CARE HOSPITAL & ANR. vs VEMUGANTI VENU GOPAL RAO & ORS.

"Any misdiagnosed disease or condition can be deadly because the conditions are left untreated or receive the wrong treatment. For people who are given a false-negative diagnosis for HIV, the results can be catastrophic: not only might they fail to get the treatments they need, but they could unknowingly and unwillingly infect others with the virus" The present Revision Petition has been filed before this Commission under Section 21(b) of the Consumer Protection Act, 1986 against the impugned order dated 22.09.2014 in Appeal No. 488 of 2013 passed by the State Consumer Disputes Redressal Commission, Andhra Pradesh (in short, ''State Commission''). The State Commission dismissed the Appeal filed against the order passed in Complaint No 866 of 2009 dated 22.08.2012 by the District Consumer Disputes Redressal Forum, Hyderabad (in short, ''District Forum'').,

Facts in brief: The Complainant, Mr. Vemuganti Venu Gopal Rao, underwent aortic wall replacement, on 19.06.2008 at M/s Quality Care India Ltd., Hyderabad (in short, Care Hospital), OP-1. After 3 months, on 13.09.2008, he visited Dr. R. R. Srinivas, at Srinivasa heart Centre, Hanamkonda and Dr. U. V. Vishnuvardhan Reddy at Karimnagar with the complaint of ulcer in the mouth. As per advice, the HIV test was performed on 02.10.2008 which revealed HIV 1 Positive. It was confirmed by Western Blot method from M/s Thyrocare Technologies Limited.

Therefore, the Complainant consulted the OP 1 and informed OP 1, that prior to AVR operation , he was HIV Negative, but then, he became HIV positive. The Complainant submitted that his six attendants donated blood, but it was not transfused to him. During operation, the OP transfused blood drawn from other donors, which was not properly tested for HIV. Hence, it was negligence of OPs, by which Complainant contracted HIV infection. Therefore, complainant filed a complaint before the District Forum.

The District Forum, partly allowed the complaint and directed the OPs to pay Rs.5,00,000/- as compensation and Rs.2,000/- towards costs, jointly and severally. Subsequently, First Appeal filed by the OP before the State Commission was dismissed.

Aggrieved by the order of the State Commission the OPs/Petitioners filed this Revision Petition.

At the admission stage, the Counsel for the OPs vehemently argued that the Hospital is a Super Specialty Hospital. They have taken total care and caution during screening of blood of patient. The blood units from blood bank are screened for HIV and all were negative. There was negligence. Hence, there was no chance of HIV transmitting through blood transfusion. He had brought our attention towards the expert report given by the Osmania General Hospital by Professor Dr. Radha Kumari and Dr. N. Srinivasa Rao, Professor of Medicine, which is reproduced as below: Medical Expert Opinion: We are of the opinion that reports of Sri V. Venugopal Rao, who was treated in care Hospital, Nampally, Hyderabad reveal the following observations:

a. The patient underwent HIV spot test on 25.04.2008, followed by Elisa on 24.05.2008, which are non reactive.

b. Patient underwent Aortic Valve replacement on 19.06.2008.

c. HIV status positive from sample received on 30.10.2008. The report was issued by APSACS, VCCTC Dist. Headquarters Hospital, Karimnagar.

d. CD 4 counts-134 reported (very low) on 31.10.2008 by MGM Hospital, Warangal.

It is very much possible to acquire HIV, if safe blood transfusion is not given. However, the CD 4 count will not fall so low, in a span of 4 months and 10 days. As per the literature, the incidence of false negativity of Elisa is 0.0003%, which cannot be ruled out.

Hence, we opine that there is a possibility of HIV positive status of the patient, before surgery.

We have perused the blood bank register of OP-Hospital (Annexure 11), which revealed all donors are tested negative for HIV. The patient was investigated prior to operation; the lab report dated 24.04.2008 Annexure P-1 is the HIV spot- negative. The patient was tested for HIV after 3 months of operation, by Dr. Vishnu Vardhan Reddy and the Serology report Annexure P-3 revealed HIV as weak reactive, by Tri Dot method. It was further confirmed by Surya Pathology lab that the report was reactive. Thereafter, it was again confirmed by Western Dot Method, on 03.10.2008.

The Counsel further argued that there were chances of false negative results. There may be a chance, that the patient might have contracted HIV infection, when the operation was postponed for 2 months.

It should be borne in mind that the Complainant approached the OP for a major surgery; the OPs hospital is one of the tertiary care hospitals. It is a well-known fact that Spot test results is not 100% accurate and reliable. We are surprised to note that the OPs have performed spot test for HIV testing. It was a super specialty hospital having all sophisticated infrastructure. Hence, every patient expects highest standard of care in diagnosis and

treatment. Certain health care professionals and hospitals are considered specialists in their field. Accordingly, they are held to be of higher standard of care. Specialists are expected to use the same degree of care that a reasonably competent specialist with similar training and experience would use under similar circumstances. It was necessary that OPs should have performed HIV test with the kits of high specificity and sensitivity like ELISA instead of Spot test. The Counsel further submitted that, a patient might be suffering from HIV prior to operation; the Spot test gave result as "False Negative". We are not impressed by this argument.

The principle of Egg shell''s skull is applicable here, therefore, OPs cannot take defence on the grounds, stated supra. This rule holds one liable, for all consequences, resulting from his or her tortious (usually negligent ) activities leading to an injury to another person, even if the victim suffers an unusually high level of damage (e.g. due to a pre-existing vulnerability or medical condition ). The term implies that if a person had a skull as delicate as that of the shell of an egg, and a tortfeasor who was unaware of the condition, injured that person''s head, causing the skull unexpectedly to break, the defendant would be held liable, for all damages resulting from the wrongful contact, even if the tortfeasor did not intend to cause such a severe injury( http://en.wikipedia.org/wiki/Eggshell_skull ). The OPs Hospital Laboratory report (Microbiology/Serology Report) is devoid of details of type of Spot test performed. The two reports from different laboratories which have performed Spot test (Tridot) revealed reactive result. As the patient''s age was of 70 years'' therefore, it will be ridiculous to suspect that, he contracted HIV through any sexual contacts. Hence, we do not find any flaw in the order passed by the State Commission.

The complainant investigated for HIV testing from different laboratories and from Andhra Pradesh AIDS Control Society (APACS) VCTC revealed that the complainant was infected with HIV positive. The learned counsel for the petitioner/OP has contended that the petitioner was already infected with HIV positive, prior to operation and the HIV testing done on 25.4.2008 was False Negative. Four units of blood transfused during operation were negative for HIV and there was no deficiency in service on the part OP. In this context, we have gone through medical literature and research articles on HIV-AIDS published by NACO and WHO; which revealed that, Antibody tests may give false negative (no antibodies were detected despite the presence of HIV) results during the window period , an interval of three weeks to six months between the time of HIV infection and the production of measurable antibodies to HIV seroconversion . Most people develop detectable antibodies approximately 30 days after infection, although some develop seroconversion, later. The vast majority of people (97%) have detectable antibodies by three months after HIV infection; a six-month window is extremely rare with modern antibody testing. The Committee was constituted by The Superintendent, Osmania General Hospital, Hyderabad comprised of Dr.N.Srinivasa Rao, Prof of Medicine and Dr.Radha,Prof of Microbiology observed in their report [ para (d)] that the CD4 count of the patient was 134 on 31.08.2008, thus opined that It is very much possible to acquire HIV if safe blood transfusion is not given. However, the CD 4 count will not fall so low in a span of 4 months and 10 days.

We have gathered information from WHO texts/review/literatures that (i) Is a negative test 100% accurate? i.

i.

HIV tests after the 3 month window are more than 99.97% accurate. They work for all types and subtypes of HIV. The "window period" is the length of time after infection that it takes for the virus to become detectable by HIV diagnostic tests. The length of the window period varies depending on the type of diagnostic test used and the method it employs to detect the virus. The window period varies slightly from person to person. It is extremely rare for a HIV-infected person not to develop antibodies by 3 months after a potential exposure. What is a ''false negative'' test result? A false negative test result occurs when the test shows negative and the person is really HIV positive. This is very rare and usually occurs during the window period when people are newly infected but the test can''t quite pick up the infection. As with other types of tests, there is always a small margin of error. With antibody-only tests (3rd generation) only 0.3% of tests (3 tests in every 1000) will be false negative, after 3 months. Sensitivity/Accuracy of HIV Tests:

Third-generation tests detect all types of antibodies, which makes them more sensitive than the first-generation and second-generation tests. These assays can detect antibodies about 21-24 days after infection.

Fourth-generation tests can simultaneously detect both HIV antibodies and antigens. Tests that look for the p24 antigen can detect it, within 14-15 days . Tests can detect plasma HIV RNA (ribonucleic acid), within 10 days of infection.

Thus, very few medical tests have 100% accuracy. There will still be rare cases where someone is HIV positive and not picked up. Therefore, we are of considered view that, the OP hospital laboratory was careless and made a wrong diagnosis of HIV at initial stage. It was not a standard of practice expected from one super speciality hospital. As per medical record, it is apparent that, the patient''s HIV status was positive, after blood transfusion, during AVR operation. We cannot rule out the possibility that any blood donor would have been in Window Period. We cannot rely upon "Ifs" and "Buts" therefore, the principle of Res Ipsa Loquitor is applicable in this case. It was a negligence, passivity and inaction by the OPs. Therefore, we don''t want to interfere with the order passed by the State Commission. Accordingly, the revision petition is dismissed. The State Commission observed that, the complainant died during the course of pendency of appeal, therefore, the OPs should pay the compensation amount to the LRs of the deceased, within 90 days, from the date of receipt of this order, otherwise it will carry further interest @ 12% pa, till it''s realisation.