State Consumer Disputes Redressal Commission
R.K. Khanna vs Ajay Kumar on 30 August, 2007
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: 30-08-2007 Complaint Case No. C-145/2003 1. Shri R.K. Khanna, Complainant No.1 S/o Sh. R.N. Khanna, R/o B-604, Geetanjali Apartments, Vikas Marg, Delhi-110092. 2. Smt. Preeti Khanna, Complainant No.2 W/o Shri Varun Khanna, R/o 136, Mandakini Enclave, New Delhi. Presently at 603, Al Safa Building, Bur Dubai, UAE. 3. Shri Sachin Khanna, Complainant No.3 S/o Sh. R.K. Khann, R/o Sh. R.K. Khanna, R/o B-604, Geetanjali Apartments, Vikas Marg, Delhi-110092. Versus Dr. Ajay Kumar, Respondent No.1 Senior Consultant, Gastroenterologist, Hepatologist And Therapeutic Endoscopist, B-62, Anand Vihar, Vikas Marg Extension, Delhi-110092. 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 prescribed a medicine the side effect of which were not explained to the complainant and were such that caused fungal infection and ultimately resulted in the death of the wife of the complainant, the complainant has through this complaint sought compensation of Rs. 44,56,999/-.
2. The complainant No.1 has alleged negligence on the part of Dr. Ajay Kumar in the treatment of his wife Smt. Lata Khanna as a result of which she expired on 12.03.2003. Complainants who are husband, daughter and son of the deceased have claimed compensation of Rs.44,56,999/-.
3. Case of the Complainants, in brief, is that in early July 2001, Smt. Lata Khanna the deceased wife of the complainant No.1 started feeling uncomfortable from stomachache. She was also feeling loss of appetite. She started occasionally passing blood in her stool. The deceased was under the treatment of Dr. Anurag Tandon at Metro Hospital Noida for over a year and was diagnosed as suffering from Ulceractive colitis. Deceased had been under the treatment of OP-Dr. Ajay Kumar, from 27th September 2002 until March 1st 2003 for ulcerative colitis.
The Colonic Biopsy report dated July 26, 2001 conducted by Dr. S. B. Kulkarni, M.D. Pathologis, confirmed the diagnosis as Inflammatory Bowel Disease (IBD) inderminate. In view of the given nature of illness and longevity of her treatment, it was decided by family members to take a second opinion by consulting Dr. Kumar to establish the correctness of her treatment by way of correlating the diagnosis and treatment of both the doctors. With this in mind, from September 27th 2000 until October 20th 2001 both doctors Anurag Tandon and Dr. Kumar were consulted but only the treatment of Dr. Kumar was followed throughout.
4. It was agreed to put the deceased under the treatment of Dr. Kumar, since his clinic was very near to the residence of the deceased. OP-Dr. Kumar recorded her weight at 49 kgs and noted that the patient reported bloodstains in her under garments for the last 4-5 days. Dr. Kumar started her on tab Neurobion, once a day and prescribed Entofoam ointment to be applied as Enema. Rest of the medicines were to continue as prescribed earlier. Caught in this dilemma when the patient had a sudden loss of faith in Dr. Kumar the complainants were evaluating options of either going back to Dr. Tandon or stay with Dr. Kumar under his treatment. Meanwhile from October 12th 2003 to October 20th 2003 the condition of the deceased deteriorated rapidly. She could not hold anything in her stomach as she ate and suffered diarrhea 8 to 10 times a day, almost immediately after eating. On occasions she would pass blood also. An opinion was taken from Dr. Tandon who advised that a colonscopy should be done to determine the future course of treatment. Petitioner No.3 also spoke to Dr. Kumar on 22nd October, 2002 who concurred with the decision. In consultation with Dr. Kumar it was decided to get the colonscopy done at Metro Hospital. After reviewing the colonscopy report and comparing it to the colonscopy done a year ago he explained that the ulcer colitis has expanded to the whole colon as against being impaired only on the left side a year ago, that the patient has had relapse. Dr. Kumar prescribed the patient to reduce the Wysolone medicine (steroid) to 30 mg. On November 5th 2003 Dr. Kumar increased the dosage of Wysolone (steroid) from the 30 mg once a day to 45 mg once a day. The patient looked physically fit and showed encouraging signs of improvement and progress. With permission from Dr. Kumar she traveled to Dubai on 28th November 2002 to visit and stay with her daughter-complainant No..2 and her family. Dr. Kumar prescribed Imuran. He merely termed it as a wonder drug for Smt. Lata Khanna. Dr. Kumar advised that the deceased should undergo surgery for a complete cure, as she is not responding to the medication. The deceased was diagnosed suffering from PANCYTOPENIA induced by the drug with trade name imuran (salt composition is AZATHOPRINE). Despite best efforts the deceased could not be saved and expired. It was revealed that Dr. Kumar at no stage during the treatment educated or advised the deceased or/and the complainants of the potential hazards in the use of IMURAN. Manufacturer of IMURAN warn about the absolute necessity for doctors to notify educate and special warnings for the use of imuran to patients and advocate revealed that the consequences of prescription of IMURAB, its administration, its side-effects, precautions and warnings to be taken by the Doctors prescribing and patients taking IMURAN has received serious attention from pharmaceuticals and experts in the field. There were numerous publications about the same which were all existing before 24th Jan.2003 which were assessable and available to all medical experts including the OP. Inter alia the following publications have widely emphasized the side-effects, precautions and warnings about the drug IMURAN. OP failed to exercise due diligence and care in the treatment of late Smt. Lata Khanna and in the administration of the treatment resulting in her death. Hence this complaint.
5. OP Dr. Kumar denied any negligence or deficiency in service in the treatment of deceased Smt. Lata Khanna and raised the following please in his defence:-
(i) The complainant is liable to be dismissed because of non joinder as the complainants have not impleaded Dr. Anurag Tandon and Dr. Randhir Sud who had also been treating the patient in addition to the OP.
(ii) That the patient died while being treated by Dr. Randhir Sud at Ganga Ram Hospital and hence he becomes a necessary party. The complaint is bad for non joinder as the United Insurance Company, with whom the Op had a valid professional indemnity insurance during the relevant period has not been impleaded.
(iii) That Smt. Lata Khanna was suffering from ulcerative colitis. Ulcerative colitis can have many life threatening complications and that it can be treated and controlled but cannot be completely cured. They had chosen Dr. Ajay Kumar in addition Dr. Anurag Tandon for their own convenience. The complainants had made some suggestions regarding steroid therapy, wanting hospitalization for intravenous steroid therapy.
(iv) That the Op gave his considered professional opinion that oral steroids were equally effective and hospitalization was not necessary for this purpose. It is denied that the OP increased the dose of steroids. He had in fact reduced the dose from 30 mg OD to 25 mg OD for 1 week followed by further reduction to 20 mg OD for 1 week.
(v) That since her response to conventional drugs was not satisfactory, the patient and the accompanying complainants were told by the Op that he would like to give a trial with the drug called IMURAN before recommending surgery. The patient of the complainants died due to the progression of the main disease process and possibly contributed by the effects of steroids on the immune system probably due to or significantly contributed by fungal septicemia and contributed by lung aspiration and also by cerebral artery thromobosis.
(vi) That there had been no negligence whatsoever in the treatment and conduct of the Op towards the patient.
6. OP besides filing his own affidavits has also filed affidavits of Dr. Anil Chaturvedi, family physician of the complainant, Dr. Randhir Sud and Dr. Rakesh Tandon.
7. Aforesaid conspectus of rival claims and contentions of the parties boil down to a solitary contentious point that whether Dr. Kumar was negligent in not following the instructions for administering so called wonder drug IMURAN and whether the death of the deceased took place due to side effects of the drug Imuran prescribed by the OP inspite of his having recommended the surgery to which deceased did not agree.
8. To prove the negligence on the part of Dr. Kumar learned counsel for the complainants has referred to and relied upon the medical literature and instructions of the Company for its use which has manufactured this drug and which was known as wonder drug, special warnings and precautions for use of this drug have been given in clause 4.4, which is as under:-
There are potential hazards in the use of Imuran. It should be prescribed only if the patient can be adequately monitored for toxic effects throughout the duration of therapy.
It is suggested that during the first 8 weeks of therapy, complete blood counts including platelets, should be performed weekly or more frequently if high dosage is used or if severe renal and/or hepatic disorder is present. The blood count frequency may be reduced later in therapy, but it is suggested that complete blood counts are repeated monthly, or at least at intervals of not longer than 3 months.
Patients receiving Imuran should be instructed to report immediately any evidence of infection, unexpected bruising or bleeding or other manifestations of bone marrow depression.
There are individuals with an inherited deficiency of the enzyme thiopurine methyltransferase (TPMT) who may be unusually sensitive to the myelosuppressive effect of azathioprine and prone to developing rapid bone marrow depression following the intimation of treatment with Imuran.
This problem could be exacerbated by co-administration with drugs that inhibit TPMT, such as olsalazine, mesalazine or sulphasalazine.
9. Learned counsel for the OP has referred to death summary relied upon by the complainant (Annexure 13) which is as under:-
DEATH SUMMARY This 63 year old female known case of ulcerative colitis (Pan Colitis) since last 6 months on steroids since last 4 months and on Azathiopine 50 mg since last one month presented with complaints of difficulty in swallowing (4 days). Patient was examined and found to have extensive oral candidiasis. On investigation she was found to have pancytopenia (? Drug induced). Patient was managed with I/V Neopogen (G-CSF), platelet apheresis and blood transfusion along with nasogastric greeding and antibiotics. However, her pancytoponia failed to improve and she also developed respiratory distress (X ray bilateral patchy pneumonitis with effusion). On 08-03-2003 patient desaturated and went into altered sensorium. She was shifted to ICU, intubated and put on ventilatory support. CXR suggestive of hydropneumothorax ICD also put by chest physician and there was evidence of hemothorax. Patient was developed left sided hemiplegia. CT(Head) was suggestive of B/L MCA territory infarct Rt>Lt.
Inspite of all possible measures (repeated RT. Apheresis and Inj. Neopogen patients condition did not improve and had sudden cardiac arrest at 12/3/2003 on 8.50 P.M. CPR was started but could not be resuscitated and was declared dead at 9.20 P.M.
10. Learned counsel has contended that as per literature of the Company the OP was required to take blood count test every week for the first 8 weeks. But in this case the OP did not follow these instructions as for the first occasion when he advised for the blood count only after one week. Learned Counsel further contended that OP had advised administration of steroid on four different occasions without advising blood count which include on 19-02-2003 when he last saw the patient. Counsel further referred to Annexure VII whereby the surgery was advised by explaining need of surgery and type of surgery and on the same day again advised taking Imuran 50 mg OD without taking blood count which was again violation of instructions. It is further contended that even expert evidence produced by the OP also says that blood count test is mandatory and the patient must understand importance of this blood count test as a result of which fungal infection took place that ultimately resulted in death.
11. As against this learned counsel for OP has referred and relied to Review in depth Thiopurine Therapy by McGovern and Travis page 221 regarding the precautions for the use of the drug Imuran. Relevant extracts are as under:-
Blood count monitoring during thiopurine therapy:
The manufacturers of AZA recommended weekly full blood counts for the first 8 weeks of therapy followed by blood counts at least every three months. There is no evidence that this is effective. The authors practice is to perform a full blood count every 2-4 weeks for 2 months and then every 4-8 weeks. The rationale for this approach is that, if patients who develop thiopurine associated myelotoxicity, approximately half will develop within 2 months and nearly two thirds within 4 months. Just as important is the advice to patients to report promptly should a sore throat or any other evidence of infection occur. Profound leucopenia can develop suddenly and unpredictably in between blood tests, although patients (and their general practitioners) should be reassured that is rare (around 3% over all).
12. OP also referred to para 9 of the affidavit of Dr. Randhir Sud which is to the following effect:-
9. That I recommend that Imuran should not be used when the patient has a compromised renal or hepatic function. Minimum monitoring requires a base line HB, TLC and Platelet Count, followed up by these investigations ever 2-3 weeks.
When low doses of Imuran are used at least once a month monitoring of HB, TLC & Platelet count is essential for the first 3 months of therapy. In case the patient develops any symptoms & signs of stomatitis, glossitis, thrush, bruises, infection or bleeding, he must immediately report to his doctor and the clinician must promptly get the blood investigation done.
13. On the premise of the aforesaid medical literature, followed by the affidavit of Dr. Randhir Sud, counsel for the OP has contended that OP followed the same protocol which is recommended by the Indian and Western authors as he had done the first blood count on 1st February and then recommended platelet count besides other tests on 19th February. In this OP has relied upon Ex.
R-3 which is requisition of admission given to the deceased on 19th February 2003 when they had agreed for the surgery after his counselling. This requisition gives instructions for Neurologist and residents and includes CBC, complete blood count and other investigations and referral for surgery by Dr. BML Kapoor. However, patient did not turn up for admission and came only on 1st May i.e. after three months. Thus there is no deficiency of any kind whatsoever on the part of the OP.
14. While refuting the aforesaid contentions of the OP, the counsel for the complainant has averred that the cause of death as projected in the written statement by the OP was due to the progression of the main disease process and possibly contributed by the side effects of steroids on the immune system probably due to or significantly contributed by fungal septicemia and contributed by lung aspiration and also by cerebral artery thrombosis. However, autopsy is necessary to establish the cause of death in such a patient and even cursory examination of the Death Summary dated 25-03-2003 signed by Dr. Randhir Sud himself reveals that he was not sure as to the cause of Pancytopenia, as he has put a question mark before drug induced.
According to the counsel this confirms that drug imuran or one or more of so many other drugs that the patient was being given was only presumed to be the possible cause of Pancytopenia and it was never confirmed or established to be due to Imuran therapy. Further that it has also not been established that the cause of death was Pancytopenia as the same document also reveals that the patient had also developed hydro pneumothorax and B/L Middle Cerebral Artery territory infarct. As to why these complications occurred and what was their contribution to the death of the patient could be found only by Blood cultures, Fungus cultures, trephine bone marrow biopsy during her life time and by autopsy after her death.
15. Counsel for the complainant has further referred to the following prescription of Sir Ganga Ram Hospital at the time of admission, which is Anenxure 8.
ULC Colotis Pancolic Fungal stomatitis On steroids Admit urgently.
16. So far as fungal stomatitis is concerned there is a question mark put by the doctor.
As regards the death certificate the learned counsel for the complainant has contended that according to this summary the patient was admitted in the hospital on account of fungal stomatitis because of steroids, which is 45 by the death summary. On investigation she was found to have pancytopenia, which according to the learned counsel, means blood count has reduced because of drug induction and which fortifies suspicion of the doctors of Ganga Ram Hospital as to the fungal stomatitis. The learned counsel for the complainant has also relied upon the cause of death as shown in the death certificate which was as under:-
Ulceratius coltis & pancytopenia with immuno suppression.
Thus according to the learned counsel aforesaid cause of death was result of side effect of the drug Imuran.
17. While justifying the prescription of imuran 50 mg OD on 19-02-2003, the learned counsel for the OP contended that OP did not want to discontinue with this because there was no chance of side effect at that time which could possibly be attributed to the said drug and in the past surgery was being advised but the complainant was not agreeable for that. Hospitalisation was advised only for surgery and not for drug as medical literature nowhere says that this drug should be administered at Hospital. What is suggested is that it should be done under supervision. Dr. Randhir Sud expert of Ganga Ram Hospital has recommended that this drug should not be used when the patient has a compromised renal or hepatic function.
Minimum monitoring requires a base line Hb, TLC and Platelet count, followed up by these investigations every 2-3 weeks. When low doses of Imuran are used atleast once a month monitoring of Bh, TLC and Platelet count is essential for the first three months of therapy. In case the patient develops any symptoms and signs of stomatitis, glossitis, thrush, bruises, infection or bleeding, he must immediately report to his doctor and the clinician must promptly get the blood investigation done. According to the learned counsel during the period no such symptoms or signs were visible or appeared nor was complained, nor were reported to the OP and therefore Dr. Kumar, by no stretch of imagination and even remotely can be held guilty for negligence in administering the deceased the drug Imuran nor was the death result of side-effects, if any of the drug.
18. We have accorded thorough consideration to the rival contentions and claims. Question of ascertaining medical negligence has been cropping up time and again. Guidelines and criteria for ascertaining the medical negligence laid down in Bolams case reported in (1957) 2 AII ER 118, 121 D-F still hold the field. This test, in popular parlance is known as Bolam Test after the name of the petitioner.
In short 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)
19. Bolam test was accepted with approval in the following judgments:-
(I) Sidway V. Bethlem Royal Hospital Governors and Others 643 All England Law Reprots (1985) 1 All ER.
(II) Maynard V. West Midlands Regional Health Authority 635 All England Law Reports (1985) 1 All ER.
(III) Whitehouse V. Jordan and Another 650 All England Law Reports (1980) 1 All ER.
20. Presumably because of persuasive value of Bolams case that 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. Observations of Supreme Court 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.
21. While dealing with the concept of criminal medical negligence as well as the medical negligence the broad principles laid down by the Supreme Court are -
(i) That the guilty doctor should be shown to have done something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do.
(ii) Hazard or the risk taken by the doctor should be of such a nature that injury which resulted was most likely imminent.
22. Although, there is a distinction between the medical negligence of a criminal nature and simplicitor medical negligence but consumer is entitled for compensation on account of both kinds of negligence. The test for holding the medical professional liable for criminal negligence should be such which should manifestly demonstrate utter act of rashness and negligence whereas ordinarily the medical negligence or deficiency 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 (Section 2(1)(g)).
23. To ascertain the medical negligence, cumulative conclusions drawn from various decisions can be summed up in the form of following queries? Decision will depend upon the answers:-
(i) Whether the treating doctor had the ordinary skill and not the skill of the highest degree that he professed and exercised, as everybody is not supposed to possess the highest or perfect level of expertise or skills in the branch he practices?
(ii) Whether the guilty doctor had done something or failed to do something which in the given facts and circumstances no medical professional would do when in ordinary senses and prudence?
(iii) Whether the risk involved in the procedure or line of treatment was such that injury or death was imminent or risk involved was upto the percentage of failures?
(iv) Whether there was error of judgment in adopting a particular line of treatment? If so what was the level of error? Was it so overboard that result could have been fatal or near fatal or at lowest mortality rate?
(v) Whether the negligence was so manifest and demonstrative that no professional or skilled person in his ordinary senses and prudence could have indulged in?
(vi) Everything being in place, what was the main cause of injury or death. Whether the cause was the direct result of the deficiency in the treatment and medication?
(vii) Whether the injury or death was the result of administrative deficiency or post-operative or condition environment-oriented deficiency?
24. There is no dispute that the patient was suffering from advanced ulcerative colitis and appeared to be resistant to conventional medical treatment and the patient was adamantly refusing medical surgery which many such and other patients who are scared of the unforeseen effects of surgery do. After having consulted and received treatment from various doctors the deceased came to the OP. OP counseled the complainant and suggested that he would try conventional medical treatment and if it does not succeed she will have to go for surgery. Out of 10 visits of clinics the first 6 visits pertains to conventional medical treatment which showed significant improvement and by the 6th visit she was almost symptom free. Then she went abroad for two months and on her return from there she developed severe diarrhea and when she approached OP on 24-01-2004 i.e. the 7th visit, OP again counseled for surgery because medical treatment had failed. But she adamantly refused for surgery and it was in these circumstances that Dr. Kumar gave option of Imuran which is a drug with adverse indications but it has potential side effects. He explained in details about the drugs probable effects and side effects and the need for close follow up and monitoring to the patient and the accompanying husband. He as a matter of abundant precaution advised Imuran therapy in low doses of 50 mg OD and advised her to come every week and also advised for blood check up which was done on 01-02-2003, then on 19-02-2003 when she came to the OP. It was the considered opinion that she was not responding to the Imuran therapy, he then decided to have surgery and explained all the procedure and expected benefits and the possible problems and gave them requisition slip for admission to Apollo hospital where he was attached. He advised admission and prescribed investigations including platelet counts. What else he was expected to do. Time and again the patient and her husband and relatives reverted to him having immense faith in him. Inspite of the fact that there were no perceptible side effects, OP-doctor all the time advised her for surgery. Medical literature nowhere provides that this drug should be administered at hospital or during hospitalization. He was not a quack who did not know the potential risks or side effects of the medicine and therefore gave low doses inspite of the fact that the manufacturer of the drug claimed it a wonder drug. Record shows that he had taken the platelet counts on every occasion inspite of her having shown signs of improvement. He had followed the same protocol as recommended by Indian and Western authors. Even Dr. Randhir Sud put a question mark as to fungal stomatitis being result of or side effect of the drug. He even was not sure whether cause of death was pancytopenia. According to him where low doses of Imuran are given, monitoring of Hb, TLC and platelet count is done once a month. That was what Dr. Kumar had done. What if a patient did not report for long against advice and even did not report about symptoms and signs of stomatitis, glossitis, thrash, bruish, infection or bleeding. Still Dr. Kumar while recommending for surgery to Apollo on their agreeing to it gave instructions for Neurologist and residents which included CBC, complete blood count and other investigation.
25. Above all, the cause of death as shown in the autopsy report was progression of main disease process and mainly attributed by fungal septicemia and lung aspiration
26. Thus from any aspect we may hold up the matter, OP-Doctor cannot be held guilty for any kind of negligence much less the medical negligence as he was a skilled person and treated the deceased with all possible care and did what he was expected to do and did not do what he was not required to do nor was the drug Imuran administered in low dosage and with all care and caution by taking complete blood counts as and when required including platelets nor was the death result of induction of Imuran.
27. In the result, we find no substance in the allegations of medical negligence and dismiss the complaint.
28. Complaint is dismissed.
29. 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.
30. Announced on the 30th August, 2007.
(Justice J.D. Kapoor) President (Rumnita Mittal) Member jj