This complaint coming up before us for hearing on 01-07-14                                in the presence of Sri Sk. Mohammad Jan, advocate for complainant and                         Sri Chekuri Sreepathi Rao, advocate for opposite parties, upon perusing the material on record, after hearing both sides and having stood over till this day for consideration this Forum made the following:-

O R D E R

Per Sri A. Hazarath Rao,  President:-      The complainant filed this complaint under section 12 of the Consumer Protection Act seeking payment of Rs.2,00,000/- together with interest @24% p.a.; Rs.3,00,000/- towards mental agony; Rs.30,000/- towards medical expenses and Rs.90,000/- towards other expenses besides costs of Rs.10,000/-.

2.   In brief the averments of the complaint are these:

          The complainant on 29-03-13 approached the opposite parties with a complaint of chest pain and for general check-up.   After analyzing reports of ECG and ECHO, doctors of the opposite parties informed the complainant that he had a problem in the heart and advised angiogram test and prescribed medicines for temporary relief.  On 01-04-13 the doctors of the opposite parties advised the complainant to have blood tests before undergoing angiogram.   After verifying the blood report doctors of the opposite party informed the complainant that he had HCV infection and that they should not treat the patient under Arogyasree scheme.                             The complainant paid Rs.12,000/- for angiogram test.   Doctors of the 1^st opposite party informed the complainant that there was no medicine for his treatment unless HCV is cured.   Due to that advice the complainant had undergone mental depression and sustained severe heart stroke at early hours of 02-0413.   After angiogram test doctors of the 1^st opposite party informed the complainant that the valves were blocked in three places and directed the complainant to go to NIMS, Hyderabad.   The opposite parties discharged the complainant on 06-04-13.   After examining the reports obtained at the hospital of the opposite party one Dr. R.V. Kumar of NIMS sent the complainant to a gastroenterologist to know the viral load of the hepatitis.   The gastroenterologist prescribed to undergo HCV RNA ECR quantitative and RNA genotyping test.   The complainant incurred Rs.15,500/- for the said tests.   Due to lack of beds in NIMS, the complainant and his family members waited for another thee days at Hyderabad and later got admitted on 17-04-13.   The doctors at NIMS Hospital declared that the complainant was not suffering from hepatitis ‘C’.   The complainant gave blood samples in another laboratory M/s Vijaya Diagnostics, Hyderabad and their report also showed HCV as negative.   The doctors at NIMS, Hyderabad did CABG (by pass surgery) to the complainant on 06-05-13 under Arogyasree scheme and discharged on 16-05-13.   The complainant during treatment at NIMS, Hyderabad spent about Rs.55000/- for tests and and expenses of his family.   The complainant suffered with severe heart attack due to refusal of the opposite parties for treatment under Arogyasree scheme and false reports, the complainant lost reputation in the society and suffered mental agony and incurred unnecessary expenses of Rs.90,000/-.   The opposite parties collected huge amounts from the complainant by giving false screening tests.   The inhabitants of the vicinity stopped to come to the complainant’s house and refused to take drinking water under the guise that the complainant had some venereal disease.   Due to the attitude and behaviour of the opposite parties the complainant suffered a lot mentally and financially and it comes within the purview of the deficiency in service.   The opposite parties committed deficiency in conducting improper investigation without skill and knowledge and reasonable competence in the field of investigation.   The opposite parties did not possess adequate infrastructure and other facilities to conduct investigations.   The complaint therefore be allowed.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      

3.   The contention of the opposite parties in nutshell is hereunder:

          The complainant approached the opposite parties on 29-03-13 and underwent Echocardiogram test.   The opposite parties advised on the same day to undergo blood test.   But the complainant went home without undergoing blood test.   Again the complainant on 01-04-13 visited the opposite parties with a complaint of chest pain for last three days.   The opposite parties advised the complainant for immediate admission.   The opposite parties on 01-04-13 collected blood sample from the complainant for necessary test and investigation.   The complainant came for admission on 02-04-13 only.   The complainant already developed an inferior myocardial infarction when approached the opposite parties.   The timing of myocardial infarction had no co-relation with HCV report as contended by the complainant.   The ECG taken at the time of admission had already revealed that the complainant suffered an inferior myocardial infarction which was fully evolved.   The complainant therefore was not thrombolysed.  If the complainant had suffered myocardial infarction as alleged, the ECG would have shown the changes of hyper acute inferior wall myocardial infarction and complainant would have been treated by thrombolytic therapy at the time of admission.   All baseline investigations in the O.P.D. including ECG, Echo and preliminary blood test and consultation charges were done free of cost under Arogyasree.   Inspite of screening HCV test being positive, the opposite parties did not proceed with further confirmatory tests as was done at NIMS as this would delayed treatment for several days because such tests are available only at Hyderabad.   Inspite of HCV test being negative at NIMS they have not proceed with bye-pass surgery without detailed confirmatory test reports.  Even at NIMS the highly expensive tests were not done free of cost and the patient had to bear all expenses even at the premier Government institute.  The complainant consented for emergency intervention line of management under payment category with imported medicated stent if required.    The cost of emergency angiogram for single room is Rs.8000/-.   All patients with virology status positive (HIV, HBsAg or HCV) have to purchase special kit for following the world wide practice of ‘universal precautions’ to prevent infection  of medical personnel including operating physician, scrub nurse and technicians.   The cost of this kit was approximately Rs.4,000/- and will bee charged extra.  There was no discussion about Arogyasree for stenting as they insisted on imported medicated stents which are not provided to Arogyasree patients.   Under those circumstances, the complainant was admitted under payment category   after initial detailed discussion regarding stent quality.   After the angiogram in view of multiple blocks it was decided to send the patient for bye-pass surgery.  In view of recent myocardial infarction and patient gradually stabilizing on medical management, cardiac surgeon suggested to wait for               2 to 3 weeks and the patient was discharged on 06-04-13 in a stable condition with an advice to consult medical gastro enterology and cardio thoracic surgery.   The anti Hepatitis-C virus antibody test is performed at Department of clinical microbiology and it was based on enhanced chemiluminescence’s immunoassay (CLIA).   The said method is considered to be equal or on par with those of Enzyme linked Immuno Sorbent Assays (ELISA) available in the market.   The opposite parties used kits supplied by Ortho clinical immunodiagnostics, a constituent company of Johnson & Johnson.   This test is screening test and it cannot be used for confirming any case as reactive or positive.  All the cases which turned to be reactive or positive by these screening test needs to be confirmed with confirmatory test like HCV genotyping and then only should be declared as a positive for HCV.   The complainant had undergone quantitative HCV viral load assay and HCV genetyping at M/s Vimta Labs, Hyderabad.   Quantitative HCV viral load assay revealed that the viral load is below the detectable limits and it is not confirmatory and needs to be confirmed by HCV genotyping.   HCV genotyping report of M/s Vimta labs revealed that viral load was detected but could not be genotyped as viral load present was very low.   This means that the complainant had HCV infection but not in a detectable range which means HCV infection is in the early stage of disease progression.   HCV genotyping report further revealed that the test needs to be repeated after interval of two weeks to get the real confirmation of the status of infection.   The complainant had not under gone any repeated investigations after two weeks as evident by his documents.   The HCV genotyping stands as world wide standard test for confirmation of HCV infection.   As per HCV genotyping reports, there is definite evidence of low HCV viral load indicating infection.   CLIA kit was supplied by Ortho Clinical Diagnostics and as per the said kit protocol any value above 1.0 is considered as a reactive.   Since the complainant’s sample had given a value of 5.31 and as such the opposite party have declared the complainant as suffering from HCV positive as per the kit protocol and there was no technical error.   Any discrepancy with regard to the test result or quality of a kit has to be dealt with Ortho Clinical diagnostics of Johnson & Johnson.   HCV viral load and HCV antibody levels may vary to patient from patient by various immunological mechanism at a given situation or stage of infection.  For observing all the above facts, the opposite parties acted in a prudent manner by following prescribed medical standards and protocol.   The opposite parties did not commit any deficiency in service.   The opposite parties microbiology laboratory was certified by National Accreditation Board for Laboratories as per the Government of India norms.   The complainant approached the Forum with unclean hands by suppressing material facts.   The opposite parties used to keep medical records of the patients confidentially and they did not disclose any information to public.   The opposite parties did not disclose the reports of the complainant to anybody except to the 1^st degree relatives who attended the complainant during admission.   The complainant’s claim was on imaginary issues.   Due to filing of this type of petitions, the doctors may not be able to discharge their duties sufficiently and cannot take decisions spontaneously required at the time of treatment and as such the genuine patients ultimately will suffer.   There was no cause of action and the one alleged is concocted one.   The complaint therefore be dismissed with costs.

4.  Exs.A-1 to A-23 on 02-04-14 and Ex.A-24 on 01-07-14 were marked on behalf of complainant.  The complainant also examined a witness i.e., microbiologist of M/s Vimta Labs and during her evidence Ex.X-1 was marked.   No documents were marked on behalf of opposite parties.  

5.   Now the points that arose for consideration in this complaint are:

          1.    Whether the opposite parties committed deficiency in service by                     giving a false report to the effect that the complainant was                             suffering from HCV?

          2.  Whether the complainant is entitled for the amounts claimed as                       damages?

          3. To what relief?

6.   Admitted facts in this complaint are these:-

          1.  The complainant approached the opposite parties on 29-03-13 and                            underwent ECHO (Exs.A-1 and A-2).

          2. The complainant on 01-04-13 underwent test for HCV, HIV and

                   HBS Ag (Ex.A-3).

          3. The opposite parties advised the complainant to undergo CABG.

         4. The complainant got admitted into the hospital of the Ops

              on 02-04-13 (Ex.A-8, A-9, A-10, A-11, A-12 A-13 and A-14). 

          5. The complainant was discharged on 06-04-13 (Ex.A-15).

          6. The complainant approached M/s Vimta Labs for HCV test and paid                              Rs.15,500/- (Exs.A-16 to A-18).

          7.   The complainant approached NIMS, Hyderabad and there                                underwent investigations (Exs.A-19 and A-20).

          8.  The complainant also underwent investigations on 23-04-13 at

                   M/s Vijaya Diagnostic Center (Ex.A-21).

9. The complainant on 06-05-13 underwent CABG at NIMs,      Hyderabad under Rajivarogyasree (EXs.A-22 and A-23).

          10. The complainant again approached the opposite parties on

                   01-07-14 and underwent investigations (Ex.A-24).

          11. The complainant had not undergone any treatment at

                   Opposite parties hospital.

7.  POINT No.1:-     Hepatitis C is a serious liver disease that results from infection with the Hepatitis C virus.  Hepatitis C has been called a silent disease because people can get infected and not know it.   The complainant is questioning laboratory report (Ex.A-4) dated 01-04-13 where it was mentioned as reactive for HCV test and it was so mentioned in Ex.A-7 coronary angiogram report.  Burden is on the complainant to prove that Ex.A-4 was erroneous in respect of HCV test.  The complainant relied on Exs.A-17, A-18, A-19, A-20, A-21 and A-24 to discharge his burden.   The opposite parties also relied on Exs.A-17 and A-18 and the evidence of PW2 (Microbiologist of M/s Vimta Labs) to support their contention.

8.      In Ex.A-4 report the opposite parties mentioned “reactive 5.31” as against HCV test.   PW2 studied MD., in micro biology and is working as clinical microbiologist at M/s Vimta Labs.  M/s Vimta Labs analyzed the sample belonging to the complainant on a reference by NIMS.   The complainant summoned Dr.Madhavi Latha (PW2) to corroborate his contention.  PW2 stated that under her supervision the sample taken from the complainant was analyzed for HCV (Hepatitis-C virus) quantitative PCR (polymerase chain reaction) and HCV genotyping.  PW2 stated that she signed the originals of Ex.A-17 and A-18.   In Ex.A-17 it was mentioned “HCV RNA not detected or below the detection limit of the assay i.e., <33.6 IU/mL”.  In Ex.A-18 it was mentioned “very low viral load, hence could not be genotyped”.    

9.      PW2 in her cross examination stated that the expression used in Ex.A-18 ‘very low viral load, hence could not be genotyped denotes the level (presence) of RNA could be <33.6 IU/mL.   PW2 also stated that quantitative PCR is not meant for diagnosis of HCV infection and qualitative PCR test which can be used for diagnosis of HCV is not available in M/s Vimta Labs.   Quantitative PCR was meant for prognosis (test for treatment response of known cases of HCV only).  It can therefore be inferred that the tests undergone by the complainant at M/s Vimta Labs vide Exs.A-17 and A-18 was not meant for diagnosis of HCV infection.   The evidence of PW2 coupled with Exs.A-17 and A-18 will not corroborate complainant’s case in any way.  

10.       Ex.A-19 and A-20 revealed that the Department of Micro Biology, NIMS adopted ELISA test procedure in analyzing complainant’s sample and their report revealed negative as against HCV.  The opposite parties adopted enhanced chemiluminescence’s immunoassay (CLIA) test procedure for analyzing the sample as seen from Ex.A-4. PW2 in her chief examination stated that CLIA test is little better than ELISA test for diagnosis of HCV. The contention of the opposite parties that they adopted better procedure in analyzing sample is corroborated by the testimony of PW2.       

11.   The complainant on 23-04-13 had undergone clinical investigation for HCV at M/s Vijaya Diagnostic Center and obtained the original of Ex.A-21.  M/s Vijaya Diagnostic Center adopted the method ‘immunodot assay’ in analyzing the sample.   In Ex.A-21 report it was mentioned as non reactive against HCV antibodies.   The complainant on 17-04-14 for the reasons best known to him undergone clinical investigations at the opposite parties hospital and obtained Ex.A24. In Ex.A-24 it was mentioned “non reactive” as against HCV.    The opposite parties at this time adopted rapid immunoblot assay in analyzing complainant’s sample.  The procedure adopted in analyzing the sample by M/s Vijaya Diagnostic Center under Ex.A-21 and the opposite parties under Ex.A-24 in our considered opinion are one and the same. 

12.    In Ex.A-21 it was mentioned that a negative test result does not exclude the possibility of exposure to or infection with HCV, HCV antibodies may be undetectable in early stages of infection, this test is a screening assay,  it should not be used a sole criteria for diagnosis of HCV infection, its result should be confirmed by other supplementary methods.   In Ex.A-24 the opposite parties also mentioned that the performed test/s are screening tests only, all reactive results need to be confirmed with specific confirmatory tests.  

13.   The Department of Micro Biology, NIMS under Ex.A-19 and A-20;               M/s Vijaya Diagnostic Center under Ex.A-21 and the opposite parties under Ex.A-24 did not adopt CLIA test procedure.   As already observed CLIA test procedure is better than ELISA test procedure (PW2).   The opposite parties in order to support their contention relied on the expression “very low viral load, hence could not be genotyped”.   The contention of the opposite parties that they adopted the available best procedure (CLIA test) and diagnosed the complainant suffering from HCV infection in our considered opinion was corroborated by the above expression used by M/s Vimta Labs in Ex.A-18.   We therefore opine that the Exs.A-19 to A-21 and A-24 did not assist the complainant.   In view of the afore mentioned discussion, we hold that the opposite parties did not commit any deficiency in service i.e., in mentioning reactive in Ex.A-4 as against HCV test and answer this point against the complainant.  

14.  POINT No.2:-   In view of our above findings, in the result the complainant is not entitled to any compensation and answer this point also against the complainant.

15.   POINT No.3:-   In view of above findings, in the result the complaint is dismissed without costs. 

Typed to my dictation by Junior Stenographer, corrected by us and pronounced in the open Forum dated this the 8^th day of July, 2014.

Sd/-XXX                                     Sd/-XXX                               Sd/-XXX

MEMBER                                     MEMBER                              PRESIDENT

APPENDIX OF EVIDENCE

Witness examined:    Dr. Madhavi Latha, PW2

DOCUMENTS MARKED

For Complainant:

For opposite parties:    NIL   

For witness:

                                                                                                Sd/-XXX

                                                                                                PRESIDENT

NB:   The parties are required to collect the extra sets within a month after receipt of this order either personally or through their advocate as otherwise the extra sets shall be weeded out.