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.

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 22^nd. 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 31^st and his phone call of the day before. Michael’s liver enzymes were even higher than they were when checked on May 18^th, 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 2^nd, 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 26^th.

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 22^nd 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 22^nd 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 27^th. 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 6^th, 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 24^th 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.