Appeared at the time of arguments

For the Complainant       :        Dr. M.C. Gupta, Advocate

For the Opp. Parties       :        Mr. S.B. Prabhavalkar, Advocate,

Pronounced on:  9^th June   2023

ORDER

1.       The Complaint is a voluntary Consumer Association, providing legal help to the needy. In the instant case, the patient Mr. Jinendra Shah (since deceased, hereinafter referred as, the ‘patient’), a young 31-year boy, working as a Managing Director in Neerja Jewellery in Dubai. He, while on India visit, suffered a fracture of left humerus due to vehicle accident. He was operated on 01.12.2003 in Ahmedabad. However, the fracture could not heal properly and resulted into non-union. The patient consulted Dr. Rajesh Gandhi (OP-1) at Mumbai, who advised bone grafting. Accordingly, the patient was admitted in the Gandhi Nursing Home of OP-1 on 03.06.2004 and after pre-operative anesthesia fitness, the bone grafting procedure was fixed on 04.06.2004. The OP-1, anticipating requirement for bone grafting to aid in fracture healing asked the relatives to bring bone tissue for grafting from Tata Tissue Bank. Accordingly, the bone tissue was brought and handed over to OP-1, but the OP-1 did not feel the use it as bone graft taken from patient’s body for grafting was deemed adequate. This fact came to the knowledge of the Complainant’s after obtaining the medical record. Thus, the OP-1 performed two surgeries, which became major surgery. He did not explain why it was performed without consent. After surgery, the Anesthetist left the hospital and thereafter, the patient was shifted to Ward, without keeping him in the recovery room for observation. The OP-1 came to the ward and told the relatives that the patient was fine and would regain consciousness by the evening. After some time, the breathing stopped and the patient’s nail became bluish, the nurse was called, who told that there was no pulse or heartbeat. The OP-1 recorded in the case sheet that external cardiac massage was started immediately. At 1.00pm, the heartbeat returned, thus resuscitated after 45 minutes, during which the patient suffered hypoxic brain injury. It was further alleged that no ECG was taken, no cardiac shock was given, there was no defibrillator in the room and the patient was unconscious throughout. At 1.00pm, the doctors arranged for a transfer to a higher center to Leelavati Hospital. However, the patient reached Leelavati Hospital in brain dead condition. The patient remained unconscious till death. As the patient was brain dead, the kidneys and eyes were voluntarily donated by the relatives. The patient was declared dead on 09.06.2004. Being aggrieved, the Consumer Complaint was filed by the wife of the patient – Mrs. Neha and her daughter Ms. Neerja, claiming compensation of Rs.1,75,39,000/- from the OPs.

2.       The Opposite Parties filed their written versions and denied the any negligence during the treatment. It was submitted that the claim was exaggerated on false, frivolous and vexatious grounds.  The OP-1 further raised technical objections   that the Complainants have not produced any Succession Certificate declaring Complainant No.2 and 3 as the heirs. It was further submitted that the Complainants have not filed any written expert testimony to prove their case.

3.       The OP-1 submitted that after the patient was brought out of Operation Theatre, the clinical parameters were normal and there was no indication of any untoward effect, the pulse, BP, Respiration were normal and the patient's condition was alright. The patient was moving his limbs and in fact the father of the patient volunteered to hold the right hand of the patient to avoid IV line from going out. The OP-1 further submitted that it was medical mishap, caused the death. The postmortem report submitted by Cooper Hospital revealed pulmonary embolism in an operated case of vehicular accident. Therefore, no negligence be attributed to the OPs-1 and.

Arguments:

4.       I have heard the arguments from the learned Counsel for both the sides. Perused the material on record, inter alia, the Medical Record and gave thoughtful consideration.

Arguments on behalf of Complainants:

5.        The learned counsel for Complainant argued that it was the case of Res Ipsa Loquitor. It was submitted that a young man aged about 31 years without any disease, was admitted for the simple and rather minor surgery of bone grafting for non-union of fracture of left humerus bone sustained 6 months earlier. In the circumstances, his becoming brain dead within about two hours of surgery was most unexpected and unusual. Prima facie it was medical negligence. Thus, doctrine of res ipsa loquitor applies.  

6.        The patient was declared dead at 1.20 a.m. on 9.6.2004. The cause of death shown in the post mortem report was erroneous and not acceptable. The patient's organs, such as kidneys and eyes were offered for donation by his father and father in law to Lilavati Hospital. According to affidavit of Dr. Purandare's expert opinion the cause of death was not pulmonary embolism. Even at Lilavati Hospital, it was not suspected even after clinical, radiological and other investigations. All chest x-rays, ECHO,  Color Doppler studies were  normal.

7.        The learned counsel for the complainant argued on the Fallacies in the Post Mortem Report. The qualifications and experience of Dr. P M Shinde who performed the Postmortem were not known. Thus, every word of PM report does not become a gospel truth simply. The PM report stated probable cause of death as "Death due to pulmonary embolism in an operated case of vehicular accident (Un-natural)". The autopsy surgeon failed to send a part of the lungs for histopathology examination, which was needed in all cases of pulmonary embolism. He failed to send a portion of the brain, even though   the brain was congested and edematous.

8.        The OPs have produced the opinion of Dr. F P Candes, the Forensic expert. The learned counsel argued that the conduct of Dr. Candes was such that it fails to inspire confidence in his objectivity and impartiality. There seen many fallacies in his opinion and his statements were contrary to the facts.  

9.        The Counsel further argued that the OP-1 caused unavoidable injury to the patient. It was not a minor surgery but it was a combination of two separate surgeries (Cutting out a bone piece from the iliac crest / hip of the deceased and grafting it at the fracture site). In that case why complainants were asked to bring graft from the Tata Tissue Bank.  The OP-1 did not use the same, but without prior consent, performed surgery upon the hip bone (iliac crest) of the deceased to take out a bone piece from there. Thus the minor surgery was converted into a major surgery and, thereby exposed the patient to additional stress and caused his death. As a matter of fact, the patient never regained consciousness in spite of the efforts made by OP-1.  

Arguments from Opposite Parties

10.      The learned counsel for the OP-1 argued that the Complainant has not produced any medical literature in support of their case that death was not due to pulmonary embolism and/or why the cause of death mentioned in the post mortem report was incorrect/ erroneous. On the other hand the Opp. Parties have produced literature on acute pulmonary embolism and also to point out the high mortality rate in orthopedic cases and other literature such as the American journal of medicine, "Management of Venous Thrombolism" and other related literature.

11.     The Learned Counsel for the OPs submitted that the pulmonary embolism in an operated case of fractures is a known complication. Thus no negligence is attributed to the Operating surgeon or anesthetist. OP No.1 has relied upon Medical Text Book (Practice in Anesthesia by W.D. Wylie 1972 edition). The OPs reiterated their evidence and treatment given to the patient.

Discussion

12.     The Complainants have made a feeble attempt to substantiate the medical negligence by filing the affidavit of Dr. Hasumatiben Ranchodlai Patel, (Dr. H. Patel) MD Forensic Medicine. The OPs in support of their contention had filed the affidavits of independent experts’ viz. Dr. Vinod Laheri, Orthopedic Surgeon and Dr. Lata S. Choudhary, Anesthetist. The OP No.1 filed the affidavit of Dr. Candes who supported the findings given by Dr. Shinde, Forensic Surgeon in the PM report and stated that the observations made by Dr. H. Patel are incorrect.

13.     In the instant case, it is evident that during fall in BP, the OPs took prompt steps with Dr. Udayan Desai. Sr. Anesthetist. The endotracheal intubation was done immediately, thus there was no delay or wasting of "golden hour" as alleged by the complainants. Dr. H. Patel has did not suggest what could be the negligence and the cause of death.

14.     Post-Mortem was done by Dr. P. M. Shinde at Cooper Hospital on 9.5.2004 at 12:30 P.M. The relevant points noted:

1. Evidence of undergoing surgery over # of left humerus.
2. Surgical incision showing evidence of both kidneys removal.
3. Brain- congested edematous.
4. Lungs froth-fine blood clots evidence of bilateral pulmonary embolism congested bulky edematous oozing of coffee colored fluid with froth on cut section. Congested bulky edematous oozing of coffee colored fluid with froth was seen on cut sections of lungs. Fine blood clots were the only evidence of pulmonary embolism.
5. Evidence of removal of kidneys.
6. Cause of Death pulmonary embolism in an operated case of vehicular accident.

15.     I have perused the expert opinion of Dr. H. Patel on the pulmonary embolism. According to her: -

1. Massive pulmonary embolism (Bilateral) cannot be the cause of death as the embolus has to come from big vein like popliteal , femoral and iliac vein.
2. Emboli released from fracture sites are emboli containing bone marrow and fragments of bone and fat.
3. A medium size embolus must be distinguish from agonal or post mortem clots which can only be done by HP. Examination which was not done in this case.
4. There are no signs of Rt. Sided failure due to pulmonary embolism.
5. The cause of death has to be one which caused brain stem death.

16.     It is pertinent to note that the affidavits of Dr. Francis Pelagic Candes, Dr. Vinod J. Laheri & Dr. Latha S. Chaudhari, opined that:

In the present case the patient was treated with proper care, there was no deficiency or negligence on the part of Dr. Rajesh Gandhi or Dr. Amul Parikh. They were diligent and very careful while conducting this case. The treatment given to this patient during hospitalization, surgery and post-operatively were as per medical norms.

 …xx….

The post mortem reports one apparently from Lilavati after initial procedure and one from the coroner Dr. Shinde are not aligned simply because the organs had been harvested before body was sent to coroner. The extended  incisions from kidney harvesting may well mask and confuse the original incision for harvesting bone graft since they are approximately aligned in one plane and direction anteriorly. Further it is a fact that the surgeon had anticipated bone graft - was indicated procedure anyway as relatives had been asked to procure bone graft from Tata Hospital.

E. The death of the patient itself is unfortunate and the actions of donating kidneys and other organs is indeed a noble act on part of the complainants family but that in itself does not serve to hold the treating doctor guilty of negligence where none exists based on strict law on negligence.

17.     Expert Opinion: - Dr. Uday R. Purandare, Ex-professor and head of department of Forensic Medicine at S.B.K.S. Medical College. He did not accept the cause of death as pulmonary embolism stated by the autopsy surgeon. According to him, it was an afterthought and the case papers being prepared later on, therefore, the negligence was not proved. Most of the experts opined on the basis of the same records.

18.   I have perused the medical record of Gandhi Hospital (OP-1). He prescribed one block of cancellous bone from tissue bank at Tata Memorial Hospital. It was not use during the surgery, but the graft was harvested from the iliac crest. The blood investigations were performed. The referral slip dated 04.06.2004 was to admit the patient under Dr. Milind Padgaonkar in ICU. The Lilavati Hospital record revealed that at 4.45 p.m., the patient was brought from Gandhi Hospital with endotracheal intubation. Immediately the treatment was started and the Patient was put on the mechanical ventilator.

19.     The PM report revealed there was froth and fine blood clots in the larynx and trachea suggestive of bi-lateral pulmonary embolism. The both the lungs are congested, bulky, edematous and coffee color fluid with froth on cut section. Those findings are consistent with pulmonary embolism. It is pertinent to note that after the death the kidneys of the deceased were removed through lumbar transverse incision, therefore the iliac crest incision taken from bone graft was unnoticed. Skin incisions are the same for all approaches. Make an incision along the subcutaneous border of the iliac crest at the point of contact of the periosteum with the origins of the gluteal and trunk muscles, carry the incision down to the bone.

20.     In the Instant case admittedly the Complainant accepted the amount under insurance policy on the basis of the Postmortem report. No inquest proceeding were initiated against the PM report issued by the then Coroner of Municipal Hospital. The Complainant had not initiated any criminal proceedings and in fact accepted the provisional death certificate issued by Lilavati Hospital. Thus, Dr. Purandare’s allegation that PM report was bias and it was based on manipulated evidence.

21.     The Deep Vein Thrombosis (DVT) was one of the causes of pulmonary embolism. The OP-1 brought my attention to Medical Textbook “A Practice of Anesthesia’, wherein Deep Vein Thrombosis was discussed. It reads as below:

Deep Vein Thrombosis

So many factors can contribute to venous thrombosis in the post operative period that it is probably unwise to dogmatise unduly on the importance of any one. The association of several conditions such as a severe operation in the pelvis of an old, obese patient in cardiac failure who has varicose veins, and a protracted period of immobilization after operation, may well culminate in venous thrombosis. Although perhaps the most important predisposing factor is a previous history of deep vein thrombosis, too often a fatal pulmonary embolism occurs unexpectedly soon after a trivial operation in a fit, young patient and is the first indication of venous thrombosis (Sevitt, 1962b).

Therefore, in the instant case, the OPs-1 and 2 carried out Cardio-respiratory resuscitation as soon as patient developed cardio-respiratory arrest. External Cardiac massage was started and Inotropic drugs were given with Injection Decadron. Endotracheal intubation done - oxygen given through the Endotracheal tube and connected the Mechanical Ventilator with air and oxygen. The patient was monitored during above procedure with ECG monitor and pulse oxymeter.

22.      From the medical literature, there are three main sources of bone graft material: autologous (harvested from the patient’s own body), allograft (from cadaveric bone, e.g. from a tissue bank) and synthetic substitutes. Autologous bone grafts, where healthy bone is extracted from another site in the person's own skeleton, have the advantages of retaining the inherent regeneration and remodelling properties of living bone in addition to being free from the risks of disease transmission and autoimmune rejection associated with allografts. A common practice amongst surgeons is to combine autologous harvested bone graft with bone graft substitutes for reconstruction of a bony defect. This technique may maximise the unique properties of autologous bone graft whilst minimising harvest volume as synthetic substitutes contribute to the bulk for reconstruction. However, the iliac crest (the curved ridge at the top of the pelvis) has been considered the "gold standard" source for bone graft procedures due to the relatively large volume of bone that can be harvested from the pelvis. It allows the harvesting of cancellous bone, corticocancellous bone strips, or even tricortical bone, as appropriate. The harvested bone provides the full spectrum of osteogenic, osteoconductive, and osteoinductive properties, as well as structural support if needed (tricortical bone graft).

23.     I would like to rely upon some precedents of Hon’ble Supreme Court. In the case of V. Kishan Rao v. Nikhil Super Speciality Hospital[1], the Hon’ble Apex Court observed as below:

"...To fasten liability in the cases of doctors causing death of their patient due to medical negligence, the courts have to have a direct evidence of negligence which caused death. Unless the act of negligence is a 'gross' one, mere mistake or some inadvertent slip may not by itself be evidence of negligence to fasten liability of a doctor. It is well settled that where the doctors act carelessly and in a manner which is not expected of a medical practitioner, then in such a case an action would lie. Mere deviation from normal professional practice is not necessarily evidence of negligence."

          The recent decisions of Hon’ble Supreme Court in the case S. K. Jhunjhunwala vs. Dhanwanti Kaur and Another^[2] 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.

The Hon’ble Supreme Court in the case of Devarakonda Suryasesha Mani & Ors. versus Care Hospital, Institute of Medical Sciences & Ors[3], while dismissing the appeal filed by the Complainant held that:

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. 

24.     Based on foregoing discussion, it was an unfortunate death due to sudden pulmonary embolism. I do not find any negligence or failure of duty of care from the OPs. They have performed their duty as per reasonable standard of practice. The Complaint is dismissed. There shall be no Order as to costs.