PER DR. S.M. KANTIKAR, MEMBER

 Complaint:

1.                            The Complainant, Smt. Sarita, filed this complaint, under section 21 of the Consumer Protection Act, 1986 against the Air Force Hospital, Gorakhpur, UP, OP-3, alleging medical negligence in treatment of her 9 year old son, Master Aditya Vikram, who died due to negligence and carelessness on the part of   OPs-4 & 5, i.e. Dr. Arun Dutta, Dr. Manisha Bishwas, contesting OPs and Dr. Ashwini Kumar, proforma OP. She prayed for action against the OPs-4 & 5 claiming damages to the tune of Rs.25,00,000/-. The Complainant’s husband was serving under control of OP-1 & 2. The Complainant’s son was legally entitled for medical treatment from OP-3.

2.                              Master Aditya, fell sick, on 26.03.1998, for which the Complainant took her son to the hospital of OP-5, Dr. Manisha Bishwas for medical treatment. The OP-5, after examining Master Aditya Vikram, advised for a CT Scan of head from Gomti Medical and Diagnostic Centre, Gorakhpur. It was performed on 26.03.1998. After going through the CT Scan report, the OP-5 told the Complainant not to worry, as it was just a minor disease, having a blot on the right side of head. The OP-5 started the treatment. On 27.03.1998, Master Vikram was taken for confirmation of TB disease, which was found to be negative. The treatment was continued, but no improvement was seen in the health of master Vikram.

3.                            On 28.03.1998, Master Vikram’s condition deteriorated. The OP-5 was requested by the Complainant to take an expert opinion from Gorakhpur Medical College. But, OP, again assured the Complainant that there was absolutely nothing to worry, there is no need for any reference to any other place or to any medical expert and OP-5 continued her treatment with ‘ALBEN DOZOLE’, till 31.03.1998. The condition further worsened, Master Vikram started vomiting, left hand and leg became paralyzed which was brought to the notice of OP-5 and requested to take the opinion of Neuro-Surgeon. But OP-5 turned a deaf ear to it. She flatly refused to refer the patient to a better medical institute. Hence, Master Aditya, further deteriorated with continued vomiting for 3 days, with fever and headache. Thereafter, OP-5 put the patient on dangerously ill-list (DIL). On 03.04.1998, the doctor falsely assured the Complainant, again, that Master Aditya would be preferably alright, within a few days. On 04.04.1998, at the request of the Complainant, her husband and a few well-wishers, the OP-5 referred the case to Command Hospital, Lucknow, on 05.04.1998, along with one attendant. Accordingly, the Complainant and her husband boarded the available train for Lucknow, but unfortunately, Master Vikram died at Gonda Railway Station which was declared by the Railway Doctor. Hence, the body was brought back to Gorakhpur and handed over to OP-3, which was kept in Mortuary and handed over to Police, for post-mortem report. On 07.04.1994, the post-mortem was performed by Dr. C. P. Srivastava at District Hospital, Gorakhpur (Annexure-C-2). Therefore, alleging medical negligence on the part of OP-4 & 5 in the diagnosis treatment and the deficiency in service in delayed referral to the higher center, the complainant filed this complaint and prayed for total compensation amount of Rs.25 lacs with 12% interest, p.a.

    Defence:

4.                            The opposite parties 1 to 5 filed their affidavit through Sqn. Ldr. D. N. Gupta of 12 AF Hospital, Gorakhpur (U.P.). The first point taken in defence was that the complainant has no jurisdiction to file this case under CP Act, because the deceased boy, master Aditya Vikram, was not a consumer. Also, the entire treatment was free of cost i.e. such free service would not fall, within the ambit of service under Section 2(1)(o) of the Consumer Protection Act, 1986. Further, the OP-5, Dr. Monisha Biswas filed an affidavit-evidence and her educational qualifications as MD Pediatrics. She has admitted that Master Vikram was brought to her, on 26.03.1998, with a complaint of weakness in the left upper and left lower limb. She has diagnosed the patient as left sided Hemiparesis with left facial nerve palsy (upper motor neuron type) and suspected the Space Occupying Lesion (SOL) either Tuberculoma or Cysticercosis in the right side of the brain, which was the cause for left sided hemiparesis/hemiplegia. Thereafter, she started treatment of the patient with doses of Albendazole.  Accordingly, OP-5 advised urgent CT Scan of brain. As the CT scan facility was not available with 12 Air Force Hospital, the patient was sent to Gomti Medical and Diagnostic Centre in Gorakhpur by service ambulance and the CT scan was performed.  OP-5, herself telephonically, obtained the CT scan report from Dr. Anurag Gupta, the Radiologist. The CT scan showed focal ring enhancing lesion having slightly hyperdense margins. This was explained to the patient’s parents and started treatment with Carbamazepine (an antiepileptic drug) and anti oedema therapy.  The opposite party No. 5 carried out blood test, X-Ray-chest and Mantoux test to rule out evidence of tuberculosis in the said patient, which was proved negative.  Therefore, the patient was started on Tab. Albendazole under steroid cover for neuro-cysticercosis, which is a standard treatment protocol. Since the patient did not show improvement, he developed right-sided headache and vomiting. Thereafter, Tab. Albendazole was ‘stopped’ and he was put in cerebral decongestive therapy (Inj. Mannitol + oral Glycerol).  The patient developed low grade fever and on next day with signs of meningeal irritation for which antibiotic Inj. Cefotaxime and treatment of tuberculosis was started.  Then, it was possible to transfer the patient to Command Hospital (Central Command), Lucknow, on 04.04.1998, for further investigation and management by Neuro-physician. Accordingly, free railway warrant was made available to the complainant’s husband (sick and sick’s attendant on 4.4.1998) for boarding, the early train, going to Lucknow. However, he got reservation done on 05.04.1998, at his own convenience. On 05.04.1998, the OPs 4 and 5, with all due care and precaution managed to send the patient to Lucknow, along with one senior Psychiatric nursing attendant. It was further averred that the course of therapy was appropriate for Cysticercosis/tuberculoma, which was to be continued for about 28 days or 9 to 12 months, respectively, and repeat CT scan was needed after completing the therapy. Therefore, the child was treated with appropriate therapy and with standard care and caution.  Hence, the OPs prayed for dismissal of the complaint.

Arguments and Findings:

5.                            We have heard the counsel for the parties. The counsel for complainant reiterated the facts of the complaint and vehemently argued that the OPs have not properly diagnosed the disease of Master Vikram, thereafter unnecessarily treated the patient with Albendazole, for long duration, which was contraindicated. OP-5 was negligent, as she has not referred the patient in time, to the Neurosurgeon, due to which, neurological signs had developed in the patient. Thus, it was total gross negligence and deficiency in service on the part of OP-5.

6.                            We have perused the medical records available on file and perused the report from Medical Council of India and also the opinion obtained from the Department of Neurology. 

(a) The expert opinion is reproduced as below:

DEPARTMENT OF NEUROLOGY

G. B. PANT HOSPITAL, NEW DELHI-2

                                                                             Dated : 09^th February, 2011

The Board met again on 09.02.2011 at 2.30 PM. The CT Scan Head (4 films) of Master Aditya Age 9.6 years done on 26.03.1998 was reviewed.  The CT showed a ring enhancing lesion in the right thalamic area with irregular walls and surrounding oedema, effacement of the right quadrignimal cistern and minimal pressure on the right lateral ventricles.

                             Possibility of

1.     Tuberculoma/Tubercular abscess with minimal mass effect

2.     Glioma

Even though there was no history of convulsions the child was being given prophylactic antiepileptic medication (Tegrital).  Patients with intracranial space occuplying lesion with raised pressure can deteriorate rapidly or can have convulsions leading to cardio respiratory arrest.

This might have happened in the case of Master Aditya.”

(b)         A Board of Medical Experts was constituted on the directions of the Medical Council of India.

The comments dated 23.12.2012 from Department of Paediatrics, Maulana Azad Medical College are also annexed herewith, which runs as follows:

“In reference to letter no. MCI-23(I)/Med(PG)/2012/139754 dated 20/10/2012, kindly find the comments on the matter as below:

A qualified pediatrician with post-graduate qualification (MD Pediatrics) can treat a child with neurocysticercosis/tuberculoma.  In fact, such children are primarily managed by pediatricians either as inpatients or outpatient cases.

Further, diagnosis and management of these conditions in children in part of the both undergraduate and postgraduate pediatric curricula.  These topics are included in the theory textbooks and patients of these conditions are admitted, discussed and managed in the pediatric wards during the post-graduation training.

Moreover, the data on pediatric tuberculoma and neurocysticercosis from India has been generated from pediatric departments of different medical colleges, as is evident from the list of publications attached as Annexure I

The standard treatment guidelines for neurocysticercosis have been given by various organizations/groups (Garcia, et al. Clin Microbiol Rev. 2002; 15: 747-56 and Garcia, et al. AM J Trop Med Hyg. 2005; 72:1 3-9); those provided by Indian Academy of Pediatrics are attached as Annexure II.  Management of tuberculosis and tuberculoma has been detailed by the WHO, by the Government of India under the RNTCP, and other groups; the one provided by Indian Academy of Pediatrics is provided in Annexure III.”

7.                            We have perused the medical literature on management of child epilepsy, childhood tuberculosis and relevant books on Pediatrics. Accordingly, we find that OP- 5 is a qualified Pediatrician and she treated the patient as per standard of practice and reasonableness. It was consistent with standard treatment of neurological manifestations, specific to neuro-cysticercosis by Tablet Albendazole, and it was not in excess dose. She had advised properly and carried out relevant investigations, at proper time. There is no deviation from normal practice. The treatment with Tab. Albendazole and Steroids was correct; we do not find that drugs were given /prescribed in excessive dose. Therefore, we are of the considered view that there is no medical negligence on the part of any of the opposite parties.

8.                            The Medical Literature relevant in this case is as follows:

                   NEUROCYSTICERCOSIS (NCC) IN CHILDREN

                   Treatment: Therapeutic measures for NCC may be considered as:

(i)           Symptomatic/supportive

(ii)          Definitive-medical/surgical treatment for cysts.

·        Most cases have partial seizures, hence carbamazepine is the preferred drug: Other AEDs could also be used, provided the efficacy and side effects are carefully considered.

·        Corticosteroids: A short course of corticosteroids is generally used concomitantly with anti-cysticercal therapy to prevent or ameliorate any adverse reactions that may occur due to the host inflammatory response during the active inflammatory phase.

·        Definitive Therapy

The debate, whether, medical treatment for NCC is effective or ineffective, has continued for long, even though, praziquantel and albendazole have been found effective against T. Sodium cysticerci, in several studies. The two main outcome measures of cysticidal therapy are (i) Cyst destruction and (ii) seizure control.

Cyst Destruction:       Both praziquantel and albendazole were found to be effective in destroying viable cysts. The main controversy revolves around the use of these agents, in cases with enhancing lesions, as they are considered to represent degenerating cysts.

Choice of Cysticidal Drug:    Although, both praziquantel and albendazole have been found effective in NCC, Albendazole is better than praziquantel, which is less expensive and better tolerated. It also has a greater penetration into the subarachnoid space and is, therefore, better for treatment of subarachnoid increases, with co-administration of steroids and is not affected by phenytoin and carbamazepine, whereas, the drug praziquantel, decreases, with co-administration of steroids, and with phenytoin and carbamazepine, which are generally used as, first line anticonvulsants in patients, with seizure due to NCC. Albendazole is currently the drug of choice for treatment of NCC.

Albendazole has been used in a dose of 15mg/kg/day in 2-3 divided doses for 28 days. Shorter durations of 14 days to 8 days have also been used. In a placebo-controlled trial of one week vs. four weeks albendazole therapy in children with one to three enhancing lesions both the regiments were found to be equally effective.

·        How is diagnosis of NCC made?

Neuroimaging is the mainstay of diagnosis of NCC. Lesions, suggestive of NCC on CT, in patients, with compatible clinical picture in endemic areas are usually diagnosed as NCC. The major drawback of these criteria is that they do not help a clinician, to differentiate NCC, from tuberculoma.

·        MRI and CT Scan, which is a better modality for diagnosis?

CT is claimed to have sensitivity and specificity of over 95% for the diagnosis of NCC (8). The sensitivity of CT is much lower for ventricular or cisternal forms of the disease. MRI is the most accurate technique to assess the degree of infection, location and the evolutionary stage of the parasites. It visualizes well the perilesional edema and the degenerative changes of the parasites, as well, as small cysts or those located in the ventricles, brainstem, cerebellum, base of the brain, eye and spine. CT is more sensitive for the detection of calcifications. The main disadvantages of MRI are its high cost and limited availability. Thus, in our setup, CT Scan may be the first investigation and reserve MRI imaging, for patients with inconclusive CT findings. Because of high incidence of small enhancing computerized tomographic lesion in our country, a CT Scan is indicated, after first focal seizure.

·        What is the treatment for NCC?

The treatment modalities that can be offered to patients include (i) larvicidal agents to kill the larvae; (ii) corticosteroids to decrease or prevent inflammation; (iii) anti-epileptic drugs to prevent or decrease the severity and number of seizures; (iv) surgical based therapies, including measures to remove the cyst and shunt placement for hydrocephalus.

·        What is the role of corticosteroids in management of NCC?

                   Cortisteroids are used as an adjunct to cysticidal therapy to control the inflammatory reaction that usually occurs 2-5 days, after initiation of therapy and decrease the symptoms (headache, nausea, vomiting and seizures) caused by the death of larvae. Its usage has not been standardized and is given empirically, for a variable duration of 5-28 days.

9.                            Medical Negligence was discussed in several land mark judgments from Hon’ble Supreme Court of India and abroad. It was decided that, ‘No sensible professional’ would intentionally commit an act or omission, which would result in harm or injury to the patient, since the professional reputation of the professional would be at stake. A single failure may cost him dear in his lapse.

As Lord Clyde stated in Hunter vs. Hanley 1955 SLT 213:

“ In the realm if diagnosis and treatment there us a ample scope for genuine difference of opinion and one mane clearly is not negligent merely because his conclusion differs from that of other professional men… The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care….”

10.                         We cannot apply the doctrine of res ipsa loquitor in this case, as simply because a patient has not favorably responded to a treatment given by OP-5. We cannot straightaway hold OP-5 liable for medical negligence. The Supreme Court in Jacob Mathew’s case:

“ A medical practitioner faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act. Obviously, therefore, it will be for the Complainant to clearly make out a case of negligence before a medical practitioner is charged with or proceeded against criminally. A surgeon with shaky hands under fear of legal action cannot perform a successful operation and a quivering physician cannot administer the end-dose of medicine to his patient.” 

When a patient dies or suffers from some mishap, there is a tendency to blame the doctor for this. Things have gone wrong and, therefore, somebody must be punished for it. However, it is a well-known fact that even the best professionals, what to say of the average professionals, sometimes have failures. A lawyer cannot win every case in his professional career, but surely he cannot be penalized for losing a case, provided he had appeared in it and made his submissions.

Therefore, on the basis of forgoing discussion, judgments of Hon’ble Supreme Court and on the basis of medical literature, we are of considered view that the opposite parties are not liable for any medical negligence. Accordingly, we dismiss the complaint. Parties are directed to bear their own costs.