Appeared at the time of arguments

Pronounced on:  8^th January 2021

ORDER

1.       Both the Appeals have been filed against the Final Judgement / Order dated 09.12.2009 passed by the State Consumer Disputes Redressal Commission, Odisha, Cuttack (hereinafter referred to as the “State Commission”) in Consumer Complaint No. 57 of 2001 wherein the State Commission did not hold the Opposite Parties liable for medical negligence and dismissed the complaint. However it held the Tata Memorial Hospital for functional irregularities and ordered the Opposite Parties Nos. 1 & 2 to compensate the Complainant No. 2 by making a payment of Rs. 1 lakh plus Rs. 10,000/- towards the cost of litigation.

2.       For the convenience, the facts are drawn from First Appeal No. 53 of 2010. The Appellants were complainants and the Respondents were the Opposite Parties in the complaint and they are accordingly referred in this Order.

3.       Brief facts:

The Complainant No. 1 is voluntary Consumer Association and the Complainant No. 2 (Shyam Sundar Dash) is the employee of IMFA Ltd. at Therubali (Odisha). His daughter Shrutilekha Dash, about 16 years of age, (since deceased, hereinafter referred to as the “patient”) was taken to IMFA Hopsital, Therubali in the month of December 1998 for pain in left leg / knee.  She was further referred to the Orthopedic Surgeon, Dr. Rama Chandra Rao at District Hospital, Raigad, wherein Biopsy of left knee joint was performed and it was diagnosed as Osteosarcoma of left knee. Thereafter, the IMFA Hospital referred the patient to Tata Memorial Hospital (hereinafter referred to as “TMH”) at Mumbai. On 26.02.1999, the Complainant No. 2 admitted his daughter to TMH.  On 29.06.1999, Dr. Rajesh Badhwar (hereinafter referred to as the “Opposite party No. 3”) Surgeon, Bone & Soft Tissue Service at TMH examined her and confirmed the diagnosis of Osteosarcoma. She was advised for few cycles of Chemotherapy followed by knee replacement with artificial limb at a later stage. The patient underwent Chemotherapy for more than five weeks and on 29.04.1999 was advised by the attending surgeon for Total Knee Replacement (TKR) with KOTZ Modular Implant. A total estimate of Rs. 3 lakh was intimated to the Complainant. It was alleged that the order for prosthesis (implant) from M/s Howmedica - the Opposite Party No. 4 was delayed because of the faulty internal administration of TMH. The supplier did not supply the required Prosthesis   within the stipulated time because TMH did not clear previous dues of the supplier. The prosthesis having different measurement was requisitioned. Though the Prosthesis was available at discounted price with the help of Cancer Patient Aid, but TMH refused to accept it. It was further alleged that the patient was admitted in February, 1999 but the surgery was delayed to 15.09.1999, which caused additional expenditure due to increased higher price for prosthesis and the patient had undergone one more dose of Chemotherapy which was harmful for the patient. The Complainant further alleged that both the operative teams i.e. Cancer Surgeon and Plastic Surgeon were not present during the surgery which has a norm in such surgical process.  The Plastic Surgeon too came to the Operation Theatre  after  two hours of the knee replacement surgery only on getting an emergency call. He expressed his dissatisfaction for such delay and told that it may cause infection to the operative wound.  The plastic surgeon also expressed displeasure that there was no water available in the Operation Theatre for hand scrubbing; therefore he had to go to another Operation Theatre. It was further alleged that the Prosthesis was not implanted properly which caused damage to the blood vessels and profuse bleeding. It was the carelessness and deficiency in service of treating doctors due to which the patient developed infection at operated site. Thereafter, the doctors at TMH again advised to replace the Prosthesis with free fibula grafting with additional dose of Chemotherapy. It was alleged that though, the Surgeons at TMH were aware that further treatment would not yield any positive result, yet, they asked the Complainant No. 2 to deposit additional Rs. 1.5 lakh for Surgery and Rs. 2 lakh for post-surgery Chemotherapy. However, the patient’s father did not agree and he returned to Therubali. On 08.03.2000, the patient got admitted in nearby Christian Hospital, Bischam at Cuttack. The infected Prosthesis was removed on 15.04.2000, however the severe wound infection persisted.  It was alleged that after removal of the Prosthesis, it came to light that different size of prosthesis was used during surgery at TMH. It was bigger in size, did not fit in to the patient, which caused damage to the vessels and caused further delay in reconstructive Plastic Surgery. The Prosthesis bears different numbers, and nowhere the name of the manufacturer or the place of its manufacture was mentioned , thus it  gave the suspicion that the Prosthesis used was of an inferior quality. As a life saving measure, the Doctors at Christian Hospital, Cuttack (Opposite Party No. 5) carried out amputation of the leg. She stayed in the Hospital from 08.03.2000 to 20.06.2000 but could not recover from infection and expired on 08.12.2000. Being aggrieved by alleged deficiency of service and medical negligence of the treating doctors, a Consumer Complaint No. 57 of 2001 was filed against the Opposite Parties Nos. 1 to 4 before the State Commission, claiming compensation of Rs. 19, 90,400/- with interest at the rate of 18% p.a. jointly and severally. 

4.       The Opposite Parties Nos. 1 and 2 jointly filed their Written Version through the Medical Superintendent of TMH and they denied any negligence or deficiency in the treatment of the patient. The Opposite Party No. 4 M/s Howmedica Duchem Laboratories Ltd. filed a separate written version stating that it cannot be held liable as the business of the company had already been transferred. The Opposite Party No. 3, Dr. Rajesh Badhwar had expired and accordingly the claim as against him was abated. The Opposite Parties Nos. 5 & 6 are formal parties, against whom no relief had been claimed. The Opposite Parties Nos. 1 & 2 raised preliminary objections that the State Commission neither had the (i) pecuniary jurisdiction, nor the (ii) territorial jurisdiction, to entertain and try the present Complaint under the Consumer Protection Act, 1986, as the Complainant prayed for the compensation and costs of Rs. 19,90,400/- along with interest @ 18% p.a. i.e. from  15.09.1999 till the date of realization of the amounts; which after calculation exceeds Rs. 20 lakhs which is beyond the pecuniary jurisdiction of the State Commission. The Opposite Parties further submitted that the State Commission did not have the territorial jurisdiction to entertain the Complaint because both the Opposite Parties are located at Mumbai and do not have any branch or other office in Odisha and/or do not carry on their activities in any other city other than Mumbai. 

5.       It was submitted that, the patient was referred from IMFA Hospital to the TMH on 26.02.1999. The patient was admitted at TMH under the care and supervision of Senior Consultant, Dr. Rajesh Badhwar (hereinafter referred to as the “Opposite Party No. 3”). After investigations, the diagnosis of a highly aggressive bone tumour - Osteosarcoma of left leg was confirmed. The patient was advised for Chemotherapy sessions, and thereafter, resection of the cancer affected bones i.e. Total Knee Replacement (TKR) Surgery and implant of an Artificial Prosthesis in lieu of the amputated limb. The Chemotherapy in four cycles was completed between March to June, 1999 and on 28.06.1999, Dr. Badhwar examined the patient and suggested that to undergo TKR Surgery within short span of time with Prosthesis of 9 mm diameter would require to be implanted. As the patient was running fever, therefore for short period she left the Hospital and again came back to TMH in August, 1999. As the patient was immuno-compromised and highly prone to the infections, therefore the 5^th session of Chemotherapy for September, 1999. Accordingly, an Indent Order was placed by TMH on 27.08.1999 to the Opposite Party No. 4 for obtaining Howmedica Modular Prosthesis. The Prosthesis was received by TMH on 31.08.1999.

6.     On 15.09.1999, Dr. Rajesh Badhwar and his Orthopaedic team performed   TKR- i.e. resected the bones afflicted with cancer and implanted the Prosthesis (Howmedica Modular Resection System / KOTZ Modular Femur & Tibia Reconstruction System) while the Plastic Surgery team of TMH successfully carried out the reconstruction of the limb. The patient then attended the OPD of TMH, after three months on 16.12.1999, and complained of pain for which she was taken to Dr. Ajay Puri at TMH, who after examination advised immediate admission and removal of Prosthesis at the earliest. However, the patient’s father refused for admission and removal of Prosthesis at TMH. He took the patient to his native Village at Therubali. Thereafter the patient for on 18.03.2000 got admitted to Christian Hospital at Bisam, Cuttack on 18.03.2000 wherein the Prosthesis was removed on 15.04.2000. Therefore, the patient’s father himself was negligent who did not follow the advice of Dr. Ajay Puri and the removal of Prosthesis was done after four months delay.

7.     It was submitted by the Opposite Parties Nos. 1 & 2 that the Prosthesis being a foreign body, sometimes it may not suit every patient and may cause infection, therefore its removal was recommended. It is a known complication that about 15% of cases show infection on implantation of Prosthesis. After the removal of the Prosthesis at Christian Hospital, Cuttack, the Complainant wrote two letters to TMH on 07.06.2000 and 24.07.2000 by which he thanked TMH for the co-operation and treatment of his daughter. He expressed his desire to return the removed Prosthesis to the Hospital and requested to refund the cost of Prosthesis. However, in reply the Medical Superintendent of TMH pointed out by letter dated 04.08.2000 that the Prosthesis was custom built and once implanted, same cannot be re-used on any other patient. The patient eventually died on 08.12.2000 due to the aggressive nature of Osteosarcoma  as a consequence of lung metastasis.  There was no deformity.   

8.       Being aggrieved by the Order passed by the State Commission, the Complainant No. 2 filed First Appeal No. 53 of 2010 for enhancement of compensation, whereas the TMH Hospital filed First Appeal No. 115 of 2010. The First Appeal No. 53 of 2010 filed by Complainant for enhancement of compensation, whereas the Opposite Parties Nos. 1 & 2 filed First Appeal No. 115 of 2010 for the dismissal of the complaint and  to set aside the observations of alleged irregularities   State Commission.

9.       I have heard the learned counsel for both the sides.

10.  The learned Counsel for the Complainant reiterated the facts and their affidavit of evidence. The learned Counsel for the Complainant submitted that vide Order dated 29.08.2017 of this Commission, the Opposite Parties Nos. 5 to 7 are formal parties against whom no relief is sought, therefore, the notice was not issued. He further submitted that since the Opposite Party No. 3 had expired, no cause of action survived qua the Opposite Party No. 3. The name of the Opposite Party No. 3 was deleted vide Order dated 17.07.2015.

11.     The learned Counsel for the Opposite Parties Nos. 1 & 2 vehemently argued and reiterated the submissions made in affidavit of evidence. On the preliminary objection the learned counsel argued that the State Commission did not have Pecuniary Jurisdiction in view of the judgment of Ambrish Kumar Shukla Vs Ferrous Infrastructure (P) Ltd., 2016 SCC Online NCDRC 1117 and Anil Textorium (P) Ltd.  Vs Rajiv Niranjanbhai Mehta, III (1997) CPJ 31 (NC), and further argued that the compensation claimed by the Complainant exceeds Rs. 20 lakh which was more than the jurisdiction of the State Commission. He further argued that the State Commission, did not have the territorial jurisdiction to entertain the present Complaint against the Opposite Parties. The cause of action, if any, for the alleged deficiencies and negligence averred against the Opposite Parties Nos. 1 & 2 had admittedly arisen at Mumbai and no cause action arisen partly or wholly in Odisha. He relied upon the Judgments of the Hon’ble Supreme Court in the case National Textile Corporation & Ors. Vs Haribox Swalram & Ors. (2004) 9 SCC 786 and Kusum Ingots & Alloys Ltd.  Vs Union Of India & Ors. (2004) 6 SCC 254.  Thus the complaint was liable to be dismissed by the State Commission.  

12.     On merit; the learned counsel for the Opposite Parties argued that the patient suffered highly aggressive bone cancer. The doctors at TMH treated the patient as per standards. The learned counsel further argued that Osteosarcoma is a highly aggressive bone tumour affecting mostly children in the adolescent group and prognosis is bad due to lung metastasis with chances of survival up to 5 years.   Therefore even after best possible treatment, the death of a patient cannot be attributed to any medical negligence by the treating doctors or the hospital.  He further submitted that based on the evidence of two medical experts (one expert was appointed by State Commission), the State Commission observed that the functioning of the Hospital was not “free from irregularities” which may have contributed to the suffering of the deceased Srutilekha Dash and without discussing the reasons, awarded Rs. 1 lakh as compensation to the Complainant No. 2.

13.     I gave thoughtful consideration to the arguments advanced by the learned counsel of both sides and perused the Medical Record, the literature and the Order of the State Commission.

14.     The incident happened in the year 1999 and we are now in the year 2020. Almost two decades have elapsed. The State Commission has already dealt with the preliminary objections on maintainability of the complaint (territorial and pecuniary jurisdiction). Therefore, I proceed to decide the matter on merit. The Complainant’s grouse was that the patient was admitted to TMH in February, 1999, but the surgery was conducted after 6 months delay in September 1999. As per standard medical literature and text books, it is pertinent to note that the Osteosarcoma is a highly aggressive malignant tumour.  Before the surgical treatment, the patient needs to stabilize with the few cycles of Chemotherapy. Depending upon the patient’s clinical response the treating doctor decides the Chemotherapy schedule for “pre” (neoadjuvant) and “post” (adjuvant) operative stages. Generally, pre-operative cycles range from 3 to 5 sessions of chemotherapy. In the instant case it was decided to give five cycles of neoadjuvant Chemotherapy between February, 1999 and August, 1999.  Thus, the allegation of Complainant is not sustainable that surgery could have been done after 4 cycles of Chemotherapy and the unwanted 5^th cycle of Chemotherapy which delayed the surgery was not required.  During the treatment, nothing prevented the Complaint No. 2 to seek 2^nd opinion from institution of his choice or any competent doctor, which he failed.

15.     In the instant case, the Complainant neither led any expert evidence nor produced any medical literature to prove medical negligence. However, the State Commission obtained opinion of an Independent Expert Doctor – Dr. Rabin C. Mishra, Professor of Surgery & HOD, Acharya Harihar Regional Cancer Centre, Cuttack. The affidavit of evidence dated 18.10.2006 from Dr. Ajay Puri, Associate Professor (Bone & Soft Tissue Unit) of TMH is on record. The combined reading of both the expert opinions nothing is established about any lapses or failure of duty of care at TMH and does not corroborate the allegations of negligence raised by the Complainant No. 2. Thus, the State Commission rightly held that there was no medical negligence from the Opposite Parties.

16.     Regarding the procurement of Prosthesis, the Complainant alleged that it was delayed by the TMH. It is apparent from the prescriptions that after the 4^th cycle of Chemotherapy on 28.06.1999, Dr. Badhwar wrote the prescription that “patient would require Prosthesis of appx. 9 mm diameter”.  It means Dr. Badhwar noted the clinical findings and his advice. In my view, the Complainant   misconceived about the treatment aspects. The said prescription was neither an “Indent” for placing an order to procure the Prosthesis nor suggestive of   detailed specifications of the size of Prosthesis.

17.     After administration of the 5^th cycle of Chemotherapy in August, 1999, the patient was fit for operation at the end of September, 1999. It is apparent from the challan of the supplier Howmedica (the Opposite Party No. 4) that on 27.08.1999 the Indent/Purchase Order for HMRS KOTZ Modular Prosthesis was placed by the TMH. The Prosthesis with all its parts of different configurations was received within 3 days by the Hospital on 31.08.1999. Thus, an allegation of complainant that there was delay in procurement of the Prosthesis because of non-payment of earlier dues by TMH is unsustainable. 

18.     The KOTZ Modular Knee Prosthesis is a set of several different components including Str Anch, Extension PC, Femoral Joint, Proximal Tibial Fixation Plate, Bearings, Wedges, Clips, Bone Screws etc. These components come in   different sizes /configurations. The sizes may usually vary with measurements taken on a clinical examination and the exact size can only be determined on the Operating Table by the operating surgeon.  In the instant case on 28.06.1999, Dr. Badhwar on a clinical examination of the patient asked for the diameter of the main Prosthesis to be approximately 9 mm. However, the exact measurements taken during operation on the Operating Table indicated that the patient required Prosthesis of 10 mm diameter.  Therefore, the Complainant’s allegation about Prosthesis of a different size than that prescribed earlier was used which resulted in pain to the patient which had to be ultimately removed is not sustainable. It is pertinent to note that this was not a case where the Prosthesis with 9 mm diameter was not available at the time of operation. However, the operating Surgeon – Dr. Badhwar during surgery decided to use a Prosthesis with 10mm diameter.  It was the wrong presumption of the Complainant that “oversized” Prosthesis would have caused pain to the patient.

19.     The Complainant alleged that the Prosthesis procured in the name of Srutilekha Dash was not implanted while a used prosthesis originally implanted in another patient – Ritika Naik had been implanted.   In my view , it was a baseless allegation   that the Batch Codes of the Prosthesis procured for Srutilekha Dash also did not tally and match with the Batch Codes of the Prosthesis which were later removed from Srutilekha Dash at Christian Hospital, Cuttack. It is evident from the Manual / Literature published by Howmedica that the numbers inscribed on the different parts of the Prosthesis are generic in nature and reflect the Code Number of every part as 6465 -..-. The handwritten challan of Howmedica   revealed various parts of different sizes of the Prosthesis required during the surgery of Srutilekha Dash and the   Howmedica prosthesis Code No. was  6465-0-020.   The contention of the Complainant in this regard is just imaginary.

20.     The allegation of the Complainant about complete mismanagement during the Surgery in the Operation Theatre as both the Orthopaedic Surgeon and the Plastic Surgeon  were not present at the same time is also not sustainable.  It should be borne in mind that the instant surgery was a major surgery and is to be performed in two stages by the two separate teams of doctors, each headed by the Senior Surgeons.  The first part of the surgery is performed by the team of Orthopaedic Surgeons who do excision of the diseased bones and implantation of the Prosthesis, then the reconstruction of the tissues around the operated area is to be done by  the second Team  of Plastic Surgery. Therefore, there was no need of Plastic Surgeon to be present during 1^st part of surgery.  The Plastic surgeon is called once the resection of tissue is required after the job is completed by the Orthopaedic Surgeon.  Such allegation of the Complainant is based on conjectures and surmises; and is therefore vague.

21.     The vague allegation that no water was available for the Plastic Surgeon for scrubbing.  In TMH usually the Operation Theatre Complex consists of number of operation theatres and had never a problem of water. The scrubbing areas for several adjacent Operation Theatres are common. I do not think that could have materially affected the surgery of the instant patient.  I further note that as per the Operation Record, the resection of the diseased bone, implantation of the Prosthesis and reconstruction surgery was successfully done and uneventful i.e., without any complications.   

22.     The treating doctors at TMH have attempted it for limb salvage which in the interest of Srutilekha Dash a young girl of 16 years of age. If infection occurs,   then the better option would be that the Prosthesis be removed.  On 16.12.1999   the patient was evaluated at TMH and advised immediate admission for removal of Prosthesis.  However, patient’s father instead of admission went back home and after almost 4 months, in April, 2000 at Christian Hospital, Cuttack got the Prosthesis removed and the left leg got amputed. The amputation of leg shall not be construed as   a result of “irregularities” in the functioning of the OP Hospital.

23.     It should be borne in mind that simply proving the suffering of ailment by the patient after the surgery 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., (2019) 2 SCC 282 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 is possessed of 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. In other case Achutrao Harbhau Khodwa Vs. State of Maharashtra, 1996 Vol 2 643 the Hon’ble Supreme Court has held

“The skill of medical practitioner differs from doctor to doctor.  The nature of the profession is such that there may be more than one course of treatment which may be advisable for treating a patient.  Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution.  Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession and a court finds that he has attended on the patient with due care skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence.”

24.     To conclude, the doctors at TMH have made correct diagnosis of Osteosarcoma. There was no deviation from the duty of care as the cancer specialist / operating surgeon to decide the time of operation after appropriate chemotherapy cycles and use of   proper implant during surgery. Thus the treatment plan was correct as per standard of practice. The cancer surgery consumes hours and needs  team of doctors including plastic surgeon whose role starts  only after the   removal of cancerous lesion and thus, there was no need for plastic surgeon to remain personally present throughout the surgery. It is pertinent to note that the patient died after eight months of the surgery and it was not due to any infection or any deficiency in duty of care of the treating doctor. The patient died due to metastasis in the lungs which is known in the Osteosarcoma – the aggressive malignant tumour.   The expert opinion did not comment on any deviation of treatment or negligence by the doctors at TMH.

25.     Based on the above discussion, it cannot be attributed to medical negligence of the treating doctors or the TMH. The impugned order to the extent it is directed against Opposite Parties No. 1 and 2 cannot be sustained and is accordingly set aside.  Resultantly, F.A. No. 115 of 2010 filed by the O.P.s is allowed and F.A. No. 53 of 2010 filed by the Complainant is dismissed. Consequently the Consumer Complaint is dismissed.

26.     Considering the sufferings of 16 years young girl who died of highly aggressive bone cancer (Osteosarcoma) and the loss & agony of the bereaved parents who spent two decades in the litigation, with my sympathies for the parents of deceased, let Tata Memorial Hospital extend its charity and donate the amount deposited before this commission along with accrued interest to the Complainant No.2. 

However, it shall not be construed as a precedent in any manner. 

The Registry is directed to disburse the amount to the Complainant No. 2 as stated above, within 4 weeks.