Pronounced on:  25th May 2022

ORDER
DR. S. M. KANTIKAR, MEMBER

1. The Appellants challenged against the impugned Order dated 11.09.2012, passed by the State Consumer Disputes Redressal Commission, New Delhi (hereinafter referred to as the ‘State Commission’), whereby the Appellants Nos. 2 and 3 were directed to pay a sum of Rs. 10 lakh holding liable for medical negligence.
2. For the convenience, the Parties are referred as placed in the Original Complaint filed before the State Commission.  
3. The facts are that Master Akash the Complainant (Complaint filed through his mother), after birth, at the age of 3 days, was operated for the correction of diaphragmatic hernia on 13.06.1998.  It was performed by Dr. Ajay Kumar, the Opposite Party No.3 at Kalawati Saran Children Hospital (KSCH) (hereinafter referred to as the ‘Opposite Party No. 2’). During operation, the baby was given blood transfusion twice as 50ml and 100ml on 13th and 16th June, 1998. The blood was brought from the Blood Bank at Smt. Sucheta Kriplani Hospital, New Delhi (hereinafter referred to as the ‘Opposite Party No. 4 – SSKH’). The baby was discharged on 23.06.1998. 
4. Thereafter, Master Akash was brought to the hospital on 06.08.1998. It was diagnosed as follow up case (FUC) of diaphragmatic hernia with intestinal obstructions and adhesions. On 07.08.1998, the Opposite Party No. 3 performed second operation of exploratory for adhesionolysis at KSCH and discharged after a week on 14.08.1998.  The baby was kept under follow-up till the end of 1999, at same Hospital. It was stated that during 17.12.1998 to 01.01.2000 the baby continued to remain sick and unhealthy, frequently suffered from fever, pneumonia and cough etc.  In the year, 2003, Master Akash developed Episclerits (disease of eye), consulted eye specialist on 05.04.2003 at KSCH.  X-rays chest, blood test were conducted but, it was alleged that the treating Doctor never advised HIV testing because of fear being exposed.  Again in 2005 the child suffered diffuse pain in abdomen and consulted in OPD at KSCH on 14.09.2005.  On the insistence of the few well-wishers, the parents of Master Akash got HIV testing done at VMMC & Safdarjung Hospital, New Delhi. It was reported on 09.01.2006 as HIV positive – AIDS and he was admitted in Safdarjung Hospital for further treatment.  He was discharged on 18.01.2006 and advised for follow up and remained under observation at AIIMS & Safdarjung Hospital.  It was alleged that entire episode was sheer deficiency and medical negligence on the part of the Opposite Parties. 
5. Being aggrieved, the Complainant filed the Complaint before the State Commission and prayed Rs. 22 lakh along with 18% interest as compensation. 
6. The Opposite Parties filed their respective written versions and denied entire allegations. It was submitted that the doctors, who treated the patient, were skilled and qualified.  The blood was brought from the Blood Bank of SSKH of the Lady Harding Medical College and transfused to save the life of baby.  The Blood Bank issues blood after doing all mandatory tests for HIV and HbsAg as per the statutory guidelines of Drugs Controller.  Only negative tested blood was issued to the patient.  Thus there was no question of negligence and/ or deficiency on the part of the OPs.  The instant complainant deserves to be dismissed. 
7. On hearing the parties and the evidence, the State Commission partly allowed the Complaint and directed the Opposite Parties Nos.2 & 3 to pay Rs.10 lakhs as compensation.
8. Being aggrieved the Opposite Parties filed the instant Appeal.
9. We have head the learned Counsel on both the sides and perused the material on record.
10. The learned Counsel for the Appellants vehemently argued that the State Commission ignored the opinion of an expert of the medical board, which held no medical negligence or carelessness from the Opposite Parties.  The learned Counsel further submitted that for more than 3 years (01.01.2000 till 14.03.2003) the patient might have taken treatment from different doctors. In April 2003, baby was consulted at KSCH for Episcleritis and respiratory infection, but thereafter for almost 2 ½ years (23.04.2003 to 13.09.2005) he did not turn up to the Hospital. Thereafter, in September 2005, the baby was brought to KSCH for abdominal pain and during treatment in early January 2006, HIV positive was diagnosed. His CD4 lymphocyte count was 54/cmm and Master Akash was referred to Safdarjung Hospital for anti-HIV treatment. Therefore, the possibility of contracting HIV through blood transfusion was ruled out, but it might be due to the treatment taken in different hospitals during 2000 to 2005.   
11. The learned Counsel further submits that every unit of blood issued by the SSKH Blood Bank was fully tested for HBsAg and HIV, as a mandatory request of Drug Controller. Same was confirmed from the observation of Panel of Experts from Maulana Azad Medical College (MAMC).  It was also observed that even with the best of screening, transmission of HIV through the blood transfusion during the window period is possible. The Blood Bank follows the NACO guidelines and diagnostic kits are provided by the Government.  The serologically positive blood is discarded by the blood bank as per the NACO guidelines. 
Observations
12. Contaminated blood is a potential source for transmission of HIV. In the scenario provided, the possibility of contracting HIV from blood or other blood-contaminated appliances cannot be excluded in the case Master Akash.  The discharge summary also refers to a second blood transfusion at age of 2 ½ months.  We need to look for the details of any other potential source of HIV transmission.  Often, there is a lag between contracting HIV infection and its clinical diagnosis.  The blood transfusion is a well-documented source for transmission of HIV infection since 1985.  Due to the stringent regulations of  Drugs Controller of India for functioning of blood banks -  the mandatory  screening of blood has drastically reduced the risk of HIV transmission and other infections. Even with the best of screening, it is not possible to exclude the small risk for transmission of such infections. Not adhering to the mandatory screening   amounts to medical negligence. The certificate of issued to Master Akash by CGHS dated 19/12/2006 was detected HIV positive in Jan 2006.  He, therefore, requires specific anti-retroviral treatment (ART) throughout his life and at present he is under treatment at AIIMS, and  Safdarjung Hospital, New Delhi.
Comments and Conclusion:
13. From the standard text books on Microbiology, NACO guidelines and books on Transfusion Medicine that, the person during window period may test as HIV negative. The window period ranging from approx. 20 to 30 days (depending on type of the diagnostic kit used).  Therefore, if such donor’s blood is transfused, the chances of HIV infection are more.  Even with the advanced NAT testing (Nucleic Acid Amplification Technology), the window period has been reduced and HIV detection is possible at early stage.   Therefore, in our view, even today the blood transfusion carries the risk of HIV infection.  
14. As per the HIV-AIDS publications of NACO and WHO, the antibody tests may give false negative  (no antibodies were detected despite the presence of HIV) results during the window period i.e.  an interval of three weeks to six months  after the HIV exposure.  Most people develop detectable antibodies approximately 30 days after infection, although some develop seroconversion, later.  After the 3 month window period, the HIV tests for all types and subtypes became accurate upto 99.97%.  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. The fourth-generation tests can simultaneously detect both HIV antibodies and p24 antigen within 14-15 days. It can detect plasma HIV RNA (ribonucleic acid), within 10 days of infection.  Thus, in the instant case, in the instant case, we cannot rule out the possibility that the blood donor would have been in Window Period. 
15. It is pertinent to note that the Opposite Parties failed to produce the blood bank register and the test reports to  prove that the blood units were HIV negative.  It is pertinent to note the B+ blood was issued twice, once 50 ml on 10.06.1998 vide D No.3439 and another 100 ml on 16.06.1998 vide D. No. 3481.  It was transfused on on 13th and 16th June, 1998. There is nothing on record to ascertain how only 50 ml and 100 ml blood was drawn and the methodology used for HIV testing. No details of Microbiology/Serology Report creates doubt in our mind. It is evident that the child Akash was detected HIV positive in year 2006 i.e. after 5 years of blood transfusion. During the said period he frequently suffered recurrent respiratory tract infections and took treatment from various hospitals.  There was possibility of HIV infection due to other sources cannot be ruled out.  Therefore, it is difficult to conclusively attribute negligence of the Opposite Parties who transfused blood to Master Akash.
16. From the medical literature, both the terms “HIV” and “AIDS” refer to the same disease.  Whereas HIV refers to the HIV virus itself, AIDS refers to the syndrome the latent effects of HIV infection. HIV related stigma and discrimination still exist worldwide, although they manifest themselves differently across countries, communities, religious groups and individuals. Now doubt, the child contracted HIV and throughout his life he has to live with HIV and he subsequently likely to develop complications of AIDS.  Therefore, considering the peculiar facts and the nature of disease, in the ends of justice, we affirm the compensation awarded by the State Commission.  
17. We have perused the Medical Board Expert Opinion dated 25.05.2010.  The relevant paragraphs (iii) and (iv) are more relevant, which is reproduced as under:-
iii) The question has been raised as to whether the case of Master Akash is a case of medical negligence: ………………… The screening for HIV infection was made mandatory for every unit of blood collected for transfusion in Delhi, India since 1989 (Indian Journal of Pathol Microbiol 39 (2): 139-142, 1996).  Thus there was adequate time unto 1996 for the HIV screening, inter lia, of blood to be a part and parcel of blood banking practice and to adhere to the then prevailing policy for the testing and disposal of blood not adhering to it will tantamount to medical negligence on the part of the Appellants.  
So as long as the state and prevailing policy on the mandatory screening for HIV was adhered to, it cannot be deemed that there is any medical negligence whatsoever.
iv) the summary reports and the document provided concerning treatment of Master Akash in his post – operative treatment at AIIMS, New Delhi and VMMC & Safdarjung Hospital are indicative of confirming HIV/AIDS required specific anti-retroviral treatment.
18.     The allegation of the Complainant’s son of having contracted HIV from the transfusion of contaminated blood at KSCH, which was supplied by RSSB blood bank. As per Schedule F (K) to the Drugs and Cosmetic Rules, it is made try to perform tests on blood for transmissible diseases like HIV, Hepatitis B and C, Malarial Parasites, VDRL and syphilis. Complete donor screening by detailed questionnaire is very important. If the blood donors are in window period, HIV test may be negative. The next pivotal question is whether or not the treating doctor had taken a valid or real Consent from the Complainant before the blood transfusion. The Opposite Parties have not placed any cogent evidence in this regard. Therefore, it amounts to deficiency in service of the treating doctors. 
19. The incident occurred in 1998 and now, it is beyond 2 decades, therefore at this stage discussion on “ifs” and “buts” is certainly injustice to the HIV victim and against the object of the benevolent Consumer Protection Act. It is an admitted fact that Master Akash during 3 months of age received B+ve blood for the Adhesinolysis operation in the year 1998. Thereafter, he suffered recurrent respiratory infections and   was detected HIV in early year 2006. 
20. As per the WHO medical literature, the HIV positive people could progress to AIDS in just a few years due to severe depletion of immune system, they develop multiple infections and certain cancers.  Due to recent therapeutic advancement, now there is Anti-Retroviral therapy (ART) available which has proved to be very effective in helping the patients to live longer. It is known that the government hospitals under guidance of NACO providing ART treatment free of charge. 
21.     The Complainant, in his prayer, claimed compensation of Rs. 22 lakh with interest @ 18% per annum. To award just and fair compensation, we have to consider several points like the actual expenses for the medical treatment, travel and emotional sufferings of the parents. We also cannot ignore that the life expectancy of Master Akash would depend on strict regular ART and healthy diet. 
At present, the child is around 24 years of age. Certainly, he has already undergone untold sufferings and in future, he will still continue to suffer HIV related stigma and discrimination. The compensation cannot be measured in monetary terms.  In our view, on priority, he should be provided adequate health facilities (regular ART treatment) and benefits through different welfare schemes of the Govt. for HIV positive people.
22. Based on the foregoing discussion, we affirm the compensation awarded by the State Commission, accordingly, the Appellant is directed to pay Rs. 10 lakh to the Complainant within six weeks from today, failing which the amount shall carry interest @ 9% per annum till its realization.  
The First Appeal is dismissed. There shall be no order as to costs.