Dr. Shabir Husain vs Centre For Sight, Delhi & 6 Ors

Dr. S.M. Kantikar, Presiding Member

The present Complaint has been filed under Section 21 of the Consumer Protection Act, 1986 by Dr. Shabbir Hussain (hereinafter referred to as the ‘Complainant’) against Centre for Sight, Delhi (OP-1), Centre for Sight, Hyderabad (OP-2), Dr. Santosh G Honavar-Consultant Ophthalmic & Plastic Surgeon, Dr. Anil Kumar Bura-Consultant Anesthetist and Dr. Subhash Kiran Yalamanchili- Consultant Anesthetist (hereinafter referred to as the Opposite Parties) for the alleged medical negligence which resulted into death of the Complainant’s son.

The Complaint

2.1 The complainant’s son, Sohail Husain, aged 19 years (since deceased, hereinafter referred to as the ‘patient’) was met with road accident and suffered multiple injuries to the head, face, and eyes. He initially he was treated at Jabalpur Hospital from 26.11.2015 to 24.12.2015 and underwent various surgeries including corneo scleral tear repair, lower lid repair, and lacerated wound debridement. On 29-30.01.2016 the Complainant and his wife approached the Centre for Sight (OP-2) at Hyderabad for the treatment of mild disfigurement of the right eye lower lid i.e. "Cicatricial ectropion lower lid." Dr. Santosh Honnavar (OP-3) and Dr. Anilkumar Bura (OP-4) after examination of the patient suggested treatment plan for lateral tarsorrhaphy. On 17.03.2016, the patient underwent the Oculoplasty surgery under General Anesthesia (GA) as recommended by OP-3. It was alleged that the OP-4 has not done Pre anesthetic checkup (PAC) nor any physician examined the patient. The PAC dated 29.1.2016 done for peri-ocular injection of 5 FU was not enough for the surgery under GA. Even the investigations were not seen before surgery. Thus the attitude of OPs 3,4,& 5 was casual since admission. It was further alleged that The Complainant was not given opportunity to discuss with the OP-4 about the choice of anesthesia. The OP-2 does not have basic lifesaving facilities, well equipped ICU and no cardiologist was present in OP-2. The OPs were interested in the financial gain rather the patient care. The Consent was signed by the patient when he was taken to operation theatre (OT), as there was no option but sign on dotted lines. It was alleged that the OP-3 and 4 were aware of recent past treatment received by the patient could have deferred the operation as it was not an emergency. The previous two surgeries wre performed after tracheostomy which was indication for that intubation could be difficult and could lead to complications.If the PAC would have done carefully, it would have found difficult airway with MAllampatti Grade IV. Most of the eye surgeries are performed under Local anesthesia, thus the decision of OP-3 and 4 to perform elective surgery under GA was rash and negligent. Allegedly, after the operation, the patient was handled unprofessionally, resulting in a cardiac arrest. The OPs acted unethically by calling an ambulance from Apollo Hospital instead of handling the situation themselves. It was alleged that patient was transferred to Apollo Hospital without providing proper ventilator or monitoring during transportation. OP-4 refused to disclose the cause of death but mentioned cardiac arrest. OP-5 issued the Death Certificate after nine months. The doctrine of RES IPSA LOQUITUR is applied, and circumstantial evidence and CCTV recordings suggest inadequate anesthesia reversal and casual and irresponsible management, supervision, and monitoring afterward. On 17.03.2016 the Complainant filed the Complaint with Jubilee Hills Police Station, Hyderabad.

2.3 Being aggrieved by negligent conduct of the OPs caused death of complainant’s son the Consumer Complaint was filed before this Commission and prayed sum of Rs.12/- crores along with interest @12% p.a. on various heads.

Defence: -

3.1 The OPs 1 & 2 filed their replies and denied negligence. The services at OP-2 are from qualified professionals and strictly adhered to all requisite norms and regulations. The OPs 3, 4 & 5 filed common Written Version, denied the allegations of medical negligence. They stated that the Complainant not to trivialize the planned surgery as “minor” surgery – it was indeed a major surgery needing 2-3 hours to carefully dissect the eyelid stuck due to multiplanar scarring, followed by harvesting the skin graft from the back of the ear or inner arm as appropriate, stunning of the graft, and also suturing of the donor area. The details of treatment were discussed with the patient and his father (complainant) thus it was not merely verbal but the informed consent for the surgical procedure and General Anaesthesia (GA), were signed by both the complainant and his son.

Arguments:

4.1 Heard the arguments at length, the learned Counsel on both the sides reiterated their evidence on record. They have filed medical literature on the subject and textbook references.

4.2 Arguments on behalf of Complainant

The Learned Counsel for the Complainant reiterated the facts and evidence. He argued that the operation could have been easily deferred. The OPs being influential persons in Hyderabad would cover the negligent act carried out by them.

4.2.1 The Counsel further argued that the Affidavits of the two experts filed on behalf of OP’s were biased and false. The experts and the OPs are professional colleagues and friends. Those two experts have been brought to defend the indefensible and to misguide the Commission.

4.2.2 The Counsel further argued on the following points viz Informed consent, Pre-operative evaluation; Anticipated Difficult Airway & its Consequences-, CPR & Resuscitation, Shifting out the dead body as live, Cause of death, Death Certificate & Death Note, Discharge Summary & Death Report issued simultaneously, Refusal to give Medical Records, CCTV Footage etc. He further argued that the requisite immediate and effective life-saving measures were not undertaken, it was breach of the professional and ethical duties expected. There was delay in calling an ACLS ambulance, which shows lack of preparedness on the part of the Opposite Parties.

3 Arguments on behalf of the OPs :

The learned counsel for OPs reiterated their evidence. They have brought my attention to the consent form and relevant medical record.

4.3.1 The counsel submitted that the patient was advised surgery under GA because of well-considered reasons as below:

Because of the multiplanar scar involved that needed delicate dissection, harvesting of the graft and consecutive suturing of two separate areas, the surgery was anticipated to take about 2-3 hours

Pain-free patient comfort yet optimal dissection could not have been assured with regional anaesthetic agent would have made the judgement of correction of eyelid deformity difficult

Xylocaine with adrenaline is known to compromise on the success of skin graft and plain xylocaine alone would not have provided for minimal bleeding in the dissected area, and bleeding itself in the bed of skin graft is detrimental to graft success. Moreover, he had already undergone two session of GA. Any expert surgeon would have followed the same course of action.

4.3.2 He further argued that the Complainant deliberately concealed the facts. The PM report issued by Osmania Medical College stated the cause of death as "Sudden cardiac arrest - post surgical status". The complainant has not annexed the signature page of the consent form for anaesthesia which carries the signatures of the patient, complainant and anaesthesiologist. The police at PS Jubilee Hills, Hyderabad, had sent the matter for expert opinion to Sarojini Devi Eye Hospital, Hyderabad. Dr. Subrahmanyam Mallajosyula, who reviewed the matter in detail and categorically stated that no negligence was made out,. Thus there was no deviation from the standard medical protocols, and the patient's death was due to cardiac arrest which is a rare but possible complication of general anaesthesia.

Observations and Discussion:

I gave my thoughtful consideration to the argument, have taken reference from few standard books on Anaesthesiology, Internal Medicine.

5.1 From the pleadings in the complainant, it is evident that the complainant being an Ophthalmologist raised a number of allegations related to services and facilities available at OP-2 as a day care centre. The complainant was also in a position to better understand the treatment plan. The severity and side effects of treatment were clearly explained at every step. The OP2 in its affidavit submitted that the centre is a specialized day care ophthalmic centre having facility with world class ophthalmic equipment and adequate critical care facilities. In case of unpredictable complications referral mechanisms are kept in place with multi-speciality or general hospitals such as Apollo Hospital, Hyderabad.

5.2 The allegation that Informed Consent was not taken. The surgery was performed under GA, I do not find any deviation from standard of practice, it was performed after obtaining the Informed Consent . I have perused the Consent forms. It is evident that the OPs 3 to 5 took informed consent from the Complainant. The consent forms run in to 4 pages. On careful perusal, it comprised of all ingredients of an informed consent (BRAND) - explained the Benefits, Risks of treatment, Alternatives or No treatment and its proper Documentation with signature of parties. I would like to refer guidelines laid down by the Hon’ble Supreme Court in the Samira Kohli judgment .The relevant para:

·         19. A doctor has to seek and secure the consent of the patient before commencing a 'treatment' (the term 'treatment' includes surgery also). The consent so obtained should be real and valid, which means that: the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what he is consenting to."

5.3 The next point for consideration is whether the surgery could have been deferred. The complainant himself was a doctor, he was insisting for surgery to be conducted at the earliest in January 2016 itself, at the time of 1st visit to OP-2. Based on clinical evaluation and examination, OP4 was of the opinion that Complainant's son had poor mouth opening and a difficult airway; therefore in the meantime he could undergo the minor procedure as scheduled on 30-01-2016, he would need further evaluation and then reassessment for general anaesthesia fitness before correction of cicatricial ectropion with skin grafting after 6-8 weeks as planned.

5.3.1 The patient was re-examined and evaluated on 17-03-2016 for GA and he was found to be fit for the surgery which was then proceeded with. Thus in my view the treating doctors were not in any haste or hurry to conduct surgery. It is pertinent to note that the Complainant decided to arrive from Jabalpur on the day of surgery despite clear instructions from the treating doctors to arrive a day prior to the surgery for OPD consultation and physical evaluation.

5.4 In the instant case on 29.01.2016 pre-anaesthetic evaluation was done by OP4 for minor procedure as scheduled on 30.01.2016, he would need further evaluation and reassessment for general anaesthesia fitness before correction of cicatricial ectropion with skin grafting after 6-8 weeks as was planned. Even the advance PAC performed on 29.01.2016 was with the intent of forthcoming surgery under general anaesthesia -- evaluation of airway and the need for a re-evaluation are all clearly stated in the pre-anaesthesia evaluation form of 29.01.2016. It is pertinent to note that the Complainant has filed the Pre-anaesthetic checkup (PAC) form dated 17.03.2016, but the grouse of Complainant was that the PAC dated 17.03.2016 was never conducted and further alleged it as a fabricated document. However, the Complainant in FIR (criminal complaint) stated that the PAC was conducted on 17.03.2016 by the OPs - 3 to 5. Therefore, the allegation that the PAC was not conducted on 17.03.2016 is not sustainable.

5.5 I have perused the letter issued by Dr. A. K. Grover from Sir Ganga Ram Hospital, who clarified about general anaesthesia in the instant patient. It is reproduced as below:

TO WHOM IT MAY CONCERN

I have seen the clinical details and the photographs of the patient. The photograph indicates that there was a severe Ectropion of the right lower lid requiring a thorough dissection with excision of scar followed by a full thickness graft harvested from another site possibly post auricular.

In a patient requiring a surgery in a severely scarred area, where local anesthesia is less effective and also a patient requiring surgery at multiple sites (as would be necessary in this patient for harvesting of a graft), general anesthesia is the anesthesia of choice and would be my preference.

Thus, the general anaesthesia was the choice of treatment.

5.6 The allegation that the patient was shifted hurriedly from OT to recovery room. The CCTV footage evidence from the OT clearly shows that reversal and recovery were unhurried and the patient was shifted from the OT to the recovery room only after complete recovery. Patient's blood pressure was 100/70 mm Hg, pulse rate was 92/min and of normal quality, and saturation was 100% at the time of shifting to the recovery room at 1.22 PM. Same temperature was maintained in the OT and in the recovery room as 24 degree C. Monitoring in the recovery room was by a set of trained nurses under the supervision of the anaesthesiologist.

5.7 The Complainant alleged that the OPs 3 – 5 resorted to poor pre-operative, operative and post-operative care vis-à-vis the Patient. From the medical records it is evident that, the surgery was uneventful and he was shifted to the recovery room in stable condition. Once the Patient’s saturation came to 95%, the nurse immediately called the OP 4 who attended to the Patient immediately. The Patient was started on CPR along with other relevant efforts including Defibrillation for close to one hour. Thereafter, for further management as per the referral arrangements between the OP 2 Hospital and Apollo Hospital, the Patient was shifted to the Apollo hospital in an ACLS Ambulance with OP-4. The CPR continued in the ambulance as well. Therefore in my view, there was collective effort made by OPs 3 – 5 to save the patient, thus they have acted with their reasonable degree of skills and followed standard medical practice. It was affirmed by the Medical Board of Sarojini Devi Hospital (Hyderabad). The resuscitation efforts persisted at Apollo Hospitals for 58 minutes before the patient was declared dead.

5.8 It is evident that the patient was shifted to Apollo Hospital as a tertiary centre, but the complainant’s presumption that it was done to escape the liability. I do not find any merit in this submission. Referring the patient to tertiary care facility is not negligence. As per the statement of Apollo Hospitals, that the patient developed asystole when he reached the hospital. The ACLS was continued for 58 minutes before the patient was declared dead. Therefore, the allegation of Complainant that the patient was dead before he was shifted  is not sustainable.

5.9 The pre-operative, operative and post-operative care was provided to the patient by the experts in their respective specialties. The pre-anaesthetic evaluation, procedure of induction and administration of anaesthesia, extubation and recovery, and care in the recovery room were as per reasonable standard and follow the guidelines laid down in the institutional SOP for Anaesthesia; that resuscitation measures were optimal under the circumstances.

5.10 The allegation that that the OP 3 (Ophthalmologist) was not present during the CPR, the OP-3 as an Ophthalmologist and Oculplastic Surgeon had a limited role for eye correction surgery. The surgery was successful and no allegation raised for the same. Moreover, the OPs 4 & 5 along with nursing staff was doing CPR efforts. Therefore, the allegation of absence OP-3 pales into insignificance.

5.11 It is pertinent to note that the two Expert Opinions were field by OPs. One Dr. Subramanyam for OP 3 and Dr. Sathyanarayana for OPs 4 – 5. Those opinions satisfy the guidelines laid down by the Hon’ble Supreme Court in the case of Ramesh Chandra Agrawal vs. Regency Hospital Ltd. & Ors.[ AIR 2010 SC 806]. On the contrary, the Complainant’s Expert Opinion Dr. Mahesh P. Nagar merely makes a passing reference to the EU Resuscitation Guidelines. The Complainant has raised objections, but not put credible challenge or cross examined to the Expert Opinion of the Medical Board, Sarojini Devi Hospital.

5.12 Regarding the infrastructure of OP-2 Hospital, it was submitted that it is a full-fledged specialized ophthalmic hospital having all necessary equipment for surgeries under local and general anaesthesia. It has established referral mechanisms with multi-speciality hospitals (Apollo Hospital). The OP-2 is complied with the Clinical Establishments (Registration and Regulation) Act, 2010. The Complainant, being an ophthalmologist himself was aware of the facilities, standard protocols and understood the treatment plan with potential side effects. He accepted the treatment plan, including surgery under general anaesthesia after discussion with the OP-3 to 5. The medical records, death certificate, and post-mortem report, were issued to the Complainant.

5.13 It is transpired that the complainant concealed crucial facts and documentation, including the post-mortem report and the signature page of the consent form for anaesthesia. In the case of SP Chengalvaraya Naidu (dead) vs Jagannath (dead)[ AIR 1994 SC 853], it was held that

"A litigant, who approaches the court, is bound to produce all the documents executed by him which are relevant to the litigation if he withholds a vital document in order to gain advantage on the other side than he would be guilty of playing fraud on the court as well as on the opposite party."

The expert committee constituted on the directions of the Director of Medical Education, Government of Telengana, by the Superintendent of Sarojini Devi Eye Hospital, consisted of professors of Ophthalmology and Anaesthesiology. It observed as below:

Observation:-

“1. Surgery (skin grafting) was indicated in this patient, and because extensive scarring and prolonged duration of surgery, general anaesthesia was necessary, and an informed consent was obtained. Skin grafting is a peripheral procedure and does not entail systemic issues. It went on smoothly. The surgical procedure performed in this patient itself cannot be implicated at all as the cause for death of the patient and so the Surgeon cannot be held responsible in any way for this unfortunate incident.

The anaesthesiologist has performed preoperative assessment twice and two anaesthesiologists have performed preoperative assessment before accepting the patient for surgery. Anaesthesiologists has obtained informed consent, has performed routine and unhurried intubation, extubation and recovery without any evidence of over dosage of anaesthesia drug, has handed over the patient to the recovery nurse for multifunction monitoring under supervision of the anaesthesiologists, was readily available when called, was with the patient all throughout from the time he was called, and has provided reasonable resuscitation care under the circumstances, despite which this unfortunate incident has occurred.

6.1 According to the report, the Oculoplasty procedure was done on the patient under the supervision of two anaesthesiologists and the patient was constantly monitored. The induction, intubation, extubation, and recovery appeared routine and unhurried. The patient was handed over to the postoperative nurse in the recovery room for monitoring under the supervision of anaesthesiologists. Around 45 minutes after surgery, the patient's SPO2 dipped to 95%, triggering an immediate response from the anaesthesiologist. Despite prompt response and the application of life-saving measures, the patient had a sudden cardiac arrest.

6.2 In my view, the Complainant failed to discharge his burden of proof. The unfortunate death of the patient does not tantamount to medical negligence in the instant case.

The Hon’ble Supreme Court in the case of Jacob Mathew’s Vs State of Punjab [(2005) SSC (Crl) 1369], observed as under:

“When a patient dies or suffers 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 well known that even the best professionals, what to say of the average professional, 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 appeared in it and made his submissions.”

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. In Kusum Sharma & Ors. v. Batra Hospital & Medical Research Centre & Ors.[ (2010) 3 SCC 480] case the Hon’ble Supreme Court held as below:

"a medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field. It would not be conducive to the efficiency of the medical profession if no doctor could administer medicine without a halter round his neck. It was further held that it was our bounden duty and obligation of the civil society to ensure that the medical professionals are not unnecessarily harassed or humiliated so that they can perform their professional duties without fear and apprehension."

Similarly, in another case, Devarakonda Suryasesha Mani v Care Hospital, Institute of Medical Sciences[IV (2022) CPJ 7 (SC)], it was held as below:

“..2. Unless the appellants are able to establish before this Court any specific course of conduct suggesting a lack of due medical attention and care, it would not be possible for the Court to second-guess the medical judgment of the doctors on the line of medical treatment which was administered to the spouse of the first appellant. In the absence of any such material disclosing medical negligence, we find no justification to form a view at variance with the view which was taken by the NCDRC. Every death in an institutionalized environment of a hospital does not necessarily amount to medical negligence on a hypothetical assumption of lack of due medical care.”

In the instant case, I don’t find any cogent reason to hold OPs conclusively liable for the alleged negligence. The team of doctors has performed their duty as per the standard of care. The Complaint fails, it is dismissed.

The parties to bear their own costs.