HINABEN NIKUNJBHAI BHAVsAR vs M.P.SHAH CANCER HOSPITAL And THE GUJARAT CANCER AND RESEARCH INSTITUTE

BY way of this complaint, the complainant has prayed for compensation in the sum of Rs. 7,00,000 on account of loss of one of the organs and pain, shock and suffering caused to the complainant as a result of medical negligence and deficiency in rendition of medical service on the part of the opponents as per the following brief allegations of facts made in the complaint.

THE complainant was having complaint of painless tumour on her breast. She, therefore, consulted her family doctor who advised for consultation at opponent No. 1 hospital for investigation of tumour for finding out whether there was malignancy or not. She, therefore, consulted opponent No. 2 in opponent No. 1 hospital on 16.5.1996. She paid Rs. 10 by way of case charges. She was examined by opponent No. 2, who rendered provisional diagnosis of fibroadenoma. He advised for X-ray/Mammography of chest to confirm the location of tumour and causation thereof. She paid Rs. 410 for such investigation. X-rays were taken on the same day and on the next day she went for taking the report when upon further examination she was advised to have F.N.A.C. report. She paid Rs. 280 for such report. Said examination was carried out by opponent No. 3 in the opponent No. 1 hospital. She was required to go for the report after 4 to 5 days. On that occasion she was informed that there was malignancy on the left side of her breast and the said organ was required to be removed. It has been alleged that the complainant requested the 2nd opponent to consider whether any other therapy was possible instead of removal of breast. Opponent No. 2 informed that removal of the breast was the only best available option in order to come out of danger of malignancy. She was also informed that question was one of hospitalisation of 20 days. Considering her young age and future of her minor children, she opted for getting herself operated. Various kinds of preoperative tests were performed against payment of fees of Rs. 150 for ECG, Rs. 565 for blood grouping, RFT, LFT, etc. She was informed that necessary surgical procedure would be carried out by opponent No. 2 who would be available on 4.6.1996. In the meantime she was again advised for X-ray report for which she paid Rs. 100. She was informed that operation could be performed on 4.6.1996 in the afternoon. She was accordingly admitted for surgery on 3.6.1996. Accordingly, operation was performed at 3 p.m. on 4.6.1996 and the breast was removed. She paid operation charges of Rs. 2,000 on 6.6.1996. She was under treatment thereafter till 14.6.1996. Dressing was applied on 15.6.1996. She was required to spend Rs. 1,306.30 for medicines/treatment suggested by the opponents. At the time of discharge, she consulted opponent No. 2 on 14.6.1996 and she was shocked to learn that the surgical pathology report did not show any evidence of malignancy/cancer and the tumour was non-malignant/benign. It has, therefore, been alleged that on account of wrong diagnosis and erroneous tests carried out from the side of the opponents, she lost her left breast. According to her, Mammography report dated 15.5.1996 also suggested excision biopsy but the surgeon [opponent No. 2] failed to do excision biopsy of cancer for the complainant. It has, therefore, been submitted that she suffered a great deal of hardship and lost her important organ of body on account of deficiency in rendition of medical services by the opponents. First opponent, vide reply Exh. 10 denied the allegations contained in the complaint. It has asserted that on clinical examination, opponent No. 2 felt satisfied that the complainant was having fibroadenoma on her left breast requiring detailed reports as particularised in the reply. The Mammography report obtained from opponent No. 1 hospital on 15.5.1996 confirmed the possibility of fibroadenoma. Accordingly, it was confirmed that she was having a lump in her left breast with T2N0M0 size. With a view to confirm whether the lump was malignant or benign, the complainant was advised to get herself examined for the test known as Fine Needles Aspiration Cytology (FNAC) which is one type of biopsy. As per the Manual and Atlas of Fine Needles Aspiration Cytology, the diagnosis of such test would be 50% to approximately 95%. The Cytology Department carried out the test through opponent No. 3 doctor and upon minute examination of the slides, her findings were: (i) High cellularity and cellular overcrowding. (ii) Cellular atypia. (iii) Fragments of myxoid stroma were not found.

These features of the examination lead to the diagnosis of malignancy. The complainant, her husband and parents were explained in detail about the nature of the lump as also requirement of the surgeon to put incision of at least 5 c.m. away from the lump with the result that Mastectomy was necessary and after obtaining such consent the complainant was operated for removal of the malignant lump from left breast. The operated lump was once again sent for histopathology department for further examination to find out the type of malignancy and final diagnostic report given by the concerned doctor indicated that the lump was non-malignant. It has been asserted that as per the aforesaid Manual, the sensitivity of FNAC biopsy of breast cancer would be approximately 50% to 95%. The Manual further mentioned as a rule histological confirmation prior to definitive treatment should be obtained wherever there is disagreement between cytology and mammography. It has, however, to be acknowledged for the information regarding tumour type that is sometimes provided by frozen section and that it might influence surgical management. It has also asserted that triple diagnosis is the combination of clinical examination, mammography and FA biopsy. If all the three investigations are in agreement, a lesion would either be benign or malignant and the diagnostic accuracy would be 99%. It has been suggested that some fibroadenomas, probably those in a growing phase, might show nuclear enlargement and anisokaryosis which might be further exaggerated by crush or drying arte facts. According to the 1st opponent there are some diagnostic pitfalls under certain conditions, one of them being fibroadenoma. Epithelial atypia might be extremely worrisome in some fibroadenoma. Again, the presence of single benign nuclei should prevent a false positive diagnosis. The myxoid stroma characteristic of fibroadenoma is also a very helpful sign. Besides, occasional false positive diagnosis are sometimes revealed when histological slides are re-examined. While noting the usefulness of FNA test, it has been asserted that the complainant was admittedly having lump/tumour in her left breast and even if it was assumed that the lump was benign, in certain cases such lump would necessarily have to be removed looking to the ailment and/or condition of the patient. In the present case even if the patient would have been having benign lump, it would have always desirable to remove it from the breast as it could be harmful in future. The 1st opponent has, therefore, prayed for dismissal of the complaint. The 1st opponent has filed further affidavit Exh. 16. It has been asserted that on account of the contradiction in the report of FNAC and histopathology, 1st opponent with a view to obtain 3rd opinion, sent the slides to Tata Memorial Hospital, Bombay. Dr. R.F. Chinoy, a renowned Pathologist of the country examined the slides and sent his report dated 12.5.1997 annexed with the affidavit in reply. The observations of Dr. Chinoy as contained in his articles have been noted in following terms. "By definition the term ''borderline lesion'' implies a disease which straddles the chasm between benign and malignant tumours. It obviously must have some worrisome features suggestive of malignancy. The term has a clear understanding in realm of ovarian tumours where synonymous terms used include tumours which are ''probably of low malignant potential'' or those which are ''indeterminate'' or ''intermediate'' or ''possibly malignant''. The definition offered by Rosai is conceptually more graphic and he describes borderline ovarian growths as ''tumours showing some or all of the features associated with carcinoma but lacking definite stromal invasion."

Extrapolating this to the breast would mean we would have to include and discuss conditions which have some features of malignancy and or carry some amount of risk for developing invasive cancer in the future. Literature in that respect has been noted in form of table 1 which would indicate that fibroadenomas, particularly complex fibroadenomas, would show atypian ductal hyperplasia as a disease with moderately increased risk and duct carcinoma in situ as high risk category and premalignant condition. Accordingly, patients with fibroadenoma have a low risk factor of about 2.1 times higher than amongst patients without fibroadenomas. Thus, risk increases to about 3.1 amongst patients with complex fibroadenomas. Patients with complex fibroadenomas have a small long term risk of developing invasive carcinoma. In the conclusion part of the excerpt it has been noted that the modern emphasis is on early diagnosis of breast diseases. This has led to the biopsy of very small lesion that are often of controversial significance. The Pathologist is obliged to interpret a variety of lesions, which are often difficult diagnostic problems because they are ''borderline lesions'' or ''risky'' diseases. The surgeon seriously contemplates radical surgery on the strength of the histopathology report. Thus, even medical science also admits the possibility of commissioning of error for misjudgment during the diagnosis of Borderline Lesions of Breast. It has been asserted that even otherwise the patients with fibroadenomas are not immune from the risk of developing malignancy in future. The histopathology report of the complainant confirmed that she was having fibroadenomas, florid hyperplasma and she was already carrying the risk 2.1 times higher than amongst the patients without fibroadenomas. Thus, there were ample possibilities of developing cancer in her left breast in future. Under such circumstances it was always advisable to remove such breast with a view to avoid even slightest possibility of developing cancer in future.

The 2nd opponent has filed written statement at Exh. 24. While denying the allegations contained in the complaint, it is asserted that the facts with regard to performance of surgery are correct. Upon his clinical examination of the complainant, he found that the patient was having retroarcular lump in the left breast (T2N0M0). The complainant was advised X-ray and Mammography and the Mammography report was in concurrence with the clinical diagnosis. It suggested lump with soft tissue opacity in left retroarcular region and one margin of lump was irregular. He has referred to Clinical Radiology of the Breast by Eric Rosebuck under the heading ''Referrals from the breast clinic''. He accordingly suggested for FNA procedure which was routinely followed internationally to arrive at a definite conclusion in regard to real type of lump. According to him, the FNAC was performed by Dr. Muitaza I. Laxmidhar, an M.S. in general surgery having experience in Onco surgery from January, 1995 to January, 1997 and has been working as fellow surgeon since March, 1997. The FNAC test was performed and the sides were sent to the cytopathology department where opponent No. 3 performed the relevant procedures and tests and submitted an authentic report stating that the lump was malignant with tissue typing. Opponent No. 3 is stated to be experienced pathologist having a bright career not only in the hospital but even during her academic career. Her pathology reports have been heavily relied on in the hospital. He has also asserted that there have been a number of mastectomy operations in the hospital and there are at least 46 cases of cancer treated by performing such operation from 1994-95 till August 96. The operation was performed by him on the specific finding rendered by opponent No. 3. He has made reference to the FNAC procedure called as a novel intervention for diagnosis of the type of lump. He has also referred to European Journal of Surgical Oncology, 1997, saying that the triple assessment method which is the basic principle of investigation of the palpable breast lump would have to be followed. According to him, as per the medical literature as also as per the leading Pathologist Mrudula Sampat, the test is now well accepted technique for the diagnosis and management of palpable solid breast masses. He has made reference to another medical Literature to show that the pre-operative diagnosis lead into a right conclusion of performing surgery which he did after taking consent from the complainant and the relatives. In the penultimate para of his written statement he has averred that "Opponent No. 3 has, for the reasons best known to her, taken 9 slides of FNAC with her and this can be verified from cytology register at item No. 898. In this register, there also appears the findings of cytological examinations. Slides which were sent to the Tata Institute for examination, do not carry the aforesaid 9 slides, which speaks volumes about the way opponent No. 1 has acted": He has accordingly prayed for dismissal of the complaint

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OPPONENT No. 3 has filed affidavit in reply at page 145 with Exh. 18. While denying the allegations contained in the complaint, she has asserted that she is M.D. in Pathology and Bacteriology and had been rendering her services as such in the 1st opponent hospital from 2.7.90 to 4.9.95. Thereafter, she had been rendering her service as visiting Pathologist in the same Institute from 1.1.96 to 8.2.97. She was required to perform her duty as Pathologist in the Pathology Laboratory. Accordingly, at the relevant point of time, when she was only a visiting Pathologist and not a salaried employee, she had an occasion to examined the slides having smear sent to her with usual requisition from bearing the name of the complainant. The slides were made in concerned department and not in the Cytology Department. Such slides when received by her were examined and her examination revealed ''CA. Lt. Breast-nodular lesion-subareolar Area''. Her findings of the examination were as noted in the 1st opponent''s written statement. According to her, the diagnosis made by her with respect to the slides was correct. She has, therefore, prayed for dismissal of the complaint alleging that she was wrongly involved in the case. She had also occasion to submit her affidavit dated 15.9.1998. The original was not on record and, therefore, by consent of the learned Advocates xerox copy thereof has been taken for consideration. There, she has reiterated the aforesaid statement with a clarification that she resigned from her occupation as visiting pathologist at the 1st opponent hospital with effect from 8.2.1997. She had no occasion to take any of the slides whatsoever with her as alleged by opponent No. 2 in the excerpted para 13 of his reply and any manipulation if made in cytology register in the above connection, would be false and got up. According to her, opponent No. 2 had deliberately made false allegation against her.

OPPONENT No. 5 the New India Assurance Company Limited has filed pursis adopting the written statement of opponent No. 3. The complainant has filed affidavit in rejoinder. The parties have produced xerox copies of documents as also excerpts from medical literature referred to by them. The complainant has been cross-examined at Exh. 37 as also Exh. 41. She has admitted that she had pain in left breast requiring her to go to the 1st opponent hospital. According to her, if she was advised for biopsy before surgery she would have gone for the same. She admitted that she studied up to B. Com. and she went to 1st opponent hospital of her own and in the company of her husband and her mother. She also admitted that she paid for the required tests and test reports and also consented for the surgery on her own. Opponent No. 2 has been cross-examined. On behalf of opponent No. 1 Dr. Devendra Patel has been examined at Exh. 52. He has adhered to what he has stated in his affidavit in support of written statement of opponent No. 1. Opponent No. 2 has been cross-examined at Exh. 49 and he admitted that at the time of clinical diagnosis he felt that the tumour would be cancerous and that was his provisional diagnosis. He has also admitted that fibroadenomas would necessarily be cancerous. It might as well be non-cancerous. He also admitted that there was no diagnosis of cancer by the Radiologist. He admitted that no part of the lump was sent for biopsy before operation. He wrote the lump to be malignant on the back of the FNAC report. He described the procedure of taking out the samples for sending the same for FNAC report. He was shown the excerpts from Manual and Atlas of Fine Needles Aspiration Cytology Breach Chapter VII-132: ''As a rule, histological confirmation prior to definitive treatment should be obtained whenever there is disagreement between cytology and mammography. It must be acknowledged that additional information regarding tumour type is sometimes provided by frozen section and that this may influence surgical management''. The witness, however, did not fully agree with the said excerpts. In his cross-examination by the complainant''s learned Advocate, he has asserted that the tumour was at such a place it was not possible to remove it separately and in that event the breast was required to be removed. Opponent No. 3 has been cross-examined at Exh. 50. She has adhered to the FNAC Test performed by her upon receipt of the slides from the pathology department in 1st opponent hospital. We have gone through the aforesaid pleadings of the parties, xerox copies of the documents placed on record of this complaint, evidence adduced by the parties and the medical excerpts which have been read by the learned Advocates for the parties. We have also gone through the decision submitted for our consideration.

ALTHOUGH the complaint consists of bulk of papers, the facts which have been asserted and replied run into a narrow compass. It is not in dispute that the complainant had tumour in her left breast. She also admitted in her cross-examination that she had pain requiring her to approach the first opponent, where 2nd opponent had an occasion to examine her. On clinical examination opponent No. 2 the surgeon had diagnosed fibroadenomas obviously requiring further tests to be performed with a view to confirm whether the tumour was malignant or not. He accordingly referred the complainant for radiological examination and mammography. It also revealed and confirmed the diagnosis made by the 2nd opponent. It was further necessary to have FNAC test performed before going for removal of tumour. Accordingly he had instructed for samples being taken for FNAC test. Dr. Laxmidhar had taken samples and 9 slides were prepared. Such slides were sent to the cyto-pathology department of the 1st opponent as per the procedure of the hospital. It is also not disputed that opponent No. 3 had an occasion to perform cyto-pathology examination on the slides and accordingly to her the diagnosis was (i) High cellularity and cellular overcrowding; (ii) Cellular atypia; (iii) Fragments of myxoid stroma were not found. It is not in dispute that 2nd opponent therefore, had an occasion to advise for surgery. However, the complainant would submit that she had suggested for an alternate remedial measure for which there is no corroborative evidence. Besides, she had ample intervening period of more that two weeks for having second opinion before going for surgery. It has transpired in the evidence that the tumour was at such a place that it was advisable to have surgery of the tumour which could have been done by removal of the breast. It is not in dispute that the complainant and her relatives had specifically agreed for surgical procedure as advised by 2nd opponent. Accordingly, surgery was successfully performed. However, when the specimen from the tumour was sent for biopsy the biopsy examination revealed that the examination did not disclose malignancy. That has created a problem in so far as the parties are concerned. With a view to confirm the final diagnosis of the biopsy the 1st opponent hospital sent the samples to Tata Memorial Hospital and Dr. R.F. Chinoy in his communication dated 12.5.97 has reported as under: "I received your parcel with the 41 stained H&E slides. No FNAC slides were received. The report of the same is attached herewith. I suspect that the initial pre-op smears must have shown very cellular aspirates, which usually happens with breast fibroadenomas. If very cellular smears are prepared roughly, or where there are crushing artifacts. There is a chance that the aspirates are over interpreted as malignant. Even otherwise these can be very worrisome. I suspect this is probably what has happened. It is well documented in literature as a serious pitfall leading to overdiagnosis and many centres of repute have also had this experience. Fibroadenomas are notoriously very cellular aspirates and most of the errors of judgment occur in this area of breast cytology. This is probably an error of judgment of the cytology smears, and not due to any negligence or carelessness. The patient quite naturally must be disturbed, but I hope she will understand if this is explained to her with patience".

[Emphasis supplied]

IT would appear from the aforesaid report that FNAC slides were not sent for confirmation of diagnosis rendered by opponent No. 3 insofar as slides which were received by her for FNAC were concerned. Therefore, the allegations so far as she is concerned are themselves incomplete in nature. IT cannot for a moment be said that her diagnosis was either erroneous or susceptible of any suspicion. IT is not the case of the 1st opponent hospital that there was anything done with the slides by opponent No. 3 or any one on her behalf. IT is surprising that opponent No. 2 comes out with such a statement and without there being any support for such a statement which has been reproduced. The record which has been placed in the file does not indicate any thing with regard to the slides having been done away with or tampered with or removed in any manner so as not to make available for further examination. In fact such is not the case submitted from the side of the opponent hospital. In that view of the matter, the allegations about deficiency in rendition of medical service on the part of opponent No. 3 concerning pathology report are apparently half way and that too without any justification or evidence. If that is so her report with regard to FNAC examination of slides in question cannot be questioned and subjected to comparison with the other reports. Assuming that some error might have been committed there, the same has been explained by the 1st opponent in the aforesaid affidavit in reply as also in the communication of Dr. R.F. Chinoy of Tata Memorial Hospital where he has in terms stated that the initial pre-op smears must have shown very cellular aspirates which usually happens with breast fibroadenomas. The observations emphasised would further go to indicate that fibroadenomas that are notoriously very cellular aspirates and most of the errors of judgment occur in this area of breast cytology. IT would, therefore, clearly appear that no medical negligence can ever have been attributed or upheld in so far as opponent No. 3 is concerned. While reiterating that we do not endorse the allegations made by opponent No. 2 in the aforesaid para 13 of his affidavit in reply and we seriously take an exception to such a type of approach on his part, we have no other alternative but to find that no case of medical negligence has been made out in so far as he is concerned. His clinical diagnosis would clearly indicate that the patient was suffering from fibroadenomas. He did not merely rely on the clinical diagnosis but sent the complainant for radiological examination and Mammography and report of such examination clearly lent support to his clinical diagnosis. With a view to further ascertain whether the tumour which was diagnosed as fibroadenomas is malignant or not, he referred further examination known as FNAC which was also performed as stated above. The combination of three examinations obviously led to the conclusion that it was in the interest of the patient to remove the tumour and removal of the tumour of the kind which the complainant suffered from would require removal of the breast. Thus, it is not possible to find any deficiency in rendition of surgical on the part of opponent No. 2.

The complainant has not been able support her cause from any expert opinion. The medical literature which has been read before us, in the light of the other medical literature which has been referred to by the opponents would clearly indicate that there was a possibility of error of judgment either in cytopathology examination or in surgical management of the ailment from which the complainant suffered.

WITH the aforesaid broad view of the matter, we would prefer to give weight to the affidavit in reply of the 1st opponent Dr. Devendra Patel and his cross-examination which would clearly indicate that in case of tumour from which the complainant suffered, it was always advisable to go for surgical management of the tumour with a view to avoid risk to life as even if it was found that the tumour was non-malignant it might have developed malignancy in future. In the background of the aforesaid state of the complainant''s case, we would now like to refer to the decision of the Hon''ble National Commission in the case of Jagdishwar Singh v. Jaslok Hospital and Research Centre and Ors. reported in I (2005) CPJ 60 (NC)=2005 (1) CPR 15 (NC). While reiterating the principle that a reasonable degree of care and skill is expected from doctors, they do not undertake that they would positively cure the patient nor he undertakes to use the highest possible degree of skill. It has been observed that FNAC (Fine Needles Aspiration Cytology) is pointed out to be a preliminary diagnosis procedure taken recourse prior to biopsy and is not a final diagnostic procedure like biopsy. It has, however, been submitted on behalf of the complainant that some medical literature would indicate that clinical examination, Mammography and FNAC when combined would provide best diagnostic method for a correct preoperative diagnose of mammoral lesions. Each technique influences other one because each technique has different limitation. Clinical examination was performed. Cytology and Mammography were performed. Where there is diagnostic discord between physical examination, mammography or aspiration finding, biopsy is performed. Opponent No. 2 doctor has explained that the site of tumour was such that it would need removal of the breast instead of going for further biopsy examination. Here, triple test was available with him for taking decision for surgical management of the tumour suffered by the complainant. The medical literature shown and read by the complainant''s learned Advocate would not take the matter any further if the expert opinion which is on record from Tata Memorial Hospital as well as in the form of evidence of Dr. Devendra Patel is taken into consideration.

BEARING in mind the facts and circumstances of the case as also the nature of evidence placed on record, we have no alternative except to find that the complainant has failed to establish any medical negligence or deficiency in rendition of medical service on the part of any of the opponents. We have, therefore, no alternative except to pass following order. ORDER The complaint is dismissed, with no order as to costs. Complaint dismissed.