Per Hon’ble Shri Narendra Kawde, Member

Introduction :-

[1]     Consumer complaint is filed in the year1998 which was placed on board for hearing and disposal from Sine-die list.  Since the old record was not in good condition, both the parties have reconstructed the record with consent.         

Case of the complainants :-

[2]     Under the medical advice of the opponent no.2 and 3 i.e. Dr.K.T.Dholakia and Dr.Saanjay Agarwala, the complainant underwent left knee joint replacement in the operation theatre of the opponent no.1-P.D.Hinduja National Hospital And Medical Research Centre on 29/03/1996 as the complainant was suffering due to Rheumatoid Arthritis.  Opponent no.2 then being reputed name in the branch of knee replacement and with assurance that adequate follow-up will be personally carried out by the opponent no.2, the complainant was convinced to undergo for such knee replacement.  However, to the dismay of the complainant, opponent no.2 never turned up during the post-operative period, though complainant continuously suffered joint pain followed with puss formation and at one such occasion, though complainant became totally immobile.  One Dr.Chakravarthy claiming to be assistant of the opponent no.2 i.e.Dr.Dholakia visited the complainant who removed plaster from the knee joint on 06/04/1996 and cleaned the wound and dressing was done.  Simultaneously, x-ray was taken out.  On constant complaints of pains in the knee joint, the complainant was prescribed certain medicines including pain-killers.  Physiotherapy exercise also was suggested.  Pain in the operated area, though having taken pain killer and the antibiotics never subsided.  Pain continued to be there and at the time of removal of plaster on 06/04/1996 who Dr.Chakravarthy and other team suggested that the severe pain complaint would gradually subside and there was nothing to worry about it.  Complainant was never comfortable during entire hospitalization period effective from 27/03/1996 and more particularly post-operative period effective from 29/03/1996 till discharge on 06/04/1996.

[3]     Dr.Chakravarthy on 10/04/1996 dressed wound as there was [serosanguineous] fluid discharge and took swab for sending it to the culture.  The wound was opened to facilitate drainage.  However, oozing never stopped.  The report of wound swab culture showed that there was “Staph Aureus Bacteria”.  Oozing of fluid never stopped.  Therefore, it was decided by the opponent no.2 to lavage the wound on 12/04/1996 and the complainant was kept NBM [nothing by mouth].  Lavage was carried out in the operation theatre on 12/04/1996 under general anaesthesia by Dr.Chakravarthy under the supervision of opponent no.2.  Antibotic injection Vancomycin was administered after the lavage to prevent further oozing.  However, oozing did not stop.  Complainant was having varying temperature between 98.5^oF and 100^oF.  Opponents were unable to attribute any reason for persistent fever.  WBC count had gone up due to prevailing infection.  Again on 15/04/1996, wound swab was sent for culture and sensitivity test.  Report of the said wound swab culture still showed growth of Staph Aureus Bacteria and therefore, opponent no.3 changed the medicine and put the complainant on Cap.Klox 500 mg and Cap. Omizac.  Additionally, Tab.Survector was prescribed by the opponent no.3 so as to contain nervousness of the complainant as probable cause for the mild fever.  In spite of efforts and change of medicine from time to time, the complainant could not get any relief whatsoever and the mild fever was persistent.  On second occasion, the wound lavage was carried under General Anaesthesia on 19/04/1996 and wound was sutured and swab was sent for culture and sensitivity.  Since there was no relief, complainant was advised to stop exercise of left leg and was put on heavy dosage of antibiotics.  On 23/04/1996, drain tip was sent for culture and the report showed that there was no bacterial growth.  Opponent no.2 i.e. Dr.Dholakia, who carried out the operation, never attended the complainant in person after post-operative period in spite of complainant’s frantic efforts.  Complainant was finally discharged on 25/04/1996. 

[4]     Again on 03/05/1996, sutures on lavage portion were removed by the opponent no.3.  Complainant incurred total expenditure of Rs.2,12,589/- and Rs.4,200/- during entire hospitalization period.  On advice of the opponent no.3, complainant herself got admitted on 07/06/1996 in the hospital of opponent no.1 on second time for treating infection.  Pre-operative investigations, as suggested, were carried out as per the directions of the team of the doctors.  Even after operation, on second time on 09/06/1996, complainant could not get relief and continued to be febrile (i.e.with fever).  In spite of medication and other treatment, temperature escalated and opponent failed to explain the cause.  Mild fever continued till discharge on 19/06/1996.  Opponent no.3 opined possibility of rejection of prosthesis by complainant’s body and if such possibility occurred, fusion of the knee joint was the only alternative.  Complainant spent Rs.48,297/- at the time of second operation.

[5]     Finally on 20/06/1996, the complainant succeeded to have an appointment with opponent no.2 for 1^st time after the sutures were removed on 03/05/1996.  On examining complainant, opponent no.2 told that the ‘Staph Aureus bacteria’ had not been totally eradicated and therefore changed and prescribed the medicines to Ceftum – 1gm/day and Pelox 800 mg/day for two weeks.  On examining, fresh x-ray and ESR level, opponent no.2 advised to stop all drugs previously prescribed and prescribed application of the Rubinsol ointment for the pain.  Opponent no.2 expressed that he had performed hundreds of total replacement of knee joint operations and nothing can or has gone wrong.  Even after change of prescription, there was unbearable joint pain coupled with redness and warmth, the complainant was unable to walk.  Complainant and her husband therefore went to Dr.A.Mullaji for second opinion who diagnosed “possible loosening of the joint” and asked the complainant to take fresh x-rays.  Said x-rays revealed distinct black line at the cement and bone contact area [loosening].  Thereupon, complainant consulted Dr.Sanjiv N. Amin, a qualified Rheumatologist who examined the complainant and observed that there was warmth, effusion and 20 degree flexion deformity.  In this situation, complainant was unable to bear weight on the left knee without the support of splint. Dr.Amin diagnosed that there was rampant active infection of the knee.  Dr.Amin advised revision surgery to be performed in USA. It was also advised by Dr.Amin that there was not chance of successful revision surgery in India considering the extent of rampant infection in the knee.  Dr.Amin facilitated revision surgery of knee in the USA carried out by Dr.Chitranjan S. Ranawat of Lenox Hill Hospital, New York. 

[6]     In the USA at Lenox Hill Hospital, Dr.Ranawat examined the complainant and studied all the previous repors, x-rays and case papers vindicated varus alignment [i.e. abnormal angulation of the knee joint with the angle pointing away from the midline] grossly of about 15 degrees.  He also suggested serological sepsis [bacterial invasion].  Sensitive test was carried out of the bacteria to antibiotics to prevent infection by discontinuing use of antibiotics for a week.  Culture and sensitivity report carried out in Dr.Ranawant’s hosipital showed sparse amoutof methicillin resistant “Staph Aurous” infection which was detected earlier in the hospital of opponent no.1 in the culture report of 10/04/1996.  Dr.Ranawat carried first stage i.e. revision of left total knee arthoplasty involving removal of components inserted by the opponents during surgery carried on 29/03/1996. Thereafter, Dr.Ranawat carried out second stage surgery for reimplantation of left knee arthoplasty after completing an antibiotics regimen of 6 weeks.  During the surgery under epidural anaesthesia, the knee joint was opened and the wound swab was taken and sent for culture and sentitivity.    It was found that large quantity of serosanguineous discharge from the knee.  Extensive synovectomy was performed.  With these two stage successful revision surgery in USA and thereafter complainant got complete relief. 

[7]     Complainant alleges deficiency in service against the opponents on the following counts:-

1. It is alleged by the complainant that service to be rendered by a surgeon not only mean to perform the operation but also treat the patient post-operative.  Opponent no.2 i.e. Dr.Dholakia rendered deficient service as in spite of frantic efforts, he could not attend the patient during post-operative period. 
2. Second allegation is that the Staph Aureous bacteria in the wounds entered in the operation theatre itself either through surgical equipment used in the operation or cement which used for cementing artificial knee joint to the bone or failure to provide sterile environment for the operation by ensuring sterile operation theatre.  Growth of Staph Aureous bacteria developed which was confirmed in test report carried at Lenox Hospital, USA.
3. Third allegation pertains to varus alignment [not in order] grossly of about 15 degrees and settling of the posterotibial femoral component into varus alignment and loss of bone attributed to gross negligence of opponent nos.1, 2 and 3.
4. Fourth allegation pertains to failed lavage of wound on two occasions within a span of two weeks as infection was not totally eradicated due to lack of care and precaution by the opponent nos.2 and 3. 
5. Fifth allegation against the opponent nos.2 and 3 again pertains to failed lavage as entire fluid was not aspirated and as a result infection persisted and Staph Aureous bacteria continued to grow.  Opponent no.2 and 3 were negligent in performing the wound lavage.
6. Sixth allegation levelled against the opponent nos.2 and 3 that they were negligent in performing in knee joint surgery properly as there was uneven gap in the knee joint. 

[8]     It is further averred that Opponent no.3 was full aware about puss formation at the operated site when for the first time plaster was removed on 06/04/1996. Bacteria Staph Aureous entered and developed into operated site during the operation on 29/03/1996.  Though it was within the knowledge of the opponent no.3, except administering heavy dosage of drugs, opponent no.3 did nothing to aspire fully the wound.  Finally, the complainant put up the case stating that had the opponent nos.2 and 3 were diligent in discharging their duties, infection would not have spread.  As a result, complainant would not have been subjected to painful conditions and forced revision surgeries step no.1 and 2.  The complainant was required to spend an amount of US$ 43,03.84 in the year 1997 equivalent to Rs.15,74,370/- at the then prevailing rate followed by other expenses of Rs.2,33,705/- putting together Rs.18,08,075/-. 

[9]     Complainant has filed this consumer complaint alleging deficiency in service against the opponent no.1 for not ensuring disinfection of operation theatre/hospital room occupied by the complainant which failed to control the growth of Staph Aureous bacteria since blood culture report established growth of said bacterial in the knee wound.  Against the opponent nos.2 and 3, it is for the lack of care, negligence and failed operation of knee joint followed by absence of proper treating of the infected wound by removing fully the puss formation [upto full aspiration].  Their failure compelled the complainant to undergo two stage revision surgery that too in USA.  Lastly, the complainants have claimed jointly and severally against the opponent nos. 1, 2 and 3, an amount of Rs.18,08,075/- as compensation together with costs of the complaint.

REPLY OF THE OPPONENTS IN BRIEF:-

          Opponents have filed written versions opposing contentions and claim of the complainant. 

Reply of the Opponent no.1:-

[10]    On behalf of the opponent no.1 i.e. P.D.Hinduja Hospital, Dr.Suganthi Iyer, Head of Department, Emergency Medicine has filed written version opposing present Consumer complaint stating that the opponent no.1 operates hospital services on non-profit basis and main object of the opponent no.1 is to render effective medical care and provide medical relief to all class of the people.  It is a reputed institute having tertiary care with post-graduate studies.  Opponent no.1. is having panel of eminent doctors of faculties of medicine.  Complicated issues raised in the consumer complaint ought not to be adjudged and decided under the provisions of Consumer Protection Act, 1986 as it involves complication question of the factual, expert, medical and legal issues.  The complainant without approaching patient relation department to resolve the problem knocked the door of the State Commission with pre-determined and pre-conceived notions.  Opponent no.1 has observed a very liberal open door policy in respect of work of the Patient Relation Department.  Consumer complaint is based on presumptions and conjectures without any cogent and valid documents or opinion.  No specific allegations of omission or commission on the part of the opponent no.1 while attending the patient are agitated.  Patient was admitted on her own choice in special class of the hospital.  Opponent no.2-Dr.Dholakia, who carried universal practice in more than one hospital for operating patients, has medical team known as ‘KTD Unit’ in each of the hospital used to attend the patient for post-operative management as opponent no.2 made it clear in no uncertain terms to the patient that after operation KTD Unit would take care of the patient.  Post-operative pain reported in operated area or left leg of the patient is falsified on perusal of nursing notes and other hospital record. 

[11]    Prior to surgical procedure, operation theatre and the surgical equipments used in the process of the operation or any of the implants or materials treating the patient were sterilized and non-contaminated.  Implants, cement and such other material used in surgical procedures are gama-sterilized before packing by the manufacturer.  All the said implants are open by the doctors only at the stage of surgical procedure [in the operation theatre just before operation].  Patient was operated and treated in operation theatre no.4 and she was the first patient to be treated for the day.  Operation Theatre no.4 is special orthopaedic theatre with ultra clean system fitted therein.  Effective ventilation control filtered air supply is in place.  Air is cleaned, modified in temperature and humidity and there is provision of dust free air.  There are 20-22 air changes within every 60 minutes as various air purification systems are installed on the said theatre.  Controlled temperature between 60-70^o F and humidity in the said theatre is maintained below 70%.  Importantly, bacterial action is induced by periodical use of U.V.Radiation in the operation theatre suite. Internationally, medically recognized medical protocol is followed to maintain good traffic control system in the operation room area. 

[12]    Opponent no.1 hospital has an Infection Control Committee headed by a senior, qualified and experienced Medical Consultant and at the relevant time Dr.F.P.Dastur, Head of Department (Medicine) was the Chairman of the I.C.C. who was assisted by around 15-20 members each of the whom was a senior, qualified and experienced person picked from various medical, administrative, nursing and support facilities/services.  Monthly meeting of I.C.C. takes place. I.C.C. also reviews and studies the area sampling reports/tests fortnightly in various areas/departments of the hospital including operation theatres, lobby, wards and other patient care areas.  I.C.C. has laid down certain protocols in respect of patient care practice with a view to minimizing transfer of infection agents which carries total hospital inspection scrupulously.  In addition, Head of Department, Anaesthelogy and Operation Theatre Nursing Superintendent are personally entrusted with the task of cleaning the operating room suite and ensuring that a sterile and aseptic environment is maintained.  All operating rooms are regularly cleaned. 

[13]    Internationally recognized protocol to ensure aseptic treatment is carried.  At the time of operation of the complainant operation theatre no.4 air sampling report were well within the normal limits.  Complainant must prove her allegations recording strict evidence.  Operation procedure was carried out on the patient without showing any sign of infection as the said patient responded positively to the treatment.  Finally, the opponent no.1 denied developing of bacterial infection in the hospital as alleged by the complainant and prayed for dismissal of the complaint.

Reply of the Opponent no.2:-

[14]    Opponent no.2-Dr.K.T.Dholakia, who carried out total knee joint replacement surgery, has filed his written version denying all the allegations levelled against him.  However, Dr.Dholakia expired on 17/06/2004 and application dated 14/07/2004 to that effect has been moved.  Said application was allowed and opponent no.2 was deleted as stated by all the parties to the consumer complaint.  However, order to delete opponent no.2 is not available in the complaint compilation.  It may be because the file has been reconstructed.  Since all parties agree to take it as true, complaint cannot be proceeded against the opponent no.2.  Therefore, consumer complaint abates as against the opponent no.2-Dr.Dholakia.

Reply of opponent no.3-Dr.Saanjay Agarwala [who assisted in carrying out the knee replacement operation in the team of the opponent no.2] :-

[15]    The opponent no.3-Dr.Saanjay Agarwala has averred that due to nature of medico-legal, case which is complicated, Hon’ble State Commission is not competent to adjudicate upon the same because such a complicated case is properly adjudicated in the Civil Court where precise and elaborate medical evidence can be adduced.  The complainant has approached this State Commission to file consumer complaint with pre-conceived and predetermined notions. Said complaint is based on presumptions and conjectures without any cogent and valid opinion on the record.  Complainant voluntarily co-opted and underwent various clinical examinations.  During the post-operative period, she was treated by other colleagues who were part of Dr.K.T.Dolakia Unit.  Each of the members of the Dr.K.T.Dolakia Unit is highly qualified, adequately trained, vastly experienced and equally competent for the task undertaken.  No abnormity was detected in the pre-operative investigations and since patient was physically fit was advised for knee joint replacement surgery on 29/03/1996 and it was the first case slotted for operation on the said day and date.  Operation was uneventful and successful.  Patient was monitored post-operatively.  There was no abnormity whatsoever as alleged.  There was no rise in temperature during 30/03/1996 to 06/04/1996.  No infection was noticed during medical investigations undertaken and various parameters monitored upto 06/04/1996.  On 10/04/1996, slight oozing was noticed from the wound and therefore, necessary investigations were ordered and carried out viz.culture sensitivity test etc.  Complainant was put on antibiotic Augmentin and Vancocin.  Lavage of the wound was carried out on 12/04/1996.  Necessary antibiotics i.e.Klox and Amikacin were prescribed after getting culture sensitivity report was availed.  Earlier antibiotics were discontinued.  Patient was responding the line of treatment.  On 19/04/1996, patient was taken for wound debridement and secondary suturing.  Appropriate sized drain tube was inserted in dependent position.  Wound lavage was sent for investigation.  Patient’s fluid drain from the drain tube was duly monitored.  The patient was responding well to the line of treatment and amount of fluid drained was greatly reduced and had become clear.  Therefore, on 23/04/1996, drain tube was removed and the drain tip was sent for C & S investigations.  Wound was good and healthy and there was no local discharge.  There was marked improvement and she had undertaken the prescribed graded physiotherapy regimen.  Patient was discharged on 25/04/1996 as found fit and necessary advice in respect of medical therapy and physiotherapy regimen was given.

[16]  On 03/05/1996, patient followed up for removal of secondary sutures.  At this point of time, late Dr.Dolkia-opponent no.2 examined the patient thoroughly and no abnormity was detected.  Late opponent no.2 observed that the wound had healed and that there was no soaking.  On certain complaint, opponent no.3 attended the patient on 07/06/1996 as the late opponent no.2 was out of station.  During the clinical examination of the complainant, it was noticed that the patient had complained of pain, swelling and redness on the operated site for two days and low grade fever for two days.   Therefore, it was decided to carry out a ‘Synovectomy’ which is an indoor procedure.  The patient was examined by Dr.V.R..Joshi and Dr.F.D.Dastur [members of the team].   On the same day, Synovectomy and lavage were successfully carried out and proper line of treatment commenced.  Patient was discharged on 19/06/1996 in good condition without any complaint.  Thereafter, the patient visited his private clinic on different occasions and was promptly attended.  Late Dr.K.T.Dolkia used to make it clear that the post-operative management of the patient would be taken care of.  However, late opponent no.2, by making such arrangement, did not give patient’s responsibility/stopped attending to the patients.  By this arrangement, day to day responsibility to attend the patient was taken by the opponent no.3 and he used to do the same in co-ordination and consultation with the late opponent no.2 in respect of patient’s operated by the opponent no.2.  Further, Dr.Saanjay Agarwala averred and denied that the patient’s pre-operative investigations/reports were absolutely normal and ideal.  Absence of cold and cough does not preclude a hidden underlying condition within the patient. 

[17]    During the first time hospitalization i.e. from 30/03/1996 to 06/04/1996, the patient was post-operatively given normal drugs.  The patient never complained of any pain. Patient was comfortable during this period as per the nursing record.  There is no complaint whatsoever, much less of constant pain during the said period.  Daily order sheet maintained by the hospital also reveals that the treatment was not altered and there was no complaint of constant pain as made out.  During the investigation reports, slightly elevated WBC count etc. was noticed.  Patient was connected with P.C.A.Pump (Epidurally). Immediate preventive measures were taken by putting the patient on necessary antibiotics, besides carrying out other medical procedures as indicated by the clinical setting of the patient then.  Looking at the setting of the condition of the operated site and clinical setting of the patient lavage of the operated site was carried out by the opponent no.2-Late Dr.K.T.Dholakia.  Report dated 12/04/1996 clearly shows that the discharge from the operated site (sample collected on 10/04/1996) had shown growth of S.A.Bacteria which was sensitive to Methicillin.  A smear was collected on 11/04/1996 and Culture Report of which was available on 13/04/1996 which continued to show that S.A. as sensitive to Methicillin and that the prescribed antibiotic was appropriate.  Smear Culture of the operated site was repeated on 15/04/1996, report of which was available on 17/04/1996.  Said report clearly shows that the Bacteria were ordinary staph aureous for which prescribed antibiotics was given. In view of constant monitoring of the patient, opponent no.3 denied the medical negligence leading to deficiency in service. 

EVIDENCE :-

[18]    Complainant has filed affidavit evidence supporting the contentions raised in the consumer complaint.  However, opponents failed to file affidavit evidence except filing expert opinion of Dr.Laud in support their contentions.  Both the parties relied on medical summary/report   recorded by Dr.Sajiv Amin, Rheumatologist and the hospital record.  We have appreciated all these material placed before us at the proper stage while dealing with the allegations of the complainant.

ARGUMENTS :-

[19]    Learned counsel Mr.Bimal Bhabda for the complainant argued that the complainant was operated upon for left knee joint after ascertaining the physical fitness by carrying out certain medical tests.  However, thereafter, the complainant did not get relief as the hospital record would show that the complainant was restless with fever and continuous pain in the knee joint.  Only after carrying out culture sensitive swab test on 12/04/1996, Staph Aureous Bacteria were found in the wound.  The bacteria were sensitive to Methicillin. Repeated culture tests continued to show development of Staph Aureous Bacteria and that the drug Methicillin was prescribed, yet the complainant did not get any relief from pain and fever.  Opponents went on changing medical prescriptions which resulted into drug resistance as medicine and injections administered did not provide relief from pain and the temperature.  Initially on detection of the Staph Aureous Bacteria in the laboratory test report first obtained, methicillin and injection Vancomycin was given, yet no relief. Next time, the test report showed continued existence of Staph Aureous Bacteria.  Opponents have changed the medicine by prescribing Cap.Klox 500 mg and Cap Omizac.  However, with administration of changed drug, no relief was in sight.  Thereafter, on discharge from the hospital, heavy dosage of “Klox 2 gms/day and Cifran, Bescosules, Autrin Tramazac - OS for pain, Vitamin C” were prescribed.  Medicines did not provide the relief.  On 03/05/1996, opponent no.2-late Dr.Dholakia on the basis of case papers advised to stop all the earlier medicines and instead prescribed “Ceftum 1 gm/day and Pelox 800 mg/day” for two weeks.  Late Opponent no.2 was unable to explain as to how occasional temperature continued in spite of changing drugs and medicines from time to time. 

[20]    Learned counsel further submitted that complainant has incurred expenditure of Rs.2,65,086/- for hospitalization period.  There is enough contradiction in the written versions of the opponent no.1 and opponent no.3 about ‘stable condition of the patient/complainant’ as the hospital record shows otherwise.  Though the patient was unstable with continuous pain and occasional fever of 99.6^oC and 100^oC as recorded in the hospital indoor case papers with complaint of pain, opponents have failed to control Staph Aureous Bacteria infection in the wound.  Defence of late opponent no.2 stating that the patient was comfortable during the period of hospitalization i.e. 30/03/19996 to 06/04/1996 is perfect contradiction to the notes in the indoor case papers wherein complaint of pain and occasional fever about 99.6^oC and 100^oC has been recorded.  Wound never dried up and the infection continued though the opponents defence is contrary.  Lavage was carried out, yet slight oozing from wound and temperature could not be controlled.  On expert advice of Dr.Amin, the complainant decided to proceed for revision surgery to be carried out in U.S.A. as such treatment was not perfectly available in India.  Two stages revision surgery was carried out in USA at Lenox Hill Hospital, New York by Dr.Chitranjan S. Ranawat.  First Stage consisted of revision of left total knee arthoplasty which was inserted by the opponents during the surgery on debridement and insertion of antibiotics impregnated cement spacer and subsequently Second Stage consisted of reimplantation of left total knee arthoplasty after completing an antibiotics regimen of 6 weeks.  Complainant was hospitalized in the Lenox Hill Hospital of spent an amount of US$ 4303 [equivalent to Rs.15,74,370/- then prevailing rate of Rs.36.6 per US$ 1] and air fare charges of Rs.2,33,705/-.  Thus, complainant was compelled to spend a total amount of Rs.18,08,075/-.

[21]    Learned counsel Mr.Bhabda for the complainant attributed alleged short-comings to the negligent attitude of the opponents particularly, Late opponent no.2 who failed to carry out total knee replacement surgery uneventfully as complainant had continued pain in joint with fever.  Opponents failed to aspirate the entire fluid as a result of which the infection persisted and there was growth of Staph Aureous Bacteria.  Learned counsel for the complainant relied on affidavit of evidence of the complainant.  Learned counsel for the complainant also tried to attribute Staph Aureous Bacteria disease to the hospital infection.  So far as the treatment part of the disease is concerned our attention was drawn to the text material - Arthroplasty of the Knee - Chapter 22 - Staphylococcal Aureus - “As drug resistance is so common among staphylococci, the appropriate antibiotic should be chosen based on antibiotic sensitivity tests.  Benzyl penicillin is the most effective antibiotic, if the strain is sensitive.  Methicillin was the first compound developed to combat resistance due to penicillinase (beta lactamase) production by staphylococci.  Due to the limitations in clinical use of methicillin, cloxacillins are used instead against penicillinase-producing strains.” Learned counsel heavily relied on medical history recorded by Dr.S.N.Amin, Rheumatologist in his letter dated 07/10/1996 address to Dr.Chitranjan Ranawat of Lenox Hill Hospital, New York, USA.  Dr.Amin has observed, after examining the patient/complainant, there was marked warmth,  effusion and 20 degree flexion deformity.  Complainant wwas unable to bear weight and active infection was noticed in the knee.  X-ray report revealed early loosening of the tibial prosthesis.  Owing to this physical condition, complainant was compelled to undergo the stage revision surgery in USA carried out by Dr.Ranawat. 

[22]    Learned counsel Mr.Yogesh Naidu for the opponents argued that Medical history of patient recorded by Dr.Amin shows that complainant was suffering from Rheumatoid Arthritis [hereinafter to be referred to as ‘RA’] since 1976.  Complainant was almost bedridden in 1979 and consulted a rheumatologist in 1980 who prescribed Aurothiomalate injections.”  Mr.Naidu brought to our notice from the text material [Indian Journal of Rheumatology 2011 March Vol.6, No.1] that “the patient with RA have an increased incidence of joint infections and respiratory infections per se. The incidence of infection in rheumatoid patient is higher than osteoarthiritis as RA patients have more avenues open for infection.  Several studies support the association of RA with increased risk of prosthetic joint infection.  The diagnosis of prosthetic joint infection following TKA in patients with RA is not always easy.  Joint effusion after TKA is considered as a manifestation of certain inflammatory reactions with prosthetic joints.  Niki et al investigated causes of joint effusion following TKAand analysed the phenotypic characteristics of synovial fluid leukocystes for each cause.” According to Mr.Naidu, increased risk of joint infection is higher in case of RA patient total knee replacement and complainant was no exception as she was known case of RA as reported by Dr.Amin.  Treating of wound and medication was as per standard international protocol.  Complainant vaguely alleges medical negligence to treat the patient without producing on record counter evidence.

[23]    Learned counsel further submitted that complainant failed to bring on record expert evidence to demonstrate that Staph Aureous Bacteria growth is attributed to hospital infection.  As the expert evidence of Dr.N.S.Laud on behalf of the opponents clearly indicates ‘Staph Aureous Bacteria infection usually occurs from inoculation of the wound during surgery or endogenous source from the patient’s own body.’  Opponents have already taken a defence by filing written version that there is a regular internal Hospital Infection Control Committee consisting of experts of various subjects as its Members.  The task of the said Committee is to ensure disinfection in the hospital and hospital area.  The implants, cement and such other material utilized in the surgical procedure are gama-sterilised and then packed by the manufacturer.  These implants are opened only at the penultimate stage of the surgical procedure.  The patient i.e. the complainant was treated in Operation Theatre No.4 was the first patient of the day.  The operation theatre was cleaned with ultra clean system fitted therein with effective ventilation system providing effective controlling filtered air supply.  There is no chance of humidity in said theatre.  Learned counsel Mr.Naidu admitted that there is no other expert evidence in support of the defence of the opponents.  However, according to him, the complainant failed to adduce documentary evidence u/s.13(4) of the Consumer Protection Act, 1986 to prove the allegations of medical negligence against the opponents, about standard protocol of treatment, surgical procedure in treating of wound and medication prescribed by the opponents.  It is unfortunate that the complainant was required to undergo revision surgery abroad for which the complainant failed to bring on record the consideration paid and expenditure incurred in USA.  In absence of late opponent no.2, the team headed under the name of ‘KTD’ consisted of Dr.Agarwal were in loop with the complainant for post-operative management.  In the medical science, the physician advising a patient to seek service of another physician is acceptable.  However, in case of emergency, a physician must treat a patient.  Late Dr.Dholakia was an eminent Orthopedic and appointed team of expert doctors named and styled as KTD Team.  The doctors consisted in the team were attending the complainant.  There is no emergency as such in case of the complainant to have been directed to attend by the late opponent no.2.  Even then, the complainant and her husband admittedly met late opponent no.2 and sought his advice.  Therefore, no medical negligence can be attributed leading deficiency in service.  Finally learned counsel Mr.Naidu prayed for dismissal of the consumer complaint as the complainant prima-facie failed to establish the case of medical negligence on the part of the opponents by leading documentary evidence.

CONCLUSION :-

[24]    We have perused the voluminous record with the help of learned counsels of both the parties.  It is admitted fact that the complainant underwent surgery for replacement of left knee joint on 29/03/1996 in the hospital of the opponent no.1 performed by Late Dr.K.T.Dholakia with the assistance of the opponent no.3-Dr.Saanjay Agarwala.  Admittedly, the complainant has spent an amount of Rs.2,65,086/-.  From the pleadings and documents on record, we proceed to deal with allegations raised in the complaint against the opponents.  Late Dr.Dholakia i.e. opponent no.2 examined the patient only once after operation.  The team of the late opponent no.2 consisting of opponent no.3 and others attended the patient as and when required while in hospital and thereafter. As per the medical ethics, the doctor is under obligation to take care of his patient and should endure to add to the comfort of the sick by making his visits at indicated hours to the patients.  However, late Dr.Dholakia made it clear that post-operative care would be taken by his team as he was busy professional attached to several hospitals.  As rightly pleaded by the learned counsel on behalf of the opponents that “physician advising a patient to seek services of another physician is acceptable, however in case of emergency a physician must treat the patient. No physician shall arbitrarily refuse treatment to a patient.” What we find from the hospital record is that the patient was well looked after by the opponent no.3 and the team constituted by the late opponent no.2.  Hospital record does not show medical emergency of the patient.  Therefore, opponent no.2 visit was not necessitated.  In view of this, the allegation tried to be made out of deficiency in service against the opponents on this ground is not sustainable.  [Allegation – Para 6(a)].

[25]    Opponents followed the standard protocol of treatment for healing of wound and to treat growth of Staph Aureous Bacteria which is evidence from the hospital record.  Complainant did not adduce evidence to counter and establish that the standard protocol was not followed by the opponents.  Obviously, it is the domain of the medical practitioners to exercise reasonable degree of skill and care with knowledge.  Therefore, it is not possible to hold that the opponents have not applied the degree of skill and care with their expertise.  At one point of time, the culture report carried out on 23/04/1996 showed no growth of Staph Aureous Bacteria.  Therefore, the allegation of failed lavage of wound and draining the entire fluid [total aspiration] cannot be established against the opponents.  [Allegation – Para no.6(d & e)].

[26]    Allegations of the complainant about growth of infection is also not sustainable to establish that the growth of Staph Aureous Bacteria was solely from the hospital source/hospital theatre or surgical equipments used in the operation in view of expert opinion of Dr.Laud available on record.  The opinion clearly indicates “Staph Aureous Bacteria usually occurs from inoculation of the wound during surgery or endogenous source from the patient’s own body.”  Complainant failed to adduce expert evidence or the authentic related material to establish that growth of Staph Aureous Bacteria solely acquired during surgery or operation theatre born.  Because as per the expert opinion led as evidence indicates this growth of Aureous to endogenous sources from the patient’s own body also.  Moreover, the measures for sterilization of the operation theatre and hospital and surgical equipments as narrated by the opponent no.1 for effective control of infection have not been countered by placing evidence to the contrary.  Therefore, the allegation of growth of Staph Aureous Bacteria attributing solely to the opponents is not tenable. [Allegation – Para No.6(b)].

[27]    In absence of authentic material and expert evidence to the contrary led by the complainant, it is impossible to hold that post-operative treatment [to treat wound] was wrong, the allegations of medical negligence on this count against the opponents are not sustainable. 

[28]    Now, we proceed to deal with allegation of negligence in performing the knee joint surgery and reported uneven gab in knee joints as in Para 6(c)&(f).  Two documents available on the record are very much important for our consideration to deal with this allegation.  First one Medical history/summary recorded by Dr.Sanjiv Amin, Rheumatologist on 07/10/1996 and forwarded to Dr.Chitranjan Ranawat of Lenox Hill Hospital, New York, USA.  Second one is the hospital record of clinical examination of the patient carried out on 08/06/1996 by the opponent no.3 available in the complaint compilation [at Page No.155].  Firstly, we deal with findings of the clinical examination.  Admittedly, Dr.Sanjay Agarwala i.e. opponent no.3 examined the patient on 08/06/1996 for complaint of infection post-operative knee joint wound.  It is recorded by the opponent no.3 as “Prosthetic components found loose”.  Patient was under the care of the opponents till July 1996 as the last visit to the opponent was on 29/07/1996.  It is constant case as put by the complainant that no relief from continued pain and occasional fever was even experienced during the post-operative period.  Since this is a hospital record/case paper, it cannot be denied by the opponent.  Complainant heavily relied on the opinion of the opponent no.3 about possibility of ‘rejection of prosthesis components’ by body of patient as a possible reason for not getting relief.  It was also reported and advised by the opponent no.3 that in such cases, fusion of the knee joint was the only alternative though later on denied by the opponent no.3 in his written version.  However, complainant has filed affidavit evidence reiterated the opinion of the opponent no.3 about loosening of prosthetic components.  Therefore, mere denial of the opponent no.3 is of no avail to the opponents.  There is no reason as to why the statement made in the complaint and supported by affidavit evidence needs to be ignored especially when it is supported by the documentary evidence, mainly recorded opinion of opponent no.3 in the hospital case papers.  There is no record to show that what steps have been taken by the opponents to address ‘loosening of prosthetic components’.  Opponents have failed to bring on record documentary evidence to show what corrective steps were taken after clinical observations.  Since the complainant did not get the relief, approached first time Dr.A.Mullaji for second opinion who diagnosed possible loosening of joint which was evidenced by carrying out fresh x-ray which revealed distinct black line at the cement and bone contract [loosening].  Opinion of Dr.Amin vindicated, clinical opinion of the opponent no.3 in this behalf who opined “Prosthetic components found loose”.  Thus, found no relief from continuous pain and the fluid oozing out of knee joint wound, complainant consulted Dr.Sanjiv Amin, a qualified Rheumatologist.

[29]    Now, we will deal with medical summary recorded by Dr.Sanjiv Amin, Rheumatologist brought on record by the complainant and relied upon by both the parties.  The learned counsel of the opponents heavily relied on this medical summary to relate that in case of patient with Rheumatoid Arthritis [RA] indicating total knee replacement, risk factor of infection is high.  Complainant/patient, as reported by Dr.Amin, suffered from Polyarthritis as early as in 1976.  Patient was put on treatment and administered immunosuppressive drugs as treatment of RA and on one occasion, the patient was bed-ridden in the year 1979.  Therefore, according to him the patient was prone to get infection which was treated by the opponents.  However, in the said report it is recorded that “x-ray of the left knee that was obtained last month revealed early loosening of tibial prosthesis…………” and “For past one week, the pain and swelling re-appeared and on examination, there is marked warmth, effusion and 20 degree flexion deformity.  She was unable to bear weight on the left knee without the support of splint……”.  The learned counsel of the opponent only partly relied upon this medical summary and conveniently ignored to refer other observations from the said summary.  This medical summary/record of the complainant has to be considered in toto.  The Lerned Counsel Mr.Naidu did not refer to recorded observation of Dr.Amin about effusion and 20 degree flexion deformity and loosening of the tibial prosthesis.  Early loosening of tibial prosthetic components has been suppressed as history recorded by Dr.Sanjiv Amin.  Here, at this point of time, Dr.Amin advised for revision surgery and referred the complainant/patient to Dr.Chitranjan Ranawat, Lenox Hill Hospital, New York, USA.  Complainant underwent two stages surgery at Lenox Hill Hospital.  First stage was for revision of left total knee arthoplasty for removal of components inserted by the opponents during surgery on 29/03/1996 carried out by opponents.  Second stage surgery was carried out by Dr.Ranawat for re-implantation of left knee arthoplasty.  There is enough material on record to demonstrate that the complainant left for USA, admitted in Lenox Hill Hospital and underwent two stages corrective surgery for which the complainant spent an amount  of US$ 43,03.84 in the year 1997 equivalent to Rs.15,74,370/- at the then prevailing rate followed by other expenses of Rs.2,33,705/- for to & fro travel.  These submissions are supported by affidavit evidence of the complainant.  Therefore, there is no reason to disbelieve the statements made on the affidavit, particularly in absence of any documentary evidence contrary brought on record by the opponents.  Interestingly, opponents have failed to file affidavit evidence.  Two stage revision surgery was necessitated as can be seen from record owing to loosening of tibial prosthetic components as recorded by the opponent no.3 during clinical examination of the patient on 08/06/1996.  For want of corrective measures by the opponents, the complainant left in painful post-operative conditions.  Failure of the opponents to attend the clinically diagnosed problem certainly attributes to the medical negligence leading to deficiency in service.  Though the opponents possess skill and knowledge of their subject, but failed to take corrective steps. 

[30]    Now, it is important and necessary to place on record as to what constitutes medical negligence.   A doctor owes certain duties.  Negligence on the part of a doctor is simply failure to exercise due care.  Negligence constitutes following three ingredients so far as the consumer case is concerned:-

1. Doctor owes duty to take care of the patient.
2. Doctor should not breach this duty of care.
3. Otherwise, complainant has to suffer injury due to this breach.

          Medical negligence is not different thing as the doctor is service provider to the patient. 

[31]    We find it appropriate to bring on record laws laid down by the Hon’ble Apex Court to deal with alleged medical negligence.  Hon’ble Supreme Court in celebrated case of – Bolam vs. Friern Hospital Management Committee – (1975) 2 All ELR 118 – observed that “negligence in law means this: some failure to do some act which a reasonable man in the circumstances would do, or the doing of some act which a reasonable man in the circumstances would not do; and if that failure or the doing of that act results in injury, then there is a cause of action.”  Further, it is observed that “A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.”  In yet another case of  – Laxman Balakrishna Joshi vs. Trimbak Bapu Godbole & ors.- AIR 1969 SC 128 – the Hon’ble Apex Court held that “A person who holds himself out ready to given medical advice 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 and competence judged in the light of the particular circumstances of each case is what the law requires.”  Admittedly, negligence is an essential ingredient of the offence.  Medical practitioner would be liable only when his conduct fell below that of the standards of a reasonably competent practitioner in his field.

          The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care.”  Standards laid down in the case of Bolam were reiterated by the Hon’ble Supreme Court in case of the - Jacob Mathew vs. State of Punjab and Anr. – (2005) 6 SCC 1, followed in the case of – V.Kishan Rao vs. Nikhil Super Speciality Hospital and Anr. – (2010) 5 SCC 513. 

Failure of opponents conforms with constituents of medical negligence, therefore, complainant is entitled to claim compensation.

 [32]   We are aware if the medical practitioner acts in accordance with the practice approved by responsible body of medical men skilled in that particular art, no question of deficiency in service arises. However, there is clear breach of legal duty which was required to be exercised by the opponents.  Failure has warranted complainant to undergo miseries and pains and submitted herself to revision surgery.  In the facts and circumstances of the case, the consumer complaint deserves to be allowed partly.  We hold accordingly and pass the following order.

Pronounced on

9^th December, 2014.