ANUPAM DASGUPTA
This appeal challenges the order dated 02.05.2003 of the Andhra Pradesh State Consumer Disputes Redressal Commission, Hyderabad (in short, the State Commission) in complaint case no. 83 of 1998 by which the State Commission dismissed the complaint. The appellants were the complainants and the respondent the opposite party before the State Commission. On the complainants filing this appeal, this Commission first dismissed it by its order dated 21.04.2004. The complainants/appellants went up in appeal against that order by way of special leave petition before the Supreme Court and the Court, by judgment dated 16.09.2005, set aside the said order of this Commission and remanded the matter back for disposal according to law after giving opportunity of hearing to the parties.
FACTS
2. The essential facts, gleaned from the pleadings, evidence and documents on record before the State Commission, are as follows:
(i) D. H. Kumari, complainant/appellant no. 1 (hereafter, Kumari), aged 46 years in 1997, went to the Rheumatology Clinic of the respondent Institute (hereafter, NIMS) in May 1997 with complaints of knee joint pain, etc. She was diagnosed with osteoarthritis and treated therefor. Sometime towards the end of this treatment, Kumari complained to the Rheumatologist of a lump in her left breast. The Rheumatologist, therefore, referred her to Dr. G. Suryanarayana Raju, Surgical Oncologist in the Oncology Department of the NIMS.
(ii) She presented herself on 12.09.1997 at the evening Special Clinic and was examined. The record of physical/clinical examination noted down by Dr. Raju are as under:
œ12/9/97 C/o Pain and swelling left breast
X 2 mths
Painless slow growing
No nipple discharge
Had hysterectomy for dysmenorrhoea
CIN / early ca
Para2 children LCB “ 22 yrs
No family h/o of breast cancer
O/E Mod built and nourished
Au0 70
Left breast sub areolar swelling
3x3 cm firm. No skin involvement
Rest of the breast supple
Axilla “ small axillary LN palpable
No SCLN
Rt Breast “ supple
Nipple areola NAD
Axilla NAD
Adv: Mammogram “ bilateral
FNAC “ Lump L breast? [Emphasis supplied]
(iii) The cytopathology report dated 17.09.1997 of the Fine needle aspiration (FNA) of the lump in Kumaris left breast read as under:
œDIAGNOSIS:
FINE NEEDLE ASPIRATION BIOPSY
POSITIVE FOR MALIGNANT CELLS
COMMENTS:
Cellular smears show numerous neutrophils, foamy histiocytes, apocrine cells, multinucleate cells and a few anucleate squamous cells.
However, there are cells with mitotic activity.
The features are consistent with Carcinoma - breast.?
(iv)After seeing (Kumari with?) the FNAC report, Dr. Raju wrote on 17.09.1997 the following in her case record:
œFNAC “ Ca L breast “ carcinoma
97Y1616 dt. 17.9.97
Adv: MammogramAdmit Wd 4?
[Emphasis supplied]
(v) The patients œProgress Record? at the NIMS shows that on 18.09.1997, Kumari was posted for surgery on 19.09.1997. The consent for this surgery was obtained on the same Record and read as under:
œI/we have been explained the surgery, its necessity, assoc. risks/complications and the procedure of mastectomy and hereby give consent for the surgery of (illegible?) mastectomy, anaesthesia and blood transfusion as required necessary (sic).
Sign D. B. Eswari
Relationship “ daughter?
The œCheck list of pre-operative care? also recorded, inter alia, œConsent taken in the patients chart.?
(vi)On 19.09.1997, Kumari underwent Maddens Mastectomy of her left breast under general anaesthesia. The fully typewritten Operation Record read as under:
œ-Mass in sub-areolar region.
-No E/o Axillary lymph nodes.
PROCEDURE: Horizontal elliptical incision. Skin flaps raised- superiorly upto clavicles, inferiorly upto rectus sheath anterior abdominal muscle, laterally upto anterior border of latismus (sic “ latissimus) dorsi. Medially upto mid part of sternum. Breast along with anterior pectoral fascia dissected from chest wall. Inter pectoral fatty tissue and fatty tissue around axillary vein cleared. Axillary vein based. Fatty tissue from axilla dissected preserving long subscapular nerve of bell. Specimen taken out. Haemostasis secured. Wash given with normal saline. Romovac drain kept one anterior to pectoral muscle another in the axilla. Blood loss around 400 ml; duration of surgery 3 hrs.
Dr. S. Sridhar?
[Emphasis supplied]
Incidentally, nowhere did the Operation Record show the name or signature of the Surgical Oncologist, Dr. G. Suryanarayana Raju.
(vii)Next relevant document on record, chronologically, is the histopathological report of the excised breast sample. This report, dated 01.10.1997, read as under:
œGROSS DESCRIPTION:
Recd. mastectomy specimen measuring 25 x 14 x 2 cm with skin attached measuring 7 x 4 cm with nipple and areola. C/s shows g/w areas extending throughout the tissue. Some are hard in constancy. Beneath the nipple there is a 2 x 2 x 2 cm yellowish granular area. Rest of the breast shows grey white rubbery areas.
DIAGNOSIS:
BIOPSY
ABCESS
FEMALE BREAST
COMMENTS:
Micro: Multiple sections studied from the breast. There is a lesion in the sub-areolar region composed of central area of necrosis, dense infiltration by lymphocytes and plasma cells. The ducts show destruction of lining epithelium with regenerative changes. Adjacent ducts show papillomatosis. Rest of the areas shows fibrocystic disease.
The features are consistent with Subareolar abscess, left breast.?
[Emphasis supplied]
(viii) Some other relevant documents brought on record by the parties also need to be read:
(a) The first document appears to be a revised version of the histopathological report dated 01.10.1997 (original reproduced in sub-paragraph (vii) above), with the following additional note at the end:
œNOTE: THE DUCTAL EPITHELIOSIS and THE REGENERATING EPITHELIAL REACTIONS ARE LIKELY TO SHOW ANISONUCLEOSIS WITH DARK STAINING NUCLEI. HENCE ON FNAC THESE CELLS MAY BE INTERPRETED AS NEOPLASTIC.?
There is no explanation how and when two versions of the same report got filed before the State Commission.
(b) The second is a report dated 04.03.1998 of the Division of Pathology of the National Institute of Nutrition (Indian Council of Medical Research), Hyderabad. This report reads as under:
œSlides for Opinion
Sr. No. 7/98
Date: 4.3.98
Name: D. H. Kumari Age: 46 Sex: Female
Clinical Diagnosis: Ca. Breast
Nature of material: Two FNAC slides
Ref. No.: 97Y1616
Opinion: Ref. by:
œBoth slides showed sheets of neutrophils along with Plasma cells, histiocytes, macrophages and scattered small groups of duct epithelial cells showing features of degeneration.
‘‘‘Suggestive of an abscess.
No evidence of any malignancy in these slides.
Sd/-
PATHOLOGIST
Dr. B. SESIKIRAN, M.D.
Assistant Director, National Institute of Nutrition?
[Emphasis supplied]
(c) The third is also a report by the same organisation and reads as under:
œSlides for Opinion
Sr. No. 8/98
Date: 4.3.98
Name: D. H. Kumari Age: 46 Sex: Female
Clinical Diagnosis:
Nature of material: 4 slides
Ref. No.: 3016/97 P, Q, R, S
Opinion: Ref. by:
œHaematoxylin Eosin stained sections appeared to have been sampled from nipple and areola region exhibited a subareolar chronic abscess with surrounding region exhibiting periductal inflammation with duct ectasia. One of the sections, probably from a deeper plane exhibited only a scattered lymphocytic infiltrate.
There was no evidence to suggest any malignancy in these sections.
‘‘‘Suggestive of a subareolar abscess.
Sd/- (by the same Doctor as above)
[Emphasis supplied]
(d) The fourth document is the Discharge Record of Kumari. This had, inter alia, the following observations:
œNo cervical lymphadenopathy.
Left breast examination showed 2 x 2 cm sub-areolar swelling, hard, freely mobile, not fixed to the skin, not fixed to the chest wall.
Nipple and areola normal.
No E/o of axillary lymphadenopathy. FNAC of swelling showed Adenocarcinoma.
Per operatively mass in sub-areolar region.?
[Emphasis supplied]
MAIN ALLEAGTIONS IN THE COMPLAINT
3. Against this background, we may notice the main allegations and claims in the complaint:
(i) On 24.10.1997, Kumari received, on request, two histopathological reports, both dated 01.10.1997. After seeing these reports, complainant no. 2 (Kumaris husband) became panicky, as the reports did not mention the existence of carcinoma in Kumaris left breast.
(ii) On 27.10.1997, complainant no. 2 requested the Director, NIMS to hand over to him the slides of Kumaris (excised) breast tissues prepared by the Pathology Department which were reported upon in the aforesaid (2) reports. On receiving the slides, he sent them to the National Institute of Nutrition, Hyderabad for fresh examination and opinion. The National Institute of Nutrition confirmed, by its two reports of March 1998, opined that none of the slides showed any sign of carcinoma of the affected breast.
(iii) Thus, the treating doctors at the NIMS had negligently and wrongly diagnosed the problem of Kumari as breast carcinoma and subjected her to unnecessary mastectomy.
(iv) As a result of the misdiagnosis and subsequent unwarranted mastectomy, Kumari was made to suffer total disablement of her left arm due to consequent lymphadenoma. She could not carry on with her routine household responsibilities because of this permanent disability. This apart, the unwarranted mastectomy disrupted her conjugal life. As a result, she was also unable to look after her mentally challenged son, complainant no. 4 and, overall, suffered from serious emotional stress and depression. Her daughter, complainant no. 3, was of marriageable age and she too was adversely affected by Kumari's condition.
(v) For the said alleged acts of negligence, the complainants claimed from NIMS a total compensation of Rs. 20 lakh, comprising Rs. 10 lakh as compensation for trauma, mental agony, etc., to herself, Rs. 2 lakh for complainant no. 2 towards loss of conjugal life and extra burden in looking after the children and Rs. 12 lakh for the three children, complainants no. 3 to 5, for the loss of affection, looking after and mental trauma that each of them suffered.
AFFIDAVIT EVIDENCE OF THE OPPOSITE PARTY/RESPONDENT
4. The NIMS contested the complaint by filing counter affidavit of the Executive Registrar (Dr. John Appa Row) and evidence affidavit of the Surgical Oncologist (Dr. Raju). Notably, NIMS chose not to file any written version. The Cytopathologist (Dr. Aruna Prayag) who conducted the FNAC did not file any affidavit before the State Commission (though a copy of what was claimed to be her affidavit was much canvassed during the hearing before us). The Surgical Oncologist Dr. Raju filed his affidavit in July 2002, i.e., nearly 19 months after the complainants filed their affidavits.
(i) In his affidavit of 15.03.1999, Dr. John Appa Row, Executive Registrar, NIMS averred, inter alia, as under:
œ¦ Having made specific allegations against particular officers of the NIMS, the complainants did not choose to make such officers as opposite parties to afford them an opportunity of explaining the allegations that are made against them in addition to the allegations that are made against the Institute in question. Having claimed Rs. 20 lakh as compensation the complainants did not choose to implead the insurance company, who are supposed to compensate the NIMS in case of any such awarding of damages.
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œAfter conducting necessary tests on the first complainant, it was felt that the painful lump in her left breast be removed. It is only pursuant to the reports received on conducting FNAC test at the Pathology Department of the opposite party, Dr. G Suryanarayana Raju, who is competent to deal with the matter, rightly advised the first complainant to have mammogram of her left breast from the Apollo Hospital, Jubilee Hills, Hyderabad and it is on obtaining the consent of the first complainant and her attendants it was planned for removal of the left breast. Removal of the left breast in the context of the current circumstances was felt necessary and accordingly the same was removed.
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œIt is true that histological report did not disclose carcinoma. But this is subsequent to the event. The concerned doctors are of the view that this has occurred not because of any negligence or a wrong judgment but it is only due to the possible errors that may occur in the matter of pathological reports. Therefore, there is no medical negligence and neither the doctors of NIMS nor the NIMS can be held responsible for medical negligence.?
[Emphasis supplied]
The last contention in the affidavit above was based on a report dated 10.11.1998 of Dr. K. S. Ratnakar, Head, Department of Pathology and some medical literature furnished by the latter, which were also produced before the State Commission. Dr. Ratnakars letter to the Executive Registrar, NIMS was in reply to the latters letter of 30.10.1998 and the copy produced before the State Commission bore the initials (dated 10.11.1998) of Dr. Raju also, meaning he had seen the said letter at that stage itself. These dates are important because the complaint was filed on 17.09.1998 and the first notice issued by the State Commission was served on the OP on 08.10.1998.
(ii) In his affidavit of 11.07.2002, Dr. G. SuryanarayanaRaju averred inter alia as under:
œ4. It is humbly submitted that the first complainant again approached Dr. G. Narsimlu and 12.09.1997 with a complaint that there was pain and swelling in the left breast and lump in the breast is growing gradually in a short period, cancer was suspected. It is further humbly submitted that the first complainant was referred to Dr. G. Suryanarayana Raju, Head of the Department, Surgical Oncology Department as Dr. G. Narsimlu suspected that the lump in the breast to be cancerous. It is respectfully submitted that it is common in south India particularly among women between the age group of 30-45 years, there is every likelihood of breast cancer as per the medical statistics.
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6. It is humbly submitted that the first complainant has undergone mammogram test and the test revealed the suspicion of malignancy and it is further humbly submitted that the mass had the features of malignancy rather than abscess. It is respectfully submitted that on examination of the mass, which is pain less “ no history of fever and normal in colour and whereas the inflammatory abscess has the features of pain “ red in colour “ history of fever and tender when it is touched. It is respectfully submitted that the history of the first complainant is that the lump in left breast was noticed two months back, pain less, slowly progressing, no history of nipple discharge, no history of lump in axilla and no history of lump in right breast or axilla. The above features clearly matching with the malignancy in the breast.
7. It is humbly submitted that first complainant was advised to undergo FNAC test, which is relatively easy, less complicated and less expensive. The complainant approached the Pathology Department on 17.09.1997 and the report of the FNAC test revealed that positive for malignant cells breast and the comments offered by the Department of Pathology were as follows:
œCellular smears show numerous neutrophils, foamy histiocytes, apocrine cells, multinucleate cells and a few anucleate squamous cells. However, there are cells with mitotic activity. The features are consistent with Carcinoma-breast.?
8. It is humbly submitted that the deponent herein has suspected the carcinoma on 12.09.1997, basing on the suspicion of Dr. G. Narsimlu, who initially examined the first complainant. It is respectfully submitted that the report of FNAC further confirmed the suspicion of the carcinoma and the deponent herein advised the first complainant that the carcinoma is in early stage.
9. It is humbly submitted that the deponent herein after discussing with the members of the family with regard to the malignancy and also the prevalent breast cancer in south India from among the women between the age group of 30-45 years. It is further humbly submitted that in order to remove the lump in the left breast surgery is inevitable. It is respectfully submitted that as the FNAC report and features of the lump in left breast are correlating the with the description of carcinoma, the deponent has thought it fit to remove the left breast of the first complainant instead of going for a limited surgery in the interest of the first complainant.
10. It is humbly submitted that the mastectomy operation was conducted on the first complainant by the deponent herein after explaining the implications of the surgery and the condition of the patient was explained to the patient and her attendant daughter. It is respectfully submitted that the doctors of the opposite party has taken informed written consent from the attendants of the first complainant for proceeding with the said surgery.
11. It is humbly submitted that the deponent herein has conducted the mastectomy operation by removing the entire left breast including the malignant tumour of 3x3 cm in size. It is respectfully submitted that the deponent apart from other pathologists have suspected the tumour to be malignant and also there is every likelihood of cancer spreading to other organs of the body of the first complainant.
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14. It is humbly submitted that after going through the report of Histopathology the deponent herein has advised the first complainant to come for reconstructive surgery and there is every possibility to bring back the left breast to normalcy. But the first complainant has not turned up for reconstructive surgery for the reasons best known to her. It is respectfully submitted that for removing the mass in left breast, which is 3x3 cm. in size, surgery is necessary. If the surgery was not conducted at an early stage, even though the tumour suspected to be malignant, then it may have serious repercussions on the health of the first complainant and there is every likelihood of spreading of dangerous cancer to the other organs and the chances of survival are very difficult and it may take away life of the patient in question. It is respectfully, submitted that due to conducting surgery on the patient in question, there cannot be any mental disorder of disorder of permanent incapacitation in terms of lymph edema resulting in swelling and total disablement of left arm as alleged by the complainant. Further, in the absence of giving chemotherapy and radiation therapy the question of developing lymph edema to the complainant does not arise.?
[Emphasis supplied]
FINDINGS OF THE STATE COMMISSION
5. After considering the pleadings, evidence and material brought on record (particularly, the report of Dr. Ratnakar and the medical text cited by him), the State Commission held as under:œThe opposite party contends that without making the concerned doctors and the Pathologist as parties, the complaint is not maintainable. They relied upon the judgment of the National Commission reported in 2002 (4) ALT NC wherein it is stated that unless the doctor is made a party, vicarious liability cannot be fastened to the hospital. In this case also the doctor is not made a party. Therefore, this decision squarely applies to the facts of this case. Non-joinder of the doctor as a party to the complaint is therefore fatal to the maintainability of the complaint. As such the complaint has to be dismissed in limine.
œNo doubt histopathology report shows that there are features consistent with subareolar abscess. In the text cited above at page 709 under the heading Subareolar Abscess, it is observed, ¦ with the presence of nipple retraction and a mass, the lesion can be clinically confused with a neoplasm such as adenoma of the nipple or breast carcinoma. It is further observed, 'Subareolar abscess of the breast demonstrates some of the potential diagnostic pitfalls for a false-positive diagnosis of malignancy that can occur in any inflammatory process including those involving the breast. These include the presence of groups of atypical ductal cells squamous atypia and fragments of exuberant granulation tissue. Four of our initial 8 cases demonstrated some of the findings which could potentially lead to a false-positive diagnosis of malignancy, if the other cytological features of subareolar abscess were not appreciated. A ruptured epidermal inclusion cyst arising in the skin of the breast shares similar cytologic and histologic features with subareolar abscess, but the peripheral location of the epidermal inclusion cyst should clearly separate that lesion from the central subareolar abscess.'?
œFrom this it is clear that subareolar abscess can be very often confused for false-positive diagnosis of malignancy. In view of these circumstances, we cannot reach the conclusion that there is negligence on the part of the doctor or there is any deficiency in service on the part of the opposite parties.?
ARGUMENTS OF THE PARTIES
6(i) It is against this background that we have heard the parties, on remand of the matter by the Supreme Court on the basis of the Court's judgement in the case of Savita Garg (Smt.) v Director, National Heart Institute [(2004) 8 SCC 56].
(ii) To assist this Commission with the case of the appellants, Ms Surekha Raman was appointed as Amicus Curiae. Mr. G Ramakrishna Prasad and Mr. Thomas Mathew, learned counsel argued the case for the respondent NIMS and the Doctors concerned. Both Ms Raman and Mr. Mathew cited further medical literature and furnished synopses of their written arguments.
7. Ms Raman has argued on several counts:
(i) First, relying on the Harrison's Principles of Internal Medicine, 12th Edition, Volume 2, she has drawn attention to the standard practice of initial evaluation and diagnosis in case of suspected breast cancer. On the said topic, the above-mentioned textbook reads as under:
œPhysical examination should begin with a visual inspection¦ ...
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Further evaluation of suspected cyst might include a repeat examination of the breast immediately following the next menstrual period in a pre-menopausal woman, the use of ultrasound to confirm the impression that the mass is fluid-filled, removal of the cyst with a fine gauge needle and re-examination of the breast to document that the cyst has disappeared. The latter is the preferred approach in symptomatic patient because it will usually relieve the pain and the patient will be reassured that this is not cancer, unless the cyst fluid is grossly bloody or re-accumulates rapidly.
If the breast examination leads to any suspicion that the mass is malignant, biopsy should be performed. Biopsy should be preceded by a mammogram, which may better define the extent of the lesion, demonstrate other suspicious masses, and serve as a baseline obtained before distortion of normal breast architecture by biopsy. Abnormalities on mammogram that suggest a breast cancer include: (1) distinct, irregular, often crablike densities, (2) clusters of five or more micro-calcification is, each less than 1 mm in diameter and all in an area of less than 1 cm or (3) architectural distortion without a benign explanation such as a scar from a prior biopsy.?
[Emphasis supplied].
Ms Raman has emphasised that the above-mentioned standard protocol of initial evaluation and diagnosis of a breast lump ought to have been followed by the Surgical Oncologist in Kumaris case before deciding on (modified) radical mastectomy.
(ii) Secondly, the appellants had completely relied on the evaluation and diagnosis of the Surgical Oncologist who had himself twice advised a mammogram. In the absence of the report of the advised mammography, the Surgical Oncologist ought to have insisted on the said test before directing the patient to get herself admitted to the hospital and scheduling the mastectomy the very next day.
(iii) Thirdly, even if FNAC was one of the reliable diagnostic tools for detection of carcinoma of breast, in the case of the present patient who did not have a family history of breast cancer and had had a breast lump only for the past two months, it was imperative for the Surgeon to seek further confirmation of the results of the FNAC with other tests before deciding on mastectomy. Even an ultrasound imaging was not advised in this case.
(iv) In arriving at its finding, the State Commission relied on the single piece of medical literature produced by the OP, without appreciating that the possibility of an FNAC leading to a false-positive diagnosis of malignancy in lieu of a subareolar abscess of the breast also had an equally valid opposite implication. Because, by itself, an FNAC test could lead to a false-positive diagnosis of malignancy, it was all the more necessary for the OP to have undertaken more confirmatory tests before giving an unequivocal diagnosis of carcinoma of the breast.
(v) Fourthly, the consent that was obtained did not show that the Doctor/Surgeon concerned had discussed the full implications of the proposed mastectomy with the patient, explaining to her why mastectomy alone was the proper treatment and why no other course was advisable “ the consent read as if the mastectomy had already been decided and only some of its features needed to be explained to the patient. It is not enough for a Surgeon to explain to the patient the procedure and consequences of the surgery already decided by him/her; it is necessary for the Doctor to explain to the patient various alternatives that would be available in the patients case, depending on the nature, stage and extent of the disease and the relative advantages/disadvantages of each course/alternative and then proceed to the surgery after obtaining consent.
(vi) Moreover, in this case, there was no such urgency as to warrant taking up mastectomy within just two days of the FNAC report that led to complete removal of the left breast (and some other associated parts of the chest). Even according to the medical literature produced on behalf of the respondent (in the course of hearing of this appeal), it was necessary to first do proper staging of the mass/tumour before deciding the line of treatment, including the type of surgery and associated adjuvant therapy. This was not done in this case. Citing reliable medical literature readily available on the Internet, Ms Raman has argued that considering the facts of the case, a lumpectomy would have been an equally feasible option.
8. On the other hand, on behalf of the respondent Mr. Mathew has argued as under:
(i) As admitted by complainant no.2 in his letter of 27.10.1997, the Cytopathologist had collected two samples of the lump tissues; one on 13.09.1997 and the other on 17.09.1997 and only after analysing both samples reported confirming breast cancer. The second sample was obtained as a measure of ample precaution, in the words of complainant no.2. Kumari was once again advised to undergo mammography and thereafter get admitted to the NIMS for preoperative preparation and surgery. The mammogram, done at the Apollo Hospital, Hyderabad also led to the suspicion of malignancy of the tumour in the left breast.
(ii) Dr. Raju neither impressed upon the patient and her husband that it was an emergency nor suggested immediate surgery. However, as a matter of routine in such cases, they were advised an early surgery to prevent spread of cancer cells. In the present case, the patient and her husband preferred to have an early surgery and treatment at the NIMS.
(iii) On 19.09.1997, a modified radical mastectomy (total mastectomy and axillary clearance) was performed on the left breast of the patient under general anaesthesia, after obtaining written consent of the patient and her daughter. The surgery and the patient's post-operative recovery were uneventful. During the course of her hospital stay, Kumari's progress was monitored and there was no lapse or professional negligence on the part of the hospital.
(iv) After the final histopathology report was received from the Department of Pathology, Dr. Raju compared it with the FNA cytopathology report and discussed the matter with the team of Pathologists. After discussion with the Pathologist concerned, it was clarified that the lesion was inflammatory with adjacent neoplastic papillomatosis. The Pathologist made a note that ductal epitheliosis and the regenerating epithelial reactions were likely to show anisonucleosis with dark staining nuclei. Hence, on FNAC these cells might be interpreted as neoplastic.
(v) Regarding confirmatory tests for cancer before surgery, the FNAC report indicated carcinoma breast without any ambiguity or any other suggestion/doubt. The mammogram showed only a dense lesion in the region of the lump. The copy of the mammogram report was handed over back to the patient/complainant. The letter dated 27.10.1997 written by complainant no. 2 confirmed that two samples were taken for FNAC, the first on 13.09.1997 and the second on 17.09.1997. Later, Dr. Raju wrote an explanatory letter dated 27.10.1998 to the Director, NIMS in which he stated that he had advised the patient to undergo mammography to plan for further treatment and that the mammogram got done by the patient revealed a dense lesion with architectural changes in the same area of the lump. The complainants did not disclose the crucial fact of Kumari having undergone mammography though this was stated by Dr. Raju in his affidavit dated 10.07.2002 before the State Commission.
(vi) Dr. Aruna Prayag, Associate Professor who had examined the FNA sample and prepared the report was an experienced Cytopathologist. The Institute dealt with about 250 cases of breast cancer per annum. Since the institute was a Teaching Hospital, the faculty members of the Department always discussed the findings and reports with the Residents. In the present case also, there were discussions with the Pathologist as was evident from the letter dated 07.11.1998.
(vii) FNAC is a highly reliable and specific confirmatory test for diagnosing breast cancer, with accuracy of up to 95-96 per cent. In this case, based on clinical suspicion and mammographic evidence of the lesion, two FNAC tests were performed before proceeding with definitive treatment like surgery, chemotherapy or radiotherapy or combination of the above. In this context, Mr. Mathew has cited medical literature, viz., extracts/articles from the American Journal of Surgery, 1997, 174, vol. (6), pp. 694-98; British Journal of Surgery, December 2005, vol. 75, Issue 9, pp. 847-50; Royal Australasian College of Surgeons, 1988; Lead Cytopathologist, Aotea Pathology (Online Journal); and The Surgical Clinics of North America, Breast Cancer Management, October 1999, vol. 79, pp. 991-1005.
(viii) As regards incision biopsy not being done to check the findings of the FNAC, Mr. Mathew has argued that this was not necessary according to the standard protocol in this behalf, because a diagnostic incision biopsy would be indicated only if the findings of the FNAC were inconclusive, doubtful or suggestive of more than one possibility. In this case, the clinical examination and the mammogram were both suggestive of cancer of the breast, the latter showing a dense lesion in the region of the lump. Moreover, two samples of fine needle aspirates of the lump tissues were drawn and the FNAC finding was conclusive. An experienced Cytopathologist did the microscopic examination of the aspirates. Four members of the Faculty of the Department of Pathology discussed the report. Further, an incision biopsy of the subareolar region would have been very painful to the patient because the region is particularly sensitive. Therefore, the Surgeon was justified in not choosing to go in for diagnostic incision biopsy of the lump and instead deciding on modified radical mastectomy based on the clinical examination, mammography result and the FNAC report.
(ix) Finally, Mr. Mathew has made two related points. Relying on some further medical literature, viz., Cancer Related Information of the American Cancer Society (on the website Medline); The Surgical Clinics of North America, Breast Cancer, Strategies for the 1990s, August 1990, Vol. 70, Number 4, pp. 831-51; an Article on Juvenile Secretory Carcinoma and Juvenile Papillomatosis; European Review Medical Pharmacol Sci 2004, 4 (4), pp. 99-103; a Case Report, Breast Cancer, January 1998, vol. 5, No. 1, p. 87; and Journal of the Royal Society of Medicine, Vol. 102, No. 6, on Nipple Excised and Areola Retained after Total Mastectomy (NEAT), Mr. Mathew has arguedthat the cytological features of the lesion in this case confused the Pathologists to conclude that the neoplastic cells were cancerous although the underlying lesion was proliferative, hyperplastic papillomatosis with fibrocystic abscess, i.e., benign. That the pathologists found some technical problems in differentiating normal cells from cancerous cells in this case might be attributed to the associated papillomatosis. Assuming that only the lump was excised, the associated papillomatosis might have grown and recurred as another lump of benign or malignant nature. This would have led to another set of arguments on the lines like incomplete removal of the lump or misdiagnosis. Thus, according to Mr. Mathew, in the present case the attending Doctors at the NIMS dealt with Kumari professionally without leaving any scope for subsequent misinterpretation, in a bona fide manner, and proceeded with the surgical treatment with due consent.
MEDICAL LITERATURE REVIEW
9. It is useful at this point to notice the recommendations and certain diagrammatic algorithms described in Harrisons Principles of Internal Medicine (17th Edition, Volume I):
The œAlgorithm for Breast Palpation? (Figure 86-1, Approach to a palpable breast mass, p. 564) shows, inter alia, that both for pre-menopausal or post-menopausal patient with a dominant breast mass, aspiration of the mass should be done to ascertain if it is a fluid-filled cyst or a solid mass and, if the aspiration confirms a solid mass, mammogram would be the next diagnostic step; if the mammogram is œsuspicious?, biopsy of the mass should be resorted to. Though the algorithm discussed in the book describes various possibilities and corresponding courses of action, only the above-mentioned scenario is noted here because this alone is applicable to the case of Kumari.
Further, the œAlgorithm for Diagnosis? (Figure 86-2 The œTriple Diagnostic Technique?, p.564) suggests that for a œsuspicious dominant mass?, a mammogram should be done first and then biopsy, irrespective of whether the mammogram is œsuspicious? or otherwise. Even if ab initio (i.e., on visual examination) the œdominant mass? is considered œnot suspicious?, mammogram should still be done. If the mammogram is also œnot suspicious?, fine needle aspiration (FNA) should be undertaken. If the FNA cytology also turns out to be œsuspicious?, biopsy ought to be resorted to. In other words, the entire thrust of the recommendations in this authoritative textbook of international following is to first subject a patient with physical symptoms like those of Kumari to a mammogram.
On mammography, the book states:
œDiagnostic mammography should not be confused with screening mammography, which is performed after a palpable abnormality has been detected. Diagnostic mammography is aimed at evaluating the rest of the breast before biopsy is performed or occasionally is a part of the triple-test strategy to exclude immediate biopsy.
Subtle abnormalities that are first detected by screening mammography should be evaluated carefully by compression or magnified views. These abnormalities include clustered microcalcifications, densities (especially, if spiculated) and new or enlarging architectural distortions. ¦¦¦. A reasonable approach is shown in Fig. 86-4.?
The œMammography Algorithm? displayed in Figure 86-4 can be read as under (though this is not as elegant as shown in the book):
œMammographic abnormalityAdditional studies including spot magnification, oblique views, aspiration and ultrasound, as indicatedAssess risks:
NormalRoutine follow-up
Probably normal; cancer risk 3%3-6 month follow-up
Probably benign; cancer risk 3-20%Stereotactic core or
surgical biopsy
SuspiciousSurgical biopsy?
[Note: œ? should be read as œto be followed by?]
On fine-needle aspiration cytology, the book has the following to say:
œSeveral points are essential in pursuing these management decision trees. First, risk-factor analysis is not part of the decision structure. No constellation of risk factors, by their presence or absence, can be used to exclude biopsy. Second, fine-needle aspiration should be used only in centers that have proven skill in obtaining such specimens and analyzing them.? [Emphasis supplied]
10. Some more standard literature on the subject may also be referred to. In The Essentials of Clinical Oncology, Editors Robert de W Marsh and J Samuel has the following in Chapter 12. Breast Cancer (pages 127 “ 154):
œCLINICAL FEATURES(pp 132 - 135)
A properly conducted clinical examination of the breast can detect up to 50 percent of the cancers not detected by mammography alone. Examination of breast in premenopausal women should be carried out one week after the onset of the last menstruation when breast engorgement and nodular texture of breast tissue are usually decreased.
The clinical features are grouped into local effects, lymph node involvement, distant metastases and systemic effects.
Local effects are: a breast lump, skin thickening, dimpling of the skin, peau d orange and nipple discharge.
Axillary and supraclavicular glands require careful clinical evaluation.
The features of metastases, pleural and pericardial effusion, hepatomegaly, ascites and other intraperitoneal masses.
Among CNS involvement, special attention must be paid to the presence of brain metastasis, spinal cord compression and meningitis carcinomata.
Among the systemic effects, loss of appetite, bone pains, headache and paresthesia of the extremities are not uncommon.
DIAGNOSIS (sic OF?) ANY MASS IN THE BREAST SHOULD BE CONSIDERED FOR A BIOPSY EVEN IF MAMMOGRAMS ARE NEGATIVE
Virtually all breast cancers are diagnosed by Fine-Needle Aspiration Cytology (FNAC), Core Needle Biopsy, Incisional or Excisional Biopsy. Detected either on a mammogram or palpation. A palpable mass in a womans breast represents a potentially serious lesion and requires triple assessment, namely, proper clinical examination, mammography and fine needle aspiration biopsy regardless of the age of the woman. The initial objective is to distinguish simple cysts from solid lesions, which can be accomplished with needle aspiration or a USG. A positive result on cytologic examination after aspiration is sufficiently accurate to justify one stage diagnosis and treatment, with confirmation by examination of a frozen section obtained during the procedure. An inconclusive or a negative cytology warrants a biopsy of the lesion. All solid masses should be subjected to FNAC or excision biopsy.
MAMMOGRAPHY (Figure 12.1)
Mammography is the radiological examination of the soft tissue of the breast. It has a major role in assessing clinically palpable and non-palpable breast lesions. Any abnormality found on mammography should be taken into account with the patients symptoms and the results of other investigations, e.g., FNAC, core biopsy, etc., before planning definitive treatment. In the hands of an experienced radiologist, breast mass as small as 2-3 mm can be identified in 85 to 95 percent of cases. Mammography should be avoided in adolescence, pregnancy and lactation unless there is other evidence of malignancy. All women with breast cancer should have a mammogram in order to reveal the extent of the disease, to determine if there is multifocal disease or identify a lesion in the opposite breast. Scintimammography is a newer device in which intravenous radioactive element, Technetium “ 99m (99mTc) is used to identify abnormal masses in the breast, and if any, can be imaged with a Digital Gamma camera. This technique helps in differentiating benign and malignant lesions and to determine the presence of multicentric tumours in the breast.
ULTRASONOGRAPHY
Ultrasonography is a useful non-invasive imaging tool for investigating palpable lumps in the breast. It is complementary to mammography and will be able to pick out benign lesions more accurately.MRI
It is not used routinely but is a sensitive tool for detecting occult breast cancer foci. MRI is useful in selective situations like detecting a subtle primary in the breast in patients presenting with carcinoma of unknown primary. It also helps in studying the local extent of the tumor and its multicentricity. MRI is very useful in distinguishing local recurrence from scar tissue in a previously irradiated breast.STAGING AND EVALUATION (Tables 12.1 and 12.2)
The most widely used staging is the American Joint Committee on Cancer (AJCC) classification, which is based on the tumor size (T), the status of regional lymph nodes (N) and the presence of distant metastasis (M). Clinical staging is determined after physical examination and appropriate radiologic studies have been performed. Pathologic staging is determined following surgery for operable breast cancer. Pathologic tumour size may differ from clinical tumor size. In additional, axillary nodal metastases that were not clinically evident may be detected after pathologic examinations.
Table 12.1: The American Joint Committee on Cancer (AJCC) Classification
| T0 | No evidence of primary tumor |
| T1 | Tumor less than 2 cm in diameter |
| T2 | Tumor between 2-5 cm in diameter |
| T3 | Tumor greater than 5 cm in diameter |
| T4 | Tumor fixation to chest wall or skin |
| T4a | Involvement of chest wall (ribs/serratus anterior/intercostals muscle) |
| T4b | Skin (satellite nodules/ peau de orange/ ulceration0 |
| T4c | Both a + b |
| T4d | Inflammatory carcinoma |
| N0 | No axillary nodes |
| N1 | Palpable, mobile, ipsilateral axillary nodes |
| N2 | Fixed ipsilateral axillary nodes |
| N3 | Internal mammary nodes |
| M0 | No metastasis |
| M1 | Contralateral axillary nodes/supraclavicular nodes/contralateral breast tumor |
| M2 | Distant metastasis |
Table 12.2: Staging of Cancer; TNM classification “ 1997
| Stage | ||||
|---|---|---|---|---|
| 0 | Tis | N0 | M0 | |
| I | 2.2% | T1 | N0 | M0 |
| IIA | 11.8% | T0 | N1 | M0 |
| T1 | N1 | M0 | ||
| T2 | N0 | M0 | ||
| IIb | 21.9% | T2 | N1 | M0 |
| T3 | N0 | M0 | ||
| IIIA | 21.3% | T0 | T2 | M0 |
| T1 | T2 | M0 | ||
| T2 | N2 | M0 | ||
| T3 | N1 | M0 | ||
| T3 | N2 | M0 | ||
| IIIB | 28.7% | T4 | Any N | M0 |
| Any T | N3 | M0 | ||
| IV | 14.0% | Any T | Any N | M1 |
TREATMENT (pp 140-141)
The understanding that breast cancer is no longer a regional disease but a generalized disease had led to the shift of treatment from drastic radical surgical procedures to the reliance on multidisciplinary treatment.
Over a century, the treatment of breast cancer was based on Halsteads theory, which taught that breast cancer spreads by direct permeation to regional nodes. These nodes act as filters from where disease spreads further up, once they are overloaded with tumor cells.
This concept was the basis of radical mastectomy, wide removal of a breast bearing tumor with en bloc dissection of the regional nodes.
But the occurrence of distant metastasis in œtotally excised cancers? led to the detection of micrometastasis. It is now held that the breast cancer is a systemic disease and micrometastasis occurs even at the time of detection of the disease. So a regional treatment alone does not solve this vexed problem of breast cancer. Patients may present with distant metastatic disease in the absence of metastasis in the axillary nodes at initial presentation.
At present, the management of breast cancer is multidisciplinary involving the surgeon, pathologists, radiotherapists, medical oncologist, psychologists and social workers. The success of the treatment depends on the coordinated approach of these specialists. The various options of treatment are as follows:
LOCOREGIONAL TREATMENT
Breast conserving therapy (lumpectomy, breast irradiation and surgical staging of the axilla)Modified radical mastectomy (removal of the entire breast with level I-II axillary dissection) with or without breast reconstruction
Adjuvant radiation after mastectomy “ regional radiation
Adjuvant systemic therapy
Cytotoxic chemotherapy
Endocrine manipulations
TREATMENT OF EARLY STAGE BREAST CANCER
Locoregional treatmentBREAST CONSERVATIVE SURGERY
The last three decades of 20th century has seen a shift from radical treatment to breast conservation. Different surgical techniques for the removal of the breast lump employed are:Lumpectomy “ when the lump is removed with little surrounding tissue.
Segmentectomy or quadrantectomy “ where a segment or quadrant of breast harboring the tumor is excised.
However, with simple conservative surgical excision alone, patients are found to have high incidence of local recurrence. Hence, adjuvant radiation to the remaining breast is added and it has now been proved that in suitable cases for breast conservation, limited resection with irradiation gives similar or even better prognosis when compared to radical surgical procedure.?
THE ISSUES
11. From the rival arguments summarised above, the issues that arise for determination in this case are as under:
(i) Whether the Surgical Oncologist followed the standard medical protocol and displayed reasonable skill and care in (provisionally) diagnosing that the lump in Kumari's breast was cancerous?
(ii) Whether the microscopic analysis of the fine needle aspirate was done with the degree of care expected of an average Cytologist of reasonable skill and competence?
(iii) Whether, according to standard medical protocol, any prior/further diagnostic tests were indicated for confirmation of the disease before deciding to undertake modified radical mastectomy?
(iv) Whether the consent for the surgery obtained in this case can be considered a valid consent?
(v) Whether, in the given circumstances, there is a case of medical negligence/deficiency in service on the part of the NIMS and the doctors attending on Kumari?
DISCUSSION
12. It needs no emphasis that in determination of the issues, particularly those dependent on the facts as they existed at the relevant point of time, reliance would have to be placed on the medical records and other documents that were contemporaneous. If the averments and documents, recorded much after the actual event, run contrary to or travel beyond the contemporaneously recorded observations/records, they would have to be discounted as efforts to œimprove? the case, whether by the complainants/appellants or the OP/respondent.
13(i)(a) On the first issue, the starting point is what constitutes the standard medical protocol for clinical observations and diagnostic tests to determine the existence of cancer of the breast (or, otherwise) when a patient presents herself with the complaint of a breast lump noticed two months back. There is a plethora of medical literature on the subject. From the excerpts of the authoritative medical textbook (Harrisons Principles of Internal Medicine, 12th Edition) cited by the appellants (vide paragraph 6(i)(a) above) it is seen that the first stage consists of physical observation and palpation of the breast to check if the mass/lump is distinctly different from the surrounding tissue or œdominant?, because œamong the most often described features of breast cancers are irregularly shaped, firm or hard, painless nodules or masses?. In this case, the Surgeons observations were:
œleft breast subareolar swelling, painless(ly) slow growing, 3 x 3 cm (mass), firm (but) no skin involvement, rest of the breast supple; small axillary lymph nodes palpable (but) no SCLN (supraclavicular lymph nodes).?
[Note: Words/phrases in parenthesis supplied]
(i)(b) This set of initial observations of the Surgeon leading him to a provisional diagnosis of the breast tumour being likely malignant and advising diagnostic tests of mammogram and FNAC, in that order, cannot be faulted, in view of the standard protocol recommended in the above-mentioned reputed medical textbook.
(ii)(a) What appears to have happened after 12.09.1997 is, however, considerably different from the standard medical protocol. After that date, the next set of observations was recorded by Dr. Raju in the NIMS medical record on 17.09.1997 and read as:
œFNAC “ Ca L breast “ carcinoma
97Y1616 dt. 17.9.97
Adv: Mammogram
Admit Wd 4? [Emphasis supplied]
(b) It is undisputed that Kumari came to see Dr. Raju on 17.09.1997 after her initial visit in the evening of 12.09.1997. In other words, if Kumari had indeed undergone (bilateral) mammography, as advised by Dr. Raju on 12.09.1997 (according to NIMS, at the Apollo Hospital, Hyderabad because there was no facility for mammography at the NIMS), it could have been only between 13.09.1997 and 17.09.1997 because she was admitted to the NIMS as an in-patient on 18.09.1997. What, then, was the point of Dr. Raju again advising mammography on 17.09.1997?
(c)If, on the other hand, Kumari came, on her second visit to Dr. Raju on 17.09.1997, with the mammogram done at the Apollo Hospital sometime before 17.09.1997 and showed him the mammogram and the associated report on that date, it was a minimal professional requirement on the part of Dr. Raju to have recorded his observations regarding the said mammogram in the NIMS case record, instead of again advising mammogram on 17.09.1997. Thus, there is no mention in the contemporaneous medical records of the NIMS showing that Kumari underwent mammography any time after 12.09.1997 and before (or, upto) 17.09.1997.
(d)It is only in his explanatory letter dated 27.10.1998 to the Director, NIMS, i.e., over one year after the relevant time and on notice issued by the State Commission on the complaint having been received by NIMS that Dr. Raju stated for the first time:
œSince the pathology report favouring the malignancy (sic) I have (sic) advised her to undergo mammography to plan for treatment. Mammogram also revealed a dense lesion with architectural change in same area of the lump and I had advised her to undergo surgery in view of the presence of lump which was of cancerous nature.?
[Emphasis supplied]
Yet, the foregoing clarification found no mention in the affidavit dated 15.03.1999 filed the Executive Registrar, NIMS.
(e) Further, even in his own affidavit of July 2002, Dr. Raju did not go beyond stating, œ¦ ¦ ¦ the first complainant has (sic) undergone mammogram test and the test revealed suspicion of malignancy ¦? Notably, this affidavit of Dr, Raju did not mention œdense lesion? or of the œarchitectural change? of the breast œin same area of the lump?.
(f) The foregoing detailed review of the relevant medical literature clearly demonstrates the need for bilateral mammography as the first diagnostic tool in a case of suspected cancer of the breast - Fine Needle Aspiration Cytology (FNAC) should follow and not precede mammography. In fact, the Textbook titled œEssentials of Clinical Oncology? goes to the extent of recommending that all women with suspected breast cancer should have mammography done in order to reveal the extent of the disease: to determine if there is multi-focal disease or identical lesion in the contralateral (opposite) breast.
(iii)(a) The next part of the recommended standard protocol is the staging and evaluation of the cancer once it is confirmed that there is breast cancer. This is based on the standard classification adopted by the American Joint Committee on Cancer (AJCC), which takes into account the size of the tumour, the status of regional lymph nodes and presence of metastasis (spread of cancerous cells to body areas away from the main tumour) “ vide Tables in paragraph 10 above. For this, physical examination and appropriate radiological tests are needed. Therefore, before undertaking any definite line of treatment, particularly radical surgery, it is the standard protocol to do and record staging of the disease in accordance with the AJCC classification parameters.
(b) The aforesaid Textbook also advises that for early stage of breast cancer, locoregional treatment is the standard protocol. The first line of approach in locoregional treatment is breast conservation surgery which, according to this Textbook, has emerged over the last three decades of the 20th century as the mode preferred to radical surgery; in other words by the time Kumaris surgery was advised, this line of treatment was well known and in practice as the preferred option.
(iv) Thus, no evidence was placed before the State Commission to show that Dr. Raju actually followed the standard diagnostic protocol, including bilateral mammography and staging of the cancerous tumour before finally concluding that Kumari had carcinoma of the left breast and deciding the line of treatment (modified radical mastectomy).
(v)(a) On the second issue regarding the degree of skill and care adopted by the Cytopathologist in conducting the FNAC and reporting on the result, the first point which stands out is the discrepancy in the version of the OP before the State Commission and that in its appeal before this Commission. Though an attempt was made to show that the Cytopathologist (Dr. Aruna Prayag) had filed her evidence affidavit before the State Commission, the original record of the State Commission did not bear that out. In fact, there is no mention of such an affidavit in the list of documents filed by the parties with the State Commission nor is there any discussion in the State Commissions impugned order on the so-called affidavit of the Cytopathologist.
(b) The next aspect is that at no stage in the proceedings before the State Commission was it averred on behalf of either the NIMS or any of the Doctors concerned that the cytopathology report of 17.09.1997 was based on two samples of fine needle aspirates of the tumour tissues in Kumaris left breast. In fact, neither the medical record of the NIMS nor (the copy of) the cytopathology report dated 17.09.1997 filed before the State Commission makes any mention of even the date on which the sample was drawn nor any noting to indicate if there was one sample or more. It was complainant no. 2 (Kumaris husband) who mentioned in his letter dated 27.10.1997 to the Executive Registrar, NIMS that two FNA samples were drawn, the first on 13.09.1997 and the second on 17.09.1997 before giving the cytopathology report. He also stated that the Pathology Department staff had told him that the second sample had been collected œas a measure of ample precaution?. If this was so then it is all the more surprising that neither the cytopathology report nor the letter of 07.11.1998 of Professor K.S. Ratnakar to the Executive Registrar nor the affidavit dated 15.03.1999 of the Executive Registrar before the State Commission found it necessary to mention this œmeasure of ample precaution?. Further, the OPD record produced before the State Commission has no mention of even a single FNA sample being drawn though it has a noting dated 17.09.1997 of the finding in the FNAC report, in the handwriting of Dr. Raju. Drawing a fine needle aspirate sample of a sub-areolar tumour in a breast would be a painstaking process because the needle has to be inserted several times to draw tissues (or, fluid) from various parts of the tumour. In other words, for this, Kumari would have had to come to the designated room/laboratory at the NIMS, undergo preparations and the Cytopathologist or a trained Technician would have had to draw the sample/s under at least local anaesthesia. Such a procedure would surely need to be recorded, even if in the briefest words, in the patients medical record. Notably, the NIMS did not produce any record at all of drawing of the FNA sample of Kumaris breast before the State Commission though it took the extraordinary step of producing two versions of the same report dated 17.09.1997, one with a special footnote, as already noticed.
(c) Another related aspect is that in his affidavit evidence Dr. Raju stated, inter alia, œThe complainant approached the Pathology Department on 17.09.1997and the report of the FNAC test revealed that positive for malignant cells breast ¦ ¦ ¦?. Thus there are several inconsistencies in the versions of the OPs Doctors regarding the date and number of FNA samples.
(d) Further, on two separate samples of FNA tissues drawn on different dates, can there be only one report? Even at the appellate stage, no medical literature was produced before us to show that this would constitute a standard medical practice.
(e) On the one hand, there is no reason to disbelieve the version of complainant no. 2 that the NIMS staff in question told him that they had drawn a second sample on 17.09.1997 as a measure of ample precaution. On the other, the related documents do not show any evidence of this being done. Further, complete absence of any medical record and of even a passing mention of a second FNA sample in the letter dated 07.11.1998 of Dr. K.S. Ratnakar or the counter affidavit dated 15.03.1999 of the Executive Registrar would lead to the conclusion that only one FNA sample was drawn on 13.09.1997 but, for reasons known only to them, the NIMS staff told complainant no. 2 a different story.
(vi)(a) As regards the third issue of consent for the surgery, the law on the subject has been laid down by the Apex Court in its judgment dated 16.01.2008 in the case of Samira Kohli vs Dr. Prabha Manchanda [(2008) 2 SCC 1]:
œ48. Having regard to the conditions obtaining in India, as also the settled and recognised practices of medical fraternity in India, we are of the view that to nurture the doctor-patient relationship on the basis of trust, the extent and nature of information required to be given by doctors should continue to be governed by the Bolam test rather than the œreasonably prudential patient? test evolved in Canterbury. It is for the doctor to decide, with reference to the condition of the patient, nature of illness, and the prevailing established practices, how much information regarding risks and consequences should be given to the patients, and how they should be couched, having the best interests of the patient. A doctor cannot be held negligent either in regard to diagnosis or treatment or in disclosing the risks involved in a particular surgical procedure or treatment, if the doctor has acted with normal care, in accordance with a recognised practice accepted as proper by a responsible body of medical men skilled in that particular field, even though there may be a body of opinion that takes a contrary view. Where there are more than one recognised school of established medical practice, it is not negligence for a doctor to follow any one of those practices, in preference to the others.
49. We may now summarise principles relating to consent as follows:
(i) A doctor has to seek and secure the consent of the patient before commencing a œtreatment? (the term œtreatment? includes surgery also). The consent so obtained should be real and valid, which means that: the patient should have the capacity and competence to consent; his consent should by voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what he is consenting to.
(ii) The adequate information to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that the doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote of theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.
(iii) Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorised additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorised, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorised procedure until patient regains consciousness and takes a decision.
(iv) There can be a common consent for diagnostic and operative procedure where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.
(v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment?.
(b) The original record of the case before the State Commission shows that the consent for the surgery was recorded on 18.09.1997 in the following words:
œConsent for the surgery
We have been explained the surgery, its necessity, associated risks/complications and the procedure of mastectomy and hereby give consent for the surgery of © mastectomy, anaesthesia and blood transfusion as required necessary.
Signature : D. B. Eswari
Relationship : Daughter?
(c) It is totally unclear why, when that consent was taken on 18.09.1997, it could not be Kumaris own consent because she had already been admitted as an inpatient. The law laid-down on the subject (supra) is explicit that when a patient is in a position to give consent, the consent has to be taken from him/her only. Further, the doctor concerned (or at least a member of the team of doctors attending on the patient) has to explain the pros and cons of the disease and as well as the available and suggested courses of treatment. In this case, it is obvious that neither the Surgical Oncologist himself nor the Dr. Sridhar (Senior Resident) came and explained to Kumari before obtaining her consent (or, for that matter consent of D. B. Eswari) “ the whole process appears to have been carried out by some student nurse. Hence, we have no hesitation in holding that the œconsent? taken in this case was neither œreal? nor œvalid.?
(vii) As regards the fourth issue on need for additional diagnostic tests prior to decision on the surgery, our conclusion, based on a detailed discussion of the facts of the case and the medical literature, is recorded in para. 13(iv) above. We may, however, add that as non-invasive a test as an ultrasonography of the affected breast could have been done with benefit, as advised in the Textbook on Clinical Oncology excerpted above, viz., œUltrasonography is a useful non-invasive imaging tool for investigating palpable lumps in the breast. It is complementary to mammography and will be able to pick out benign lesions more accurately.?
(viii)(a) As regards the issue of medical negligence, if any perhaps no fault can be found with the approach of the Surgical Oncologist if one agrees with him that this was a clear case of carcinoma of the breast. However, whether the surgery should have been modified radical mastectomy with axillary clearance or a form of breast conservative surgery (for example, lumpectomy) and also taken up within 48 hours of the FNAC report being available, would obviously depend on the nature and stage of the cancer.
(b) In this context, the views of the Surgical Oncologist as expressed in his affidavit and his reasoning assume significance. In his own words:
œ... ¦ As FNAC report and the features of lump in left breast are correlating with description of cancer, the deponent thought it fit to remove the left breast of the first complainant instead of going for a limited surgery in the interest of the complainant?.
He further adds:
œ¦ ¦ If the surgery was not conducted at an early stage, even though the tumour suspected to be malignant, then it may have serious repercussions on the health of the first complainant and there is every likelihood of spreading of dangerous cancer to the other organs andthe chances of survival are very difficult and it may take away life of the patient in question.?
Yet, in the same affidavit, Dr. Raju also states, inter alia:
œ¦ ¦ ¦ the report of FNAC further confirmed the suspicion of the carcinoma and the deponent herein advised the first complainant that the carcinoma is in early stage.?
(c) From these averments of the Surgical Oncologist, it is obvious that he had decided on modified radical mastectomy right after/on 17.09.1997 in the firm belief that the tumour was malignant and that it was in a stage where a limited surgery would have led to spreading of cancer to other organs. Even if it is assumed that the Surgical Oncologist had enough diagnostic information at his disposal to conclude that the tumour was cancerous, it is seen from the medical record, the so-called consent as well as discussion above that there was no attempt at all to do a medically valid staging/evaluation of the disease in order to decide whether to go in for modified radical mastectomy or a limited/conservation surgery. Such a decision based on appropriate staging was surely necessary.
(ix) Some more aspects of the records relating to the surgery and post-surgical care need to be noticed:
(a) It has been all along stated that it was Dr. G.S N. Raju, the Surgical Oncologist who conducted the surgery. However, the photocopy of the typed record of the surgery produced before the State Commission shows that Dr. S. Sridhar was the Surgeon. He was assisted by Dr. Ramakrishna while Dr. Padmaja was the Anaesthetist and Roja Rani the Staff Nurse. The typed record has also has the name of Dr. S. Sridhar as the Surgeon who prepared the patient in the OR. In fact, the entire note of the Surgery has no mention of the name of Dr. G.S.N. Raju. This would surely raise serious doubt as to whether it was Dr. G.S.N. Raju, Surgical Oncologist or Dr. S Sridhar, Senior Resident (SR) who actually conducted the surgery. At the least, it would cast grave doubts on the truthfulness of this very important piece of medical record maintained and produced by the NIMS.
(b) It may also be noticed that Dr. Raju repeatedly recorded the size of Kumaris breast lump as 3x3 cm (in his initial notes dated 12.09.1997 as well as in his affidavit before the State Commission) whereas both the Histopathology Report and the Discharge Summary record the size as 2x2 cm.
(c) In respect of the post-operative care/treatment, the daily Nursing Charts show that immediately after the surgery on 19.09.1997, it was Dr. S. Sridhar who recorded his observations in the œ?Progress Record/Doctors Orders? in his own hand. On 20.09.1997 too it was Dr. Sridhar who saw Kumari. Dr. Raju, who saw Kumari only on 22.09.1997, did not seem to have recorded any observation on the patients condition. The date-wise entries thereafter show that Dr. Raju did not see Kumari till 01.10.1997, when she was discharged.
(d) Though it has been claimed by Dr. Raju in his affidavit that he advised Kumari to come for reconstructive surgery as there was œevery possibility to bring back the left breast to normalcy?, the medical record produced before the State Commission reveals that neither on 13.10.1997 nor on 24.10.1997 did Dr. Raju suggest any reconstructive surgery. The Histopathological Report of the excised breast was available on 01.10.1997. The first entry where breast reconstruction advice was recorded is of 01.12.1997 though on 24.10.1997, Dr Raju himself saw Kumari and recorded that the wound had healed well and there was n o chest wall collection.
(x) So much for post-operative care! And, so much for truthful averments/recording of medical documents!
14. In view of the detailed discussion above, we have no hesitation in holding that the respondent NIMS was guilty of medical negligence and deficiency in service on the part of the main Doctors, viz., Dr. Raju and Dr. Prayag who provided treatment to D.H. Kumari that culminated in a hasty, medically unsupportable, rather insensitive and hence a most traumatic decision to remove her left breast.
15(a) As regards compensation for the grievous injury suffered by D.H. Kumari and her family as a consequence, the demand was for grant of Rs. 20 lakh “ Rs. 10 lakh to herself, Rs. 2 lakh to her husband, complainant no.2 and Rs. 8 lakh for the children. Beyond this break-up, however, there is no detail to support the demand. While no amount of money can indeed compensate a woman of 46 years for the physical pain and injury, feelings of personal violation and emotional trauma caused by a set of negligent acts leading to removal of a breast, we can also not overlook the legal parameters for grant of compensation. In our view, the ends of justice in this much-delayed case would perhaps be met if the sum of Rs. 10 lakh were awarded as compensation.
(b) Accordingly, we partly allow the appeal, set aside the impugned order of the State Commission and direct the NIMS to pay to D. H. Kumari compensation of Rs. 10 lakh and costs of Rs. 50,000/-, by demand draft within 4 weeks of the date of this order, failing which the entire amount of Rs. 10.5 lakh will be payable with interest @ 9% per annum from that date.
(c) Before parting with the matter, we would like to place on record our deep appreciation of the assistance rendered by Ms. Surekha Raman as Amicus Curiae and direct the Registry to disburse a sum of Rs. 10,000/- to her towards reimbursement of out-of-pocket expenses.