Mrs. SAMIKSHA BHATTACHARYA,  MEMBER 

This instant complaint has been filed by the complainant against the OPs under Section 17 (1) (a) (i) of C.P. Act, 1986 alleging medical negligence.

The facts of the case, in brief are that the complainant, after being pregnant, was under care of consultant  Dr. Chanchal Kumar Gain and as per his advice and ICTC protocol, the complainant was advised to examine certain blood tests and other tests including HIV from any recognized/ certified laboratory/Diagnostic Centre.  As per advice of the consulting doctor, the complainant went to the OP No.1/Diagnostic Centre on 06.04.2016 for certain blood tests including HIV test. The OP No. 1 being certified laboratory/Diagnostic Centre conducts various pathological tests of the patient party. The OP No. 1 took the blood of the complainant for test according to the prescription of the consulting doctor and after HIV CI & II and P24 antigen test, after checked twice, done by OP No. 2, it revealed that HIV positive according to reference value. The complainant after receiving test report and knowing such result of blood test was shocked and she was mentally disturbed day-after-day. For such report lots of dispute were cropped up in the family of the complainant. The husband of the complainant not only refused to maintain and negligent his wife but refused to recognize her as his wife and ultimately the complainant was compelled to leave the matrimonial house in pregnant condition with threats of future life by her husband by her husband.

Knowing such result/report of blood test of HIV positive, the matrimonial and paternal family members of the complainant started to create mental pressure on her. He was badly  neglected in her parental house also and for such mental disturbance and shocked the physical condition of the complainant was deteriorated day after day in pregnant condition. In such a situation, finding no other alternative, the complainant had rushed to RG Kar Medical College & Hospital/O.P. No.3 (Proforma O.P.) for further test and examination of blood for HIV test further. Blood test including HIV test was conducted by R.G. Kar Medical College Hospital on 11.04.2016 and it revealed HIV non-reactive for HIV (I & II). After receiving  such test report, the complainant  again went to Subodh Mitra Cancer Hospital and Research Centre/ O.P. No.3 at Rudrapur Rural Hospital, North 24 Parganas, on 04.05.2016  for further  confirmation and the report of Subodh Mitra Cancer Hospital and Research Centre also revealed that HIV (I & II) non-reactive report.

From the above facts and reports, it is clear that the OP No. 1 and OP No. 2 issued false and defective report in the name of the complainant for which the complainant was neglected, mentally tortured and was homeless at the mercy of her parents and other relatives and also lost her goodwill, dignity and prestige in the society. The complainant gave birth to a baby girl with good health but the innocent baby has been deprived from love, affection and blessings of her father since birth. The complainant sent an Advocate’s notice on 03.10.2016 to the OPs No. 1 & 2 stating the facts and asked to pay compensation for such negligent act with regard to issuance of wrong and defective report and the said letter was duly received by the OPs No. 1 & 2 but did not act accordingly.  From the acts of the Ops No. 1 & 2, it is clear that they are deficient in rendering service and due to negligent act on the part of the OPs No. 1 & 2, complainant has suffered mental agony which hampers her prestige in the society and she became homeless with a new born baby. Hence, the petition of complainant praying for direction upon  OPs No. 1 & 2 to pay compensation to the tune of Rs.40,00,000/- due to complainant’s mental, agony, loss of prestige  and dignity in the society along with cost of Rs.50,000/-.

Ops No. 1 & 2 filed their written version to contest the case.

In their written version, OPs NO. 1 & 2 denied all material allegations inter alia stated that prior to dealing with the allegations set forth in the petition of complaint, it is imperative to highlight the actual facts of the case for proper adjudication and fair trial.  The complainant, who was pregnant at the time  under the care of Dr. Chanchal  Kumar Gain, has sent  her blood sample at the OP  No. 1 diagnostic centre on 06.04.2016 for pregnancy screening  which involves  certain blood tests along with HIV test, as per doctor’s advice.

Accordingly, the said pregnancy screening was done on the said date i.e., 06.04.2016 of which the HIV test (HIV I and HIV II)  report revealed to be positive. The initial  results were positive, the specimen  was centrifuged  and subjected to repeat testing. These steps were taken in accordance with the instruction manual   and medical protocol. Be it noted that upon such  positive findings of the test report, the OP Diagnostic Centre had delivered the said report in the sealed envelope at the residence of the complainant through one   of its blood collection/delivery personnel with a message requesting the said complainant to visit the OP Diagnostic Centre along with the report as early as possible. Thereafter the complainant never  visited the OP Diagnostic Centre and as such the OPs No. 1 & 2  were completely unaware of what  had happened upon receiving  the HIV Test Report until receiving the instant petition of complaint together with annexure. The complainant has preferred  the instant  case against the OPs No. 1 & 2 alleging deficiency  in rendering medical service by making  mere allegations and averments without any cogent  document in support of  the same. Nowhere in the  four corners of the   petition of complaint,   could establish that what was done should not been done and what  was not done should have been done as per accepted medical practice and the same be supported by expert  evidence or available  medical literature as was  decided by the Hon’ble National Consumer  Disputes Redressal Commission  in the reported decision   reported in 2004 CTJ 175 (NC).

The test  conducted  in the laboratory  of the OP No. 1 Diagnostic Centre being only a qualitative  screening test, no definite comment  or impression regarding the test outcome was made.  Only the values obtained from “ABBOT Architect” “instrument [Model: i1000SR] following  repeated  tests was served to the patient.  As such, this report  cannot be judged as the final conclusive diagnosis for HIV infection. Moreover, interpretation of the test  results reported by the laboratory and subsequent clinical decisions should be done solely by a medical professional or an expert  in medical science as categorically mentioned in the terms and conditions  governing the test   reports. But in the instant case it seems that no such assistance of medical professional had been sought for. The alleged events that have occurred in the complainant’s family following the  report are based  solely on a non-medical person’s perception and interpretation of test result. As such the laboratory  or any of its personnel  cannot be held responsible for an individual’s personal  indecision and activities. Moreover,  as per usual practices in the laboratory, samples are retained for a period of 72   hours for the purpose of retesting if any confusion or  dispute arises concerning the test reports. In this case, neither the patient  nor any representative on her  behalf has contacted the laboratory for any clarification but rather  seemed to have preferred to make an issue. OPs No. 1 & 2  denied the  test report  of R.G Kar Medical College Hospital and Subodh Mitra Cancer Hospital  because fact looms large that the instrument used for HIV testing at the OP Diagnostic Centre is ABBOTT ARCHITECT. The architect HIV Ag/Ab combo assay demonstrates a high sensitivity value of 100%  in specimens from individuals clinically diagnosed with HIV infection in various studies. This Architect system HIV Ag/Ab Combo assay is a 4^th generation  immunoassay technique for the simultaneous qualitative detection of HIV p24  antigen and antibodies to HIV 1 a and HIV 2 in human serum or plasma. By this method early detection of HIV  infection during the first weeks of infection by capturing the presence of p24  antigen can be made in human seem before seroconversion or  anti HIV- antibodies development  occurs. During this period all  other tests based  antibody capture  principle including the Rapid Tests fail to detect early HIV Infection.The method or principle used for HIV testing a R. G. Kar Medical  College and Hospital were rapid.Tests like SD BIOLINE which are 3^rd generation one step  anti-HIV 1/HIV 2 (Rapid tests).These methods are (SD Bioline HI-1/2 3.0) immunochromatographic (rapid) tests for the qualitative detection of antibodies of all isotypes specific to HIV -1 and HIV – 2 simultaneously in human whole blood and serum  or plasma. However they have their own limitations. Immunochromatographic testing alone cannot be used to diagnose AIDS even if the antibodies  against HIV -1 and/or HIV-2 are present in a patient’s specimen. Further it is important to note that a negative result does not eliminate the possibility of HIV – 1 and/or HIV-2 infection. The specimen may contain low levels of antibodies to HIV-1  and/or HIV-2.

 As  such it is self-evident from above that the qualitative screening/assessment of HIV  done by 4^th generation immunoassay technique is undoubtedly  more well equipped and advanced then 3^rd generation rapid tests as was used at R.G Kar Medical College and Hospital.

 As regards the test  done at Subodh Mitra Cancer Hospital,  although  the test results were negative, but nowhere in the four corners of the report did they bother to specify the instrument and/or mode used for  such HIV assessment. Surprisingly, the complainant and her caring husband instead of placing reliance on the findings of such upgraded  4^th generation immunoassay technique relied on simple rapid tests  done in laboratories  that are  ill equipped  to perform such advanced tests like  immunoassays. Instead of taking necessary action against her own husband for his conduct, the complainant has preferred to blame the OPs No. 1 & 2  for her husband’s actions.

The instrument ABBOTT Architect is one of the best state of art automated  analyser. It is approved by various national and international authorities. Proper maintenance, calibration of the instrument is done on a regular basis. The quality control  procedure  is run simultaneously with test samples to  rule out any analytical errors. However, all serological tests have certain limitations even  when conducted with the best  skill and advanced technology. The test results may be true or false positive, true or false  negative depending on the presence of certain  clinical conditions during the time of conducting the tests, like  stage of infection or disease,  presence of inter freeing antibodies or presence of other physiological or disease states, if when  s present, concomitantly may influence the  test results.

All  screening test reports when positive cannot be considered as a sole indicator for decision  making. It is mandatory on the part of   the  treating physician or medical consultant to confirm the results so obtained by superior confirmatory or supplementary test  to derive any conclusive diagnosis regarding the presence or absence of any disease or infection. The Western Blot  Test is the most reliable confirmatory assay for the diagnosis of HIV Infection in which antibodies of specific molecular  weights can be detected.  In the instant case, the complainant did not bother to go  for any confirmatory test but rather simply preferred to rely on simple rapid tests that too done on 3^rd  generation  technology.

Hence, the OPs No. 1 & 2 have prayed for dismissal of the complaint case with  the compensatory cost since the complainants have failed to establish any deficiency in service on the part of the OPs No. 1 & 2.

Though, the authorized representative   of  OP No. 3 appeared before this Commission but no written version was filed on behalf of OP No. 3. Hence the case was proceeded ex parte against the OP No. 3.

OP No. 4 being the proforma OP No. 4 appeared before this Commission and filed their written version.

In their written version,  OP  No. 4  has stated that a cruel conduct has been meted with the complainant by OPs No. 1 & 2 with regard to testing of HIV at the time of her pregnancy. It is true that during her pregnancy  Dr. Suggested the complainant  for HIV test in compliance with ICTC protocol  from any recognized laboratory. The  doctor probably advised the complainant to go to Organ Diagnostic Centre/OP No. 1 on 06.04.2016 and the report of haematology   came out resulting Rh (c) Factor is positive. This result caused a great draconian effect on the complainant because the husband  of the complainant had doubt about his wife and the complainant  became the  victim of the situation. Upon receiving the positive HIV report done by  OPs No.  1 & 2 the complainant went to OP NO. 3 for the same test which was conducted on 11.04.2016 and the result was  given on 16.04.2016 where the test report was found  negative. To become double sure, the complainant came to the OP  No. 4 for such test and blood sample was given and the department and serology tested the  blood  sample on May 4, 2016 and the result of  investigation of HIV 1 and HIV 2 both were found non-reactive. The OP No. 4 has submitted in their written version  that there  is no iota of error  in the blood  test being  done by OP  No. 4. For the  purpose of proving correctness of the  report and the  error of testing by OPs No.  1 & 2 the OP No. 4 has been made as the proforma  OP. The photocopy of  the reports are annexed with the written version of OP No 4. OP No.4 has further stated in their written version that the report of the OP No. 3 & 4 be considered as clinically bona fide and under these circumstances, the OP No.4 being the   proforma OP has prayed for exchanging their name from the proceeding and to pass the  appropriate order.

In the course of argument, Ld. Counsel for the complainant has stated that it  is made clear that the OP No. 1 and OP No. 2  issued  false and defective report of the  blood sample of the complainant and they did not take or use proper method at the time of her blood test for which the complainant was neglected, tortured mentally, and homeless at the mercy of her parents and other relatives but also  lost her goodwill, self-dignity and prestige   in the society. The complainant delivered a female baby with good health  but the innocent baby was deprived from the blessings and custody of her father since birth. For the conduct of the OPs No. 1 & 2 being the ISO 9001: 2008 Certified Lab – Diagnostic Centre committed  gross negligence by issuing a  wrong and defective report after taking necessary charges and the act of OP No. 1 & 2  is absolutely deficient in rendering services and they have   performed  negligent act  causing mental agony and lowering  down the  prestige  of the complainant  in the society and  unfortunately the complainant along with her new born baby  became homeless  for which  the OPs No. 1 &2  are liable to pay the compensation to the tune of Rs.40,00,000/-  towards expenses  for  fooding, lodging and future development of new born baby in the society who after birth did not get love  and affection of her father.

The Ld. Counsel  for  the OPs No. 1 & 2  has argued that the complainant, who was pregnant, at the time  and  under the care of the Dr. Chanchal Kumar Gain, had sent blood  sample to OP No. 1/ Diagnostic Centre  on 06.04.2016 for  pregnancy screening which  involved certain  blood tests along with HIV test as per doctor’s advice. Accordingly, the said pregnancy  screening  was done on the said date i.e., 06.04.2016 of which  the HIV 1 and HIV 2 test done  and it revealed to be positive. After the initial results were positive, a specimen was centrifuged and subjected to  repeated tests. This step was  taken in accordance with the medical protocol. The OPs No. 1 & 2 delivered the report at the residence of the complainant with a message requesting the complainant to visit the  OP  Diagnostic Centre along with the report as early as possible. But the  complainant  never visited the OP Diagnostic Centre. The test conducted in the laboratory of OP No. 1 being  only a qualitative screening test no definite  comment or impression regarding the test  outcome was made. Moreover,  the interpretation   of the test  results reported by the laboratory.  Subsequent clinical decision should be done solely by a medical professional or the expert in medical science. But in the instance case, no  such assistance of medical professional  had been sought for. The positive result of HIV infection  obtained by the method which was used by the OPs No. 1 & 2, must be confirmed further  by PCR test in test samples  even  when Western  Blot results are negative or intermediate early in the course of disease. The diagnose of HIV is accomplished by the virologic and serologic markers. The appearance of these markers  follows a predictable pattern.  Immediately, after HIV  infection, low levels of viral RNA may be present  although this is not consistently  detectable by  today’s method. This period before HICRNA and serologic markers  are   known as the eclipse period.  Simple  rapid tests for detective HIV antibodies are available for use in illequipped   laboratories to perform advanced test like immunoassays and in settings  where last results can be delivered with little delay.

A negative result  by the immunochromotography  principle   does not exclude the possibility or exposure or infection because of lower levels of antibodies to HIV 1 and HIV  2. These tests  are applied for subsequently testing of the patient’s sample, in this case, as advised by  her consultant. The kit insert or this  rapid procedure clearly states that the  positive and  negative report  obtained by these methods do not confirm the presence  or absence of  decease. Any positive result needs to be confirmed by serological testing like immunochroassays. The reactive rapid tests be confirmed according to the  4^th generation algorithm. These patients with positive rapid tests  should undergo further  testing by 4^th generation algorithm  in order to  confirm the  infection of HIV.

In the instant case, the patient’s sample was analysed  properly  as per instructions in the assay procedure. The steps taken are in accordance with the instruction  manual and international protocol. These  tests have certain limits even  when conducted with the  possibility  of skilled and  advanced technology. The rest results  may be true or  false  positive, may be true or false negative.  In the case of HIV, false positive screening test results may be  associated for the presence of antibodies to class II antigen such as  may be seen following pregnancy, blood transfusion, transplantation or though antibodies,  disease  like influenza,  acute viral infection. In support of her  argument, Ld.  Counsel for the OPs No. 1 & 2 has annexed the  national guidelines for HIV test issued  in July, 2015.

The Ld. Counsel for the OPs No. 1 & 2  has further stated that the   motive  of the complainant’s husband is under scanner because  if he believes  the test reports from OPs No. 1 & 2  to be correct  then   why  is he not ready in a similar  manner to accept the  test reports conducted  by  OP NO. 3 and OP No. 4. Instead he decides to pick and choose  test reports according to his choice which might  suit his interest. Whatever may be the  findings of the test reports,  the complainant’s husband’s activities in the regard his condemnable  and is socially not  justified. In support of  her  argument, Ld. Counsel  for the OPs No. 1 & 2  has cited the following judgments,  passed by  the Hon’ble  National Commission :

1. I (2018) CPJ 232 NC
2. 2015 (2) CPR 570 NC
3. 2018 (2) CPR 296 (NC)
4. 2004 CTJ 175 (NC)
5. 2017 (2) CPR 272 (NC)
6. 1996 SCC (4) 332
7. 2005 (3) CPR 70 (SC)
8. 2004 CTJ 175 (NC)
9. 2015 (2) CPR 253 (NC)

Upon hearing the parties and on perusal of the record, there is no denial that the complainant being the pregnant lady gave her blood sample  on 06.04.21016 to OPs No. 1 & 2 for pregnancy screening test  along with other blood tests. It is also admitted fact that the report of HIV test revealed positive conducted by OPs NO. 1 & 2. It is also admitted fact that the complainant thereafter went to OP No. 3  for  confirmation of HIV test on 11.04.2016 which revealed  negative HIV report.  Then the complainant again gave her blood sample to OP No. 4 for HIV test on 14.05.2016 which also further revealed HIV 1 and HIV 2 was non-reactive. Therefore, there is no denial by the OPs No. 1 &2  that they gave the report  of the complainant for her HIV test as positive.  Thereafter, one  Govt. Hospital being the OP No.  3 and  another  Hospital being the OP No. 4 both tested her blood sample and revealed the report HIV  negative. In course of time, the complainant gave birth to her female child and the  child become healthy.

The argument on behalf of the OPs No.  1 & 2 that the test report may revealed false positive  cannot be taken into consideration since the blood test for the HIV conducted by OPs No. 1 & 2 was done by 4^th generation method that is ABBOTT ARHCHITECT. In course of her argument, she always  tried to convince us that the 4^th generation test  is more confirmative and which is accepted as per international standard of protocol. The OPs No. 1 & 2  used the 4^th generation  method. Moreover, the allegation against the complainant did not visit the OPs  No. 1 &  2  for further test  as per advice of the delivery personnel, who gave the report at the  residence of the complainant, cannot be acceptable since no such document has been produced before us for such message towards request for repeat test. If this argument  is true then the Ops No. 1 & 2 could take the blood sample from the  complainant further for HIV test. If the second screening is necessary then   it was the duty of the OPs No. 1 & 2 to take the blood sample further. Since the test results of OPs No. 3 & 4 revealed negative HIV test and which was not denied  by OPs No. 1 & 2. The OPs No. 1 & 2  have submitted that there is no  proof  that the OPs No. 3 & 4 gave the right report but OPs  No. 1 & 2  had not taken any initiation to send the  blood sample of the  complainant further for the HIV test even after initiation of the complaint case. Therefore, it is  proved that OPs No. 1 & 2 gave the wrong report to the complainant for her HIV test.

Now, the question  is what effect and mental harassment was caused upon the complainant for providing wrong   report of the complainant’s  blood test for HIV confirmation. In our society, even among the  educated persons if it is revealed  that he/she is carrying  HIV positive  test,  many people lowers down  his or her prestige in the society and start to doubt about his/her character.

Once, the report came  positive many persons cannot believe that this report may be wrong report and the further HIV negative report  may not  be   believed by the society. From the  evidence on affidavit  and questionnaire and reply filed by  both the parties, it  is evident that complainant could not  stay in her matrimonial house, after the HIV  positive report done by OPs NO. 1 &  2. It is also evident  that her new born baby could not get the blessings  and affection of her father.  Due to the negligent  act of the OPs No. 1 & 2, the complainant as well as her new born baby  suffered a lot. The argument on  behalf of   the OPs No. 1 & 2 that they have used the most appropriate and advanced technology. Therefore,  it was  their duty to take the blood sample further from the complainant  rather  the Ld. Counsel  for the Ops  No. 1 & 2 has argued that they have requested by their messenger to give the blood sample of the complainant without any documentary/cogent proof. The Ops No. 1 & 2 probably cannot imagine that a wrong report  can  cause  defamation of the complainant  in  her society. The argument on   behalf of the OPs No. 1 & 2 that the report of OPs No. 3 & 4 may be false cannot be taken into consideration since the onus of proof lies upon the OPs No. 1 & 2, no such initiation  was taken by the OPs No. 1 & 2 by not taking further blood sample from the complainant  and to send it for HIV confirmation.

The OPs No. 1 & 2 claim that they have done the test with the instrument which is certified by reputed international registered Quality Assurance  Bodies to have met ISO 9001:2008, EN ISO 13485:2012 standards. The machine is maintained and calibrated regularly by Abott Healthcare customer support specialists. Quality control materials are run daily in their instrument to ensure that  test  quality before sample run  and to avoid analytical errors using customised reagents.  But the OPs No. 1 & 2 have not reported to their instrument manufacturing company  asking them how the wrong report came. OPs No. 1 & 2 have not demanded any clarification from the pathologist concerned also who perform the blood test,  in question, of the complainant.

Further, argument on behalf of OP No. 1 &  2  that the absence of  expert report in the present case. In our considered view, in the present matter there is no need of expert report.  If there is any doubt on the part of the Ops No. 1 & 2, they can ask for further HIV test of the complainant and her baby. The judgments cited by the Ld. Advocate for OPs No. 1 & 2, being at  variance, would be misplaced.

We have to keep in  mind  that  the complainant has not come before this Commission for any monetary loss, but  she has prayed for compensation for lowering down  her prestige and dignity in the society.

Without giving to the final conclusion if the declaration is given and if subsequently said report or declaration is found to be incorrect, it is a case of negligence. In serious cases and highly sensitive cases, like HIV confirmation tests, where  the report is of the HIV positive, not only the patient will be disturbed,  but also family will be disturbed. The diagnostic centre is  under legal and  moral duty  to come to  the final conclusion in spite of its findings. It cannot  take recourse  subsequently to say that error  is possible and/or result is positive  and/or false positive. Whenever there are cases of false positive, the Diagnostic Centre has to conclude that  it is not a false  positive, but it is certainly positive result. It appears that the  Diagnostic  Centre is aware of all these things, since  it has put up with report and the sample was checked twice. Therefore, from their own note on  the report  puts an obligation on  them to carry out further tests and advice according to the patient. In the present case, no such advice  was given  by the OPs No.1 & 2. It is the complaint who being suspicious  about the result and went to another Govt. Hospital and further went to another hospital and got it  confirmed that  by the result of the complainant was wrong. If all these circumstances taken together it becomes crystal clear that the declaration  which was made on 06.04.2016 by the OPs No. 1 & 2 that the complainant was suffering  from HIV was not made after due care as required to be done by the Diagnostic Centre in the interest of the complainant and  more especially the disease like HIV because it  not disturbs  the complainant but also disturbs her whole  family and her husband has threw her out in carrying stage from the  matrimonial house. It is also a social stigma  and people thereafter tries to shun such person. Therefore, duty of the Diagnostic Centre and more of the pathologists  are more rigorous. Hence, it is proved that OPs No. 1 & 2 are deficient  in rendering service and as such, the complainant is entitled to relief with compensation for her mental agony  and harassment.

In medical negligence case the quantum of compensation is  highly subjective in nature and in the instant case the complainant was humiliated for her character as the social prestige is one of the most precious aspect of human life. A huge compensation also cannot return  her social prestige and dignity, but a monetary compensation can at least heal her pain to some extent.

The OPs No. 1 & 2  have played fast and loose with the complainant and have caused harassment and mental agony to her, which is unacceptable and  this practise needs to be deprecated.

In view of above discussion, the complainant has substantiated her case and she is entitled to relief. Accordingly, the complaint case succeeds.

Hence,

                      It is

               ORDERED

The complaint case is being No. CC/4/2017  be and the same is allowed on contest against  the Ops No. 1 & 2 and dismissed against the OP NO. 3 ex parte and dismissed against OP No.  4 on  contest.

The OPs No. 1 & 2  are directed to pay a sum of Rs. 20,00,000/- (Rs. twenty lakhs) only  as compensation to the complainant within 45  days from the date of this order i.d., the amount shall carry simple interest @ 6% p.a. from the date  of passing this order till   its realization.    

The complaint case is, thus, disposed of accordingly.