(Typed to the dictation of Smt.M.Shreesha, Hon’ble Member)
The brief facts as set out in the complaint are that the complainant is a renowned radiologist and joined in M/s Vijaya Diagnostic Center, Hyderabad as a senior Radiologist and also was attending other hospitals as part time doctor and was earning Rs.50,000/- per month. The opposite party no.1 is the company, opposite party no.2 is the Managing Director of opposite party no.1, opposite party no.3 is the consultant ortho and spine surgeon of opposite party no.1. Opposite party no.4 is India Medtronic Pvt. Ltd., a company and opposite parties no.5 and 6 are the manager and territory manager of opposite party no.4. The complainant submits that he has been suffering from chronic neck pain radiating to both shoulders and upper back since 1997 for which he had an MRI and consulted a neuro surgeon who advised for C3/C4 – C4/C5 anterior cervical discectomy which was done at Madras and left for fusion. As this also did not relieve the pain, the complainant had C2 to C5 Radio Frequency Rhizotomy at Apollo Hospitals, Jubilee Hills which also did not relieve pain. In 2007 the complainant went to Delhi to one Dr.G.P.Dureja, who tried Botox 200mg to his neck muscles and both trapezius muscles which also did not help him.
The complainant submits that he went to opposite parties no.2 and 3 for his unbearable pain and showed all his medical reports and the opposite parties no.1 to 3 assured the complainant that he would be relieved from the problem as they have sufficient infrastructure and expert doctors. Thereafter the opposite party no.3 gave prescription dated 11.10.2008 suggesting for decompression of C5, C6 and spinal cord stimulator. The complainant had undergone pre-surgical tests and MRI. The MRI test revealed disc prolapse and mild cord compression at C5/C6. A diagnosis of C5-C6 disc prolapses +fnss was done and the complainant was advised to get a posterior decompression of C/5-C/6, C/6-C/7 also to get the spinal cord stimulator implanted. Opposite party no.6 representing opposite party no.4 along with opposite parties no.1 to 3 informed the complainant that he had spinal cord stimulator and stated that it is also known as dorsal column stimulator which generates electric impulses producing a tingling sensation that alters the perception and that the device is implanted into the epidural space either by percutaneous approach or by surgical laminectomy or laminotomy and that pulse generator or RF receiver is implanted in the abdomen or buttocks and once it was inserted by operation his pain would be relieved. The complainant stated to opposite parties no.1 to 3 that before implantation of SCS it is better to have a trial implant as suggested in the literature for at least 10 days. But the opposite parties assured the complainant that trial is not necessary.
The complainant submits on 26.11.2008 that he admitted to opposite party no.1 hospital for surgery. At the time of admission, the complainant asked for a single deluxe room but the staff of opposite party no.1 stated that they do not have a single deluxe room available but have supper deluxe room and they will charge the price of single deluxe room for the super deluxe room. On 27.11.2008 the opposite parties without trial, conducted the operation and implanted spinal cord stimulator and the pace maker in the complainant’s right abdominal wall to get the required stimulations in the NCE, shoulders and upper back. At the time of operation, Dr.Mone Chandrasekhar who is the complainant’s friend assisted the opposite parties without anticipating any fee on the request of the complainant. On 1.12.2008 the complainant was discharged along with discharge summary by charging a sum of Rs.6,15,460/- towards his treatment. Opposite party no.6 representing the opposite party no.4 started trying for the programming of the SCS with the complainant on the third day after the surgery. He tried for one hour to program the pace maker to get the required stimulations in the NCE, shoulders and upper back of complainant but the stimulations were coming in both the hands only and not in the neck, shoulders and upper back. Thereafter the opposite parties no.5 and 6 visited the complainant’s house several times and tried all possible combinations to program the SCS to get the required stimulations but did not succeed to get the stimulations upto the level of the upper arms and not even to the shoulders. After about trying for 15 to 20 days after the complainant was discharged, opposite parties no.2 and 3 advised the complainant to come to opposite party no.1 for programming the SCS along with opposite parties no.5 and 6 but they could not achieve the required stimulations.
The complainant submits that as all the efforts of the opposite parties failed for nearly two months, the complainant developed severe spasms in his neck and upper back muscles and suffered more pain than what he had before undergoing the SCS and decompression procedures. All the opposite parties told the complainant that they would send the complainant’s x-rays and the whole case report to Asia Pacific region expert at Australia. On 6.2.2009 as there was an international conference in pain management experts in SCS at Kamineni Hospitals, the complainant got himself registered as a candidate for the workshop. Dr.G.P.Dureja also telephoned the complainant from Delhi to meet him on 6.2.2009 at the workshop. Dr.G.P.Dureja, Dr.Rama Rao Pasupuleti from USA, all the opposite parties along with programmers tried to get stimulation into the complainant’s neck, shoulders and upper back but failed to get the required stimulations. The two expert doctors ultimately came to the opinion that the operation and acts done by all the opposite parties failed and the spinal cord stimulator must be removed and re-introduced percutaneously. On 25.2.2008 the complainant went to the opposite parties who advised the complainant to got do Delhi to Dr.G.P.Dureja for removal of SCS and re-implanting it percutanesouly. Dr.G.P.Dureja and Dr.Ramarao Pasupulati are of the opinion that a SCS should never be implanted permanently without a trial implant at least for ten days.
The complainant submits that due to decompression of C5/C6 and C6/C7 and fixing of screws and rods at C5C6 and C6C7 levels without the knowledge and consent of the complainant, knowing fully well that the complainant had anterior cervical distectomy in the year 2003 at C3 to C5 levels which had fused C3,C4, C5 vertebrae causing a lot of restriction on the movement of the neck of the complainant and caused permanent disability. The SCS is just lying in the complainant’s epidural space line harming foreign body only and detrimental to the health of the complainant. The complainant is not in a position to carry out his professional work and loosing his professional earning as qualified radiologist since 1.12.2008. The opposite parties also removed some part of the flesh which is not necessary for the operation and caused grievous injury to the complainant’s health. All the opposite parties caused physical and mental damage to the health of the complainant by the failure of SCS and fixation of screws and rods, loss of earning and loss of other aspects. Therefore, the complainant got issued legal notice dated 30.3.2009 to all the opposite parties to which opposite parties no.1 to 3 neither replied nor paid any amount mentioned in the legal notice but the opposite parties no.4 to 6 gave reply admitting failure of the spinal cord stimulator. Hence, this complaint seeking directions to the opposite parties to pay a sum of Rs.99,15,480/- along with costs.
Opposite parties 1 to 3 stated that basing on MRI report, the complainant was suggested to undergo surgery of posterior decompression of C5-C6 and C6-C7 as the film and report was suggestive of mind cord compression at C5-C6. With a good intention of preventing the risk of surgery twice i.e. 1) for the posterior decompression of C5-C6 and C6-C7 and 2) spinal cord stimulator implantation, it was offered to the complainant who was aged more than 65 years to undergo both the procedures at one go so that the risk of two surgeries can be avoided for which the complainant agreed gladly and was convinced about the procedure planned. They denied that they have assured him SCS will give complete 100% relief from the pain as the SCS once implanted will cover mainly neck shoulders and upper back. Whereas Dr.Subbaiah has clearly explained to the complainant that the spinal cord stimulator implantation is proposed as a last resort to try and alleviate the pain and suffering to the extent possible. It has been explained to the complainant that SCS is the application of low voltage electric stimulation to the spinal cord to block the feelings of pain and this therapy was developed from the fact that nerves send message by electrical impulses. Sensation of such a pain, touch or temperature is felt because of nerve ending sends a signal through the spinal cord to the brain and this stimulation interferes with the transmission of a pain signal to the brain. Neuro stimulation is an effective alternative to repeated back surgery medication or other therapies, however this does not correct the original source of pain and when the therapy is successful, anticipated goal is 50-75% pain relief.
They denied the complainant’s allegation that he was never informed about the price of SCS or the lateral mass screws and the rods inspite of his request. On the contrary, the price of all the implants used and the SCS was clearly informed and he was aware of the cost of SCS before he came to hospital for treatment. The fact is that the complainant was advised to undergo SCS prior to admission into opposite party hospital by other pain management experts elsewhere. They denied the allegation that opposite parties 1 to 3 and their staff tricked the complainant to escalate the bill and grab the amounts and that the staff representing opposite parties 1 to 3 at the admission counter when the complainant asked for a single deluxe room replied that they do not have a single deluxe room but have super deluxe rooms and the hospital will charge the price of single deluxe room. They denied the allegation that one Mone Chandrasehar, friend of the complainant, a Neuro surgeon assisted Dr.RAvindranath and Dr.Subbaiah in doing the surgery and that he was not pain anything but the hospital has charged for the assistant surgeon fee also. They submitted that upon the request of the complainant to allow Dr.M.Chandrasekhar, who is his friend to observe the procedure being done to the complainant was heeded and Dr.Chandrasekhar was allowed to observe the procedure being done and he was only an observer and Dr.Kasi, Registrar of Orthopedic Department assisted in this surgical procedure on the complainant and the charges levied in the bill are towards the assistance of Dr.Kasi. They submitted that the pricing for the products manufactured by any organization/company are within the exclusive right of the manufacturer and distributor of such products. They denied that after the surgery, Sri Suresh Nair representing M/s Medtronic Pvt. Ltd. Started trying for the programming of SCS on the third day after surgery. They further denied that stimulations at the right place are not coming despite the efforts of Mr.Manish Kumar and Mr.Suresh Nair when tried at the residence of the complainant. Despite the fact that the leads are placed at perfect positions to give stimulations from the SCS on the spinal cord during the operation which was evidenced in the x-ray films taken post operatively, the reason as to why the required stimulations are not being achieved is very difficult to comprehend. They denied the allegation that despite the efforts of opposite parties for nearly two months, the complainant developed severe spasms of his neck and upper back muscles and is suffering from more pain than before.
Opposite parties 1 to 3 submitted that the alleged developments of these spasms were never complained to them during these two months while the complainant was in touch with them. They further submitted that Dr.Subbaiah took the opinion of Asia Pacific region expert at Australia by sending him the x-ray films and the whole case, it was rather surprising to that expert also that the placement of the leads as prescribed for this case has been done which is evidenced in the x-ray films and was perfect. They denied that they informed the complainant on 06-2-2008 that there was an international conference in pain management and experts in SCS are coming from all over the world to Kamineni hospitals on 06-2-2009. The complainant’s version of trails by various experts at the international workshop in pain management held at Kamineni hospital on 06-2-2008 on complainant to program the SCS but were unable to get stimulations at the desired location is totally false and to their knowledge, no such conference was organized on 06-2-2008 and the complainant has sought treatment only in November, 2008 with the hospital. They further submitted that the complainant alleged that the two expert doctors ultimately came to the opinion that the operation and the acts done by the opposite parties failed and the SCS must be removed and reintroduced percutaneously and one Dr.G.P.Dureja asked the complainant to come to Delhi to his clinic and stay for 3 days which is also false as to the best of their knowledge, no such conference was organized on 06-2-2008 and the complainant sought treatment from them in November, 2008. They further submitted that the complainant alleged that SCS was completely put off from 9-2-2008 whereas the complainant sought treatment from them only from November, 2008.
The complainant mentioned that one Dr.Rama Rao Pasupuleti from USA sent an e-mail agreeing with the decision taken by Dr.G.P.Dureja and that they were of the opinion that a SCS never be implanted permanently without trial at least for 10 days but they denied the same as the veracity of the said e-mail is not known and second the e-mail copy was not furnished. Opposite parties 1 to 3 denied the allegations made by the complainant and submitted that the procedure performed on the complainant was done with his full consent and was clearly counselled on the expected complications before he was taken up for surgery. They submitted that they have given the best possible care to the complainant and charged accordingly. They submitted that they have raised bills only for the drugs administered and also denied that without his consent and knowledge, they have removed some flesh endangering his life and submitted that there is no deficiency in service or unfair trade practice and the claim made by the complainant is without any proof, basis and false and prayed for dismissal of the complaint with costs.
Opposite party no.4 filed counter stating that the complainant is a chronic severe neck pain patient for the last 12 years who was treated by several eminent surgeons and hospitals in the country but could not get relief from any of them. As the last resort he opted for Spinal cord Stimulation therapy (SCS) which is not curative but if successful provides 50% to 75% relief in suitable cases. SCS is the application of low voltage electrical stimulation to the spinal cord to block the feeling of pain. The position of lead is very important in SCS so that a tingling sensation is felt in the area where pain was felt earlier. Positioning is a cooperative effort between the patient and physician during implantation. This therapy was developed from the fact that nerves send messages by electrical impulses. Sensation of such a pain, touch or temperature is felt because a nerve ending sends a signal through the spinal cord to the brain. This stimulation interferes with the transmission of pain signal to the brain. Neuro stimulation is an effective alternative to repeated back surgery, medication or other therapies. However, this does not correct the original source of pain. The question whether to go for this treatment is to be decided after a thorough discussion between the patients and the doctors and hospital and evaluation of the extent of benefit which may accrue in a given case.
Opposite party no.4 submits that there is no privity of contract between the complainant and opposite parties no.4 to 6. It is the prerogative of the complainant to opt for a particular mode of treatment and to approach a hospital or a doctor of his choice. Hospitals and doctors evaluate the condition of the patient and a decision is taken in consultation with the patient. There is no dispute that the SCS was supplied to M/s Global Hospitals and that it was implanted on complainant by opposite party no.1 hospital. Hospitals buy the product as per their requirement and there is no privity of contract between the company and the ultimate patients who opt for such treatment. The process involves well established medical procedure and the expertise of doctors in performing surgery, placement of implants and positioning of the leads etc. Thus, it is not mere resale of the device by the hospital or doctors and the service provided by the hospital and doctors is a comprehensive one. As a company it has a distinct legal entity, there was neither any requirement nor was it necessary to implead any of the employee’s separately. As per the communication dated 22.2.2009 one Dr.Ramrarao Pasupuleti, one of the doctors who attended the international conference, has confirmed that the device was working and the stimulation is being received at the extreme end. Thus admittedly the equipment/device is functioning and hence the allegations against the opposite parties are baseless. According to the complainant he is receiving stimulation at the extreme ends, but he needs stimulation at neck and back, the issue is limited to exploring the possibility of repositioning of the leads. Several attempts at reprogramming using different stimulation parameters were done without success. Thus it is clear that the doctor and hospital have made all efforts to help the complainant. Unfortunately, the complainant did not pursue the suggestion of his own doctor for repositioning the lead for reasons best known to him. In view of the above it is clear that the complaint is untenable and speculative in nature. As the placement of the device and the leads was done based on the discussion between the doctors complainant, even assuming there is a need for repositioning of the leads, such a thing can only be done at the instance of complainant and in consultation between the patient and the doctors. Hence, the opposite party no.4 prayed for dismissal of the complaint.
Opposite parties no.5 and 6 while adopting the counter filed by the opposite party no.4 stated that they are merely employees of opposite party no.4 which was supplied the spinal cord stimulation device to opposite party no.1 hospital. They have merely tried to help in programming of the SCS device implanted on the complainant out of goodwill and therefore there was no need to make them parties in the complaint.
The complainant filed affidavit by way of evidence and marked Exs.A1 to A23 on his behalf and opposite parties also filed their affidavits by way of evidence and got marked Exs.B1 to B6.
The brief point that falls for consideration is whether there is any negligence on behalf of the opposite parties 1 to 3 in
a) implanting SCS?
b) Whether informed consent was taken?
c) in excessively billing the complainant?
d) Whether there is any deficiency of service on behalf of O.Ps. 4 to 6?
It is the complainant’s case that he is a radiologist by profession earning around Rs.50,000/- per month and has been suffering from chronic neck pain radiating to both shoulders and upper back since 1997 for which he has consulted many neuro surgeons and neuro physicians for his treatment. In 2003 he suffered from severe neck and left trapezious which was intolerable and he had MRI and consulted a neuron surgeon who advised him a C3-C4/C4-C5 anterior cervical discectomy which was done at Chennai and left for fusion. This did not relieve the complainant’s pain and he consulted many pain management specialists and had facet joint injections which did not help him. Later the complainant had C-2 to C5 radio frequency rizotomy at Apollo Hospital which also did not relieve his pain. In 2007 he went to Delhi to one Dr.G.P.Durja who tried Botex 200mg to his neck muscles and trapizious muscles which also did not help him. The complainants submit that there is severe upper back pain with pain in the neck and shoulders.
At this point time, the complainant approached opposite parties 2 and 3 and showed all the medical reports and narrated his problem to opposite party No.6 also. The complainant submit that opposite parties 2 and 3 informed that they would charge nominal amounts at ‘actual prices’ for the machines and drugs and operation charge. Believing their words and assurance, the complainant agreed for treatment in opposite parties 1 to 3 hospital. On 11.10.2008 opposite party No.3 gave a prescription suggesting decompression of C5 and c6 and spinal cord stipulation. The complainant underwent pre-surgical tests. The MRI showed disc prolapse and mild cord compression at C5/C6. A diagnosis of C5/C6 disc prolapse + FNSS was done and he was advised surgery of decompression of C5/C6 + spinal cord stipulator to get rid of the pain. Opposite parties advised the complainant to get a posterior decompression of C5/C6, C6/C7 and also get spinal cord stimulator. Opposite party No.6 representing opposite party No.4 submitted that they had excellent spinal cord stimulator known as dorsal column stimulator and once it is inserted in to the body he would be relieved of the problem. The complainant submits that the opposite parties induced him to believe the trial is not necessary and the price should not be worried about. The complainant’s submit that it is stated in the literature that it is advised that SCS should not be permanently implanted without a trial implant at least for 10 days. The complainant was assured that he could continue to do his regular work as radiologist and be relived of the pain.
The complainant further submits that when he asked for single deluxe room, the staff of opposite parties 1 to 3 forced him to take super deluxe room and told him that they would charge the same price as that of the single deluxe room . On 27.11.2008 the pace maker was implanted in the complainant right abdominal wall to get the stimulations in the neck shoulder and upper back. On the request of the complainant, Dr.Mone Chandra Sekhar who is the complainant’s friend also assisted the opposite parties without anticipating any fees. The complainant was discharged on 1.12.2008 without making sure that the SCS was working and a bill for Rs.6,16,460/- was given to him. The complainant submits that he underwent pain in the neck shoulder and upper back and stimulations were coming in both the hands but not to his neck shoulder and upper back. Opposite parties 5 and 6 representing opposite party no.4 visited the complainant’s house several times and tried to program SCS and opposite parties 2 and 3 advised him to come to opposite party No.1 and they tried for almost one hour and all their efforts failed for nearly two months. Thereafter the complainant attended a pain management conference where Dr.D.P.Duraja who treated the complainant earlier was also attending the conference. Dr.D.P.Duraja asked the complainant to come to Delhi and get the SCS removed. Opposite party No.3 had written the same in the prescription dated 25.2.2009. They were also of the opinion that SCS should never be implanted permanently without the trial implant at least for 10 days. The complainant submits that long list of drugs was made up to escalate the bill. The SCS was lying in the complainant’s epidural like a harming foreign body and he is not in a position to carry out his professional work. The opposite parties caused physical and mental damage to the 68 years old complainant and he got issued a legal notice dated 30.3.2009. Opposite parties 1 to 3 did not reply and Opposite parties 4 to 6 replied admitting failure of the SCS. Hence, the complainant submits that there is negligence on behalf of the opposite parties as the pacemaker was put off on 9.2.2009 and opposite parties fixed the screws and rods C5/C6 and C6/C7 without the knowledge of the complainant knowing fully well that the complainant had anterior cervical discectomy in the year 2003 at C3 to C5 level which are fused C3 C4 C5 vertebra causing lot of restriction on the movement on the neck. The fixing of the screws and rods at C5 C6 and C6 C7 caused more restrictions. The pace maker with the battery is lying in the right abdomen of the complainant and the failed SCS is lying in the complainant’s neck and the opposite parties even negligently operated without any trial and removed some flesh unnecessarily for which the complainant is claiming Rs.99,15,480/-.
It is the case of opposite parties 1 to 3 that the complainant himself stated that he was suffering from neck pain since 1997 that is for more than 12 years and has taken treatment for this period of 12 years in various hospitals. The complainant himself stated that he met Dr.Duraja who tried different modalities of treatment and suggested the complainant to undergo SCS and only in the year 2008 the complainant approached opposite parties 1 to 3. Opposite parties have explained to him that SCS may provide relief only to a certain extent and may not have the entire desired effect. The complainant himself is a radiologist and by the time the complainant approached the opposite parties he had already taken MRI from another hospital and opposite parties have suggested him to undergo surgery of posterior decompression of C5 to C6 and C6 to C7 and only with the good intention of preventing the risk of surgery twice for the posterior decompression of 1) C5-C6 and C6-C7 and 2) Spinal cord stimulator implantation, it was offered to the complainant who was aged more than 65 years to undergo both the procedures at one go. The cost of the surgery, the implants and the probable stay in the hospital was clearly explained to the complainant. The complainant was also in touch with the earlier pain management doctors whom he consulted for his problem with which he was suffering from the last 12 years. The opposite parties deny that they have ever assured 100% success with SCS and that it will give complete relief from the pain. Dr.Subbaiah had explained to the complainant that the spinal cord stimulator is proposed only as a last resort to alleviate the pain and suffering of the complainant and improve his quality of living.
Opposite parties 1 to 3 submit that SCS is the application of low voltage electric stimulation to the spinal cord to block the feeling of pain. This therapy was developed from the fact that nerves send messages by electrical impulses. The stimulator interferes with the transmission of pain signal to the brain. When other types of medical interventions have failed to provide relief, neuro stimulation may help. When the therapy is successful the anticipated goal is 50-75% pain relief. The opposite parties deny that the complainant was not informed of the cost of SCS and he was also advised by other pain management experts prior to insert SMS. They deny the allegation of the complainant that he was charged a super deluxe room and he was promised that he would be charged for single deluxe room. They also deny that they escalated the bills and charged him excessively. The cost of the implants and the entire procedure cost were explained to the complainant prior to the surgery. They deny that they ever forced the complainant to pay Rs.50,000/- on 26-11-2008 and Rs.2,00,000/- on 29-11-2008. They issued the bills as per normal procedure and the price charged in the bill is as per the MRP. The price charged for the drugs is also as per MRP.
It is also an admitted fact that Dr.Mone Chandrasekhar, who is complainant’s friend and a senior Neuro Surgeon, was allowed to observe the proceedings being done on the complainant. He was present through out the operation as an observer and Dr.Kasi, Registrar of Orthopedics Department assisted in the surgical procedure. The charges levied in the bills are towards the assistance of Dr.Kasi. They deny that Mr.Suresh Nair representing India Medtronics Pvt. Ltd tried SCS on the third day after surgery. They contend that these spasms were never complained to opposite parties 1 to 3 during the 2 months time and Dr.Subbaiah took the opinion of Asia Pacific region expert at Australia by sending him the x-ray films and the placement of leads who opined that it was perfect. The complainant sought treatment with them only in November, 2008 and they are not aware of any pain management conference on 06-2-2008. They further contend that the e-mail sent by Dr.Ramarao Pasupuleti of USA does not mention that SCS should never be implanted permanently without trial atleast for 10 days. The complainant was advised by his personal doctor Dr.Dureja to undergo SCS and the complainant was fully convinced that the SCS was only modality of therapy to be tried as a last resort and that there is absolutely no deficiency in service on their behalf in the implantation or in the billing or in the surgical procedure which was followed as per medical standards.
It is the case of the opposite party no.4 representing India Meditronics Private Limited that SCS is an application of low voltage electrical stimulation to the spinal cord to block the feeling of pain and the positioning of lead is a co-operative effort between the patient and the physician during implantation and neuro stimulation is the effective alternative way when other types of medical intervention have failed. He further submits that SCS does not correct the original source of pain and that opposite party no.4 is into this business of word class implantation of SCS with a reputation for product quality. The privity of contract is between opposite party no.4 and the hospital and not with the complainant. It is the doctors who are the experts to examine the patient and determine the suitability or otherwise of the type of treatment. Opposite party No.4 further contends that the complainant himself in his communication dated 22-2-2009 admitted that the device was working and the stimulation is being received at his hands but he needs stimulation to his neck and back for which the repositioning of the leads should be explored. The complainant himself states that several attempts of re-programming have been done without success. Thus it is clear that the doctors and the hospital have made all efforts to help the complainant.
Opposite party no.4 reiterates that the complainant had severe chronic neck pain for the last 12 years and that SCS does not correct the source of pain but only alleviate the pain and provides relief. Opposite party no.4 further contends that the complainant being a doctor by profession cannot state that the implantation was done without trial and complications of implantation are not only limited to surgical procedure but also include lead migration, infection, epidural hematoma, paralysis and even death in rare cases. In the instant case admittedly pre-surgical tests were done and consent was obtained, surgery was successful and wound had healed. Opposite party No.4 also contends that the treatment is reversible and that the complainant ought to have asked for removal of the implant if he was not satisfied and if any reposition of lead has to be explored, it has to be done at the instance of the complainant and in consultation with the doctors. There is no expert opinion to state that trial implantation is necessary and opposite party No.4 has no privity of contract with the complainant. Opposite party no.4 also filed medical literature with respect to Medtronic Pain Therapies and sought for dismissal of the complaint.
Opposite party No.5 is the Area Manager of India Meditronics Private Limited and Opposite Party No.6 is the territory manager of the same company and both of them have adopted the counter of opposite party No.4 and reiterated the facts.
Now we address ourselves to whether
1) SCS implantation by the opposite parties was unnecessary and the procedure itself was negligent?
Ex.A1 and Ex.A2 refers to all the pre surgical tests performed by Vijaya Diagnostic Centre, which the complainant submits were done at the instance of opposite parties 1 to 3 and evidence that all the necessary pre-investigative tests were performed prior to the surgical procedure. Ex.A3 is the prescription given by opposite parties 1 to 3 and A4 is the copy of discharge summary given by opposite parties. In this discharge summary, it is clearly stated in history that he was advised Spinal cord stimulation for further management and that necessary investigations have been done. The discharge summary also suggests that consent was taken and on 27-11-2008 surgery of decompression of C5-C6/C6-C7 and spinal cord stimulation was done. He was managed with antibiotics and the suture removal was planned for 12-12-2008. This discharge summary has been issued by Dr.Subbaiah, Consultant Orthopedic and Spine Surgeon. Ex.A9 is dated 12-12-2008 and is the copy of the prescription given by opposite parties 1 to 3 at the time of suture removal and states that the wound has healed well. This evidences that the surgical procedure as such had gone smoothly and there is no negligence. Ex.A10 is the copy of diagram showing cycles of spinal cord stimulator and the pace maker. It is seen from the record that the complainant once again on 25-2-2009 i.e. after two months of removal of sutures went to opposite parties 1 to 3 who gave prescription Ex.A11 in which they have noted neck pain and pain to both shoulders and the plan was to pull down leads to C2-C3 level. It is the complainant’s contention that this evidences that the spinal cord stimulator had failed but it is apparent from the record that no where opposite parties 1 to 3 stated that this SCS would be a permanent solution for the complainant’s problem and also no where does the prescription state that there was failure of the stimulator. In fact by the complainant’s own submissions, the personnel of opposite party no.4 have even come to the residence of the complainant and tried to assist him in alleviating the pain. The complainant contends that this Ex.A11 evidences that the stimulator had failed which we find unsustainable since it is only the prescription in which opposite parties 1 to 3 have submitted that the lead should be pulled down to C2-C3 level and the peripheral never stimulations.
The complainant further relies on the e-mail sent by Rama Rao Pasupuleti and it is the main contention of the complainant that in the e-mail it is mentioned that the stimulator implantation should be done only after a trial period of 10 days. A brief perusal of the e-mail does not show any such statement. It only states that the lead is suggested to be placed subcutaneously in the neck. Ex.A12 is the copy of the legal notice dated 30-3-2009 sent by the complainant to the opposite parties and Exs.A14 is the reply by opposite parties 4 to 6. The complainant once again contends that in their reply opposite parties 4 to 6 have admitted that the spinal cord stimulator has failed. A brief perusal of the submissions of opposite parties 4 to 6 in their reply notice does not anywhere state that the spinal cord stimulator is a permanent cure or that there was any negligence in its implantation or that it has failed. It is pertinent to note that both in their affidavit and also in the reply notice, opposite parties 4 to 6 who are the manufacturers of the said SCS have contended that SCS does not correct the original source of pain and that if the therapy is successful the expected goal is 50-75% pain relief. We also observe from the medical literature that neuron-stimulation is an effective alternative to repeated back surgery mechanism or other therapies and this stimulation interferes with the transmission of pain signal to the brain. We observe from the record that the complainant did not file any expert opinion except for the e-mail of Rama Rao Pasupuleti in which the said expert has not mentioned anything about implanting the stimulator for a trial period of 10 days but only stated about re-position of the lead points. There is absolutely no expert opinion on record to state that there was any negligence in the medical treatment rendered by the opposite parties and even this re-position of leads is admitted by the complainant himself was tried by the doctors to their best. He even submitted that opposite parties 5 and 6 visited his house several times and tried possible combinations but the stimulations were coming only to his upper limbs and not to the shoulder level. When it is seen from the medical literature that SCS is only a therapy based treatment and will not cure the original source of pain, the contention of the complainant that he was assured 100% pain relief cannot be sustained keeping in view that
a) that the complainant himself is a Radiologist with expertise in the medical field and
b) being fully aware of the procedures and having signed the Special Informed consent, the complainant cannot now turn around and state that they should have implanted it for a trial period of 10 days.
c) The complainant’s problem is also of chronic nature for which he has been suffering for the last 12 years prior to the procedures.
It is also not known as to why the complainant for reasons best known to him has not approached his earlier doctor for re-position of the leads if there was any negligence on behalf of opposite parties 1 to 3. This procedure is reversible as seen from the literature and it is also not known as to why the complainant did not approach opposite parties 1 to 3 to remove the implant if it is not a success and if it is harming his body as stated so in his complaint.
It is also pertinent to note that the complainant already had problem of severe neck pain radiating to both shoulders and upper neck since 1997 that is for a period of more than 12 years and admittedly as mentioned in his very complaint. He consulted many neuron-surgeons and neuron-physicians and was not successful. Even in 2003, he had severe neck and left trapezius which was intolerable and he had an MRI done and anterior cervical discectomy was done to C3-C4-C4-C5 in Chennai which was not successful. Thereafter he consulted pain management specialists and also had joint injections which did not help him. Later he had C2-C5 Radio Frequency Rhizotomy at Apollo Hospitals which also did not relieve his pain. In 2007, he met G.P.Dureja who tried Botox 200 mg which also did not help him. The complainant had tried all methods of treatment for a period of 12 years and without success and opted for SCS treatment based on the advice of his own doctor, Dureja. With this history, the SCS implantation was done by opposite parties 1 to 3 only to alleviate his pain and no where is it stated that it would cure his pain to 100%. To reiterate the complainant himself is a doctor and suffering from this pain since last 12 years and has voluntarily approached opposite parties 1 to 3 on the advice of his own doctor Dureja and got the implantation done. The doctors have performed both the surgeries on the same day to avoid the risk of dual surgeries i.e. C5-C6 and C6-C7 and also SCS implantation. Now the complainant cannot turn around and state that they ought to have done trial implant for 10 days. In fact the complications that arise out of implantation like infection, epidural hematoma, paralysis etc. were not faced by the complainant. Exs.B1 to B3 which depict the entire case record and treatment rendered by opposite parties 1 to 3 in which we see no negligence in the very conduction of the operation or in any post operative treatment. The complainant also stated that he was getting stimulation in both the upper limbs but not in the shoulders, neck and upper back. So this construes that SCS was functioning and the doctors including opposite parties 5 and 6 have admittedly tried their best in assisting the complainant.
We also observe from the reply to the interrogatories on behalf of opposite party no.4, the complainant had clearly stated the entire gamut of treatment that he had undertaken for the last 12 years. In question 8, when opposite party No.4 asked him that despite best efforts of opposite parties, he did not get the required stimulations, the complainant replied that SCS used for him has been a defective one and that a trial implant should have been done before permanent unit is placed. About SCS procedure in the medical literature filed by the complainant himself, it is stated as follows:
The trial procedure
The stimulation trial usually requires a short procedure. This procedure is often performed on an out patient basis at a hospital, pain clinic, or at a day surgery centre. The trial implantation may be performed under light sedation or, less frequently, under general anathesia. Often, or that is needed is a local anesthetic to numb the area where the leads are inserted.
During the procedure, one or more leads are placed in the space along the spinal cord. The leads are typically inserted using a needle. The exact placement depends upon the location of your pain. When the leads are positioned in the best location, they are connected to a portable external generator. Once connected, the system generates mild electrical pulses that will be programmed to replace your areas of intense pain with a more pleasant sensation known as paresthesia.
Your doctor determines the length of the trial period. It may last for only a few days or several weeks. A longer trial may allow you to test how well you respond to stimulation through out the day while a shorter trial can be appropriate if your response is immediate and pain relief is dramatic.
As seen from the aforementioned literature filed by the complainant, the period of trial also is decided by the doctor and this trial can last even for several weeks and in the permanent procedure it is clearly stated as follows:
Even though an SCS system is called permanent, spinal cord stimulation is a reversible therapy. If you want to discontinue treatment at any time the implanted parts can be turned off or removed.
Therefore the contention of the complainant that opposite parties 1 to 3 were negligent in not performing a trial implant is unsustainable firstly, the trial implant period itself can run into several weeks and in the instant case, the complainant has approached the doctors again within two months and also the permanent procedure is reversible. It is also pertinent to note that the complainant was asked in the interrogatories by opposite party no.4 that two expert doctors relied upon by the complainant himself i.e. Pasupuleti Rama Rao and Dureja have advised him to remove the device and reintroduce the same percutaneously and that Dr.Dureja agreed to do it in his clinic. Therefore, we do not see any substantial grounds as to why the complainant has not got the procedure reversed if he found that the stimulator was not successful or that the positioning of leads was not done properly.
We rely on the judgement of the apex court, with reference to duties of the doctors to the patients, the National Commission in TARUN THAKORE v. Dr.NOSHIR M.SHROFF in O.P.No.215/2000 dated 24-9-2002 reported in Landmark judgements on Consumer Protection P-410 held as follows:
'The duties which a doctor owes to his patient are clear. A person who holds himself out ready to give medical advise and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person when consulted by a patient owes him certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires'
In INDIAN MEDICAL ASSN. v. V.P.SHANTHA (1995) 6 SCC 651 the court approved a passage from Jackson and Powell on Professional Negligence and held that'
'The approach of the courts is to require that professional men should possess a certain minimum degree of competence and that they should exercise reasonable care in the discharge of their duties. In general, a professional man owns to his client a duty in tort as well as in contract to exercise reasonable care in giving advise or performing services'.
Supreme Court then opined as under:
'The skill of medical practitioner 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'.
To reiterate, there is no evidence on record to establish that SCS implantation is a permanent cure or that opposite parties 1 to 3 have been negligent in the very implantation of SCS or that the treatment rendered by opposite parties 1 to 3 have been negligent in the very implantation of SCS or that the treatment rendered by opposite parties 1 to 3 is not as per standards of medical parlance.
b. Whether informed consent was taken.
The Hon’ble Supreme Court in Samira Kohli Vs. Dr. Prabha Manchanda & Another reported in (2008) 2 SCC 1 opined that
(i) A doctor has to seek and secure the consent of the patient before commencing a 'treatment' (the term 'treatment' includes surgery also). The consent so obtained should be real and valid, which means that : the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.
(ii) The 'adequate information' to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.
(iii) Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure w
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ill not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision. (iv)There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery. (v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment. We observe from the exhibits, that an informed consent was taken evidenced under Ex.B4, which is a general consent and Ex.B5 which is a Special Informed consent which are never denied by the complainant in his affidavit. The complainant himself being a Radiologist signed the consent form which clearly states the medical procedure and therefore now to allege that the doctors were negligent in not going for a trial implant is unsustainable. We rely on the decision of the National Commission in 2004(2) CPR 45 (NC) wherein it was held that 'In the absence of expert evidence, no medical negligence can be accepted'. It is pertinent to note that Nizams Institute of Medical Sciences in their expert opinion (Ex.A23) has stated that, the result of spinal cord stimulator is 50% only as per the reported literature and also that the documents submitted to them does not state whether consent was taken. However, we observe from Exs.B4 and B5 that consent was taken and this is not denied by the complainant. Lastly the complainant has also not filed the affidavit of Dr.Mone Chandrasekhar who, on behalf of the complainant was allowed to be present during the procedure. Therefore we hold that opposite parties 1 to 3 have taken the informed consent from the complainant as per law. c) Whether opposite parties 1 to 3 have charged the complainant excessively and have inflated the medical bills? It is the contention of the complainant that the opposite parties have escalated the value of the spinal cord stimulator from Rs.3,00,000/- to Rs.4.3 lakhs and also claimed an amount of Rs.1,06,050/- for fixation of screws and rods which was fixed without his knowledge and consent and they charged Rs.16,000/- for drugs which was not used by him and a sum of Rs.7,500/- towards fee of Mone Chandra Sekhar and instead of single deluxe room of Rs.3,000/- they charged for super deluxe room at Rs.9,600/- and therefore he was forced to pay a total of Rs.6,15,460/-. Firstly, there is no evidence on record that the stimulator is Rs.3,00,000/- and that opposite parties have excessively charged Rs.4.3 lakhs. The contention of the complainant that Rs.1,06,050/- was charged for fixation of screws and rods at C5 C6 and C6 C7 was without his knowledge and consent is unsustainable in view of Exs.B4 and B5 which are the general informed consent and Special consent which clearly state that Surgery at C5 C6 and C6 C7 levels is being conducted along with SCS implantation. Therefore to state that it was done without the complainant’s consent does not hold good. The other contention of the complainant that Rs.16,000/- was charged for drugs which were not used by him is also not supported by any documentary evidence. The single deluxe room charges are Rs.3,000/- and super deluxe room charged are at Rs.9,600/- and the complainant himself submits that he was promised that though he used super deluxe room he will be charged for single deluxe room charges. This is also not supported by any documentary evidence and moreover having enjoyed the facilities of super deluxe room, the complainant, a doctor, cannot now turn around and say that he ought to have been charged only for single deluxe room charges. Before any surgical procedure, the estimation of costs are given to a patient and the complainant being a doctor himself ought to have taken the entire estimation prior to surgery if it was not given. Keeping the aforementioned reasons, we are of the considered view that opposite parties 1 to 3 have not charged any excessive amounts for the complainant to contend any deficiency. Keeping the aforementioned judgments and material on record, we observe that opposite parties 1 to 3 are not negligent and consequently no liability can be fastened upon opposite parties 4 to 6 who only supplied the stimulator to opposite parties 1 to 3. In the result this complaint fails and is accordingly dismissed. There shall be no order as to costs.