PER DR. S.M. KANTIKAR, MEMBER                                    

Complaint:

1. This complaint is filed by the Consumer Education and Research Society, Ahmedabad as Complainant-1 and Mr. Pritish Mafatbhai Shah as Complainant-2 against the Surgeon OP-1, Dr. K. M. Shah, and Anesthetist OP-2, Dr. Anil J. Patel, for alleged medical negligence in treating the patient, Mr. Pritesh Shah negligently which resulted into a pathetic and vegetative condition of the patient, throughout life. The Complainant No.2 is an officer of Bank of Baroda, about 38 years of age, who approached OP-1 on 31.07.2004, for a swelling in the left side of the neck as a result of tooth extraction on 10.07.2004. OP-1 diagnosed it as Ludwig’s Angina and advised for a surgery. Patient was taken for surgery on 01.08.2004, Dr. Anil J. Patel, OP-2 administered anesthesia to the patient at 8 a.m. but due to some problems after administering anesthesia, the said operation could not performed. Suddenly the OP-1 came out of the Operation Theatre (OT) and informed the patient’s relatives about the serious condition, that patient’s heart had stopped working and they are trying to revive him. There was panic among the OT staff, who had to run around for arranging oxygen cylinder. After some time, the OP-1 came out from the OT and informed about successful revival of the patient. The patient was unconscious, also, it was an emergency, and therefore OP-1 immediately shifted the patient to ICU of Bhailal Amin General Hospital (BAGH) for further management, at 12:05 a.m. on 01.08.2004. At BAGH, several investigations like EEG with Brain Maps, MRI brain, X-ray were performed and finally the patient became Vegetative form. He was admitted in BAGH almost, for two months and was discharged on 28.09.2004, (Ann. C) without any improvement. Mr. Pritesh continued to be in vegetative state. Further the patient was on domiciliary nursing care and nutritional supplements, which led to heavy expenses and mental agony to all family members. The Complainant-1 (CERS) made correspondence with OP-1, (Ann. D), which was replied by the OP-1 on 28.02.2005, (Ann. E). Thereafter, the Complainant served a legal notice, (Ann. F) on the OPs on 28.04.2005 and asked to pay a compensation to the Complainant-2 in the sum of ₹ 99,50,000/-. It was replied by OP-1 & 2 on 20.05.2005 through their Advocate, (Annexure G) denying negligence. Hence, dissatisfied with the reply and due to alleged deficiency in medical services and negligence in the treatment, the complainants filed this complaint against both OPs and prayed for compensation in favour of the Complainant No.-2 the sum of ₹ 1,32,12,627/- towards loss of income plus ₹ 15,80,000/- towards loss of other benefits and pain and suffering of the family members ₹ 48,48,840/- towards expenses for medical treatment and maintenance of Complainant No-2 Mr. Pritesh M. Shah, and also to pay ₹ 50,000/- as costs to Complainant No.-1 and 2, each.  

Defense:

               2.   The OP-1 and OP-2 filed their written versions, and affidavits and resisted the complaint. The OP-2, Dr. K. M. Shah, submitted that the complication of Ludwig’s Angina had arisen in the patient since a long time after tooth extraction, as the patient and his relatives were considering the situation to be a minor condition. The infection developed in the floor of the mouth and later spread to the soft tissue of the left side of the neck. The patient was earlier examined by Dr. N. V. Shroff, the ENT Surgeon, who, looking to severity of swelling, referred him to OP-1. The patient approached the OP-1 on 31.07.2004 for Ludwig’s Angina. The patient was unable to open his mouth. The Ludwig Angina is a very serious disease with severe bacterial infection and swelling of the floor of the mouth. OP-1 further submitted that “the said procedure was performed the patient developed sudden cardiac arrest. The OP-1 has not performed the operation on the Complainant and the patient suffered cardiac arrest before the surgery could be performed on the Complainant No-2. The cardiac arrest of the patient was not due to the anesthesia given to the patient but it was due to the multiplicity of the factors emerging from the advanced state of Ludwig’s Angina and consequential severe respiratory obstruction causing hypoxia. It is incorrect and denied that the patient was in vegetative state or died solely because of negligence of the OPs.

3.  The patients like Complainant No.-2 are more prone to develop cardiac arrest with their medical condition of Ludwig’s Angina, trismus (inability to open mouth), short neck and obesity. The patient suffered from a cardiac arrest due to upper respiratory airway obstruction caused due to severity of infection.

4. The patient suffered cardiac arrest due to pre-existing Ludwig’s Angina, which caused severe breathing problems.

5. The OP-2, Dr. Anil Patel filed his evidence, that he is a qualified MD, practicing anesthetist for the last 15 years, and he carried portable ventilator, cardiac monitor and a pulse oximeter for the purposes of anesthesia and have successfully anesthetized many complicated, serious and high risk patients. The Ludwig’s disease carries a high mortality rate as it can lead to blockage of the airways. The most common cause of death in this disease is respiratory compromise. In most cases of Ludwig’s Angina, it is imperative to go for surgical intervention so as to prevent any blockage in the main airway. The OP-2 produced the relevant literature on the subject (Exhibit- OP-2/1), the Article on Ludwig’s Angina from the Mpilo Medical Journal Exhibit OP2/2 and regarding high mortality rate of the disease as Exhibit OP-2/3.

6.  As the patient was scheduled to undergo a surgery for Ludwig’s Angina on 01.08.2004, the patient and his wife gave the consent. The fitness of the patient for general anesthesia was confirmed and with all the preparation, pre-anesthetic oxygen was also stated with the use of face mask. He further submitted that there are essentially two common methods of airway management in patients suffering from Ludwig’s Angina-tracheostomy using local anesthesia and tracheal intubation using general anesthesia. It is submitted that tracheostomy using local anesthesia is not feasible in patients with advanced stages of infections due to the anatomical distortions of the anterior neck. Even tracheal intubation is known to have frequent failures. In support of his contention OP-2 produced a copy of an article indicating the difficulties in managing the airways in patients with deep neck infections ( Exhibit OP-2/4 and OP-2/5), and  Internet printouts from the medical website www.pubmed.gov  as Exhibit OP-2/6.
7. The OP-2 tried to intubate the patient but could not open the mouth of the patient fully, due to the edema in the floor of the mouth and oropharynx. It is stated that due to a sudden fall of oxygen saturation and low blood pressure of the Complainant-2, endotracheal intubation was abandoned and the face mask ventilation was carried. At this point, the OP-1 was asked to do a tracheostomy. However, before the said procedure could be performed, the patient developed sudden cardiac arrest. The OP-2 submits that the cardiac arrest of the patient was not due to the anesthesia given to the patient.

                   Both the OPs submitted that, Oxygen saturation was monitored and it was 96%. The OP-1 and 2 contended that due to intense resuscitation efforts they revived the patient after cardiac arrest. The OP-2 further stated that since the cardio-respiratory system took time to respond to the resuscitation efforts due to the condition of the patient, there was shortage of oxygen to the brain leading to brain damage. It is further stated that the relatives were informed of the whole unfortunate event and it was also explained that every effort was made to revive the patient. OPs denied about non- availability or shortage of oxygen cylinders in the OT. After resuscitation, the patient was taken to BAGH for assisted Cardio-Respiratory Support, the OP-2 accompanied the patient along with resuscitation bag and oxygen cylinder.

Arguments and Findings:

8. We have heard the counsel for the parties. The Counsel for complainant reiterated the facts mentioned in the complaint. His main argument was, that the OP-1 and 2 did not receive the patient properly, lost the Golden Hour, there was no Oxygen Cylinder in the OT, during such emergency episode, the staff was running here and there to procure Oxygen cylinder. Due to lack of oxygen and delay in resuscitation, the patient suffered Cerebral anoxia (lack of oxygen supply to brain), by which the patient became vegetative. The counsel further submitted that, it was the case of Res Ipsa Loquitor. Therefore, the OPs are liable for negligence.

The counsel for OPs submitted that, The Hospital of the OP-1 possesses a very well equipped operation theatre with stage-of-the-art equipments and apparatus including oxygen support systems. Also, the availability of oxygen in the operation theatre was ensured by OP-2 at the stage of pre-anesthetic check-up and preparation for anesthesia. The cardiac arrest can happen due to a variety of reasons, without involving any element of any error, omission or negligence. There are two common methods of airway management which are – tracheostomy using local anesthesia and tracheal intubation using general anesthesia. Tracheostomy using local anesthesia is not feasible in patients with advanced stage of infections due to anatomical distortions of the anterior neck. Tracheal intubation is generally a preferred form of procedure for treating Ludwig’s Angina although there are difficulties in conducting tracheal intubations. Option of endotracheal intubation was considered the best suitable method in the given situation and the OPs in this critical and crucial moment, exercised the best judgment, keeping in view the complicated health conditions including the distorted neck anatomy of the patient. The tracheostomy would result aspiration of pus into lungs and mediastinum (heart, etc.) leading to severe aspiration pneumonia and life threatening complications.

9.   The Counsel for OPs argued that , the onus/ burden of proof  is upon the complainant to prove medical negligence. He relied upon the judgments of the Hon’ble Supreme Court in the cases of Ravneet Singh Bagga vs. KLM Royal Dutch Airlines (2000) 1 SCC 1, Dr. C. P. Sreekumar Vs S.Ramanujam (2009) 7 SCC 130. Further, on the point of Res Ipsa Loquitor, the Counsel relied upon celebrated authority of Jacob Methew’s case (2005) 6 SCC 1, and State of Punjab vs. Shiv Ram (2005) 7 SCC 1.

10.  We have perused the medical records of OP-1 hospital, the clinical and OT notes. We have gone through the medical literature submitted by both the parties and the various judgments on medical negligence delivered by Hon’ble Supreme Court and by this Commission.

                   We are of view that there is no rationale in attributing the cardiac arrest of the patient to the anesthesia which was not administered. It was due to Ludwig’s Angina and lot of edema in the floor of the mouth and oropharynx causing respiratory obstruction and hypoxia. The patient suffering from Ludwig Angina, trismus (inability to open mouth), short neck and obesity are more prone to develop cardiac arrest. We do not think that it was due to any act of omission or commission by OPs. The OPs took utmost care after cardiac arrest for revival of the patient and after revival, with the consent of relatives of patient, the patient was immediately shifted to Bhailal Amin General Hospital for cardio-respiratory support and management. Furthermore, the principle of ‘Res Ipsa Loquitor’ has no applicability to the facts of the present case, because the things were not   within the absolute control of the OP doctors. The patient was obese, huge abscess on the left side of neck since long time, which cannot be said to be within the control of the OP.  It is apparent that, patient and his relatives, delayed to take the treatment, they took the Ludwig’s Angina after tooth extraction casually and carelessly.

11.  The medical literature Ex.14 “Airway Management in Adult Patients with Deep Neck Infections” Anesth Analg 2005;100:585-589 revealed that,

Patients with deep neck infections present challenging airways for an anesthesiologist. These infectious processes are not common but, untreated, may progress rapidly to airway obstruction that could be lethal. A common cause of death in patients with deep neck infections is acute loss of the airway during interventions to control it. Various techniques are available to secure the airway, but the success and safety of these techniques in patients with deep neck infections have not yet been established.

Tracheostomy using local anesthesia has been considered the “gold standard” of airway management in patients with deep neck infections, but it may be difficult or impossible in advanced cases of infection because of the position needed for tracheostomy or because of anatomical distortion of the anterior neck.

“ Tracheal intubation in patients with deep neck infections is challenging. The distorted airway anatomy, tissue immobility and limited access to the mouth make orotracheal intubation with rigid laryngoscopy difficult.

Another article Ex 1/8 “Deep Neck Abscesses & Life threatening infections of Head and Neck” ( Feb 1998) mentioned as ;

The most common cause of death in Ludwig Angina is asphyxia. Airway control is the first priority of treatment, followed by intravenous antibiotics and timely surgical drainage. The method of controlling the airway in Ludwig Angina is controversial and may include close observation, tracheotomy, fiberoptic intubation or cricothyroidotomy. Airway control is not always needed with close observation in an ICU. Blind oral or nasotracheal intubation or attempts with neuromuscular paralysis is of contraindicated in Ludwig Angina as they may precipitate an airway crisis. Tracheotomy is still the most widely used method of airway control but some authors feel the risk of aspiration pneumonia (from close proximity of the track site to open neck wounds) and the risk of mediastinal infection as reasons to avoid tracheostomy if possible. Cricothyroidotomy is usually not a good option with in patients with massive neck edema.

The article “Cardiac Arrest” Ex 1/10 revealed as

“Arrested” blood circulation prevents delivery of oxygen to all parts of the body. Cerebral hypoxia, or lack of oxygen supply to the brain, causes victims to lose consciousness and to stop normal breathing, although agonal breathing may still occur. Brain injury is likely if cardiac arrest is untreated for more than 5 minutes, although new treatments such as induced hypothermia have begun to extend this time. To improve survival and neurological recovery immediate response is paramount.

12. We have perused the OT register; the Oxygen Purchase and Utilization register produced by the OP-1. It clearly reveals that there was sufficient stock of oxygen cylinders on the day of operation. Thus, the patient did not suffer due to lack of Oxygen during surger

13. We have perused a catena of judgments of Hon’ble Supreme Court and that of this Commission which had discussed ‘Medical Negligence.’ The Hon’ble Supreme Court held in C. P. Sreekumar (Dr.) vs. S. Ramanujam, (2009) 7 SCC 130,  case, as follows:-
    • the onus to prove medical negligence lies largely on the claimant and that this onus can be discharged by leading cogent evidence. A mere averment in a complaint which is denied by the other side can, by no stretch of imagination be said to be proved. It is the obligation of Complainant “to provide the facta probanda as well as the facta probantia”

  In Jacob Mathew’s case , the Hon’ble Apex Court has observed as following: -

“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”.

               McNair J, in Bolam v Friern Hospital Management Committee; stated that; 'A doctor is not guilty of negligence, if he has acted in accordance with a practice accepted, as proper, by a responsible body of medical men, skilled in that particular art. Putting it another way round, a doctor is not negligent if he is acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view.

14.  Hon’ble Supreme Court in the  Martin F De souza case has observed  that:
    • 47.            Simply because a patient has not favorably responded to a treatment given by a doctor or a surgery has failed, the doctor cannot be held straightaway liable for medical negligence by applying the doctrine of res ipsa loquitur.  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

15. On the basis of forgoing entire discussion, we are of considered view that, complainant failed to prove negligence on the part of OPs. We do not find any short comings by the OPs in the treatment of patient, Mr. Pritesh, during emergency. Therefore, we dismiss the complaint. No order as to costs.