National Consumer Disputes Redressal
H R Megh vs Dr Jasjit Chhachhi Nursing Home on 21 July, 2011
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI FIRST APPEAL No. 126 of 1999 (From the Order dated 21.01.1999 in Complaint Case No. 58 of 1997 of the Punjab State Consumer Disputes Redressal Commission, Chandigarh) 1. H. R. Megh House No. 2-A, Old Bara Dari Jalandhar City, Punjab 2-4. Harsh, Karan and Varun Kumar Appellants Sons of H. R. Megh House No. 2-A, Old Bara Dari Jalandhar City, Punjab versus 1. Dr. Jasjit Chhachhi Nursing Home Through Dr. (Mrs) Jasjit Chhachhi, Proprietor 49, New Garden Colony, Circular Road Amritsar, Punjab 2. Dr. (Mrs) Jasjit Chhachhi, Proprietor Dr. Jasjit Chhachhi Nursing Home Respondents Amritsar, Punjab 3. Dr. B. L. Nagpal Former Professor and Head of Department of Pathology Government Medical College, Amritsar House No. 2-A, Medical Enclave, Amritsar BEFORE: Honble Mr Justice R. C. Jain Presiding Member Honble Mr Anupam Dasgupta Member For the Appellants Mr B. J. Singh, Advocate For the Respondents Mr Updip Singh, Advocate Dated 21st July 2011 ORDER
Anupam Dasgupta This appeal challenges the order dated 21.01.1999 of the Punjab State Consumer Disputes Redressal Commission, Chandigarh (hereafter, the State Commission) in Complaint Case No. 58 of 1997. The original complainants (appellants before us; hereafter referred to as the complainants) filed a complaint before the State Commission, alleging medical negligence and deficiency in service on the part of the original opposite parties (respondents here and referred to as the OPs) in treating Kamalesh Kumari (hereafter, Kamalesh) the deceased wife of complainant no. 1 and mother of the other complainants. After hearing the parties and considering the material on record, the State commission dismissed the complaint, which has led to this appeal.
II. The Facts
2. We find the discussion of facts of the case in the impugned order of the State Commission grossly inadequate. Hence, it is necessary to re-state the facts in some detail for proper appreciation of the contentions of the parties. During the period in question, Kamalesh underwent medical/surgical treatment in two phases, viz., first in OP 1 at the hands of OP 2 and then at the Post Graduate Institute of Medical Education and Research, Chandigarh (PGI) and some other hospitals. The undisputed facts gleaned from the pleadings, averments and, mainly, the documents on record are as under:
2.1 (i) Kamalesh suffered from excessive vaginal bleeding with pain at the time of menstruation (menorrhagia) and was under the treatment of OP 2 at OP 1 since October 1990. OP 2 performed a dilatation and curetting (D&C) procedure on Kamalesh on 20.10.1990 and sent the curettings (tissues) to the Government Medical College (GMC), Amritsar for histopathological examination (HPE). The HPE report dated 27.10.1990 of the D&C curettings showed chronic endometriosis with metaplasia and changes in the squamous epithelium, and advised cervical biopsy.
However, the medical record of OP 1 for this D&C did not refer to the findings of this HPE report though it contained entries of 06.11.1990, i.e., well after the date of the HPE report. Further, while this record did not mention the need for cervical biopsy recommended in the HPE report, it did note the advice of OP 2 about abdominal hysterectomy.
(ii) Kamalesh consulted OP 2 infrequently during 1990-1995. During this period, OP 2 treated Kamalesh for her continuing menorrhagia with medication.
(iii) In September 1995, OP 2 examined Kamalesh in detail at OP 1. The medical record dated 23.09.1995 of OP 1 mentioned, inter alia, the complaint of menorrhagia with pain and the existence of a uterine fibroid polyp projecting through the cervix. It also noted the finding of an ultrasonograph (USG) report, which referred to a fibroid of 25 mm. However, there was no reference to the date of this USG report nor of the clinic where it was done nor was there any mention of the D&C carried out in October 1990 or of the finding of the HPE after that D&C. This record noted the advice of several blood (pathological) tests, urine culture and ECG to be got done by Kamalesh as a pre-requisite for the Total Abdominal Hysterectomy (TAH) planned for 05.10.1995. Consent for this surgery was stated to have been given by complainant no.1, the husband of Kamalesh. During the surgery, OP 2 removed the uterus, right ovary and fallopian tube, leaving the left ovary and tube intact.
(iv) The excised uterus, cervix, fallopian tube and ovary were sent for HPE to GMC, Amritsar. Kamalesh was discharged on 13.10.1995. Kamaleshs patient record at OP 1 for the period 04-13.10.1995 mentioned the results of the pre-operative pathological tests and ECG and noted the bare fact that she had D&C five years ago. It also quoted the findings of the HPE of the excised uterus, etc., as per the report dated 18.10.1995 of GMC, Amritsar, in the following words:
HPR 18/10Chronic cervicitis with Nabothian follicles epidermization of endocervical glands Proliferative endometrium with mild hyperplasia of glands Leiomyoma with leiomyomatous polyp Ovary shows haemorrhagic corpus luteum.
[Notes: 1. Emphasis supplied.
2. For better appreciation, some of the medical terms used in the HPE report are explained below, based on medical literature available on various well-known and popular websites. The websites disclose the original standard sources of the definitions used.
(a) Cervicitis means inflammation of the cervix - the lower part of the uterus that extends about one inch into the vaginal canal, vide http://www.healthscout.com/ency/1/448/main.html.
(b) Nabothian follicle means one of a number of retention cysts on the cervix of the uterus-the sacs, which contain mucous, form when the ducts of the glands in the cervix are blocked by a new growth of epithelium over an area damaged because of infection. [M. Naboth (16751721), German anatomist], vide http://www.encyclopedia.com/doc/1O62-nabothianfollicle.html.
(c) Epidermization is not the relevant word here it should be Epidermalization, which means the transformation of glandular or mucosal epithelium into stratified squamous epithelium. This is also called squamous metaplasia, vide http://medical-dictionary.thefreedictionary.com/epidermalization.
(d) Endocervical glands mean glands of/in the endocervix; endocervix, in turn, is defined as the passageway between the external os and the uterine cavity and is also referred to as the endocervical canal. It varies widely in length and width, along with the cervix overall. Flattened anterior to posterior, the endocervical canal measures 7 to 8 mm at its widest in reproductive-aged women. The endocervical canal terminates at the internal os which is the opening of the cervix inside the uterine cavity, vide http://en.wikipedia.org/wiki/Cervix.
(e) Endometrium is defined as the uterine lining; the cells that line the uterus, vide http://www.medterms.com/script/main/art.asp?articlekey=3242.
(f) Hyperplasia (or "hypergenesis") is a general term referring to the proliferation of cells within an organ or tissue beyond that which is ordinarily seen (e.g., constantly dividing cells). Hyperplasia may result in the gross enlargement of an organ, the formation of a benign tumor, or may be visible only under a microscope. Hyperplasia is different from hypertrophy in that the adaptive cell change in hypertrophy is by increased cellular size only, whereas in hyperplasia it is by increased cellular number vide http://en.wikipedia.org/wiki/Hyperplasia
(g) Leiomyoma is a benign tumor derived from smooth muscle, most often of the uterus (leiomyoma uteri) but can occur in urinary bladder, upper intestinal tract and esophagus, vide http://medical-dictionary.thefreedictionary.com/uterine+leiomyoma. Leiomyomatous is the adjective.
(h) Metaplasia (Greek:
"change in form") is the reversible replacement of one differentiated cell type with another mature differentiated cell type. The change from one type of cell to another is generally caused by some sort of abnormal stimulus. In simplistic terms, it is as if the original cells are not robust enough to withstand the new environment, and so they change into another type more suited to the new environment. If the stimulus that caused metaplasia is removed or ceases, tissues return to their normal pattern of differentiation. Metaplasia is not synonymous with dysplasia and is not directly considered carcinogenic, vide http://en.wikipedia.org/wiki/Metaplasia]
(v) Kamalesh remained on medical leave during October 1995 - February 1996. During this period, she consulted OP 2 at OP 1 four-five times until she reported for duty on 26.02.1996 (as she was an officer of the Government of Punjab). Her leave was sanctioned based on three medical certificates issued by OP 2 on 03.11.1995, 29.11.1995 and 29.12.1995 respectively. OP 2 issued a fitness certificate to Kamalesh on 24.02.1996, after examining her. There is no record of Kamalesh going back to OP 2 at any point of time after 23.02.1996.
2.2 (i) The next set of medical records of Kamalesh shows that she went as an outpatient to the PGI on 11.05.1996. The provisional diagnosis in the OPD record was, Ca Cevx., i.e., carcinoma of the cervix.
(ii) After a biopsy, the HP report dated 18.05.1996 of the PGI recorded the diagnosis as Post-TAH (Vault)Moderately differentiated Adenocarcinoma.
(iii) On being referred for radiotherapy, the PGI record of the Department of Radiotherapy in respect of Kamalesh noted (22.05.1996), inter alia, A 48 year old lady was having irregular bleeding l/v 21/2 yrs for which she underwent TAH + SO in Oct 95 in Amritsar. No details or no HPR available. Since Feb 95, she started having discharge P/V mild, foul smelling. Complaint of spotting off & on. . At the end of a two-page summary of patient history, complaints and physical examination, the record noted the diagnosis of Adenocarcinoma (Vault).
[Notes: 1. Adenocarcinoma means cancer that begins in cells that line certain internal organs and that have gland-like (secretory) properties, vide http://www.cancer.gov/Templates/db_alpha.aspx?CdrID=46216, the website of the National Cancer Institute of the USA.]
2. A more detailed definition in relation to the situation in this case is, according to http://en.wikipedia.org/wiki/Adenocarcinoma, Adenocarcinoma is a cancer originating in glandular tissue. This tissue is also part of a larger tissue category known as epithelial. To be classified as adenocarcinoma, the cells do not necessarily need to be part of a gland, as long as they have secretory properties. Adenocarcinomas can arise in many tissues of the body due to the ubiquitous nature of glands within the body. While each gland may not be secreting the same substance, as long as there is an exocrine function to the cell, it is considered glandular and its malignant form is therefore named adenocarcinoma. Malignant adenocarcinomas invade other tissues and often metastasize given enough time to do so.]
(iv) On 27.05.1996, Kamalesh underwent a KUB x-ray and Intravenous Urogram (IVU) at the PGI, on reference from the Radiotherapy Department. While the report reflected a normal study of the kidneys, ureters and bladder (KUB), the report began with a noting of Ca Cervix.
(v) On advice of the PGI for computerised tomography (CT) scan of the abdomen and pelvis, Kamalesh underwent the scan at a private radiological clinic, viz., Dhillon C. T. Scan Centre in Amritsar on 05.06.1996. The CT scan report, made by one Dr. C. L. Thukral, M.D. (Radiodiagnosis) at the said Centre, read as under:
Well defined lobulated mixed density heterogeneously enhancing mass having hypodense necrotic areas and measuring 4.2x4.9 cm is seen in left adnexal region. Left ovary is not properly defined. There is invasion of pelvic muscles on the left side. A homogeneous globular mass measuring 4.9x5.8 cm is seen in relation with stump due to previous hysterectomy. This mass is bulging anteriorly elevating the floor of the urinary bladder. It is also obliterating the lumen of the rectum from left lateral aspect.
Fat planes between mass and urinary bladder and rectum are ill defined.
Multiple homogeneous nodular masses due to enlarged lymph nodes are seen at para-aortic (up to the bifurcation of aorta) retrocaval and rt. internal iliac sites.
Liver maintains normal size and configuration. Hepatic parenchyma appears homogeneous without focal defect. There is no evidence of intrahepatic biliary dilatation.
Gall bladder is distended.
Pancreas, spleen and both kidneys are normal.
Both ureters are outlined with contrast in their entire length.
CONCLUSION:
CT APPEARANCES ARE SUGGESTIVE OF:
SOLID PELVIC MASS FOLLOWING HYSTERECTOMY WITH LEFT ADNEXAL MASS AND LYMPHADENOPATHY.
? ENDOMETRIAL CARCINOMA STAGE III [Notes: 1. Emphasis supplied.
2. Adnexa: This Latin word (in the plural) is used in medicine in reference to appendages. For example, in gynaecology the adnexa are the "appendages" of the uterus, namely the ovaries, Fallopian tubes and ligaments that hold the uterus in place, vide http://www.medterms.com/script/main/art.asp?articlekey=2153.]
(vi) Kamalesh underwent radio/chemotherapy at the PGI. The record also shows that in June 1996, the treating doctor at the Radiotherapy Department, PGI wrote to both OP 2 and OP 3 to obtain the medical records of the patient while she underwent TAH at OP 1 and of the HPE of the uterus, etc., done at the GMC, Amritsar. That Department also wrote directly to OP 3 to send the slides and the blocks of the post-TAH histopathological examination. On receipt of the medical records of OP 1, the HPE report (duplicate copy) and the slides as well as the blocks of the tissues at the Radiotherapy Department, PGI, the slides and blocks were reviewed at PGI Histopathology Laboratory.
(vii) Rather distinct from the summary of the HPE report noted in Kamaleshs medical record at OP 1 during October 1995, the HPE report dated 18.10.1995 of GMC, Amritsar read as under:
Ch. Cervicitis with Nabothian follicle formation & epidermalization of endocervical glands.
Proliferative endometrium with hyperplasia of glands.
Leiomyoma with leiomyomatous polyp.
Ovary shows hemorrhagic corpus luteum.
(viii) The (relevant parts of the) PGI HPE report of 03.07.1996 on the slides and blocks read as under:
Received 4 slides and 4 blocks numbered 4097/95 for review.
MICRO: of the section from the cervix shows focal squamous metaplasia of the endocervical lining. The stratified squamous epithelium does not show any cellular atypia. Enlarged endocervical glands and mild chronic inflammation is seen in the sub-epithelium.
The endometrium is seen to be in proliferative phase. The myometrium shows a microscopic leiomyoma.
The section from the ovary shows a haemorrhagic corpus luteum and two small follicular cysts. There is no evidence of malignancy in any of the sections studied. [Emphasis supplied]
(ix) During the investigations/treatment at the PGI, Kamalesh also underwent another biopsy of the tumour in her left anterior vaginal wall. This HPE report of 26.09.1996, however, observed as under:
GROSS: 0.5 cm diam. lobular tissue piece BS AE.
MICRO: Section shows a tumour in the dermis going into subcutaneous tissue. The tumour cells are undifferentiated; however, at places show intracytoplasmic vascularization and positivity for Alcian blue.
Diag.: Cyst consistent with metastatic Adenocarcinoma (Primary-Uterus)
(x) Her prolonged diagnostic investigations and chemo/radiotherapy at the PGI during MayOctober 1996 notwithstanding, Kamaleshs carcinoma worsened and she developed several complications, which did not respond to the treatment. The tumour in the left vaginal wall grew and metastasized. Her general condition also worsened.
2.3 Kamalesh then underwent spells of treatment at the Mohan Dai Oswal Cancer Treatment and Research Foundation, Ludhiana during 29 October05 November 1996 and then at the Tagore General Hospital, Jalandhar. She expired on 16.12.1996
3. We have heard at length Mr. B. J. Singh, learned counsel for the appellants/complainants and Mr. U. Singh, learned counsel for the respondents/opposite parties and have gone carefully through the voluminous record as well the medical literature cited by the two learned counsel. We note with appreciation that both of them have worked very hard at their respective cases and have marshalled extensive medical literature in support of their contentions at times, interestingly enough, from the same author(s)/source(s). Before the State Commission, both parties examined their own witnesses, mostly the doctors who were the persona dramatis and the witnesses were cross-examined. During the appeal proceedings, Mr. B. J. Singh filed an application to address interrogatories to one Dr. Rajesh Gupta who was a Senior Resident in Surgery at the PGI at the relevant time and had continued there as an Assistant Professor in the Surgery Department. This Commission allowed the application and, in turn, permitted Mr. U. Singh to address his own interrogatories to Dr. Gupta. The latter replied to both sets of interrogatories, which were taken on record. Mr. B. J. Singhs further application to seek clarification on Dr. Guptas replies to his interrogatories was, however, not allowed by this Commission.
III. The Appellants/Complainants Case 4.1 The appellants/complainants case of medical negligence/deficiency in service against the respondents/opposite parties is as under:
(i) During 1990-95, Kamalesh had been consulting OP 2 off and on for her menorrhagia. OP 2 had done a D&C procedure on Kamalesh in October 1990. The HPE report dated 27.10.1990 of the curettings done at the GMC, Amritsar had specifically advised biopsy of the cervix. Therefore, before undertaking total abdominal hysterectomy (TAH) in October 1995, OP 2 should have done such a biopsy, particularly because the treatment given by OP 2 during this period had not helped Kamalesh. This biopsy would have helped determine more accurately the condition Kamaleshs uterus (endometrium, in particular) and cervix, prior to the TAH of 05.10.1995.
Instead, OP 2 went on advising TAH as the only solution.
(ii) Though OP 2 claimed that she had done a TAH, it was not in accordance with the consent of Kamalesh (or her husband, i.e., appellant/complainant no. 1) because the consent was for removal of both the ovaries and the fallopian tubes along with the complete uterus, including the cervix. However, during the actual surgery on 05.10.1995, OP 2 did not touch the left ovary and the fallopian tube, on the ground that the latter were healthy. Moreover, OP 2 did not remove the entire cervix and left a stump, making the surgery only a partial abdominal hysterectomy.
(iii) There was gross negligence in the GMC, Amritsar in conducting the post-operative histopathological investigation of Kamaleshs excised uterus, cervix, ovary and fallopian tube. In fact, the organs in question were mixed up with someone elses as a result of which the incipient cancer of Kamaleshs uterus cervix was not detected. Later, this was sought to be fraudulently suppressed by OP 3 by manipulating/destroying several pages of the original GMC record/register of receipt of samples of such organs, including those of Kamaleshs.
(iv) Though Kamalesh repeatedly complained about pain, etc., during her periodical post-surgery consultations with OP 2 (October 1995-February 1996), OP 2 paid no attention. As a result, Kamaleshs cancer progressed unabated and by the time Kamalesh approached the PGI in May 1996, her uterine cancer had reached stage III and metastasised.
(v) Had the necessary tests been done prior to the TAH, the cancer would have been detected early enough and treated with radio/chemotherapy prior to the TAH, with much better prognosis and Kamalesh may have been able to live a healthier and longer life.
4.2 Mr. B. J. Singh sought to support his contentions with the help of several authoritative textbooks of Gynaecology, like Text Book of Gynaecology including Contraception (Second Edition) by D. C. Dutta; Current Obstetric & Gynecologic Diagnosis & Treatment (Eighth Edition) edited by Alan H. DeCherney & Martin L. Pernoll; Robbins Pathologic Basis of Disease (4th and 5th Editions) by Ramzi S. Cotran, Vinay Kumar & Stanley H. Robbins; Textbook of Gynaecology and Contraception by Professor C. S. Dawn (Tenth Edition), etc. IV. The Case of the Respondents/OPs 5.1 On the other hand, Mr. U. Singh argued the following on behalf of the respondents/OPs:
(i) According to the HPE of the curettings of the D & C done by OP 2 on Kamalesh in October 1990, there was no evidence of malignancy. This HPE report was collected from GMC, Amritsar by the appellant/ complainant.
(ii) For her complaint of menorrhagia, Kamalesh was advised to undergo hysterectomy way back in 1990 itself. However, she did not do so. After October 1990, she consulted OP 2 a few times only when she would have particularly excessive menstrual bleeding.
(iii) In September 1995, she again visited OP 2 with complaints of pain and excessive bleeding and showed the report of an ultrasonograph (USG) of the uterus done in April 1995. On examination, she was also found to have a fibroid polyp, palpable through the cervix. The USG report also showed a fibroid tumour in the uterus, with endometrial hyperplasia. The report USG of 10.09.1995 showed a 25 mm fibroid tumour on the anterior wall of the uterus projecting into endometrial cavity. She was again advised an immediate hysterectomy.
(iv) Kamalesh was operated upon by OP 2 under general anaesthesia on 05.10.1995 for TAH with Bilateral Salpingo Oophorectomy after she underwent necessary pathological tests and was transfused blood because she was anaemic. The surgery was successful. As the left ovary and fallopian tube were apparently healthy, they were left intact. The entire uterus, cervix, right ovary and fallopian tube were sent to GMC, Amritsar for HPE. Kamalesh recovered normally after the surgery and was discharged on 13.10.1995. On follow-up visit of Kamalesh, the report of the HPE was handed over in original after noting down the details in Kamaleshs case file.
Kamalesh was also informed that all was well and there was no malignancy.
(v) At the time of her discharge, Kamalesh was also given a medical certificate for complete rest for one month. At the end of that period, OP 2 examined Kamalesh, found her to be healthy, her surgery stitches healed and there was no other complaint. However, Kamalesh asked for a medical certificate so that she could continue to be on leave (from her official work). In order to oblige the patient and her husband, OP 2 issued a certificate recommending extension of her leave on the same (medical) grounds. Kamalesh later requested a second extension of leave on medical ground and OP 2 again gave her the necessary certificate. Finally, on 23.02.1996, Kamalesh asked for a medical fitness certificate so that she could join back her duties. OP 2 issued the fitness certificate after she examined Kamalesh and found her fit. On earlier occasions too when Kamalesh was examined each time she came to OP 2 for extension of her medical leave, she was found to be alright, recovering well after her surgery and having no complaints.
(vi) In May 1996, OP 2 received a telephone call from the appellant/complainant 1 seeking written details of the surgery and the HPE report. These were sent on 23.05.1997, as per the case record. As the appellant/complainant 1 later sought a duplicate copy of the HPE report, it was obtained from the GMC, Amritsar and sent to him. Likewise, when appellant/complainant 1 wanted the slides and blocks of tissues (of Kamaleshs excised uterus, ovary and fallopian tube) that were sent to the GMC, Amritsar for HPE, he was advised to contact OP 3. According to the information of OP 2, appellant/complainant did obtain these slides and blocks from OP 3.
(vii) TAH and RSO surgery conducted on Kamalesh by OP 2 was entirely successful and Kamalesh recovered on the expected lines. Neither clinically nor surgically was there any reason or symptom to suspect any malignancy. The HPE report of the uterus, cervix, right ovary and fallopian tube conducted at GMC, Amritsar confirmed that there was no malignancy in any of these organs. This conclusion of the GMC, Amritsar was confirmed by the subsequent histopathological review of the slides and blocks of tissues of the excised organs carried out at the PGI as was evident from the corresponding report dated 03.07.1996.
(viii) The disease that Kamalesh actually suffered from and finally died of was different (adenocarcinoma of the vaginal vault) from that for which OP 2 treated her, i.e., endometrial hyperplasia with fibroid polyp causing excessive menstrual bleeding (menorrhagia). This was clear from the diagnosis recorded by the PGI on 22.05.1996 I. The clinical findings noted in the PGI medical record would also show that according to the staging parameters of vaginal cancer laid down by the International Federation of Gynaecologists and Obstetricians (FIGO), Kamaleshs cancer had reached stage III by that time. Adenocarcinoma of the vagina was a particularly aggressive form of cancer and hence it spread very quickly though Kamalesh was found to have no problems in February 1996 when OP 2 last examined her and issued the fitness certificate.
(ix) Thus, during the pre-operative stage as well as the course of surgery and post-surgery follow-up, all due care was taken by OP 2 and the Nursing Home to see that Kamalesh received proper treatment for her long-standing ailment of Menorrhagia. The TAH and RSO surgery was conducted in accordance with the standard practice and the excised organs were sent for HPE to the GMC, Amritsar. The GMC confirmed soon thereafter that there was no evidence of any malignancy. This finding was confirmed in the review HPE done at the PGI. Thus, there was no basis of the allegation that either OP 2 or OP 3 was guilty of deficiency in service/ medical negligence.
(x) Finally, according to the judgment of the Apex Court in Martin F. DSouza v Mohd Ishfaq [(2009) 3 SCC 1] a consumer forum was duty-bound to seek expert medical opinion in each case of alleged medical negligence. This had not been done in this case nor did the appellants take any steps before the State Commission to obtain such an expert opinion.
5.2 In support of his contentions Mr. U. Singh produced copies of the medical literature from various well-known text books like Shaws Textbook of Gynaecology Ninth Edition revised by John Howkins and Gordon Bourne; Jeffcoates Principles of Gynaecology Fifth Edition revised by V. R. Tindall; Operative Gynecology- Fourth Edition by Richard W. Te. Linde and Richard F. Mattingly, etc. V. Expert Medical Opinion
6. In view of the technical complexity of the case and the vehemence of the rival contentions of the parties, we deemed it appropriate to seek expert medical opinion on the case. Accordingly, with the consent of the counsel for the parties, a set of specific questions was framed, keeping in view the main allegations in the complaint and the submissions of the counsel for the parties in respect thereof. A report was then called for from a Medical Board consisting of Senior Doctors from the relevant medical disciplines, viz., Gynaecological Oncology, Radio Diagnosis and Pathology from the Director, Tata Memorial Centre, Mumbai. A Medical Board consisting of Associate Professor of Gynaecological Oncology, Department of Surgical Oncology; Professor and Head, Department of Radio Diagnosis and Assistant Professor, Department of Pathology of the Tata Memorial Hospital submitted its report dated 03.12.2009 and the supplementary report dated 12.03.2010. The specific questions and replies of the Medical Board thereto are reproduced below:
Report of 03.12.2009 Q (i) Whether the document, stated to be the consent of the patient Smt. Kamalesh Kumari (since deceased) for the total abdominal hysterectomy (TAH) with bilateral (or right) salpingo oophorectomy (SO) was appropriate in form and content to be regarded as a valid consent for the said surgical procedure?
A (i) The document stated to be the consent of the patient Smt. Kamalesh Kumari and enclosed in the court docket as Annexures R-33, R-34 and R-XXXIII (R-7) all appear to be identical copies of a general consent taken on admission to the said Dr. Jasjit Chhachhi Nursing Home. At no place in the enclosed form is there any mention of any surgical procedure and under these circumstances we conclude that the said consent forms are not appropriate either in form and/or content for the surgery that was performed.
Q (ii) Whether it was necessary to record the findings of the histopathological examination of the D & C tissues (conducted on the patient in October 1990 at the Dr Jasjit Chhachhi Nursing Home in the relevant patient record (1995) of the said Nursing Home, particularly when the fact of the D & C procedure having been carried out 5 years ago was recorded under the item H/O present illness? Moreover, whether it was first necessary to conduct a cervix biopsy of the patient before going in for TAH and BSO (or RSO) considering the recommendation in the histopathological report of 27.10.1990?
A (ii) It was necessary to record the findings of the previous D & C procedure carried out in 1990. This would represent good clinical practice. As regards the cervical biopsy, it would not be indicated if the cervix on clinical examination was macroscopically normal. Since this patient was known to have uterine fibroids, it would probably be ideal practice to repeat a D & C as a means of histologically evaluating the uterine endometrium prior to definitive surgery, i.e., hysterectomy. Though this would be ideal, it is not unusual for practicing gynecologists to dispense with a repeat D & C prior to hysterectomy in such cases.
Q (iii) Whether the patient record of the said Nursing Home for the period 4th to 13th October 1995 should have included the original reports of the various pathological and other tests conducted on the patient prior to the surgery on 5th October 1995?
A (iii) Considering that this patient was known to Dr Jasjit Singh and had been following up with him/her since 1990, it would seem reasonable for the doctor to have included the original reports of at least the pathological tests if not all other tests in the patient record prior to the surgery performed in 1995.
Q (iv) Whether it was necessary, as a standard medical practice, for the anesthetist to maintain a separate record of the procedure of general anesthesia, in addition to the surgical notes of the operating surgeon and to include the said report in the patient record of the said Nursing Home?
A (iv) We would regard it as standard medical practice for the attending anesthetist to maintain a separate Anaesthesia Record clearly listing all medications and anaesthetic gases/agents used during the induction and subsequent maintenance of general anesthesia during the entire course of the surgical procedure. This record would also include a record of the patients vital parameters, i.e., pulse, blood pressure, respiration, etc., during the course of the surgery. This record would necessarily be separate from that of the surgeons Operation/Surgical notes and would ideally be preserved as a part o the Patient record.
Q (v) Whether according to standard medical practice, it is necessary as part of the gross histopathological examination post-TAH and RSO, to record the length/dimension of the excised cervix, in addition to the dimensions of the uterus, ovary and fallopian tube? If so, whether the histopathological report dated 18.10.1995 of the Government Medical College, Amritsar showed that these were so recorded? If not, whether there was any significant medical omission?
A (v) In standard medical practice pertaining to gross assessment of hysterectomy specimens it is usual to report the combined length/dimensions of the uterus and cervix together. The dimensions of the cervix need not be mentioned separately and this is entirely acceptable. The report from Government Medical College, Amritsar (Annexure R-XVIII, ref:
95/4097) states the dimensions of the uterus, cervix with one fallopian tube and ovary a 12x10x8 cms. Dimensions of the resected ovary have been mentioned separately, i.e., 2.5x2.1 cm and this is entirely acceptable. We do not consider that there is any significant medical omission in the recording of the gross pathological findings.
Q (vi) Whether Total Abdominal Hysterectomy (TAH) means complete removal of the uterus as well as the entire length of the cervix upto and including the external os? Further, whether the terms vault and stump, referred to in the subsequent CT scan report of 5th June 1996, anatomically imply/refer to the same part of the female organ or whether they refer to distinct parts and whether the term stump referred to a part of the cervix left out, despite the TAH?
A (vi) We confirm that a total abdominal hysterectomy means a complete removal of the entire uterus as well as the entire length of the cervix up to and including the external os. We note that the actual CT Scan report dated 05.06.1996 is not available in the Annexures enclosed; however, in standard medical terminology the vault would refer to the top of the vagina following surgical removal of the uterus and cervix in entirety. The term stump refers to the part of the cervix which is left behind at the top of the vagina following a subtotal hysterectomy, which implies the removal of the uterine body only without removal of the cervix.
Q(vii) Whether the standard medical practice was to resort to CT scan of the relevant parts of the anatomy for typing and staging of the cancerous tumour?
A (vii) We confirm that a CT Scan of the abdomen and pelvis would represent a standard investigation for staging of gynecological cancers in general and malignant tumors of the vaginal vault in particular. We conclude that standard medical practice was followed.
Q(viii) Whether the observations in the CT Scan report of 5th June 1996 regarding a mass measuring 4.2x4.9 cms in the left adnexal region meant that the left ovary and the fallopian tube of the patient had also developed cancerous growth during the period since TAH and RSO? If so, whether such growth or the tumour could be attributed to vaginal carcinoma or to endometrial carcinoma as the primary source in a patient who had undergone TAH in October 1995?
A (viii) We note that the actual CT Scan report dated 05.06.1996 is not available in the Annexures enclosed. Under these circumstances it is not possible for us to provide an answer to this question.
Q(ix) Whether it is possible to reconcile these histopathological reports dated 18.05.1996, 03.07.1996 and 26.09.1996 of the PGI in respect of the same patient? If so, how would they, particularly the latter two reports, be interpreted harmoniously?
A (ix) In the Annexured documents we have only two histopathology reports from PGI Chandigarh dated 18th May 1996 and 3rd July 1996. The third report dated 26th September 1996 had not been included in the Annexured documents and as such no comment can be made regarding this last report. The report dated 18.05.1996 (Annexure R-26 ref: G 1085/96) is a vaginal vault biopsy report and it gives a diagnosis of Moderately differentiated adenocarcinoma of the vaginal vault. The report dated 03.07.1996 (Annexure R-13 ref: G-1439/96) represents a review of 4 histopathology slides and 4 tissue blocks obtained from the earlier surgical specimen, i.e., abdominal hysterectomy and right salpingo oophorectomy and the relevant portions of this report suggest that the endometrium is in the proliferative phase, that the myometrium shows a microscopic leiomyoma, cervix shows squamous metaplasia and mild chronic inflammation and that the ovary shows a haemorrhagic corpus luteum and small follicular cysts. The correct conclusion based upon these findings is that there is no evidence of any malignancy in any of the sections studied from the surgical specimen. Clinical experience indicates that adenocarcinomas developing de novo in the vaginal vault are more likely to represent secondary cancers, although de novo primary adenocarcinoma in the vagina are known to occur albeit very rarely. Since we are not in possession of the report dated 26.09.1996 a collective assessment of the July and September reports cannot be made.
Q(x) Whether the medical record of the PGI relating to the period after commencement of the radiotherapy of the patient reveals any observation of physical examination contrary to the diagnosis of the histopathological report dated 26.09.1996 or whether they are in consonance with the finding of vaginal vault adenocarcinoma with the primary being in the vagina?
A (x) We note that the histopathology report dated 26.09.1996 has not been included in the Annexured documents. We also note that the medical record from the Department of Radiotherapy, PGI, Chandigarh (Annexure R 11 dated 22.05.1996) indicates that the doctors suspected a vault recurrence; however, as previous surgical/histopathological details were not available; they have appropriately requested the patient to follow up with all previous clinical records for further management.
Q(xi) Whether the medical record of the PGI suggests any evidence of medical cognizance being taken of the CT scan report dated 05.06.1996, which was carried out in a private radiological clinic, but at the advice of the treating doctors at the PGI? Further, whether there is any medical evidence to suggest that the treating doctors of the PGI tool full note of the three histopathological reports dated 18.05.1996, 03.07.1996 and 26.09.1996 as well as the CT scan report of 05.06.1996?
A (xi) As noted above, we are not in possession of either the histopathology report dated 26.09.1996 or the CT scan dated 05.06.1996. Under these circumstances we are unfortunately not in any position to provide a satisfactory answer to this question.
Q(xii) Whether it is a known medical fact that vaginal cancer could develop independently with primary source being located in the vagina and reach stage III, by late May/early June 996, despite the patient having undergone TAH with right SO in October 1995 and having being declared medically fit after full examination, in late February 1996?
A (xii) We confirm that although a primary vaginal adenocarcinoma can develop de novo, it is an extremely rare occurrence in clinical practice. It is extremely difficult to be precise in predicting if such a tumour could or could not spread to reach stage III disease in a relatively short period of 6-8 months.
Supplementary Report of 12.03.2010 A (i) The CT scan dated 05.06.1996 done at Dhillon CT Scan Centre, Amritsar is suggestive of an extensive, probably malignant disease in the pelvis at the region of the vaginal vault, with associated involvement of the retroperitoneal, i.e., Para-aortic, Retro-caval and Rt. Internal Iliac lymph nodes. We also note that there is heterogeneously enhancing mass measuring 4.9x4.2 cm in the left ovarian region with associated infiltration of the pelvic wall muscles on that side. Although, the malignant nature of the left ovary cannot be conclusively ascertained on the basis of the scan, the overall CT scan appearances are suggestive of an extensive malignant disease in the pelvis with associated lymph node involvement.
A (ii) We note that there is a histopathology report dated 18.05.1996, from the PGI Chandigarh, of a moderately differentiated adenocarcinoma in a biopsy taken from a growth at the vaginal vault. Considering the above-mentioned observations, we believe that it is reasonable to conclude that the patient Mrs. Kamalesh Kumari had a disseminated malignant pelvic tumour, which was histopathologically a moderately differentiated adenocarcinoma.
A (iii) As mentioned in our earlier report dated 03.12.2009, clinical experience indicates that adenocarcinomas developing de novo in the vaginal vault are more likely to represent secondary cancers, although de novo primary adenocarcinoma in the vagina are known to occur albeit very rarely.
It is difficult for us to categorically say that the malignancy had existed at the time of the previous surgery, i.e., Total abdominal hysterectomy with Right salpingo oophorectomy, performed on 05.10.1995, and that it was missed during the surgery and on subsequent pathological examination of the surgical specimen. However, on balance, based on the site of the tumour, i.e., vaginal vault and pelvis and a histopathological diagnosis of adenocarcinoma, it is possible that a small adenocarcinoma of the uterine endometrium or endocervical canal may have been missed.
This is a purely a professional judgment on our part and a firmer opinion cannot be offered.
VI. The Legal Position 7 (i) The law on medical negligence that has evolved in India over time is essentially derived from the doctrine of professional negligence enunciated in the case of Bolam v Friern Hospital Management Committee [(1957) 1 WLR 582; (1957) 2 All ER 118 (QBD)] by McNair, J:
Where you get a situation which involves the use of some special skill or competence, then the test as to whether there has been negligence or not is not the test of the man on the top of a Clapham omnibus, because he has not got this special skill. The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill. It is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.
(ii) As quoted with approval by the Supreme Court in Jacob Mathew v State of Punjab [(2005) 6 SCC 1], the Bolam Test was summarised by Bingham, L.J. in Eckersley v Binnie [(1988) 18 Con LR] in the following words:
From these general statements it follows that a professional man should command the corpus of knowledge which forms part of the professional equipment of the ordinary member of his profession. He should not lag behind other ordinary assiduous and intelligent members of his profession in the knowledge of new advances, discoveries and developments in his field. He should have such an awareness as an ordinarily competent practitioner would have of the deficiencies in his knowledge and the limitations on his skill. He should be alert to the hazards and risks in any professional task that he undertakes to the extent that other ordinarily competent members of the profession would be alert. He must bring to any professional task he undertakes no less expertise, skill and care than other ordinarily competent members of his profession would bring, but need bring no more. The standard is that of the reasonable average. The law does not require a professional man that he be a paragon combining the qualities of polymath and prophet.
(iii) In the Jacob Mathew case (supra), a Constitution Bench of the Apex Court, after a comprehensive review of its own decisions as well as those of the Courts in the U. K., summarised the criteria for medical negligence in paragraph 48 of its judgment as under:
48.(1)xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (2) Negligence in the context of the medical profession necessarily calls for treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed. When it comes to the failure of taking precautions, what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient; a failure to special or extraordinary precautions which might have prevented the particular happening cannot be the standard fro judging the alleged negligence. So also, the standard of care, while assessing the practice as adopted, is judged in the light of knowledge available at the time of the incident, and not at the date of the trail.
Similarly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that particular time (that is, the time of the incident) at which it is suggested it should have been used.
(3) A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging whether the person charged has been negligent or not would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.
(4) The test for determining medical negligence as laid down in Bolam case, WLR at p. 586 holds good in India.
(5) xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
8. Copies of these reports of the Medical Board were made available to the counsel for both the parties and they were given opportunity to make further submissions. Both Mr. B. Singh and Mr. U. Singh made detailed further submissions, each seeking to demonstrate how the opinion of the Medical Board actually favoured his case. It is, however, not necessary to enter into the details of the submissions in view of the following discussion.
VII. Discussion
9. (i) (a) One of the principal allegations of the appellant/complainant was that because of Kamaleshs prolonged complaint of Menorrhagia and specific recommendations of the HPE conducted in October 1990, it was necessary for OP 2 to at least conduct another D&C procedure on Kamalesh and subject the curettage tissues to another histopathological examination before recommending definitive treatment like total abdominal hysterectomy and her failure to do so amounted to grave negligence. In this regard, the opinion of the Medical Board is that while a fresh D&C (prior to the TAH of October 1995) would have been ideal, it was not unusual for practising gynecologists to dispense with a repeat D&C prior to hysterectomy in such cases.
(b) As regards the 1990 recommendation of a biopsy of the cervix and failure of OP 2 to do so before undertaking the TAH in October 1995, the opinion of the Board is that such a biopsy would not be indicated if on macroscopic clinical examination of the cervix, it appeared to be normal.
(ii) (a) The second main allegation in the complaint was that as a result of failure of the OP 2 to get the necessary D&C (and HPE of the D&C tissues) done prior to the TAH, Kamaleshs real ailment, viz., adenocarcinoma of the uterine endometrium could not be detected. Consequently, the appropriate course of treatment was not administered, i.e., radiotherapy and/or chemotherapy prior to or after the [TAH+RSO] surgery and, as a result, Kamalesh died a painful and untimely death. The underlying assumption obviously is that Kamaleshs adenocarcinoma of the vaginal/pelvic region could not have reached stage III by May 1996 if she was all right till February 1996; in other words, for her cancer to have reached stage III in May 1996, it would have developed (and been detectable) even before the [TAH+RSO] surgery of 05.10.1995. The supporting allegations in this regard were that OP 2 did not provide the HPE report soon after the surgery of October 1995 despite repeated requests and OP 3, in collusion and connivance with OP 2, handed over to complainant/appellant 1 an HPE report of a benign case which was not that of Kamalesh.
(b) On this point, the opinion of the Medical Board is as under:
We confirm that although a primary vaginal adenocarcinoma can develop de novo, it is an extremely rare occurrence in clinical practice. It is extremely difficult to be precise in predicting if such a tumour could or could not spread to reach stage III disease in a relatively short period of 6-8 months. [Report of 03.12.2009] As mentioned in our earlier report dated 03.12.2009, clinical experience indicates that adenocarcinomas developing de novo in the vaginal vault are more likely to represent secondary cancers, although de novo primary adenocarcinoma in the vagina are known to occur albeit very rarely.
It is difficult for us to categorically say that the malignancy had existed at the time of the previous surgery, i.e., Total abdominal hysterectomy with Right salpingo oophorectomy, performed on 05.10.1995, and that it was missed during the surgery and on subsequent pathological examination of the surgical specimen. However, on balance, based on the site of the tumour, i.e., vaginal vault and pelvis and a histopathological diagnosis of adenocarcinoma, it is possible that a small adenocarcinoma of the uterine endometrium or endocervical canal may have been missed.
This is a purely a professional judgment on our part and a firmer opinion cannot be offered. [Supplementary Report of 12.03.2010]
(c) For this allegation to succeed, it would have been necessary for the complainants to first establish that the HPE report of the GMC, Amritsar that was ultimately made available by OP 2 and OP 3 pertained to someone other than Kamalesh. We are unable to accept this allegation because it is purely conjectural and based on a conspiracy theory without any iota of evidence in support. Even if it is accepted that the pages of the original register of the Pathology Department of GMC, Amritsar which included the entry relating to receipt of the excised uterus, etc., of Kamalesh from OP 2/OP 1 had been mutilated/tampered with, that fact by itself would be hardly sufficient to lead to the conclusion of conspiracy that the complainants would like to lead us to. In fact, had the complainants been serious about this allegation, they would have filed a criminal complaint the first complainant/appellant was certainly in an official position to do so. Therefore, we have to conclude that the HPE report on record was that pertaining to Kamalesh. That being so, the allegation of negligence on the part of OP 2 for failing to detect symptoms of malignancy in Kamalesh before or during the surgery would fall through surely, if a regular HPE could not detect any signs of malignancy in any of the organs in question, it would be absurd to expect the gynaecologist conducting the surgery to do so. In this case, the findings of there being no malignancy in any of the tissues examined were confirmed by the July 1996 review of the slides and blocks at the PGI.
(d) However, none of the foregoing fits squarely with the subsequent facts of Kamaleshs cancer, particularly the location and the stage of the tumorous growth and its origin, as determined in the course of her treatment at the PGI. As the opinion of the TMH Medical Board would show, the only possible explanation which could accommodate most of the observed facts is, ..... it is possible that a small adenocarcinoma of the uterine endometrium or endocervical canal may have been missed.
(e) Is the conclusion summarised in sub-paragraph (d) above sufficient to hold either OP 2 or OP 3 guilty of medical negligence in treating Kamalesh? The answer has to be a No. For, the law on the subject lays down:
The standard is that of the reasonable average. The law does not require a professional man that he be a paragon combining the qualities of polymath and prophet. [Eckersley v Binnie, supra] (3) A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess.
The standard to be applied for judging whether the person charged has been negligent or not would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.
(4) The test for determining medical negligence as laid down in Bolam case, WLR at p. 586 holds good in India. [Jacob Mathew, supra] From the conclusions of the TMC/TMH Medical Board it follows that it would indeed have been a gynaecologist of extraordinary professional competence to have detected the cancer that Kamalesh had probably developed in the uterine area sometime prior to her [TAH+RSO] surgery. The legal criteria for medical negligence do not permit us to judge the quality of medical service rendered by OP 2 by the standards of such extraordinary competence. Likewise, despite the attempts of the complainants/appellants to show that OP 3 manipulated the HPE report of the excised uterus, etc. of the deceased Kamalesh, the alleged case is not established and consequently, the failure, if any in detecting any malignancy during the said HPE cannot also be held to constitute medical negligence in view of the subsequent review report of the PGI.
(f) The other allegations raised by Mr. B. J.
Singh, particularly that relating to the validity of the consent on record need not be gone into because they do not figure in the complaint per se and were obviously raised for the first time during the appeal proceedings. However, we consider it appropriate to emphasise that the methods and standards of maintaining medical records of cases and of obtaining consent at the OP 1 Nursing Home left much to be desired, not only according to the views of the TMC/TMH in this case but also, and more important, according to the law laid down on the subject by the Apex Court in the case of Samira Kohli v Dr. Prabha Manchanda and Another [(2008) 2 SCC 1].
10. In conclusion, while we are deeply sympathetic to the family of the late Kamalesh, we are unable to hold any of the respondents/OPs guilty of medical negligence in treating Kamalesh. The appeal is, therefore, dismissed with no order as to costs.
Sd/-
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[R. C. Jain, J] sd/-
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[Anupam Dasgupta]