Appeared at the time of arguments

For the Complainant       :       Mr. Mohak Bhadana, Advocate

For the Opp. Parties       :       Mr. Rohit Jain, Advocate with

                                              Dr. S.S. Saha, OP-2 in person

Pronounced on:  23^rd May 2023

ORDER

DR. S. M. KANTIKAR, PRESIDING MEMBER                            

1.           The present Complaint has been filed under Section 21 of the Consumer Protection Act, 1986 by Smt. Reena Bansal through her husband Ankur Goel (hereinafter referred to as the ‘Complainant’) against the Sir Ganga Ram Hospital (OP-2) & Dr. S. S. Saha-Sr. Consultant (Dept. of Plastic Surgery) – (OP-2) for the alleged medical negligence caused to the Complainant which rendered her permanently disabled, bed ridden and in a vegetative state. 

2. The Complaint:

2.1     On 02.05.2007, the Complainant, Reena Mittal (hereinafter referred to as the ‘Patient’), was admitted under Dr. S.S. Saha (OP-2) at Sir Ganga Ram Hospital (OP-1 - SGRH) for “Amelo Blastoma Right Ascending Ramus of Mandible surgery”. It was alleged that the surgery was delayed by two days without any reason, and eventually it was performed on 05.05.2007. The surgery started and continued until 0041 hrs on 06.05.2007. The jaw bone was reconstructed with the help of the fibula bone (graft). The patient was shifted to post-operative ICU under the care of the Anesthesia team and put elective ventilation. However, about 24 hours after the surgery, it was noticed that the Complainant's left upper limb was not moving. The CT scan of brain showed dense right MCA infract with mass effect. The doctors took measures to decrease Inter Cranial Pressure (ICP). The OP-2 did not seek the opinion of a Neurosurgeon or other experts. On 07.05.2007, the patient was shifted to the main ICU. It was alleged that despite being a renowned hospital, OP-1 failed to arrange blood at the time of surgery and resorted to 3 units of Autologous Transfusion by which patient’s Hb% become 8.4%.

2.2 On 09.05.2007, Dr. Rana Patir, a Neurosurgeon, performed a decompressive craniotomy to control the increased ICP and impending herniation. The patient was continued to be on ventilator. On 15.05.2007, Dr. Sumit Ray and Dr. Vinod Singh performed a tracheostomy in the ICU. The patient developed infection, therefore, she continued to have fever, and she was put on a ventilator under sedatives. On 18.05.2007, the patient was taken off from ventilator, but she remained in unconscious state. Thereafter, noticed pus discharge from the craniotomy site and high grade fever. Eventually, on 18.06.2007, a second surgery was performed to treat ventriculitis (inflammation of the ventricle), and she was kept for observation. On 12.07.2007, the patient was again put on a ventilator. On 18.07.2007, the Neurosurgeon performed septal perforation and removal of necrotic brain tissue. On 02.08.2007, the Complainant underwent VP shunt surgery, and   on 13.08.2007, she   moved back to the ICU due to a blockage of the tracheostomy tube. on 14.08.2007, she was shifted out of the ICU. It was alleged that the patient developed breathing complications due to improper placing of tracheostomy tube. On 24.09.2007, another Neurosurgery was performed, but there were no signs of improvement and she became in vegetative state.

2.3     Being aggrieved due to gross negligence of OP-1 & OP-2 the Complainant filed this Consumer Complaint through her husband Mr. Ankur Goel and prayed Rs. 12.07 Crore as compensation.

3.      Defence:

3.1     The Opposite Parties have filed their Written Versions, denying allegations of medical negligence. It was submitted that the complaint lacks cause of action and time-barred as it was filed after three years.

3.2    The OP-2 Dr. S. S. Saha submitted that the surgery was initially scheduled for 03.05.2007 but postponed due to the non-availability of blood as the patient's blood was AB Negative, quite rarely only seen in 0.2% of the population. The surgery was conducted on 05.05.2007 by using patient's autologous blood and the blood arranged at the blood bank of OP-1 hospital. After 24 hours of surgery in the ICU, the patient showed signs of reduced limb movement on the left side.

3.3       The OP-2 also submitted that the patient was under observation of the doctors in Neurovascular surgery and ICU. The tracheotomy was performed after obtaining informed consent from the patient's attendants. Despite best possible care, the patient developed craniotomy wound infection, urinary infection and cerebrospinal fluid (CSF) infection.  She was operated for ventriculitis.

3.4     The OP-2 further submitted that the tracheostomy tube was blocked due to secretions, the ICU consultants took its care and changed it. The OP-2 denied about improper fitting of the tracheostomy tube and denied that the patient was unable to breathe properly for three hours. On 01.07.2007, the patient was opening her eyes spontaneously following the commands. The OP-2 further submitted that there was a surgical misadventure during the surgery, resulting in the avulsion of Right internal carotid artery (ICA). Despite all efforts were taken to save the complainant's life. The OP-2 submitted that the report of Dr. Anil Vardani was not based on the treatment records and it was more sympathetic than factual. The Nizam's Institute case, which the Complainant relied shall not be a binding precedent to this case. The OP-2 submitted that the Complainant had not paid the hospital bill amounting to Rs.2,27,61,178/-.

3.5      The OP-1- Sir Ganga Ram Hospital filed its reply. The hospital   adopted the evidence submitted by Dr. S.S. Saha (OP-2).

4.      Arguments:

4.1     We have heard the arguments from the learned Counsel for both the sides. Perused the material on record.

4.2     Arguments on behalf of Complainant

4.2.1  The learned Counsel for the Complainant reiterated the facts. He argued on the expert report dated 16.03.2009. He submitted that on 05.05.2007 at the time of surgery the Internal Carotid Artery (ICA), got avulsed in the hands of OP-2, which he admittedly sutured. The OP-2 ought to have involved vascular surgeon to repair ICA. In the instant case, due to avulsion of ICA, there was prolonged deprivation of blood supply to the patient’s brain which eventually put her in a vegetative state.  He submitted that the OPs in their reply admitted it Avulsion of ICA was surgical misadventure, but failed to take necessary steps in order to restore its function. The Counsel brought our attention to the meaning of AVULSION from Tabre's Cyclopedic Medical Dictionary  as "A tearing away forcibly of a part or structure"; and it further illustrates as: "if fingers, toes, feet, or hands are completely avulsed, they may be successfully re-joined to the body if prompt and expert surgical care is available". In the present case, the OP-2, despite being aware of the avulsion at his hands remained negligent throughout and failed to get the complainant's avulsed ICA repaired.

4.2.2  The OPs have categorically averred that during traumatic dissections the injury to the vessel often renders it fragile and precludes direct repair, but the OPs were silent as to whether the aforesaid eventuality was informed to the patient or her relatives before surgery.

4.2.3  This Commission took an opinion from the Director General Health Services (DGHS) on 09.11. 2009. It was categorically observed that during dissection ICA was avulsed as it was friable. To stop the torrential haemorrhage, it was ligated. The DGHS expert body observed that clinical findings and details of advice were not available in the medical record. 4.2.4     The learned Counsel for the Complainant argued that in the instant case patient at present is in a vegetative condition and needs for throughout her life constant nursing and medical assistance. Therefore complainant deserves adequate compensation. He relied upon the Nizam's Institute of Medical Sciences v. Prasanth S. Dhananka[1] case.  

4.3    Arguments on behalf of Opposite Parties

The learned Counsel for the OPs reiterated their evidence and the details of the treatment. He submitted that   recurrence rate of Ameloblastoma following curettage is high; therefore resection of 2 cm margins is considered the most effective solution[2]. The surgeon explained the possible consequences of the proposed surgery, the patient gave consent for surgery. The report of Dr. Anil Vardani was not based on the patient’s treatment records. His conclusion appears to be more influenced by sympathy. The DGHS issued a report dated 09.11.2009, stating that the surgery and treatment provided to the complainant were in line with established medical ethics and that no medical negligence was observed during the management of the patient.  

5.       Observations and Discussion:

We have perused material on record and few standard text books on Surgical Pathology and Plastic Surgery.

5.1 The case of the complainant emanates from the medical negligence committed at the time of surgery and was not on the post-operative care procedure.    

5.2   Plastic Surgery is the primary speciality to treat tumors of facial bones. In the instant case Mandibulectomy followed by its reconstruction with microvascular transfer of Fibula Bone, re-establishing its arterial and venous flows. The vascular repairs, both macro and micro vascular, are primary domain of Plastic Surgeon, therefore in our view, the OP was a the most qualified person to decide about feasibility of repairing ICA , at the time the unfortunate incidence took place. Upon perusal of OT notes, it is evident that routinely Vascular pedicle for Free Fibula Flap are exposed through a separate incision, after fixation of Fibula graft to Resected Mandible. It was an accepted standard of method of reconstruction of Mandible.

5.3     The vascular injury and bleeding are complications which can occur during any surgery, which all surgeons strive hard to avoid and do their best to control. Still many a times, such efforts can fall short of and can still have complication either in the form of loss of function or life. But such is the vagaries of life, especially for a Surgeon.

5.4     To repair ICA either primarily or with saphenous vein patch /PTFA graft needs clamping of both ends of injury site. This effectively blocks the ICA, which will lead to Neurologic damage of brain, if not reversed within five, at the most ten minutes. In the present case, to assume, when ICA is bleeding, to extend 4 cm incision, identify and isolate and clamp both ends of ICA, do  a primary end to end repair within in 10 minutes so that neurological damages are prevented looks practically impossible.

5.5     Comments on expert witnesses (4) on behalf of Complainants.

We have perused the e-mails sent by the expert witnesses.

5.5.1  Dr. Guthikonda Murali and Dr. Amresh S. Bhaganagare opined that to call somebody in the building while applying pressure on vessels. In our view, as such, it will not help, it will practically cut of circulation to brain, while losing the blood.

5.5.2  Dr. Benjamin W Starnes – the Vascular surgeon from University of Washington, expressed that “ICA can only be handled with ligation if repair is impossible”. It was pertinent impossible situation in the instant case. In his opinion a vascular surgeon consultation was necessary. In our

view, the OP-2 the Plastic surgeon was well qualified and experienced to perform such repairs. It’s a Primary domain of Plastic surgeons.

5.5.3  Dr. Peter Y Milne’s e-mail states that 25% chance of stroke, if ICA is ligated. The dilemma of making right decision in such grave situation is very well reflected in the present case.

5.5.4 Knowing well that repair of ICA cannot be done in 10 minutes, to save life of the patient from bleeding. The surgeon OP-2 braved the ligation, but he did not run away from his responsibility of reconstructing the mandible defect. He discharged his duty to the patient, of complete reconstruction, since the patent had 75% chance of no neurological injury, as expressed by last expert witness. We would like to add further that assuming in the same hospital setting of tertiary care, if  injury to either Brachial or Femoral artery  causing distal ischemia, and if the patient’s general condition is good, in such situation despite availability of  Plastic surgeon failure to repair   vessels leading to limb loss would constitute Negligence.

5.6       We have perused the report (opinion) given by Dr. Anil Vardani holding   OP-1 prima-facie for medical negligence on following points.

1. The anaesthesia records for 11 hours during surgery show stable haemodynamic parameters and do not justify the claim of a life threatening situation where ligation was the only answer. Also no blood requirement was made to blood bank or to the family during the surgery
2. There is no evidence of attempts by the surgeon to manage the patient after a surgical injury caused to the artery in an area where there was no disease by arranging massive blood transfusion or attempting a surgical repair. No vascular or neurosurgeon was called for vascular repair, which should have ideally been done within three hours.
3. No remedial measures or a neurology consult was taken after ligation of internal carotid artery. Timely intervention by Neurologist and use of anti edema drugs could have prevented increase in cerebral edema. Rather it took more than 24 hours for the doctor to call a neurologist in a multispeciality hospital.

5.7     In our considered view, the opinion of Dr. Anil Vardani appears bias to support the complainant. The patient had multiple vascular anomalies both in the leg and neck. The friable neck vessel was paradoxically similar to atherosclerotic vessel. Even with minimal handling ICA got avulsed at its junction with carotid artery, which was abnormally high in bifurcation.  The treating team of doctors in OP-1 hospital treated the Post-operative   complications with decompressive craniotomy on 09.05.2007. Thereafter,  on 15.05.2007, elective tracheostomy was performed. The severe meningitis was improved and the ventilator was gradually weaned off.  Her were stable and she   gradually recovering with hemiparesis left side.  Because of this unexpected complication, the patient's stay had been prolonged.   

5.8     It is transpired from the evidence of the OPs that since the day of treatment till date, the OP Hospital is providing best treatment to the patient. The relatives of the Complainant till 05.08.2015 had not paid Rs. 2,27,61,178/-. The OP-1 Hospital as a good gesture considering the condition of the patient was continuously providing treatment.   

6.  Catena of judgments from Hon’ble Supreme Court and this commission have discussed what constitutes medical negligence.

6.1     In Arun Kumar Manglik v. Chirayu Health and Medicare Private Limited case the Hon’ble Supreme Court held that the standard of care as enunciated in Bolam case must evolve in consonance with its subsequent interpretation by English and Indian Courts. The Court held as under:

“45. In the practice of medicine, there could be varying approaches to treatment. There can be a genuine difference of opinion. However, while adopting a course of treatment, the medical professional must ensure that it is not unreasonable. The threshold to prove unreasonableness is set with due regard to the risks associated with medical treatment and the conditions under which medical professionals function. This is to avoid a situation where doctors resort to “defensive medicine” to avoid claims of negligence, often to the detriment of the patient. Hence, in a specific case where unreasonableness in professional conduct has been proven with regard to the circumstances of that case, a professional cannot escape liability for medical evidence merely by relying on a body of professional opinion.”

6.2     It would be more relevant in   another judgment Kusum Sharma v. Batra Hospital and Medical Research Centre, a complaint was filed attributing medical negligence to a doctor who performed the surgery but while performing surgery, the tumour was found to be malignant. The patient died later on after prolonged treatment in different hospitals. This Court held as under:

…“47. Medical science has conferred great benefits on mankind, but these benefits are attended by considerable risks. Every surgical operation is attended by risks. We cannot take the benefits without taking risks. Every advancement in technique is also attended by risks.

…..xxxxx…

…72. The ratio of Bolam case [[1957] 1 WLR 582 : (1957) 2 All ER 118] is that it is enough for the defendant to show that the standard of care and the skill attained was that of the ordinary competent medical practitioner exercising an ordinary degree of professional skill. The fact that the respondent charged with negligence acted in accordance with the general and approved practice is enough to clear him of the charge. Two things are pertinent to be noted. Firstly, the standard of care, when assessing the practice as adopted, is judged in the light of knowledge available at the time (of the incident), and not at the date of trial. Secondly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that point of time on which it is suggested as should have been used……. xxxx…….

6.3.    It should be borne in mind that simply proving the suffering of ailment by the patient does not amount to medical negligence. The Hon'ble Supreme Court has recently held in the case S. K. Jhunjhunwala Vs. Dhanwati Kaur and Anr[3]., that a doctor or surgeon cannot assure that the outcome of any surgery would be beneficial.  The court held that a professional might be held liable for negligence either if they do not possess the requisite skills that they claimed to have, or they don't exercise the skill which they have.  While referring to the judgements, the court said that the human body is like a highly complex machine and a doctor could not assure full recovery of a patient. The only assurance that such a professional can give or can be understood to have given by implication is that he possessed the requisite skill in that branch of the profession which they are practising and while undertaking the performance of the task entrusted to them, they would be exercising their skill with reasonable competence, court added.

7.      Medical Literature on Ameloblastoma: [4]

7.1     Ameloblastoma is a benign odontogenic tumor of epithelial origin. It is locally aggressive with unlimited growth capacity and has a high potential for malignant transformation as well as metastasis. Ameloblastoma has no established preventive measures although majority of patients are between ages 30 and 60 years. Treatment of Ameloblastoma is focused on surgical resection with a wide margin of normal tissue because of its high propensity for local regional invasion; but this is often associated with significant patient morbidity. The relatively high recurrence rate of Ameloblastoma is influenced by the type of molecular etiological factors, the management approach, and how early the patient presents for treatment. It is expected that further elucidation of molecular factors that orchestrate pathogenesis and recurrence of Ameloblastoma will lead to new diagnostic markers and targeted drug therapies for Ameloblastoma.

Ameloblastoma presents clinically as a slow-growing relatively painless tumour. Due to its locally aggressive growth characteristics, Ameloblastoma can rapidly become a massive and expansible tumour causing tooth mobility, tooth displacement, and a grotesque facial appearance if the patient delays getting treatment.

7.2     The research article “Surgical management of Ameloblastoma: Conservative or radical approach[5] described that;

Ameloblastoma has a high rate of local recurrence if it is not adequately removed. In our opinion, radical surgical resection of ameloblastoma is the treatment of choice. Especially in cases of large, expansive tumors a radical surgical protocol is a very good option to prevent relapse of the tumor on a long-term basis. Reconstruction of the defects with bone graft material allows good functional and esthetic outcome and decreases the number of surgeries. For reconstructing the mandible we prefer bone grafts from the iliac crest. The natural curvature and variable bone height offers the possibility of exact reconstruction of the defect.

8.       Based on the discussion above we do not find any merit to conclusively attribute medical negligence of the opposite parties (the doctors and hospital). The Complaint fails.

The instant Consumer Complaint is dismissed. There shall be no Order as to costs.