National Consumer Disputes Redressal
S.K. Sharma vs Dr. Praful B. Desai on 27 November, 2002
Equivalent citations: II(2003)CPJ90(NC)
ORDER
B.K. Taimni, Member
1. Appellant was the Complainant before the State Commission where his complainant was dismissed as no case of medical negligence could be proved against the Respondent.
2. Brief facts of the case are that the Complainant's wife (since deceased) got a Mammogram done on her on 23.4.94 whereafter she was advised to consult the Respondent Dr. Praful Desai of Tata Memorial Hospital Mumbai. The deceased who is a qualified Doctor- Gynaecologist - for the first visited the Respondent On 11.8.94 where she was examined by Dr. Patil and was found to be having cancer of Right Breast which was brought to the notice of the Respondent. On 12.8.94, the Respondent was referred to Dr. Gopal, Senior Chemotherapist at the Tata Memorial Hospital where after examination, Dr. Gopal started chemotherapy treatment on 17.8.94 and completed three cycles on 28.9.94. She was examined by Dr. Gopal, the doctor incharge of Chemotherapy and the Respondent on 10.10.94. Progress was noted as 'very good' and was advised one more cycle of chemotherapy which was done on 9.11.1994. She was again examined by two Senior Doctors of the Hospital, Dr. Srivastava, Senior Radiotherapist and Dr. Dinshawthen head of the Department of Radiotherapy and noted that response to chemotherapy of affected Right Breast is good and also noted that - Left Breast is normal. She underwent Radiotherapy in between and regression was found to be excellent. The deceased underwent more cycles of chemotherapy on 27.1.95 and 9.3.95. In between she is regularly being examined by the other doctors and the Respondent. It is at this time that the Respondent notices 'degenerating tumour cells'. Surgery of Right Breast (MRM - Modified Radical Mastectomy) is carried out on 27.4.95 at Breach Candy Hospital by the Respondent. Dr. Dinshaw examines the patient on 22.5.95, who notes 'L-axilla and LS/G node + palpable'. Deceased visits the Respondent on 1.6.95 - after which the deceased goes to USA for treatment of cancer. On return to India, she undergoes one more cycle of chemotherapy on 31.8.95 at Tata Memorial Hospital and is seen by the Respondent on 21.9.95. After that the Respondent never saw the deceased even though the deceased was admitted with Tata Memorial Hospital for full cycle of Taxol. Perhaps, the deceased went to USA again and then came back to India and expired on 14.3.96. Thus alleging medical negligence on the part of the Respondent, a complaint was filed by the Complainant - the husband of the deceased - before the State Commission who after hearing the parties and perusal of material and evidence on record dismissed the complaint, hence this appeal against the order of the State Commission.
3. The argument of the learned Counsel for the appellant is two fold -one-that the left breast was left unattended which amounts to negligence; for this he wishes to derive support from the clinical diagnosis done on 11.8.94 by Dr. Patil at the Tata Memorial Hospital in which Dr. Patel had noted - 'L axilla -tiny node' and, secondly, line of treatment adopted by the Respondent was not the correct one. What was done was chemotherapy, followed by Radiotherapy, followed by surgery. The argument of the learned counsel for the Appellant is that, surgery should have been done immediately after detection of cancer of the breast. For this argument, he wishes to draw support from an article written by the Respondent on this subject.
4. We have seen the material on record and heard the arguments. Before we go on to discuss the merits of the case, we find it necessary to detail as to what does one understands by the term 'medical negligence'? Halbury's Laws of England (Third Edition Vol-26 Page 17 defines 'negligence'.
"22. Negligence : duties owed to patient. A person who holds himself out as ready to give medical (a) advice or treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person, whether he is a registered medical practitioner, or not, who is consulted by a patient, owes him certain duties, namely, a duty of care in deciding whether to undertake the case; a duty of care in deciding what treatment to give; and a duty of care in his administration of that treatment (b). A breach of any of these duties will support an action for negligence by the patient(c).
23. Degree of skill and care required. 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 requires (d; a person is not liable in negligence because someone else of greater skill and knowledge would have prescribed different treatment or operated in a different way(d); not is he guilty of negligence if he has acted in accordance with a practice accepted as proper."
5. It is essential to understand the contents of this definition as it both epitomizes and manifests medical negligence. We go on to examine this case in the light of above definition. There is no dispute on the point that the Respondent Doctor possessed necessary skill and knowledge and rightly decided to undertake the case. Only point at issue is '- duty of care in deciding what treatment to give. This challenge is two-fold - No mammography and resulting non attention of left breast and line of treatment should have been surgery in the first instance. We have seen the material on the first count produced by the appellant. Chapter 27 of the Book 'Cancer - Principles and Practice of Oncology' deals with 'Breast Cancer' P-926 deals with 'Screening of Cancer'. Relevant portion reads as under:
"-----With this information (result of studies) plus a continued reduction in mammographic exposure, there appears to be general agreement that mammography as a screening procedure appears clearly to be of value over the age of 50 years and probably should not be used in the general population under the age of 35 years. The correct approach to the women between 35 years and 50 years is still under discussion and depends on many of the assumptions used. For example, there seems to be as yet no clear evidence that mortality is reduced by screening patients in this age group - thus, whatever your estimation of risk, if there is no clear gain, mammography should not be employed. The dose received during mammography has been reduced due to the appreciation of this potential hazard. High-quality mammograms can be made with (SIC) rad administered to the breast and substantially lower does may be achieved. All these considerations are for women in the general population; special exceptions should be made for patients identified in high-risk groups. These high-risk groups include at the minimum those patients with a very strong family history, especially those whose mother and sister have had the disease. Their likelihood of having the disease under the age of 40 years and bilaterally is extremely high. It should also include those patients who will have already had a breast cancer on the other side, as the incidence of second tumors appears to be approximately 1% per year of risk after the diagnosis of the initial breast cancer. Finally there are women who have had a suspicious biopsy of breast lesions who need careful follow up.
The debate on breast cancer screening has resulted in effective reduction in the mammographic exposure without significant loss in the sensitivity or specificity of the procedure. This appears to be a valuable contribution. Mammography is an important addition, too, but cannot substitute for physical examination in the screening of asymptomatic women for breast cancer. Both procedures may find tumors undetected by other means. In the HIP study, approximately one-third of the tumors were found by mammogram alone, while 40% of the tumors detected were not seen on the mammograms." (emphasis supplied)
6. It is important to note that the deceased was 42 years of age. Two salient point emerge from above - one that the correct approach (to screen for breast cancer to women between 35 years and 50 years is still under discussion and secondly, Mammography is no substitute for physical examination (emphasis supplied).
7. Reliance has also been placed by the appellant on the Book - "Clinical Oncology
- A manual for studests + Doctors)" published by Springer Verlag - Berlin Hidelberg New York - 1973 P-209 reads as under:-
"Mammography can sometimes detect occult mammary careinoma in patients with no clinical signs"
8. It, at best says 'can sometimes detect'. It does not go on to say that Mammography is the only course.
9. The appellant has also relied upon, what appears to be a paper presented at the 32nd Annual Meeting of the Society of Surgical Oncology Inc. held in Georgia in April 1979 where is one of the paper on "Multicentricity of clinically occult Mammary Cancer
- Implications for Treatment", it is stated that a 'Mammography as an adjunct to clinical examination has detected a number of breast cancers which have been non palpable..... The fact to note is that it is a paper and not a Reference Book on the subject and furthermore, in the instant case, cancer was found to be palpable, hence has no relevance in the present case.
10. Considering in totality, the above material, in our view, does not help the appellant. To the contrary it supports the case of the Respondent that physical examination of the patient was done which is supported by the material on record. As per hospital record, we also see that left breast was examined on 11.8.94 and on 15.11.94 when left breast we found to be normal and again on 21.5.95 when 'L/axilla + LS/G node + palpable' is noted. The statement of the Complainant is not substantiated by the material on record that left breast was not examined at all. There is no challenge to the written version filed by the Respondent that what Dr. Patil noted for left breast was 'L axilla - tiny note' was in fact a 'fatty nodule'. WE also see on Hospital record dated 11.8.94 of which so much is made out that in the drawing of the left breast there is a question mark. Thus this cannot be said to be a definite proof of leaf breast having been affected by cancer. Left Breast was never affected, hence never treated specifically. We also see that chemotherapy is a systemic treatment which addressees the body as a whole and not to a particular part in the body. Thus we see no merit in the argument of the appellant that 'Mammography' was a 'must' and left breast remained unattended.
11. The second argument advanced by the appellant relates to the line of treatment. In the Book - 'Cancer Principle and Practice of Oncology' brought on record by the appellant - Page 928 of Chapter 27 deals with 'Treatment of Local and Regional Disease' The two most commonly used endpoints to judge the effectiveness of local and regional treatment are (1) local and regional tumor control and (2) survival. Despite the general acceptance of thee two endpoints, each presents difficulties in analysing the results of treatment. While it is clear that the object of treatment is to eradicate all cancer in the breast, chest wall, and draining lymph node areas, it is not now possible to determine at the end of the treatment if this has been accomplished. As a result, follow-up information on patients is required to detect any reappearance of cancer in these areas. Such a reappearance is termed local or regional recurrence, and is taken as an indication of the failure of the treatment to achieve eradication of the cancer. In contrast, the absence of local or regional recurrence is termed local-regional tumor control and is taken as evidence for the eradication of cancer.
In this way, survival is more a selection of case selection, whereby patients with earlier disease have less likelihood of distant spread and, hence have better survival.
P-1293 of the same book is relied upon by the Respondent which reads as under:
"Disease free survival after combined chemotherapy and radiation there was significantly better than after either modality alone....."
"There has been as increasing trend toward the use of induction chemotherapy before undertaking local treatment in the management of LABC. This approach has several potential benefits, including the prompt treatment of presumed systemic disease the reduction of tumor burden before definitive local thereby and the use of the response of the primary tumor as in -----
12. Appellant has relied on the Book 'Clinical Oncology' - supra. Of this page 210-211 under the heading - Treatment' reads 'Despite the advances of radiotherapy, the most usual and most effective treatment is surgery'. However, at page 211, we also see the following 'Some variants either more conservative (sparing of pectoral muscles) or most destructive (removal of the internal mammary lymph nodes as well) as also widely practiced.'
13. In the instance case as per record when the deceased came for the first time, she already had T4N1M stage of cancer which is the penultimate stage - an advance stage of cancer. When on examination and on other indicators, it was found to be a case of Right Breast Cancer, adopting a conservative approach she was treated with chemotherapy and Radiotherapy. As per material on record - She responded well and regression of disease was noted as 'very good'. When recurrence was noticed, surgery (MRM) was done. This we find is as per the material on - Treatment of local and regional Disease' in the literature on the subject supplied by the appellant.
14. The sole authority relied upon by the appellant is the article written by the Respondent. Since from this perspective this is a crucial document, we like to quote it at some length:
Contributions to science is a gradual process and it is usually the result of painstaking observations backed by sound scientific data collection and evaluation. Conservation of breast in cancer in appropriate clinical settings, adjunctive chemotherapy in premenopausal node-positive patients and the beneficial effect of antioestrogens in ER-ve postmenopausal patients are some examples of significant recent contributions in the management of breast cancer. Notwithstanding the newer advances, it is rare that conventional principles in therapy, firmly established by years of constant evaluation can be dislodged in a hurry.
Ever since Halsted laid his tenets for radical operation for breast cancer, his objective was to rid the patient of the local ravages of the disease and cure the patient. McWhirter sounding the first discordant note, on conventional radical mastectomy, still had local control of the disease as the primary objective. Biological nuances of breast cancer were unknown at the time and it was that maximal local surgery was the prerequisite for a case. In so doing, however, Halsted laid the foundation of the concept of local control which by whatever method achieved, was the sheet anchor of successful treatment for long-term cure. Despite all the advances is chemotherapy, the role of appropriate initial surgery and radiotherapy when indicated, continue to be the crucial factors in achieving a long-term local control which is the first pre-requisite for a cure of breast cancer. Indeed, local control may not result in a cure, but there can be no cures without local control.
Rather than choosing the right method radical mastectomy, modified radical mastectomy, simple mastectomy of lumpectoms wit axillary dissection) for a given clinical setting surgeons initiated lesser procedures for all patients and began taking shelter of the radiotherapy and chemotherapy umbrella to control and cure breast cancer. Their expectations were soon bellied.
A quick review of the literature reveals that leaving behind axillary modes in Stage II disease, has a significant impact on long-term survivals at ten years. In one of the first such trials published. Atkin's data' can be questioned, because the radiotherapy does was probably inadequate by today's standards. In this series the ten year survival (Stage II) was 60% with conventional treatment and only 25% with conservative surgery and radiotherapy.
(Emphasis supplied.)
15. There is no dispute on the fact that this was a case of pre-menopausal breast cancer. As per first para above, in such a case conventional principles of therapy are supported by the author/Respondent and Conventional line of therapy was adopted; in the second para, what we see is that key word for adopting surgery is 'when indicated'. Nothing is shown before us that it was 'indicated'. As regards third papa above, suffice to say, that its relevance is for IInd stage cancer patients - where as in the instant case, it was a case of IVth stage cancer. T4N1M - as per staging given in the Book (Supra) Chapter 27 cancer of breast P - 923 or Stage III (last stage) as per the Book 'Clinical Oncology- A manual for students and doctors' supra.
16. In the affidavit filed by the Respondent, he has defended and reiterated his line of treatment which has not been rebutted. In any case, Appellant failed to examine the Respondent or any other doctor before the State Commission as also before us to prove his case. No attempt has been made to examine him and confront him on the line of treatment suggested in his article and not followed the case. Hence in the circumstances evidences given by way of affidavits becomes final. We are also aware of the fact that each case shall have to be dealt on the facts and circumstances of each case. Since no two cases are same, we are unable to appreciate the argument that what the Respondent wrote in an article - he should have followed that procedure. Negligence is proved by evidence - oral or documentary - which the applicant has failed to prove in this case. Nothing has been shown to us, based on the literature on the subject, that surgery was the only treatment. As per material on record, Respondent followed an accepted practice. At worst even if we find that two options were there and the Respondent adopted one, as per settled law, this cannot amount to medical negligence.
17. In our view the appellant has failed to prove, based on my material on record, the two grounds on which the order of the State Commission has been challenged. Here was a case of advanced stage of cancer- where a combination of chemotherapy and radiotherapy was administered. Yet when the disease recurred, then surgery was done. The Respondent Doctor followed the accepted procedure. It is unfortunate that still the deceased patient could not be saved but it cannot be said that death was caused by any negligence on the part of the Respondent. In our view, no case of medical negligence is proved as per the definition of negligence cited earlier.
18. This appeal is dismissed. Parties to bear their own costs.