breaded and pre-browned stuffed chicken products and this illness cluster based on information gathered in conjunction with the State of Minnesota Departments of Health and Agriculture. Using epidemiological evidence, case-patients have been identified in Minnesota with illness onset dates ranging from May 9, 2015 to June 8, 2015.

Additionally, on June 24, 2015, FSIS was notified of, and is investigating with the State of Minnesota, a second, separate Salmonella Enteritidis illness cluster with another strain. FSIS suspects that there is a link between the frozen, raw, breaded and pre-browned stuffed chicken products and this illness cluster based on information gathered in conjunction with the State of Minnesota Departments of Health and Agriculture. Using epidemiological evidence, case-patients have been identified in Minnesota with illness onset dates ranging from April 5, 2015 to June 8, 2015.

The products the illnesses may be associated with appear to be ready-to-eat, but are in fact raw and need to be fully cooked before consumption. Frozen, raw, breaded and pre-browned stuffed chicken products covered by this alert and similar products, may be stuffed or filled, breaded or browned.

Screen Shot 2015-07-01 at 9.18.53 PMStewart, you and your counsel can complain all day that you could have proved the opposite, but that would not have worked.

BOBBY RAY HULLETT’S SALMONELLA ILLNESS AND DEATH

Bobby Ray Hullett, known to friends and family as Pete, and his wife Shirley lived in Maiden, North Carolina. The Hulletts were married for forty-five years and worked together at the Southern Glove mill for thirty years. Pete was a soft-spoken man who worked all his life. Early in his career at Southern Glove a huge press crushed one of his hands leaving him with one functional hand. Despite his hand injury, Pete continued to work uninterrupted at Southern Glove until his retirement shortly before his death.

Pete was also able to take care of the house, garden, and car, which he loved to tinker with. A man of quiet pride, Pete never complained about his misfortune, and taught his sons to never make excuses for themselves. Pete liked football, bowling, and wrestling, but he loved NASCAR. Pete and Shirley were also devoted to their church, which they attended three times a week, and they especially enjoyed the gospel choir. Pete always provided for his family and was Shirley’s constant companion throughout the decades of their marriage.

Shirley Hullett had two young boys from a prior marriage when she married Pete. Pete helped raise the boys, Tony and Dale, and was the only father they knew. When Dale was only seventeen he had a son himself. Dale turned to Shirley and Pete to be surrogate parents. And so Shirley and Pete also raised Dale’s son Bobbie who is now thirty-five and remains devoted to his grandmother. Dale passed away from complications from chronic liver disease in his early 50’s.

At the time of his illness and death, though on high blood pressure and cholesterol medications, Pete was a very healthy person. He was also a frequent consumer of Austin-brand peanut butter crackers. In fact, in the days leading up to the illness that would take his life, Pete ate the crackers as a snack two or three times a day.

Pete’s symptoms began on November 23, 2008, with vomiting and severe dizziness that eventually caused him to lose consciousness and collapse on the kitchen floor. That night, he suffered from excruciating abdominal cramps and experienced multiple bouts of both watery diarrhea and vomiting. The next morning, the severity of Pete’s illness became dramatically apparent. Shirley recalls:

By Sunday night he thought he had a virus, he was up and down all night throwing up and with diarrhea. Monday morning he had gotten up and felt very weak, he took out the trash and came back into the house. He then collapsed on the kitchen floor, and I could not get him up. He asked me to call my son Tony to come help. Tony got off work and immediately came to the house. Tony did not want to wait for the ambulance, so he picked Pete up and put him in the car and drove to the hospital.

In the emergency room at Catawba Valley Medical Center in Hickory, North Carolina, doctors assessed Pete’s condition. After triage in the ER, Bernard Crain, MD, who recorded a blood pressure of 84/56 and pulse of 129, saw Pete. Pete was rehydrated, which brought up his blood pressure slightly, and was given oxygen by mask. Dr. Crain also ordered intravenous Phenergan for Pete’s severe nausea.

Despite being very ill, Pete was able to give a medical history, reporting no heart attack or diabetes, and no prior surgeries or other major health concerns. Dr. Crain ran an EKG that was compared to one done in 2004, and while no significant pathology was suspected, the strip did show sinus tachycardia with a heart rate around 130[1]. Pete had to suffer the placement of a Foley catheter and urine and blood specimens were sent to the lab.

Pete’s lab results were abnormal, indicating decreased kidney function by an elevation in his BUN and creatinine.[2] He was also acidotic, having an increased amount of carbon dioxide in his bloodstream.

Pete was in kidney failure, ill with severe ongoing gastrointestinal symptoms, and had to be admitted to the hospital for further care. Kenton Sanders, MD, saw Pete next, shortly after 5:00 PM on November 24. At this point, Pete was still coherent enough to offer Dr. Sanders a detailed medical history. He related that he had no recent history of antibiotic usage; that he had a vague history of multiple sclerosis for three years; and that he had recently been taking Lipitor, baby aspirin, and another blood pressure medication.

Upon examination, Dr. Sanders thought Pete appeared ill and “quite fatigued.” An abdominal exam revealed tympany to percussion[3], but bowel sounds were present, and there was no tenderness noted. Because of Pete’s severe and ongoing diarrhea, Dr. Sanders’s impression included the comment, “The room has the smell of Clostridium difficile,” and included the diagnosis of acute onset nausea, vomiting and diarrhea suggestive of gastroenteritis. He further indicated that Pete’s kidneys had likely failed as a result of “a prerenal component,” which is a reference to the severe volume depletion and dehydration Pete had experienced as a result of his gastrointestinal losses.

Dr. Sanders admitted Pete to the medical floor on telemetry and pulse oximetry, and he continued his IV fluids and oxygen. He began Pete on the antibiotic Flagyl, and ordered that samples of stool, urine, and blood be tested.

Less than an hour after seeing Dr. Sanders, Pete suffered additional bouts of green, foul-smelling diarrhea. The nurse checked on him periodically to make sure that he was as comfortable as possible under the circumstances. When rechecked around 8:00 PM, the nurse reported that Pete was lethargic, but very alert and oriented, and that he was responding appropriately to questions.

Shortly after 11:00 PM, however, the complexion of Pete’s illness began to change. A portable chest x-ray had been done, which showed no change, and afterward a nurse checking on Pete found him having notable shaking that had not been present just minutes before. His pulse was high—in the 140-150’s—and Pete began talking incoherently. He was also unable to follow the simple command of opening his eyes when prompted. A portable pulse oximetry read 54% on two liters of oxygen, so the nurse increased the oxygen to three liters. There was, however, no change in Pete’s oxygen saturation. The nurse immediately called Dr. Sledge, who ordered that Pete be transferred to the critical care unit (CCU).

In the CCU, Pete was unresponsive when lifted into bed. Shortly thereafter, at just before midnight, the lab called Dr. Sledge to notify him that Pete’s lab values were grossly abnormal and consistent with severe metabolic acidosis.[4]

Just after midnight on November 25, 2008, an electrocardiogram was done that was abnormal, showing sinus tachycardia and signs of an acute myocardial infarction. Dr. Sledge made an addendum note:

I was called by 3rd floor nursing staff due to decreasing level of consciousness and decreasing blood pressure. Patient has been transferred to ICU. ABG reveals severe metabolic acidosis. He was started on bicarb drip earlier tonight by Dr. Sanders due to shallow respiratory and unresponsiveness and will need intubation. I discussed code status with the wife. She wants everything done. Will ask anesthesia to insert ETT and central line.

In the early morning hours of November 25, Thomas Hill, MD, inserted a left subclavian central line and an endotracheal tube (ETT) for mechanical ventilation. Once these were in place, the results of another arterial blood gas study again showed severe metabolic acidosis. A short while later, Pete’s level of consciousness increased, allowing him to better appreciate what was going on. This frightened him badly and, ultimately, wrist restraints had to be used to keep him from pulling out the central line and ETT that Dr. Hill had just inserted. For Shirley, seeing her husband in restraints in the midst of his suffering was profoundly upsetting. Pete seemed to be getting worse by the hour despite the doctors’ efforts.

Physician notes around 2:10 AM indicated that Pete’s urine output was poor, despite receiving two liters of normal saline and ongoing fluid hydration. The differential diagnosis now listed shock, acute renal failure, diarrhea with white blood cells in the stool, and still questioning C. diff, although by history Pete had not been on any recent antibiotic therapy[5]. Respiratory failure was also now listed in the differential along with metabolic acidosis. Laboratory results at 2:43 AM showed liver dysfunction and continued kidney dysfunction.

At 4:00 AM on November 25, 2008, Pete was awake and looking at the nurse, squeezing her hands, and moving his toes on request. However, at 5:00 AM, blood gas alarm values were reported by the lab, again with significant metabolic acidosis, as reported to Dr. Sledge.

Pete’s family was in the room with him at 7:00 AM when the ICU/CCU physician came in to see him. He explained to them that Pete had suffered an acute myocardial infarction (MI) with cardiogenic shock and that his prognosis was poor. He was producing very little urine and was in acute renal failure. He remained on the ventilator, and the doctor indicated in his chart notes that Pete might not survive the day.

For Shirley, Pete’s hospitalization was a long nightmare. She never spoke to him again after Tony took him to the hospital because he was on a ventilator; she could only watch his torment as his life ebbed away. Her memories are vivid:

He had needles stuck in him, it seemed like there were fifteen to twenty needles total. I told him I loved him, I asked him if he loved me and with a pitiful look he nodded his head yes. It broke my heart to see him in this condition; the doctor told my family and myself that there was not a doctor in the United States that could save him. Every organ in his frail body was shutting down,

At 9:00 AM on November 25, Pete was awake but lethargic. The doctors gave him vasopressors to keep his blood pressure up. He still wore the wrist restraints so he would not pull out his breathing tube. The doctor came in to discuss Pete’s condition with the family again. Tony recalls that while Pete was unable to talk, his eyes reflected the pain of his overwhelming infection.

At about 9:30 AM, Sanjay Patel, MD did a cardiology consultation. Dr. Patel reviewed the history that had brought Pete to the ER and his subsequent admission event. He noted no prior cardiac history but that Pete had reported hypertension and hyperlipidemia. Pete’s cardiac labs were consistent with a recent infarct. Dr. Patel’s impression was shock with a possible cardiogenic component, but with his concurrent renal failure thought the cardiac component to be less likely. He agreed that Pete’s prognosis was not good.

At about 11:00 AM the same day, the laboratory called an alarm value to Dr. Kaariainen, which was to report that the blood cultures drawn the day before were showing positive growth of gram-negative rods. At about 12:25 PM, an IV with the antibiotic Levaquin was started. At 4:00 PM, Pete accidentally pulled out his arterial line, and respiratory therapy came in to try to place a new one without success.

At 10:00 PM that night, Pete was still alert enough to move his arms and feet a little when asked, but his hands were cold and cyanotic to exam. Serology for C. diff was negative. A stool sample was positive for occult blood, but negative for the protozoan parasites Giardia and for Cryptosporidia.

At midnight on November 26, 2008, Pete was still alert and oriented, but lethargic. But by 4:00 AM on the 26th Pete’s level of consciousness was declining. His eyes were partially open, but there was no response to verbal stimulation. The doctor discussed Pete’s grave and worsening condition with Shirley. Pete was no longer responding, although his eyes were open and he appeared to look around. His laboratory results reflected progressive organ failure.

At 8:00 AM nurse notes indicate that Pete was obtunded but did arouse to pain. Dr. Luney came in to evaluate him and reviewed his chart and labs, and confirmed his prognosis was grave. He continued to diagnose shock, hypotension, acidosis, and multiple organ system failure, now with lab evidence of liver failure as well as renal failure.

At 11:30 AM on November 26, hospice came in to consult with the family and to discuss the procedures they should follow when Pete experienced cardiac arrest, which they fully expected. They decided on a partial code procedure, as they were still awaiting other family members to arrive and did not want to terminate life support until later in the week.

Pete continued to decline throughout the day on November 26. His heart rhythm worsened and though his blood pressure held at greater than 100 systolic, he remained unresponsive and his skin continued to show mottling. At 6:20 PM, Pete’s blood pressure suddenly fell, and drugs to support blood pressure were given, but had no effect. Pete’s family was summoned. As Shirley and Bobby entered Pete’s room, Pete rose up slightly from his bed to look at them, fell back, and was gone.

With his family at his bedside, Bobby “Pete” Hullett was pronounced dead at 6:32 PM on November 26, 2008, the day before Thanksgiving.

Two days later, Pete’s blood cultures were finalized as positive for Salmonella group. In his “Death Summary,” of November 26, Dr. Kaariainen included the following diagnoses at death:

  1. Multifactorial shock including cardiogenic shock, septic shock and hypovolemic shock
  2. Respiratory failure with ventilator support and significant difficulty Inadequate oxygenation despite 100% FI02 saturation settings on the ventilator
  3. Large acute myocardial infarction, troponin peaking at 45
  4. Acute liver failure from shocked liver
  5. Severe oligo-anuric acute renal failure from acute tubular necrosis from shock
  6. Severe underlying metabolic acidosis including lactic acidosis, suspected likely ischemic colitis
  7. Ongoing upper gastrointestinal bleeding with anemia
  8. Hyperkalemia
  9. Leukocytosis
  10. Multiple other medical comorbidities contributing as noted In the admission history and physical

Dr. Kaariainen commented, “He was felt to be in shock from a multifactorial etiology including cardiogenic shock from his acute MI, hypovolemic shock from diarrhea and dehydration, as well as probable sepsis from an intra-abdominal source given his severe unresponsive metabolic acidosis and lactic acidosis.”

The “Death Summary” also explained that Hickory Cardiology Associates was consulted and that Pete was treated medically for his acute MI with the limitation that “we were unable to use significant doses of ACE inhibitors or beta blockers given his already pre-existing acute renal failure and hyperkalemia as well as his profound hypotension.”

On December 23, 2008, Pete’s stool culture that had been collected on November 25, 2008 was issued the final result: positive result: SALMONELLA TYPHIMURIUM – HEAVY GROWTH.

CAUSATION

It is clear that Mr. Hullett’s Salmonella infection and death are directly linked to his consumption of contaminated Austin-brand peanut butter crackers manufactured by Kellogg Company.

Specifically, Mr. Hullett consumed Austin-brand peanut butter crackers on a near-daily basis in the days leading up to the onset of his illness in November 2008. The crackers were purchased as a local Food Lion grocery. He began to suffer from symptoms consistent with a Salmonella infection around November 23, 2008, and a stool sample submitted on November 25, 2008 confirmed his Salmonella infection. Also, a blood sample collected on November 24, 2011 cultured positive growth of gram-negative rods, confirming that bacteria were in his blood stream.

Further testing revealed that he had been infected with Salmonella serotype Typhimurium. Pulsed Field Gel Electrophoresis (PFGE) fingerprinting of the bacterial isolate revealed a genetic match to the pattern linked to the nationwide outbreak strain of Salmonella associated with contaminated PCA peanut product used by Kellogg Company in the manufacture of its peanut butter crackers.

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[1]           There were also frequent premature ventricular contractions, but the doctors felt that was unchanged from Bobby’s prior EKG.

[2]           Creatinine is a breakdown product of creatine, which is an important part of muscle. A serum creatinine test measures the amount of creatinine in the blood. The normal range (NR) for creatinine is <1.2. A high level of serum creatinine is a marker of poor kidney function, because its presence at high levels shows that the kidney is not functioning properly to eliminate this by-product from the blood. The other such marker used is blood urea nitrogen, or BUN, which forms when proteins are broken down. The normal range for BUN is 5-17.

[3]           Tympany on a physical exam is a resonating sound typically due to intestines distending with gas.

[4]           Metabolic acidosis often occurs in the setting of acute renal failure as the kidneys normally remove acid from the body.

[5]           Clostridium difficile bacterial infections often occur in patients who have recently taken antibiotics with the resulting disruption of their normal intestinal flora which creates an opportunity for C. diff. to overgrow resident bacteria and cause diarrhea. Pete would test negative for C. diff.

Today, the Court in Georgia Federal Court in the criminal case against Stewart Parnell, et al., allowed the defense to question whether PCA and Stewart Parnell was responsible for the death of nine.  Yes, you were and here was one of them.

Screen Shot 2015-07-01 at 8.36.04 PMCLIFFORD TOUSIGNANT’S SALMONELLA ILLNESS

The Early Years

Clifford Frederick Tousignant (Cliff) was born in Duluth, Minnesota, in 1930, to Violet and Clifford Tousignant, Sr. He was an adventurous and fearless young man, known for his introspective nature and generous heart. At the age of 16, Cliff joined the Army in the Civil Air Patrol. He loved the military and serving his country, a duty he maintained for 22 years.

During that time, he fought in the Korean War and earned three purple hearts. The only thing Cliff loved more than his country was his family. He had six children—Paul, Marshall, Susan, Calvin, Jane, and Lou, and eventually became a grandfather to fifteen children, and a great-grandfather to fourteen children. As his family recalls, “He could often be seen with them crawling all over him. He loved every minute of it and loved being in photos with them as well.”

In addition to his loving nature, Cliff was also known for his generosity. One family story that is told often:

The night of his death I sat and spoke with my brother-in-law, Dan Herrick. He shared a story with me. When he and my sister, Jane, were first married, like many Americans times were tight. My dad would make up reasons to come over and fix things that were never even broken. He would give them money as a way to help them get by. He helped out many of us over the years, including his own parents when he joined the army as a teenager. As long as he had a few dollars in his pocket, he was willing to help others as best he could.

After leaving the armed forces, Cliff entered the security field, working for Frasier Shipyards in Superior, Wisconsin until his retirement.

When Cliff was diagnosed with diabetes, he took it seriously, and did his best to care for himself, but despite his best efforts he lost his right leg to the disease when it was amputated in 1985. He also lost four toes on his left foot. But ever the fighter, he did not let the loss of his leg and toes slow him down. After he purchased a motorized wheelchair, Cliff was as mobile as ever.

A Man Loved By Many

For those who knew him best, Cliff could usually be found enjoying a good football game or sharing stories about his past experiences with friends. As his brother, Robert, recalls, he was a “gentle, soft, loving person. That’s not to say that he was a push-over. Although he did not rile easily, when he did he could be very vocal.” Cliff had no qualms about standing up for what he believed to be right.

The memories and stories of those he left behind after his untimely death are the only true way to explain what an extraordinary man, father, grandfather, brother, and friend Clifford Tousignant was to those who knew and loved him. What follows are some of those family memories:

***

My parents divorced when I was 23 years old. My father never dated to much after that so he was pretty much on his own. Of course, that made me want to include him with my family much more at the time. At that time my husband and I had only 1 child our daughter Sarah. We spent one to two days a week with my Dad. Having him over for dinner or him always wanting to take us out to eat. When Sarah was 6, I became pregnant with my 2nd child. We were so excited as was my Dad. Close to my due date, my Dad came down to where I was working to take me to lunch. I had been having a backache all day. I remember him saying ” Maybe you’ll have your baby later today.” I did. My son Brian was born that evening. I called my Dad, he was so happy and showed up at the hospital early the next morning to meet his new Grandson.

As much as he always loved holding the babies and hugging all of his grandkids, he and Brian would just grow closer as Brian got a little older. Being a military man my father just related to guys better. He and Brian became very close, with Brian spending many nights at grandpa’s place. My Dad did so many things for him and with him. He took him on train rides, boat rides, sent Brian flying in a small airplane and just waited on the runway for his return. Brian loved to always go and spend the night at Grandpa’s. It was special, just the two of them. We spent every Thanksgiving with him for years. We always had a birthday party here with our kids on his birthday and on theirs.

It was never a surprise for the kids to come home from school and find their Grandpa here. Brian started to play football at age 12. Now football was my Dads most favorite thing. I’d always go pick my Dad up and off to the game we’d go. Brian’s games were on Saturdays and my husband was always working so my Dad was my loyal companion. He’d sit out there with me in the rain and cold and never complained. He loved that Brian was playing football. My Dad went to every single game with me for 4 years until he moved to Brainerd. My brother Marsh even brought him back here to attend one of Brian’s high school games.

When my brother Marshall retired, he moved my Dad to Brainerd. At that time I was working full time, had one child in college and one in high school. Life was very busy. My Dad spent about 3 years in Brainerd before he passed away. It was nice for my brother and his family to get to spend a lot of time with Dad. It was so different having my Dad not here in Duluth, but I knew my brother and his family were taking good care of him. We’d see him when we could get down there and call. Marshall brought him back to Duluth lots of times so we were still able to see him here in Duluth too.

The last time I saw my Dad was on December 31, 2008. My husband, Sarah, Brian and myself visited him in the hospital in Brainerd. It was hard to see him so sick. He was in the hospital being treated for food poisoning. He looked so happy when we walked into that room. We had a great visit with him that day. I will always be so thankful for that day. I left that day feeling so sad to see him like that but I knew my Dad would get though this because he had always bounced back from everything. I spoke with Marshall, getting updates, just waiting for him to get better. On Sunday January 11, 2009, Marshall called to tell me that he was putting Dad back in the hospital. The next morning Marshall called to tell me that our Dad was gone.

This was devastating to us. This man who had been such a big part of our lives was no longer here. At first I couldn’t get past the shock of it. As more details of how he got the food poisoning came out I just got really angry. My father should not have died from eating peanut butter! How unfair is that? Someone precious to my whole family was taken before his time. We miss him so much.

***

My father raised me on his own from 7th grade on when he and my mother divorced. He and I drove out to Las Vegas together and lived there for a while while I was in Jr High. We then moved back to Duluth and lived there together all through High School. Every time I moved during college (5 times) he was there to help. When I was injured in a severe diving accident he was there. Often times I was asleep in my hospital bed and would wake up; he was there sitting next to me. Not saying a lot but by my side.

My father was a guy that was always helping someone. He did it when he was in the army in Korea, he did it when he came back here after the war and as a person on a very fixed income was helping his brothers and sisters. He wasn’t a man that needed much but was willing to help those that were in need.

He will not only be missed by his children but his siblings, his grand kids and great grand kids. My son will only have fleeting memories of him because he was taken from us at a young age. I purchased season tickets to the new open air Gophers football stadium. He will never be able to go and enjoy an outdoor football game for the team that he loved and that I love now as well. I was recently scrolling through my blackberry and came across his number. I can’t bring myself to delete it. I wouldn’t have to be making a decision like that if he was still with us today.

***

Cliff and I were 20 years apart. He was in the army and when he came home on leave he stayed with his family. His oldest son, Paul, is only one year younger than me so I remember a lot of hectic times. My parents always told me that when Cliff went in the service at 16 years old, he would send his whole check back home to my parents because of the tough times they were going through. Cliff owned a home in Duluth and when the youngest, Louis, was born, Luella (also known as “Toots”), Louis’ mother, had to go back to the hospital with blood clots. I stayed at their house for a month helping out. That’s when I really got to know my brother.

When his wife left him taking all the furniture, but leaving Cliff to raise Louis, I was very supportive of Cliff. I found him a lawyer and went to all court dates with him. Our mother was in a nursing home for 18 months and every weekend I would bring her home and Cliff would come over on Sunday for BLTs with her. When Cliff moved to Brainerd, I talked to him every week. My husband and I went to see him every spring and fall.

I have Rheumatoid Arthritis and ended up disabled. My husband’s company ended after 12 years. Cliff sent $50.00 to us every month for 2 years until my husband could get social security.

Cliff’s Exposure and Salmonella Infection

In late 2000, Clifford moved to Brainerd, Minnesota to live with his son, Marshall. He remained there until November 14, 2008, when he moved into the Good Samaritan Woodland Skilled Nursing Facility, also in Brainerd.

On Friday, November 14, Cliff arrived at his new home. At the time of his admission, Cliff’s health issues were limited to diabetes mellitus, which had caused nerve damage, pain, and numbness in his hands and feet, gastroesophageal reflux disease (GERD), high cholesterol, and autoimmune thrombocytopenia (low platelet count). Cliff’s thrombocytopenia was being well controlled with twice monthly treatments of platelet infusions. His baseline platelet count was determined to be 20,000—a number achieved immediately following a platelet transfusion. Over the days following the transfusion treatment, the platelet level would slowly drop. Once the number dipped below 15,000, another platelet infusion was given.

With regard to Cliff’s diabetes, Marshall—who lived just a short drive away—continued to see his father on a near-daily basis and took part in monitoring his insulin doses.

The move to Good Samaritan Woodland was a good fit. It allowed Cliff to explore his sociable nature while also be under the attentive care of skilled nurses. As was noted in an early intake:

He does like to visit and talk to people. When he is feeling good he likes to take his scooter outside and ride to the clinic or out to eat. Mr. Tousignant has a friendly and upbeat attitude. [He] appears to cope well with change. Resident has good support from his son who lives in the area and visits often.

Cliff got to know his neighbors well, and was frequently found chatting them up. He also enjoyed the meals at Good Samaritan Woodland, one of his favorites being peanut butter sandwiches, a meal he ate almost daily.

His new life at Good Samaritan Woodland continued without much excitement through December. Early in the month he did have a persistent cellulitis on his right arm that required a brief hospitalization at St. Joseph’s Medical Center, but he was otherwise doing well.

All was well until a marked change occurred on Sunday, December 28. That day, Cliff began to have diarrhea. When staff members at the nursing home were made aware of the development, they obtained a stool sample and sent it to the St. Joseph’s Medical Center lab to be cultured and tested.

Throughout the rest of Sunday and into the next day, the frequency of Cliff’s diarrhea episodes increased steadily. When checked on Monday morning, he had passed a large stool and was in distress over the situation. He demanded to be taken to the hospital for treatment.

Cliff’s son, Marshall, arrived a short time later to visit and calmed him down a bit. But the diarrhea and abdominal cramping continued without relent. He was given Imodium, but it did little to slow the frequency of his loose stools.

Hospitalization One—December 30, 2008 to January 4, 2009

On Tuesday, December 30, he was again noted to have “loose brown stools” and additional amounts of Imodium were provided. Dr. Halverson became concerned, as dehydration can be a serious health risk with profuse diarrhea like that afflicting Cliff. He gave orders for Cliff’s transfer to the St. Joseph’s Medical Center emergency room for further evaluation. Marshall was called and notified of the decision. At approximately 10:40 AM, an ambulance arrived and he was transferred to the hospital without incident.

While in the ambulance, he was given IV fluids and a check of his blood pressure revealed it to be elevated at 149/80, along with a blood sugar level of 217. The ambulance arrived at the ER in about five minutes. He was promptly examined and noted to be suffering from diarrhea—at least three to five episodes per day—over the previous days that was described as “pure water,” with some mucus and very foul smelling. His platelet count had dropped to a low 11,000, and thus a transfusion was ordered to help with blood clotting. Of note, his right conjunctiva was bleeding at the time of the initial exam.

Cliff was moved to a room a short time after his admittance. His decreased short-term memory retention was noted, but it was not a problem. The results from his stool culture sample obtained on December 28 were still pending at the time, but the treating physician believed his diarrheal illness could be a Salmonella infection or possibly from a viral source. A blood transfusion was initiated at 1:00 PM, improving his platelet count.

Overnight Cliff remained calm, despite the intense pains and diarrhea. In the morning he was re-checked and found to be alert and oriented. His blood pressure was checked and had come down to 126/68, a significant improvement from the day prior. Later that afternoon the results of his stool culture were finalized and revealed the reason for his declining health—he was infected with Salmonella. He was discontinued on the antibiotic Rocephin and changed to Bactrim.

Although he remained connected to IV fluids, Cliff’s urine output began to decrease. He was therefore encouraged to sip juice and other fluids frequently. After nearly a week of profuse diarrhea, his rectum and scrotum were unsurprisingly red with irritation and bloody drainage. His treating physicians were worried about infection of that area, making frequent cleanings of the perianal area necessary, but no less pleasant for Cliff. He was noted to frequently “yell out” in pain during the cleanings, and would then become upset and frustrated with his caregiver.

The next day, January 1, 2009, marked the beginning of a new year, and also a slight turnaround for Cliff. He was in better spirits than he had been for the past few days, although he was still having “loose mushy green stools,” albeit a little less frequently. The pain medication was also providing relief from the stabbing abdominal cramps.

The seemingly unending blood draws and cleanings began to wear on Cliff, a man who was normally very sweet and gentle, but who valued his independence and privacy. He particularly dreaded the perianal cleanings, but due to the never-ending diarrhea it was necessary. The skin in that area was significantly compromised, causing constant pain and itching. To Cliff, it was pure misery.

Over the next three days, Cliff’s diarrhea continued to be a problem, as was the related skin breakdown in the perianal area. It eventually became ulcerated, with “bloody abrasions throughout peri area.”

Cliff’s body also ached all over and grew increasingly weak. By Saturday, January 3, he required almost complete assistance just to get in and out of the bed, a marked turnaround for a man previously mobile and independent despite his reliance on a wheelchair. That night, after yet another nurse woke him up and the accumulated frustration got the better of him, Cliff had an angry outburst. It was just too much. Between the blood draws, perianal cleanings, diarrhea, body aches, and required assistance just to get out of the bed, he could not contain himself.

Thankfully the next day, Sunday, January 4, brought some good news. The frequency of Cliff’s bouts of diarrhea had significantly slowed and he was feeling better. Other than keep him hydrated and provide assistance as needed, there was little else the hospital could do at that time to treat his Salmonella infection. He was thus discharged that afternoon to the care of the Good Samaritan Woodland Skilled Nursing Facility and transported by medivan.

Cliff was relieved to be back at the familiar surroundings of Good Samaritan Woodland. But over the next week, he continued to struggle with loose stools that simply would not abate.

Hospitalization Two—Sunday, January 11, 2009

In the afternoon on Sunday, January 11, Marshall stopped by to check on Cliff and visit for a little while. He noticed a shift in his dad’s demeanor, who turned lethargic and agitated before becoming completely unresponsive. Marshall had no idea what was going on, and in a panic went to the nursing station to request an immediate blood sugar check and an ambulance to take Cliff to the ER.

The ambulance arrived at 4:40 PM. Marshall and the nurses relayed the events leading up to their arrival, including that Cliff’s blood sugar had tested 99, then 106. While he was awake, he would not respond to anyone. The emergency medical technicians moved Cliff to the ambulance and sped off to St. Joseph’s Medical Center with Marshall not far behind in his own vehicle.

At the hospital, Cliff was assessed for his unresponsive spell. Marshall had arrived by then and explained that his father was in the hospital just last week for a severe Salmonella infection, and that his diarrhea persisted. The decision was made to admit him again for further tests and motoring, including blood glucose monitoring, IV fluids, and another stool culture.

He was noted to be weak, lethargic, and “in such a state that he cannot carry on any useful conversation.” He also passed two loose, brown, liquid stools shortly after being admitted. A gastrointestinal consultation was requested. It was noted that Cliff was previously treated with Cipro after being diagnosed with a culture-confirmed Salmonella infection, but that he continued to decline. It was further noted that “there has been an outbreak of Salmonella at the nursing home.”

That night, he passed a bloody liquid stool, and began vomiting. The vomiting episodes came frequently, and lasted all through the night. A blood sample collected at the time of admission was cultured and confirmed to be positive for Salmonella—the bacteria had made its way from his gastrointestinal tract into his blood stream. The prognosis was dire.

By morning on January 12, he was completely unresponsive. A plan was made for the insertion of a central line catheter and for the transfusion of platelets to combat his plummeting platelet count, but unfortunately those plans did not amount to anything. At 11:08 AM, Cliff took his last breath and quietly passed away. The final diagnosis—Salmonella Gastroenteritis.

At the time of his death, Cliff left behind six children, fifteen grandchildren, and fourteen great-grandchildren.

CAUSATION

It is clear that Cliff’s Salmonella infection and death are directly linked to his consumption of contaminated peanut butter manufactured by King Nut using peanut butter product manufactured by Peanut Corporation of America (PCA).

Specifically, Cliff consumed peanut butter sandwiches on a near-daily basis in the days leading up to the onset of his illness in late December 2008. He began to suffer from symptoms consistent with a Salmonella infection around December 28, 2008, and a stool sample submitted on that date confirmed his Salmonella infection. Also, a blood sample collected on January 11, 2009 cultured positive for Salmonella, confirming the bacteria was in his blood stream.

Further testing revealed that he had been infected with Salmonella serotype typhimurium. Pulsed Field Gel Electrophoresis (PFGE) fingerprinting of the bacterial isolate revealed a genetic match to the pattern linked to the nationwide outbreak strain of Salmonella associated with contaminated PCA peanut product used by King Nut in the manufacture of its peanut butter.

Dean Norman, MD, a geriatric medicine specialist, reviewed Cliff’s records and provides the following opinion on the relationship between his confirmed Salmonella typhimurium infection and his death:

Mr. Tousignant was 78 years old when he was admitted to Woodland Care Center in November of 2008. His major medical problems included diabetes and diabetic neuropathy resulting in numbness in his extremities, right below the knee amputation and multiple amputations of toes of left foot presumably as complication of diabetes, polycystic kidney disease with high levels of protein in his urine, autoimmune thrombocytopenia (low platelet count and platelets are necessary for adequate coagulation), dementia and hyperlipidemia. He had undergone splenectomy in the past in an attempt to improve his autoimmune thrombocytopenia. Of note, he was on multiple medications including the immunosuppressant medications prednisone and mycophenolate mofetil. Despite these problems, Mr. Tousignant was usually alert, able to carry on a conversation. He required assistance for transferring from bed to wheelchair but was able to self propel himself in wheelchair. He enjoyed watching John Wayne movies and listening to music.

Mr. Tousignant developed mild cellulitis (infection of the skin) of his right upper extremity in early December of 2008 and was briefly admitted to St. Joseph’s Medical Center for intravenous antibiotics and discharged back to the nursing home on oral antibiotic therapy after he showed substantial improvement. However, he was readmitted to St. Joseph’s Medical Center on December 28, 2008 after experiencing several days of diarrhea. In the hospital it was noted that he had bloody drainage from his rectum and he suffered from perianal (around the rectum) discomfort. Subsequent stool specimens were culture positive for Salmonella species but negative for other gastrointestinal pathogens.

His symptoms improved on antibiotics and he was discharged back to Woodland Care Center on January 4, 2009. However, the following week, on January 11, 2009 he was transferred back to St. Joseph’s after his son found him to be unresponsive and he was subsequently found to have hypoglycemia (low blood sugar). A blood culture on admission was positive for Salmonella species with similar antibiotic sensitivities to the original pathogen found on his last admission stool cultures. Despite antibiotic therapy Mr. Tousignant’s condition deteriorated and he passed away the next day on January 12, 2009.

It is my opinion that, to a reasonable degree of medical probability, Mr. Tousignant’s illness resulting in admission to St. Joseph’s Medical Center on December 28, 2008 was due to salmonella enteritis (inflammation of the gastrointestinal tract). Usually this infection is due to consuming contaminated food and is usually self-limited. However, in the elderly and patients whom are immunocompromised as was the case with Mr. Tousignant the infection can result in bacteremia (bacteria in the blood) and overwhelming infection. His final admission to St. Joseph’s was clearly due to worsening salmonella infection as evidenced by salmonella bacteremia and this infection directly led to his demise.

oboise-300x169The Central District Health Department (CDHD) is investigating a Salmonella outbreak associated with the Boise Co-op deli – specifically food purchased from the deli after June 1, 2015.

As of July 1, 2015, approximately 290 cases of Salmonella are associated with this outbreak. Preliminary test results showed Salmonella growth in raw turkey, tomatoes and onion. However, additional laboratory tests are pending and the specific cause of the outbreak remains undetermined.

Salmonella is a bacteria that can cause diarrheal illness in humans. They are microscopic living creatures that pass from the feces of people or animals to other people or other animals. There are many different kinds of Salmonella bacteria.

Salmonella serotype Typhimurium and Salmonella serotype Enteritidis are the most common in the United States.