re: Comins v. Steinman July 22, 1995 Dear Ms. Joyce, .PP I have reviewed the materials that you sent me on the above captioned case, and I have the following observations. .PP The plaintiff's offer of proof relies entirely on the expert opinion of Daniel Ornt, M.D., a letter from whom concludes the Plaintiff's Offer of Proof. .PP A) Dr. Ornt's allegation, In paragraph 4, of his letter: "Merel Comins died ... from metastatic carcinoma of the renal pelvis." is vulnerable to challenge. The report of a pathologic examination obtained on 07-31-91 makes a diagnosis of poorly differentiated adenocarcinoma. The report further states .sp .in +5 "Possible primary sites include lung stomach pancreas and possibly breast." A "Surgical Addendum" to the foregoing report states: "Both renal cell carcinoma and urothelial carcinoma appear unlikely, based on histology, but are not completely excluded as possible primary sites." .sp .in -5 A separate cytology report, dated 08/26/91, of urine sediment from a nephrostomy tube states: .sp .in +5 "poorly differentiated carcinoma with papillary features.... Malignant cells, isolated and clustered, with focal papillary arrangement.... .br NOTE: Although the morphology of these cells may be seen as a poorly differentiated urothelial cell carcinoma, an adenocarcinoma should be considered in the differential." .sp .in -5 I interpret the foregoing reports as indicating a high degree of uncertaimty regarding the primary site of the patient's malignancy. The second paragraph of Dr. Joseph Halperin's consultation note of August 16, 1991, suggests what is confirmed by a critical review of the entire record: that the hypothetical location of the primary site of Mrs. Comins malignancy was never inferred from reliable pathologic data, but was a poorly substantiated conjecture on the part of the patient's baffled physicians, a conjecture which was subsequently canonized in the medical record by uncritical repetition. In the absence of reliable pathological evidence, carcinoma arising in the lung of an individual, who, like Mrs. Comins has been a chronic smoker, is statistically far more likely than the transitional cell carcinoma of the kidney. .PP Two issues concerning Mrs. Comins' diagnosis require to be distinguished. In order to prevail, the plaintiff must show that she indeed suffered from kidney cancer. In my judgment, the evidence on this point is inconclusive. Beyond the existence of kidney cancer, however, the plaintiff must show that the kidney cancer originated in, or was primary to the kidney, because if the renal cancer was metastatic, the disease would already have been incurable when it first manifested itself, presumably by the transient hematuria. It seems to me that if there was a carcinoma in the pelvis of the kidney, it is quite possible if not indeed likely, that this carcinma was metastatic, that it had spread to the kidney through the blood stream. Metastases are the rule in cancers of the breast and lung, for example, which are statistically much more likely than cancers of the renal calyx. The tumor was sufficiently undifferentiated to preclude any morphologic identification of its origin. The plaintiff's burden of proof, therefore, entails not only the demonstration that there was a cancerous tumor within the right renal calyx, but also that the tumor originated from within the kidney, an assertion for which I find little if any support in the record. .PP I am struck by the gratuitous inclusion in the pathology report following nephrectomy of the statement: "Urine cytology specimens taken prior to surgery are reviewed (C91-7470 and C91-7558) and the presence of malignant cells is confirmed." The clinicians responsible for the management of Mrs. Comins' illness find themselves in the embarrassing dilemma of having removed a non-cancerous kidney from a patient, already in renal failure, who needs every bit of kidney function she has. It would be surprising indeed, if, subsequent to removal of a non-cancerous kidney, review of pre-operative urine cytology, had done anything other than "confirm the presence of malignant cells." This potentially embarrassing situation also goes a long way to explain the uncritical diagnostics post nephrectomy. To the physicians caring for Mrs. Comins the diagnosis of transitional cell tumor of the kidney had become an essential shield against the vindictive anger of the patient and her family. It was a diagnosis they could no longer afford to question. To me, however, it seems not impossible that review of the urine cytology by a suitably masked cytologist would shatter the single pathologic finding on which the diagnosis of transitional cell tumor rested. I looked for, and was unable to find, the microscopic pathology report on the nephrectomy specimen. I consider this document cricial to Dr. Steinman's defense. .PP Finally, the circumstance that when the affected kidney was removed in January 1991, no carcinoma was found on pathological examination requires the plaintiff to theorize that Mrs. Comins died of a tumor so sensitive to treatment that it was wholly wiped out by chemotherapy at the site of its original appearance. Such an hypothesis is likely to be as implausible to a layman as it is to myself. However, to form a responsible "expert" opinion on this issue, I should have to confer with oncological pathologists and to review the relevant medical literature. The hypothesis that the urine cytology (C91-7470 and C91-7558) was in error raises the interesting possibility that there there was in fact no renal transitional cell cancer at all, but that Comins vs. Steinman is a genuine twentieth century Salem witchhunt. .PP B) Dr. Ornt further asserts that Dr. Steinman's treatment fell below the accepted standard of care .nf .sp .in +5 "1. by failing to consider a cancer as a rule-out diagnosis in a patient presenting with gross blood in her urine. ... 3. by failing to appreciate Mrs Comins' history of analgesic nephropathy as a risk factor for developing renal carcinoma." .in -5 .sp .fi .na I have carefully reviewed Dr. Steinman's office notes, and I find no evidence that Dr. Steinman "failed to consider" the possibility of cancer, or that he "failed to appreciate" ... analgesic nephropathy as a risk factor. Dr. Ornt has no way of inferring what Dr Steinman considered or failed to consider, or appreciated or failed to appreciate. It is invidious and improper to purport to infer Dr. Steinman's mental processes from the medical records. The legal standard for medical records in Massachusetts has been defined by the Board of Registration in Medicine. Massachusetts requires a physician to maintain only such medical records as are necessary for him to care for his patients. It does not require of a physician to concoct self-serving memoranda of his meditations in order to demonstrate conformity with a hypothetical and fictitious standard of care which a disgruntled patient's expert witness might some day invent. .PP On page 2 of his letter, Dr. Ornt faults Dr. Steinman for failing to order "any follow-up ultrasounds or other tests to rule out a cancerous process." On page 3 of his letter, Dr. Ornt faults Dr. Steinman for .sp .in +5 "failing to order further appropriate diagnostic tests (cystostopy of the bladder, IVP (intravenous pyelography) and/or CT scan or the kidney) as required by the standard of care to rule out a cancerous process when the ultrasound on 05/21/90 showed bilateral small kidneys and an enlarged right renal collecting system and pelvis." .in -5 .sp The clear inference from Dr. Ornt's strictures is that he is offended by the apparent parsimony of diagnostic procedures: it doesn't seem to matter to Dr. Ornt what is done. More risks should have been taken, more money should have been spent. Dr. Ornt really demands is more expensive ritual; and that, in my opinion, is of benefit neither to the patient nor to the society. .PP I will review Dr. Ornt's suggestions seriatim. The decision on when or whether "follow-up" ultrasounds should be performed reflects the intuitive judgment of the physician. Three considerations enter into this decision. The first is that the symptoms and the hematuria subsided promptly, *) .FS *) One reference in the record is to a duration of forty eight hours, another reference is to one week. .FE The second is that the presence of bilaterally small kidneys is indicative of chronic renal disease, not of cancer. The third is that the mild hydronephrosis is not uncommon in patients with chronic renal disease, is most frequently a consequence of partial chronic obstruction secondary to renal calculi, and will persist after these have been passed. In light of these three considerations, I believe that Dr. Steinman's decision not to repeat the ultrasound was not unreasonable. .PP The utility of a CT scan of the abdomen may be inferred from the findings on CT scan 13 months later, when that examination showed only hydronephrosis and a necrotic lymph node. The degree of hydronephrosis in May 1990, was adequately and accurately demonstrated on the ultrasound test obtained at that time. The lymph node, given the demonstrably rapid growth of the cancer, is not likely to have shown up on CT scan at this early date, and would not have been diagnostic of any specific cancer if it had been demonstrated. .PP The intravenous pyelogram, which Dr. Ornt suggests, is accompanied in patients with chronic kidney disease by significant risks of total renal failure. Given the fact that the hydronephrosis was mild, and given the subsidence of the hematuria, Dr. Steinman's decision not to subject his patient to the risks of an intravenous pyelogram also seems defensible to me. .PP The cystoscopy which Dr. Ornt recommends would do nothing to advance the diagnosis of renal tumor. The appropriate test, not mentioned by Dr. Ornt, is retrograde pyeolography which is in essence a surgical procedure, requires to be performed under general anesthesia, entails risks of perforation of the ureter and of the the well understood complications of anesthesia. It was Dr Steinman's duty and prerogative to weigh the risks of this by no means innocuous procedure against its anticipated benefits. One cannot now recreate in ones mind the intellectual or emotional ambience within which that decision had to be made; and to purport to be able to do so is either naive or dishonest. .PP Massachusetts law requires a physician who performs potentially harmful diagnostic procedures to obtain the patients informed consent, and in the process to inform the patient not only of the hazards of the procedure but also of the gravity of the disease it was intended to detect. Thus, in order to be able to perform these diagnostic tests which Dr. Ornt so indiscriminately advocates, Dr. Steinman would have had to explain to Mrs. Comins that he proposed to search for malignancy which, no matter how early it might be detected, was, in a large proportion of patients, incurable. (To demonstrate the difficulty of this task it might be useful to challenge Dr. Ornt to tell us what information he would have provided to Mrs. Comins if she had been his patient.) .PP The record clearly shows that Mrs Comins had been emotionally ill much of her life; indeed it was an emotional disturbance that had led her to consume the excessive amount of fiorinal which caused her kidney disease. It seems likely, to judge from her refusal of diagnostic procedures on previous occasion(s), that Mrs. Comins, fully informed of their hazards, would have refused the diagnostic procedures which Dr. Ornt espouses. Certainly the choice with which Dr. Steinman would have had to confront her, would have caused her considerable emotional distress, and quite possibly irreparable emotional harm. .PP And to what end? None of the procedures would have provided definitive answers, nothing more than hints as to whether the supposedly curative treatment, removal of the kidney, would have been worth the pathophysiologic cost. The benefit of prophylactic nephrectomy, furthermore, would depend not only on the actual presence of tumor in the kidney, which could never be told with certainty until the kidney had been removed, but also on the absence of metastatic disease elsewhere in the body, a fact which is inherently unknowable. .PP The reason Mrs. Comins went to see Dr. Steinman over the years was that she had chronic renal disease, which was likely to become worse and might at some future time require renal dialysis. While in an individual with healthy kidneys, nephrectomy for localized cancer or for any other reason, is well tolerated and leads to no disability, in a patient such as Mrs. Comins, nephrectomy is often the prelude to renal failure and the need for lifelong dialysis. Dr. Ornt points out correctly that to the extent that patients with analgesic nephropathy incur a higher risk of transitional cell carcinoma the cost/benefit ratio of potentially complicated diagnostic procedures for this cancer is somewhat lower; he ignores the fact that for such patients the cost/benefit ratio of attempting to cure or ameliorate the disease with nephrectomy is substantially higher, because unlike the otherwise healthy patients, none of the renal failure patients can really afford the loss of a kidney. It was an intuitive perception of this distortion of the cost/benefit ratio, in my judgment far more persuasive than Dr. Ornt's jejune urgings, which, albeit unadvertised in Dr. Steinmans medical notes, was the compassionate and eminently proper rationale for a less than normally aggressive diagnostic workup of Mrs. Comin's transient hematuria. .PP Dr Ornt states that if Mrs. Comins' transitional cell carcinoma had been detected in May 1990 a nephrectomy then "would have afforded her the best opportunity for treatment and cure." Assuming, arguendo, that Mrs. Comins did have a primary transitional cell carcinoma, a truly early diagnosis would have been possible either by incisional biopsy of the renal calyx, a procedure that would have been fraught with unusual risks in a patient with advanced bilateral renal disease; or by nephrectomy without prior pathologic confirmation of the diagnosis, which would have placed her, as her subsequent history demonstrates, at significant risk of being deprived unnecessarily of one of her marginally functioning kidneys. Nephrectomy, whether of a cancerous or non-cancerous kidney, would have inflicted on her the enhanced risks of renal insufficiency and consequent need for chronic dialysis. Arguably if a transitional cell tumor could have been detected at an earlier stage, palliative treatment might have been more effective, but it is misleading to suggest any significant likelihood that Mrs. Comins would have been cured; and in her case it is much more true than in the case of the non-uremic patient to say that the attempt to obtain a cure of an inherently incurable cancer may well be worse than the disease. .PP It appears from the record that of the numerous physicians who reviewed the recent history of Mrs. Comins illness and who examined and treated Mrs Comins from May 1990 through July 1991, none considered the transient hematuria or the symptoms of disseminated malignancy to be suggestive of urothelial carcinoma, a circumstance which strongly supports Dr. Steinman's treatment as well within the accepted standard of the community; else each of those physicians should have been required by a duty to Mrs Comins, at minimum promptly to bring Dr. Steinman's mistake to his attention or to correct it. But none of the various physicians who recapitulated Dr. Steinman's reports in their records, took such action. .PP Rather, given the health-care crisis in which the country finds itself, and the need to forego those diagnostic procedures which are ordered principally to protect the physician against irrational malpractice claims such as the one at issue, perhaps it is it is Dr. Ornt's rather than Dr. Steinman's practices which require to be scrutinized for possibly being below the accepted standards of practice in the community. .PP I consider this report with its implicit criticism of Dr. Steinman's colleagues as inappropriate for inclusion in the reply which you will file in answer to the plaintiff's offer of proof. I should, of course, be pleased to provide you with an opinion letter devoid of arguments which are not essential to your defense strategy. =============================== Other thoughts: 1. The ureteroscopy on which the apple core lesion was found was not diagnostic for lack of histological confirmation. Gross visual identification of a presumed tumor through the ureteroscope is insufficient evidence for nephrectomy. 2. The intuitive conclusion that a symptom which disappears is not serious may be controverted by the literature, but is nonetheless compelling. Suppose a ureteroscopy had been done, nothing had been found, and the ureter had been perforated, nephrectomy had been done for operative injury ... 3. The literature holds microscopic hematuria to be more significant than gross hematuria in the diagnosis of tumors and states that microscopic hematuria may be intermittent: thus setting up an elaborate and expensive protocol for early detection of tumor.