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Oncology
Stomach Symptoms Not responsive to Tagament and Further Delay in Diagnosing Stomach Cancer, Causing Loss of Chance of Survival.
Eight years earlier, the patient was treated for a malignant thymus gland condition causing myasthenia gravis. He underwent surgery and radiation therapy and was successfully treated. He did receive follow up care, and this was all appropriate medical therapy.
According to your cover letter and the records, on March he sought care by Dr. #1 because he had stomach pains and a 25-lb. weight loss. The patient was prescribed Tagamet for pain, which he took for two weeks and had no relief. Since the patient had progressive symptoms, including vomiting, and although the blood test was positive for hepatitis A antibody, the other liver function studies would not support a serious case of hepatitis. There was no jaundice and most of the liver enzymes were normal. In my opinion, the patient should have been seen without further delay and should have had an upper GI x-ray study ordered and performed.
In essence, within 3-4 weeks after having first seen Dr. #1, having not responded to Tagamet, and with significant weight loss and persistence of symptoms, the upper GI x-ray would have confirmed the presence of a tumor in the stomach.
Although the ultrasound study is appropriate to order, it is only significant if positive. It was negative for gallstones or gallbladder disease and found no other abnormalities involving that area of the abdomen. Possibly, it was misinterpreted by the radiologist, Dr. #2. He describes the liver as normal in appearance. At that time, this would be evidence against the tumor invading into the left lobe of the liver, or into the adjacent pancreas gland. He describes no gross abnormality of the pancreatic bed or spleen. This was on April.
On April 2 in the office records of Dr. #1, is a note for a GI consult with a doctor whose last name appears to be #2, and the note shows that the patient did not see that physician. Why didn't this occur?
Dr. #1 had a duty to either order the upper GI x-ray study, or have the patient referred to a specialist which, in this case, would be a gastroenterologist. That is what his note does reflect. This issue needs to be clarified. And why didn't Dr. #1 then order the GI x-ray study himself?
Because the patient's condition did not improve and he in fact did worsen, he returned to care under his original treating physician, Dr. #3, and he referred the patient to Dr. #4. By that time, the patient had lost 40 lb. Dr. #4 and Dr. #5 did further evaluations on the patient, including a CAT scan on July 10, at the same radiology facility. This found "a large infiltrating mass involving the gastric antral wall extending towards the duodenal sweep (the first part of the small intestine). The posterior aspect of the thickened stomach wall is inseparable from the pancreatic contour. Rule out gastric neoplasm versus severe inflammation from peptic ulcer disease." Also, enlarged lymph nodes were found in that area.
On July 26 Dr. #5 performed an endoscopy procedure (passing a light telescopic tube down the mouth into the stomach), and found a "large ulcerated mass occupying entire region of antrum (the bottom portion of the stomach) from 55 centimeters from incisors (teeth downward, as measured) to the pylorus (the sphincter muscle between the stomach and the duodenum) displacing pylorus, obvious gastric neoplasm (cancer)." A biopsy revealed the presence of malignancy that looked like adenocarcinoma. A surgical consultation was requested and performed.
On August 6 at the Hospital #1 the patient underwent exploratory surgery and a partial gastrectomy. The cancer was invading the pancreas and the left lobe of the liver, and the surgeon felt he would be able to remove that tumor. Thereafter, the small intestine was sutured back to the remaining stomach for intestinal continuity. To proceed with that surgery at the time was a judgement call, and is acceptable in my opinion.
The pathologist found the cancer and noted microscopically that this was "a lymphoma of mucosa - associated lymphoid tissue (MALT type)." This was a high-grade transformation that also involved the lymph nodes surrounding the stomach.
This is a rare type of cancer that begins in a stomach ulcer and is associated with the Helicobacter germ. When found early, it responds very well to antibiotic therapy for this germ as a cause of an ulcer. However, as time passes, the tumor transforms into a more malignant grade, as occurred here. That resulted in the huge stomach mass that invaded into the liver and pancreas and spread to the adjacent lymph nodes.
When detected early, treatment with antibiotic therapy and low-dose radiation therapy (which is less toxic to the body) has a very high cure rate. I discussed this case with a radiation oncologist, and recent articles reveal that up to a 99% cure rate is attainable when this tumor is detected early.
However, by the time the patient was operated upon, this tumor had progressed to a more advanced state and, despite subsequent treatment with chemotherapy and radiation therapy, the tumor did progress as noted on the follow up MRI scans and the patient died five month later. He developed fluid in the chest that was drained, and complications from the original surgery that were appropriately treated.
Although the expert I spoke with is willing to review the records and testify, there are a number of problems with this case. First of all, by the time the patient saw Dr. #1, he had a 25-lb. weight loss and it is acceptable for a physician to assume the patient had an ulcer based upon his symptoms and treat with an anti-acid type medication, such as Tagamet. This therapy is usually given for two weeks, and even up to a month in time. If that medication does not relieve the symptoms, then further investigative studies are performed, either by that physician or by referral. This would include an upper GI x-ray study, and this generally would take another week or so in scheduling by the treating physician or, if a referral takes place, there can be an additional week or two delay.
Therefore, even under the best of circumstances, the patient would not have had the upper GI series x-ray and report back to the doctor until within about a month of reporting to Dr. #1. This decreases the delay to two months. By that point in time, clearly the tumor had enlarged and was invasive. But even at that time, radiation therapy would have made some difference to prolonging the survival of the patient, according to my initial discussion with his oncology expert. The additional two months did decrease the chances of longer survival.
There is another matter, as I mentioned above, in that there was a referral to a Gastroenterology that the patient did not follow through with. Why didn't that consultation take place? Obviously, the defense will claim contributory negligence. That should be addressed in affidavit format, if you are going to pursue this case prior to expert review.
Obviously, the patient was suffering for a number of weeks or months before he saw Dr. #1, which resulted in that 25-lb. weight loss. Did he see any other physician during that time? That earlier intervention, before he saw Dr. #1, certainly would have made a substantial difference to the outcome.
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Misdiagnosis
of metastatic breast cancer resulting in additional pain and
suffering and premature death from preventable complications.
The major questions in this case were whether or not this 74-year-old patient with a "known history of multiple sclerosis" since age 63 (which is very unusual), breast
cancer Stage 1 (tumor without spread to lymph nodes) at age 68, who was on the tumor-slowing anti-estrogen, tamoxifen
(Nolvadex), and with a known history of multiple previous falls and spine and rib injuries, was misdiagnosed for her metastatic (spreading) breast cancer, and what difference that made to her comfort level, responsiveness and longevity.
She had increasing weakness of her legs associated with
abdominal and back pain, and was properly hospitalized at the Hospital #1 from
8/2 through 8/7 under the care of Dr. #1, her cancer specialist (?). She was seen by
a second oncologist, Dr. #2, on 8/4, who raised the probability of metastatic cancer to
her spine and recommended that a neurosurgeon might perform decompressive surgery to
remove the pressure of the cancer squashing her spinal cord, or have it treated by
radiation therapy to reduce her back pain and reduce the risk for paraplegia (paralysis
of the lower half of her body). His care was good at that time.
Because of her "history of multiple sclerosis," which can cause
paraplegia, her osteoporosis (weak bones) from the steroid therapy for her presumed
diagnosis of multiple sclerosis and multiple spinal compression fractures, there would
be significant confusion in arriving at the correct diagnosis to focus the best course
of therapy.
The x-rays, including CT scan with myelogram and contrast dye
(she could not have an MRI because of her cardiac pacemaker), on 3/4 "demonstrates
extradural (outside the spinal cord covering) defects (space occupying masses) at the
T10 (tenth thoracic [chest] vertebral) level presumed to be due to a compression
fracture with retropulsion (posterior displacement) and surrounding hematoma." This can be from her osteoporosis weakening the bone and causing it to crush and
shift position and/or from breast cancer spread to that site causing the bone to
be eaten away and fractured.
The day before she had a "Total Body Bone Scan," which uses
a radioactive compound that is absorbed differently by normal bone than by diseased
or damaged bone or by cancer replacing bone. The radiologist, Dr. #3, interpreted
that study showing "abnormal uptake" in her ribs and spine, and said, "1. Multiple
areas of increased uptake in the ribs and upper thoracic spine, consistent with
metastatic disease. 2. More globular focus of increased uptake is noted at approximately
T11. The size and intensity of this activity suggests probable metastatic disease with
possible compression fracture."
He also said, "The pelvis, hips and lower extremities (legs) are
otherwise normal."
With cancer of some kinds, the CEA antigen test is elevated,
and hers was grossly elevated to 56.4 (normal is 0-5). Her mother and brother had
colon cancer but her colonoscopy (visualization of her entire large intestine [colon]
by a flexible lighted instrument like a garden hose) did not show any colon cancer.
Therefore, based on all of the above, she had metastatic breast cancer. Although she
was "Stage I" at the time of her breast cancer surgery six years before, and although
we speak of five-year survivals that some patients want to think of as "cure," it is
not the same thing. In fact, we also have a 10-year survival rate statistic too.
At that time, her blood calcium level was normal. Cancer
chews up the bone and can release a large amount of calcium, which can elevate
the blood calcium level, causing confusion and even light coma. That happened
to her by 11/30, four months later.
The patient was denied surgery to decompress her spine
(and at the same time a piece of flesh would have been examined by a Pathologist
to confirm that it was metastatic breast cancer). However, they noted her to be
a very high surgical risk because of her other medical problems and morbid obesity.
However, radiation therapy would have reduced the risk of her developing hypercalcemia
(high blood level of calcium) and paraplegia (paralysis of her legs and incontinence),
and also would have decreased her pain and suffering.
The blood test called alkaline phosphatase is an enzyme
produced both by the liver and bone (although it can be distinguished as to its
source by additional testing). On 8/5 it was normal at 103 (normal is 40-125).
She was discharged on 8/7. That note was prepared by Dr.
#4 and a copy was sent to Dr. #1, her "attending physician." That discharge summary
raised the concern that the "bone scan revealed multiple areas of uptake in ribs
and also in her thoracic spine, which may very well have been from previous areas
of trauma (injury)." He also said, "Tumor markers (the CEA test and the CA 27.29)
are currently pending at the time of discharge." As I noted, the CEA was very
elevated, but the CA 27.29 (which is specific for some metastatic breast cancers)
was normal at 7.4 (normal is 0-38). The laboratory "final report" was noted to
be on 8/8 in her medical records.
With the typed bone scan report as they had in her medical
record and the elevated CEA and other x-ray findings, she had symptomatic metastatic
breast cancer to her spine and ribs. Her spine, as a minimum, should have been
treated by radiation therapy to reduce her pain and risks for paraplegia and hypercalcemia.
Dr. #1, her attending Physician, should have followed up on that most relevant blood test.
The failure to do so is a departure from the standards of care, in my opinion, and
denied her the chance to receive timely radiation therapy which would have reduced
her risks, as noted above.
At the time of her discharge on 8/7, "The patient was generally
in improved spirits, but had considerable lower extremity weakness at the time of discharge" (five days after her admission with weakness of her legs).
She was transferred for rehabilitation to the Hospital #2 where,
on admission, the power in her legs was noted to be 3 out of a maximum of 5. Since her
arms were 4 out of 5, the weakness was not an overall lethargy. It was accurate and
pathologic. She remained there until 9/22, and she and her family were trained to
care for a paraplegic. She became paraplegic in that hospital without therapy to
destroy the cancer in her spine. She also had increased pain and suffering from all
the efforts to mobilize her to try to strengthen her, which was not possible with her
spinal cord being squeezed by the tumor as if it were trapped in a closing vise,
going from paraparesis (weakness) to paraplegia.
Dr. #5 noted in the discharge summary, "We had breast cancer
markers drawn during her hospitalization at the Rehabilitation Hospital with follow up
with her doctor, Dr. #6, as an outpatient making certain that this, in fact, was not a
malignant metastatic process." On 8/17, the CEA test was done and was now three times
higher at 155.2. That result was available in their records the next day and no action
was taken. That, in my opinion, is further negligence. The CA 27.29 had been normal but
now was 27 (4 times higher than 12 days earlier). If Dr. #1 would have followed up on
the previous abnormal CEA test, all this would have been noted. When the CEA result
was available by 8/18, an oncologist should have been called and clearly would have
noted the change from the previous test (by simply calling the laboratory or hospital
for a copy of the test results). Her calcium was normal on 8/9.
A Neurologist, Dr. #7, was called in to see her on 8/19 by Dr.
#5 and said, "History of multiple sclerosis diagnosed at age 65, which I think is extremely
unusual and I have to question the diagnosis without any records to back this up." I agree.
He noted that Dr. #2 was evaluating her for the possibility of metastatic disease.
He did not think that multiple sclerosis was the cause of her weakness and related it
to her vertebral fracture, whatever it was caused by.
She went home on 9/22 with no specific treatment for her metastatic
cancer. In my opinion, that was negligence by the rehabilitation hospital, and those
physicians, including that "attending Physician" who also was noted to be Dr. #8.
She was admitted to the Hospital #3 on 11/30 "mild to moderately
somnolent and has trouble with short-term memory." Only 200 cc (7 ounces) of urine was
collected from her bladder catheter the past 24 hours, she had decreased appetite for two
weeks and was "fully dependent for several months." Her calcium was very elevated to 14
(normal is 8.9-10.1), her blood (serum) sodium was very low at 122 (normal is 134-144)
(it was borderline low at 132 on 8/26), and both caused her mental state to be diminished
and were reversible. Her alkaline phosphatase now was grossly elevated to 308.
In the course of her testing she had another Total Body Bone Scan
on 12/6. This was interpreted by Dr. #13, a Radiologist. He also reviewed the Total Body
Scan of 8/3 and compared both. His findings are revealing. Dr. #13 said, "The
abnormalities within the pelvis appear to be without change. The foci of increased
uptake within the proximal (upper) right femoral shaft (thigh bone) are without change."
Also, "The intense area of increased uptake involving the right humeral head
(upper arm at the shoulder joint) appears to be new or increased when compared
with the previous study. Otherwise, there is no significant change."
It appears, based on the comparison evaluation by this Radiologist,
that the previous Radiologist, Dr. #3, failed to note the metastatic abnormalities on his
interpretation of the Total Body Bone Scan of 8/3 where he said, "The pelvis, hips, and
lower extremities are otherwise normal."
The significance of this negligence is that it would have been very
highly supportive of metastatic cancer. Her previous falls did not fracture her pelvis or
right leg. That, plus the very elevated CEA, would have pointed the finger even more
strongly at metastatic cancer as the problem with her spine. She then could have had
radiation therapy to all the sites of cancer spread and would have decreased her chance
for the elevated calcium from cancerous bone destruction, low sodium from her poor appetite
caused by the elevated calcium and enlarging areas of metastatic cancer.
Thus, her chance of choking on her tablet and chocolate pudding
causing her respiratory and cardiac arrest resulting in her irreversible coma on 12/5
and death on 12/10 would have been much less.
I also want to point out what Dr. #14 noted, "Apparently the family
stated that the patient, after breakfast, subsequently became less responsive and appeared
to have difficulty breathing. She then had a witnessed arrest and a Code was called. When I arrived the patient was found to be apneic (not breathing)
and being bagged (with mask and hand pump ventilator). She was also pulseless
at that time. She was emergently intubated (tube put into her windpipe for
ventilation purposes) and chest (heart) compressions were begun." She had
her pulse restored, but because of the long time without oxygenated blood going to
(perfusing) her brain, she never awoke from her coma and, with family's agreement,
the ventilator was turned off on 12/10 and she died.
When Dr. #14 arrived she was pulseless and was being ventilated
("bagged"), but apparently no one was doing chest compressions to force oxygenated blood
through her body. How much of a delay was there and when did the "C" (cardiac) part of "CPR" begin?
Since she was being "bagged," the airway was patent and she was being ventilated.
There is the standard formula "ABC" which means to secure a potent airway,
then breath (ventilate the lungs) and then do cardiac (chest: breast
bone downward compressions squeezing the heart against the backbone, rhythmically,
to get a "pulse"). It would appear that he negligently delayed the "C" when the
"A" and "B" were already taken care of. He first spent time to intubate her (put
the endotracheal tube into her windpipe: trachea) and then did the "C." Document all that in detail. Delays in A, B, and C can all each cause irreversible
brain damage. She did not have cancer spread to her brain as the cause of her coma
(anoxic encephalopathy) that directly led to her death.
As the family said, if she had trouble swallowing on 12/4 and
on 12/5 could not swallow without choking, then the Nurse who gave her a medication
(tablet) in chocolate pudding was negligent. All Doctors involved in that direct
care who failed to stop all oral intake until she was capable of safely swallowing
would also be negligent.
She would have died from the effects of her metastatic cancer.
It was not curable. However, earlier radiation therapy in August would have
decreased her back pain and reduced the risk of hypercalcemia. And if it occurred,
more specific therapy may have made some greater difference and further reduced her
risks for choking and arrest.
I do not believe that she had a pulmonary embolus (traveling
blood clot blocking the heart/lung circuit) because immediately after her arrest,
her blood oxygen levels were excellent (PO2 of 122 with a 98.1% saturation) and the
pattern of events is not consistent with that diagnosis. There was no chest pain and
negative EKG findings of right ventricle strain.
How long she would have lived is speculative, but I believe at
least for some months. With radiation therapy and then narcotics, her suffering would
have been manageable.
Hospitals have different policies on which doctors can be
allowed to admit and treat patients. That is not negligence. It is economics and "politics."
Based on all of the above, all Doctors as noted were negligent,
as well as the second two hospitals because of their employees and agents.
In this case, I would recommend Experts available on our
independent Consulting Staff in Radiation Therapy, Oncology, Radiology, Physical
Medicine and Rehabilitation, Nursing, Anesthesiology or Intensive Care or Emergency
Room Medicine about the delayed CPR issue and a Doctor of the same specialty as Dr.
#1. Supply good copies of the two Total Body Bone Scans and the CT scans. A good
copy means that you cannot tell them apart when viewed in front of a light.
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Overdose of chemotherapy causing
nerve damage.
According to the records, the patient was 24 years of age, developed
symptoms of low back pain, fever and chills, and on physical examination had an enlarged
spleen. He was admitted by Dr. #1 and the diagnosis was leukemia. When the blood count
came back the next day and it was analyzed by the physicians at the hospital, it was determined
that he had acute undifferentiated leukemia. Dr. #1 decided to start the patient on
vincristine and prednisone (a steroid) therapy, and that was reasonable care.
However, regarding the dosage of vincristine (also called Oncovin),
the manufacturer, Lilly, and the Food and Drug Administration warn, with regard to overdose: "adults can be expected to experience severe symptoms after single doses of 3 milligrams
per meter square or more." The recommendation is that the drug should be administered
intravenously at weekly intervals, and for adults the dose should be "1.4 milligrams per
meter square."
The patient weighed approximately 160 pounds, and therefore he was
not an over-large person. Thus, the dosage should have been less than 2 milligrams
intravenously, and they gave him twice that dosage three times.
Vincristine can cause various symptoms, including sensory impairment
and paresthesias (abnormal sensations), which the patient experienced in his fingers and
his feet, as well as it can cause loss of deep tendon reflexes, foot drop, ataxia (impaired
coordination walking), and paralysis. The patient experienced all this, and that occurs "with continued administration."
In my opinion, Dr. #1, the Physicians, and the Hospital departed
from the accepted standards of care in prescribing and giving to this patient an overdosage
of vincristine, and they continued to give that overdosage after the patient developed his
initial symptoms as I will discuss below.
The first dosage was given on July 19. This is confirmed by the doctor's
order, the doctors' progress notes, the medication index, and the nurses' progress notes.
On July 26, the eighth day of hospitalization and a week after
getting his overdosage of vincristine, the doctors' progress notes noted "minimal paresthesias
in fingertips," and the plan was to "continue vincristine 4 milligram intravenously today." This note is by Dr. #1.
The patient was also being seen by the interns and residents and there are
numerous other progress notes showing the medications that the patient was receiving. All these
physicians, in my opinion, had a duty to this patient not to endorse and give an overdose of
medication.
On August 2, the fifteenth day of hospitalization, the patient received
another 4 milligrams of vincristine intravenously.
Although the patient was admitted to the hospital, also with back pain,
on August 5, he had increasing soreness and aching in his lower back. That was not considered
as a possible red flag for problems.
On August 9, on his twenty-second hospital day, was given another 4
milligrams of vincristine intravenously.
On August 11, he developed an elevated temperature, had a positive blood
culture for germs, and did receive appropriate antibiotic therapy. He additionally had the
herpes virus infection in his mouth and also received the appropriate anti-viral drug,
Zovirax.
On August 12, the on-call physician noted that the patient had myalgia
(muscle aches), mainly in the lower extremity, and generalized muscle weakness. This was
also noted in the records as weak legs and tingling in his hands and feet on August 14.
They concluded that this was "neurotoxicity (nerve poison) effect of vincristine."
On August 15, he had no reflexes from his knees down, and had weakness
in his leg muscles. Again they noted this as "neuro-toxicity of vincristine with long tract
weakness." The tracts they are referring to are the spinal cord columns of nerve flesh.
On August 15, they again noted that the patient had neurotoxicity
of vincristine to the long tracts of the spinal cord.
On August 17, there was some improvement in his muscle strength.
The patient was being sent to physical therapy.
The August 21 notes show that his strength was improving, but he
still had no reflexes in his ankles.
On July 26, the doctors' progress notes show an order for vincristine to be given at 4 milligrams intravenously, and this is signed by Dr. #1. On August 2, a Doctor whose name appears to be "#2" wrote an order to give the patient 4 milligrams of vincristine intravenously. This same physician also wrote the order for August 9, the same way.
The Nursing Administration record shows the patient did receive that medication on July 19, July 26, and August 2. The patient also received the cancer-fighting drug, Adriamycin, at 40 milligrams intravenously three times, first on August 4, on August 5, and then on August 6. This is a slight overdosage, but the toxic effect relates to heart failure, not nerve damage, and the dosage usually has to be cumulative over a 300-400 milligrams total to cause serious problem for heart injury.
According to the nurses' notes, the patient was walking in the halls on July 22, and was walking in the room on July 24. Thus, he was not admitted with nerve damage. They show he received the vincristine on July 26. On July 27, the patient was complaining of slight numbness in his fingertips as noted in the nursing assessment box, your page number 260. They similarly noted the findings on July 28, your page number 263. On July 30, on page 279, the patient was weak but he was up in the room.
With the numbness in his fingertips, the physician should have assessed the dosage the patient received since this is a well-known nerve damage effect from vincristine, and the higher the dosage, the more nerve damage the patient can experience. This is a red flag that they did not heed, and in my opinion, they all departed from the accepted standards of care.
According to the Nurses' notes, on August 10, the patient had difficulty with numbness in stepping down involving his left foot. This is documented a day after he received his forth and last dose during this hospitalization.
His weakness got worse, he was only able to be out of bed walking with assistance, and then with physical therapy and time, he was able to walk with the use of a quad cane. This is a cane with four feet at the bottom that helps stabilize the patient when walking. Even by August 22, the nurses' notes show that the patient still had some weakness in his legs and slight numbness in his fingertips.
In my opinion, the drug Phenergan, which is used for nausea and vomiting, for some tranquilization, and to increase the effectiveness of narcotic medication, was not the cause of this weakness. Sometimes Phenergan is negligently injected directly into the sciatic nerve behind the hip area. This causes severe shooting pain down the leg and can cause some paralysis, particularly a foot drop type situation. But that is not the situation here since the patient developed symptoms involving both legs, and there is no evidence that he received Phenergan injections negligently into the sciatic nerves involving both legs. Furthermore, the symptoms involving his fingertips and the nature of the progression of the condition would be consistent with vincristine toxicity secondary to the overdosage he received four times.
According to the records, including the two bone marrow samples, the patient did have some remission from the forms of chemotherapy, which included the drug methotrexate, given into the spinal fluid sac.
In my opinion, except for the four negligent overdosages of using vincristine at the level of 4 milligrams instead of 2 milligrams, the patient did receive proper medical care.
I have not seen any of the outpatient records, nor the electro-myogram and nerve conduction studies if they were done, nor any of the subsequent records from other hospitalizations. Furthermore, I do not know if the patient received any further treatment with the drug vincristine.
According to the daughter's deposition, apparently the patient developed infection, and that may have been the proximate cause of his death secondary to his leukemia, or possibly contributed to by anti-cancer drug therapy of which I have not seen any subsequent records.
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- - -
I have discussed this case with one of our Oncology (chemotherapy) Experts, and he agreed that the dosage was excessive and is known to cause this type of problem.
It would be helpful to see subsequent hospitalization records and any outpatient records referring to his chemotherapy and his neurologic condition. Since I have not seen the final records, I do not know whether or not his death was related to any substandard care, or was a consequence of recurrent leukemia and related infection.
If he did receive vincristine another year, it would be important to see the dosage level that he received at that time, as well as the potential for alternative drug (anti-cancer) therapies.
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