State Consumer Disputes Redressal Commission
Naresh Kumar vs Sunil Blood Bank & Transfusion Centre & ... on 13 February, 2006
IN THE STATE COMMISSION : DELHI IN THE STATE COMMISSION : DELHI (Constituted under Section 9 clause (b)of the Consumer Protection Act, 1986 ) Date of Decision: 13th February, 2006 Complaint Case No. C-101/1992 Shri Naresh Kumar Complainant Sector III/535, In Person. R.K. Puram, New Delhi. Versus Sunil Blood Bank & Transfusion Centre & Anr. Opposite Parties 806, Arjun Nagar, Kotla Mubarakpur, Through Opp. Defence Colony, Mr. S. Pattjoshi, New Delhi-110024. Advocate. CORAM : Justice J.D. Kapoor- President Ms. Rumnita Mittal- Member
1. Whether reporters of local newspapers be allowed to see the judgment?
2. To be referred to the Reporter or not?
JUSTICE J.D. KAPOOR, PRESIDENT (ORAL) On account of having suffered from Hepatitis B due to blood trans-fusion during her delivery which was purchased from the OP-Blood Bank, the complainant, has through this complaint sought compensation of Rs.5 lacs.
2. It may be stated at the outset that the complaint was decided by this Commission vide order dated 27.3.91 whereby a compensation of Rs.20,000/- was awarded. However, the appeal, filed by the respondent before the National Commission was allowed vide order dated 19.1.1992 on the ground that impugned order was passed ex-parte and the respondent was not afforded adequate opportunities of being heard. This is how the matter is now being decided on merits and after affording adequate opportunities to both the parties in support of their respective case.
3. Allegations giving rise to this complaint in brief are that wife of the complainant was admitted on 17.8.89 in Safdarjung Clinic, SDA, New Delhi for delivery of a child. She was discharged on 23.8.89. The owner of the clinic, Dr.,(Mrs.) Indira Kohli gave the complainant on 17.8.89 itself, a written blood Requisition Form bearing her signature to procure one unit of Group A blood positive from the said Blood Bank before performing cesarean operation upon complainants wife. The requisitioned quantity of the blood was purchased by the complainant from the OP for a sum of Rs.200/- vide cash Bill No.1846 dt.17.8.89. This blood was transfused to the wife of the complainant on 17.8.89 itself by Dr.(Mrs) Indira Kohli of the Safdarjung Clinic.
4. On 26.11.89 his wife started having fever, vomiting etc. She was taken to CGHS Dispensary No.43,R.K.Puram. The Doctor on duty mentioned on CGHS Sl.Noi.45140/89 Token No.37359 dated 28.11.89 that she might be suffering from Hepatitis B. She was also advised to get her blood tested from Safdarjung Hospital, for the purpose. The doctor incharge vide Sl.No.119346 dt.5.12.89 of Safdarjung Hospital Laboratory intimated that she is HBs Ag positive patient. Thereafter she remained under treatment with Dr.Y.K.Joshi of Gastroentroogy and Human Nutrition Unit of AIIMS, New Delhi
5. She suffered from Hepatitis B for more than two months. She had fever, vomiting, loss of appetite. She also lost as much as five Kgs of weight. This caused her acute mental and physical suffering (Two zerox copies of her medical treatment at AIIMS OPD No.15231/89 GEC Department dated 28.12.89 onwards are enclosed and also the blood test report dated 27.12.89).
6. The virus of Hepatitis B was also transmitted to her husband, the complainant and he also suffered from Acute Viral Hepatitis B and remained under treatment with Dr.Y.K.Joshi of Gastroentrology and Human Nutrition Unit, AIIMS vide OPD No.17862/90 dated 12.4.90 and also on medical rest from12.4.90 to 6.6.90. During this period he suffered from fever, headache, loss of appetite skin allergy, weight loss, extreme weakness.
7. Dr. Y.K.Joshi, of Gastro-entrology and Human Nutrition Unit of AIIMS was of the opinion that the blood purchased from the Sunil Blood Bank had Hepatitis virus in it. Its transfusion to Ms. Indu Behl resulted in her suffering from Hepatitis B. Hence this complaint.
8. The allegations of having suffered a Hepatitis B through blood transfusion which was purchased from OP have been denied by the OP. Version of the OP in this regard is as under:
(i) The blood supplied by the OP was screened and tested by ELISA technique which was the latest and most sensitive test. All precautions and tests as expected of an authorised blood bank were carried out before supply of any blood and therefore, the OP cannot be accused of in any way for supplying any defective quality of blood.
(ii) The opposite party is a blood bank vide licence No. 776 of 1983 which has been renewed from time to time. The licence is granted by the Drugs Controller & Licensing Authority, Delhi Administration in accordance with the Drugs Act, 1940. The license is of course subject to the conditions as may be specified in the rules and the conditions mentioned in the license itself.
The staff and technicians employed by the Blood Bank are also approved and mentioned in the license itself.
(iii) At the time of collecting blood, the blood donors are screened and the blood is accepted only from those donors who are found fit after the test and after recording all data in the Donors Data Form which is signed by the medical officer and the donor himself.
(iv) After screening the blood samples in the blood bank each blood sample is sent to a specified AIDS Surveillance Centre. Only after it is passed by the Centre Incharge and a report of HIV negative is given, the blood is made available for supply to the intending purchasers.
(v) In the present case on 16-8-1989 a bottle of blood was collected from a donor namely Mohan Chand, S/o Hari Dutt after conducting the necessary tests required for accepting blood from the donor. The donors data form was duly completed and signed by medical officer and bore LTI of the donor.
(vi) The name of the technician whose signature is appearing in the relevant page of the register which is annexed as Annexure-A to the OPs written statement is Mr. D.S.Das who conducted tests of the particular blood. The credentials of the technician Mr. Das cannot be doubted in view of the fact that Mr. Das who has been working with the OP, before working with the OP has worked for 20 years in the Armed Forces as Blood Transfusion Officer and about 20 years in the Safdarjung Hospital Blood Bank. Shri Das is an approved technician as would be clear from the certificate of Renewal for License for the relevant period i.e. 1.1.89 to 31.12.90.
(vii) The reputation and quality of blood supplied by the OP is clear from the affidavit dated 27.8.93 submitted on behalf of Dr. Kohli in response to the interrogatories issued to her by this Commission.
(viii) As would be seen from the affidavit dated 8.6.93 filed by Dr. Y.K. Joshi of the All India Institute of Medical Sciences in response to the interrogatories on behalf of the OP, it is clearly stated by Dr. Joshi that only if the patient was negative for BhsAg prior to blood transfusion and then there is a blood transfusion, then it can be said that the blood was responsible for Hepatitis B whereas neither the patient nor her husband was tested for HbsAg before the blood transfusion and therefore, it will not be reasonable to point out that the blood was responsible for Hepatitis B in the complainants wifes case. The reply field by Dr. Y.K. Joshi to the interrogatories from H to M raised by the OP also makes it clear that there were various roots and causes for transmission of a Hepatitis B other than blood transfusion. The reply also clearly states that the patient was not tested for anti-bodies, neither the patient nor her husband were tested for Hepatitis B before. So it cannot be said whether the patient or her husband were suffering from the decease earlier which could have resurfaced because of favourable environment.
(ix) The patient was not tested for type of anti-bodies i.e. whether 1gG or 1gM. In the recent onset infection type of antibodies for pt. Upto six months is 1gM and later on 1gG. This infection is recent or old cannot be ascertained.
Because for the diagnosis of recent onset Hepatitis B it is a must that pt. must be positive for HbsAg Antigen by Elisa method and must be positive for 1gM antibodies.
(x) The complainant has taken a plea that the child of the patient should have contracted HbsAg has the mother been a carrier of the disease. It is important to point out that as the blood is transfused prior to the actual delivery i.e. during the caesarian operation and it takes only a very short time to mingle with the blood stream and the child as such should have got infected. But even otherwise even if the mother was a carrier it is not necessary that the disease would be transmitted to the baby
(xi) Dr. Joshi was the first doctor who had treated the patient and if Dr. Joshi is not certain as to fix the responsibility on the blood bank for the transmission of HIV positive virus to the patients then it will be unnecessary to go into the question of awarding compensation in favour of the complainant and against the OP holding that the OP was responsible for the suffering of the patient.
(xii) That a study was conducted in All India Institute of Medical Sciences in 1988 on Post transfusion Hepatitis after the Cardiac Surgery where in all 250 patients in which status regarding Hepatitis before the surgery was checked by Elisa method and all were found negative. All patients went under cardiac surgery. Out of 250 patients 215 patients were given blood transfusion.
All the blood used was from AIIMS Blood Bank and was tested for Hepatitis B by elisa method. 15 patients (6.9%) developed post transfusion Hepatitis out of which three patients have Hepatitis B (1.4%). The cause given for Hepatitis B is low level of HbsAg which could not be detected by Elisa method. So above study confirms that even after doing Elisa test for screening of blood pt. can still develop Hepatitis B because low level of BhsAg cannot be detected. (Prospective Controlled study of post-transfusion hepatitis after cardiac surgery in a large referral hospital in India by Dr. Dasarathy S, Dr. Misra S.C., Dr. Acharya S.K., Dr. Irshad M, Dr. Joshi Y.K., Dr. Venugopal P., Dr. Tandon B.N., Liver 1992. 12: 116-120).
(xiii) Diagnosis of recent origin Hepatitis B is not established as a type of test is not indicated. Neither the test was repeated to confirm it. Every test has false positivity and false negativity.
9. In addition the counsel for the OP has also relied upon the following causes that may result in causing Hepatitis B.
i) Syringes and needles used during course of treatment can also be the source of infection.
ii) Surgical instruments could also be the source.
iii) Sexual and intimate contact could also be the source
iv) Limitation of Medical Science with every latest test(Elisa) 5-10% cases cannot be detected.
10. In view of the medical opinion of Dr. Y.K. Joshi as well as the medical study and literature referred and relied upon by the OP and reproduced above we find it difficult to arrive at irresistible conclusion that the blood supplied by the OP was the solitary cause of Hepatitis B but at the same time we find the OP guilty of deficiency in service in as much as violation of Drugs and Cosmetic Rules 1996 and Drugs and Cosmetic Act 1945 relating to the labeling of the blood sample. Relevant extracts of rules are as under:-
Labeling : The label on the container states (1) the ABO group; (2) the Rh group; (3) the total volume of fluid, the proportion of blood, and the nature and volume of anticoagulant solution; (4) the date on which the blood was withdrawn; (5) the expiry date which should not exceed 21 days from the date of withdrawal of blood; 96) the storage conditions; (7) that the blood must not be used for transfusion if there is any visible evidence of haemolysis or other deterioration; (8) for blood of group O whether haemolysins are present or not and if they are, that the blood must be administered only to recipients of blood group O.
11. In the instant case the blood sample sold by the OP did not adhere to the aforesaid mandatory requirements of Drugs & Cosmetic Rules of 1996 in as much as that the body of the sample did not carry the blood testing kit which is apparent from the bills supplied by the OP nor do these have the mandatory page numbers.
Merely because the possibility of blood sample being not contaminated or not having resulted in Hepatitis B particularly by giving benefit of doubt to the OP does not absolve the OP from selling blood sample without adhering to the mandatory requirements of Drugs & Cosmetic rules 1996 from compensating complainant. Deficiency as defined by Section 2(1) (g) means any fault, imperfection, shortcoming or inadequacy in the quality, nature and manner of performance which is required to be maintained by or under any law for the time being in force or has been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service.
12. In our view the amount of compensation awarded by this Commission earlier i.e. Rs. 20,000/- shall meet the ends of justice not for selling contaminated blood sample but not selling the blood in the manner as provided under Rule 96 of Drug and Cosmetic Rules.
13. Complaint is disposed of in aforesaid terms.
(Justice J.D. Kapoor) President (Rumnita Mittal) Member