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Judgment
Controversy in this case falls in a narrow compass i.e. whether the complainant No. 1''s wife Smt. Kiran Verma was suffering; from Hodgkin''s disease or non-Hodgkin''s disease and whether she was treated wrongly; of Hodgkin''s disease despite the fact that she was suffering from Non-Hodgkin''s disease. 2. According to the complainant Smt. Kiran Verma was first brought to Batra Hospital (OP-1) on 1-2-1997 for treatment of a node in lower abdominal region and the doctors on 7-4-1997 opined that she was suffering from Hodgkin''s Lymphoma. Despite the fact that Ranbaxy Speciality Mumbai/Ranbaxy Laboratory ultimately opined on 6-10-1997 that Smt. Kiran Verma was suffering from Lennerts Lymphoma, still the treatment/prescription was not changed due to the negligence and callous attitude of the opposite parties and she eventually died on 14-10-1997 at the age of 45 years leaving behind the husband and three sons-complainants. The complainants claimed following reliefs:
In Rupees
Bills paid to the Hospital 1,12,000/-
Medicine Purchased 1,60,000/-
Travelling Expenses 50,000/-
Expenses on Complainants No. I Boarding & Lodging 60,000/-
Loss of Business during stay in hospital 1,20,000/-
Loss on account of loosing Customers permanently 6,00,000/-
Compensation for, loss of Company of wife to complainant No. 1 10,00,000/-
Compensation for loss of mother to children 15,00,000/-
Compensation for mental agony & trauma to complainants 25,00,000/-
61,02,000/-
Case of the opposite parties, l. to 5 in brief: 3. Smt. Kiran Verma was brought to the Batra Hospital for the first time on 1-2-1997. After detailed examination including CT Scan she was diagnosed to be suffering from Hodgkin''s Lymphoma stage III B. Taking into consideration the clinical, radiological and histopathological features of her disease she was started on chemotherapy (ABVD Regimen). The chemotherapy was changed to COPP regime on 29-8-97 and to CHOP Regime on 29- 9-97 keeping in mind the large cell lymphoma. She was treated in the hospital from time to time after conducting several tests. The patient was brought to the hospital again on 13-10-97 with severe diabetic kefoacidosis and chest infection. She acquired chest infection and septicemia due to her long standing diabetes and she died due to severe diabetic ketoacidoses. Though the patient was put on life support measures her condition did not improve and she was declared dead on 14-10-97. 4. The OPs 1 to 5 contended that the complaint is wrong and misconceived and thus li able to be dismissed with exemplary costs. Submissions made by complainant No. 1 : 5. The deceased was brought to Batra Hospital (OP-1) on 1-2-1997 as she was suffering from one inguinal node in initial stage. She was examined by Dr. D. Ghosh (OP-4) who conducted FNAC test which indicated granulomastous lyrnphodenitis suggestive of tuberculosis. On 28-3-1997 she was again examined by Dr. Kapil Kumar (OP-3) and he advised for biopsy, the test report received on 7-4-1997 indicated Hodgkin''s Lymphoma (Lymphocytic Depletion Type ''LDHD'') Cancer disease wherein Sr. Consultant Pathologist had specifically advised immuno-chemistry test for further investigation to confirm the diagnosis of LDHD. 6. The Lymphoma is a cancer disease having two types viz. Hodgkin''s Lymphoma and Non-Hodgkin''s Lymphoma and both are quite different diseases. This is a mysterious and dangerous disease. To distinguish between HD and NHL, it is necessary to conduct the immuno-chemistry test. The importance of the test is given in the Ackarman''s Medical Text "Surgical Pathology" in the following words: "There is probably no other method that has so revolutionised the field during the past 50 years as the immuno-histochemical technique. The advantages are obvious : remarkable sensitivity and specificity, applicability to routinely processed material (even if stored for long periods) and feasibility of an accurate correlation with the traditional morphologic parameters." 7. In the standard medical text book on Cancer viz. "Cancer Principles and Practice on Oncology, 6th edition by Lippincott Williams & Wilkins page 2347 relating to Lymphocytic Depletion Hodgkin''s Disease LDHD, it is stated that "Before the availability of immunophenotyping studies, many cases diagnosed as LDHD were, in reality, the cases of large B cell lymphoma or large T cell lymphoma." 8. Complainant No. I vehemently submitted that the hospital authorities did not refer the slide to Ranbaxy Laboratory in April 1997 as per the advice of their own Sr. Consultant Pathologist nor did they handover the slide to him. The question of handing over the slide to him does not arise because the practice followed is that the hospital authorities with their covering letter requesting for certain tests to be carried out would be sent to Ranbaxy Laboratory. This was not contracted by the learned counsel for the opposite parties. Ignoring the requirement of immuno-chemistry test, treatment was started by the oncologist of ON i.e. Dr. A.K. Anand by chemotherapy ABVD regime meant for Hodgkin''s Lymphoma (LDHD) on 12-4-1997 and continued till 7- 6-1997. He further submitted that failure to conduct this absolutely required immunochemistry test immediately or within time, amounts to serious deficiency in service as well as gross medical negligence. 9. He also submitted that on 9-4-1997 Cr Scan Test was conducted. Liver and bone marrow were found to be normal as per report dated 12-4-1997. It proves that the patient was brought to OP-1 on 1-2-1997 when the disease was not progressive and normal bone marrow indicates it is not Hodgkin''s disease but could be high grade NHL. He quoted Robbins "Pathologic Basis of Disease" 5th edition by Cotran, Kumar and Robbins under the subject : High Grade Lymphomas - "Involvement of liver and spleen is not common at the time of diagnosis, but when it occurs, the lymphoma cells form large destructive masses rather than forming the uniform miliary nodules that involve B-cell areas in low grade follicular lymphomas. Bone marrow involvement is relatively uncommon in these patients, especially at the time of diagnosis. With progressive disease however the marrow may be involved and rarely a leukemia picture may emerge." 10. Thereafter, three course of ABVD started on 12-4-1997 were meant for LDHD. The disease was found to spread to organs-liver (08-8-1997) spleen (29-08-1997) bone marrow (30-09-1997). This spreading and failure of ABVD (three course) treatment indicate disease to be NHL. 11. To support his contention he quoted the medical text "Systematic Pathology" wherein it is stated that - "However all forms of NHL have potential to spread to other lymphnodes, liver spleen and bone marrow." It is admitted by the opposite parties 1 to 5 in their written version that at the time of relapse, the disease (spreading) on 29-8-1997, it was thought that the patient was not responding as such a quick relapse is not commonly seen in Hodgkin''s Lymphoma. It was taken lightly and thought that it could be large cell lymphoma. The chemotherapy was thus changed to COPP regimes-meant for Non- Hodgkin''s Lymphoma (NHL) on 29-8-1997 and subsequently it was changed to CHOPP Chemo also meant for Non-Hodgkin''s Lymphoma (NHL) on 29-9-1997. The hospital should have arranged for immuno-chemistry test for confirmation disease of the NHL (B or Tcell) which has three grades (low, intermediate and high) each one of them differ in response to chemotherapy. He quoted the aforesaid book by Robins to support his arguments. "Although we speak of NHL as a group, we should recognise that it encompasses a wide spectrum of disorders, differing in patient''s age at onset, the cells of origin and response to therapy, it is therefore necessary to classify NHL into various subgroups." 12. The treatment of chemotherapy is not costly but causes the serious side effects and reduces the TLC (Total Leucocyte Counts). TLC count is required to be checked before the chemotherapy. Despite the low TLC, patient was administered chemotherapy. Looking to the seriously deteriorating condition of the patient, on repeated requests of complainants, specimen of biopsy of inguinal node (3-4-1997) was sent to Ranbaxy Laboratory for immuno-chemistry test on 3-10-1997. The report was received on 6-10-1997 from which it was revealed that the patient was in fact suffering from Lennert''s Lymphoma (Lympho epitheoliode) T cell High Grade Lymphoma) i.e. Non-Hodgkin''s Lymphoma NHL or large cell Lymphoma instead of LOHD. He quoted the medical text book "Cancer Principles & Practice of Oncology, 6th Edition by Lippin Cott William & Wilkins" wherein the immunotype for Lymphocytic Depletion Hodgkin''s disease LDHD described as under: CD 30+, CD 15+, CD 45+. Which says the essential condition that the well known marker of NHL "CD 45" should be negative for the establishment of the diagnosis of LDHD. 13. On the other hand, report of Ranbaxy test dated 6-10-1997, ''CD 45'' which was found to be positive. This was admitted by the opposite parties in their replies to the interrogatories. This clearly proves that wrong treatment was started on 12-4-1997 without going for immuno-chemistry test inspite of the pathologist''s advice in the present case due to which the ''ct" 1 disease namely tenne it''s Lymphoma (NHL) spread to liver. spleen, bone-marrow and as a result. the patient died on 14-10-1997. OP''s have stated in the reply to the interrogatories that immuno-chemistry is of recent advent where quality assurance was suspect. After receipt of the report dated 6-10-1997, if there was any bona fide doubt upon any aspect, the Sr. Pathologist of OP could have sent her disagreement with the report in writing to the Ranbaxy Lab. The very fact that they have not done so, proves that the report of the renowned laboratory which indicated Lennert''s Lymphoma or non-Hodgkin''s, Lymphoma (NHL) was correct. The Hospital''s doctors gave treatment for Hodgkin''s Lymphoma disease by ABVD regime of three course starting from 12-04-1997. 14. The complainant further submitted that un-controlled, uncured, eight months long standing cancer disease and unnecessary chemotherapies have resulted in unsuitable low immuno response. Due to this the patient developed chest infection which was noticed on 13-10-1997. Complainant submitted that due to the untimely death of the patient by gross negligence and serious deficiency in service on part of OP 1 to OP 5 has resulted into loss in business and disruption of studies of his three sons. This has resulted in several visits to the hospital and he incurred huge expenditure from 11-04-1997 to 13-04-1997 (b) from 06-08-1997 to 18-08-1997 (c) from 29-08-1997 to 01-09-1997 (d) from 29-09-1997 to 04-10-1997 (e) from 13-10-1997 after-which she expired on 14-10-1997 at OP No. 1. He also branded this negligence,as Gross histologic negligence. Submissions of the Learned Counsel for the Opposite Parties : 15. Shri Manvendra Verma (for OP No. I to 5) submitted that the complainant No. It''s wife Smt. Kiran Verma was brought to the Batra Hospital for the first time on 01-02-1997. After thorough examination it was discovered that she had multiple lymph nodes in the right inguinal region with history of ''B'' symptoms in the form of fever, night sweat and weight loss. On examination, similar nodes were also detected in the right auxiliary region. The patient was accordingly advised pep smear and mammography. Mammography was advised once again on 28-03-1997 when the patiented tine. h coital for the second time as the mammography had not been done in-spite of the previous advice. The auxiliary region is the armpit region and the biopsy of the nodes present in this region is alleged to have been got done by the patient in November 1996 at some hospital in Baraut and the same was diagnosed as chronic pyogenic abscess. 16. Fine needle aspiration cytology (FNAC) was done from the right inguinal lymph nodek on 01-02-1997 and it was reported as granulomstous lymphadenitis suggestive of tuberculosis. 17. The patient on her second visit to Batra Hospital on 28-03-1997 was advised biopsy of the inguinal node which was got done by her only on 03-04-1997. The result reported was Hodgkin''s lymphoma with lymphocyte depletion type. 18. The CT Scan of the Thorax and abdomen which was got done on 09-04-1997, revealed soft tissue mass in the right lower zone of the thorax and a soft tissue density lymph node mass was detected in the internal and external iliac lymph node groups. The bone marrow examination was carried out on 12-4-1997 to complete the work up. Bone marrow, however, showed no infiltration. Thus, it was stage III involvement of lymph nodes in region on both sides of the diaphragm. Suffix''B'' is added when the patient shows symptoms in the form of fever, night sweat and weight loss, as was noticed in this case. The patient was thus diagnosed to be suffering from Hodgkin''s Lymphoma Stage III B. The patient was also suffering from Diabetes and Paroxysmal Supraventricular Tachycardia. A diagnosis of lymphoma is based on following characteristics : (a) Clinical signs and symptoms. (b) Radiological investigations like CT Scans, X-rays etc. (c) Bone marrow examination. (d) Biopsy from the affected lymph node. 19. Despite the FNAC report being Granulomatous lymphodenitis which usually means tuberculosis - no treatment was started due to clinical suspicion of it being a more sinister disease than tuberculosis. Biopsy of the lymph node done from the same was suggestive of Hodgkin''s lymphoma - lymphocytic depletion type. This diagnosis fitted well with the patient''s history, clinical examination and feel of the lymph nodes (rubbery) in the groin, CT Scan report of chest and abdomen revealing multiple lymph nodes, a characteristic of Hodgkin''s lymphoma. The patient was administered the first cycle of chemotherapy (ABVD regime) on 12-04-1997. 20. Pathological diagnosis of Hodgkin''s lymphoma is based on the identification and presence of Reed Sternberg (RS Cells). This is considered to be the essential element in all forms of Hodgkin''s lymphoma. Finding of typical RS Cells in characteristic cellular background alongwith patient''s history, CT Scan and bone marrow reports (showing no infiltration) were sufficient evidence for diagnosis of Hodgkin''s lymphoma in this patient. 21. Immunohistochemistry was advised but not considered very essential inter-alia for the following reasons : Immunochemistry in 1997 was still in its infancy in our country with the quality of testing being questionable. Further one test was not considered adequate for diagnosis of an aliment for which considerable experience existed with the clinicians and pathologists of this country. Like many other techniques, immuno his to chemistry has many potential pitfalls that needs to be acknowledged by the pathologist interpreting the reaction in order to prevent the technique being misleading rather than helpful. It is a highly complicated test which requires strict quality control and experienced pathologist to interpret the results. Such expertise was not available in our country at the said time therefore it was not considered absolutely essential to depend on immunohistochemistry for diagnosis in this case. 22. The diagnosis by immunohistochemistry is based on detection of certain markers in the biospy tissue. For Hodgkin''s disease CD-15, CD-30 and detection of B Cells antigen is required for a successful/helpful diagnosis. The frequency with which CD 15 and CD 30 are detected varies in reported series, probably because of technical problems. 23. Failure to detect CD 15 and CD 30 or expression of B Cells antigen does not preclude a diagnosis of Hodgkin''s disease. 24. Initially the patient responded well to the chemotherapy treatment. Symptoms like fever, appetite improved and lymph nodes in the groin started reducing in size. It is a well documented medical fact that only 60-70% of patients in Stage III B respond well to chemotheraphy. After 3 courses, the disease showed sign of relapse and the treatment was thus changed to the second line of chemotherapy i.e. COPP regimen on 28-08-1997. As this also did not have the desired effect the same was changed to CHOPP regimen on 29-09-1997, keeping in mind the large cell lymphoma. 25. At this point Ranbaxy Labortory was requested to conduct Immunochemistry Test and the same showed the following results :
CD 45 +ve
CD 43 +ve
CD 15 +ve
CD 20 +ve
These results are at best equivocal and do not confirm whether it is Hodgkin''s or non-Hodgkin''s Lymphoma. CD 15 is positive in Hodgkin''s Lymphoma and CD 20 can also be positive in 5% of the cases of Hodgkin''s Lyim phoma disease. The testing lab however, did not test for CD 30 a very important marker of Hodgkin''s lymphoma disease. CD 45 and 43 are the markers of non Hodgkin''s lymphoma and the same were also positive. This result was thus not reliable or sufficient to rule out one diagnosis over the other. It is a medically accepted fact that few patients of Hodgkin''s Lymphoma can develop non-Hodgkin''s lymphoma. Patients with nodular lymphocyte predominant Hodgkin''s Disease have a slightly higher risk of developing Non-Hodgkin''s Lymphoma. 27. The diagnosis of lymphoma despite all technological in quite a few patients remains a dilemma. The complainant''s wife was diagnosed as a case of Hodgkin''s lymphoma with a high degree of certainty and she responded well to the treatment. However, the disease relapsed which happens in 30-40% of all cases of advanced stage III B Hodgkin''s lymphoma. 28. Considering the possibility of conversion of Hodgkin''s disease to non-Hodgkin''s lymphoma the 2nd line of chemotherapy was also tried but the same did not have the desired effect and the patient succumbed to the advanced stage of Hodgkin''s lymphoma Stage III B. 29. He further submitted that the doctor had reduced the dosage of chemotherapy on seeing the reduced TLC count. For example on 30-08-1997 the TLC has gone down to 3900 and the doctor recommended schedule of chemotherapy dosage may be reduced. Similarly, on seeing the TLC count at 2300 on 29-09-1997 the chemotherapy schedule was reduced and when the TLC count was high, chemotherapy schedule was increased. 30. He quoted from the reply to the interrogatories on behalf of OP 1 to 5 by OP No. 2 Dr. A.K. Anand, MD which is as follows : "The results of the tests from Ranbaxy Lab were conflicting. For Hodgkin''s disease CD - 15 and CD 30 and B Cell antigen is required for diagnosis. (Cancer principles and practice of Oncology 6th edition, by Lippin Cott, Williams and Wilkins, page 2347). In the patient''s case both HD and NHL markers were positive." 31. It is true that the disease was diagnosed as Lannert Lymphoma by the Ranbaxy Lab but OPs disagree with their interpretation because of clinical and radiological investigations and morphological typical case on biospy, recent advent of a test (IHC) whose quality assurance was a suspect and it showed possibility for both HD and NHL. 32. If CD 45 and CD 43 were positive so were markers CD 15 and 20 which indicate the presence of Hodgkin''s disease. Patient of Hodgkin''s disease with CD 20 positive have very poor prognosis. 33. Hence, he reiterated that diagnosis of Hodgkin''s disease and the treatment given was correct. Ld. Counsel for OP No. 6 adopted the arguments of the Ld. Counsel for OP 1 to OP 5. Rejoinder submissions made by complainant No. 1 : 34. The patient was having multiple auxiliary nodes in the armpit region and the same was removed long back in November 1996. He quoted from the report of Batra Hospital and Medical Research Centre Discharge summary note which reads as under : On examination no palpable cervical or axillary nodes. Pt. inguinal lymphademopathy. They were not present when the patient went to Batra Hospital. FINDINGS : 35. Thomas Hodgkin (Born 1798) Physician based at London discovered a new disease or granuloma which is since then referred to as Hodgkin''s disease. 36. According to Robbins Pathologic Basis of Disease, Vth Edition, Chapter 14 under the heading Malignant Lymphomas it is stated that : "Within the broad group of malignant lymphomas, Hodgkin''s disease (Hodgkin''s lymphoma) is segregated from all other forms, which constitute the non-Hodgkin''s lymphomas. Although both have their origin in the lymphoid tissues, Hodgkin''s disease is set apart by the presence of a distinctive unifying morhologic feature, the Reed Sternberg giant cell. In addition, the nodes contain non-neo-plastic inflammatory cells, which in most cases out number the neoplastic element represented by the Reed Sternberg Cell." "Although we speak of NHL as a group we should recognise that it encompasses a wide spectrum of disorders, differing in patient age at onset, the cells of origin, and,response to therapy. It is therefore necessary to classify NHL into various sub-groups." HODGKIN''S DISEASE : 37. Hodgkin''s disease like NHL is a disorder involving primarily the lymphoid tissues. It arises almost invariably in a single node or chain of nodes and spreads characteristically to the anatomically antiguous nodes. Nevertheless, it is separated from NHL for several reasons. First, it is characterised morhologically by the presence of distinctive neoplastic giant cells called Reed Sternberg (RS) Cells admixed with a variable inflammatory afltrate. Second, it is often associated with somewhat distinctive clinical features, including systemic manifestations such as fever. Finally, the target cell of neoplastic transformation has yet to be identified with certainty. Non-Hodgkin''s Lymphomas : (NHL) are the malignant neoplasms of the immue system of the body and are more common than Hodgkin''s Lymphoma. The biologic and clinical behaviour of NHL are quite distinct from HD and thus the two are quite different diseases. NHL is most frequent in young adults (20-40 years). Its incidence is showing an upward trend due to increasing incidence of AIDS. Majority of NHL arise in lymph modes (65%) while the remaining 35% take origin in extra-nodal lymphoid tissues. However, all forms of NHL have potential to spread other lymph nodes, liver, spleen and bone marrow. CURE "It has been known for more than 30 years that some patients with non-Hodgkin''s lymphoma (NHL) can be cured using chemotherapy. In the past decade, advances in molecular medicine have provided exciting insights into the biology of NHL. The viral and bacterial etiology of certain lymphomas has now been well established. Cell surface antigens have been defined lymphomas has now targets for therapy with monoclonal antibodies and radio-immunotherapy. Moreover, knowledge of critical cell signalling pathways and the results of gene expression analyses have provided opportunities for targeted therapy with novel small molecules. With these advances, improved survival has been observed in patients with aggressive NHL, and there is great optimism for patients with indolent histologies." (Cancer Principal & Practice of Oncology - 7th Edition by Vincent T. De Vita, Jr., Samuel Hellman, Steven A. Rosenberg published by Lippincott Williams & Wilkins) 38. Importance of immunohistochemistry in detecting Hodgkin''s Lymphoma. In Ackerman Surgical Pathology Immunohistochemistry has been described as under. Briefly stated, immunochemistry is the application of immunologic principles and techniques to the study of cells and tissues. The original method, devised by Coons, consisted of labelling with a fluorescent probe an antibody raised in rabbits and searching for it (and therefore for the antigen against which the antibody was directed) in tissue sections examined under a fluorescent microscope following incubation. The technical improvements that supervened in subsequent years have been responsible for these methods, becoming a staple of the histopathology laboratory. 39. On 09-04-1997 Dr. Anand of Batra Hospital referred the case to Dr. Geeta Deshmukh, Sr. Consultant Pathologist who observed as follows : Cross : Specimen consists of multiple lymphnode masses largest mass measures 6 x 4 x 3 Cms. Microscopy : Sections show effacement of architecture. There is marked proliferation of histiocytes with fair number of tumour giant cells. Mitesis is frequent. Few reed Sternberg like cells seen. There is focief necresis Few epithelioid like cells and few langhan''s cells seen. Impression : Histomorphological features are suggestive of Hodgkin''s lymphoma (lymphocytes depletion type) Adv : Immunochemistry to confirm the diagnosis. 40. This is clear cut advice by a doctor who is highly qualified and is also a Senior Consultant Pathologist of the same hospital, was ignored by the same doctor who referred the case to her. The very same doctor after the patient had suffered several chemotherapies, on 29-09-1997 requested immunohistochemistry and specimen taken on 09-04-1997 which was kept in the refrigerator by the hospital, was sent to the reputed Ranbaxy Laboratory at Mumbai which received the specimen on 03-10-1997 and submitted the report on 06 10-1997 as follows :
RESULTS COMMENTS
Markers
CD45 Positive Inguinal Lymph node
CD43 Positive Most of the lymphoid cells are positive for CD45, Most of the small and large atypical lym-phoid cells are positive for CD43.
CD15 Positive-a few cells only
CD20 Positive
Only a few scattered monocytes are positive for CD15. Brands of lymphoid cells in the cortex and medulla are positive for CD20. LENNERTS LYMPHOMA (HIGH GRADE LYMPHOEPIII ELIOID T CELLS LYMPHOMA)
This was signed by Dr. Ramesh B. Deshpande, Consultant Pathologist of Speciality Ranbaxy Limited, Mumbai. Ranbaxy lab has clearly"indicated that the patient was suffering from Lennerti''s Lymphoma (High Grade Lymhoepithelioid T Cell Lymphoma) which is a non-Hodgkin''s disease. 42. We fail to understand the logic of not sending the specimen on 09-04-1997 and the belated decision to send the same to the Ranbaxy Laboratory on 29-09-1997. 43. Let us look into some of the reasons given by the ld Counsel for the (OP 1 to 5) why immunochemistry was advised but not considered it as essential. Immunochemistry in 1997 was still in its infancy. Immunochemistry has many pit falls like many other techniques. It is a highly complicated test which requires strict quality control and pathologist to interpret the results. The diagnosis by Immunohistochemistry is based on detection of certain markers in the biopsy tissue. Lymphoma is a cancer of lymph nodes which are scattered over the body. Hodgkin''s lymphoma has an orderly method of spread in the body from one region to another. The bone marrow examination of the patient was normal despite stage III B of the disease. Pathologist have categorically mentioned the presence of Reed Sternberg Cells a characteristic feature of Hodgkin''s lymphoma. Let us analyze whether these averments are true . In Ackerman''s Surgical Pathology it is clearly stated under sub-heading immunohistochemistry There is probably no other method that has so revolutionised the file during the past 50 years as the immunohistochemical technique. The advantages are obvious; remarkable sensitivity and specificity, applicability to routinely processed material (even if stored for long periods) and feasibility of an accurate correlation with the traditional morphologic parameters. The next issue to be examined is whether it has many potential pit falls and requires experienced pathologist to interpret the results. Dr. Ramesh B. Deshpande, Consultant Pathologist who is an MD working in Speciality Ranbaxy Ltd., a renowed laboratory can certainly be rated as a qualified and experienced pathologist. He has given his clear opinion that it is a Non-Hodgkin''s disease. Ld. Counsel for the opposite parties states that the diagnosis by Immunohistochemistry is based on detection of certain markers in the biopsy tissue. Report of the Ranbaxy laboratory clearly shows that they have analyzed the several markers and only on the basis of the study made they have come to the conclusion that it is LENNERT''S LYMPHOMA (HIGH GRADE LYMPHOEPITHELIOID T CELL LYMPHOMA. Hodgkin''s lymphoma has an orderly method of spread in the body from one region to another. But the report of the hospital indicates the lymph mode has not spread to different regions but it was concentrated in the inguinal region. Pathology report of Batra Hospital has not categorically mentioned presence of reed stem burg cells. It has only mentioned as ''few reed stern burg like cells seen''. To quote, Robbins "Pathologic Basis of Disease", 5th edition by Cotran, Kumar and Robbins under the subject "Morphology" - A distinctive tumor giant cell known as the Reed-Sternberg (RS) Cell is considered to be the essential neoplastic element in all forms of Hodgkin''s disease, and its identification is essential for the histologic diagnosis. It is somewhat anticlimactic to report that cells closely simulating or identical with RS Cells have been identified in conditions other than Hodgkin''s disease. RS-like cell have been found in infectious mononucleosis and in solid tissue cancers, mycosis, fungoldes, lymphomas, and other conditions. Thus, although RS cells are requisite for the diagnosis, they must be present in an appropriate back-ground of non-neoplastic inflammatory cells (lymphocytes, plasma cells, eosin ophils). Stated another way, the RS cell is necessary but not sufficient for the diagnosis. The Id Counsel for the OPs has attached the result of immunohistochemistry tests taken by the Ranbaxy Laboratory stating that it did not confirm that it is a non-Hodgkin''s Lymphoma. 44. The specimen of the patient was referred by the Batra Hospital to the Ranbaxy Lab. They have not produced the reference letter before us. If CD 30 markers is important then they could have asked for testing for the same. This is a lapse on the part of the hospital authorities and not on the part of the lab. It is common knowledge that if blood sugar or lipid profile has to be tested by taking blood of the patient, the doctor refers the patient to a lab with a request to a conduct a particular test because, such test are expensive. Secondly, if Batra Hospital authorities were not satisfied with the result of the Ranbaxy Lab they could have written another letter to the lab to conduct another test for CD 30 which they have not done. It appears that they are raising this issue as an after thought to defend their indefendable actions. 45. In the medical text written by Robbins, Kumar, Cotran page 634 under the title''Pathologic basis of disease'', it is stated that all forms of non-Hodgkin''s Lymphoma have potential to spread from their origin in a single node to other node and eventually disseminate to spleen, Liver and Bone Marrow. Complainant''s wife suffered from the disease at the initial stage from April 1997, wherein liver was found to be normal as per CT Scan, spleen was normal as per ultrasound test and bone marrow test also indicated its normalcy. After five months of treatment until September 1997, respective repeated tests indicated that liver was involved, spleen was found involved and enlarged and bone marrow was slightly hypocellular. This is yet another indication that the patient was suffering from Non-Hodgkin''s Lymphoma disease. 46. In a high risk patient like this, a specialist in Medical Oncology cannot claim superiority over a Histopathologist. All these doctors have to work as a team and take a collective decision to treat patient then only the patient can be cured by providing proper treatment. In this case it is evident that doctors at Batra Hospital not only neglected the view of histopathologist of their own hospital where they are working but also the histopathologist of Ranbaxy laboratory. This is very strange considering the averments made by the Id Counsel for OP 1 to 5 in which it is submitted that Immunohistochemistry is a highly complicated test which requires strict quality control and experienced pathologist to interpret the result. It is relevant to note that he has not stated that it requires an experienced Oncologist to interpret the result. 47. Now let us see what was the treatment given to the patient. The first cycle of treatment by chemotherapy was started by AB VD regime meant for Hodgkin''s Lymphoma (Lymphocytic Deplition type) LDHD, on 12-04-1997 without any pathologic confirmation as was advised by the Histopathologist in her Histopathology report on 07-04-1997. On 29-. 08-1997 the patient''s treatment changed to second line of chemotherapy that is by COPP regime (meant for Non-Hodgkin''s Lymphoma) again without any pathologic confirmation. The reasons can be seen from the written statement which is as follows : 48. On 29-08-1997 as per the patient was not responding as Hodgkin''s Lymphoma it was thought that it could be large cell Lymphoma. The line of treatment changed from ABVD regime meant for Hodgkin''s Lymphoma to COPP Regime (meant for non-Hodgkins Lymphoma) and subsequently to COPP Regime on 29-09-1997 (meant also for non-Hodgkin''s Lymphoma). In "Cancer Principles and Practice of Oncology" it is clearly stated that "before the availability of immunophenotyping studies, many cases diagnosed as LDHD were, in reality, cases of large B cell lymphoma or T Cell lymphomas, often of the anaplastic large cell lymphoma (ALCL) type. Cases of the reticular variant of LDHD may be difficult to distinguish from ALCL." 49. The essential components of the modern tort of negligence propounded by Percy and Cahrlesworth are as follows : (a) the existence to take care, which is owed by the defendant to the complainant; (b) the failure to attain standard of care prescribed by the law, thereby committing a breach of such duty ; and (c) damage, which is both casually connected with such breach and recognised by the law, has been suffered by the complainant. 50. Under section 2(1)(g) of CP Act 1986 deficiency. means -any fault, imperfection, shortcoming or inadequacy in the quality, nature and manner of performance which is required to be maintained by or under any law for the time being in force or has been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service. 51. The SC in Indian Medical Association v. V.P. Shantha, AIR 1996 SC 550 has held that a determination about deficiency -in service is to be made by applying the same test as is applied in an action for damages for negligence. 52. In Ganga Ram Hospital v. D.P. Bhandari, 1992 (1) CPR 796 (NC) the National Commission held that medical professionals are expected to exercise and provide reasonable degree of skill and knowledge and also exercise reasonable degree of care in treating patients. A medical man rendering professional service for consideration is liable under Consumer Forum if he falls short of the standard of a reasonable skillful medical person in his field. 53. In Dr. Sr. Louie v. Smt. Kannolil Pathumma, 1993 (1) CPR 422, the National Commission held that for establishing negligence in diagnosis or treatment on the part of the doctor before Consumer Forum, the test is whether the doctor has been proved to be guilty of such failure as no doctor of ordinary skill could be guilty of it acting with reasonable care. 54. Shelat J. delivering the judgment of the SC of India in Dr. Laxman Balkrishna Joshi v. Dr. Trimbak Bapu Godbole, AIR 1969 SC 128 laid down the criteria for determination of the professional duty of a medical man in the following way : A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person when consulted by a patient owes him certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give, or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. 55. In Jacob Mathew v. State of Punjab and Another, (2005) 6 SCC 1 : AIR 2005 SC 3180 the Hon''ble Apex Court has observed as follows : "Negligence in the context of the medical profeation necessarily calls for a 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 or method 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. The classical statement of law in Bolam case, (1957) 2 All ER 118 at p. 121 D - F (set out in para 19 herein), has been widely accepted as decisive of the standard of care require both of professional men generally and medical practitioners in particular and holds good in its applicability in India. In tort, it is enough for the defendant to show that the standard of care and the skill attained was that of the ordinary competent medical practitioner exercising an ordinary degree of professional skill. The fact that a defendant charged with negligence acted in accord with the general and approved practice is enough to clear him of the charge. It is not necessary for every professional to possess the highest level of expertise in that branch which he practices. Three things are pertinent to be noted. Firstly, the standard of care, when assessing he practice as adopted, is judged in the light of knowledge available at the time (of the incident) and not at the date of trial. Secondly, 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 point of time (that is. the time of the incident) on which it is suggested as should have been used. Thirdly, when it comes to the failure of taking precautions, what the ordinary expertence of men has found to be sufficient; a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence. A person who holds him4 our ready to give medical advice and treatening of impliedly undertakes that he is possessed of skill and knowledge for that purpose. Such a person when consulted by a patient owes him certain duties viz, a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to be given or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence. judged in the light of the particular circumstances of each case, is what the law requires. The doctor no doubt has a discretion in choosing the treatment which he proposes to give to the patient and such discretion is relatively ampler in cases of an emergency." See in the light of above citations, the findings of the case elucidated earlier clearly indicates negligence on the part of opposite parties. However, we would like to lay emphasis on the following fact : 56. In the case at the time of treatment availability of immunohisto chemistry test was well known and it was recommended by the Senior Consultant Pathologist of the Batra Hospital on 09-04-1997 and the treating doctors of the same hospital disregarded this advise and continued to treat the patient on the basis of their own assumptions. Subsequently, when their line of treatment did not give any relief to the patient the very same doctors referred the same specimen for Immunohisto chemistry test to Speciality Ranbaxy Ltd. Mumbai and when this Ranbaxy Laboratory at Mumbai submitted their report on 06-10-1997 on the basis of the examination from the same specimen taken on 09-04-1997 gave their comments i.e.: "Lennert''s Lymphoma (High Grade Lymphoepithelioid T Cell Lymphoma i.e. non-Hodgkin''s Disease", the doctors of the hospital disregarded this observation by inventing their own logic which is not comprehensible. 57. Therefore, we hold that the opposite parties are negligent in treating the patient which caused untold suffering to the patient and hastened her death. 58. Coming to the issue of compensation, the complainants have claimed Rs. 61,02,000/-. The complainants deserve to be reimbursed towards payment made towards bills of the hospital to the tune of Rs. 1,12,000/-. They have also claimed Rs. 1,60,000/- for the medicines purchased and Rs. 1,10,000/- for the expenses towards travel, boarding and lodging. As the bills have not been produced for medicines, travel, boarding and lodging, we award a lump sum of Rs. 1,50,000/- towards these claims. The complainants have claimed Rs. 1,20,00/- towards the loss of business and Rs. 6,00,000/- towards losing customers permanently. As no proof has been provided for the same, we are not in a position to award any compensation towards this. Complainant No. 1 has claimed Rs. 10,00,000/- toward loss of company of wife. We consider an amount of Rs. 2 lakhs as just and reasonable towards this loss. Rs. 15,00,000/- have been claimed as compensation for the loss of mother of three children. We consider Rs. 3,00,000/- to be a reasonable compensation for the same. Finally the complainant has claimed Rs. 25,00,000/- for compensation for mental agony and trauma. As we have awarded compensation towards loss of wife/mother we do not deem it necessary to award further compensation towards mental agony and trauma. 59. Accordingly, the compensation to be awarded works out as follows :
Towards Hospital bill Rs. 1,12,000/-
Towards cost of medicines, travel, boarding and lodging Rs. 1,50,000/-
Compensation for loss of company of wife Rs. 2.00,000/-
Loss of company of mother to each child 1,00,000 x 3 = 3,00,000/- Rs. 3,00,000/-
Rs. 7,62,000/-
As a team of doctors functioning at opposite party No. 1 hospital have treated the patient it may not be proper to separate their role while fixing responsibility of medical negligence. Accordingly, awarded amount should be paid jointly and severally by the opposite parties Nos. 1 to S. As they are insured this amount shall be paid by the Insurance Company to the complainants. The opposite parties I to 5 shall also pay Rs. 25,000/- as costs to the complainant. The above amount shall be paid within a period of 60 days from the date of this order. Petition partly allowed.