Pronounced on: 11th February 2022 ORDER DR. S. M. KANTIKAR, PRESIDING MEMBER 1. A doctor couple, Dr. Samir Jain and Dr. Pooja Jain, dentist by profession were practicing at Gaya. On 16.04.2012 Dr. Pooja (since deceased herein referred to as “the patient”) had symptoms of fever, sore throat and myalgia. She consumed medicines Azithromycin and Paracetamol for 3 days and started attending her dental clinic from 21.04.2012. On 24.04.2012 around at 1.00 p.m., she felt stress, state of confusion and irritable mind, therefore she came back to home. She consulted Dr. A. N. Rai, a renowned physician, who examined her but was unable to find the cause. He advised to take her to advance medical centre for further management. Accordingly, in the morning on 25.04.2012, they travelled by road from Gaya to Patna, and then flew to Delhi. She was accompanied by her husband and father in law – Dr. Vijay Jain. During their travel from Gaya to Patna, once she got generalized convulsions (seizures) which lasted for one minute and similar two convulsions occurred in the flight, which lasted for 30 to 60 seconds. According to the Complainant, the convulsions were organic / psychogenic in nature without any mouth frothing, and tongue bite or injury. On landing at Delhi airport, the patient was directly taken to Sir Ganga Ram Hospital (SGRH) by an ambulance and was admitted in Emergency ward at 11.15 AM. After preliminary assessment and treatment, she was intubated and shifted to I.C.U. and put on ventilatory support. The treatment was started with anti-epileptic, anti-malarial, antibiotics and antiviral drug (Acyclovir). The M.R.I. and other blood reports revealed normal findings. She was ex-tubated after two hours. 2. On the same day evening, the parents of Dr. Pooja and their close family friend Dr. S.P. Kalantri with Dr. Jyoti Sehgal (OP-4) reached SGRH. Dr. Jyoti was a former PG student of Dr. Kalantri and was presently working as an Associate Consultant in the Deptt. of Neuroscience in The Medicity at Gurgaon (hereinafter referred to as the ‘Medanta’-OP-1) . The Complainant alleged that for the better care and treatment, the OP-4 advised the family members to shift the patient at Medanta. Therefore, under impression that the presence of OP-4 would be more helpful, the patient was shifted to Medanta by ambulance on 26.04.2012. The patient was admitted in the Neuro I.C.U. headed by Dr. Sumit Singh (OP-3) with Dr. Jyoti Sehgal (OP-4). It was alleged that the condition of patient was stable and all the blood investigations, E.E.G., M.R.I.(twice) and CSF study (Lumbar Puncture) were normal, except slightly low Serum Calcium level. In spite of all normal reports, unnecessarily the patient was administered with heavy doses of higher antibiotics, antiviral drugs and steroids. It was further alleged that both the consultants (OP-3 & 4) had never arrived for final diagnosis, but treated the patient on experimental basis unethically to generate more revenue. The Complainant and his father requested the doctors to take a second opinion or refer the patient to AIIMS, Delhi or PGI Chandigarh or CMC Vellore but they evaded it. Therefore, the complainant himself tried to get the patient admitted in AIIMS, Delhi, but his efforts failed and as no option left, the patient was again shifted to SGRH on 08.05.2012 at about 1.00 pm. After 39 days, during the treatment, she expired on 15.06.2012. It was alleged that the Complainant sold jewelry of his wife to pay hefty bills of Medanta and SGRH. After the patient’s death, the Complainant and his father, Dr. Vijay Jain have consulted and discussed with many senior doctors, also got information from the advanced medical literatures that the treatment given at Medanta was not correct, wherein many drugs were unjustified and unethical including IVIG (Rs. 56,000/- per day). 3. Being aggrieved by the untimely death of his wife, Dr. Samir Jain filed the Consumer Complainant under Section 21(a)(i) of the Consumer Protection Act, 1986 (hereinafter referred to as “the Act 1986”).The Complainant, in support of his case, filed his affidavit of evidence as (PW-1) and opinion with an affidavit of Dr. Pranshu Kumar as (PW-2). 4. In the defense, the OPs filed their respective written version and denied any negligence during patient’s treatment at Medanta. It was submitted that the Complainant made false statements and suppressed material facts about the details of the previous treatment taken at Gaya, Patna and SGRH. It was further stated that the patient died in SGRH after 39 days of treatment, no previous treatment details were made available, and therefore the OPs are not liable for any medical negligence. 5. The OP-4, Dr. Jyoti Sehgal, in her reply denied about any suggestion made to the patient’s family members to shift the Patient to OP-1. The Complainant and attendants on their own accord took discharge against medical advice (DAMA) from SGRH on 26.04.2012 and shifted the Patient to Medanta at 2:45 pm. She was directly admitted in ICU under the observation of the Senior Consultant Dr. Sunit Singh, OP-3 being the Head of Department and OP-4 being Associate Consultant, from Neuro department. It was denied that the patient was in stable condition while shifting from SGRH. The patient was unstable, drowsy, irritable and violent. She had recurrent attacks of true seizures and she was intubated. She also had urinary incontinence. The Glasgow coma scale (GCS) was E4 M5 V2 i.e. E4 (opening eye spontaneously), M5 (localizing to pain), V2 (incomprehensible sounds). The provisional diagnosis of Viral Encephalitis was made and treated as per the standard protocols. However, on 08.05.2012 against medical advice, the Patient’s father-in-law got the patient discharged from the OP-1 Hospital and shifted back to SGRH, wherein she survived for 39 days and passed away on 15.06.2012. Therefore, no medical negligence or deficiency attributed to the OPs. 6. We have heard the arguments from both the sides, perused the material on record inter alia the medical record of the Medanta Hospital. The previous treatment details taken at Gaya and also the medical record of SGRH for 39 days (08.05.2012 to 15.06.2012) were not available. 7. The learned counsel for the Complainant vehemently argued that it was a case gross negligence from the OPs, which caused death of young doctor. The treating doctors failed to make definite diagnosis of Typhoid or Malaria or Dangue or Herpes Encephalitis or Rabies. For Typhoid Dot IgG and IgM tests of no significance were done but it was to be confirmed by Blood Culture. The treatment started with higher antibiotics like Inj. Ceftriaxone and Inj. Monocef 2gm IV twice a day for 7 days. The blood test for M.P. (Malarial Parasite) was negative, even then unnecessarily administered IV Inj. Falcigo IV for 5 days. Even The MRI and CSF reports were normal but the patient was treated with anti-viral Inj. Acyclovir for 10 days, which was known to cause several adverse effects like tremors, lethargy, agitation, disorientation, convulsion and coma. He further argued that the OPs-3 & 4 failed to understand the type of seizures whether true or false. To differentiate it, a simple cost effective test Serum Prolactin level was not advised. The treating doctor suspected that the seizures were due to very low calcium level. The convulsions were not controlled despite use of eight anticonvulsants/ antiepileptic drugs namely Phosphenytoin, Leveratacitum, Valproicacid, Medazolam, Propophol, Pantothal sodium, Oxcarbazepine and Lacosamide. Thus, due to such indiscriminate use of drugs, more harm caused to the patient and she developed Refractory Status Epilepticus. The first drug of choice was Lorezapam to control status epilepticus, but the same was used much at late stage. Further the treating doctors suspected Autoimmune Encephalitis, and wrongly advised Methyl Prednisone for 5 days and then I.V.I.G. for 5 days. Thus, the doctors were experimenting with the patient to raise the hospitalization bills. 8. The learned Counsel for the Complainant brought our attention to the opinion given by one Dr. Pranshu Kumar, the Ex. Sr. Resident in Cardiology at Max Hospital. The Counsel also relied upon few medical literatures and some of the decisions of the Hon’ble Supreme Court in Dr. Laxman Balkrishna Joshi v Dr Trimbak Bapu Godbole[1] and Arun Kumar Manglik v Chirayu Health & Medicare Pvt Ltd.[2] 9. The learned Senior Counsel for the OPs, Mr. Joy Basu, argued the matter. He brought our attention to few medical literatures on the subject. He submitted that the patient was brought from Gaya to SGRH in critical condition. She had 5-6 episodes of Generalized Tonic-Colonic Seizures (GTCS) and urinary incontinence. The diagnosis was made as True Seizures and not false/psychogenic seizures. He reiterated the entire chronology of the treatment given at OP-1 and submitted that the entire treatment given to the patient was as per the standard protocols under neurology practice. To facilitate to the Complainant and the family to seek a second opinion, the Patient’s medical record with all CDs of EEG, MRIs and blood reports were issued to the relatives of the Patient. The complainant left the OP-1 hospital on 08.05.2012 against medical advice (LAMA) and shifted the patient to SGRH wherein she was under treatment for 39 days before her death. DISCUSSION: 10. The main questions before us that whether the seizures were True or False (psychogenic) and the treatment given at Medanta Hospital was as per the reasonable standards in neurology practice. 11. We have noted the chronology of the patient’s entire treatment. As per record, Dr. Pooja Jain (deceased patient) consulted Dr. A.N. Rai at Gaya for her complaints on 24.04.2012. After examination he suggested to take her at higher center for further management. Accordingly on 25.04.201 her husband and her father in law (both were doctor) brought the patient from Gaya to New Delhi at Sir Ganga Ram Hospital, Delhi as an emergency case. She was intubated and shifted in ICU and put her on ventilator support and later extubated in two hours. The MRI and blood tests were normal. The treatment was started with anti-epileptic, anti-malarial, antibiotics and antiviral drug (Acyclovir). It is evident from the record that on 26.04.2012, from SGRH the Patient got discharged against medical advice (DAMA) and by ambulance, at 2:45 pm she was shifted to OP-1 in critical condition. The patient was admitted in neuro ICU under the observation of OP-3 and 4. The investigations like routine blood tests, Cerebrospinal Fluid (CSF), typhoid, malaria, Magnetic Resonance Imaging (MRI) and Electro encephalogram(EEG) were performed. At 3:30 pm, the Critical Care team examined the patient. She was drowsy, semi-conscious, restless and agitated, also noted skin rash on the back. The provisional diagnosis of viral encephalitis was made. The Patient’s Blood Pressure was low and SPO2 (with oxygen support) was 100%. Medication to improve her BP was started and an Arterial line was put to monitor the BP. Therefore further Polymerase Chain Reaction (PCR) test to confirm Herpes and CSF culture was advised. The reports were awaited and as per standard Neurology protocol till then the specific medicines Acylovir (anti-viral), Pantocid (antacid), Monocef (for suspected brain infection / typhoid) and Levepil (anti-epileptic / seizures). 12. As per the observation of Critical Care specialist, on 27.04.2012 at 2:45pm, the patient had GTCS for 30 seconds, which aborted on its own. Therefore, as the earlier dosage of Levipil was insufficient, the Neurologist started Phosphenytoin (anti-seizure drug). The Patient again suffered seizures at 10 am, did not abort spontaneously, therefore injection of Midazolam was given, but despite that at 10.10 am the GCS was E4,M6,V2 [Spontaneous eye opening (E4) with moving of all limbs (M6) and making some incomprehensible sounds (V2)]. The tests for serum ammonia, calcium, magnesium, and leptospirosis were ordered. Resultantly, Inj Phenytoin (anti-seizure drug) was advised. At 11:00 am Dr. Atmaram Bansal, the Epileptologist at OP-1, Hospital, examined the patient and noted repeated focal (on one side of the body) seizures. Therefore medicines were stepped up and started Tab Lacosamide, an anti-epileptic drug. Again at 12.50 pm the Patient had generalized seizures which did not abort on its own, therefore Inj Lorazepam was administered. The Patient again, at 4.00 pm, suffered generalized seizures which did not abort on its own; Midazolam drip was started to stop seizures. The Patient was seen by OP-4 at 5.20 pm and intubated, after discussion with OP-3 for urgent MRI was done at 8.30 pm, it was reported as normal; however, as the Patient had continued with periodic seizures, therefore the same medicines continued. In the evening the Patient developed fever, the blood counts were on higher side, injection of Augmentin was stopped and Inj Zosyn was substituted. 13. It is pertinent to note that on 28.04.2012 at 3:15 pm despite the Patient being on drug Profol and Midazolam infusion along with 3 anti-epileptic drugs but the Patient had another generalized seizure though she was under heavy sedation. On 29.04.2012 in order to ruleout unusual causes of encephalitis, the doctors in consultation with the family members of the patient advised investigation like Anti N-Methyl-D-Asparate (NMDA) receptor antibodies, and anti Volage gated Potassium channels (VGKC) antibodies. However, the consent was given on 01.05.2012, only for Anti NMDA receptor antibodies tests. The report would take at least 2 weeks. Therefore as per the standard protocol in Neurology, steroid was started to cover unusual cases of encephalitis. 14. On 30.04.2012 despite higher antibiotics coverage, the infection was not under control. The EEG revealed features of a very high epileptic focus over the left posterior head region along with evidence for moderate degree of diffuse cerebral dysfunction. The findings confirm the seizures were genuine, and not false. Since the seizures were not getting controlled after discussion with the Epileptologist, Dr. Atmaram the drug dosages were increased. 15. On 01.05.2012, OP-3 examined the patient and found seizures on the left side of the body which progressed to whole body. Therefore, at 2 pm Thiopentone was started and her serum Phenytoin level was 5.8 microgram/dl. , which was less than the toxic dose. But, at 4.45 pm, the patient developed refractory status epilepticus; the condition wherein severe convulsions do not respond to a combination of multiple anti-epileptic drugs. Therefore, Thiopentone infusion was started but still condition of the Patient was deteriorating, therefore the option of IV-IG/plasma exchange was considered with subject to consent from the Patient side. The blood Creatine Phosphokinase (CPK) levels were high, indicative of continuous muscle activity because of real seizures. The patient again had a seizure at 6 pm and therefore, the dose of Thiopentone was increased to 200mg/hr. In the night at 11.45 pm the Patient was reviewed by an Epileptologist, and her EEG showed an acceptable response to the medicine given. 16. On 02.05.2012 the Patient remained seizure free till the morning. However, the Patient developed fever in the afternoon. On examination at 6.30 pm and at 8.15 pm she had two seizures and her condition continued to deteriorate. Therefore, the Patient was put on Intravenous immunoglobulin (IV-IG) and the dose of Thiopentone was increased to 250 milligrams at 8:15pm. However, in the midnight the Patient’s condition continued to deteriorate. The Patient once again got a seizure in the night, therefore from 6.15 am in the morning (3.5.2012) the dosage of Thiopentone was increased to 270mg/hr. The dosage was increased up to 550 mg/hr depending on the number of seizures. On 5.5.2012 at 7:00 am the Patient clinically and on EEG did not show signs of seizures, the anti-epileptic drugs were gradually tapered and Thiopentone was reduced to 150mg/hr. However, in the evening she continued to have abnormal facial movements despite Lorazepam, infusion of Midazolam and Propofol. Therefore, again the dosage of Thiopentone was increased to 450mg/hr. The Patient had another seizure and the dosage of Thiopentone was again increased to 500mg/hr and Injection Gardinal 60 mg twice a day was added. The oral medicines were actually tapered. 17. It appears that the doctors suspected Auto Immune Encephalitis and to rule out advised NMD receptor and anti VGCA antibodies tests but the complainant did not agree. Therefore administration of Methyl Prednisone and IVIG for five days was not wrong advice of the treating doctors. 18. It is pertinent that, the doctors first time, on 07.05.2012, noticed the touch induced seizures in the patient, therefore suspected rare possibility of Rabies, which in any manner shall not be construed as wrong of treating doctors at OP-1. There are instances of Rabies after 10-20 years of rabid animal bite. The family members refused consent for required tests for the patient. 19. On 8.5.2012 at 12.50 pm the Patients father-in-law took the discharge from the OP-1 (LAMA) and shifted the patient by critical care ambulance to Sir Ganga Ram Hospital wherein she was treated for 39 days from 8.5.2012 but she expired on 15.6.2012. 20. We have gone through the standard medical text books viz. Harrison’s Internal Medicine and Oxford Textbook of Epilepsy and Epileptic Seizures. Few medical literatures on “true and false seizures”, “typhoid” and “malaria” namely; (i) The coexistence of psychogenic nonepileptic and epileptic seizures in the same patient is more frequent than expected: Is there any clinical feature for defining these patients?[3] (ii) Dual diagnosis of epilepsy and psychogenic nonepileptic seizures: Systematic review and meta-analysis of frequency, correlates, and outcomes[4]. (iii) Psychogenic non-epileptic seizures (PNES) in the context of concurrent epilepsy – making the right diagnosis[5]. (iv) Infections of the Nervous System – Viral Infections[6] (v) Infections of the Nervous System – Parasitic Infections[7] 21. Another point for discussion is the opinion of Dr. Pranshu Kumar, which, in our view, does not materially substantiate or validate the Complainant’s case. His opinion was in the nature of evidence furnished on behalf of the Complainant. He was a private doctor. He based his opinion on the patient’s medical record, as was available with the Complainant. He was a Cardiologist, and even though he was not a subject matter expert in Neurology (seizure disorders), he gave his opinion in a field with which he had never been associated. It bears emphasis that this Commission, finding no need for it, did not seek expert medical opinion from a board comprising of experts in the concerned faculties, and constituted by a reputed premier independent medical institute (the bench, if it so felt necessary, in its considered wisdom, could have sought expert opinion from such board; but the bench did not find such necessity in the instant case). This finds support from the decision of Hon’ble Supreme Court in Nikhil Super Specialties case[8]. 22. The medical literature revealed us that there are many types of seizures, but the two main categories are epileptic and non-epileptic. As per Oh's Manual there is occasionally no clinical way to distinguish True or False seizures, and thus EEG testing must be embarked upon, to everybody's embarrassment and dissatisfaction. In the differentiation, the history and an eye witness have obviously prime importance. The pseudo-seizures are a physical manifestation of psychological distress, are not due to epilepsy. Changes to electrical impulses in the brain do not play a role, but a past trauma, anxiety, or a history of abuse may be the underlying cause. Typical epileptic seizures occur when an electrical disturbance in the brain’s nerve cells causes a person to lose control of their body. Their muscles may jerk or seize up uncontrollably, and they may also lose consciousness. 23. To sum up initially, the patient was admitted in ICU at SGRH on 25.04.2012 and discharged on the next day i.e. 26.04.2012. The discharge summary revealed the diagnosis as ‘fever with altered behavior with GTCS? Viral encephalitis, ?Malaria ?Metabolic ?tubercular’. The treatment given was inj. Acyclovir, inj. Falcigo, inj. Monocip, inj. Levipil, IV nor adrenaline. Thereafter, from 26.04.2012 to 08.05.2012, the patient was treated under Neurology Department at Medanta under the observation of OPs-3 & 4 and their team of specialist. As discussed above, the doctors treated her with antiviral, antibiotics and antimalarial drugs with standard doses. The anticonvulsant drugs were modified depending upon the type, severity and number of convulsions. Despite that, the convulsions were not under control. It is pertinent to note that on 8.5.2012 the patient discharged LAMA from OP-1 hospital and again shifted to SGRH, wherein same line of treatment was continued till death on 15.06.2012 for 39 days. Therefore, medical negligence is attributed to the doctors at OP-1 hospital. There was neither deficiency in service nor medical negligence. In the instant case, the doctors diagnosed the convulsions as True Seizures and not pseudo-seizures, therefore Psychiatry opinion was not sought and the Serum Prolactin level has no significance. Even the doctors cooperated with the patient’s family members to seek second opinion. 24. . In S. K. Jhunjhunwala vs. Dhanwanti Kaur and Another[9] wherein the negligence alleged was of suffering ailment as a result of improper performance of surgery. It was held that there has to be direct nexus with these two factors to sue a doctor for negligence. It was further held that in every case where the treatment is not successful or the patient dies during surgery, it cannot be automatically assumed that the medical professional was negligent. To indicate negligence there should be material available on record or else appropriate medical evidence should be tendered. The negligence alleged should be so glaring, in which event the principle of res ipsa loquitur could be made applicable and not based on perception. Similarly, the Hon’ble Supreme Court in Kusum Sharma & Ors. V. Batra Hospital and Medical Research Centre & Ors.[10] discussed about standard principles to establish medical negligence. In the case of Achutrao Haribhao Khodwa & Others V State of Maharashtra & others[11], the Hon’ble Supreme Court noticed that: in the very nature of medical profession, skills differs from doctor to doctor and more than one alternative course of treatment are available, all admissible. Negligence cannot be attributed to a doctor so long as he is performing his duties to the best of his ability and with due care and caution. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession. 25. Based on the available evidence of both sides and on the discussion made above, it appears that, in the instant case, the team of doctors in Medanta Hospital performed their duties with reasonable and requisite care and standard; medical negligence could not be established against them. Resultantly the Complaint fails, and the same stands dismissed.
[3] M.I. Yon et al. / Epilepsy & Behavior 105 (2020) 106940 [4] M.A. Kutlubaev et al. / Epilepsy & Behavior 89 (2018) 70–78 [5] Liampas et al. Acta Epileptologica (2021) 3:23 [6] Chapter 57B, Neurological Diseases Part-3 (1457 to 1487) [7] Chapter 57D, Neurological Diseases Part-3 (1505 to 1528) |