Dr. S.M. Kantikar, Member
1. No one ever knows what the outcome would have been had the other treatment modality been used. While everyone believes they know the recipe for their best personal series, no one knows what the best treatment would be for patients facing the dilemma. However, doctors cannot give a warranty of the perfection of their skill or a guarantee of cure. If the doctor has adopted the right course of treatment, if he is skilled and has worked with a method and manner best suited to the patient, he cannot be blamed for negligence if the patient is not totally cured. Thus, in the cases of Brain Aneurysms, it will be usually a conflicting issue, if the justification offered by surgeons to clip or having coil an aneurysm.
2. The Complainant Mr. Vijay Dutt, a healthy middle aged successful businessman of M/s Dutt and Company, resides at Indore. He was suffering from Migraine and was under treatment of a well-known Neuro-physician Dr. (Mrs.) Nadkarni at Indore. Since, his migraine continued despite medication, Dr.(Mrs.) Nadkarni advised him for CT scan of brain and higher investigations; which then, revealed Aneurysm in the right side of the brain. Thereafter, Dr. (Mrs.) Nadkarni advised the Complainant to undergo Angiography of the brain for the proper diagnosis and further management. Accordingly, on 30.03.2000, he visited the Jaslok Hospital and Research Centre Bombay (Mumbai) for consultation with the OP-1 Dr. Nagpal. The OP No. 1 and his fellow professional colleagues there, examined the Complainant. Thereafter, the OP-1 impressed upon the Complainant to get himself admitted in Jaslok Hospital (OP-2) for treatment and assured of best medical treatment for Aneurysm there. Believing those words of appraisal, on 23rd March, 2000 the Complainant (herein referred as œPatient?) got himself admitted at OP-2 under the treatment of OP-1. Dr. Srinivas B. Desai, at Jaslok Hospital (the OP-2) conducted Cerebral Angiography along with CT Scan which confirmed the existence of Bilateral Middle Cerebral Artery (MCA) Aneurysm. Accordingly, the OP-1 advised and insisted the Complainant to undergo a surgery immediately or otherwise he would die soon, of rupture of aneurysm. Due to repeated emphasis by OP-1 about the sudden death, the Complainant was forced to agree for immediate surgery of aneurysm. The OP-1 and complainant discussed line of best available treatment for MCA aneurysms. Thereafter, to arrange the finances for the expensive surgical treatment, the patient went back to his hometown at Indore. On 02.05.2000, the patient got admitted to the OP No.-2 hospital under the treatment of OP No.-1. After a discussion again, about the method of treatment with OP-1, the patient, his wife and other accompanied family members expressed their willingness for the Coiling method as their choice of the treatment. But, same request was blatantly turned down by the OP-1, and he insisted that he would perform the operation by employing the Clipping Method. According to him, the Clipping Method has permanent cure as compared to the Coiling Method where relapse of Aneurysm occurs after a passage of time. Therefore, on such persuasion and insistence of OP Nos.-1 and 2, the Complainant was left with no option but to accept the Clipping Method. Hence, the Complainant literally signed the consent under coercion. On 03.05.2000, OP-1 performed the operation by the Clipping Method. Postoperatively, immediately, after ex-tubation, the patient noticed difficulty in his speech, and right hemi paresis with right side paralysis. Angiography study was performed immediately, which showed the non-filing of the middle cerebral artery beyond the clip. Thereafter, OP-1 re-operated upon the patient on the same day, removed the clip, and re-applied the same. Later on, the patient learnt that, at the time of the first surgical procedure, the OP -1 had wrongly clipped the MCA at the wrong place, therefore, it resulted in stoppage of the blood circulation to his brain, for almost three hours. It has led to impairment of speech and Right side paralysis. The Complainant was in a semi-coma condition for seven days, thereafter was kept in the Intensive Care Unit (ICU) for ten days, the next seven days in semi-ICU of the hospital(OP-2). The Complainants hospitalization was for almost 40 days. After the discharge from the hospital, the Complainant was under constant medical treatment and supervision. He further incurred regular monthly expenses of Rs.4,000/- for physiotherapy, and Rs.1,500/- per month, for speech therapy. The Complainant produced opinion/reports from two doctors from Indore, Dr. Apoorva Pauranik, Consultant Neurologist and Dr. Sunil Athale, Neuro-Physician (Page No.182) and at (Page No. 183). Further, on 18.07.2000 the complainant consulted Dr. O.P. Bajpai of Indore, who advised him to undergo special physiotherapy treatment, abroad.
3. Complainants main allegations on the OP No.-1 and 2, that they were guilty of medical negligence and deficiency in service as OP-1 applied wrongly the clip on the artery instead of the aneurysm. Due to such negligence, he suffered severe impairment of speech and Right sided paralysis. He incurred heavy medical expenses for operation, the physiotherapy, and speech therapy. He suffered mental agony. Therefore, the Complainant, Vijay Dutt filed this complaint through his wife Dr. Mrs. Veena Dutt seeking relief in the sum of Rs.52,46,199.80/- towards the reimbursement of expenditure, loss of earnings and damages. He also prayed for Rs.1,00,000/-, as lump sum amount towards future expenditure like medical treatment in India/abroad, domiciliary expenses etc.
The complaint is supported by affidavit evidence and Annexures A to E.
Defense:
4. Dr. Nagpal, a Neurosurgeon, the OP-1 from Jaslok Hospital, Mumbai (OP-2) filed the written version and affidavit evidence. OP-1 submitted that around mid-March 2000, the patient, Mr. Vijay Dutt, from Indore, was referred by his Neurologist and Family Physician Dr. Nadkarni. For his long-standing headache and giddiness, he was investigated by CT scan and diagnosed as a case of left middle cerebral artery aneurysm (a swelling on the blood vessel of the brain) at Indore. OP-1 examined him, after taking detailed history. He reviewed the CT scan report and confirmed the diagnosis of left Middle Cerebral Artery (MCA) aneurysm in the brain. OP-1 submitted that, over an hour long discussion took place with the complainant regarding further investigations, like angiography of brain to ascertain the size, location of aneurysm, the implications of the diagnosis, and its complications, if not treated in time. Despite the real danger of a hemorrhage, the patient chose to return home. Thereafter, the Complainant discussed his problem with the OP on the phone, at least twice, from Indore, seeking clarifications on some points and indicated that he was waiting for his wife to return from America. He finally returned after a month, with his wife and sister and got admitted to Jaslok Hospital on 28th April, 2000.
5. At the time of admission at OP-2, digital subtraction angiography (DSA) was carried out. It showed middle cerebral artery aneurysms on both sides, the left one being large, wide neck. Further, OP-1 explained in detail, about two surgical methods of treatment, one by Coiling and another by Clipping method, the success rates and, about all potential complications, like intra-procedural rupture of the aneurysm, occlusion of a major artery, death, and hemiplegia and speech disturbance. The Complainant got himself discharged on 29th April, 2000, and requested for some time to think over, about the treatment.
6. Thereafter, on 02.05.2000, the Complainant got himself admitted in OP-2. Again, another round of detailed discussions took place between OP-1 and Mr. Dutt, his wife and his sister, Shabana. OP-1 explained about the location of the aneurysm (swelling in the artery) at the MCA Territory, due to its large size and wide neck, endovascular route (coiling) was not suitable for occlusion, and therefore clipping surgery was the ideal method of choice. The complications of surgery were also discussed again. OP-1 submitted that, he had suggested the name of Dr. S. B. Desai, a Neuro-radiologist, from OP-2, who performs non-surgical endovascular treatment (coiling), if so desired, the Complainant may approach him, but patient refused it, and expressed his choice of treatment by surgical method. OP-1 submitted that, each time, the patient and his relatives sought assurance about the success of surgery.
7. On 03.5.2000, OP-1 conducted the Clipping operation, in conjunction with Senior Neuro-surgeon, Dr. S. K. Pandya. The operation was performed with utmost care, applied clip at the correct position, i.e. on the neck of the aneurysm and it was confirmed that the MCA and its branches were all outside the clip. Post-operatively, the patient had slight weakness on the right side of the body, with speech problem, which was detected, after he awoke, in the operation theatre, itself. An immediate DSA was done, which showed non-filling of the middle cerebral artery, hence the patient was re-operated and re-checked the position of clip. He found that the clipping was proper, MCA was not caught by the Clip and all the branches of arteries were found, free of the clip. OP-1 submitted that those findings are mentioned in Operative Notes of patients indoor case papers of the Jaslok Hospital. Thereafter, on 6.05.2000, the patient was shifted to post-operative intensive care unit (ICU), for complaining difficulty in breathing, intubation was done. Over a period of time, i.e. in the next month, the patient slowly recovered due to dedicated care, physiotherapy and speech therapy. The notes in case paper, on 25.05.2000, by Speech Therapist Mrs. Parulkar, mentioned that, patient was able to speak œspontaneous, single common words?. At the time of discharge from Jaslok Hospital, he was walking with little support, understood oral commands. The OP-1 filed the affidavits of two doctors, who were part of entire management of the patient. OP-1 furnished Annexure A, about his qualification and Annexure B “the text book and Journal references. OP-2, Jaslok Hospital submitted in its evidence that the Complainant and his family members had been duly informed about the costs of treatment during the pre-surgery consultation sessions and thereafter the Complainant had given his consent to such surgery. Hence, OP-2 denied that the patient was charged exorbitantly and the Complainant is entitled for any refund. Hence, prayed for dismissal of complaint.
8. We have heard the arguments of both the parties, the written arguments are also placed on file. Counsel for the complainant vehemently argued that OP-1 had committed medical negligence, he has not properly informed about the management of his aneurysm. He had performed the Clipping surgery, despite request from patient and his relatives, who preferred the Coiling method. The clipping was wrongly applied; hence patient suffered loss of speech and developed paraplegia of right side. OP-1 is represented by an authorized representative, Dr. Kamath, a medico-legal consultant. He advanced arguments to prove that OP-1 acted as per Standards of medical practice, there were several pre-operative detailed discussions Pros and Cons of surgery and counseling sessions took place between OP-1 and the patient, his sister and wife. After convincing only, the patient agreed for the said surgery. He performed the Clipping Method for the MCA aneurysm, it was wide neck aneurysm. It was admitted by the OP-1 that the Complainant had speech difficulty and developed slight paralysis immediately, post-operatively, and also the post-operative DSA showed an occlusion of right Middle Cerebral Artery. The OP-1 took up the Complainant for re-operation, at which the artery was found free of the clips. Further submission was that the said artery had gone into spasm (or unexplained contraction), which was the main cause of the complication that arose in this case. The allegation that the Clip was wrongly applied and/or that the surgery leads to any type of complications, is not correct as per the record and the findings on re-operation are totally false and presumptuous. This is further supported by the affidavit of Dr. Sunil Pandya, an Eminent and Senior Neurosurgeon, who was assisting the OP-1, during the surgery.
9. Findings and Discussion:
On perusal of the Degree and Experience Certificates of OP-1 present on file, it is true that OP-1, Dr. R. D. Nagpal is and experienced Super Specialist, Neuro-Surgeon, working in OP-2 hospital, the relevant paras are reproduced as under:
a) I say that Dr. Ranjit Nagpal, OP-1 in this matter had approached me on 26th April, 2000 for a Joint Consultation regarding the case of the Complainant. I say that at that tome Dr. Nagpal had explained the complete history and circumstances of the case to me. I further say that at that time I had reviewed the films of the Digital Subtraction Angiogram (an X-ray to view the arteries of the brain) of the patient Mr. Dutt.
b) I say that on reviewing the same, I notices that the said Angiogram showed that the patient was having two aneurysms(swelling of the wall of the artery), a large wide-necked aneurysms on the left middle cerebral artery and a smaller one on the right middle cerebral artery. In my opinion, both these needed treatment, particularly the larger one, as early as possible.
c) I say that I was later on informed by Dr. Nagpal that the patient had agreed for surgery on the aneurysm, which was scheduled for 3rd May 2000. On this day I assisted Dr. Nagpal for the surgery. The said left middle cerebral artery aneurysm was carefully isolated. The neck of the aneurysms was identified and clipped. Before this it was made sure that the middle cerebral artery and its branches were free and not occluded by the clip. Post-operative right sided weakness, and speech disturbance was noted in the operation theatre as soon as the patient was awake. To clarify the situation an immediate digital subtraction angiogram was performed. This showed non-filling of the middle cerebral artery and the aneurysm. The patient was shifted to the operation theatre immediately. Re-exposure of the operated area confirmed that the clip was on the neck of the aneurysm and the middle cerebral artery and its branches were free. Following this, the operation was terminated. The probable cause for non-filling of the middle cerebral artery was either spasm or thrombosis of the vessel.
To enlighten our medical knowledge, we have perused several medical text books in Neuro-surgery, the literature on this subject of MCA aneurysms and its management.
10. Therefore, it was not an accident or mishap during or after surgery. The witness, Dr. Srinivas Desai, an Interventional Neuro-radialogist also opined that the surgical clipping is the preferred method of choice in wide neck aneurysms.
11. The Medical Board Report from AIIMS, New Delhi, dated 23.06.2012 opined that the OP adopted correct method of surgery and adopted proper treatment during emergency re-surgery. The relevant Extract is reproduced as below:
a) Both procedures i.e. coiling or clipping are possible in such cases. Final decision depends on anatomy of the aneurysm, patients choice, clinical expertise and facilities available at the centre. Decision of treating doctor to clip large aneurysm was justified.
b) The surgeons decision to conduct surgery/clipping seems justifiable as per the information available to us. Regarding complications and second surgery can be stated that hemiparesis (weakness of one half of the body) is a known complication of MCA aneurysm surgery/coiling and emergency re-surgery may be required in certain circumstances. In the case, second surgery seems to be justified.
c) No.
12. To enlighten our medical knowledge, we have perused several medical text books on Neuro-surgery, the research articles on this subject of MCA aneurysms and its management.
13. A brain aneurysm, also called a cerebral aneurysm, is a weakened area of a blood vessel's wall, according to the National Institute of Neurological Disorders and Stroke. Brain aneurysms can rupture, causing bleeding in the brain. The aneurysms are acquired lesions caused by a combination of hemodynamic stresses (luminal factors) and defective vessel wall responses (abluminal factors). Brain aneurysm patients can undergo microvascular clipping, a procedure in which a surgeon places a clip on part of the aneurysm. For patients harboring an un-ruptured cerebral aneurysm, treatment options vary and may include surgery, endovascular (Coiling) treatment, or no treatment at all.The Neurosurgical clipping is still an important therapy for MCA aneurysms, especially for aneurysms, with very wide necks or complicated geometry.
14. Choosing the method treatment for an aneurysm:
Each aneurysm is different in each patient. Doctors must evaluate the risk factors that favour treatment vs. non-treatment and decide which technique may be best suited. Its important to consult with experts in this field having different expertise and training backgrounds. This should include a discussion with a cerebrovascular neurosurgeon who specializes in surgically clipping aneurysms, a neurosurgeon with endovascular expertise, a Neuro- interventionist, or a Neuro-radiologist who specializes in the less invasive treatment of cerebral aneurysms by coiling.
15. Treatment of an aneurysm:
The best treatment depends on many things, including, whether the aneurysm has ruptured or not. A ruptured aneurysm usually requires treatment right away, because the re-bleeding rate remains quite high. However, the treatment time and options for treatment, depend on the size, location and shape of the aneurysm, as well as the patients overall medical condition. If an aneurysm hasnt ruptured, the treatment decision depends on its size, location and shape, and the patients symptoms.
16. Several research and review articles describe theAdvantages of Clipping (Surgical) over Coiling (endovascular) method:
œSurgical clipping as the preferred treatment for aneurysms of the middle cerebral artery?Acta Neurochir (Wien). Nov 2011; 153(11): 2111“2117. The relevant paragraph is reproduced as below:
œThis contemporary study confirms that good results are achieved with clipping of MCA aneurysms. All attempts to treat MCA aneurysms endo-vascularly, often with the use of novel (not clinically tested) endovascular devices, are unjustified in a situation where an excellent surgical solution is at hand?.
However, for the middle cerebral artery (MCA) aneurysms, endovascular coiling is less likely to be applied as routine. However, application of endovascular coiling to MCA aneurysms has shown higher procedural failure rate and unfavorable results when compared to the application to the aneurysms at other sites. [(ISAT group, Lancet 2002), (Suzuki S, Neurosurgery 2009)].
1. J Cerebrovasc Endovasc Neurosurg. 2012 December; 14(4):289~294
Middle cerebral artery (MCA) aneurysms are easily accessible via surgical approach because of their relatively superficial location and configuration, but are usually not suitable for endovascular coiling. Surgical treatment thus seems to be preferred over endovascular treatment in this setting. The surgical clipping is considered as the gold standard. We believe that surgical clipping of un-ruptured small MCA aneurysms results in favourable clinic-angiographic outcomes. Therefore, surgical clipping may be safely recommended for patients with small un-ruptured MCA aneurysms
2. Stroke. 2013; 44:988-994
Published guidelines for the treatment of un-ruptured cerebral aneurysms recommend that œmicrosurgical clipping rather than endovascular coiling should be the first treatment choice in low-risk cases.? Presumably, all patients treated with clipping in the Perspective database were offered clipping because the treating surgeon thought that it was a reasonably low-risk procedure related to coiling.
3. Complication:
Vasospasm and Stroke (MayoClinic.com)
The complication of brain aneurysm clipping is vasospasm, in which the blood vessel's width changes. With vasospasm, the width can widen and narrow rapidly, which affects blood flow explains that a blocked blood flow from vasospasm can lead to an ischemic stroke, which causes severe headache, sensation changes and mood changes. Patients may experience decreased alertness and might even lose consciousness. Vision problems can occur, such as decreased vision, double vision and loss of vision.
17. Further, we put reliance upon several decisions of the Honble Apex Court.
* In a key decision on this matter in the case of Dr. Laxman Balkrishna Joshi v Dr. Trimbak Bapu Godbole, held that if a doctor has adopted a practice that is considered œproper? by a reasonable body of medical professionals who are skilled in that particular field, he or she will not be held negligent only because something went wrong. Doctors must exercise an ordinary degree of skill.
* In AchutraoHaribahau Khodwa and Ors. Vs. State of Maharashtra and Ors., MANU/SC/0600/1996. The Honble Supreme Court noticed that in the very nature of medical profession, skills differ from doctor to doctor and more than one alternative course of treatment are available, all admissible. Negligence cannot be attributed to a doctor so long as he is performing his duties to the best of his ability and with due care and caution. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession.
* It is worthwhile to mention here the Bolams case BolamVs. Frien Hospital Management Committed (1957) 1 WLR 582 it was also held that a doctor is not negligent if he is accordance with standard practice merely because there is a body of opinion who would take a contrary view. In Hucksv. Cole (1968) 118 New LJ 469, Lord Denning stated that a medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.
18. Therefore, in the entirety of forgoing discussions and considering the medical literature, the opinion from the Medical Board of Experts at AIIMS, we are of considered view that, OP-1 has adopted the Clipping method, as one of the best choice, it was performed with another Neuro-Surgeon, Dr. Pandya. We do not find any negligence committed by OP-1, during, and/or after operation. Accordingly, we dismiss the complaint. Parties are directed to bear their own costs.