The original complainant Smt Anjali Karmakar since deceased (substituted by her husband and son) as alleged that Anjali Karmakar was railway employee and for operation of her Tumor she went to B.R. Singh Hospital at Kolkata and the Railway Doctor advised her to bring the Paraffin Blocks of the Tumor for making ER/PR test and originally complainant paid Rs.1,800/- for making her ER/PR test to op no.1 and that test was done on 21.03.2006 and op no.2 issued a test report asserting ‘negative’ what means higher degree of cancer and after that on the basis of the said report issued by the ops, complainant was treated by doctors who administered chemotherapy on several occasion.

          Thereafter she became ill and felt weakness and loss of physical ability.  So she took advisee of Dr. S.H. Advani, Ex-Doctor of TATA Memorial Hospital, Mumbai at Park Nursing Home, Kolkata, who changed the medicine and the complainant took 6 cycles of chemotherapy and said doctor also found some hard tissues on the same place where the operation was done and the doctor suspected that it could not be happened and advised the complainant to show it to the Surgeon who operated the same.  But in the mean time disease spreaded all over the body for taking chemotherapy treatment on the basis of the medical test report issued by the ops.

          When instead of curing the disease there was advanced spreading of the cancer in all over parts of the body of complainant Anjali Karmakar at this stage she went to Mumbai TATA Memorial Hospital/Center where she got prolonged treatment but no development was detected by the doctor and suspected and challenged the medical test report.  So, again some tests were made by TATA Memorial Hospital/Center where ER report came as ‘Positive’ and that report came in the month of December 2009 and doubt of the doctor became truth.

          So their specific case is that due to wrong prolonged treatment on the basis of examination reports issued by ops as negative the disease entirely affected in her right breast as well as other part of the body and complainant became mentally, physically suffered and also spent huge money for the said medical treatment only for the laches and negligent manner of testing of Paraffin Blocks report and ultimately complainant Anjali Karmakar filed this case.  It is further submitted that Dr. S.H. advani, a competent Oncologist at Park Point Nursing Home at Kolkata that in any case of breast problem if Paraffin Blocks for 4 years or more is kept it is not lost its original nature and quality to recognize its specification and if the said report is considered it can safely be said the report of ops are erroneous and in the above circumstances, complainant prayed for compensation for negligent act of the ops.

          On the other hand ops by filing written statement submitted that the complaint is barred by limitation and there is no deficiency in service to the complainant and it is further submitted that complainant had approached the op no.1 at Kolkata Clinical Centre in August 2006 with Paraffin Block (Block No.1018C) containing a tissue which was allegedly removed from her breast for result of biopsy and the complainant instructed op no.1 to conduct an Estrogen Receptor Test (hereinafter referred to as ER/PR Test) on the said Paraffin Block.  It is specifically mentioned that admittedly only one paraffin block was handed over to the op no.1 and said paraffin block was sent to a collection centre for the Delhi based pathology lab with the same name for testing it.  Test was conducted on the said paraffin block and complainant handed over the paraffin block to a collection centre and the actual test was conducted by the pathology lab in Delhi only and the ER/PR test was conducted on the paraffin block handed over by the complainant and the said test is standard test performed by a machine through a globally accepted mechanism and as an additional measure for confirming that the machine functions properly during the test and two pre tested tissues has consistently tested positive in various unrelated tests in the past and the other has tested negative.  So, the result of the test conducted by that machine on the sample provided by the complainant came out to be negative and same was conveyed to the complainant vide the test report dated 21.03.2006.  But complainant never visited the Delhi Lab or the Kolkata collection centre after this, however, in 2011, the ops received a notice from Hon’ble Forum along with copy of the complaint alleging deficiency of service against the ops.

          It is further submitted that ER/PR is not a determinative test for cancer.  It only assists in guiding the treatment that is to be meted out to the patient, once breast cancer is detected, the standard procedure is to perform mastectomy for the removal of all cancerous tissues from the body of the patient and the recurrence/spread of the disease to other part of the body (metastasis) therefore cannot be imputed to the ER/PR test and once the cancerous tissues are removed from the body, parts of them are preserved as sample for performing diagnostic tests on them in future.

          It is further alleged that the process of conducting the ER/PR test is a standard procedure through globally accepted mechanism and the sample is put in the machine and if the level is found to be positive, the machine shows the sample having turned brown.  Similarly if the level is found to be negative, the machine shows the colour of the sample as having turned blue and two pre tested tissue samples are kept alongside the actual sample to confirm that the machine is working fine and a negative ER/PR report shows a higher degree of cancer and a positive report shows a milder degree of cancer.

          It is further alleged that pathologist had absolutely no role to play in determining whether the sample provided by the patient is positive or negative and his role is restricted to reflect on paper the findings of a globally accepted mechanical process for further independent analysis by a medicinist.  The pathology lab/pathologist merely conveys the result of the test to an expert along with necessary test sample for independent evaluation and it is then the medicinist/surgeon who has to independently analyze the report and decide the manner and the quantum of the treatment which is to be meted out to the patient.

          It is further alleged that if different samples of cancerous tissue collected from the same breast when put though the ER/PR test may give completely different findings.  Thus each sample upon testing gives a result independent of all the result that may be produced by other sample of cancerous tissues from the same breast.  Ordinarily if multiple samples are tested and even one sample tests positive, the ER/PR are universally accepted as being receptive and the pathologist is bound to convey the result as positive.  However, if only one sample is tested and the test shows a negative report, the pathologist is bound to convey a negative report to the patient.

          As because the ER/PR test is not a determinative test for detection of cancer and neither is it a determinative test for the treatment to be prescribed to the patient, another test known as the Human Epidermal Growth Factor Receptor 2 (HER2) is required to be conducted before prescribing any treatment for the patient.  But the said HER2 test was not conducted in 2006 when the ER/PR test was conducted.  So, the averment of the complaint that the treatment prescribed to the complainant was completely dependent on the result of the ER/PR test is false and misleading.

          Moreover there is no such assertion in the complaint that TATA Memorial Hospital tested the same sample as was tested by the ops since the complainant has failed to prove that sample tested by the op and TATA Memorial Hospital were kept in proper and necessary condition required for the preservation of the sample and that the same sample was tested by the op and TATA Memorial Hospital, so the complaint is liable to be dismissed on that ground.

                                                    Decision with reasons

          On proper study of the complaint and the written version and also relying upon the argument as advanced by the Ld. Lawyers of both the parties and also after proper evaluation of the medical treatment sheet particularly the report of op regarding breast cancer immunology Histectomy chemistry report dated 20.03.2006 is challenged by the complainant as erroneous report and complainant’s whole allegation is that due to said report subsequent treatment was continued up to 2009 by Dr. Advani Ex- Doctor of TATA Memorial Hospital, Mumbai and after that report dated 21.03.2006 no further testing was made by any doctor who treated her in respect of her disease cancer and fact remains that thereafter on 03.12.2009 Histo-pathological test was done by TATA Memorial Hospital, Mumbai. 

          When Right Chest Wall nodule;  Excision biopsy was tested and it was found that result was infiltrating carcinoma with lobular pattern amidst sclerosis and on that date Histopathology report in respect of the report relates only to the sample submitted that all samples/slides/blocks submitted for evaluation will be retained by the  Paraffin Blocks stained slide – (1018C) (09W/205) and from that report it is found that Histochemistry result was positive in respect of ER/PR but in respect of cerb B2 – negative.

          So considering both the reports it is clear that Anjali Karmakar has been suffering from cancer and it is also admitted fact that at B.R. Singh Hospital her left sided breast was operated on 15.02.2006 and since 21.03.2006 (date of report of the clinical report of op) and till received of history of health report of TATA Memorial Hospital on 03.12.2009 complainant was under treatment of Dr. Advani and Dr. Advani as Cancer Specialist treated her.

          But it is most surprising that during that period complainant was administered with so many chemotherapy but there is no report of any further test report regarding the result of application of chemotherapy on each occasion but it is mandatory for each doctor to determine what is the progress of each application of chemotherapy.  But complainant has failed to produce any such paper to show that Dr. Advani in all respect after each chemotherapy further tested improvement of the disease cancer and at the same time it is proved that when right chest wall nodule;Excision biopsy at TATA Memorial Hospital it was found that ER/PR was positive (Score-9) and PR positive (Score-2).  But E-Cadherin – negative for membranous staining.

          Fact remains the Paraffin Block was sent from Kolkata to Delhi Testing Centre and it was tested by a machine and result of the machine was given by the doctor to the complainant.  Now question is whether that report is erroneous or defective

In this context we have gone through some medical journal and determining or for searching out wherefrom we have gathered that prior different dates immunology histochemistry of Estrogen Receptor activity from Lab to Lab, service to service, person to person and there are many factors that can affect Estrogen Receptor which is crossing, whether it is weekend or week day, what type of species is being used etc and once the immunology histochemistry test are done the report also veries from service to service and at the same time selection of tissue for testing is important.  So it is true that for different factors the machine read the result negative but truth is that the result reveals that complainant was suffering from cancer.  But it is mandatory on behalf of the doctor who is treating the cancer patient to further verify the aforesaid test report of the cancer that is degree of cancer case when the Paraffin Block result is negative or positive that is nothing but the different degree.  But fact remains that the complainant has been suffering from cancer.  But in this case it is admitted fact that complainant has been treated by the Onkologist doctor and also by Dr. Advani of TATA Memorial Hospital and who treated her on and from 16.03.2006 (date of pathological report issued by the op) and till 03.12.2009 (reports issued by the TATA Memorial Hospital).  Then it is clear that complainant was alive for more than 3 years and during that period she had been treated by so many doctors, many chemotherapy was administered in her body by the treating doctor.  But no doctor had any point of time thought for a moment that there was necessity to assess the degree of cancer after applying of each chemotherapy.  But fact remains after each chemotherapy it is mandatory for the treating doctor to determine the degree of cancer because without observing the degree of cancer each and chemotherapy must be administered and that is the theorization of medical science in respect of treatment in case of a cancer.  Moreover in this case there was scope on the part of all the doctors who treated the complainant from 21.03.2006 to 31.02.2009 for further testing or by adopting most scientific method HER-2 but that had not been done by the doctor because one doctor cannot conclude that it was sufficient to check that change the receptor status because part of this discordance is formed technical impression of the test.

          Moreover technical artifact when testing receptor status in breast cancer is complicated assessment of their partial ramification but outcome.  So it is found that without HER-2 test it would not be finally tested to determine what is the degree of cancer.  But in this case the doctors who treated Anjali Karmakar from 21.03.2006 to 03.12.2009 did not advice for HER-2 testing or further testing of ER/PR or any further Histochemistry, but treatment was continued and so many chemotherapy was administered.  But no doctor had any point of time challenged the present report of the op’s dated 21.03.2006.  Anyhow after lapse of 4 years if some Paraffin Block is examined by any other testing centre in that case several factors would be considered because there was scope of change of the result on the ground age of the Parafffin Block which is preserved and in this regard doctor La Jas Pusztai Paris Medicine Director of Doctors Medical Oncologist Section at E.L. University has pointed that there are different type of immunology of histochemistry determination of Estrojen receptor activity from Lab to Lab, service to service, person to person and there are many factors that can affect Estrogen receptor testing which is closing whether it is weekend or week day what type of specification but what procedure is being used.  Once the immunology histochemistry are shown as read and report also varies from service to service and fact remains if anyone take part of tumuor that was ischemic or nercotic when one may get a false negative also.  So, after lapse of 3 years of Paraffin Block could not have given proper result and may be for that reason for lapse of 4 years degree negative was found positive that means she has been suffering from cancer.  But by that time for lapse of three years said Paraffin Blocks gave result positive bit it is proved that she was suffering from cancer.

          So, considering that fact it is found that complainant has miserably failed to produce any report in between 21.03.2009 (disputed report) and report of TMH on 30.12.2009 and probably complainant has withheld those testing report after administering of each chemo and if those testing report would be placed before this Forum in that case it would be cleared that initially it was negative and due to continuous treatment by applying chemo the degree of cancer lowered to some extent and at the same time as per opinion of doctor Lajos Pusztai technical impression the facts status changes after lapse of three years if some Paraffin Blocks is tested invariably different result must have to come and in this case that happened.  So, apparently there is no such material before this Forum to hold that op issued any defective erroneous report in support of ER/PR.

          At the same time for 3 years on and from 21.03.2006 complainant was treated by the many doctors and she was administered chemothereapy but no doctor at any point of time pointed out that the report was erroneous.  Rather after administering chemotherapy complainant continued her life for another 3 years and thereafter from 21.03.2006 till filing of the complaint on 01.03.2001 complainant was alive and her treatment had been continued by her doctors but no doctor had any at any point of time pointed out that report was erroneous and practically complainant is admittedly suffering from cancer and the treating doctor Dr. Advani who treated her after left breast removal never opined that report was erroneous and if actually the report had been erroneous in that case after administering chemo therapy complainant’s position would be very serious and death would be caused then and there.

          So, considering the entire fact and circumstances, we have gathered after consulting the above expert doctors journals of the said University and we are sure that complainant has miserably failed to prove any sort of negligence on the part of the ops and at the same time complainant has failed to prove any error in support of report dated 21.06.2003.

          But after considering the said journal written by Dr. Lajospuz Tai it is proved that HER-2 testing is must in case of breast cancer.  Sometimes after operation it is aggravated.  Anyhow Ld Lawyer for the op submitted that practically for erroneous report of the ops this disease was entirely treated on the alleged breast as well as on the other parts of the body and if we accept the argument of the complainant in this regard then we are sure that the doctors who treated her for 3 years were negligent, they had their duty to test the degree of cancer after each administering of chemo therapy but complainant has failed to produce any such document that doctor administering chemo therapy tested the degree of cancer and in this regard it is to be mentioned that before administering chemo therapy various factors in respect of degree of chemo therapy should be determined which is vital for checking the degree of cancer in all respect.  As per opinion of Dr. Lajospush Tai if a test is 90% acute for example 10% of the result on first testing will be negative and approximately 20% of the result of repeatedly will be discordant and said doctor has also opined that anyway receptor status test if conducted in want of labor and thereafter it is conducted it different Centre in that case it is obvious cause for receptor discondant invent of therapy.  Further it has opined by the doctor that ER/PR status change in 23% of sample after  they were airmail from one centre to another.  Further opined that ER/PR tests can change if refuses on the same specific without any change get actual marker status and as per his opinion technical artifacts when testing receptor status in blood cancer complicate assessment of their judicial manufacturers on the out come.  So, considering all the above opinion of Dr. Lajorpush Tai and also considering the present fact we are convinced to hold that there was other changes and change of status of ER/PR due to testing of some at different centres and for transmission of the same from Kolkata to Delhi then Delhi to Kolkata thereafter Kolkata to Mumbai and for some other various factors. 

          So, apparently we have gathered that the present allegation against the ops are not at all substantiated.

          Further it is found from the complainant’s own complaint that Dr. Advani at the time of examination of the complainant was discussed to it that her diseases on the same place where the operation was done and suspected that further recoveries is being made and asked the complainant to go to the series which operated her.  Then it is fact that there was some filed of the operating --------and there is no such material befor this Forum that complainant as per advice of Dr. Advani the doctor of BR Singh Hospital for further ------------ or not.  But that is not subject matter of this case.  So we are not entertained into that matter when there is no allegation against the doctor who operated her in B.R. Singh Hospital.  But we are only restricted to one point whether the report of the op was erroneous or not.  But in this regard we have discussed the entire matter and also considered the aspect regarding ER/PR test by the ops and the subsequent treatment was done by the doctor where that was not in respect of the disputed report dated 21.03.2006 by the ops and practically complainant have failed to prove it by producing his doctor who treated her, complainant on the basis of that report not only that from 21.03.2006 to 03.12.2009 no further test report was produced by the complainant to show that in between that for that report the cancer growth was increased rather it is found that the degree of cancer was decreased after lapse of 3 years.

          In view of the above finding we are of conclusion that changes in receptor status and clinical outcomes must be inconsistent and this view is also consorted by Asiatic Society of --------------Medicines Disease National Society of Doctors Center Society Surgical Oncologist of Asiatic Society for Radiation Oncology and so we are convinced that the doctor who treated the complainant after operation for her cancer disease did not advice for HER-2 testing which was must and if it would not be done in that case the treatment must be otherwise and more than scientific and practically for the laches of the doctors who treated the complainant, the complainant failed to recover from her cancer disease.  But it is proved beyond any manner of doubt disputed pathological report issued by ops are not expert for growth of cancer or death of the complainant ultimately and fact remains the present complainant legal heirs have not produced continuous treatment sheet issued by their Dr. Advani or other doctors who administered chemo therapy etc on various occasion and also have not produced further test report from in between the period from 21.03.2006 to 03.12.2009.

          In the light of the above observation and facts we are convinced to hold that the complainant has miserably failed to prove any sort of negligent and deficient on the part of the ops in between the such disputed report dated 21.03.2006 and for which the complaint fails.

          Hence, it is

                                                          ORDERED

          That the complaint be and the same is dismissed on contest without any cost against the ops.