Several medical literatures on the bone cancer and the standard medical textbooks on Oncology mentioned that ;
As malignant primary bone tumors are rare cancers, and as management is complex, the accepted standard is to provide access to the full spectrum of care. The cancer treatment centers, the therapy is usually given within the framework of prospective, often collaborative, clinical studies, or established treatment protocols. An initial chemotherapy can have life changing consequences, but unfortunately osteosarcoma is an aggressive form of cancer, and increase in size after chemotherapy can result in limb sparing surgery or an amputation depending on the stage and spread of the cancer.”
1. With this preface, I take up this complaint filed under Section 21 (a) (i) of the Consumer Protection Act, 1986, alleging gross medical negligence on the part of the opposite parties during treatment of Osteosarcoma- the bone tumour.
2. Brief facts necessary to appreciate the issue raised in this Complaint are:
That Mr. Vishnu Raj Choudhary, since deceased, (hereinafter referred as ‘the patient’) aged about 25 years was diagnosed at Pune for Bone Cancer of his left leg(Tibia), in May 2014. The complainants took him for further treatment to Mumbai in June, 2014 at Tata Memorial Centre (TMC) /OP-1 and consulted Dr. Asish Gulia and Dr. Ajay Puri (OP-2) at Osteosarcoma Department. Various tests were performed and on the basis of test reports, Dr. Asish Gulia and OP-2 assured the complainants that the disease was 100% curable, as the tumor was localized and in primitive stage in the left tibia, with no signs of metastasis. Believing the words of assurance given by both the doctors, the patient opted for treatment in OP-1 Hospital from 1.7.2014. PET/CT Scan was performed on 3.7.2014, the report (Annexure 1, herein after referred to as A-1), confirmed the diagnosis of localized tumour- as sarcoma in the left tibia without any distant metastasis. The histopathology examination (HPE) report dated 4.7.2014 (A-2), also confirmed it as a “High Grade Pleomorphic Osteosarcoma”. On 7.7.2014, OP-2 advised initial 4 sets/cycles of chemotherapy and then surgery, which thereafter was to be followed by another set of chemotherapy to end the treatment. The OP1 also assured that initial four cycles of the chemotherapy were to check the progress of tumor cells, which would be helpful in eradicating the tumor cells completely and the post-surgical chemotherapy would be as a preventive measure.
3. Patient underwent four cycles of chemotherapy from 8.7.2014 to 3.12.2014 at an interval of every 21 days. After the 2nd cycle of chemotherapy a blister developed over the skin at the place of tumor, upon which the complainants consulted OP 2, who advised that it was just a side effect of chemotherapy. Despite chemotherapy, the tumor size increased, but OP-2 did not change the medicines and also refused to perform surgery at that stage. On 11.9.2014, 3rd cycle of chemotherapy was given. The MRI of left tibia with knee was done on 29/9/2014. The report (A-5) showed residual tumor and cortical destruction on the left lateral aspects of the left tibia and incidentally also showed small, 7 mm size, ring enhancing lesion within the Gastrocnemius muscle of left leg, suspected to be Granuloma Cysticercus. Thereafter at the insistence of the complainants, the CT Thorax was performed, the report dated 10.10.2014(A-6) revealed three small nodules (two calcified and one metastatic) of less than 5 mm in the lungs of the patient. The complainants immediately requested OP-2 to remove the three nodules from the lungs by surgery, but OP -2 assured that the chemotherapy is effective and the condition of the patient is under control, there was no need for immediate surgery and will be done as per fixed schedule. Complainants alleged that due to worsening condition of the patient, OP 2 was requested to change the medicines, which was declined. It was clear that the chemotherapy was not of much help to the patient, as lungs nodules would have been treated by the surgery, but OP 2 had adopted wait and watch policy. The 4th cycle of chemotherapy was given on 10.11.2014. From 18.10.2014, the patient was admitted as indoor patient. As per nursing assessment record (A-8) which was filled by the complainants, specifically asked for assistance to the patient during walking, transfer, bathing, toilet etc. On 20.10.2014, the day of surgery at about 8.00 a.m., the team of doctors of OP 2 asked the patient to take immediate bath. At that time, neither hospital attendants nor patient’s attendants were present because complainant No 1 had been sent to purchase some necessary articles and complainant No. 3 was completing the formalities for the surgery at the administrative window of the OP-1. Therefore, having left with no other option, the patient himself, with the help of crutches reluctantly went to bathroom, but slipped and suffered a fracture of left tibia. Thus, according to the complainants, the patient was a victim of carelessness and negligence of OP 1 and OP 2. Verbal complaint was lodged with the management of OP-1, which was of no avail. After incident, all the Doctors in the team of OP 2 disappeared. Thereafter, complainant No. 1 and 3, themselves took the patient for X-ray in the emergency ward. Till evening, the patient remained unattended by any doctor and no plaster was put on the broken limb. The complainants were trying to contact the OP 2 since morning till evening, but every time, OP 2 avoided them, and did not even attend the phone call. Finally in the evening, one junior doctor attended the patient and plastered the broken limb. Neither OP-2 nor any other doctor in OP-1 Hospital took the injury seriously, which was deficient and careless attitude on the part of the OPs, OP-2 postponed the surgery for the reason that patient would have to wait for one more month for union of broken bone, but it transpired that it was deferred because OP 2 had to go abroad, due to delay in the treatment of the patient developed post fracture complications, the left leg would have been saved from amputation, if the corrective measures had taken at the earliest,; it was gross negligence of doctors at OP-1 Hospital, that the patient’s left leg had to be amputated at AIIMS, which finally led to his death.
4. It was also alleged that, chemotherapy caused complications in the condition of the patient which became worse day by day. On 21.10.2014, the 5th cycle of chemotherapy was given to the patient without opting for immediate surgery which itself shows that the intention of OP-2, was only to loot the patient by raising bills in the name of chemotherapy. Thereafter, 6th set of Chemotherapy was given to the patient on 11.11.2014. MRI report dated 27.11.2014 compared with the previous MRI report dated 29.9.2014, showed increase in the extent of the altered marrow signal abnormality in the left proximal tibia and there was increase in the size of extraosseus soft tissue. On 27.11.2014, after much insistence by the patient and the relatives, the OP-2 advised PET/CT scan. It was done on 28.11.2014, the report (A-11) revealed metastatic stage of the tumor, which had spread below the knee in the left leg also. Thus, it was alleged that, the metastasis had developed due to failure of OPs in controlling the growth and spread of the tumor, which was initially fully curable.
5. The complainants’ allegations are that, though the patient was diagnosed as primary stage of ‘Non Metastatic high grade Osteosarcoma’, despite knowing the medical history and critical condition of the patient, the OP 2 and his team of doctors did not act promptly, if appropriate measures had been taken at the earlier stage, it would have saved the left leg from amputation and also precious life of the patient, the OP wasted precious time by giving unwanted chemotherapy to the patient, which caused adverse results only; to save their own skin and reputation, the OP 2 advised for amputation of the left leg in any other hospital, and thereby indirectly asking the patient to take discharge from OP-1 hospital. Immediately thereafter, the complainants consulted Dr. Rastogi and Dr. Julka, doctors in AIIMS, New Delhi upon their advice which the complainants took a decision to have the patient discharged from OP 1 to save his limb and life. On 8.12.2014, the patient was admitted in AIIMS. Both the doctors expressed their helplessness to salvage the left leg of patient. The doctors told that it was a pathological fracture due to Sarcoma of bone, which never re-join. Both the doctors were perplexed by the fact that how and why OP-2 took a chance for two months despite knowing very well that such bone never rejoins. Both the doctors told the complainants that OPs 1 and 2 destroyed the life of the deceased patient by negligent and casual treatment. Finally, due to damaged condition of the left leg and skin, Dr. Rastogi and Dr. Julka amputated left leg of the patient on 13.12.2004. Thereafter, the patient was referred to Dr. Sameer Bakshi, OP-3 for further treatment of cancer in AIIMS itself. OP-3 was appraised about the previous chemotherapy treatment to the patient. However, OP-3 further gave 7th and 8th cycle of chemotherapy to the patient. On 16.2.2015, CT Thorax (A-14), revealed multiple nodules i.e. metastasis in the lungs. Thereafter, OP-3 continued 9th, 10th and 11th cycle of chemotherapy on 26.2.2015, 12.3.2015 and 21.3.2015. It was alleged that, OP-3 gave chemotherapy despite the fact that the complainants were insisting for immediate surgery for the removal of nodules in lungs. However, after each cycle of chemotherapy, condition of the patient deteriorated and he was critical with intolerable pain. On 7.4.2015, CT Thorax report (A-15) revealed multiple nodules in the lungs, which were beyond the scope of excision /surgery. On the basis of PET/CT Scan report dated 17.6.2015 (A-16), OP-3 informed the complainants that nothing can be done and chemotherapy should be stopped. Thus, OP-3 was grossly negligent and callous in attitude who gave repeated cycles of chemotherapy without surgical removal of lung nodules.
6. Dissatisfied with the treatment of AIIMS, the patient was shifted to Medanta Hospital, Gurgaon on 14.6.2015 for further treatment, where he was diagnosed for Metastatic Osteosarcoma with cord compression, disseminated mets (stage IV) (A-17). On 3.7.2015, the patient was discharged from Medanta Hospital. Thereafter, he took treatment in Fortis Memorial Research Institute, Gurgaon from 22.7.2015 where he was diagnosed as Osteosarcoma (Post Chemotherapy) with spinal and lung metastasis. Finally, on 9.8.2015, the patient died.
7. Thus, alleging gross medical negligence on the part of OPs 1, 2 and 3, the complainants filed complaint before this Commission, praying for compensation to the tune of Rs.7,36,00,000/- from the OPs under different heads. Complainants also prayed for distribution of compensation in NGO/Charitable Organization ,working for the treatment of Cancer patients.
8. At the admission stage, I have heard Mr. Deepak Anand Learned counsel for the complainants. He vehemently reiterated the facts and chronology of events during treatment of deceased patient Mr. Vishnu Raj Choudhary. He also submitted that the patient was victim of medical negligence during the treatment of cancer given by OP1 to 3. Also, the OPs had indulged in unfair trade practices. The OPs (hospital and doctors) had caused deliberate delay, dereliction of duty, professional misconduct and abuse to the humanity. Thus, OPs deserve stern action. He submitted that the hospital is vicariously liable in the instant case. The doctors have not adopted reasonable care, the skill and knowledge. OPs 2 and 3 gave unnecessary treatment to the patient, as the cancer was at very early stage and was fully curable. OPs threw the patient in the death well after amputating the left leg, it was the unacceptable standard of practice. The OP-2 deliberately did not operate the patient at the initial stage because; it could have affected the schedule of his foreign trip, he continued with the chemotherapy cycles even after knowing that chemotherapy was not effective and it had also caused blisters over the skin, no preventive measures were adopted by him to prevent blisters; the OPs 1 and 2 did not bother to assist the patient despite, the fact that it was specifically mentioned in the patient’s Nursing Assessment Sheet that he needed assistance, OP never gave any option of other line of treatment to the complainant or patient and thus, it was a gross and culpable negligence of OPs 2 and 3, which resulted in the death of the patient within a year after the diagnosis.
9. Notice on admission of the Complaint hearing was issued to the OPs. Opposing the admission of the Complaint Mr Sandeep Narain, Learned Counsel appearing on behalf of OPs 1 and 2 submitted that the treatment at OP-1 Hospital , a reputed cancer hospital in India. Patient was treated as per standard protocol. There was no negligence on the part of OPs 1 and 2. Mr. Subodh Kr. Kaushik the Learned Counsel appearing for OP 3 did not make submission.
10. I have perused the medical record of TMC, AIIMS, Medanta Hospital and Fortis Hospital. It is an admitted fact that the patient was diagnosed as “High Grade Pleomorphic Osteosarcoma of left tibia”, same was confirmed by PET/CT, MRI and HPE. Looking into the chronology of events, the patient suffered pathological fracture due to the highly malignant lesion. Subsequently, despite initial chemotherapy, the lesion showed increase in size and he developed lung metastasis and skip metastasis in the left leg. Thereafter, the patient approached AIIMS where, he underwent palliative amputation and thereafter, five more cycles( 7th to 11th ) of chemotherapy from January to March, 2015. Thereafter, he took treatment in Medanta from June 2015, there whole body PETCT done on 19.6.2015, which showed metastases in lung, subclavical lymphnodes, bilateral pulmonary nodules and skeletal metastasis. It also revealed involvement of spinal vertebrae - focal uptake in D8, and diffuse uptake with paravertebral soft tissue in D11. In Medanta Hospital also, the patient was treated for pain management followed by palliative radiotherapy. It was planned for hypofractionated or conventional radiation for the pain control and also laminectomy at D11, because of impending cord compression to prevent paraplegia. After supportive care, the patient was discharged from Medanta. Then patient got admitted in Fortis Hospital at Gurgaon on 22.7.2015. He underwent D11 corpectomy & decompression with cage & D10-D12 lateral screw & rod fusion. He remained in ICU for post-operative care under Neuro Critical Care team. Despite all those measures, the patient died on 9.8.2015.
11. The main question for consideration is whether there was any medical negligence or any shortcomings on the part of OPs while treating the patient? It is clear from the medical record four aforesaid hospitals that OP 2, is a qualified Oncologist, working in the Osteosarcoma department at TMC/OP-1, as per standard chemotherapy protocol, he had started the treatment of Osteosarcoma initially with cycles of chemotherapy and thereafter planned for surgical excision, however, the chemotherapy did not show expected results and the tumor size increased., after 4th cycle of chemotherapy, the surgery was planned, but on the day of surgery, unfortunately the patient suffered a Fracture of left Tibia because of slip in bathroom. As per medical literature, it was a “Pathological fracture”, unlike fractures of normal bone, pathologic fractures occur during normal activity or minor trauma due to weakening of the bone by disease. Conditions associated with pathologic fractures include underlying metabolic disorders, primary benign tumors, and primary and metastatic malignant tumors. The patients with high grade bone malignancy are prone to pathological fractures irrespective of any trivial trauma or without any cause. In the instant case, the allegation is that, due to non-availability of the attendant, the patient slipped and had a fall in the bathroom, which resulted in fracture. In my view, it was a pathological fracture due to severe bone destruction and growing malignant tumour in the left tibia. The patient had gone into the bathroom without any assistance on his own volition. He could have waited for the assistant. Therefore, I do not find any lapse on the part of OP 1/hospital. As per medical record, for the fracture, doctors put an external splint , along with appropriate pain control, which is a standard treatment in case of pathological fracture.
12. On the subject of prognosis and management of Osteosarcoma, I have gone through few medical books viz Cancer: Principles & Practice of Oncology by DeVita, Hellman, and Rosenberg, Surgical Pathology by Ackerman. Also took reference from few research and review articles namely;
“Osteosarcomagenesis: Biology, Development, Metastasis and mechanisms of pain” (https://cdn.intechopen.com/pdfs-wm/53758.pdf)
“The overview Osteogenic Sarcoma Treatment Protocols” (http://emedicine.medscape.com/article/2006667- Mohammad Muhsin Chisti)
13. According to medical text and literature:
Ideally, all cases of suspected bone tumors should be discussed at a multidisciplinary team that includes the radiologist who has interpreted the imaging and the pathologist who has reviewed the biopsy material and the surgeon and oncologist undertaking treatment. This will minimize the risk of errors in diagnosis, staging, risk assessment, and treatment. Curative treatment of high-grade osteosarcoma consists of chemotherapy and surgery. Compared with surgery alone, multimodal treatment of high-grade localized osteosarcoma increases disease-free survival probabilities from only 10%–20% to >60%.Chemotherapy has dramatically improved survival in these patients. Prior to the use of chemotherapy, the majority of patients developed metastasis after surgery. Treatment is commonly given over periods of 6–10 months. Whenever possible, patients with osteosarcoma should receive chemotherapy in the context of prospective trials, which is regarded as standard of care.
14. General treatment recommendations for patients with osteosarcoma are listed below:
Stages IA-IB (low grade):
- Primary treatment for patients with low-grade osteogenic sarcoma includes wide excision only.
- Chemotherapy, either prior to excision or postoperatively, is not typically recommended.
- Periosteal lesions are one exception where adjuvant chemotherapy may be indicated postoperatively.
Stages IIA-IVB (high grade):
- Chemotherapy is warranted for all stages of high-grade osteogenic sarcoma.
- For nonmetastatic osteosarcoma, two to three cycles of chemotherapy are typically given preoperatively (neoadjuvant); three to four cycles of chemotherapy are given postoperatively (adjuvant).
In patients with a poor response to chemotherapy or in tumors unlikely to respond to chemotherapy, early surgery obtaining wide margins should be considered; in some cases this may require amputation.
15. The complainants alleged that if the hospital had operated the patient earlier then the amputation of left leg could have been avoided, which was unavoidable after chemotherapy. After going through the medical literature it is clear that, as per medical literature chemotherapy given before and after surgery will cure many people with osteosarcoma. An initial chemotherapy can have life changing consequences, but unfortunately osteosarcoma cancer is an aggressive form of cancer, and inadequate response to chemotherapy can result in limb sparing surgery or a amputation depending on the stage and spread of the cancer. The staging workup includes magnetic resonance imaging (MRI) of the entire length of the involved bone, computed tomography (CT) of the chest, and technetium radionuclide bone scanning. Positron emission tomography (PET) or a PET/CT scan can be considered in special circumstances. In the instant case, as per OP-2, the tumor response assessment before surgery was clinically doubtful and relevant, hence OP-2 took a decision and advised relevant investigations like MRI, PET/CT .
16. In Catena of judgments of Hon’ble Supreme Court and this Commission the principles for judging whether there was Medical Negligence in the treatment of patient have been enunciated. In Kusum Sharma & Others vs Batra Hospital & Medical Research Centre and others, (2010) 3 SCC 480, the court observed that,
50. 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 25benefits without taking risks. Every advancement in technique is also attended by risks.
51. In Roe and Woolley v. Minister of Health (1954) 2 QB 66, Lord Justice Denning said : `It is so easy to be wise after the event and to condemn as negligence that which was only a misadventure. We ought to be on our guard against it, especially in cases against hospitals and doctors. Medical science has conferred great benefits on mankind but these benefits are attended by unavoidable risks. Every surgical operation is attended by risks. We cannot take the benefits without taking the risks. Every advance in technique is also attended by risks. Doctors, like the rest of us, have to learn by experience; and experience often teaches in a hard way."
17. In Jacob Mathews Case, (2005)6 SCC 1, the Hon’ble Supreme Court observed that:-
“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.”
18. In another case Achutrao Haribhau Khodwa and others versus State of Maharashtra and others (1996) 2 SCC 634 Hon’ble Supreme Court has made the following observations
“The skill of medical practitioners differs from doctor to doctor. The very 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 the 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.”
19. In the case of Dr. Laxman Balkrishna Joshi vs. Dr. Trimbark Babu Godbole and Anr., AIR 1969 SC 128 and A.S.Mittal v. State of U.P., AIR 1989 SC 1570, it was laid down that certain duties of doctor which are: (a) duty of care in deciding whether to undertake the case, (b) duty of care in deciding what treatment to give, and (c) duty of care in the administration of that treatment. A breach of any of the above duties may give a cause of action for negligence and the patient may on that basis recover damages from his doctor.
20. Bearing in mind those principles, in my opinion OP-2 and OP-3 had followed and treated the cancer patient as per Standard Chemotherapy Protocol. I do not find any breach of their duty of care. The pathological fracture and subsequent deterioration of patient’s health was due to the High Grade Osteosarcoma disease itself.
21. It will be appropriate to quote a crucial observation by the Hon’ble Supreme Court in the Kusum Sharmas’s case (Supra) that:
52. It was also observed in the same case that "We must not look at the 1947 accident with 1954 spectacles". But we should be doing a disservice to the community at large if we were to impose liability on hospitals and doctors for everything that happens to go wrong. Doctors would be led to think more of their own safety than of the good of their patients. Initiative would be stifled and confidence shaken. A proper sense of 26proportion requires us to have regard to the conditions in which hospitals and doctors have to work. We must insist on due care for the patient at every point, but we must not condemn as negligence that which is only a misadventure.
22. I do not find any ground for admission of the instant complaint, because the allegations cannot be construed as medical negligence. Therefore, on the basis of foregoing discussion, to avoid the scope for unwanted litigation and disservice to the needy cancer patients in our country, the complaint is dismissed at the admission stage.