DR. S. M. KANTIKAR, MEMBER Trust has traditionally been considered a cornerstone of effective doctor–patient relationships. The need for interpersonal trust relates to the vulnerability associated with being ill, the information asymmetries arising from the specialist nature of medical knowledge, and the uncertainty and element of risk regarding the competence and intentions of the practitioner on whom the patient is dependent. 1. Shri B. D. Singh, the complainant,( herein referred as “patient”) an employee of M/s Borosil Glasswork Limited,(in short “ M/s Borosil”) met with an accident in the factory premises on 18.4.2001 and suffered serious crush injury on his left foot. Immediately, he was taken to OP 1/Dr. Balabhai Nanavati Hospital for treatment at about 10.30 a.m. After first aid, the patient was kept waiting in the ward. At 11.30 a.m., X-ray and other investigations were completed and emergency operation was lately performed at 4.00 p.m. Crucial time of 5 hours was lost. This delay attributed to losing of left foot of patient. OP 2 performed operations on three occasions to amputate the left foot piece by piece on 18.04.2001, on 23.04.2001 and 02.05.200, therefore the patient was hospitalized for a long time. Thereafter, on 16.05.2001 the complainant obtained discharge on the advice of his employer’s panel doctor and approached another hospital i.e. Paramount General Hospital on the same day, under care of Dr. Utkarsh K. Angachekar, wherein , patient’s left leg below the knee was amputated. 2. Therefore, it was alleged that, OP 2 at first instance , failed to assess actual need for amputation, but unnecessarily, performed three times amputation. It was a gross negligence. The complainant suffered severe mental trauma. The complainant suffered partial permanent disability, he is on artificial limb. Hence, the complaint was filed before the State Commission, Maharashtra in the month of September, 2001. 3. The State Commission vide its order dated 3.8.2015 allowed the complaint and directed the OPs 1, 2 and 3 to pay lump sum amount of Rs.6 lakh with interest @ 9% per annum from 11.9.2001 till realization along with costs of Rs.25,000/-. 4. Aggrieved by the impugned order, opposite parties 1 and 2 filed two separate appeals bearing No. 748 of 2015 and 752 of 2015 before this Commission for dismissal of complaint. 5. The learned counsel for appellant/OPs Mr. Y. C. Naidu vehemently argued that, the complainant’s case is based on main two points i.e. amputation of limb was done in piece by piece and secondly, the consent form was not proper. He further submitted that, the complainant raised the issue of consent without any allegations pleaded in the complaint. The State Commission acted perversely and observed the matter beyond pleadings. The State Commission relied upon the principles regarding Consent laid down by Hon’ble Supreme Court in Samira Kohli’s case and held the OPs liable for failure to take informed consent. 6. The counsel brought our attention to the evidence on record. He brought our attention to the sequence of events, i.e. from the time of admission till the time of operation. Regarding consent, the counsel for OP brought our attention to the details recorded in the progress sheet in the medical record on day- to-day basis with signatures and specific date, time details. He submitted that, OP-2 amputated initially part of left foot, done cleaning and debridement of the wound. It was the misconception of the complainant that OP undertook amputation three times. Later on, patient developed discolouration of the toes and sensation decreased. As the condition of the affected area was deteriorating, forefoot amputation was duly explained to the patient and his relatives. After obtaining of consent of the complainant, forefoot amputation was carried out on 23/04/2001 (syme’s amputation) and is well documented technique with inherent benefit and advantage to the patient in the process of re-habilitation. On 30/04/2001, wound dressing was carried out when minimal sloughing was noted. Wound was finally debrided and dressing was carried out on 02/05/2001. This opponent came to know that the complainant and his relatives were enquiring with him to have below the knee amputation. Therefore, it was decided to post the patient for below the knee amputation on 17/04/2001 and patient offered his consent while preparing for the plan below knee amputation. The OP-2 came to know that patient insisted discharge against medical advice which was finally granted as DAMA (Discharge against medical advise) on 16.05.2001. 7. The counsel further argued on the legal issues, and put reliance upon the judgments of Smt. Vinitha Ashok vs. Lakshmi Hospital & Ors., Civil appeal No. 2977 of 1992 decided on 25.9.2001, the National Textile Corporation Ltd. vs. Nareshkumar Badrikumar Jagad & Ors. Civil Appeal No. 7448 of 2011 decided on 5.9.2011, I. C. Mehta vs. Divisional Engineer, Telegraphs, Rewari 1986-99 CONSUMER 4745 (NS). 8. The rival arguments adduced by Mr. Vikas Nautiyal the learned counsel for the complainant was that the OP attended the patient at very late stage, same observations are made by State Commission Even after the patient’s arrival at the hospital, the precious time was lost though the complainant sustained profuse bleeding. The operation was taken place at 4.00 p.m. The delay has aggravated seriousness of crush injury leading to repeated amputation. OP 2 operated the patient three times for amputating the left leg piece by piece after ankle level. Thus, it was not a proper treatment. Therefore, as per the disability certificate the patient suffered 25% partial permanent disability of lower limb. He brought our attention to the admission record of Dr. Utkarsh K. Angachekar at page 156, which reveals; “Amputation of left foot at level of ankle joint (Syme’s Amputation). Sutures were in-side. Foul smelling, Purulent discharge was coming from the suture limb. Wound edges were necrotic. Swelling of the leg was present upto the level of calves. Warmth / temperature of local area was increased. Pressure on would edges resulted in a gush of purulent material from wound. Lymphodenopathy left insured, region present. Nodes tender to touch. Patient gave history of injury on 18.04.2007 to left foot which was operated on the same day. Subsequently, amputation at level of injury knee performed on 23.04.2007. A. further procedure was performed on 02.05.2007. Dressings were being done at regular intervals.” 9. The counsel further submitted that, OP-2 failed to take free, valid and informed consent, not explained the nature of surgery required to undergo and its aftermath effect. Consent was recorded in a very routine matter on a printed format. He relied on the Supreme Court authority in the matter of Sameera Kohli vs. Dr. Prabha Manchanda & Anr. I (2008) CPJ 56 (SC) whereby the Hon’ble Apex court laid down the guidelines for consent of the patient commencing from treatment. Consent so obtained should be real and valid and patient must have capacity and competence to consent. It is obligatory for doctor to disclose nature and procedure of the treatment and its purpose, benefit and effect. The OPs obtained consent each time of amputation as a very routine manner. Just signature of the complainant and his relatives available on each time were obtained. In one go, decision to amputate specific portion not taken by the OP-2, as specified in Mercer’s Textbook of Orthopedic and Trauma – 10th Edition. 10. We have perused the voluminous medical record and the standard medical text books in orthopedics authored by Cambell’s, Mercer’s and Waston Jones. As per the medical record and progress sheets from OP-1 hospital, the patient suffered severe crush injury as a result of fall of heavy metal weight on left foot. It was diagnosed as compound communited-taraso-metatarsal fracture along with dislocation of the joint and toes. OP-2 had initial task was of fixation of affected bony structure and stabilization of soft tissue. It was carried out with minimum surgical incision. Open wounds were debrided and affected limb was secured with sterile bandage. The procedure was carried out in orthopedic operation theatre in total aseptic condition. 11. To decide this appeal we need to discuss, the two questions which swirl around that, OP-2 performed amputation three time and the OP-2 failed to take informed consent. On perusal of medical record, it reveals that, the patient was admitted in the hospital at 10.30 a.m. on 18.04.2001. The treatment chart clearly reveals that the treatment was started at 10.30 a.m. itself by IV fluids, DNS, RL etc. It is pertinent to not that thereafter the indoor case papers were prepared. We have noted the admission record,(at page 276), which reveals the Indoor Registration No. 21/004460 dated 18.04.2001 at 11:18:48. It clearly shows that the treatment was already started before the registration i.e. first aid treatment. Further, the record shows the consent for re-construction of foot fracture ( in short “ # “) was taken on 18.04.2001 (Pg 282). The name of operation or procedure is mentioned as i.e. re-construction of foot fracture (#), SOS amputation. The said consent form is signed by the patient himself and his brother, Shri R. D. Singh at 3.00 p.m. The open reduction was performed by OP with ‘K’ wire, Fixed by Torso matatersal joint dislocation and debridement. The OPs with his prudence, obtained consent for dressing (P.280), the dressing was done in the OT. The consent form was signed by the complainant himself and one of the attendant. The notes clearly reveal dressing details at page 285. The record further reveals proper consent was taken on 23.04.2001for foot amputation, signed by Smt. Anitha Singh, probably wife of the complainant. The OP-2 performed amputation in the afternoon. Thereafter, the 2nd debridement of the wound was done by the OP on 2.5.2001 with proper consent. Therefore, we are of the considered view that the consent was taken at every occasion, it was an informed consent. 12. The operative notes maintained by OP-2 clearly mention that thorough cleaning of wound was done. Debridement was done. The Calcanium and Talus along with necrotic tissue were excised, wound closed with layers, stay sutures taken. Applied compression bandage. As per Mercer’s Textbook of Orthopadics and Trauma, under Chapter “ Amputation”, the relevant text at page 395 narrated Syme’s amputation regarding early, intermediate and late Amputation. The text Intermediate Amputation is reproduced as under: “Where in an injured limb, the decision to amputate is taken after ineffective attempts to obtain a limb with reasonable function. Presently, we have technical advances to salvage traumatized limbs that would have been amputated in earlier days. The ultimate function of the limb thus salvaged, after numerious operations prolonged hospitalization and enormous financial costs, must be weighed against the functional capabilities of modern prosthesis fitted after early amputation. When the degree of destruction does not justify early amputation, experience is required to judge the advantages of early amputation and prosthetic fitting against prolongs surgical efforts with a dubious end result and limited recovery. A second opinion is immensely helpful especially in the present era of increasing litigation should be considered. 13. In our view, the OP/doctor followed the same procedure while doing the amputation of the patient’s forefoot. We have noted few affidavits on file viz Dr.Hatolkar a Medical Supdt of OP hospital, Dr.Bakul Mehta a visiting Medical officer of M/s Borosil, Dr. Utkarsh K. Angachekar ofParamount Hospital and Dr.A.R. Karkhanis (Orthopedician) clearly stated that there was no negligence in the treatment of OP-2. 14. It should be borne in mind that, the treating doctor/ orthopedic surgeon will try to save the limb as much as possible. In the present case the patient having suffered a crush injury involving the front portion of the foot (i.e. forefoot involving the five phalanxes (toes), all five matatarsals bones, tissue muscles and tendons involving the above bone structure), the Syme’s amputation was the optimal procedure for saving the limb. In case of accidents, industrial injuries etc. involving crush injuries, compound wounds etc. debridement of the wound in the first instance is necessary. Taking reference from Mercer’s Textbook of Orthopaedics and Trauma, the “six hour rule” is somewhat obscure and the rationale for this appears to have some animal based evidence. In any event, in the instant case the debridement was carried out well within four hours. Further, the patient has presented with infection as the wound site for the first time 21 days post procedure. The medical therapy was started on empirical basis immediately even as culture and sensitivity studies were being done. 15. As per the text book by Rockwood and Green’s Fracture in Adults, under chapter “Initial management of open fractures” discussed about treatment options. The salvage or amputation is important decision to be taken by the treating doctor. It is often difficult decision that requires experience. Availability of advanced soft tissue reconstruction techniques using microsurgery and skeletal reconstruction devices has made limb salvage technically possible even in extreme cases. If not carefully chosen, the patient may be subjected to prolonged attempts at reconstruction with multiple surgeries but finally have a secondary amputation. Every attempt must be made to avoid the “triumph of technique over reason” and a decision regarding the probability of amputation should be made during the index procedure or at least before the definite soft tissue reconstruction procedure is attempted. The need for primary amputation may be obvious in certain instances. However, many injured limbs fall into a gray zone where the availability of an objective assessment criteria would be helpful. Debridement and Lavage:- Thorough debridement is important if the risk of infection is to be minimized. Debridement is an active surgical procedure and not just wound washing. All foreign material and tissues that are contaminated or suspected to be avascular are systematically removed so that whatever is left behind is vascularized living tissue, devoid of contamination. A secondary aim of debridement is also to minimize risk factors for infection such as dead space or hematoma so that the incidence of infection is reduced. Debridement should be done as soon as possible after injury and the traditional teaching was that it preferably be completed within 6 hours. The aim was to prevent contamination from becoming infection and early debridement will prevent colonization of the bacteria within the tissue. 16. In this context, we rely upon the Jacob Mathew’s Case, (2005) SCC (Crl.)1369, Hon’ble Supreme Court observed that higher the acuteness in emergency and higher the complication, more are the chances of error of judgment. The court further observed as under:- "25......At times, the professional is confronted with making a choice between the devil and the deep sea and he has to choose the lesser evil. The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Which course is more appropriate to follow, would depend on the facts and circumstances of a given case. The usual practice prevalent nowadays is to obtain the consent of the patient or of the person in-charge of the patient if the patient is not be in a position to give consent before adopting a given procedure. So long as it can be found that the procedure which was in fact adopted was one which was acceptable to medical science as on that date, the medical practitioner cannot be held negligent merely because he chose to follow one procedure and not another and the result was a failure." Cuort further observed that, “If the hands be trembling with the dangling fear of facing a criminal prosecution in the event of failure for whatever reason - whether attributable to himself or not, neither can a surgeon successfully wield his lifesaving scalpel to perform an essential surgery, nor can a physician successfully administer the life-saving dose of medicine. Discretion being the better part of valour, a medical professional would feel better advised to leave a terminal patient to his own fate in the case of emergency where the chance of success may be 10% (or so), rather than taking the risk of making a last ditch effort towards saving the subject and facing a criminal prosecution if his effort fails. Such timidity forced upon a doctor would be a disservice to society”. 17. The Counsel Mr.Naidu, paced a document on record to show that, the Complainant/patient took VRS in the year 2004 and received Rs.3,65,000/- towards his remaining service. Even all the bills of hospitalization, artificial limb charges were paid by M/s Borosil i.e. the employer. 18. Therefore, on the basis of medical record, the literature and text and forgoing discussion, there was no negligence on the part of OPs. The complainant approached the Commission in vengeance against doctor and with unclean hands. We allow this first appeals, set aside the order passed by the State Commission and consequently the complaint is dismissed. No costs. |
