National Consumer Disputes Redressal
Dr. Navdeep Singh Khaira vs Sheela Gupta on 7 August, 2009
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI FIRST APPEAL No. 374 of 2004 (From the Order dated 25.06.2004 in Complaint Case No. 62 of 2000 of the Punjab State Consumer Disputes Redressal Commission, Chandigarh) 1. Dr. Navdeep Singh Khaira 2. Medical Superintendent Appellants Dayanand Medical College & Hospital Ludhiana versus 1. Sheela Gupta House No. B 18, Power House Road Civil Lines, Bathinda Respondents 2. Oriental Insurance Company Clock Tower Ludhiana BEFORE: Honble Mr Justice R. C. Jain Presiding Member Honble Mr Anupam Dasgupta Member For the Appellants Mr Sanjiv Sharma, Advocate For Respondent No. 1 NEMO For Respondent No. 2 Mr K. K. Bhat, Advocate Dated 7th August 2009 ORDER
Anupam Dasgupta This appeal is against the order dated 25.06.2004 of the Punjab State Consumer Disputes Redressal Commission, Chandigarh (hereafter, the State Commission) in Complaint Case No. 62 of 2000. By the said order, the State Commission held the appellants (hereafter, the Opposite Parties or OPs) guilty of medical negligence and deficiency in service in treating Raj Karan, the deceased son of respondent no. 1 (Sheela Gupta, hereafter referred to as the complainant). The State Commission accordingly awarded to the complainant a compensation of Rs. 1 lakh and costs of Rs. 5,000/-, payable by the OPs within one month of receipt of a copy of the order.
2. Practically, all the material facts of the case are undisputed. Raj Karan was a patient of chronic renal failure (CRF) and he also suffered from dilated cardiomyopathy DCM (a condition in which the heart becomes weakened and enlarged, and cannot pump blood efficiently; the decreased heart function can affect the lungs, liver and other body systems). On consultation with OP 1 at his personal clinic, Raj Karan was advised to undergo maintenance haemodialysis (HD) twice a week regularly, in addition to some medication. He underwent nearly 120 such sessions of HD at the OP 2 hospital where OP 1 was the Professor of Nephrology and Head of the Nephrology Unit. The blood group of Raj Karan was B, Rh-Negative. During previous sessions of HD, he was all along transfused with blood of the same group and Rh type. However, in his scheduled HD on 17.09.1999, he was given blood of B group, Rh-Positive. He died of cardiac arrest on 19.09.1999.
3. The complainants case before the State Commission was that her son died prematurely because of the negligence on the part of the OPs in transfusing blood of the wrong Rh type during the HD session of 17.09.1999. Raj Karans blood group was B, Rh-Negative and all through the previous sessions of HD, at OP 2 hospital, he was given blood transfusion of the same group and Rh type. There was, thus, no reason to transfuse B, Rh-Positive blood during HD on 17.09.1999, without checking for cross-matching compatibility. This was what led to his sudden death on 19.09.1999.
4. The OPs contested the complainants allegations on alll grounds including, inter alia, that (i) Raj Karan was a patient of not only CRF but also DCM, (ii) patients undergoing maintenance HD for CRF have a cardiovascular mortality rate approximately 3 times higher than that of age-matched control subjects, (iii) patients suffering from DCM have a much higher mortality rate than that of the general population, with about 25% dying within 1 year and nearly 50% within 5 years and (iv) not all Rh-Negative persons have anti-Rh (D) antibodies in fact, only a few do so that not all cross-matches of Rh-Negative recipients (of blood) from Rh-Positive donors or vice versa would be incompatible, as a result of which transfusion of Rh-Positive blood may be perfectly safe. In support of these contentions, the OPs produced extracts of relevant medical texts and published articles in journals. On 17.09.1999, the Blood Bank of OP 2 supplied one unit blood of B group, Rh-Positive. This was transfused during the HD session of 17.09.1999, without any complication during the process of HD. In support of their claim, the OPs relied on the medical notes of the process of HD on 17.09.1999, which showed that it went off without any complication. They also referred to the document (cross-matching report of the Blood Bank of OP 2) produced by the complainant herself showing that, contrary to the allegation, the blood used for transfusion was cross-matched with the blood of the patient and there was no reaction of incompatibility. Had the transfused blood been incompatible, there would have been immediate reaction, in the course of the HD itself. According to the OPs, transfusion of Rh-Positive blood quite safe for a first such transfusion, as was the case here. In their appeal, they further contended that the State Commission erred in not taking cognisance of the authoritative medical literature produced by them, when nothing to the contrary had been adduced as evidence by the complainant.
5. We have heard Mr Amit Sharma, learned counsel for the appellant-OPs and Mr K. K. Bhat, learned counsel for respondent no.2, the Oriental Insurance Company. None was, however, present on behalf of the complainant on the date of final hearing.
6. Mr Sharma has reiterated the points of defence raised by the OPs before the State Commission. In the written arguments on behalf of respondent/OP 2, in addition to the points made by the OPs 1 and 2, it has been highlighted that the patient, Raj Karan died of cardiac arrest, two days after the HD in question, because he was also suffering from dilated cardiomyopathy for long and, according to an available cardiac assessment, his heart was functioning at 23% of the normal efficiency. Secondly, it was only the OP 2 hospital, which had obtained an insurance policy and there was no allegation of any specific medical negligence on the part of the said OP. Mr. Bhat contended that in the absence of any expert medical opinion and/or medical literature in support, it was thus erroneous on the part of the State Commission to accept the bald allegation of the complainant that her son died of cardiac arrest because of the transfusion of Rh-Positive blood on 17.09.1999 and that this amounted to medical negligence/deficiency in service on the part of the OP 2 hospital.
7. After careful consideration of the pleadings, facts of the case (particularly, those relating to the history of prolonged multiple ailment of the patient Raj Karan and of the HD) and the material brought on record, we are inclined to agree with the contentions of the OPs (appellants before us) for the following reasons:
(i) It does not appear to be in dispute that one unit of blood was transfused during Raj Karans HD on 17.09.1999. Elementary medical literature (also popular knowledge domain) informs us that one unit of whole blood is 450 ml (cc) in volume and approximately 45% of whole blood consists of red blood cells (RBCs or erythrocytes). It is also not in dispute that all along, until 17.09.1999, Raj Karan received B-Negative blood during his HD sessions at the OP 2 hospital, in accordance with his own blood grouping and the only transfusion of Rh (D)-Positive blood was on 17.09.1999.
(ii) Some further discussion of blood groups/types would help appreciate the controversy in proper perspective. Here too, standard medical literature (easily accessible even on the Internet) shows that what is described as B+ or B-Positive blood in lay language actually means blood of B group with Rh (D)-Positive, where D stands for the Rh (D) antigen attached to each RBC of B group blood. This (D-based) Rh typing (i.e., positive or negative) of blood would apply to any of the ABO blood groups.
(iii) D antigen [in Rh (D)] is the most important of the Rh group antigens attached to the RBCs for determination of the Rh type of an individuals blood. Needless to add, the Rh typing is in addition to the blood grouping (A, B, AB and O together referred to as the ABO grouping) for classification of an individuals blood. Thus, B-Positive blood means blood of B group with Rh D antigen present; B-Negative means blood of B group with Rh D antigen absent. Though medical literature describes as many as 43 other Rh group antigens, these antigen groups are either much less frequently encountered or are rarely clinically significant, in comparison with the D antigen. Hence, Rh typing of blood is based on the presence (Positive) or absence (Negative) of the Rh D antigen, attached to the RBCs.
(iv) In addition to the medical literature cited by the OPs regarding the effects of a single transfusion of Rh-Positive blood to an Rh-Negative recipient, we have consulted an article/chapter in reportedly the most widely followed authoritative textbook on transfusion medicine, namely, Klein, HG & Amstee, DJ in: Mollisons Blood Transfusion in Clinical Medicine (Eleventh Edition), 2005; Page 183-188. To quote the relevant part:
Rh D immunization by transfusion The response to large amounts of D-positive red cells:
When a relatively large amount of D-positive red cells (200 ml or more) is transfused to D-negative subjects, within 25 months anti-D can be detected in the plasma of some 85% of the recipients. In about one half of those D-negative subjects who fail to make serologically detectable anti-D after a first relatively large transfusion of D-positive red cells, further injections of D-positive red cells fail to elicit the formation of anti-D (see section Responders and non-responders, below). Evidence that some 85% of D-negative subjects will make serologically detectable anti-D after a single transfusion of D-positive red cells is as follows. In one series, following the transfusion of 500 ml of D positive blood, 18 out of 22 D-negative subjects developed anti-D within 5 months; none of the remaining four subjects made anti-D within 14 days of a further injection of D-positive red cells (Pollack et al. 1971). However, the red cells of this second injection were labelled with 51Cr, and in two of the four subjects without serologically demonstrable anti-D the T1/2Cr was diminished, to 4.8 and 12.1 days respectively (Bowman 1976). The number of subjects primarily immunized was thus 20 out of 22. In another series in which D-negative subjects received 200 ml of red cells, previously stored in the frozen state, 24 out of 28 produced anti-D within 6 months (average time 120 days), and two of the remaining four produced anti-D after a further injection of D-positive red cells (Urbaniak and Robertson 1981). The overall incidence of primary Rh D immunization following an injection of about 200 ml of D-positive red cells in these two series seems therefore to have been over 90% (46 out of 50). In a follow-up of D-negative patients who had received an average of 19.4 units of D-positive blood during open heart surgery, anti-D was detected in 19 out of 20 cases (Cook and Rush 1974), but this report is made a little less impressive by the fact that in seven of the subjects the antibody was detected only in tests with enzyme-treated cells and in two of these seven the antibody was detectable only on a single occasion and could not be detected subsequently. In a study of 78 D-negative patients who received D-positive blood, anti-D was detected in only 16 patients. The patients belonged to the following diagnostic categories:
Abdominal surgery, including gynaecological and urological interventions (42%); cardiosurgery (33%); trauma (14%); disseminated intravascular coagulation (5%); and miscellaneous (6%). Most patients received a single-unit transfusion (Frohn et al. 2003). These authors conclude that the probability of making anti-D in response to a D-positive transfusion is much lower in patients than in healthy volunteers. None of eight D-negative AIDS patients receiving 211 units of D-positive red cells developed anti-D; in contrast, all of six D-negative patients with other diagnoses receiving 19 units of D-positive red cells developed anti-D within 719 weeks of transfusion (Boctor et al. 2003). These observations may relate to the immunosuppression occurring in AIDS patients.
(Our Notes: (a) Emphasis supplied.
(b) Prolonged haemodialysis patients are immune-compromised. Hence, the statement above regarding immunosuppression would hold true for them too.)
(v) Thus, in simple terms, during his HD on 17.09.1999, Raj Karan received a little over 200 ml (45% of 450 ml, i.e., one unit) of Rh (D)-Positive (frozen) blood. This is very much the situation described at the beginning of sub-paragraph (iv) above. Admittedly, this was also the first transfusion of B, Rh (D)-Positive blood in his case, his blood being B, Rh (D)-Negative. He was already immune-compromised because of his undergoing prolonged HD for CRF. Further, because of DCM, his heart functioned at just about 23% of its normal capacity. According to the last paragraph of the medical text reproduced above, the probability of his developing anti-Rh (D) antibodies, to cause serious attendant complications on account of a single transfusion of Rh (D)-Positive blood in the course of his HD on 17.09.1999, was low, being immune-compromised already. Moreover, such development of anti-Rh (D) antibodies would have taken much longer average of 120 days after the first transfusion - as against his death on 19.09.1999. Even if the Rh (D) antibodies developed extremely rapidly in Raj Karan, these antibodies could have caused fatal reaction if (and when) he received a second transfusion of Rh (D)-Positive blood. The HD record of 17.09.1999 did not show any adverse reaction on that date. By the complainants own showing (despite her allegations to the contrary), cross-matching of the transfused blood was also done by the Blood Bank of OP 2 on 17.09.1999 and no incompatibility reaction was noticed. According to the medical records, Raj Karan did not receive any blood transfusion after that during his HD on 17.09.1999. These facts, read with the conclusions of the medical literature produced by the OPs before the State Commission (leave alone the further clarificatory medical text reproduced above), would stand squarely in the way of the State Commissions rather peremptory conclusion:
Before transfusing the blood, the Opposite Parties should have done cross-matching of the blood instead of straightaway opting to transfuse the blood. No doubt, the deceased was suffering from serious ailment relating to the kidneys but he died not due to his long ailment but due to cardiac arrest, which has a direct concern with the transfusion of the wrong blood. The Opposite Parties cannot wriggle out of their responsibility by simply taking the plea that the deceased was suffering from Chronic Renal Failure with dilated cardiomyopathy and that Rh-negative recipients can be transfused blood Rh-positive by cross-matching in some cases.
In view of the discussion above, these findings of the State Commission do not reflect proper appreciation of the facts of the case and the implications of the prolonged ailments of the patient in the light of the medical literature on record.
8. As a consequence, and in spite of our profound sympathies with the complainant because of her loss of her young son, we allow the appeal and set aside the impugned order of the State Commission. We order accordingly and leave the parties to bear their own costs.
[R. C. Jain, J] ..
[Anupam Dasgupta]