State Consumer Disputes Redressal Commission
Shrawan Kumar vs Sir Ganga Ram Hospital on 26 April, 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: 26-04-2006 Complaint Case No. C-199/93 Shri Shrawan Kumar - Complainant R/o WZ-61/1, Ram Garh Colony, Opp. Kiriti Nagar, New Delhi-110015. Versus (1) Sir Ganga Ram Hospital Opposite Party No.1. Rajinder Nagar, New Delhi. (2)Dr. M.P. Gupta, Opposite Party No.2. Senior Cardiologist, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi. 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) This complaint arises out of allegations of medical negligence on the part of the Opposite Party-Hospital and OP No.2-Doctor Mr. M.P. Gupta for having prescribed and administered a drug known as Heparin-injection 10,000, non-taking of which even for one day resulted in the death of a 30-year old pregnant woman.
Compensation of Rs. 8,00,000/- has been sought on various counts.
2. The past history of the complainants wife and the treatment provided to her by the OP No.2 resulting in her death is like this:-
3. Complainants wife Mrs. Archana Vigmal
- aged 30 years (now deceased) was under the treatment of OP No.2-Dr. M.P. Gupta since November, 1991 and was admitted in Sir Ganga Ram Hospital (OP No.1) where Dr. M.P. Gupta was working as a Senior Cardiologist. Deceased was pregnant at the time she came to Sir Ganga Ram Hospital because she needed urgent care of the Doctor as per his advice. She had heart trouble previously as one valve of her heart was replaced nearly three years ago in the Appolo Hospital, Madras. OP No.2 Dr. Gupta was fully aware of the condition of the patient under his treatment and he advised for injection Heparin 10,000 S/C daily alongwith tab. Lanoxin daily. As advised by him she took the medicine daily till the fateful day of her admission in the hospital.
4. It is alleged that the patients who are given Haparin injection are advised for P.T.T. test (Prothrombine Time Test) at regular intervals in order to adjust the dose of the medicine that is to increase or decrease the same. OP No.2-Dr. Gupta was approached by the complainant to get the P.T.T. test at regular intervals as required in such cases but he rejected the idea for no reason and against the medical practice and the result was that the requirement of the quantity of drug could not be ascertained by the Doctor himself who was treating the patient. This carelessness resulted in the formation of a clot in valve of the heart on 27-03-1992 and the deceased was admitted in Sir Ganga Ram Hospital because she was having breathing trouble and had vomiting. She was admitted in the hospital at 6.00 A.M. and the Doctors could not decide her treatment for hours together. She was not taken to the Internal Coronary Care Unit till 10.30 A.M. by the Doctors who were on duty and attending to her. The Doctors were busy in gossip and other ordinary affairs rather than devote to the seriously ill deceased who was at their mercy. She expired on 28-03-1992 at 8.45 A.M. leaving behind her husband and a 8 years old daughter. Deceased besides having private tuition was a regular agent for National Savings Organization and was earning more than Rs. 2,500/- per month. Hence this complaint.
5. While denying the allegations of the complainant and justifying the treatment given to the deceased patient, the OP No.2, the treating Physician has come up with the following version:-
(i) That when low dose of heparin is administered laboratory tests are generally not necessary to monitor treatment as the dosage schedule are fixed and hemorrhage rarely occurs and that a dose of 7500 to 10000 units every 12 hours is adequate and well tolerated and need not be monitored with coagulation test. The deceased had always received free services from OP No.2 and at no stage had paid consideration for the treatment or the prescription given by the OP No.2 at OP No.1 Hospital.
(ii) That the P.T.T. test was not advisable to her as she was pregnant and had already had her one valve replaced three years back. On her conceiving the Gynecologist advised her to discontinue with her pregnancy but she continued conceiving knowing the risk. Thus administration of medicine Heparin injection 10,000 was necessary for her. On 26-03-2002 she had failed to take her dose and developed problem and was admitted in the OP No.1-Hospital in the morning where she gave the statement that she missed her dose yesterday. The said dose was given immediately to her by OP No.2.
(iii) That the medicine which was advised was meant for the purpose of thinning of blood as there was artificial valve so that blood circular is complete.
(iv) As per death summary the death was due to non-taking of the medicine for one day and was not due to any overdose or low dose. She did not have any other problem for six months while taking this medicine.
6. In nutshell the defence of the OP No.2 is that when low dose heparin therapy is utilized, laboratory tests are generally not necessary to monitor treatment as the dosage and schedule are fixed and hemorrhage rarely occurs and that a dose of 7500 to 10000 units every 12 hour is adequate, is well tolerated and need not be monitored with coagulation tests.
7. In support of the aforesaid version, the OP No.2 has relied upon the following medical literature:-
(a) Goodman and Gilmans The Pharmacological Basis of Therapeutics, Sixth Edition, Macmillan Publishing Co., INC, New York, Collier Macmillan Canada, Ltd., Toronto, Bailliere Tridall, London -
(b) Principles of Internal Medicine, Editors Jean D. Wilson, M.D. Professor of Internal Medicine, The University of Texas Southwestern Medical Centre, Dallas ( c ) Manual of Medical Therapeutics, 24th Edition, Department of Medicine, Washington University School of Medicine, St. Louis Missouri, J. Willian Camphell, M.D. Mark Frisse, M.D. Editors, Asian Edition.
(d) Heart Disease, A Textbook of Cardiovascular Medicine, Edited by Eugene Braunwald, Volume 2 .
(e) Cardiovascular Pharmacology And Therapeutics by Churchill Livingstone edited by Bramah N. Singh, Victor J. Dzau, Paul M. Vanhouttee & Raymond L. Woosley.
(f) Seventh Edition Williams Obstetrics Pritchard, MacDonald, Cant, International Edition.
(g) Williams Obstetrics 21st Edition by F. Gary Cunningham, MD, Larry C. Gilstrap III, MD, Normal F. Gant, MD, John C. Hauth, MD & Katharine D. Wenstrom, Md.
Mc Graw-Hill Medical Publishing Divison.
(h) Help Desk of NCBI/NLM/NIH, Department of Health & Human Services Pregnancy and mechanical valve prosthesis : a high risk situation for the monther and the fetus. Larrea JL, Nunez L., Reque JA, Gil Aguado M, Matarros R, Minguez JA.
(i) Help Desk NLM and NIH Embolic stroke in a pregnant patient with a mechanical heard valve on optimal heparin therapy Watson WJ, Freeman J, OBrien C, Benson M.
8. The relevant information on the various aspect in the aforesaid literature can be summarized as under:-
(a) When low dose heparin therapy is utilized, laboratory tests are generally not necessary to monitor treatment; the dosage and schedule are fixed and hemorrhage rarely occurs. The only role is in maintaining anticoagulant protection for prolonged periods.
If they are initiated early in the acute treatment course, the patient must be in range, as defined by a prothrombin time of 1.5 to 1.8 times the control time for 3 to 5 days before heparin is discontinued. A second option for long term protection is the use of 7500 to 10,000 units every 12 hour is adequate, is well-tolerated, and need not be monitored with coagulation tests. Current regimens for low-dose heparin include 5000 units injected SQ 18-12th.
A highly concentrated heparin about 20,000 units ml should be used and should be injected rapidly SQ through a 25 gauge needle, followed by pressure over the injection site to minimize hemorrhage. Laboratory monitoring is not necessary.
The risk of pregnancy in women with a valve prosthesis is multifactorial and should be assessed and discussed with the patient and her family before conception. Potential problems may be related to an increased hemodynamic load, the hyper-coagulable state of pregnancy with the increased likelihood of thromboembolic events, and risk to the foetus due to anticoagulants (p.1805) and other cardiovascular drugs.
(b) Just as heparin use may result in excessive bleeding or occasional thrombosis, its withdrawal can also have adverse effects. We recently treated a child who developed massive and fatal pulmonary embolism after abrupt withdrawal of anticoagulants.
(c) Continuous anticoagulant therapy is recommended to prevent emboli. Therefore, sterilization frequently has merit.
(d) Other advantages are once-or twice-daily administration and most authors recommend that these subcutaneous administered drugs do not have to be monitored.
(e) Counseling before conception occurs and avoidence of pregnancy are recommended for women with complications in the mother and fetus.
(f) Thromboembolism can occur in pregnant patients with mechanical heart valves despite optimal heparin therapy.
9. In order to controvert the claim of the OP No.2 the complainant has referred and relied upon the following material :-
(i) The medical brochure of the company who is manufacturing the anticoagulant drug namely heparin states that there is always a risk of bleeding and thereby loss of blood and therefore it is very important to maintain the level of anti-coagulant activity (clot prevention activity) periodically, for which PTT (Prothrombine Time Test) is conducted, which cannot be avoided . The relevant portion reads as under:-
CONTROL Only when Beparine therapy is to be prolonged for more than 1 to 2 days it is considered necessary to effect control of the blood clotting time. Ideally, dosage of Beparine administered should be sufficient to be effective and yet sufficiently low as to involve a minimkum risk of Haemorrhage. An activated Partial Thromboplastin Time (PTT) value of 45-60 secs indicates some Heparin activity, and a value of 60 to 100 approx. 35-45 minutes)Probably represents adequate Heparin anti-Coagulant activity. A value of more than 100 secs.
suggests excess activity. Heparin prolongs PPT for atleast 2 hours after its administration.
(ii) Progress report of OP No.1 Hospital dated 27-03-1992 which clearly stipulates that heparin to be started after PT Test report only. Inspite of this direction of OP NO.1, OP No.2 administered dose of heparin by relying upon information provided in the internet on the subject.
(iii) When the patient went in coma OP No.1 made a mention in the progress report that patient had informed that she had missed one dose of heparin on the very first day.
(iv) If the nature of the medicine to be administered was so crucial that even the patient can die if she missed one dose then the minimum precaution to be taken by OP No.2 was to administer such dose after verifying the report of PT Test to control the dose of heparin.
(v) The problem was developed after six months and during this period she had no problem.
10. OP No.2 Doctor was present in person and he tried to explain the treatment given by him in order to show that there was no deficiency nor any medical negligence on his part. He stated that confusion is being created as to the administration of heparin without verifying the report of PTT as in this case it was because of the obstruction of mitral valve prosthesis he had given Hypokensier and as a result of which clot had disappeared. The patient was admitted under O & G with 24 weeks pregnancy and acute obstruction of mitral valve prosthesis leading to acute heart failure and CU collapse. The immediate ppl. course was discontinuation of prophylactic heparin. The patient was resuscitated & thrombolytic therapy was given IV. Obstruction of MV prosthesis and its subsequent opening was documented by bedside echos performed twice. Despite successive restoration of cardiac activity including mechanical work, the patient continued to be in intractable hypokensier despite maximal possible fluid & inotropic therapy. She also was found to have evidence of irreversible brain damage. Tue to these facts, she ultimately had a cardiac asystole & declared dead at 8.45 A.M. on 28-3-92 by the Registrar on duty.
11. OP No.1 has defended itself that there are no allegations with regard to treatment after admission on 27-11-1991 and the complainant had approached OP No.2 in the free OPD as an independent patient and therefore the OP No.1-Hospital did not receive any consideration nor for admission nor for treatment. If at all any consideration was received it was received by OP No.2.
12. We would first deal with the concept of medical negligence in context of the Consumer Protection Act, 1986 (hereinafter referred as the Act) as case of negligence arises from the definition of deficiency in service provided by Section 2(1)(g) of the Act. Deficiency as defined by Section S(1)(g) means :-
any fault, imperfection 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.
13. Now the question arises as to what are the tests or criterion to adjudge medical negligence. For the sake of brevity and avoid repetitive views of Supreme Court and other Courts we would refer to leading cases on the subject.
14. Way back in the year 1957 English Judges enunciated test as to whether there has been negligence or not in Bolams case reported as (1957) 2 All ER 118, 121 D-F Bolam Test came to be known through the decision delivered in this case as the appellants name happened to be Bolam and the test is as under:-
[Where you get a situation which involves the use of some special skill or competence then the test as to whether there has been negligence or not is to the test of the man on the top of a Clapham omnibus, because he has not got this special skill. The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill. It is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art (Charles worth & Percy, ibid., para 8.02)
15. Presumably because of this persuasive value of decision our own Supreme Court has in case after case and particularly in Indian Medical Association Vs. V.P. Shantha & Others (1995) 6 SCC 651 wherein Bolams case was also discussed has adopted this test as guidelines for the courts to adjudicate the medical negligence.
Latest judgment of Supreme Court on this aspect is Jacob Matthew Vs. State of Punjab and Another (2005) SCC (Crl.) 1369. These are as under:-
(3) A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, which reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.(4)
The test for determining medical negligence as laid down in Bolams case, WLR at p. 586 holds good in its applicability in India.
16. There is a distinction between criminal medical negligence and medical negligence simplicitor as in the former case the act should be rash and negligent like leaving foreign object in the body during operation or such like things whereas medical negligence involves element of incompetence and taking up a case which a Doctor was not competent or qualified to handle and if he was qualified he should have either done or failed to do something which no medical professional would have done.
17. As is apparent there is unvarying judicial unanimity to seek answer to the following queries while adjudicating medical negligence or otherwise:-
(i) Whether the treating doctor possessed all the requisite skill which he professed to have possessed?
(ii) Whether he had exercised the ordinary skill of ordinary competent man exercising that particular skill as it is not possible for every professional to possess the highest level of expertise or skill in that branch which he practices?
(iii) Whether he has done something or failed to do something which in the given facts and circumstances no medical professional in his ordinary sense and prudence would have done and failed to do?
(iv) Whether the risk taken by the Doctor was of such a nature that injury which resulted was most likely imminent?
18. Before testing the treatment given by OP on the anvil of aforesaid criterion of medical negligence, let us have the comprehensive view of the matter.
19. Admittedly the deceased was an OPD patient at Batra Hospital. In the OPD card she was advised to undergo PTT test once a month. Before that she was operated upon for her heart trouble in Appollo Hospital, Madras where one valve was changed. She was given clear cut advice not to become pregnant.
20. Thereafter she had been under treatment of OP No.2 since November, 1991. She did not care for the advice and became pregnant by November, 1991 itself. It was due to her pregnancy that she was advised by OP No.2 to come to OP No.1 hospital as she needed urgent care. After seeing her previous medical record regarding her heart operation, OP No. 2 advised for injection Heparin 10,000 S/C daily along with tablet Lanoxin daily. Injection was given to control thickness of the blood. Said injection being anticouglant there is always a risk of bleeding and thereby loss of blood. In ordinary case PTT test is conducted to maintain the level of anticouglant activity. Admittedly the complainant did not have the Heparin injection a day prior to her admission in the hospital.
21. Medical literature produced by the parties does not prescribe as to what precaution is to be taken in case of a pregnant woman while administering Heparin injection i.e. whether it is advisable without verifying the report of PTT test or not. The deceased was admitted under O & G with 24 weeks pregnancy and acute obstruction of mitral valve prosthesis leading to acute heart failure and CU collapse. In such a situation the immediate course was to discontinue the prophylactic heparin. The deceased was resuscitated and thrombolytic therapy was given. Obstruction of MV Prosthesis and its subsequent opening was documented by bedside echos performed twice a day. Inspite of successive restoration of cardiac activity the patient continued to intractable hypokensier despite maximal possible fluid and intropic therapy. So much so there was even evidence of irreversible brain damage. The cumulative effect of these complications led to cardiac asystole and resulted in the death.
22. There are no allegations that the OP No.2 was not a well qualified Doctor or did not possess the skill which he professed to have possessed. Only allegation is that he administered injection without insisting PTT test at required intervals to adjust the dose of the medicine i.e. to increase or decrease the same depending upon thickness of the blood.
23. No expert medical opinion has been produced by the complainant to controvert the version of OP No.2 that in case of pregnant woman administration of Heparin can be resorted to without verifying the report of PTT test as the instant case was a case of obstruction of mitral valve prosthesis. The medical literature in this regard specifically provides that option for long term protection is the use of 7500 to 10,000 units every 12 hour which is well tolerated and need not be monitored with coaugulation test. A highly concentrated heparin about 20,000 units could be used and injected rapidly SQ through a 25 gauge needle followed by pressure over the injection site to minimize hemorrhage. Medical literature also shows that risk of pregnancy in woman with a valve prosthesis is multifactorial and should be assessed and discussed with the patient and her family before conception.
24. Here the deceased was brought to the hospital with 24 weeks pregnancy. She became pregnant against the strong advice of the Doctor of Appollo Hospital, Madral. It appears that the whole complication arose because of her being pregnant at the relevant time with acute obstruction of mitral valve prosthesis leading to acute heart failure and CU collapse. Thus from any aspect we may examine the matter OP No.2 cannot be held guilty as there is no evidence that he did not exercise the ordinary skill of an ordinary competent man nor is there any evidence that he has done something or failed to do something which in the given facts and circumstances no medical professional in his ordinary sense and prudence would have done or failed to do. Furthermore, complainant has failed to prove the payment of any consideration to either OP No.1 or OP No.2.
25. As regards OP No.1, the complainant did not avail its services nor was admitted by it as a patient. Merely because OP No.2 happens to be holding O.P.D. at OP No.1 and called the complainant as his private client at OP No.1 hospital does not mean that OP No.1 had provided the medical services to the complainant either against consideration or otherwise as an unpaid patient. Thus OP No.1 is in no way liable for any fault or negligence, if at all any.
26. In the result, complaint is dismissed being devoid of merit.
27. A copy of this order as per the statutory requirements, be forwarded to the parties free of charge and thereafter the file be consigned to Record Room.
28. Announced on the 26th day of April, 2006.
(Justice J.D. Kapoor) President (Rumnita Mittal) Member Jj