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Pathology lab told to pay Rs 10 lakhs plus interest for wrong Histopathology Report
Uttaranchal: A Dehradun-based pathology and imaging centre has been held guilty of erroneously concluding that a patient had breast cancer and consequently fined Rs 10 lakh plus interest by the State Consumer Commission. The patient had undergone mastectomy based on the report.
The case goes back to 2003, when the complainant was having pain near her breast and visited. Dr. Pradeep Sharda, M.S., F.A.I.S. and F.I.C.S. for check-up. The doctor referred her to Dr. Ahuja’s Pathology & Imaging Centre for further tests. Dr. Alok Ahuja is a qualified doctor and is M.B.B.S., D.M.R.E., M.D. and Consultant Radiologist running the centre. Dr Ahuja took the blood sample of the complainant and did fine needle aspiration biopsy and the result was suggested as excision biopsy. On 20.05.2003, the doctor took the specimen of breast lump for further test and declared infiltrating ductal carcinoma.
Based on the reports, the patient went to Rajiv Gandhi Cancer Institute and Research Centre (RGCIRC), New Delhi for treatment. The said hospital, relying upon the report dated 20.05.2003 , took the complainant for surgery and removed her left side breast.
During operation, the specimen of left MRM was sent for biopsy and vide report dated 09.06.2003, it was reported that, “Diagnosed case of carcinoma breast. No residual tumour tissue seen in the breast. Axillary Lymphnodes, Level II, III tissue are free of tumour tissue”.
After going through the test report dated 09.06.2003, the doctors at Cancer Institute asked the patient's attendant to bring the remaining tissue for market study. The remaining tissues, which were kept at the pathology centre in Dehradun – Centre were taken for review of outside slide for biopsy again and in the report dated 26.06.2003 issued by RGCIRC it was observed that,
A repeat testing was done at Dr Lal Pathlabs, which observed
Based on the above two reports that patient filed a medical negligence case against all the doctors and hospitals involved, and failure of proper test report and diagnosis which caused the patient to undergo painful treatment.
In their defence, the pathology lab stated that the said pathology report was suggestive and the complainant was specifically advised to take second opinion before determining course of treatment and that is why original slides were handed over to the patient on 30.05.2003. Moreover it was stated that that the portion which was examined by pathology lab was breast lump, while the specimen examined by Dr. Lal Path Labs Pvt. Ltd. was skin nodule; that there is quite possibility that the observation regarding two different specimen may have varied; that there is always a scope or space for difference of opinion and there are limitations of pathological study, which were explained to the complainant while handing over the slide on 30.05.2003; that there is a possibility that the breast lump which was examined by the pathology lab suggested malignancy, while the skin nodule examined after breast removal, may have contained no malignance cell, as the stage of the patient was detected at the very early stage; that the specimen of excision biopsy was submitted on 20.05.2003 and the specimen was processed as per standard protocol and a comment of infiltrating duct carcinoma was proposed.
After going through the submissions the court observed
Attached is the judgement below
The case goes back to 2003, when the complainant was having pain near her breast and visited. Dr. Pradeep Sharda, M.S., F.A.I.S. and F.I.C.S. for check-up. The doctor referred her to Dr. Ahuja’s Pathology & Imaging Centre for further tests. Dr. Alok Ahuja is a qualified doctor and is M.B.B.S., D.M.R.E., M.D. and Consultant Radiologist running the centre. Dr Ahuja took the blood sample of the complainant and did fine needle aspiration biopsy and the result was suggested as excision biopsy. On 20.05.2003, the doctor took the specimen of breast lump for further test and declared infiltrating ductal carcinoma.
Based on the reports, the patient went to Rajiv Gandhi Cancer Institute and Research Centre (RGCIRC), New Delhi for treatment. The said hospital, relying upon the report dated 20.05.2003 , took the complainant for surgery and removed her left side breast.
During operation, the specimen of left MRM was sent for biopsy and vide report dated 09.06.2003, it was reported that, “Diagnosed case of carcinoma breast. No residual tumour tissue seen in the breast. Axillary Lymphnodes, Level II, III tissue are free of tumour tissue”.
After going through the test report dated 09.06.2003, the doctors at Cancer Institute asked the patient's attendant to bring the remaining tissue for market study. The remaining tissues, which were kept at the pathology centre in Dehradun – Centre were taken for review of outside slide for biopsy again and in the report dated 26.06.2003 issued by RGCIRC it was observed that,
“Three of the slides show skin with unremarkable epidermis and dermis showing well circumscribed lobular mass composed of round to oval cells with eosinophilic cytoplasm and centrally places round nuclei. Some of the cells have clear cytoplasm. Compressed cuboidal to flattened cell lined Lumina are noted in the midst of lobules. The stroma is compressed. No breast tissue is noted. No evidence of malignancy is seen. The fourth slide shows a strip of muscular tissue lined by a layer of columnar epithelium thrown in papillary projections. No specific lesion is noted”.
A repeat testing was done at Dr Lal Pathlabs, which observed
"Microsections show a capsulated intradermal tumour composed of lobular masses with extension into subcutaneous fat. Tumour lobules comprise of polygonal to fusiform cells with amphophilic to vacuolated cytoplasm. No nuclear hyperchromasia, mitosis and necrosis seen. A few cystic spaces and ducts are seen. Thin vessels are present in the tumour. Epidermis is unremarkable. One large duct lined by cuboidal cells is seen adjoining the tumour tissue”. In the impression, it was reported that, “Benign adnexal tumour. Suggestive of benign sweat gland tumour”.
Based on the above two reports that patient filed a medical negligence case against all the doctors and hospitals involved, and failure of proper test report and diagnosis which caused the patient to undergo painful treatment.
In their defence, the pathology lab stated that the said pathology report was suggestive and the complainant was specifically advised to take second opinion before determining course of treatment and that is why original slides were handed over to the patient on 30.05.2003. Moreover it was stated that that the portion which was examined by pathology lab was breast lump, while the specimen examined by Dr. Lal Path Labs Pvt. Ltd. was skin nodule; that there is quite possibility that the observation regarding two different specimen may have varied; that there is always a scope or space for difference of opinion and there are limitations of pathological study, which were explained to the complainant while handing over the slide on 30.05.2003; that there is a possibility that the breast lump which was examined by the pathology lab suggested malignancy, while the skin nodule examined after breast removal, may have contained no malignance cell, as the stage of the patient was detected at the very early stage; that the specimen of excision biopsy was submitted on 20.05.2003 and the specimen was processed as per standard protocol and a comment of infiltrating duct carcinoma was proposed.
After going through the submissions the court observed
The report dated 20.05.2003 of the complainant issued by Dr. Ahuja’s Pathology & Imaging Centre is Paper No. 14 on the record and in the said report, it has clearly been mentioned that the complainant is having “infiltrating ductal carcinoma” i.e., breast cancer. There is no mention in the said report that the findings are suggestive and that the complainant should go for second opinion before taking further treatment for curing the disease mentioned in the report.
In para 12 of the written statement, it has further been stated that there is a clear possibility that the breast lump which were examined by the opposite party Nos. 1 and 2 suggested malignancy, while the skin nodules examined after removal of breast may have contained no malignance cell, as the stage of patient was detected at the very early stage. If the complainant was suffering from an early stage of cancer, the said fact should have been mentioned in the report and she should have been clearly informed that there are chances that she might be suffering from breast cancer, but the said fact should first be got confirmed by way of second opinion and thereafter, further course of treatment should be followed by the complainant, but there is no such mention in the report, nor there is any remark that the finding is suggestive or the diagnosis found is at the early stage and the complainant need not worry about the same.
In the report dated 11.12.2003 issued by Dr. Lal Path Labs Pvt. Ltd., it has clearly been mentioned that the impression is suggestive of benign sweat gland tumour, but there is no word like “suggestive” mentioned in the report issued by opposite party Nos. 1 and 2. Thus, there has clearly been medical negligence on the part of the opposite party Nos. 1 and 2 in issuing a wrong pathology report showing that the complainant is suffering from breast cancer and on account of the said incorrect report, the complainant was operated upon and her left breast was removed.
Holding negligence the court directed the pathology lab and Dr Ahuja to pay compensation of Rs. 10,00,000/- to the complainant together with interest @7% p.a. from 29.04.2006, i.e., the date of filing of the consumer complaint till payment and Rs. 10,000/- towards litigation expenses. The consumer complaint is, however, dismissed against Rajiv Gandhi Cancer Institute.
Attached is the judgement below
Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She is a member of the Association of Healthcare Journalists. She can be contacted at meghna@medicaldialogues.in. Contact no. 011-43720751
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