VAQAR MOHAMMAD KHAN vs S.K.TANDON

THIS is a complaint under Section 17(a)(i) of the Consumer Protection Act, 1986 (for short the ''Act'') filed on 8.9.2000 by the patient complainant Vaqar Mohammad Khan and his father Nisar Mohd. Khan of Teela Jamalpura, Bhopal against the opposite party Dr. S.K. Tandon, r/o Shivaji Nagar, Bhopal for the alleged medical negligence.

THE case of the complainant is that the complainant No. 1 Vaqar Mohammad Khan who is a student of B. Com. First year has some psychiatry problem. As per complaint Vaqar Mohammad Khan used to see dreams and utter words during sleep and had become short tempered, for the last three years. THE complainant No. 2 Nisar Mohammed Khan the father of Vaqar Mohammad Khan, brought the complainant No. 1 to opposite party Dr. S.K. Tandon who is a retired Assistant Professor, Psychiatry and having his own clinic at 85, Tajul Masajid Road, Near Hamidia Hospital, Bhopal. Dr. Tandon diagnosed this case of psychiatry and prescribed some medicines. It is alleged by the complainant that in the month of April, 1999 Vaqar Mohammad Khan developed complaint of severe constipation, stomach disorder, suffocation, breathlessness and uneasiness. Due to these troubles, he was taken to Apex Hospital, Bhopal where he was admitted on 12.3.1999. On the advice of the Apex Hospital Routine Haematology (Blood Examination) got done at Chirayu Health and Medicare Pvt. Ltd. It is alleged by the complainant that this blood report revealed that W.B.C. Count were less in the blood. THE opposite party Dr. S.K. Tandon also visited the Apex Hospital and examined the complainant No. 1 and advised the doctors of hospital to continue his medicines along with other medicines of stomach disorder. So when the complainant No. 1 was discharged from the Apex Hospital, he was advised by the doctors of the said hospital to continue the treatment prescribed by Dr. S.K. Tandon. On 18.4.1999, the complainant No. 1 Vaqar Mohammad Khan had many vomiting in the day and in the evening he was suffering from fever, so he was brought to Hamidia Hospital where medicines for fever, Nausia and vomiting were given but the complainant No. 1 could not get any relief, therefore, on 19.4.1999 the complainant No. 1 was taken to the opposite party Dr. S.K. Tandon who on the basis of the new development and condition of the patient prescribed some medicines along with other earlier medicines but when there was no relief, the complainant was taken to Chirayu Hospital, where Dr. Ajay Goenka examined him and prescribed some medicines. On 20.4.1999, the complainant No. 1 first appeared in the examination but because of high faver, he could not solve the question paper, therefore, the complainant No. 2 his father brought the complainant No. 1 to Chirayu Hospital and got admitted, where treatment started and there was improvement in vomiting but loose motions continued. Though the treatment was continued but there was no relief in frequent loose motion and high fever. THEn the complainant No. 2 his father decided to take his son to Choithram Hospital, Indore. So the complainant No. 1 got discharged from Chirayu Hospital, Bhopal and shifted to Choithram Hospital, Indore on 24.4.1999 where he was admitted and examined by Dr. Ajay Jain, the Gaestro-Entrologist and patient was kept in Intensive Care Unit (I.C.U.). At this time, the complainant No. 1 had high fever and loose motions and breathlessness. It is alleged in the complaint that after 5-6 days further investigation of the blood of the complainant No. 1 revealed that there is shortage of blood in the body and W.B.C. counts were very less being 2700 as against 4000 to 10000 in normal human blood. The complainant has stated that this blood examination was done on 28.4.1999 in that blood value and Neutrophils were found less to the normal value. It was due to the better treatment of Choithram Hospital complainant No. 1''s condition improved and he was saved. It is alleged by the complainant in the complaint that complications developed due to reaction of medicines Clozapine (Sizopin) which was administered by Dr. S.K. Tandon without keeping in mind the side effects of such a dangerous drug. Thus the complainants alleged medical negligence against the opposite party, Dr. S.K.Tandon : (i) Clozapine (Sizopin) should not be initiated if W.B.C. count is less than 3500/cu.mm. It is alleged by the complainant that it was 2700 in case of complainant No. 1. (ii) The opposite party Dr. S.K. Tandon did not care to get the blood examination done every week because continuous use of clozapine causes reduction in W.B.C. and this has happened in the case of the complainant. (iii) The opposite party Dr. S.K. Tandon has committed medical negligence by prescribing doses of Sizopin. In the literature dose suggested is tablet of 25 mg once or twice daily gradually to be increased by 25 mg. daily till therapeutic effects are noticed. In the present case, Dr. S.K. Tandon prescribed 4 tablets of 25 mg. daily. (iv) The opposite party has not taken care to get the blood examined and after reviewing the W.B.C. Count doses was to be prescribed. Not following the procedure the opposite party has further committed medical negligence.

The complainant alleged deficiency in medical service has demanded a compensation of Rs. 5 lacs for sufferings, pain and mental shock to the complainant No. 1 and Rs. 53,891/- to the complainant No. 2 for medical expenses incurred by him and Rs. 5,000/- as costs of the proceedings, thus a total of Rs. 5,58,891/-.

THE opposite party Dr. S.K. Tandon submitted that he has not committed any deficiency in treatment of the complainant No. 1. On the other hand, he has fully followed the medical ethics norms and procedure for the treatment of the disease by which the complainant No. 1 was suffering. In his reply and affidavit he has drawn our attention to the prescription given by him from time to time for treatment of the patient, the complainant No. 1. In his arguments he has stated that the complainant has not mentioned that from which date the complainant No. 1 Vaqar Mohammad Khan was under his treatment. He has stated that the complainant was under his treatment from 15.10.1998. On this date he prescribed medicines for 15 days but the patient was brought to him on 22.10.1998. On this date two medicines were added and patient was advised to visit after a week. On 31.10.1998, the condition of the patient was reviewed and on the basis of symptoms some doses were increased and the patient advised to consult again after 15 days. On the other hand after 2 months i.e. on 27.1.1999 the patient was brought to him. During this period, the patient had developed some more problems of breathlessness, uneasiness, anxiousness, and frequently talking very high and his nature became irritative. He prescribed medicines for 15 days but when there was no response of medicines prescribed by him, the patient was again brought to him on 31.1.1999 i.e. within 4 days. This time again some medicines were added but the patient was not responding properly by these low dose medicines and the patient was brought on 12.2.1999. On this date when there was no improvement a new medicine Lithium was prescribed. THE patient was again brought on 17.2.1999, with the complaint of dryness in the throat, therefore, medicines Ativan was added. On 1.3.1999 same medicines were repeated and the patient was brought on 5.3.1999 on that day new tablet Mazdol was added. It is further submitted by the opposite party that there was no satisfactory improvement in the condition of the complainant then for the first time Sizopin was prescribed on 9.3.1999 for 15 days. This medicine is available on the special letter of the doctor, therefore, when this medicine was prescribed, a special letter was given. In that letter, an advice was also given for total blood picture and C.T. Skull. It has been submitted by the opposite party Dr. Tandon that apart from Psychosis, the patient was also suffering from Constipation and other stomach troubles, therefore, on 12.3.1999 the patient was admitted in the Apex Hospital where Ultrasonography test was performed on 13.3.1999 and blood test was got done from Chirayu Hospital on 12.3.1999. In the blood count, W.B.C. and Neutrophils were more than the normal but sonography test dated 13.3.1999 revealed that 2 Micreedculli seen in left kidney. In the Apex Hospital, Dr. C.C. Chaubal who is Gastroentrologist has treated the patient but the complainant has not produced prescription and treatment given by Dr. C.C. Chaubal in Apex Hospital and only filed Sonography report of the Apex Hospital. This shows that the complainant had suppressed this fact. On 26.3.1999 when the patient contacted him, he examined the blood test report of Chirayu Hospital dated 12.3.1999, in this report W.B.C. count was quite alright i.e. more than the normal limits, therefore, Tablet Sizopin and other medicines prescribed by him were continued and an advice for C.T. Skull and Blood test was given which the patient avoided. On the basis of the special letter to purchase sizopin issued on 26.3.1999, the complainant purchased medicines on 12.4.1999. Again the patient contacted him on 19.4.1999 but did not produce the C.T. Skull and blood test resport. On that day he found that the patient was mentally improved but there was complaint of vomiting. As he had not brought the blood test report, therefore, special letter for purchase of Sizopin was not given on 19.4.1999.

DR. S.K. Tandon submitted that during the treatment, the W.B.C. count of the patient was above normal limits and on 19.4.1999 when he did not bring the blood examination report, he did not give special letter for purchase of Sizopin, therefore, the complaint of stomach disorder, and high fever cannot be attributed to Sizopin tablet, hence, the complaint is baseless and be dismissed. We have gone through the complaint written statement, affidavits and documents filed by the parties. The main thrust of the complainant is that the opposite party Dr. S.K. Tandon has prescribed over doses of Sizopin tablets beyond the limits and he has not got done W.B.C. count test before prescribing these medicines, therefore, the reaction of the Sizopin tablet developed as Agranulocytosis which was a potentially life-threatening event. Now to arrive at a conclusion that whether there has been any medical negligence on the part of the opposite party Dr. S.K. Tandon or not, we have to examine the nature and disease by which the patient was suffering, the precautions before prescribing medicines and the doses have been followed by the opposite party Dr. S.K. Tandon.

IN the written reply as well as in affidavits filed and during the arguments, the opposite party has submitted that the patient was suffering from Manic Depressive Psychosis, Manic type (Mania). This Psychosis required long and continuous treatment. The symptoms of this disease are that the patient becomes irritative developed insomnia, uneasiness, breathlessness and talking irrelevant in high tone. So far as treatment is concerned, learned Counsel for the opposite party has drawn our attention to the book "Treatment of Psychiatric Disorders" by Gabbard, Second Edition Volume I at page 1155 under the head "Antipsychotic Drugs" which we quote : Antipsychotic Drugs Antipsychotic Drugs were some of the first drugs used to treat acute mania, and numerous studies have shown their effectiveness. Although the onset of action of Antipsychotic Drugs is often more rapid than that of lithium, carbamazepine, and valproic acid.

ON the basis of this literature, the opposite party Dr. S.K. Tandon has submitted that he first prescribed Trinorm which is a Antipsychotic/Neuroleptic Drug but there was no improvement in the patient, therefore, Lithium was prescribed. In the same book Treatment of Psychiatric Disorders at Page 1151, it has been recommended that if a patient is suffering from acute mania then Lithium can be the drug of choice. We quote : Lithium. xxx xxx xxx xxx xxx xxx xxx xxx Lithium is the prototypical antimanic drug and the one against which others are measured. It is the only drug currently approved by the FDA for the acute or maintenance treatment of mania and continues to be drug of choice. The opposite party Dr. Tandon has submitted that when this medicine also proved ineffective and there was no improvement in the condition of the patient, therefore, Sizopin was prescribed. The opposite party Dr. S.K. Tandon has drawn our attention to the book "Treatment of Psychiatric Disorders" by Gabbard, Second Edition Volume I at page 1321 under the head Neuroleptics Clozapine which we quote : Neuroleptics Clozapine xxx xxx xxx xxx xxx xxx xxx xxx The atypical antipsychotic agent clozapine appears to offer better results. In case reports and open series, bipolar patients refractory to neuroleptics, anticonvulsants and lithium are reported to derive substantial improvement that persists in the maintenance phase. Clozapine was reported to be beneficial for seven of seven biopolar patients with mixed episodes. Treatment was continued for 3 to 5 years during which patients made substantial improvement in psychosocial functioning case reports (Frakenburg 1993) describe a positive response during maintenance treatment of bipolar patients previously refractory to lithium, anticonvulsants, and typical neuroleptic drugs. Daily dosage of clozapine for treatment of bipolar patients ranges from 50 to 600 mg.

The submission of the opposite party that Sizopin medicine was administered to the patient at the right time as per medical literature. So far as the doses of the Sizopin is concerned, the complainant has drawn our attention to the leaflet (Ex. C-9) published by the manufacturer Sun Pharmaceutical Industries Ltd. of Sizopin in which Dosage has been mentioned which we quote : Dosage : Twenty Five mg. tablets tablet once or twice daily. Gradually increased dose by 25 mg. daily till therapeutic effects are noticed. Do not exceed a dose level of 300-450 mg./day. Subsequent dosage increments may be made once a week. Increases greater than 100 mg. should not be exceeded. To minimize risk of hypotension, seizure and sedation, divided dosage schedule is advised. Majority of patients respond well within 600 mg/day dose. Do not exceed doses beyond 900 mg/day.

FROM a bare look of the literature and the prescription of the opposite party we find that Dr. Tandon has prescribed Sizopin tablet of 25 mg. to be taken one in morning, one in afternoon and two at night i.e. 4 tablets per day this means 100 mg. per day, this dose could have been increased 100 mg. per day up to the level of 450 mg. per day but the opposite party Doctor restricted the dose only up to 100 mg. per day for a week which is well within the prescribed doses, therefore, the allegations of the overdose levelled by the complainant is baseless. Now we have to examine whether precaution of W.B.C. count was taken by the Doctor while prescribing medicines Sizopin. Literature filed by the complainant shows that "A baseline WBC count and Differential count before treatment and every week thereafter till 4 weeks after discontinuation of clozapine is recommended".

THE opposite party Dr. S.K. Tandon has submited that the patient was under his treatment from 15.10.1998 and on 9.3.1999 he prescribed Sizopin, on 12.3.1999 the blood report of Chirayu Hospital reveals that the W.B.C. count was 13,600 per cu. mm. as against 4500 to 11000 per cu. mm. being the normal value. THE Neutrophils were 82% as against 40 to 75% of the normal values. This means that even after four days of taking of Sizopin the blood level was more than the normal. Again W.B.C. Counts were 4,600/- per cu. mm. on 20.4.1999 this was also above 4,500 which minimum normal value. On the basis of this report dated 12.3.1999 Dr. S.K. Tandon repeated the medicine Sizopin on 26.3.1999. Again on 19.4.1999 because the complainant did not bring the blood and skull test report which was advised by him, therefore, special letter to purchase Sizopin was not given by Dr. S.K. Tandon. It is, therefore, clear that the precautions of W.B.C. count and Differential count before prescribing medicine were taken by the opposite party and he cannot be blamed for nay negligence. Now the question to be considered is whether the complaint of loose motion or high fever can be attributed to the medicine Sizopin. The opposite party Dr. Tandon has submitted in his reply and affidavit that the main side effect of the Sizopin is Agranulocytosis. Our attention has been drawn to the book "Treatment of Psychiatric Disorders" by Gabbard, Second Edition Volume I at page 1321 in which side effects have been mentioned which we quote : Clozapine therapy carries significant risks and limitations. These include the requirement for weekly monitoring of white blood cell count because of the risk of agranulocytosis, a substantial risk of seizures; drug interactions; and high cost. It is reasonable to reserve clozapine for patient unresponsive to other therapies in the algorithm while waiting for safer drugs with a similar profile. The opposite party Dr. Tandon has submitted that the medicine Sizopin was added on 9.3.1999. The complainant suffered loose motion and fever on 12.3.1999, this was treated as Gastroendrologic case in Apex Hospital. Again when he was admitted in Chirayu Hospital on 20.4.1999 he was treated for fever, vomiting, loose motion, loss of Apetite. This means that the symptoms are not of Arganulocytosis because of the symptoms of Arganulocytosis in medical literature is reduction of W.B.C. count. On 12.3.1999, W.B.C. count was 13.600 and neutrophils were 82% which were high than the normal. Again report dated 20.4.1999 reveals that W.B.C. count 4600 and Neutrophils were 41%. This means that even after use of Sizopin the W.B.C. count was within control limits. A perusal of prescription dated 26.3.1999 makes clear that the special letter issued by the opposite party Dr. Tandon for purchase of Sizopin on 26.3.1999 but the medicines were purchased on 12.4.1999. This means that the Sizopin purchased on 9.3.1999 for 15 days continued upto 25.3.1999 thereafter these medicines were purchased on 12.4.1999, this also makes clear that the patient was not using the Sizopin from 26.3.1999 to 12.4.1999 and on 19.4.1999 when there was complaint about fever, medicines were discontinued. Therefore, it cannot be said that the vomiting, fever, loose motion etc. was due to Sizopin.

AS per medical literature, consequent result of Agranulocytosis is reduction of W.B.C. count. If the W.B.C. count goes below up to 2000 then the medicine should be stopped. AS soon as the medicine is stopped W.B.C. count becomes normal within 5-7 days. AS it is clear from Harrison''s Principles of Internal Medicines 14th Edition Volume I page 354 which we quote : Drug induced neutropenia can be severe but discontinuation of the sensitising drug is sufficient for recovery, which is usually seen within 5 to 7 days and is common by 10 days.

THE opposite party Dr. Tandon has also produced "Minutes of the Round Table Symposia Sizpoin. THE Indian Experience" in which experiments of different doctors treating the psychiatric patient were given. In their experts opinion they have mentioned that Sizopin is effective in treating the patient and when the side effect of Arganulocytosis is observed, the use of medicine is stopped and within 5-7 days the patient recovered to the normal level. In the present case, the use of Sizopin was not recommended after 19.4.1999. This means that the doctor has taken proper care as per medical norms that unless W.B.C. count test is done Sizopin will not be recommended, therefore, the special letter for purchase of Sizopin was not issued on 19.4.1999. So far as the allegation of the complainant in the rejoinder that the special letter for purchase of Sizopin so filed were fictitious and false, the complainant has not filed any affidavit in support of his contentions whereas the opposite party has proved the documents by the affidavits of Dr. Tandon as well as by the affidavit of Shyamlal Saran, the proprietor of Naval Medicines Agency who used to supply medicines on the basis of special letter. Therefore, the contentions of the complainant cannot be accepted.

We, therefore, find that the cause of vomiting, loose motion and high fever cannot be attributed to Sizopin. Moreover, the complainant has not produced the opinion of any expert doctor to show that the treatment given by Dr. S.K. Tandon was not as per medical ethics and principles.

WHILE dealing with the case of medical negligence, the Madhya Pradesh High Court in case of Sudha Gupta & Ors. v. State of M.P. & Ors., 1999 (2) MPLJ 259, has observed thus : "Negligence-Burden of proof-Negligence is omission to do something which a reasonable man guided upon those considerations which ordinarily regulate the conduct of human affairs will do or doing something which a prudent and reasonable man would not do-There must be direct nexus between the death of a person and the negligent act-The burden of proving negligence rests upon the person who asserts it-In medical negligence cases, it is for the patient to establish his case against the medical man and not for the medical man to prove that he acted with sufficient care and skill (Paras 30-32)." The National Commission has also taken the same view observing that mishap during operation cannot be said to be deficiency or negligence in medical services. Negligence has to be established and cannot be presumed. See, the decision of the National Commission in case of Kanhiya Kumar Singh v. Park Medicare and Research Centre, III (1999) CPJ 9 (NC)=(2000) NCJ (NC) 12. Similar view has taken by the MRTP Commission in case of P.K. Pandey v. Suraj Nursing Home, II (1999) CPJ 65 (MRTP)=(2000) NCJ (MRTP) 268.

FROM the above discussion we find that the opposite party Dr. S.K. Tandon has acted with full care and diligence in treating the patient. He has exercised and applied his knowledge with full care and precaution and, therefore, we find that he is not guilty of medical negligence or deficient in service. In the result, the complaint fails and is dismissed with no order as to costs. A copy of this order be conveyed to the parties. Complaint dismissed.