State Consumer Disputes Redressal Commission
Mrs. Urmil Chopra vs Fortis Healthcare(India) Limited & ... on 25 October, 2018
STATE CONSUMER DISPUTES REDRESSAL COMMISSION, PUNJAB,
CHANDIGARH.
Misc. Application No.1491 of 2018
In/and
Consumer Complaint No.65 of 2013
Date of institution : 14.06.2013
Reserved on : 03.10.2018
Date of decision : 25.10.2018
Mrs. Urmil Chopra w/o Mr. K.R. Chopra, r/o 1327, Sector-21,
Panchkula, Haryana.
.......Complainant
Versus
1. Fortis Healthcare (India) Limited through Executive Chairman,
Escorts Heart Institute & Research Centre, Okhla Road, New
Delhi-110025.
2. Fortis Healthcare (India) Limited through Executive Director,
Escorts Heart Institute & Research Centre, Okhla Road, New
Delhi-110025
3. Fortis Hospital, Sector 62, Phase-VIII, Mohali, Punjab-160062
4. Dr. Harsimran Singh, Fortis Hospital, Sector 62, Phase-VIII,
Mohali, Punjab-160062
5. Dr. Atul Joshi, General Surgeon, Fortis Hospital, Sector 62,
Phase-VIII, Mohali, Punjab-160062.
........Opposite Parties
Consumer Complaint under Section
17(1)(a)(i) of the Consumer Protection Act,
1986.
Quorum:-
Hon'ble Mr. Justice Paramjeet Singh Dhaliwal, President
Mr. Rajinder Kumar Goyal, Member
Present:-
For the complainant : Shri Mayank Wadhwa, Advocate and Shri K.R. Chopra, Authorised Representative.
For the opposite parties: Shri Munish Kapila, Advocate. Consumer Complaint No.65 of 2013 2 JUSTICE PARAMJEET SINGH DHALIWAL, PRESIDENT:
M.A. No.1491 of 2018:
This is an application for placing on record laboratory reports of cultures and blood tests, which is supported by an affidavit of Dr. Harsimran Singh, opposite party No.4. Reply to the same has also been filed by the complainant.
2. Allowed as prayed for subject to all just exceptions in the interest of justice.
Main Case:
3. The complainant, Urmil Chopra, who is a 76 years old lady, has filed this complaint under Section 17(1)(a)(i) of the Consumer Protection Act, 1986 (in short, "C.P. Act") for issuance of following directions to the opposite parties:-
a) to award `17,13,729/- to the complainant, as
compensation by way of medical expenses;
b) to award `70,00,000/- to the complainant, as
compensation, by way of pain, suffering, mental agony and harassment;
c) to award `5,00,000/-, as compensation, by way of dearness allowance for the inconvenience and expenses caused to the family and relatives of the complainant;
d) to award cost of present complaint to the complainant; and
e) to pass such order as this Commission may deem fit and proper in the facts and circumstances of the present case.
4. "We have not lost faith, but we have transferred it from God to medical profession." ...George Bernard Shaw.
Consumer Complaint No.65 of 2013 3
5. A common man treats doctor as God on the earth. One has tremendous faith in one's heart in the doctor. When one approaches a doctor, he completely surrenders to him/her. For this reason, medical professionals should shoulder their responsibilities with all care and caution to strengthen the doctor-patient relationship. Facts of the Complaint:
6. Brief facts, as averred in the complaint, are that the complainant after consulting Dr. Harsimran Singh-opposite party No.4 with regard to her knee problem got admitted on 19.5.2011 in opposite parties Nos.1 to 3-Hospital for knee replacement operation of both her knees, which was conducted on 20.5.2011 by opposite party No.4 in opposite parties Nos.1 to 3-Hospital. The total cost of the entire operation and other miscellaneous costs was about `3,80,250/-. The complainant also spent an additional amount of `2,000/- on her medicines and the follow up treatment. The complainant was kept under observation for one week and was discharged on 26.5.2011. As per the advice of opposite party No.4 the complainant continued regular follow-ups with the opposite parties. It is further averred that the complainant was suffering from continuous severe and acute pain after the above said operation was conducted. She repeatedly complained of the same to opposite parties Nos.4 and 5, who informed her that since the operation was done recently, the pain was normal and she should bear the pain for some time. After a few weeks, the pain in the left knee of the complainant subsided gradually but the pain in the right knee Consumer Complaint No.65 of 2013 4 continued and escalated since the operation. In the month of August 2011 redness was seen on the right knee of the complainant and she was suffering with acute pain in the same. Immediately on 13.8.2011 the complainant visited opposite parties Nos.1 to 3- Hospital and consulted opposite party No.4, who asked her to consult Dr. Atul Joshi, General Surgeon-opposite party No.5. After consultation it was discovered to the utter surprise and dismay of the complainant that infection had developed in her right knee. After test reports, it was observed that there was abscess/pus formation in the right knee, which was removed three times. However, even after the removal of abscess/pus thrice from the right knee of the complainant, it sill continued to form and there was a lot of swelling in the right knee. The complainant was on complete rest due to the severity of pain and infection. It is further averred that on 2.9.2011 the complainant again consulted opposite parties Nos.4 and 5 and she was immediately admitted in opposite parties Nos.1 to 3- Hospital on the same day, where she was operated on 3.9.2011. During that operation abscess/pus was flushed out from the right knee of the complainant and she was discharged on 8.9.2011. An amount of `81,017/- was charged by the opposite parties from the complainant; besides additional amount of `12,870/- was spent on medicines. The infection continued to grow in the right knee of the complainant even after second operation and had spread to the bone of the complainant. The abscess/pus formation in the right knee continued and the complainant had no choice but to have Consumer Complaint No.65 of 2013 5 regular follow-ups with the opposite parties. It is further averred that since the condition of right knee kept on deteriorating and since the pain, redness and abscess/pus continued to grow in her right knee, the complainant was again admitted in opposite parties Nos.1 to 3- Hospital on 19.10.2011. The complainant was operated for the third time on 20.10.2011 and the artificial knee was removed after five months of the first operation due to negligence and carelessness of the opposite parties during first operation. Due to gross negligence, professional misconduct and non-expertise of the opposite parties in the common medical procedures the opposite parties failed to perform the first operation on the complainant properly due to which infection cropped up in her right knee in the first phase and subsequently after five months of pain and vigour, the right knee had to be removed. The opposite parties not only failed to treat the infection but worsened her condition; as a result the complainant remained completely bed ridden during all that period and suffered acute pain, mental agony and trauma. The complainant remained admitted in opposite parties Nos.1 to 3-Hospital for about 8-9 days for that operation and was discharged on 28.10.2011. She was again charged a sum of `1,78,818/- by the opposite parties and she further spent additional amount of `1,10,752/- towards various medicines and tests. It is further averred that in spite of the third operation performed by the opposite parties on 20.10.2011 the infection had still not healed and continued to spread in the right knee even after removal of the artificial knee. After consultation, Consumer Complaint No.65 of 2013 6 opposite party No.4 asked the complainant to consult a Plastic Surgeon for the continuing infection. It is further averred that on 20.12.2011 i.e. after almost 7 months of the first operation, the complainant got admitted in Sir Ganga Ram Hospital where surgery was performed on 21.12.2011 and she was discharged on 30.12.2011. Admission slip of the complainant categorically states that she came with excessive infection in her right knee due to knee replacement surgery and the infection along with abscess was flushed out of the right knee during that operation. Even in the opinion of the experts of the said Hospital they had never seen such a spoilt case in a routine procedure that the complainant underwent and suffered. The complainant had to spend another amount of `2,15,775/- for that operation and additional amount of `2,37,428/- on the follow up treatment and medicines. It is further averred that after the aforesaid operation where the infection was flushed out, the complainant had to undergo one more operation during which the artificial knee removed by the opposite parties, was transplanted again in the right leg of the complainant. Instead of having just one surgery, the complainant had to undergo five operations and also had to suffer the pain and mental agony for more than year, whereas had the opposite parties performed their duties and provided the service with utmost care and professionalism which reflects in their billing, the complainant would have recovered and would have been leading a normal life after undergoing the operation. It is further averred that on 24.4.2012 the Consumer Complaint No.65 of 2013 7 complainant was admitted to Sir Ganga Ram Hospital for the final surgery whereby the right knee was again transplanted and after that operation the complainant's one year long ordeal came to an end. The complainant had to spend another amount of `4,75,635/- and additional amount of `19,200/- on medicines and follow up. It is further averred that the opposite parties did not take proper care at the time of operating the complainant and due to their carelessness and negligence a fungal infection developed in the complainant's right leg. Not only this, the opposite parties were also unable to detect the kind of infection that the complainant had developed in her leg. In spite of the fact that the complainant was under constant supervision of opposite party No.4 and later opposite party No.5, they could not treat the infection and further not even bothered to inform her that if the infection did not heal, it would have led to amputation or permanent straightening of the leg. The complainant in total had 5 operations due to the negligence of the opposite parties in the first place and had to incur a total expense of `17,13,729/- on the medical treatment besides other miscellaneous expenses incurred by her under various other heads. She also suffered pain, suffering, mental agony and harassment for which no monetary amount can be affixed. The complainant served a legal notice dated 21.7.2012 upon the opposite parties for reimbursement of the medical bills and compensation under various heads but they did not reply it. Hence the present complaint alleging deficiency in Consumer Complaint No.65 of 2013 8 service and medical negligence on the part of the opposite parties for issuance of above mentioned directions to them. Defence of Opposite Parties:
7. Upon notice opposite parties appeared and filed joint written statement taking preliminary objections to the effect that the complaint is a flagrant abuse of the process of law and has been filed in order to harass, malign and blackmail the opposite parties.
The complainant has not produced any documentary or expert evidence to prove that there was any negligence on the part of the opposite parties. The complaint is bad for non-joinder of necessary parties inasmuch as Sir Ganga Ram Hospital has not been impleaded as a party in the complaint. The complainant has not approached this Commission with clean hands and has distorted the material facts with a view to mislead this Commission, which would show that the complainant had always been promptly attended to in line with the standard practice. With regard to the facts of the case it is averred that the complainant had come to opposite party No.4 on 12.4.2011 and 9.5.2011 with pain and swelling in both knees since 10 years which was associated with difficulty in walking and climbing stairs. She was having osteoarthritis of both knees and was advised Bilateral Total Knee Replacement (in short, "TKR"). Osteoarthritis results into wear and tear of joints with age, which further results in pain, stiffness and deformity. In TKR worn out surfaces of knee joint are removed and replaced with implants called prosthesis resulting improving quality of life and decreasing pain. The complainant was Consumer Complaint No.65 of 2013 9 admitted in opposite parties Nos.1 to 3-Hospital on 19.5.2011 for undergoing TKR and after having been explained everything including risks and complication of TKR including risk of infection, a written consent was obtained from her. On 20.5.2011 the complainant underwent TKR surgery conducted by opposite party No.4 as per standard norms. The Orthopaedic Operation Theatres are equipped with laminar flow apparatus and are subjected to regular disinfection and routine cultures. Moreover, same set of instruments were used for both the knees which were duly sterilized and the knee implant came in a pre-sterilized kit. After surgery the complainant was kept in the Ortho ICU for two days and then in the Ward for four days wherein complete protocols pertaining to infection control were followed till she was finally discharged. It is further averred that post operative the complainant had normal wound healing with no signs of soakage/discharge or fever was noted. The complainant started walking with a walker within 48 hours of her surgery. The walking distance was increasing as expected. The complainant complained of pain and stiffness especially at night but never had more than mild pain on walking. Her symptoms were similar on both the knees and were in accordance with the usual recovery period required for healing and while walking the patient took equal weight on both knees. She was discharged on 26.5.2011 in a stable condition. Thereafter her sutures were removed at routine time of 2 weeks. The wounds of both knees had healed normally by that time. The healing was similar in both knees and Consumer Complaint No.65 of 2013 10 there was no evidence of any infection or delay in healing of either knee. It is further averred that more than 2 months after surgery on 13.8.2011 the complainant approached opposite party No.4 with sudden onset of a small (2cm x 2cm) erythematous (reddish) swelling on the inner aspect of right knee distal to the joint line. The complainant at that time had no noticeable effusion (diffuse, generalized swelling) of the joint. She was walking with a stick. She did not have any fever and the swelling was only at one side and that too distal to the joint line, which pointed that the swelling was superficial. The patient (complainant) was informed that clinically there was nothing to suggest that underlying joint was infected. However, superficial infections may spread and for that reason immediately opposite party No.5 was consulted, who clinically diagnosed it as cellulitis just below the right knee and promptly put the complainant on anti-biotic. USG done on both knees on 20.8.2011 showed similar amount of joint fluid in both the knees and in addition 3.00 cm x 1.2 cm localized fluid collection deep to the subcutaneous tissue on the anteromedial aspect of upper tibia (inner side of knee distal to the joint line), which corroborated the clinical diagnosis of a soft tissue infection. In the meantime the complainant was managed with dressings and antibiotic. She had been followed up regularly in the OPD. It is further averred that treatment of superficial infections in the setting of knee replacement consists of antibiotic therapy with or without a localized incision and drainage (I&D). However, the treatment approach is different in deep Consumer Complaint No.65 of 2013 11 infections (deep to the joint capsule including those involving the metallic prosthesis) wherein the treatment consists of removal of the knee implant and debridement in the first stage and re-implantation of the prosthesis in the second stage after the infection had subsided. Since in the case of the complainant the clinical picture and USG were suggestive of a superficial infection, there was no need for a radical surgery in the form of 2-stage revision knee replacement at that stage. In the ensuing days, the soft tissue abscess developed a pus point superficially. Immediately aspiration of the pus was done and pus was sent for culture sensitivity, which later reported sterile. Notably the swelling and redness were still confined to small area. Opposite party No.5 came in contact with the complainant when she was sent for a general surgery consultation by opposite party No.4 and not prior to it, as is being conveyed in the complaint. Opposite party No.5 was not part of the team, who performed TKR. It is further averred that since complainant's localized abscess was not resolving with over two weeks of anti- biotic therapy and dressings, opposite party No.4 decided to perform an incision and drainage in OT. I & D is a surgery wherein an incision of 2 cm was given over the soft tissue abscess and it was drained and washed. The surgery was performed by opposite party No.4 and the same lasted 15 minutes. Intra-operatively it was found that the abscess extended till the underlying leg bone. However, there was no communication with the underlying knee joint and the knee joint was never opened in that surgery. Post operatively broad Consumer Complaint No.65 of 2013 12 spectrum IV antibiotic was given followed by oral antibiotic on discharge. C-reactive protein levels in blood tests (markers of inflammation/infection) started decreasing after I & D, which has been documented in the Investigation Flow Chart Sheet. After I&D the wound showed signs of healing and the discharge stopped. However, about a week after I&D, the discharge reappeared. Serial bacterial cultures were done but were always sterile. Thereafter the complainant underwent daily dressings under the supervision of opposite party No.4. The complainant used to walk around comfortably from the Hospital entrance to the dressing room. The complainant was regularly asked about any pain on walking to which she replied in negative. Hence the allegation that she was bedridden after surgery is false; rather, she was walking comfortably after surgery, as is apparent from Annexure C-4 (page 142 of the complaint), which is as per history given by the complainant to the Doctors of Sir Ganga Ram Hospital. It is further averred that since the wound discharge was not resolving despite anti-biotic and dressings, the complainant was encouraged to take a second opinion. Opposite party No.4 arranged consultation with Prof. Ramesh K. Sen at PGIMER, Chandigarh. The complainant was examined by Dr. Sen and his team, who advised repeating bacterial cultures after stopping anti-biotic for a week and told that the same treatment as given by opposite party No.4 should be continued. However, the wound discharge showed an increase in amount and also the nature of discharge became thin and watery, which Consumer Complaint No.65 of 2013 13 suggested that the abscess had eroded into the joint capsule and led to a communication with the knee joint resulting leakage of synovial fluid along with discharge. That implied an underlying communication and infection of the knee plant. Therefore, the decision to remove the right knee implant was taken. A revision knee replacement in the setting of infection as in the case of complainant is done in two stages. In the first stage the main aim is to eradicate infection. During this stage all the foreign material, which means the implant and the cement is removed and all visible infective tissue is excised and cleaned. In place of the implant an anti-biotic spacer is inserted which can elute anti-biotic to control the infection. Once infection is controlled the next stage involves insertion of new implant. In order to undergo debridement and implant removal, the complainant was admitted in opposite parties Nos.1 to 3-Hospital on 19.10.2011 and the right knee debridement with implant removal was done on 20.10.2011 and antibiotic loaded cement spacer was inserted. Only after insertion of the cement spacer the complainant was advised to do bed rest. Therefore, the impression which the complainant is trying to convey implying as if she had been on bed rest after her TKR surgery conducted in May 2011 is absolutely incorrect and on the contrary she was walking comfortably after TKR. However even after removing the implants, the wound discharge began after a period of one week. The complainant was told that more than one debridement (wound cleaning) is often needed in similar cases and that a new knee implant could not be inserted till infection subsides Consumer Complaint No.65 of 2013 14 completely. However by that time the complainant was taking several other opinions of her own and started getting irregular with dressings and was not interested in continuing treatment with opposite parties. Even in Sir Ganga Ram Hospital another debridement was done on 21.12.2011, which was followed by TKR revision Stage-II on 25.4.2012. It is further averred that TKR surgery was conducted in opposite parties Nos.1 to 3-Hospital by opposite party No.4 and after more than two months of the surgery the complainant developed cellulitis for which she was immediately put on antibiotic. As it evolved into a soft tissue abscess I&D procedure was also conducted. As the knee joint was involved/infected the prosthesis of complainant was removed and antibiotic spacer was placed. Therefore, a known and established procedure was followed. There was no deviation whatsoever in the procedure conducted and it is also not the case of the complainant that there was any deviation whatsoever. It is further averred that Dr. Harsimran Singh-opposite party No.4 is a Graduate of All India Institute of Medical Sciences and he has done his Post Graduation in MS Ortho from PGIMER, Chandigarh. He has done his M.Ch. (Ortho) from University of Dundee, Scotlant, U.K. He has performed over 4300 joint replacement surgeries in Fortis Hospital, Mohali over the past five and a half years. Dr. Atual Joshi-opposite party No.5 is MS (PGI) and Fellow Minimal Access Surgery. Thus, both opposite parties Nos.4 and 5 are well qualified in their respective fields. Reference to a number of judgments of Hon'ble Supreme Court and Consumer Complaint No.65 of 2013 15 Hon'ble National Commission has been made. On merits, the admission of the complainant in opposite parties Nos.1 to 3-Hospital and her treatment by opposite parties Nos.4 and 5 has been admitted. It is averred that a knee replacement surgery is amongst the most successful of all orthopaedic procedures. It has proven to significantly enhance the quality of an arthritis patient. However, a number of possible complications have been well defined in the medical literature including but not limited to infection. The metallic implant that is inserted can become a focus of infection either soon after surgery or within period of months or years thereafter for any reason. The risk of such an event varies between 0.5% and 2% in most medical series. Therefore, TKR comes with its own set of complications. Opposite parties Nos.4 and 5 did everything that would be expected from a medical professional in trying to contain the soft tissue infection. Even in the most developed countries of the West which have inherently low bacterial flora in the environment, infection after TKR is a well known and well accepted complication. In own series of over 4300 joint replacements performed by opposite party No.4 over the period of 5 years infection rate has been less than 1%. Merely occurrence of a known complication after knee replacement cannot be construed as negligence. All the averments made in the preliminary objections have been reiterated. Denying the other averments of the complaint and denying any deficiency in service and medical negligence on the part of the opposite parties a prayer for dismissal of the complaint was made.
Consumer Complaint No.65 of 2013 16Evidence of the Parties:
8. In order to prove her complaint, the complainant filed her own affidavit as Ex.C/A and affidavit of her husband; namely, Shri K.R. Chopra as Ex.C/B. She also tendered documents i.e. copies of bills along with discharge summary pertaining to operation on 20.5.2011 as Ex.C/1 (Colly), copies of bills along with discharge summary pertaining to operation on 3.9.2011 as Ex.C/2 (Colly), copy of bill dated 28.10.2011 as Ex.C/3, copy of bill dated 29.10.2011 as Ex.C/4, copy of bill dated 5.11.2011 as Ex.C/5, copy of bill dated 6.11.2011 as Ex.C/6, copy of bill dated 8.11.2011 as Ex.C/7, copy of bill dated 9.11.2011 as Ex.C/8, copy of bill dated 11.11.2011 as Ex.C/9, copy of bill dated 13.11.2011 as Ex.C/10, copy of bill dated 14.11.2011 as Ex.C/11, copy of bill dated 16.11.2011 as Ex.C/12, copy of bill dated 18.11.2011 as Ex.C/13, copy of bill dated 28.10.2011 as Ex.C/14, copy of bill dated 29.11.2011 as Ex.C/15, copy of discharge summary dated 28.10.2011 as Ex.C/16, copy of bill dated 28.10.2011 as Ex.C/17, copy of receipt dated 28.10.2011 as Ex.C/18, copy of bill dated 28.10.2011 as Ex.C/19, copy of bill dated 28.10.2011 as Ex.C/20, copy of complete summary of the bills and expenses as Ex.C/21 (Colly), copy of bill dated 30.4.2012 as Ex.C/22, copy of bill dated 1.5.2012 as Ex.C/23, copy of bill dated 5.5.2012 as Ex.C/24, copy of bill dated 5.5.2012 as Ex.C/25, copy of bill dated 5.5.2012 as Ex.C/26, copy of bill dated 29.12.2011 as Ex.C/27, copy of bill dated 31.12.2011 as Ex.C/28, copy of bill dated 2.1.2012 as Ex.C/29, copy of bill dated 5.1.2012 as Ex.C/30, copy of Consumer Complaint No.65 of 2013 17 bill dated 6.1.2012 as Ex.C/31, copy of bill dated 7.1.2012 as Ex.C/32, copy of bill dated 9.1.2012 as Ex.C/33, copy of bill dated 10.1.2012 as Ex.C/34, copy of bill dated 11.1.2012 as Ex.C/35, copy of bill dated 17.1.2012 as Ex.C/36, copy of bill dated 13.1.2012 as Ex.C/37, copy of bill dated 14.1.2012 as Ex.C/38, copy of bill dated 14.1.2012 Ex.C/39, copy of bill dated 15.1.2012 as Ex.C/40, copy of bill dated 18.1.2012 as Ex.C/41, copy of bill dated 17.1.2012 as Ex.C/42, copy of bill dated 17.1.2012 as Ex.C/43, copy of bill dated 18.1.2012 as Ex.C/44, copy of bill dated 20.1.2012 as Ex.C/45, copy of bill dated 20.1.2012 as Ex.C/46, copy of bill dated 21.1.2012 as Ex.C/47, copy of bill dated 21.1.2012 as Ex.C/48, copy of bill dated
21.1.2012 as Ex.C/49, copy of bill dated 30.1.2012 as Ex.C/50, copy of bill dated 4.2.2012 as Ex.C/51, copy of bill dated 10.2.2012 as Ex.C/52, copy of bill dated10.2.2012 as Ex.C/53, copy of bill dated 10.3.2012 as Ex.C/54, copy of bill dated11.3.2012 as Ex.C/55, copy of bill dated 13.3.2012 as Ex.C/56, copy of bill dated 8.4.2012 as Ex.C/57, copy of bill dated 12.4.2012 as Ex.C/58, copy of bill dated 21.4.2012 as Ex.C/59, copy of summary of bills as Ex.C/60 (Colly), copy of bill dated 20.11.2011 as Ex.C/61, copy of bill dated 1.10.2011 as Ex.C/62, copy of bill dated 5.10.2011 as Ex.C/63, copy of bill dated 12.10.2011 as Ex.C/64, copy of bill dated 18.10.2011 as Ex.C/65, copy of bill dated 19.11.2011 as Ex.C/66, copy of bill dated 19.11.2011 as Ex.C/67, copy of bill dated 24.11.2011 as Ex.C/68, copy of bill dated 26.11.2011 as Ex.C/69, copy of bill dated 24.11.2011 as Ex.C/70, copy of bill dated 25.11.2011 as Ex.C/71, Consumer Complaint No.65 of 2013 18 copy of bill dated 25.11.2011 as Ex.C/72, copy of total summary as Ex.C/73, copy of bill dated 30.4.2012 as Ex.C/74, copy of bill dated 1.5.2012 as Ex.C/75, copy of bill dated 5.5.2012 as Ex.C/76, copy of bill dated 5.5.2012 as Ex.C/77, copy of bill amounting to Rs.4,473/- as Ex.C/78, copy of discharge summary dated 30.12.2011 as Ex.C/79, copy of bill dated 30.12.2011 as Ex.C/80, copy of discharge summary dated 5.5.2012 as Ex.C/81, copy of bill dated 5.5.2012 as Ex.C/82, copy of bill dated 24.4.2012 as Ex.C/83, copy of legal notice dated 21.7.2012 as Ex.C/84, copy of receipts as Ex.C/85, copy of proof of delivery as Ex.C/86, copy of the certificate of fungal infection by Dr. O.N. Nagi as Ex.C/87, copy of discharge summary dated 30.12.2011 as Ex.C/88, copy of test results dated 5.1.2012 as Ex.C/89, copy of investigation results dated 20.12.2011 as Ex.C/90 (Colly). On the other hand, the opposite parties tendered in evidence affidavits of Dr. Harsimran Singh, Director, Orthopedics- opposite party No.4 as Ex.OPA, Abhijit Singh, Facility Director, Fortis Hospital, Mohali as Ex.OPB and Dr. Atul Joshi-opposite party No.5 as Ex.OP-C. They also tendered documents i.e. copy of authorization for and consent to operation, administration of anaesthesia and environmental monitoring as Ex.OP-1/1, copyof operation notes as Ex.OP-1/2, copy of environmental monitoring as Ex.OP-1/3, copy of sterilization record as Ex.OP-1/3A, ultrasound report as Ex.OP-1/4, copy of report dated 29.8.2011 as Ex.OP-1/5, copy of operation notes as Ex.OP-1/5A, copy of investigation flow chart as Ex.OP-1/6, copy of report dated 5.9.2011 as Ex.OP-1/7 Consumer Complaint No.65 of 2013 19 (nine sheets) (colly), copy of operation notes as Ex.OP-1/8, copy of authorization for and consent to operation, administration of anaesthesia and procedures as Ex.OP-1/9, copy Campbell's Operative Orthopedics as Ex.OP-1/9A, copy of medical literature as Ex.OP-1/10, copy of incidence of deep prosthetic infections in a specialist orthopedic hospital as Ex.OP-1/10-A, copy of report of PGI, MR, Ex.OP-1/11, copy of letter dated 8.1.2016 as Ex.OP-1/11A, copy of opinion of GMCH as Ex.OP-1/11B (with envelop forwarding letter and expert medical report and letter No.GMCH/Ortho/16/228 dated 5.2.2016, copy of stickers as Ex.OP-1/12.
9. We have carefully gone through the averments of both the parties and the evidence produced by them in support of their respective averments. We have also heard learned counsel for both the sides.
Contentions of the Parties:
Complainant:
10. The learned counsel for the complainant vehemently contended that the complainant visited the opposite parties in April, 2011 with knee pain and was advised with total knee replacement surgery. The complainant under the advice and treatment of opposite parties and particularly opposite party No.4 got admitted in opposite parties Nos.1 to 3-Hospital on 19.5.2011. The total knee replacement surgery was performed on the complainant-patient on 20.5.2011 by the opposite parties and the complainant was discharged from the said Hospital on 26.5.2011. The total cost of the Consumer Complaint No.65 of 2013 20 said operation was `3,80,250/-. Apart from the same, the complainant further spent money on the follow up medication, as was advised and prescribed by the opposite parties. Thereafter, the complainant felt severe discomfort and swelling in her right knee and visited the opposite parties on 13.8.2011. The complainant had been following up with the opposite parties after the aforesaid surgery.
11. The learned counsel further contented that no action was taken by the opposite parties upon the visit of the complainant and it was only as late as 29.8.2011 (i.e. after 15 days), the opposite parties chose to conduct tests to examine the swelling wherein abscess had formed. The opposite parties at that time simply drained the abscess from the right knee without examining it any further. Another procedure was conducted on the complainant on 2.9.2011 whereby the abscess was again drained out from the right knee of the complainant. The complainant was informed by the opposite parties that even though there was abscess formation and the same was even drained from the knee however, no infection has been found by the opposite parties and there was nothing serious and the complainant should not worry.
12. Learned counsel for the complainant further contended that the complainant though remained in severe pain since August, 2011 and still believed the assurances given by the opposite parties. She had been under their treatment for long and continued with the advice and treatment of the opposite parties including opposite party No.4. Consumer Complaint No.65 of 2013 21 The complainant continued to suffer severe discomfort, swelling and redness in her right knee. The abscess formation continuously persisted and recurred. The said fact has been admitted by opposite party No.4 in his cross examination that the abscess was recurring. The complainant was charged nearly `1,00,000/- for that procedure apart from the follow up expenses and medicines. It continued till October, 2011. The opposite parties always gave assurance that there was no infection in the knee despite the fact that the abscess formation was recurring time and again. There were no signs of healing. The complainant was in the hands of the opposite parties and had been diligently perusing the follow up treatment. In October, 2011 the complainant was again admitted in the hospital for removal of abscess from the right knee, however, during the procedure opposite party No.4 came out of the O.T. and sought a waiver (NOC) from the family of the complainant to remove the implant from the right knee, as it was found that the abscess had gone deep into the bone of the complainant. The complainant was again operated on 20.10.2011 and the implant was removed from her right knee where the infection had occurred. The complainant and the family had no option but to give the consent as she was on operation table in OT. Opposite Party No.4 had informed that the implant had to be removed.
13. It was further contended that the opposite parties even after the said surgery maintained that there was no infection found/detected in the right knee, at that stage, the complainant and Consumer Complaint No.65 of 2013 22 her family had lost complete faith in the working ethics and efforts of the opposite parties. The opposite parties charged nearly `3,00,000/- from the complainant for the removal of implant and follow up treatment and medicines cost.
14. It was further contended that the complainant continued her follow up with the opposite parties, but also started seeking second opinion from other hospitals/doctors. It was only then discovered that there were several lapses on the part of the opposite parties, as proper tests were not carried out. There was infection since the abscess formation was recurring and repeatedly drained off by the opposite parties. It is an admitted fact and also admitted in cross examination. However, the opposite parties maintained that there was no infection even though the condition of the patient was deteriorating in front of their eyes every single day.
15. It was further contended that if there would have been no infection, there was no cause or occasion for the abscess to recur and further the swelling would have also improved however, the condition of the patient had been worsening with the passage of time till she remained with the opposite parties. The complainant was also made to spend a substantial amount on every follow up and alleged mode of treatment which was evidently a sham by the opposite parties, as they continued to maintain that there was no infection up until the end of November, 2011.
16. It was further contended that the complainant finally shifted to Sir Ganga Ram Hospital, New Delhi, in December, 2011 after Consumer Complaint No.65 of 2013 23 seeking opinion in the end of November, 2011. Another surgery was performed at Sir Ganga Ram Hospital, New Delhi, on 20.12.2011 on the right knee and the infection was flushed out. On examination of the flushed out material it was found that it was fungal infection. The opposite parties had specifically stated the fact that similar procedure was conducted by them, as it was done at Sir Ganga Ram Hospital which itself determines and establishes the fact that the infection was very much present and the entire defence of the opposite parties is a cover up in the matter. However, due to negligent and improper recourse to cure the patient opposite parties failed to detect infection. As the opposite parties could not detect the infection which was present due to negligence and deficiency in service on their part.
17. It was further contended that the opposite parties have stated that only one test was repeatedly done by them to identify the infection, however, even after repeated tests the infection was not detected by them. The said fact again shows negligence and deficiency in service on their part, as the infection existed in the knee of the complainant. The infection was detected and cured in the surgery conducted at Sir Ganga Ram Hospital, New Delhi, within a span of 2 weeks. The complainant remained under treatment of the opposite parties from August, 2011 to November, 2011 and admittedly the opposite parties could not detect the infection which was recurring time and again.
Consumer Complaint No.65 of 2013 24
18. It was further contended that the expert report on record of complaint would show that the same is biased to say the least. The medical evidence on record of the present case has not been considered. The patient remained under the treatment of the opposite parties for over a period of 6 months but infection could not be detected. The opposite parties have failed to explain, how immediately after leaving opposite parties Nos.1 to 3-Hospital the infection was detected and cured. Thus, the same creates serious doubts on the veracity of the report submitted.
19. It was further contended that opposite party No.4 has specifically stated that the said infection normally occurs near an open wound. It is for the Doctor and the Hospital to treat the complainant and explain why they could not detect the infection? Who were responsible for it? The wound was opened up by them and even the implant was subsequently removed by them after conducting the surgery. The opposite parties in order to cover up their gross negligence and deficiency are now raising frivolous pleas and are further trying to delay the issue.
20. The learned counsel for the complainant further contended that abundance literature is available about the Candida fungal infection and made reference to the same and the effect of delayed treatment of infection of knee. It can lead to permanent deformity in cases where there is a delay in detection and treatment. The complainant at the right time was shifted from opposite parties Nos.1 to 3- Hospital and was treated in time for the said infection. The causes Consumer Complaint No.65 of 2013 25 for the said infection are normally due to accidental implantations of fungus during surgeries. He prayed that this complaint may kindly be allowed as prayed for.
Opposite Parties:
21. Per contra, learned counsel for the opposite parties vehemently contended that the complainant is seeking compensation towards the medical expenses incurred by her due to the prolonged treatment on account of the negligence on the part of the opposite parties in not being able to detect and treat the infection in her right knee. Further compensation is being sought on account of notional loss and mental agony and damages as stated in the prayer clause of the complaint.
22. The learned counsel further contended that the complainant underwent bilateral knee replacement surgery on 20/05/2011. All protocols of OT disinfection, instrument sterility and post-operative care, as per requisite medical standards were followed in the present case and the patient was recovering well in the first 3 months after surgery and she was walking comfortably as mentioned in the history of the complainant in the Discharge Summary of Sir Ganga Ram Charitable Hospital, New Delhi, Ex. C-79.
23. It was further contended by the learned counsel that on 13.8.2011 after about 3 months (85 days) of the surgery, the complainant-patient presented with sudden onset of reddish swelling 2 cm x 2 cm, present at a short distance from knee joint line on inner aspect of right upper leg. The margins of the swelling were well Consumer Complaint No.65 of 2013 26 defined, and the joint capsule was not swollen, meaning thereby that the swelling was superficial and it did not involve the knee joint. A General Surgeon i.e. Dr. Atul Joshi-opposite party No.5 was consulted to confirm the diagnosis. He concurred with the impression of the swelling being superficial and diagnosed it as cellulitis. As per recommended medical guidelines, the patient was put on oral antibiotic by Dr. Atul Joshi and complainant was told to follow up after 5 days. The patient visited him again on 18.8.2011, wherein opposite party No. 5 after discussing with opposite party No.4 advised for an ultrasound of knee to confirm the diagnosis. The ultrasound conducted on 20.8.2011 corroborated the clinical diagnosis that the swelling was localized outside the knee joint capsule and there was no difference in the amount of knee joint fluid between the two knees Ex.OP-1/4. Thereafter, Dr. Atul Joshi aspirated the pus point that had developed over the swelling on 27.8.2011 and he sent sample for gram stain and routine culture. The result showed sample to have 30-50 pus cells / HPF proving it to be an abscess, but no organism. The report is Ex. OP-1/5.
24. It was further contended by the learned counsel for the opposite parties that the diagnosis of superficial infection was based on medically sound reasons and in the interest of complainant/patient's safety. Opposite party No. 4 took opinion of opposite Party No.5 too, since he is a General Surgeon, whose routine practice includes skin and superficial infections. Therefore, the allegation that the diagnosis of superficial infection was wrong or Consumer Complaint No.65 of 2013 27 was made casually is untrue. As pus re-appeared both the Doctors decided that a formal incision and drainage should be done to decrease the infection load and minimize the chance of infection spreading deep into knee joint.
25. It was further contended that the complainant/patient was admitted for I&D and I&D procedure was done on 3.9.2011. Dr. Atul Joshi (Opposite Party No.5) was present along with Dr. Harsimran Singh (Opposite Party No.4) in the operating room. The swelling was drained and thoroughly washed according to the satisfaction of both opposite Parties Nos. 4 & 5. Opposite Party No.4 had separately sent the samples of I&D tissue and a sample taken from synovial fluid of the right knee joint at the location distant to the site of I&D for diagnosis. While taking sample from knee joint, it was confirmed that the knee joint was not communicating with the site of swelling (I&D) and this fact is also written in the operating notes Ex.OP-1/5A. The lab. reports show negative culture growth for both the samples. Subsequently, the infection markers (CRP) started decreasing till 12.9.2011 after which they showed rise. In the coming few weeks the discharge became more watery indicating leakage of synovial fluid and spread of infection deep into the knee capsule and referred to the lab report. At this point a working diagnosis of culture-negative knee joint infection was kept. As per medical literature this was not unusual, as in 5 to 34% of all knee infections, the causative organism cannot be identified primarily due to inherent slow growing nature of the organisms. Learned counsel referred to article: Consumer Complaint No.65 of 2013 28
Prosthetic Joint Infections published in Clinical Microbiology Reviews in 2014 and contended that it is one of the most exhaustive reviews covering data from over 461 international articles and includes over 2435 joint infection cases.
26. It was further contended that opposite party No.4 thoroughly searched the medical literature and had informal discussions with several colleagues to look for recommendations as to how to proceed in that scenario. In addition to it opposite party No.4 arranged complainant's consult with Dr. Ramesh K. Sen, who at that time was working as a Professor in the Orthopaedics Department at PGIMER, Chandigarh and had been treating knee joint infections for several years. The reason was that Dr. Ramesh Sen and his team could have a fresh look at the patient's clinical picture and suggest if any change in treatment plan and/or new investigations was warranted. Dr. Sen concurred with the line of treatment being given and told the patient to stop antibiotic for a week and repeat gram stain and routine culture which the patient got done at a private lab.
Results were again negative for any pathogenic growth. This part is clearly mentioned in the reply and the affidavit of Dr. Harsimran Singh-opposite party No.4. This fact stands admitted as the complainant has neither denied the same nor cross-examined Dr. Harsimran Singh-opposite party No.4 upon this point.
27. It was further contended that after this opposite party No.4 planned for two staged revision. In the 1st stage infected tissue is excised and the infected implant is removed and an antibiotic spacer Consumer Complaint No.65 of 2013 29 is inserted which elutes anti-biotic. This is usually followed by one or more debridement before it is followed by 2nd stage TKR wherein a new implant is inserted. The complainant was admitted to opposite parties Nos.1 to 3-Hospital on 19.10.2011 and was discharged on 28.10.2011 after right knee debridement with implant removal was done on 20.10.2011. Operation theatre notes are Ex. OP-1/8 and the discharge summary is Ex.C-16. After insertion of spacer the complainant was advised bed rest.
28. It was further contended that thereafter complainant became irregular with her dressings and was not keen on following up with opposite party No.4 and as per complainant's own admission she was consulting other doctors. Thereafter complainant went to Sir Ganga Ram Hospital, New Delhi and on 20.11.2011 where the complainant underwent debridement and remained admitted till 30.12.2011 and underwent stage II revision in April 2012. At Sir Ganga Ram Hospital, New Delhi, same line of treatment was followed as was conducted by opposite party No.4. The treating Doctors i.e. opposite Parties Nos.4 & 5 performed their duty to give complainant best treatment possible and opposite party No.4 in the interest of complainant/patient's safety took an expert opinion from Dr. Ramesh K. Sen at PGIMER, Chandigarh also so that he did not miss anything critical and that everything possible was done to alleviate the complainant/patient's suffering. It also means that had the complainant/patient been undergoing treatment for the same condition at a reputed institute like PGIMER, Chandigarh, the same Consumer Complaint No.65 of 2013 30 treatment would have been followed and probably same results would have been achieved.
29. The learned counsel further submitted that there are three modes of occurrences of Prosthetic Joint Infections referred to "Prosthetic Joint Infection" by Mayo Clinic, Rochester, Minnesota, USA. First is introduction of microorganisms introduced during the surgery. Second mechanism is contiguous spread of infection from an adjacent site (which happened in the present case) and third one is haematogenous seeding (which means that the infection from the distal foci may travel via blood and infect the implant). In the present case the infection was a contiguous spread from an adjacent soft tissue which despite best treatment transformed into a deep infection from a subcutaneous infection despite Antibiotic, dressing and I & D procedure. It is known to occur from a superficial infection.
30. The learned counsel further contended that despite opposite parties doing their best the complainant out of a misguided and misplaced sense of retribution instituted the present complaint levelling allegations against Opposite Parties which are bereft of medical plausibility. The complainant aims at satisfying only a layman's understanding of the complexities and nuances of treating a problem as perplexing as infection following a knee replacement. Complainant has tried to set up foundation of her case on the premise that Candida Albicans detected on routine culture at Sir Ganga Ram Hospital, New Delhi, was introduced during the first surgery and secondly that opposite parties could not diagnose and Consumer Complaint No.65 of 2013 31 treat the patient. It is submitted that the guidelines for diagnosis and treatment of knee joint infection are still undergoing improvisations and there is yet to be a consensus in measures to be taken for prevention and treatment of this malady.
31. The learned counsel further contended that so far as the complainants' proposition to the effect that Candida Albicans was introduced in the first surgery is concerned, it is clear from results of the culture. It is apparent that the said argument is totally hypothetical and lacks any medical basis. The Candida Albicans was detected at Sir Ganga Ram Hospital, New Delhi, was not detected in any of the cultures conducted at Fortis Hospital and from a private laboratory. Meaning thereby that Candida Albicans was subsequently introduced when the complainant/patient stopped follow up with Fortis Hospital, Mohali and did not undergo aseptic dressings which were regularly being done by the doctors at Fortis Hospital, Mohali. Candida albicans is a commensal of human body, meaning thereby it is fungi which is present on the skin/throughout the entire GI tract/ expectorated sputum/ female genital tract. Candida is microbiologically very easy to detect on routine bacteriological cultures and does not require any special fungal media for cultivation. The fact that Candida is detected on routine culture is supported by Mandell, Douglas and Bennett's "Principles 7th and Practice of INFECTIOUS DISEASES, edition. For this reason no one ordered for a specialised fungal stain or culture in 2011. At Fortis Hospital routine cultures were got conducted eight Consumer Complaint No.65 of 2013 32 times. All the reports were negative. Since Candida Albicans was not being detected in so many cultures from August to November 2011, therefore, it is clear that it was not present in the complainant/patient's wound/knee at that time. Even at Sir Ganga Ram Hospital, New Delhi, the treating doctors did not order any special fungal stain or culture and Candida Albicans was detected on routine culture. This supports the assertion of Opposite Parties that no other testing was required, as is being argued by the complainant.
32. The learned counsel further contended that the complainant/patient was referred to Dr. Ramesh K Sen at PGIMER, Chandigarh by opposite party No.4 for second opinion in September 2011 and he did not advise any different investigation or any special fungal or atypical bacteria culture. Similarly as per patient's own statement, she consulted several doctors, none of whom suggested any different investigation than what was ordered by opposite party No.4 nor could they diagnose the organism that caused the infection. The very fact that the complainant has not brought on record any prescription of any of the doctors whom she claims to have consulted shows that they had nothing different to offer than what was being advised by opposite party No.4. Even at Sir Ganga Ram Hospital, New Delhi, no special culture or test was done. This shows that complainant/patient never required more testing and whatever was required was done as per standard practice.
Consumer Complaint No.65 of 2013 33
33. The learned counsel further submitted that the complainant moved MA No. 168 of 2014 for referring the matter to the medical board and also moved an application suggesting the names of the expert doctors to whom the matter be referred to for an expert opinion. In the application dated 6.5.2014 she specified the names of doctors. Thereafter, this Commission referred the matter to Medical Board of the PGIMER, Chandigarh. Even GMCH, Sector 32, Chandigarh, also revisited the entire treatment record and the case file to provide its Report. The expert opinions by two Government institutions also show that the treatment rendered to the complainant was in line with standard practice and there was no deviation from a known practice.
34. The learned counsel further submitted that no orthopaedic surgeon in India had seen a case of true fungal knee implant infection till 2013. The first case of fungal knee implant infection was published by Dr. K J Reddy in 2013 (Reference No. 6-FUNGAL PROSTHETIC JOINT INFECTION AFTER TOTAL KNEE ARTHROPLASTY). As per an international review article published in 2017, which stated the incidence of true fungal knee infection across the world, the case of Dr. K. J. Reddy was still only case reported from India. Thus, the complainant's case was not a case of true fungal infection but where a commensal had colonised the wound.
35. The learned counsel in alternative submitted that the fungal infection detected at Sir Ganga Ram Hospital, New Delhi, was not a Consumer Complaint No.65 of 2013 34 true fungal infection but merely colonization by Candida Albicans. The medical literature clearly shows that the organisms are normal human flora, including fungi can colonize open wounds. In this regard opposite parties referred to articles on the infection. The complainant/patient stopped getting aseptic dressing of the wound towards the end of November, 2011 from opposite parties Nos.1 to 3-Hospital. After 3 weeks the complainant/patient underwent surgery at Sir Ganga Ram Hospital, New Delhi, who sent the sample (for the same test as sent at Fortis Hospital, Mohali) i.e. a routine culture and Gram stain. No special fungal culture or any other test was ordered by them. The sample grew candida albicans proving that this fungus got introduced later on in the wound. The discharge summary at Sir Ganga Ram Hospital, New Delhi, shows that after debridement they advised antifungal injections for 1 week only (a mention of 30 injections in a different document). Only anti bacterial were given by the Doctors in Sir Ganga Ram Hospital, New Delhi after the second stage revision in March 2012, whereas the literature for fungal infection advises a course of around 20 weeks of anti-fungals after 1st stage debridement and implant removal and anti-fungals for 12 weeks after the second stage (definitive implant insertion). The doctors at Sir Ganga Ram Hospital, New Delhi, also did not treat the infection as a true fungal infection but as a bacterial infection only. Therefore, the course of treatment followed by opposite parties Nos.4 and 5 was correct and was in line with the standard protocol of Consumer Complaint No.65 of 2013 35 treatment. There is no merit in the present complaint and the same be dismissed with costs.
Consideration of Contentions:
36. We have given our thoughtful consideration to the contentions raised before us by the learned counsel for both the sides.
37. Admittedly the complainant was admitted for Bilateral TKR in opposite parties Nos.1 to 3-Hospital and the TKR surgery was performed by opposite party No.4 on 20th of May 2011. The complainant was discharged on 26.5.2011. Thereafter the complainant visited initially for dressings and follow up check-ups. The complainant had undergone TKR for both the knees but there was no complaint with regard to left knee but she complained of severe pain in her right knee almost after 85 days of the said surgery in the month of August 2011. The complainant complained of redness around in the right knee and severe pain in it. On 13.8.2011 the complainant was examined by opposite parties Nos.4 and 5 and the treatment was provided. Opposite parties Nos.4 and 5 performed I&D procedure and the sample of the drained out material from the right knee was sent for examination. It appeared that there was leakage of synovial fluid of right knee joint at a location distant to I&D site. While taking the sample from right knee joint it was confirmed that the knee joint was not communicating with the site of swelling (I&D) and it is so recorded in the operation notes Ex.OP1/5A. The Laboratory report of both the samples was negative. Thereafter infection markers started decreasing till 12th of Consumer Complaint No.65 of 2013 36 September 2011 after which they showed rise. It would be appropriate to refer to the same in tabulated form as under:-
Hb TLC CRP 21/5 10.6 7.2 22/5 11.1 7.9 25/5 10.8 4.7 4/9 10.8 6.5 60.2 5/9 10.7 5.8 42.2 6/9 11.0 5.2 22.8 7/9 11.1 6.7 15.8 12/9 10.8 6.0 30.2 21/10 10.3 6.4 23/10 11.1 7.3 26/10 19.3 27/10 21.3
The culture was showing negative infection. As per medical literature i.e. "Prosthetic Joint Infections" published in Clinical Microbiology Reviews in 2014, it was not unusual as in 5 to 34% of knee infections, the causative organism cannot be identified primarily due to inherent slow growing nature of the organisms.
38. Not only this opposite party No.4 has taken all precautions with regard to infection in the right knee of the complainant. He consulted Dr. Atul Joshi-opposite party No.5 and also referred the complainant to Dr. Ramesh K. Sen of PGIMER, Chandigarh, who is a known Consumer Complaint No.65 of 2013 37 Orthopaedic Surgeon. He found that the protocol followed by opposite party No.4 is the standard protocol with regard to the knee infection. When the infection was suspected to be deep inside the knee joint thereafter debridement was done and appropriate measures were taken. Various types of pathology tests including microbiology tests were conducted. The Orthopaedic Surgeon in the case of infection has to rely upon the findings recorded by the pathological laboratory of the concerned Hospital. The right knee debridement was done on 19.10.2011 and the complainant was discharged on 28.10.2011. Reference can be made to the operation notes Ex.OP-1/8. As per the standard protocol spacers were inserted and the patient was advised rest. However, immediately after sometime the complainant approached Sir Ganga Ram Hospital, New Delhi on 20.12.2011 where debridement was done and the complainant underwent Stage-II revision in April 2012. A perusal of medical record reveals that the line of treatment in Sir Ganga Ram Hospital, New Delhi was the same, which was at opposite parties Nos.1 to 3-Hospital. A perusal of medical literature i.e. "Prosthetic Joint Infection" by Mayo Clinic, Rochester, Minnesota, USA reveals that infection can spread from the adjacent soft tissues so has happened in the present case. Dressings were done. I&D procedure was performed. Antibiotic spectrum of treatment was given.
39. The contention of the learned counsel for the complainant is that Candida Albicans could have been detected in routine manner Consumer Complaint No.65 of 2013 38 as it was on the very first day detected at Sir Ganga Ram Hospital, New Delhi. The same could not be diagnosed by the opposite parties. It needs to be mentioned that the Surgeons i.e. opposite parties Nos.4 and 5 cannot be held liable for the same. Ultimately they have to rely upon the pathological lab. tests reports, which were carried out and found to be negative. The tests had not pointed out existence of any fungal infection caused by the organism candida albicans, which is generally relied upon by the Surgeons. Candida is microbiologically very easy to detect on routine bacteriological cultures and does not require any special fungal media for cultivation. Candida is detected on routine culture is supported by Mandell, Douglas and Bennett's "Principles and Practice of Infectious Diseases" 7th Edition in which it has been stated as under:-
"They (Candida organisms) grow well in vented routine blood culture bottles and on agar plates and do not require special fungal media for cultivation."
At Fortis Hospital routine cultures were got done eight times and all the reports were negative, which are reproduced hereunder:-
Date Gram Stain Culture
29/8 30-50 PMN Sterile-48 hours
No organism
5/9 No PMN Sterile-48 hours
(Swab) No organism
5/9 8-10 PMN Sterile-48 hours
Synoial fluid 50-100 RBC
(sample taken on 3/9) No Organism
5/9 5-7 PMN Sterile-48 hours
Soft tissue 0-1 Epithal All
(sample taken on 3/9) No organism
Consumer Complaint No.65 of 2013 39
22/9 No PMN/No organism Sterile-48 hours
Swab-wound
3/10 0-1 PMN Sterile-48 hours
No Organism
20/10 No PMN Sterile-48 hours
Synoial fluid No organism
13/11 wound swab No PMN Sterile-48 hours
No organism
A perusal of the above reproduced culture reports reveals that steroid grain stain also did not find out presence of any organism.
40. The matter was referred to the PGI, Chandigarh for constituting a Medical Board and the Medical Board so constituted by the PGI in its report Ex.OP-1/11 reported as under:-
"Patient Urmil Chopra appeared before the medical board at 3 pm on 28.7.2014. After examining the patient and the record submitted by both the parties, the board is of the opinion that there is no gross negligence on the part of the treating surgeon as repeated bacterial cultures were done by the surgeon as per standard protocol. Debridement and re-culture was also done. It may be noted that fungal cultures are not a routine procedure in Total knee replacement and it is very difficult to suggest that the fungal infection which was diagnosed at Delhi occurred during the first surgery or afterwards." Consumer Complaint No.65 of 2013 40
Government Medical College and Hospital, Sector 32, Chandigarh also revisited the entire treatment record and the case file and reported as under:-
"The most common pathogens responsible for infection in TKR are gran positive cocci & gram- negative bacilli for which culture should be sent during debridement. Routine use of cultures for atypical bacilli & fungi are not recommended in every case."
The aforesaid expert opinions by two Government institutions also show that the treatment rendered to the complainant was in line with standard practice and there was no deviation from a known practice. No Orthopaedic Surgeon in India had seen a case of true fungal knee implant infection till 2013. The first case of fungal knee implant infection was published by Dr. K.J. Reddy in 2013 (Reference No.6- Fungal Prosthetic Joint Infection after Total Knee Arthroplasty). Thus, the case of the complainant was not a case of true fungal infection but it was a case where commensal had colonized the wound. Thus, both the reports of the abovesaid Hospitals, which are based on medical record of the case reveal that there is no fault on the part of the treating Doctor i.e. opposite party No.4, who had performed the bilateral TKR in both the knees of the complainant and thereafter gave post surgery treatment to her. Even there is no allegation against opposite party No.5 because he was called only as a Consultant; being a General Surgeon. Otherwise no medical Consumer Complaint No.65 of 2013 41 negligence has been alleged against him. Therefore, it is held that there is no medical negligence or deficiency in service on the part of opposite parties Nos.4 and 5 in performing the bilateral TKR of both the knees of the complainant and in providing the subsequent treatment to her.
41. In his cross-examination Dr. Harsimran Singh-opposite party No.4 has categorically stated that the infection has not been detected in the microbiological laboratory tests of the complainant. Even the candida albicans was not prevalent in India and it was for the first time reported in the year 2013 by Dr. K.J. Reddy. Prior to that, it was not noticed as it is not common organism. Further it is the own case of the complainant that she complained of redness in August 2011 after about 85 days of the performance of the surgery of bilateral TKR meaning thereby that the infection was not in existence when the complainant was discharged from opposite parties Nos.1 to 3-Hospital and it appeared after about three months. The possibility of infection having been acquired from other sources cannot be ruled out. Hence the Doctors-opposite parties Nos.4 and 5 cannot be held medically negligent in the treatment and the protocol used for the bilateral TKR of both the knees and the subsequent treatment given for infection in the right knee of the complainant. In this manner, the complainant appeared to have failed to point out that opposite parties Nos.4 and 5 failed to perform their duties, which were expected from them.
Consumer Complaint No.65 of 2013 42
42. Now, the question which remains to be answered, whether opposite parties Nos.1 to 3-Hospital and other staff exercised reasonable skill and care. In other words, whether the medical staff of opposite parties Nos.1 to 3-Hospital i.e. the Pathological Laboratory Investigation Department is concerned, it followed the standard protocol or it fell below the standard protocol? It is admitted that some tests were carried out with regard to gram stain and other tests. The complainant came in August 2011 complaining redness and subsequent infection for draining of which I&D procedure was carried out, though it was stated by the complainant as surgeries in the complaint. In fact, the same were minor operations for draining out and cannot be treated as complete surgeries. Be that as it may the fact remains that pathological laboratory of opposite parties Nos.1 to 3-Hospital certainly failed to find it out that the infection was caused by which organism i.e. Candida Albicans and the same was immediately found at Sri Ganga Ram Hospital, New Delhi, as is mentioned in Investigation Summary, placed on the record as Mark-A. ESR and P.T. tests were carried out but the results were anti yeast sensitivity (tissues). The tests were carried out in opposite parties Nos.1 to 3-Hospital, which resulted into not identifying the Candida Albicans. This clearly shows that there was some negligence on the part of the Pathological Laboratory of opposite parties Nos.1 to 3-Hospital, which could not find out infection in the tests conducted by it. Either the Staff was not well qualified to identify such organism or there Consumer Complaint No.65 of 2013 43 was no upto date equipment with it to identify such infection. At least the complainant remained under treatment of infection in her right knee in opposite parties Nos.1 to 3-Hospital from 13.8.2011 to 19.12.2011 i.e. for almost about four months and she had to spend for the repeat surgery; resultant TKR and for the treatment of the said infection. The conduct of the Doctors and other para medical staff of Pathological Department of opposite parties Nos.1 to 3- Hospital clearly shows that appropriate degree of professional skill, which may be the indicative of reasonable skill and degree, was not applied in this case so far as microbiological and other laboratory tests are concerned and this is not expected from a reputed hospital, like opposite parties Nos.1 to 3-Hospital. Opposite parties Nos.1 to 3-Hospital certainly fell below the standard of a reasonably competent staff in the concerned field in the said hospital. Principle of res-ipsa-loquitur (things speak itself) is sufficient to describe the proof of the fact, which is sufficient to support an inference that opposite parties Nos.1 to 3-Hospital were negligent, thereby establishing a prima facie case against them of the negligence. Hence it is held that there is medical negligence on the part of the laboratory staff of opposite parties Nos.1 to 3-Hospital particularly the pathological laboratory staff. It is, now, well settled that Hospital is vicariously liable for the medical negligence and deficiency in service on the part of all its Doctors, Nurses, Para-Medical Staff, Laboratories etc. Consumer Complaint No.65 of 2013 44
43. Medical negligence cases do sometimes involve questions of factual complexity and difficulty and may require the evaluation of technical and conflicting evidence. In the present case the complainant has been able to discharge the onus of proving on a balance of probabilities, the negligence averred against opposite parties Nos.1 to 3-Hospital. The complainant has been able to prove as discussed in foregoing paras that her case had not been handled diligently and cautiously in identifying the infection in opposite parties Nos.1 to 3-Hospital for about four months.
44. Thus, keeping in view the evidence on record, preponderance of probability and inferences, we hold that the complainant has been able to prove her case of medical negligence against opposite parties Nos.1 to 3-Hospital. In the present case, complainant has been able to discharge the onus of proving on a balance of probabilities, the medical negligence averred against opposite parties Nos.1 to 3-Hospital. We are of the view that certainly there was medical negligence on the part of opposite parties Nos.1 to 3- Hospital in giving post operation treatment to the complainant and in not identifying the infection during the various tests conducted by their Pathological Laboratory; as a result of which the complainant remained bed ridden during all that period and suffered acute pain, mental agony and trauma besides financial loss on the treatment of the said infection in opposite parties Nos.1 to 3-Hospital as well as in Sir Ganga Ram Hospital, New Delhi.
Consumer Complaint No.65 of 2013 45Quantum of Compensation:
45. It is extremely difficult to decide on the quantum of compensation in the medical negligence cases, as the quantum is highly subjective in nature. Different methods are applied to determine compensation.
46. Hon'ble National Commission in Dr. (Mrs.) Indu Sharma v. Indraprastha Apollo Hospital & Others Consumer Case No.104 of 2002, decided on 22.04.2015, observed in Paras No.53, 59 & 60 as follows:
53. A decision in the case of Spring Meadows Hospital & Anr.
v. Harjol Ahluwalia through K.S. Ahluwalia & Anr reported in (1998) 4 SCC 39. Their Lordships observed as follows:
" Very often in a claim for compensation arising out of medical negligence a plea is taken that it is a case of bona fide mistake which under certain circumstances may be excusable, but a mistake which would tantamount to negligence cannot be pardoned. In the former case a court can accept that ordinary human fallibility precludes the liability while in the latter the conduct of the defendant is considered to have gone beyond the bounds of what is expected of the skill of a reasonably competent doctor."
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59. Nizam Institute Case- 2009 Indlaw SC 1047:
In the Nizam Institute case 13, the Supreme Court did not apply the multiplier method. In 1990, twenty-year old Prasant S. Dhananka, a student of engineering, was operated upon at the Nizam Institute of Medical Sciences, Hyderabad. Due to medical negligence of the hospital, Prasant was completely paralysed. Compensation was claimed, and the matter finally reached the Supreme Court. The court did not apply the multiplier method and awarded a compensation of Rs. 1 crore plus interest. The court observed:
"Mr. Tandale, the learned counsel for the respondent has, further, submitted that the proper method for determining compensation would be the multiplier method. We find absolutely no merit in this plea. The kind of damage that the complainant has suffered, the expenditure that he has incurred and is likely to incur in the future and the possibility that his rise in his chosen field would now be restricted, are matters which cannot be taken care of under the multiplier method.
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60. Kunal Saha's Case (2014) 1 SCC 384 :
The Supreme Court rejected the multiplier method in this case and provided an illustration to show how useless the method can be for medical negligence cases. Hon'ble Justice Mr.V.Gopala Gowda opined that;:
"The multiplier method was provided for convenience and speedy disposal of no fault motor accident cases. Therefore, obviously, a "no fault" motor vehicle accident should not be compared with the case of death from medical negligence under any condition. The aforesaid approach in adopting the multiplier method to determine the just compensation would be damaging for society for the reason that the rules for using the multiplier method to the notional income of only Rs.15,000/- per year would be taken as a multiplicand. In case, the victim has no income then a multiplier of 18 is the highest multiplier used under the provision of Ss. 163 A of the Motor Vehicles Act read with the Second Schedule.... Therefore, if a child, housewife or other non-working person fall victim to reckless medical treatment by wayward doctors, the maximum pecuniary damages that the unfortunate victim may collect would be only Rs.1.8 lakh. It is stated in view of the aforesaid reasons that in today's India, Hospitals, Nursing Homes and doctors make lakhs and crores of rupees on a regular basis. Under such scenario, allowing the multiplier method to be used to determine compensation in medical negligence cases would not have any deterrent effect on them for their medical negligence but in contrast, this would encourage more incidents of medical negligence in India bringing even greater danger for the society at large."
47. Admittedly after the Bilateral TKR of both the knees of the complainant on 20.5.2011 she was kept under observation for one week and was discharged on 26.5.2011. The complainant continued regular follow-ups with the opposite parties. In the month of August 2011 redness was seen on the right knee of the complainant and there was acute pain in the same. The complainant consulted opposite parties Nos.4 and 5, who after examination observed that there was abscess/pus formation in the right knee, which was removed three times. However, even after the removal of Consumer Complaint No.65 of 2013 47 abscess/puss thrice from the right knee, it still continued to form and there was a lot of swelling in it. Ultimately, the complainant was admitted in opposite parties Nos.1 to 3-Hospital on 2.9.2011, where she was operated on 3.9.2011 and during that operation abscess/pus was flushed out from the right knee of the complainant. She was discharged on 8.9.2011. An amount of `81,017/- was charged by the opposite parties from the complainant and an additional amount of `12,870/- was spent by her on medicines. Thereafter the complainant was again admitted in opposite parties Nos.1 to 3-Hospital on 19.10.2011, where she was operated on 20.10.2011 and the artificial knee was removed after five months of the first operation. She remained admitted for about 8-9 days and was discharged on 28.10.2011. The complainant was again charged a sum of `1,78,818/- by the opposite parties and she also spent a sum of `1,10,752/- towards various medicines and tests. However, the infection had still not healed and continued to spread in the right knee even after removal of the artificial knee. On 20.12.2011 i.e. after about 7 months of the first operation, the complainant got admitted in Sir Ganga Ram Hospital, New Delhi, where surgery was performed on 21.12.2011 and she was discharged on 30.12.2011. The complainant spent an amount of `2,15,775/- for that operation in Sir Ganga Ram Hospital, New Delhi and additional amount of `2,37,428/- on the follow up treatment and medicines. On 24.4.2012 the complainant was admitted in Sir Ganga Ram Hospital, New Delhi for final surgery whereby the right knee was again transplanted and Consumer Complaint No.65 of 2013 48 after that operation the complainant's one year ordeal came to an end. The complainant had to spend another amount of `4,75,635/- and additional amount of `19,200/- on medicines and follow up. As such, the complainant had spent total amount of `13,31,495/- on the treatment of infection in her right knee in opposite parties Nos.1 to 3-Hospital as well as in Sir Ganga Ram Hospital, New Delhi regarding which various bills have been placed on record by her as Ex.C/2 to Ex.C/15, Ex.C/17 to Ex.C/78, Ex.C/80, Ex.C/82 and Ex.C/83. Hence the complainant is held entitled to the reimbursement of `13,31,495/- spent by her on the treatment of infection of her right knee. Besides this, she is also entitled to compensation for acute pain, mental tension, trauma and the continuous ordeal for almost one year. In the peculiar facts and circumstances of this case we assess the same to the tune of `3,00,000/-.
48. In view of our above discussion, this complaint is partly allowed against opposite parties Nos.1 to 3-Hospital and is dismissed against opposite parties Nos.4 and 5-Doctors. The following directions are issued to opposite parties Nos.1 to 3- Hospital:-
i) to pay `13,31,495/- (Rupees Thirteen Lakh Thirty One Thousand Four Hundred and Ninety Five only) for the expenses incurred by the complainant on the treatment of infection on her right knee;Consumer Complaint No.65 of 2013 49
ii) to pay `3,00,000/- (Rupees Three Lakh only), as compensation, for acute pain, mental tension, trauma and the continuous ordeal for almost one year; and
iii) to pay `30,000/- (rupees Thirty Thousands only) towards litigation costs.
49. The compliance of this order shall be made by opposite party Nos.1 to 3-Hospital within a period of two months from the date of receipt of certified copy thereof, failing which the amount of compensation of `3,00,000/- shall be payable with interest at the rate of 9% per annum from today till the date of actual payment.
50. The complaint could not be decided within the statutory period due to heavy pendency of court cases and due to the fact that the matter remained with the Hon'ble National Commission in First Appeal No.409 of 2017 (URMIL CHOPRA v. FORTIS HEALTHCARE (INDIA) LIMITED) from 2017 to 7th of February 2018, vide which cross-examination of witness has been allowed.
(JUSTICE PARAMJEET SINGH DHALIWAL) PRESIDENT (RAJINDER KUMAR GOYAL) MEMBER October 25, 2018 Bansal Consumer Complaint No.65 of 2013 50