PER DR. B.C. GUPTA, MEMBER

          This appeal has been filed under section 19 read with  section 21(a)(ii) of the Consumer Protection Act, 1986 against the impugned order dated 01.06.2012, passed by the State Consumer Disputes Redressal Commission, UT Chandigarh (hereinafter referred to as the State Commission) in consumer complaint No. 12/2011, filed by the appellant Sandeep Kumar, vide which, the said complaint was ordered to be dismissed, holding that there was no medical negligence on the part of the opposite parties in giving treatment to the appellant/complainant. 

2.       The facts of the case are that Sandeep Kumar, resident of Khanna District Ludhiana, Punjab, who is a qualified male nurse, is suffering from bleeding disorder, i.e., Haemophilia-A since his birth.  Haemophilia is a disease in which the clotting factor–VIII is absent in the blood, due to which once bleeding starts even from a minor injury, it does not stop normally and to stop the same, fresh frozen plasma (FFP) transfusion is required to be given.  The complainant used to get the transfusion done at the Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh to get temporary relief from the problem.  It is stated that on 2.01.2009, the complainant suffered some injury on his body and was admitted at Civil Hospital, Khanna for treatment.  According to the complainant, he told the doctor that he was feeling pain in elbow and knee joint.  He also told the doctor about the treatment taken from PGIMER, for the Haemophilia-A disease.  The said doctor instead of referring him to the PGIMER, prescribed a pain-killer tab Lyser-D, due to which his health condition became worse and he suffered from malina (bleeding in stool).  The patient was discharged from Civil Hospital, Khanna on 05.01.2009, but was advised to continue his treatment at PGIMER Chandigarh.  The complainant was admitted over there on 05.01.2009 and took treatment till 18.02.2009, during which he got several fresh frozen plasma transfusion.  It is stated in the consumer complaint that during his hospitalisation at PGIMER, he got severe allergic reaction from FFP transfusion, the colour of his urine became dark and he also suffered from loss of appetite.  He was advised to undergo some blood-tests on 27.01.2009.  As per report received, he was diagnosed for Hepatitis-C positive with genotype-3.  Dr. R.K. Dhiman, Additional Professor, Department of Hepatology, PGIMER advised him to go for treatment of chronic Hepatitis-C with injection PegInterferon Alfa2a for 6 months, the total cost of which would be ₹3,41,952/- approximately.  The complainant filed the consumer complaint in question, alleging medical negligence on the part of the respondent hospitals, i.e., PGIMER and Civil Hospital Khanna and stated that he had suffered a lot due to treatment at these hospitals, as he was no more eligible to apply for the job of a nurse in the Government and also, he could not plan for a baby, as there was chance of transmission of hepatitis–C disease through sexual contact with his wife and subsequently, to the baby.  The complainant sought compensation of ₹90 lakh from the respondents for the alleged medical negligence. 

3.       In the written reply filed by the PGIMER Chandigarh, it was interalia stated as follows:-

“4.      That the contents of para 4 of the complaint are incorrect and denied.  However, it is submitted that reactions to Fresh Frozen Plasma (FFP) are known to occur in multi-transfused individuals because of sensitization to the proteins present in blood components.  However, the reaction that occurred during current hospitalisation of Mr. Sandeep Kumar cannot be responsible for development of Hepatitis C in him.  For Anti HCV test to become positive, it takes 8 – 12 weeks after the exposure to infective material (Reference : American Association for the study of Liver Diseases.  Ghany M G et al.  Diagnosis, management, and treatment of hepatitis C : an update.  Heptalogy 2009; 49:1335-74).  The treatment of Mr. Sandeep Kumar was initiated on 5.1.2009 and the HCV test became positive on 27.1.2009 (test was reported on 29.1.2009).  In this interval of 22 days (3 – weeks), this test cannot become positive.  Hence, Hepatitis C virus positivity in Mr. Sandeep Kumar cannot be related to the current hospital stay and treatment.

5.         That the contents of para 5 of the complainant are incorrect and denied.  However, it is submitted that all blood and blood products in PGI are screened for HIV I & II antibodies, Hepatitis B surface antigen, Hepatitis C virus antibody, VDRL and malarial parasite in compliance with the Blood Bank rules within the Drugs and Cosmetics Rules, Government of India.  Only the blood and Blood products that test negative for above mentioned infections are issued for transfusions.”

4.       It was further stated in the said reply that Haemophilia – A disease is a congenital bleeding disorder and FFP transfusion are issued to the patients as a life-saving measure.  The PGIMER provides FFP support to 200 to 250 Haemophilic patients every year and the treatment is given free of cost; the gesture which had been appreciated by the Haemophilic Welfare Society, Chandigarh.

5.       The OP-2 Civil Hospital Khanna, stated in their written reply that the complaint was barred by limitation u/s 24A of the Consumer Protection Act, 1986, having been filed after the expiry of 2 years from the date of cause of action.  The patient was admitted in their hospital on 02.01.2009 and discharged on 05.01.2009, but the complaint had been filed on 17.02.2011.  The OP-2 also stated that at the time of his admission in the hospital, there was no visible injury on him and he was only complaining of some pains.  The complainant was clinically stable and examined by the doctors at their hospital and underwent x-ray examination also, which showed no bone injury.  He was prescribed tablet Lyser-20 and not Lyser-D by the orthopaedic specialist Dr. Sudhir Sethi.  Keeping in view his stable condition as on 05.01.2009, he was advised to continue his treatment for Hemophilia at the PGIMER, Chandigarh.  There was no negligence, therefore, on their part in any manner.

6.       The State Commission after taking into account the averments of the parties found the complaint without any merit and dismissed the same vide impugned order dated 01.06.2012.  Being aggrieved against the said order, the complainant is before this Commission by way of the present appeal.

7.       During hearing, the complainant argued his case in person and stated that he contracted the Hepatitis–C positive during his treatment at PGIMER, Chandigarh, because there was reaction, following the FFP transfusion.  As per the version given by the OP-1 PGIMER, the reactions of FFP are known to occur in such cases, meaning thereby that the OP-1 had admitted that the problem occurred during his treatment in their hospital.  The complainant stated that it was the duty of the PGIMER doctors to explain to him about the possible consequences of the said transfusion and to obtain his consent for the same, but the same was not done.  The complainant further stated that as per the information given by the PGIMER itself under the Right to Information Act vide their letter dated 02.02.12, it was clearly stated that Hepatitis-C virus infection could be acquired during transfusion of blood products at various occasions.

8.       The complainant further mentioned that as per letter dated 07.06.2011, issued by the OP-1, the incubation period of acute HCV infection varies from 2 to 26 weeks after exposure.  It is also stated that the incidence of transfusion – associated HCV infection is estimated at 0.01% to 0.001% per unit transfused sera.  The version of the PGIMER about the incubation period was also supported by medical literature on Hepatitis C.  The complainant has also mentioned about the information obtained from the All India Institute of Medical Sciences (AIIMS) New Delhi, in which it has been stated that the screened blood was not 100% safe.  There was a possibility of transmitting of infection after transfusion.  It is also stated in the letter dated 26.05.2011 issued by the PGIMER that patients of Haemophilia could get HCV infection through transmission of FFP.  The complainant stated that taking into account these facts, he should have been suitably compensated.

9.       The Ld. Counsel for the PGIMER stated in reply that the complainant was admitted at their Institute on 05.01.2009.  However, his blood samples, from which HCV positive was detected, had been taken on 27.01.2009.  The Ld. Counsel stated that if the infection had taken place at the PGIMER, the blood samples could not have tested positive, as a minimum time of 8–12 weeks after the transfusion was required for incubation etc., whereas the patient had hardly spent 3 weeks at their hospital by that time.  Referring to the medical literature and the reports given by them as well as the AIIMS about the incubation period of 2 to 26 weeks, the Ld. Counsel replied that the test will show ‘positive’ only after 8 weeks, although incubation period could be 2 weeks only.  As stated in the reply filed by the OP-1, it was clear that antibodies are generated in the body, only after 8 to 12 weeks, after which the test could come positive.  In the instant case, therefore, since the blood was found positive for HCV, only after 3 weeks of admission at the hospital, it was clear that infection could not have occurred due to transfusion made at their hospital.

10.     Referring to the issue of informed consent, the Ld. Counsel stated that the said point was never raised in the consumer complaint, or in proceedings before the State Commission.  The complainant was, therefore, debarred from raising this issue at the stage of appellate jurisdiction. 

11.     In reply, the complainant stated that FFP transfusion was available only at the PGIMER Chandigarh and hence, the problem could have arisen due to the treatment taken at that hospital only. 

12.     I have examined the entire material on record and given a thoughtful consideration to the arguments advanced before me. 

13.     The main issue that requires consideration in the present case is whether there has been any medical negligence on the part of either of the hospitals arrayed as OP-1 and OP-2 in the present consumer complaint.  The facts of the case are clear that the complainant is a patient of Haemophilia–A and he has been taking treatment from the PGIMER, Chandigarh by way of FFP transfusion.  According to the complainant, he contracted HCV positive following the FFP transfusion during his treatment at the PGIMER, when he was admitted there on 05.01.2009.  As per the version given by the hospital, the said infection was detected from the blood samples taken on 27.01.2009, i.e., only 3 weeks after his admission to the hospital.  The Ld. Counsel relying on medical literature says that the tests would become positive only after 8 to 12 weeks, after exposure to the infective material.  Although, it was stated in the medical literature that the incubation period of HCV is from 2 weeks to 26 weeks (5 months in one report), the OP-1 hospital has maintained that even if the incubation period is 2 weeks, the test will come positive, only after the antibodies are formed which takes 8 to 12 weeks.  The State Commission has relied upon “American Association for the stay of liver disease – Practice Guidelines – Diagnosis, Management and Treatment of Hepatitis C: an Update by Marc. G. Ghany, Doris B. Trader, David L. Thomas and Leonard B Seeff, under the heading Diagnosis of Acute and Chronic HCV Infection and Interpretation of Assays which reveals that HCV RNA, could be identified as early as two weeks following exposure, whereas, anti-HCV is generally not detectable before 8 – 12 weeks.”

14.     The State Commission also observed that as per the affidavit given by Dr. Pankaj Malhotra, Additional Professor, Department of Internal Medicine, PGIMER, Chandigarh all blood and blood products are screened for HIV I & II antibodies, Hepatitis B surface antigen, Hepatitis C virus antibody, VDRL and material parasite in compliance with the Blood Bank Rules within the Drugs and Cosmetics Rules, Govt. of India and only the blood and blood products that test negative for above mentioned infections, are issued for transfusions.  It has been stated in the information obtained from the AIIMS, Delhi also that screened blood was not 100% safe, and there is a possibility of transmitting infection after transfusion. 

15.     The subject of medical negligence has been discussed in a number of land-mark judgments given by the Hon’ble Apex Court and this Commission as well.  In the case of “Jacob Mathew v. State of Punjab [(2005) 6 SCC]” Hon’ble Apex Court have dealt with the issue of medical negligence in detail and stated in their conclusion as follows:-

“(1)      Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do.  The definition of negligence as given in Law of Torts, Ratanlal & Dhirajlal (edited by Justice G.P. Singh), referred to hereinabove, holds good.  Negligence becomes actionable on account of injury resulting from the act or omission amounting to negligence attributable to the person sued.  The essential components of negligence are three: “duty”, “breach” and “resulting damage”

16.     It is made out from above that negligence on the part of the treating doctors or the Hospital is made out only if there was a breach of duty on their part and they omitted to do something that was required to be done in the ordinary conduct of human affairs.  In the present case, however, there is not even an iota of evidence to prove that any of the treating doctors or hospital was found to be negligent in the performance of their duty in any manner.

17.       Some basic principles in dealing with the cases of medical negligence have been enunciated by the Hon’ble Supreme Court in the case of “Kusum Sharma vs. Batra Hospital” [(2010) 3 SCC 480]”. Some of these principles are as follows:-

“I. Negligence is the breach of a duty exercised by omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do.

II.  …………….

III. The medical professional is expected to bring a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires.

IV. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.

V. In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of other professional doctor.

…………….”

18.     The facts of this case make it clear that the persons who treated the complainant performed their duties as was expected from the professionals having ordinary skills in their fields and no lapse can be attributed to them in any manner.  The reports received from prominent Institutes like AIIMS and medical literature reveals that the transfusion made at the Hospital cannot be termed as 100% safe and hence, it shall not be justified to attribute any negligence on the part of the treating doctors or the hospital. 

19.     In so far as the role of Civil Hospital, Khanna, the OP-2 is concerned, it is made out that the complainant was admitted there with complaint of some pain in his knee-joints etc.  As per the discharge certificate issued by the said hospital, a copy of which has been placed on record by the complainant himself, the patient was given tablet Lyser-20 and not Lyser-D.  In his written arguments, the complainant has explained the difference between Lyser-20 and Lyser-D.  It is stated that Lyser-20 consists of serratiopeptidase whereas Lyser-D contents serratiopeptidase as well as Diclofenac Sodium.  The complainant has stated that serratiopeptidase is prohibited for patients who are suffering from blood coagulation abnormalities, but still the OP-2 had prescribed the said medicine to him.  The material on record shows that the tablet Lyser-D was prescribed by the doctors at OP-2 Hospital based on clinical examination of the patient, when he was found suffering from knee pain etc.  There is no evidence on record to prove that the prescription of the said tablet proved harmful to him in any manner or had given any side effect. The State Commission also observed that in the absence of any tangible and cogent evidence to the contrary, no case of medical negligence was made out against the OP-2 as well.

20.     During arguments in the appeal, the complainant stated that it was the duty of the OPs to obtain informed consent from him if they knew that complication could arise as a result of the treatment being given to him.  The material on record, however, says that such a plea was not taken in the consumer complaint or in proceedings before the State Commission.  The complainant, therefore, cannot be allowed to raise additional plea at the stage of appellate jurisdiction.  However, even if this plea is considered at this stage, it is clear from the version of the PGIMER that the chances of contracting such disease during the FFP transfusion were almost negligible.  A letter dated 07.06.2011 from the PGI says that the incidence of transfusion associated HCV infection is estimated at 0.01% to 0.001% per unit transfused area.  It is clear free these figures that the chances of contracting infection being negligible, negligence could not have been attributed to the treating doctors at OP-1 Hospital. 

21.       Based on the discussion above, the allegation of medical negligence against the OPs do not stand proved as rightly brought out by the State Commission in their well-reasoned order.  I do not find any illegality, irregularity or jurisdictional error in the said order.  The present appeal is, therefore, ordered to be dismissed, being devoid of any merit.  There shall be no order as to costs.