State Consumer Disputes Redressal Commission
J.S. Bedi, vs All India Institute Of Medical Sciences on 2 November, 2007
IN THE STATE COMMISSION : DELHI IN THE STATE COMMISSION : DELHI (Constituted under Section 9 clause (b)of the Consumer Protection Act, 1986 ) Date of Decision: 02-11-2007 Complaint Case No. C-131/2003 Dr. J.S. Bedi, Appellants S/o Shri A.S. Bedi, Through R/o 3068/40-D, Chandigarh. Ms. Sobhna with Mr. Gurinder Singh, Advocates. Through Legal Heirs 1. Smt. Harpreet Kaur, W/o Late Dr. J.S. Bedi, 2. Jasjit Singh, S/o Late Dr. J.S. Bedi. 3. Jasmeet Singh, S/o Late Dr. J.S. Bedi. All R/o 3068/40-D, Chandigarh. Versus 1. All India Institute of Medical Sciences, Opposite Party No.1 New Delhi, Through Director. Through Mr. Sudhir Gupta, Advocate. 2. Dr. Arvind, Opposite Party No.2 In-Charge Unit 4, Deptt. Of Surgery, Through AIIMA, New Delhi. Mr. Sudhir Gupta, Advocate. CORAM : Justice J.D. Kapoor- President Ms.Rumnita Mittal - Member
1. Whether reporters of local newspapers be allowed to see the judgment?
2. To be referred to the Reporter or not?
JUSTICE J.D. KAPOOR, PRESIDENT (ORAL) On account of medical negligence on the part of the OP, the complainant who is a doctor himself has through this complaint sought compensation of Rs. 65,25,000/-.
2. Allegations of the complainant, in brief, are that he was examined in AIIMS on 09-08-2001 by Dr. Arvind/OP No.2 and on the basis of CXR and C-T Scan, surgery was advised for the Anterior Mediastinum Tumor and operation date was fixed on 21-08-2001.
He was admitted for surgery on 20-08-2001 and the surgery Median Sternotomy and Thymectomy was conducted on 22-08-2001. After surgery he was told by the OP No.2 that he had to cut the Left Phrenic Nerve of the complainant as the same was passing through the main Thymus Mass and he was left with no other option than to cut the said nerve to remove the Thymus Mass.
The consequence of cutting of left Phrenic Nerve was that his left Diaphragm was raised and the same exists like this till date.
3. That immediately after regaining consciousness the complainant realized that he was not able to speak and he complained about the same to the OP No.2. OP No.2 took it very lightly and told to the complainant that there may be an injury to vocal chords in the process of giving general Anaesthesia before the surgery, which occurs very usually and the voice comes back to normal within 3-4 days.
4. He was discharged on 30-08-2001 i.e. 8 days later to the operation, but there was no improvement in his voice inspite of the fact that OP No.2 had assured that he will regain his normal voice within 3-4 days of the operation which was conducted on 22-08-2001.
It appeared to him that the vocal chord got paralyzed during the surgery conducted by Doctor Arvind/OP No.2 on 22-08-2001. The complainant on his own went to ENT Department (AIIMS) to get himself examined for the problem of voice suffered by him right from the day of his surgery i.e. 22-08-2001. After examination, the ENT Department of AIIMS declared left cord palsy (post operative) and suggested the complainant for speech Therapy and gave the opinion that the problem appears to have occurred due to cutting of nerve to left vocal chord during the surgery on 22-08-2001. this shows the utter negligence of OP No.2 as the voice of the complainant was totally lost during the surgery performed by him.
5. For the further negligent attitude of the OP, even the specimen of the Thymus Mass removed by the surgery dated 22-08-2001 was not sent for Histopathology test within time as noted in the Histopathology report dated 25-08-2001 and because of that no definite opinion was given.
6. That the complainant had shown the Histopathology report to Dr. Arvind who advised radio therapy for proper treatment from root which has caused that Thymus Mass. The complainant did not see any improvement in his voice or movement of the left vocal cord. He started showing himself to the Post Graduate Institute of Medical Education and Research, Chandigarh (PGIMER). The complainant was advised speech therapy by PGIMER and was given speech therapy for several sittings as per the speech assessment of the complainant as per the report of the PGIMER dated 18-02-2002.
7. In its defence and while absolving from the charge of medical negligence and administrative negligence of any kind whatsoever, the OP-AIIMS has come up with the version that on extensive examination, the complainant was found suffering from Thymoma and an anterior Mediastinal Mass was detected and was advised surgery. At the time of surgery, a big mass was found in mediastinum which was going to the left side and completely engulfing left phrenic nerve. The said tumor was infact reaching upto the arch of aorta and also reaching (partially stuck) to the left innominate vein. At the time of surgery the area was cut open from suprasternal notch to xiaphisternum, by mid-sternotomy and it was found that it is not possible to remove the tumor in toto without sacrificing the left phrenic nerve. Further it is well acknowledged and established convention that if the tumor cannot be resected in its entirety without sacrificing the nerve, then it is preferable to remove the entire portion of tumor, if the other phrenic nerve is normal and patient does not have Myasthenia Gravis or any other preceding respiratory or cardiovascular illness. Sacrificing of the involved ipsilateral phrenic nerve to achieve complete tumor excision is an accepted fact in the literature.
8. OP No.2 who is competent and experienced surgeon for such procedures, had carefully carried the procedure, however, due to the peculiar situation of the tumour completely engulfing the patients left phrenic nerve, it was a conscious decision to excise this nerve in order to leave behind no gross tumor as that would have endangered patients life later. As the tumor was reaching upto the arch of aorta and stuck to the left innominate vein, the entire tissue in that area was also excised in toto so as not to leave behind any gross tumor. That the patient left recurrent laryngeal nerve was present very close to the tumor and the nerve had to be carefully dissected and separated from the tumor to maintain its integrity at the same time not breaking the tumor capsule and leaving behind any gross tumor. This step was taken with due diligence and utmost care by the OP No.2. that in carrying out this entire procedure a lot of dissection needed to be done and was duly performed on this very fine slender nerve to separate it from the tumor.
9. However, at the same time OP has taken the stand that in the process of such extensive dissection to separate the nerve from the tumor with all due diligence the left recurrent laryngeal nerve got damaged without any visible loss of continuity. That at that point of time with the naked eyes, without a duly qualified and competent surgeon could have/ought to have done, has been done by the OP No.2 as well and the same was keeping in view the best interest of the patient. There is no element of negligence in the entire procedure.
10. In support of his allegations the complainant has relied upon the following documents:-
(i) Report dated 07-09-2001of mass sent for Histopathology test, which is to the following effect:-
Supplementary report Repeat sections taken following fixation of the thymectomy specimen show a well encapsulated tumor consisting of sheets of lymphocytee with a few scattered interspersed epithelial cells. The features are consistent with thymoma, lymphocyte predominant type.
X-ray report shows that because of the cut of the phrenic nerve the left diaphragm had risen and it reduced the left lung half of its size which causes problem in breathing.
(ii) Letter dated 31st March 2003 from Dr. Michael Polkey, Consultant Physician of Royal Brompton & Harefield NHS Trust, Sydney Street London, is to the following effect:-
It seems inevitable that Dr. Bedi must have, from what you tell me, a phrenic nerve palsy of the nerve had to be sacrificed during surgery and there is little that can be done at this stage to restore function to it.
If the ends of the nerve were sutured at the time of surgery and Dr. Bedi wishes to check whether or not potency of the nerve has been restored then this would be something that we could do for him by phrenic nerve stimulation. Similarly, if he is having any respiratory difficulty we could evaluate himwith regard to possible use of non-invasive ventilatory support.
(iii) Break up of expenses incurred for restoration (page 63).
(iv) Annexure A-9 is letter by Japanese Doctor, Dr. N. Isshiki, MD where he advised for medialization of the vocal fold; either thyroplasty or arytenoids adduction depending on the size of the glottal chink during phonation. This operation was done on 17-09-2002 involving expenses of more than Rs. 3 lacs.
(v) Discharge summary of OP-Hospital, AIIMS which suggesting nowhere as to what follow up has to be done after excising.
11. Thus according to the OP there has been no negligence whatsoever on the part of the OP in the treatment of the complainant and the complainant was treated as per the accepted procedures and further as world wide accepted practice as also mentioned in the literatures, as above.
12. We have heard the arguments of the parties at length and accorded careful consideration to the material on record particularly the medical literature relied upon by the parties.
13. On the concept of medical negligence we have culled out certain criteria from the ratio of large number of judgments starting from Bolams case followed by various judgments of the Supreme Court, some of which are as under :-
(a) Bolams case reported in (1957) 2 AII ER 118, 121 D-F
(b) Sidway V. Bethlem Royal Hospital Governors and Others 643 All England Law Reprots (1985) 1 All ER.
(c) Maynard V. West Midlands Regional Health Authority 635 All England Law Reports (1985) 1 All ER.
(d) Whitehouse V. Jordan and Another 650 All England Law Reports (1980) 1 All ER.
(e) Indian Medical Association Vs. V.P. Shantha & Others (1995) 6 SCC 651
(f) Jacob Matthew Vs. State of Punjab and Another (2005) SCC (Crl.) 1369
14. The conclusions are as under :-
(i) Whether the treating doctor had the ordinary skill and not the skill of the highest degree that he professed and exercised, as everybody is not supposed to possess the highest or perfect level of expertise or skills in the branch he practices?
(ii) Whether the guilty doctor had done something or failed to do something which in the given facts and circumstances no medical professional would do when in ordinary senses and prudence?
(iii) Whether the risk involved in the procedure or line of treatment was such that injury or death was imminent or risk involved was upto the percentage of failures?
(iv) Whether there was error of judgment in adopting a particular line of treatment? If so what was the level of error? Was it so overboard that result could have been fatal or near fatal or at lowest mortality rate?
(v) Whether the negligence was so manifest and demonstrative that no professional or skilled person in his ordinary senses and prudence could have indulged in?
(vi) Everything being in place, what was the main cause of injury or death. Whether the cause was the direct result of the deficiency in the treatment and medication?
(vii) Whether the injury or death was the result of administrative deficiency or post-operative or condition environment-oriented deficiency?
15. As is apparent the allegations are mainly twofold. Firstly that the left Phrenic nerve while operating the mass was cut and even after operation this serious error was not realized otherwise the doctor would not have left the phrenic nerve without stimulating the same or without suturing its ends. Secondly that during the surgery OP No.2 doctor cut the nerve to left vocal cord as a result of which the complainant lost his voice and inspite of complaining of the same he was told that it may be a routine momentary soarness which would go with passage of time and the complainant attended various sessions of speech therapy and despite passing of more than a year there was no improvement. However, it was only after he contacted a great Japanese Surgeon under whose advice Dr. Shankarshana performed thyroplasty (medialisation of left vocal cord) that the complainant could regain his voice though not fully as one more operation is required for nearing normalcy results.
16. In its defence the OP has taken the plea that there were two options open to the OP. One was to open the tumor capsule and dissect the tumor along the phrenic nerve and save the phrenic nerve. While this would have saved the nerve, it would have meant opening the tumor capsule and leaving behind Gross disease along the phrenic nerve.
Second option was to not open the tumor capsule and do in continuity resection of the involved phrenic nerve thus ensuring Compelte surgical resection of the gross disease but sacrificing phrenic nerve in the process. That the respondent took a conscious decision in the best interest of the complainant to adopt the second approach/method, which is duly and well accepted method under the situation in which the complainant was.
17. In support of the correctness of the decision taken by the OP No.2 that second option was the best option, the learned Counsel for the OPs has placed reliance upon the following international medical literature:-
(i) Book on General thoracic Surgery by Dr. Thomas shields, fourth edition, Chapter 134, Page 1786 that -
Patients with thymomas often are clinically asymptomatic.
The exact percetage is difficult to ascertain, although 50% is often quoted.
18. However, when detected, whether symptomatic or asymptomatic, it needs to be treated by complete surgical resection. Again quoting from Dr. Shields book All patients with Thymoma except those with clinically, grossly non-resectable disease or with spread beyond the thorax, should undergo as complete a resection of their disease as possible.
(ii) Cariothoracic Surgery by Fritz J.
Baumgarthner (page No. 245-246).
The thymoma may recur locally if its capsue has been violated. If the tumor appears invasive, radical excision may be warranted. Generally, if the patient does not have myasthenia gravis, then sacrifice or one of the phrenic nerves is acceptable, since these patients will generally still be able to be extubated, if they have a normally functioning hemidiaphragm on the other side.
(iii) General thoracic Surgery by Dr. Thomas W. Shields, (Page No. 1133 1135).
At any point where adherence of invasion to a surrounding structure is suspected, resection with the thymoma should, if possible, be performed. Protection of the phrenic nerves is important, but if curative resection requires removal of one phrenic nerve and the patient can tolerate this from a respiratory standpoint, it should be performed.
(iv) General Thoracic Surgery by Dr. Thomas W. Shields Chapter 134 (infection, tumors and cysts of the mediastinum, sections of Thymic Neoplasms (pages 1791-1792) -
All patients with thymoma, except those with clinically, grossly nonresectable disease or with spread beyond the thorax should undergo a complete a resection of their disease as possible
(v) Cured from Vocal Cord Paralysis in a Fighter Pilot by Stephen Maturo and Joseph Brennan-
The most common cause of recurrent laryngeal nerve paralysis is iatrogenic injury due to surgeries of the neck and thorax.
19. OP has also relied upon medical literature on the subject General Thoracic Surgery by Thomas W. Shields, Professor Emeritus of Surgery of Northwestern University Medical School, which are to the following effect:-
In patients with a grossly encapsulated lesion, completion excision including a total thymectomy is the procedure of choice. Simple enucleation is to be avoided except under unusual circumstances excision through a lateral thoracotomy with an unknown pre-operative diagnosis, because a small percentage of patients without myasthenia gravis develop the disease sometime in the remote postoperative period.
For very large midline tumors, Patterson (11992) suggested the use of bilateral anterior fourth intercostals space incisions with transverse section of the ternum.
In patients with gross fixation of the tumor to one or more nonvital adjacent structures, resection of the adjacent involved tissue pleura, lung, pericardium should be carried out along with complete excision of the tumor and the residual thymus gland. When one phrenic nerve is involved and a curative resection can otherwise be carried out, we recomment excision of the nerve if the patient can tolerate the loss of the function of one hemidiaphragm from from a respiratory standpoint.
This loss may be a problem in the patient with myasthenia gravis, and clinical judgment must be exercised.
The most common cause of recurrent laryngeal nerve paralysis is iatrogenic injury due to surgeries of the neck and thorax. The recurrent larygeneal nerve controls the petinets ability to obtain full glottic closure. Complete glottic, or laryngeal, closure provides for the primary function of the larynx, that being to protect the trachea from the harmful effects of aspiration CASE REPORT A 46 year old male, military command pilot with close to 4000 flying hours in high performance aircraft presented to his flight surgeon with 24 h of abdominal pain and diarrhea. He described diffuse abdominal pain without associated dysphagia, odynophagia, hemoptysis, hematachezia, cough, fevers, chills, or recent weight loss. Past medical and surgical histories along with family history were unremarkable.
He denied tobacco use and alchohol intake was infrequent. Physical exam revealed a normal cardiopulmonary and abdominal exam without evidence of abdominal tenderness or rebound. The patients voice was without weakness or hoarseness. The patient underwent six cycles of cisplatin, adriamycin, and cytoxan without significant side effects. The result was a 60% reduction in tumor volume. The patient was taken to the operating room where a sternotomy with tumor removal was carried out. He had a hoarse voice postoperatively, which upon otolaryngology evaluation was determined to be a paretic left true vocal cord. The likely etiology was damage to the recurrent laryngeal nerve during the removal of the thymoma.
20. Aforesaid conspectus of rival claims and contentions lead to the conclusion that the OP was deficient firstly in cutting left phrenic nerve of the complainant negligently while excising thyma mass as this could have been avoided and further that they left the phrenic nerve without stimulating the same or without suturing its end that caused paralysis of the left phrenic nerve as well as diaphragm. This negligence is demonstrated firstly from the X-ray report as well as the opinion given by the Doctor of London vide letter dated 11th October 2004. Secondly, inspite of cutting of the left nerve vocal cord which was subsequently rectified though partially bythe surgery undertaken by Japanese Surgeon Dr. Shankarshana.
21. Even if we accept the contention of the OP that the nerve was to be sacrificed still it was the duty of the OP to see that the phrenic nerve ends are sutured or stimulated so as not to result in paralysis.
22. In our view, lumpsum compensation of Rs. One Lack including the cost of litigation will meet the ends of justice.
23. Complaint is allowed to the aforesaid extent.
24. A copy of this order as per the statutory requirements, be forwarded to the parties free of charge thereafter the file be consigned to Record Room.
25. Announced on the 2nd November, 2007.
(Justice J.D. Kapoor) President (Rumnita Mittal) Member jj