DR. S. M. KANTIKAR, MEMBER

Fine-needle aspiration cytology (FNAC) is a simple, less time-consuming, safe, useful and highly accurate technique for breast masses and can segregate benign and malignant lesions with accuracy is achieved. However, the Triple assessment by clinical, radiological and pathological examination is a standard approach in the evaluation of breast lumps. 

 

1. The instant Appeal under section 19 of the Consumer Protection Act, 1986 (in short “the Act”) filed by the Appellant/Complainant for enhancement of compensation which awarded by the State Consumer Disputes Redressal Commission, Karnataka, Bengaluru (hereinafter referred to as the “State Commission”) in Consumer Complaint No. 187 of 2011. 

2. Brief facts are that on 09.12.2009 the Appellant/Complainant Mrs. Sajidah Shaukath, about 48 years of age underwent   routine medical checkup at Santosh Diagnostic Centre, Bangalore.  A small lump in her left breast was noticed and same was confirmed by scan/mammography. Thereafter, on 10.12.2009, she underwent Fine Needle Aspiration Cytology (FNAC) test at Anand Diagnostic Laboratory (Respondent No. 1). It was reported by Respondents Nos. 2 to 4 as ‘no evidence of malignancy’. On the basis of mammography and FNAC report, the surgeon advised no further treatment as the lump was benign (not-malignant) and she relived of tension. The Complainant alleged that the small lump has apparently grown in size, therefore, on 02.04.2011, she underwent FNAC test again at Vertis Diagnostic Centre. It was reported as malignant in nature. Therefore an emergency mammography was done and mastectomy was advised.  The FNAC slides were re-examined and confirmed that the report of the Opposite Party No. 1 was wrong.

3. The Complainant underwent left sided mastectomy on 16.04.2010 and her entire left breast along with the adjoining tissues were removed. She had to undergo 16 sessions of Chemotherapy for a period of 7 months which led to loss of hairs, immunity, and discoloration of skin.  It was alleged that the wrong FNAC report was a root cause of the mastectomy, which otherwise could have been avoided and there was complete cure.  She suffered great pain and stress, also incurred heavy expenses about Rs.4,50,000/- due to the alleged negligence of the respondents.  Being aggrieved Appellant filed a Consumer Complaint before the State Commission, Bangalore.

4. The Opposite Parties Nos.1 to 5 filed their Written Versions and raised preliminary objection that in the legal notice, the Appellant claimed compensation of Rs.2 lakh, but she claimed compensation Rs.1 crore without any justification. It was submitted that, the Opposite Party No.1 is a reputed laboratory and catering diagnostic services in South India.  They denied negligence in reporting of FNAC.  They followed the accepted standard procedure of FNAC  breast nodule.  Three slides were prepared and the FNAC was reported by the Opposite Party Nos.2 & 3 as ‘there was no evidence of malignancy’ in the sample collected. The report was verified by the Opposite Party No.4.  The report was issued to the complainant along with two slides and the third slide was retained by the Opposite Party No.1 for its record. The Opposite Party No.5 was a data entry person who had no role in reporting.  The Opposite Parties further submitted that the Complainant underwent second FNAC after about 1½ years and it was reported as a malignant in nature. It is possible that the benign tumor may change/transform to malignant.    

5. The State Commission after considering the averments and hearing the parties partly allowed the complaint and passed the Order as:

“The above complaint is partly allowed holding that Op Nos. 1 to 4 are liable for the wrong report of FNAC test given by them to the complainant and consequently Op Nos. 1 to 4 are jointly and severally liable to pay compensation of Rs. 1.00 lakh with interest at the rate of 9% per annum from the date of complaint till realisation to the complainant. Further Op Nos. 1 to 4 are also jointly and severally liable to pay cost of Rs. 10,000/- to the complainant.

       Complainant against Op No.5 is dismissed.”

 

5. Being unsatisfied by the Order of the State Commission, the Appellants have filed the instant Appeal for enhancement of compensation to Rs. 2,00,00,000/- (Rupees Two crores).

6. Heard the arguments from the learned Counsel of both the sides. 

7. Learned Counsel for Appellant vehemently argued that the State Commission on wrong computation awarded on Rs.1 lac as compensation. He submitted that FNAC is a highly reliable and confirmatory test for diagnosing breast cancer, having accuracy of up to 95%. The State Commission failed to apply principles of Bolam’s Test  in the present case wherein the respondents did not possess the requisite skill and care which would normally require for cancer diagnosis.

8. The rival arguments of the learned Counsel for respondents that their FNAC report was correct. There was no deficiency in service or negligence while reporting.  The FNAC slides were retested at three different laboratories viz., Triesta Reference Laboratory, Bangalore; Ramakrishna Diagnostic Centre, Ooty; and Oncquest Diagnostics, Bangalore; none of them opined it as malignancy.  The Counsel further submitted for diagnosis of breast cancer triple test is necessary.  The FNAC done by the Respondent No. 1 was only one part of the Triple Test. The consulting doctors need to guide the patient properly.  

9. The learned counsel further argued that, the triple test consists (i) history and clinical breast examination, (ii) imaging and mammography and/ or Ultra Sound and (iii) FNAC and/ or Core Biopsy. The sensitivity of the triple test is greater than that of any of the individual components alone to rule out malignancy. Thus, the FNAC test report cannot be viewed in isolation and it is for the doctor/ surgeon to correlate the cytological/histological report with the clinical and imaging findings and advice or refer the patient for further treatment.  The counsel relied upon an extract from the research article 'Diagnostic role of cytology in screen- detected breast cancer’ ,  which  specifically stated that ‘FNAC is a useful diagnostic tool in breast screening but in view of the number of false- negative results, cytology alone is unreliable and therefore full triple test assessment is recommended’. Same was reiterated in another article 'Breast fine needle aspiration cytology and core biopsy - guide for practice' . The core biopsy results should always be interpreted in the context of the triple test. 

10. The Counsel further brought to our attention to one publication of the National Breast Cancer Centre, Australia, 'The investigation of a new breast symptom - a guide for General Practitioners' which brought out the flow chart showing the steps required to be taken for investigation of a new breast system. It makes very clear that if mammography and / or ultra sound show the lump to be indeterminate, equivocal, suspicious or malignant the patient must be referred to be a surgeon irrespective of other test results. Once the FNAC test is done and if it is consistent with clinical and imaging findings the patient must be referred to a surgeon. As per  the American Cancer Society,   specifically stated that an 'FNAC biopsy can sometimes miss a cancer if the needle is not placed among the cancer cells'. Therefore,  all three tests must be done and it is for the treating surgeon/physician to look into the results of all three tests and take a decision based thereon.  

DISCUSSION

11. We have perused the evidence of Dr. N. Jairam, the Pathologist at Anand Diagnostic Laboratory and one expert in Surgical Oncologist Dr.Jagannath Dixit. Also gone through the standard  medical text books on Breast pathology. In our considered view the Triple Test is necessary to confirm the nature tumor either benign or malignant one.  The evidence of Dr.Jagannath Dixit, an expert in Surgical Oncologist   stated that clinical examination of the breast lump by an oncologist is most important to determine whether lump is malignant or benign, before further investigations are made.  Clinical examination includes palpation of lump, consistency, size and location of lump, skin involvement and auxiliary lymph node status and after a thorough clinical examination; patient is required to undergo a few other tests such as Ultra Sound Guidance (USG), mammography and FNAC.  He has specifically stated that the FNAC is generally to be reported by two Pathologists having experience in cytology if the smears are hemorrhagic, a-cellular or scant-cellular. The true-cut biopsy having least 5 to 6 good core tissue samples are required for opinion. He further stated that   it is the oncologist/treating physician who has to analyze all the test reports together and take a final decision about how the patient should be managed and what treatment should be given.

12. It is pertinent to note that, in the instant case, the Complainant underwent FNAC at the Anand Diagnostic Laboratory. Further, she took three opinions from different diagnostic centers and none of them have reported it as a malignancy. Thus, only FNAC is not sufficient to diagnose breast cancer. It is pertinent to note that since the mammography report dated 09.12.2009 reported as the mass in left breast, it was suggestive of malignancy.  In our view it was the duty of Appellant's doctor at the same time to refer her to a surgeon for further treatment instead of relying on FNAC report, but it was not done.  Therefore, we don’t find neither deficiency nor negligence of any Respondents herein.  

13. On combined reading of evidence of Dr. Jagannath Dixit and Dr.Jairam, it is clear that apart from FNAC, to differentiate the breast lump from benign to malignant, further investigations are necessary with clinical examination of the breast. The Clinical assessment for size, shape consistency and involvement of axillary lymph nodes is important. The Ultrasound guided mammography and FNAC will be helpful if the patient is above 35 years of age. Further, USG guided True cut biopsy followed by tumor marker studies for ER-PR , Her2neu helpful to decide the course of disease and planning the treatment modalities.  If the FNAC report is in favour of malignancy, then the treating doctor has to discuss with the Radiologist and the Pathologist to decide further mode of treatment. Therefore, only FNAC report cannot be viewed in isolation. The transformation of benign lump malignancy after some period from months to year(s) is known.  

14. It is pertinent to note that two pathologists at Anand Diagnostic Laboratory have seen the FNAC slides and mentioned about details of cellular microscopic features in the report. We note that same FNAC slide (A11731) was reviewed by three different laboratories namely, Triesta Reference Laboratory, Bangalore; Ramakrishna Diagnostic Centre, Ooty; and Oncquest Diagnostics, Bangalore.  They opined it as ‘benign epithelial proliferative lesion of the left breast’. It is also known as ‘fibro adenoma with cystic change’. It is pertinent to note that the Chanre Diagnostic Laboratory reviewed the slide and categorically suggested biopsy, clinical details and radiological correlation for definitive diagnosis. Thus, in our considered view it was the pathologists at Anand Diagnostic Laboratory reported FNAC as per reasonable skill and standard of practice (Bolam’s Test).  After the span of 1 ½ years, the tumor size in the left breast was increased to 3x4 cms.  She underwent FNAC on 02.04.2011 and malignancy was detected. 

15. We have accessed the standard text book on cytopathology of breast lesions, namely Orell And Sterrett's Fine Needle Aspiration Cytology, 5th Ed; Cytology: Diagnostic Principles and Clinical Correlates, by Edmund S. Cibas et al.; and Comprehensive Cytopathology: Expert Consult, 4th Ed. by Marluce Bibbo et al.  According to the medical text, there are numerous factors that contribute to the indefinite interpretation of FNAC. Those include (1) technical difficulties where the smears are limited by cellularity or obscured by drying artifact and or blood, (2) inexperience or unfamiliarity of the pathologist with the cytological features of breast FNAs and (3) the overlap of cytological features of certain benign and malignant conditions due to the nature of the lesion (true gray zone).

16. The lesions missed during aspiration are the common cause of false-negative cytological diagnosis. Certain carcinomas of breast which include lobular carcinoma are responsible for false-negative results. The Invasive lobular carcinomas are generally associated with high rates of false negative results. This could be because of lobular carcinomas are more likely to yield scanty cellular smear with rare intact epithelial cells. Fibroadenomas are the common cause of false positive results because of presence of occasional isolated intact cells with dissociation with epithelial nuclear atypia and high cellularity. The FNAC is unreliable in patients with invasive carcinomas less than 1 cm in diameter and for the detection of lobular and in-situ carcinoma . The other articles referred are Correlation between histopathologic and fine needle aspiration cytology diagnosis of palpable breast lesions: a five-year review ; Diagnostic potential and pitfalls of ultrasound-guided fine-needle aspiration cytology for breast lesions 

17. We would like to place a reliance upon the  observations made by Hon’ble Supreme Court in the case - Achutrao Haribhau Khodwa and others versus State of Maharashtra and others , as follows:

“The skill of medical practitioners differs from doctor to doctor. The very nature of the profession is such that there may be more than one course of treatment which may be advisable for treating a patient. Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution. Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession, and the Court finds that he has attended on the patient with due care skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence.”

 

Recently on 20 April 2022, Hon’ble Supreme Court in the Civil Appeal No.6507 of 2009 “Dr. (Mrs.) Chanda Rani Akhouri & Ors. Vs. Dr. M.A. Methusethupathi & Ors., the bench of Hon’ble Justices Mr Ajay Rastogi and Mr Abhay S Oka held that:-

"A medical practitioner is not to be held liable simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference to another." 

 

18. In our view, the Appellant claiming enhancement of compensation to Rs.2 Crore is highly inflated and unjustified. It should be borne in mind that  “Consumer Protection Act (CPA) should not be a halter round the neck"  as held in the landmark judgment of Kusum Sharma & Others Vs. Batra Hospital & Medical Research Centre & Others.   We further note that, the   Respondents have already paid the amount as awarded by the State Commission. 

19. Based on the forgoing discussion, it is conclusively not possible to attribute negligence on the part of respondents. The instant appeal is devoid of merit, it is dismissed. However, considering the peculiar facts of the case, it is directed that the Respondents shall not recover from the Complainant, the amount which has been already paid.