Medical Malpractice/Wrongful Death Complaint
Factual Allegations Re: Treatment for Colorectal Cancer
Margaret Eve Miyasaki


In 1994, Kaiser performed a sigmoidoscopy on Decedent. There was an 11-years interval between this sigmoidoscopy and the one performed on November 15, 2004, the only other sigmoidoscopy performed on Decedent. Examination of the appearance of DecedentŐs anus/perineum was performed on May 13, 2004. A digital examination was done on November 15, 2004 and March 1, 2005. There is no other medical record prior to May 13, 2004 of examination of DecedentŐs anus, perineum, rectum or colon.


Decedent was at high risk for colorectal cancer because of her age, history of hyperlipidemia, history of restricted mobility, and family history of cancer. Ň More than 90% of people diagnosed with colorectal cancer are older than 50,Ó American Cancer Society. Decedent was 74 years old when diagnosed with colorectal cancer. Decedent had hyperlipidemia since 1996. Decedent had restricted mobility due to amputation of portions of both feet because of ischemia caused by diabetes mellitus. Two of DecedentŐs brothers died of cancer when in their sixties.


Regular colorectal polyps and cancer detection procedures should have been a part of KaiserŐs health maintenance plan for Decedent; however, they were not. If symptoms of DecedentŐs precancerous colorectal polyp or cancer had been diagnosed in a timely fashion, then her treatment would have been more effective. The DecedentŐs prognosis for cure would have been in excess of 80% if her cancer had been timely diagnosed, but less than 50% after her delayed diagnosis.


May 2004, 74-year-old Decedent began to experience chronic anal leakage with passage of bright red blood for which she presented to Defendant Kaiser Hospital on two occasions during the following four months, May 14, 2004 and November 15, 2004.


DecedentŐs medical care provider misdiagnosed symptoms, anal leakage with passage of blood, reported to him by Decedent on May 13, 2004, as well as on 05/13/04, and advised Decedent to increase her fiber. An examination of DecedentŐs anus/perineum was performed, and its normal appearance was recorded.


DecedentŐs symptoms persisted. Therefore, on November 15, 2004, after routine screening for blood on tissue and stools for several months, and normal results from a digital rectal exam, a sigmoidoscopy was performed, which revealed a 20 centimeter x 30 centimeter polyp, an irregular shaped friable lesion with hemorrhage, at a depth of 10cm. Her medical care provider suspected cancer. Decedent was scheduled for a colonoscopy to be performed on November 16, 2004.


November 16, 2004, when Decedent presented for the colonoscopy, she was told that she was there to have a polyp removed. One polyp was examined by colonoscopy, which revealed it was a colorectal tumor located on half of the circumference of the rectal wall extending to the anal verge. Computed Tomography (CT) scan of the pelvis and abdomen and an abdominal ultrasound were done on the same day. CT scan revealed possible local early nodal metastases and a low-density 8 millimeter lesion in the dome of the liver. The biopsy obtained, November 16, 2004, showed a moderately differentiated adenocarcinoma.


There was a 2-1/2 month interval between diagnosis of the colorectal cancer and the beginning of treatment.


On December 27, 2004, Joe Doe, M.D. made Decedent aware of the diagnosis of large colorectal cancer. December 23, 2004, Joe Doe, MD opined that the choice of treatment, considering DecedentŐs age was "neoadjuvant therapy vs. going directly to abdominoperineal resection", doing a "coloanal procedure would be doable but silly." In other words, Dr. DoeŐs choice was to perform surgery, abdominoperineal resection (whether with pre-operative or post operative chemotherapy/radiation), which would result in a colostomy. Dr. Doe regarded the alternate surgery, coloanal procedure, which would have preserved the sphincter, to be an unnecessary extra effort since Decedent was elderly. Dr. DoeŐs belief affected his choice of chemotherapy agent, 5-Fluorouracil vs. Capecitabine. The single-agent he chose, 5-Fluorouracil, was less expensive than Capecitabine, but also less effective than Capecitabine.


January 7, 2005, Dr. Doe recommended adjuvant chemo/radiation therapy prior or post surgical resection to downsize the tumor and sphincter preservation, and for better local control of tumor recurrence. And further stated that clinical trial R-04, Phase III clinical trial preoperative radiation and Capecitabine was being compared to preoperative external beam radiation therapy and continued intravenous infusion of 5-Fluorouracil for treatment of DecedentŐs colorectal cancer.


The use of more than one chemotherapy agent increases the chance of a cancer being sensitive to treatment since it is possible that a cancer cell resistant to one drug will be sensitive to another. Of the two plans considered by Dr. Doe, the less effective treatment plan was promoted by DecedentŐs medical care provider, preoperative radiation therapy and 5-Fluorouracil, since 5-Fluorouracil used as a single-agent has only a 20% efficacy against tumors. At that time it was clearly acknowledged that 5-Fluorouracil used in combination with another chemotherapy agent had an advantage over its use as a single-agent treatment.


February 3, 2005, chemotherapy began using a continuous catheter infusion of 5-Fluorouracil delivered with concurrent external beam radiation to the pelvis, which was to be administered for 29 days, and followed by Jack Black, M.D.


Rather than determining the effectiveness of 5-Fluorouracil by using it on DecedentŐs tumor and then evaluating the size of the tumor, testing for certain factors could have been used to predetermine which tumors respond to treatment with 5-Fluorouracil prior to beginning treatment with 5-Fluorouracil. However, these medical tests were not done on Decedent before chemotherapy was started. Testing, prior to treatment with 5-Fuorouracil, would have spared Decedent unnecessary discomfort and pain caused by her toxic reactions to 5-Flourouracil and more efficacious treatment could have been used to treat her cancer.


The response of a cancer to a chemotherapy agent is determined by measuring the size of the cancer directly or the amount of marker substances produced by some tumors. The size of DecedentŐs tumor was measured; however, the treatment plan was not reassessed when digital examination done on March 1, 2005 revealed that DecedentŐs tumor, undetectable by digital examination on November 16, 2004, had increased in size, becoming a 4-centimeter exophytic mass on her right posterior wall. 5-Fluorouracil did not significantly reduce DecedentŐs tumor size, or her tumor continued to grow despite treatment, yet treatment using 5-Fluorouracil continued until completion of all series. After discovering that 5-Fluorouracil was ineffective minimization of the number of cycles of the drug that Decedent underwent would have spared Decedent unnecessary discomfort and pain caused by her toxic reactions to 5-Flourouracil and more efficacious treatment could have been used to treat her cancer


5-Fluorouracil is a frequently administered chemotherapeutic agent in treating colorectal cancer. Its adverse side effects involve toxicity of bone marrow, skin, mucous membranes, gastrointestinal, central nervous system and cardiotoxicity.


On March 8, 2005, Decedent was admitted through the emergency room with hypoglycemia, and dehydration caused by having anorexia, nausea, vomiting and diarrhea secondary to chemotherapy and radiation for advance colorectal cancer. Decedent had anorexia and diarrhea for seven days, and had continued to take her insulin. Continuous intravenous fluid replacement to restore electrolyte balance, portal vein thrombosis and gastrointestinal tract prophylaxis was begun. Gastrointestinal infection and protozoa was ruled out.


Decedent displayed adverse side effects, due to 5-Fluorouracil infusion, involving her bone marrow, mucous membranes, and gastrointestinal tract, which rapidly worsened. During hospitalization, from March 8, 2005 to March 14, 2005, Decedent had mucositis, frequent bowel movements of copious amounts of green watery diarrhea, weakness, abdominal distension, nausea, and vomiting. Kaiser medical staff administered aggressive intravenous fluids; however, the medication administered to control DecedentŐs diarrhea and vomiting was ineffective, inappropriate, and not administered in a timely fashion.


Decedent had diabetes mellitus for which she took insulin daily, prior to hospitalization, from March 8, 2005 to March 14, 2005. During hospitalization, from March 8, 2005 to March 14, 2005, DecedentŐs hyperglycemia, caused by diabetes mellitus, was not adequately controlled by Kaiser medical care providers. DecedentŐs severe toxic reaction to 5-Fluorouracil was partially caused by her medical providersŐ failure to provide adequate insulin coverage. A recent large randomized trial by Meyerhardt and colleagues [39] evaluated the effects of diabetes mellitus on the treatment outcomes and toxicity in patients with high-risk stage II and III colon cancer treated with adjuvant chemotherapy, finding that the recurrence of cancer and mortality were higher in patients with diabetes. The incidence of treatment-related grade 3 or 4 diarrhea was higher in those with diabetes, than in those without diabetes.


On March 9, 2005, Decedent withdrew her informed consent to further radiation treatment. Despite this, on March 13, 2005, Dr. Jack Black ordered radiation to be resumed on March 15, 2005.


On March 10, 2005, Decedent withdrew her informed consent to further chemotherapy treatment. On March 10, 2005, at 1:30 am, Dr. Dwight White ordered Decedent to be placed on a liquid diet and chemotherapy stopped until DecedentŐs nausea and diarrhea were controlled. Despite Dr. WhiteŐs orders, chemotherapy was continued until the 29-day cycle was finished. On March 11, 2005, at 9:30 AM, the 5-Fluorouracil series was finished.


Although from March 10, 2005 on, Dr. WhiteŐs orders remained that Decedent was to be maintained on a liquid diet only until her diarrhea and vomiting were controlled, Decedent was given solid food by Kaiser hospital staff on March 14, 2005 at 8:30 A.M. and 12:15 P.M. March 14, 2005, at 4:45 P.M. These were DecedentŐs last two meals.


By March 14, 2005, at 9:30 PM, Decedent was experiencing severe abdominal pains. As a result, two gastrointestinal series and an X-ray of the upper abdomen were performed. Decedent died on the X-ray table, in part, because of massive aspiration of fecal matter, from her gastrointestinal tract, vomited, due to obstruction caused by colorectal cancer. Kaiser hospital staffŐs failure to maintain the Decedent on a liquid diet, as ordered by Dr. White, was a substantial factor that contributed to her rapid decline in health status and led to her sudden death.


Decedent was at risk for cardiotoxicity due to 5-Fluorouracil infusion, and in fact, displayed symptoms of cardiotoxicity during hospitalization. During hospitalization, from March 8, 2005 to March 14, 2005, Decedent had frequent recurrent runs of tachycardia, which went untreated by Kaiser medical staff. March 9, 2005 an electrocardiogram was performed on Decedent. The findings of the electrocardiogram were, among other conditions, that her sinus tachycardia rate was 106 and she had a probable old inferior myocardial infarct. Decedent had chronic high blood pressure, for which she took Lisinopril; however, there was no history of chest pain, palpitation, or syncope. No chest X-ray, electrocardiogram, or echocardiogram were undertaken, which would have monitored DecedentŐs cardiotoxicity to 5-Fluorouracil. There was no continuous ECG monitoring during 5-Fluorouracil infusion. Kaiser medical staff controlled DecedentŐs hypertension, but did not treat her tachycardia.


The medical record entered on March 14, 2005, at 11:57 P.M., states DecedentŐs cause of death, which was unexpected and not preceded by typical symptomology, was secondarily attributed to respiratory arrest followed by cardiac arrest. Cardiotoxicity caused by administration of 5-Fluorouracil was a substantial factor that contributed to her rapid decline in health status and led to her sudden death.