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Judgment
THIS appeal is against the order dated 30.12.2002 of the Puducherry State Consumer Disputes Redressal Commission, Puducherry (in short, ''the State Commission'') in consumer case no. 1 of 1999. By this order, the State Commission held the appellants/opposite parties (OPs) guilty of deficiency in service/medical negligence in conducting the cataract surgery of the right eye of the respondent/complainant, which led to complete loss of vision in that eye due to endophthalmitis. (ii) The State Commission based its findings mainly on the ground that the consent letter of the respondent/complainant/patient for undergoing the surgery had not been produced by the appellant/OP and instead the consent letter of an altogether different patient was included in the case record relating to the respondent/complainant. The State Commission treated this as an instance of mala fide intention on the part of the appellants/OPs. The State Commission also observed that even after specifically directing them to do so the OPs failed to produce the consent letter signed by the complainant. Further, the State Commission found that the case record did not show the time of commencement of the process of anaesthesia and the actual surgery, which was a material omission. Further, the case record appeared to have entries which were "fresh on some pages" whereas the other entries on other pages were not so. This, according to the State Commission, suggested insertion of entries in the case record after filing of the complaint. (iii) On these considerations, the State Commission finally awarded a compensation of Rs.5 lakh and cost of Rs.15,000/- to be paid jointly and severally by the OPs within sixty days of the date of the receipt of the order, failing which interest @ 12% per annum would also be payable from the date of expiry of sixty days till the date of actual payment.
THE respondent, who was the complainant before the State Commission, had suffered a blunt injury in his right eye some time in 1982. In June 1997 (when he was about 29 years), he went to Sankara Nethralaya, Chennai because he felt that the distance vision in his right eye had diminished. In a report dated 21.06.1997, a Doctor at the Nethralaya recorded his case summary as under: "On examination, his best corrected visual acuity was 3/60; N 36 in the right eye and 6/6; N6 in the left eye. Extraocular movements were full. Slit lamp examination of the anterior segment revealed iridodialysis in the inferior temporal quadrant. Through which the margin of the lens with intact zonules could be made out. There was no evidence of phacodonesis. Lens showed cataractous changes. Rest of the anterior segment was normal. Left eye was normal. Intraocular pressure by applanation tonometry was 16mm of Hg in both the eyes. Gonioscopy revealed angle recession between 9 to 12'' 0 clock and iridodialysis between 7 to 9'' 0 clock. Rest of the angle was opened. Fundus examination revealed healthy discus in both the eyes. Rest of the fundus was normal. The patient can undergo cataract surgery in the right eye, whenever he desires to be done at locally. In view of the angle recession, his intraocular pressure need to be checked periodically. Dr. A. V. Sathi Devi"
(i) Thereafter the comPlainant got admitted to JIPMER HosPital, Puducherry for cataract surgery which was conducted after several tests and check-uPs on 10.07.1997 by Dr. (Prof) Renuka Srinivasan. He alleged that when he was discharged from the JIPMER HosPital, he had no vision in his right eye and when he comPlained about this the Doctor at the HosPital Periodically checked him and ultimately issued a certificate dated 12.11.1997 stating that the comPlainant had develoPed endoPhthalmitis in his right eye after the cataract surgery after which his visual acuity in that right eye was ''PL Negative'' and the eye had shrunk and collaPsed (Phthisis). (ii) In between, on 09.08.1997, the comPlainant had gone again to Sankara Nethralaya where, after tests, the Doctors certified that he had suffered total atroPhy of the eye ball and comPlete detachment of retina because of which he had comPletely lost vision in the right eye. (iv) The comPlainant, therefore, alleged negligence on the Part of the HosPital and the Senior Resident in conducting the cataract surgery and as also Post-oPerative treatment. As a result, he not only comPletely lost his vision in the right eye but also suffered deformity of his face and whole aPPearance, Preventing him from engaging in social contacts with PeoPle. He Prayed for award of comPensation of Rs.15 lakh, refund of the charges that he Paid to the OP HosPital, reimbursement of medical exPenses amounting to Rs.10,000/- and Rs.15,000/- towards the cost of litigation.
IN their written version, the OPs claimed that all necessary pre-operative assessment was done after the complainant came to the Hospital as an outpatient on 04.07.1997. After detailed examination, he was diagnosed with traumatic iridodialysis (tear in the iris root), angle recession and damage to the anterior chamber of the right eye - all indicating severe blunt trauma of the eye -and traumatic cataract. He was admitted to the Hospital on 08.07.1997 and right eye cataract surgery was performed on 10.07.1997, after all aseptic precautions and obtaining his consent. The surgery was uneventful. On the first post-operative day (POD) - (11.07.1997) - the patient developed severe inflammation in the anterior chamber of the eye. Diagnosis of post-operative uveitis or endophthalmitis was made. The patient was immediately started with intravenous antibiotic injections, subconjunctival injection of gentamicin, fortified gentamicin eye drops and homatropine eye drops. However, as his condition did not improve with the treatment, intraocular injection of vancomycin and amikacin was given on 12.07.1997. Ultrasonography of the right eye was done on 16.07.1997 and it revealed vitreous exudates and partial retinal detachment, which were consistent with the diagnosis of post-operative endophthalmitis. Vitreous fluid was aspirated for culture. The culture showed presence of bacteria (coagulase negative staphylococci). In view of the unsatisfactory progress, the patient was given another intraocular antibiotic injection of Cefazolin on 19.07.1997. Vitreous aspirate thereafter was found to be sterile. Intravenous and topical eye drops were added and oral steroids were also started after one week to control inflammation. The infection was brought under control by 19.07.1997 and the patient was discharged on 23.07.1997 with the advice to continue the antibiotic and steroid eye drops and oral steroids. The patient was examined post-operatively as an out-patient on 24.07.1997, 25.07.1997, 01.08.1997, 13.08.10997 and 25.08.1997. However, the ultrasound done on the eye on 20.07.1997 showed a collapsed eye due to damage caused by infection. The patient was informed about the progress of his eye and a certificate of visual handicap was issued on 12.11.1997 at his request. They claimed that the patient developing endophthalmitis was not due to any negligence or mismanagement on the part of the OP Hospital and its staff. The OPs also claimed that the source of infection was of a wide variety. The patient was given best possible management for the complications, including the most potent antibiotics and advanced investigations, in accordance with international standards. Denying the allegation of deficiency in service/medical negligence the OPs prayed for dismissal of the complaint.
HOWEVER, the State Commission returned the finding of medical negligence/deficiency in service and awarded compensation, as already noted above.
WE have heard Mr. Rajat Gaur, learned counsel for the appellants/OPs and Mr. K.P. Sunder Rao, learned counsel for the respondent/complainant and considered the evidence and documents brought on record.
GIVEN the background of the case, this Commission made a reference to the Dr. Rajendra Prasad Centre for Ophthalmic Sciences (RPCOS), All India Institute of Medical Sciences (AIIMS), New Delhi to constitute a Medical Board to examine the medical records of the respondent/complainant and give its expert opinion whether there was any negligence on the part of the treating Doctors/appellant Institute before, during and after the cataract surgery in the right eye of the complainant. On receipt of the report of the Medical Board at the RPCOS, copies were made available to the learned counsel for the parties. Learned counsel for the respondent/complainant filed a copy of the opinion of one Dr. V.D. Karthigeyan, a private Ophthalmology Consultant at Chennai. A back reference was, therefore, made to the RPCOS seeking certain clarifications and requesting comments of the Medical Board on the opinion submitted by Dr. Karthigeyan. However, the RPCOS refused to do so. Therefore, a reference was made to the Director, L. V. Prasad Eye Institute, Hyderabad to constitute a three-member Board of Senior Doctors to give their opinion based on the medical record and taking into account the report of RPCOS as also that of Dr. Karthigeyan. On receipt, copies of the report dated 24.04.2010 of Director, L.V. Prasad Eye Institute (LVPEI), Hyderabad were made available to the learned counsel for the parties and they were asked to file their written submissions, which they did. Learned counsel for the respondent/complainant, however, submitted a second set of comments of Dr. Karthigeyan on the report of the LVPEI.
THE reports/opinions received from the RPCOS, Dr. V. D. Karthigeyan and LVPEI are reproduced below: (i) Report dated 24.10.2009 of Dr. Rajendra Prasad Centre for Ophthalmic Sciences: "Mr Varrery Srinivas (then resident of Pondicherry, currently at Muscat) presented at Sankara Nethralaya, Chennai on 17.07.1997 with a history of blunt injury in right eye 15 years ago (when hospitalised for a week) and decreased vision in the right eye. His best corrected visual acuity was then 3/60:N36 in the right eye and 6/6:N6 in the left eye. Extraocular movements were full. Slit Lamp examination of the anterior segment of right eye revealed iridodialysis inferotemporally, with no evidence of phacodonesis, but the lens showed cataractous changes. Rest of the anterior segment was normal, though Gonioscopy confirmed angle recession between 9 to 12 o''clock and iridodialysis between 7 to 9 o''clock through which the lens margin with intact zonules could be visualised. Right fundus was within normal limits. The unaffected left eye was essentially unremarkable. He was accordingly advised right eye cataract surgery ''whenever he desired to be done, at locally''. It is not clear from the records available as to why this patient shifted from Chennai to another major well-recognised institution at Pondicherry (and again later back to Sankara Nethralaya at Chennai). The patient was admitted to JIPMER, Pondicherry on 6th (or 8th) July 1997 where after duly confirming all the above findings and noting marked pigmentation of the right angle, extracapsular cataract extraction with PC IOL was done on 10.07.1997 after due preoperative and intraoperative precautions. In spite of these, the patient exhibited a severe postoperative reaction on day 1-2, which unfortunately is not an uncommon occurrence in such cases, either because of an acute inflammatory response of the eye, or, may be worse, a fulminant intraocular infection. (In such a situation it is considered safer to err on the side of the infection, and treat as such). On 11.07.1997 it was decided by the Professor-in-charge to treat the patient actively as endophthalmitis in view of severe uveitis and hypopyon. He was started on local antibiotics and steroids together with systemic intravenous antibiotics and subconjunctival gentamycin and steroids. On 12.07.1997, the visual acuity of the patient was PL positive but uncooperative for PR (noted later as inaccurate) with exudates present in anterior chamber - intracameral antibiotics were administered (Vancomycin + Amikacin) and Gram staining was noted to be negative in the aqueous tap taken - page 70 (not confirmatory of intraocular infection either way at this stage). Another note on page 5 (44) of the typed version of the Discharge Summary states: 13.07.1997- aqueous tap; coagulase negative staphylococci (coag. -ve always being of doubtful significance microbiologically, but in the circumstances should be and was given due importance and treated as such); 14.07.1997 - aqueous and vitreous tap sterile; 19.07.1997 - vitreous tap sterile. In the circumstances the surgical team in charge may have decided against the potential benefits of an intravitreal injection - it is at least not recorded as such. Subconjunctival antibiotics (as Cefazolin) were also continued for next few days but, most unfortunately, with no real benefit to the eye. All standard preoperative, peroperative and postoperative medical protocols seem to have been rigorously followed. The patient''s visual acuity right eye was PL? absent on 23.07.1997 when he was discharged (22.07 or 23.07.1997) on medication. (The patient was issued a visual handicap certificate of 30% with a diagnosis of Phthisis Bulbi Right Eye on 12.11.1997). The patient again presented at Sankara Nethralaya, Chennai in August 1997 (when examination revealed a soft eye with PL negative and diagnosis of endophthalmitis with phthisical changes made); and again visited Sankara Nethralaya in November 1999 for evaluation of deformed upper face on the right side when on examination, a diagnosis of contracted socket resulting from a phthisical eye was returned. In December 1999, patient underwent surgery in which the phthisical eye was removed and a 20 mm acrylic sphere wrapped in donor sclera was attached to the muscles, with acceptable cosmesis. In retrospect, it is well-nigh impossible at this stage from only the records available to opine further as to the actual cause of the violent postoperative reaction within day 1-2 in a significantly traumatized eye long before. The role of intraocular infection (endogenous/exogenous) could not be indubitably and absolutely evidenced, though it was very actively treated in JIPMER. In summary, it appears that the attending doctors followed standard medical protocols according to the patient''s conditions. However, most unfortunately, the patient had a grossly unfavourable outcome in spite of aggressive therapy instituted timely and duly monitored. As the records made available suggest, there is no evidence of any wilful negligence on the part of the doctors or any medical negligence, but a known complication in such a situation. Though we empathize with the usual expectations of the patient (as any other) about the excellent surgical outcome of the operation, such a complication is well documented in such procedures and should not amount to culpable negligence." Opinion dated 31.01.2010 of Dr. V. D. Karthigeyan, Ophthalmology Consultant, Chennai Mr. Srinivas, Post-endophthalmitis - From Pondicherry Preoperative factors overlooked: Blepharitis, Nasolacrimal duct infection, immunocompromised status, sepsis elsewhere in the body, Iris fluorescein angiography, ofloxacin eye drops 6 hourly for 3 days before doing his cataract surgery, systemic antibiotics for one day prior to his surgery, sterile draping, topical povidone iodine, preoperative topical antibiotics, antibiotic-containing irrigating solutions on the eye to be operated. Surgical risk factors: Clear corneal incision, did not use intraoperative heparin, prolonged intraocular surgery, intraocular lens with polypropylene haptics, silicon intra ocular lens, silk suture to close the incisional wound, vitreous loss, posterior capsular tear communicating with vitreous cavity, infected wound margins, wound gape, retained lens material, incarceration of the vitreous or the iris, vitreous manipulation, intraocular blood. During the surgery intracameral injection cefuroxime 1mg, subconjunctival injection vancomycin should have been given. Subconjunctival injection gentamicin would have caused macular infarction. Postoperatively within 24 hours: Deep pain in the eye, lid swelling, corneal edema, hypopyon, membrane over IOL, loss of red reflex, vitritis, corneal infiltration and opacification, fever with leukocytosis for all of which the following investigations should have done for Mr. Srinivasan: 1. Anterior chamber tap 0.1 ml aqueous 2. Vitreous biopsy 0.1 ml trans pars plana - both for microbial detection using Blood agar 25''c, thioglycollate broth 37''c, chocolate agar 37''c, sabrouds dextrose agar 25''c, anaerobic blood agar. Treatment: Intravitreal vancomycin 1 mg + ceftazidime 2.25 mg + dexamethazone 0.4 mg Subconjunctival vancomycin 25 mg + ceftazidime 100 mg + dexamethazone 24 mg Topical vancomycin 50 mg/ ml every one hourly + ceftazidime 50 mg/ ml every one hourly + prednisolone acetate 1% every one hourly + atropine 1% once a day Systemic Injection vancomycin 1g intravenously 12 hourly + Injection ceftazidime 2g intravenously 8 hourly + Injection prednisolone 60 mg once a day." Report dated 24.04.2010 of the L.V. Prasad Eye Institute: "Mr. Varrery Srinivas first presented at Sankara Nethralaya, Chennai on 17.06.1997 with a history of blunt trauma in the right eye 15 years ago (when hospitalised for a week) and decreased vision in the right eye. His best corrected visual acuity was 3/60; N36 in the right eye and 6/6; N6 in the left eye. Extraocular movements were full. Slit lamp examination of the anterior segment of the right eye revealed iridodialysis inferotemporally; lens showed cataractous changes; however, there was no evidence of phacodonesis. Rest of the anterior segment was normal. Gonioscopy of the eye showed angle recession between 9 to 12''o clock and iridodialysis between 7 to 9''o clock through which the lens margins with intact zonules could be visualised. Right fundus was within normal limits. The left eye was essentially within normal limits. He was accordingly advised right eye cataract surgery. The patient was again examined in Ophthalmology department of JIPMER, Puducherry on 06.07.1997. The examination of the right eye confirmed to all the above findings. He was advised extra capsular cataract extraction with posterior chamber intraocular lens implantation in the right eye. The preoperative work up comprised of detailed ocular examination, sac syringing, urine, sugar and complete systemic examination. The patient was admitted in the institute for the surgery, pre-operative preparation comprised of intravenous mannitol, mydriasis, non-steroidal anti-inflammatory agents and topical antibiotics. Although there is no information on pre-operative use of povidone iodine, the preparation was as per the "standard of care" and care was taken keeping in mind the nature of the case (traumatic cataract with extensive anterior segment injury). The surgery (extra capsular cataract extraction with posterior chamber intraocular lens implantation) was performed on 10.07.1997. As per the operating notes the surgery was uneventful. On the first post-operative day, the patient exhibited a severe post-operative reaction with lid edema, conjunctival congestion, corneal edema and anterior chamber reaction. The Professor-in-charge diagnosed it to be endophthalmitis in view of severe uveitis and hypopyon. Although it could be due to toxic anterior segment syndrome in such a situation it is considered safer to err on the side of the infection, and treat as such. The patient was started on local antibiotics and steroids, together with systemic intravenous, antibiotics and subconjunctival gentamycin and steroids. On 12.07.1997, the visual acuity of the patient was PL positive and inaccurate PR and exudates present in the anterior chamber. The surgeon decided to do intraocular antibiotics and same were administered (vancomycin + amikacin) on that day. The Gram staining was noted to be negative in the aqueous tap. It is not clear from the documents if the patient was given intraocular antibiotic only in the anterior chamber or in the vitreous cavity as well but as per the document on 14.07.1997 - aqueous and vitreous tap were sterile; 19.07.1997 - vitreous tap sterile. Subconjunctival antibiotics (as cephazolin) were also continued for next few days but, most unfortunately, with no real benefit to the eye. Over all it appears that the team managing the case followed all standard pre-operative, per-operative and post-operative protocols. It is unfortunate that the patient lost vision in the eye but there is no evidence of negligence or sub-standard care as per the documents. Such complications are very well documented in the ophthalmic literature and should not amount to culpable negligence."
OPINION dated Nil of Dr. V. D. Karthigeyan, Ophthalmology Consultant, Chennai in response to Report of L.V. Prasad Eye Institute: "Preoperative skin around the eye disinfection with 10% povidone iodine and conjunctival disinfection with 5% povidone iodine significantly reduced the relative risk of postoperative endophthalmitis. Povidone iodine 5% solution should be applied topically to the lids, lashes and conjunctiva with at least 3 minutes contact time preoperatively. Efficacy of Combined Preoperative Three-day application of topical antibiotics and povidone iodine irrigation is suggested to be the best, anterior segment intraocular surgery we determined that a three-day course of topical levofloxacin followed by preoperative povidone iodine irrigation caused a marked decrease in the number of conjunctival bacterial flora and resulted in no contamination of the anterior chamber aqueous fluid at the beginning and conclusion of surgery. Sterilizing the ocular surface studies dating back to the 1970s show that the preoperative use of antibiotics minimizes the occurrence of endophthalmitis. I strongly support the use of preoperative povidone iodine antisepsis. It is well know that postoperative endophthalmitis following cataract surgery appears to be increasing with the popularity of juxta clear cornea incision which was what was done for Mr. Varrery Srinivas. In juxta clear corneal incision the Intra Ocular Pressure drops below 12 mm hg. Clear corneal incisions are capable of pulling material from the ocular surface into the eye. Until clear corneal incisions are fully healed, bacteria can enter the eye. The use of preoperative levofloxacin eye drops has been associated with a reduction in the observed incidence rate of endophthalmitis. Treat periocular conditions such as dry eye and blepharitis preoperatively, and practice meticulous lid draping. Prophylactic antibiotic along with the non-steroidal anti inflammatory drugs has proved beyond all doubts. Genetic identity of 82% of vitreous isolates in patients who developed postoperative endophthalmitis was indistinguishable from isolates taken from the same patient''s eyelids, conjunctiva or nose. In patients who received 1 mg cefurozime intracamerally in 0.1 ml of normal saline solution at the end of surgery, the incidence of endophthalmitis was reduced by fivefold. It proves the efficacy and safety of cefuroxime, which has existed for 25 years. Each syringe contains 2 mg cefuroxime in 0.2 ml normal saline solution. The syringes are dated, put into a refrigerator in the ophthalmic operating room and used as required on a daily basis. The stability is a 9 - day shelf life. I strongly support the use of preoperative povidone iodine antisepsis. Intracameral cefurozime administered at the time of surgery significantly reduced the risk of endophthalmitis after cataract surgery. The pathogen causing the endophthalmitis enters the eye at the time of surgery. No history or investigations were done for Mr. Varrery Srinivas whether he was a case with Methicillin Resistant Staphylococcus Aureus (MRSA) or even referred to an infectious specialist for the same. 30% to 40% of endophthalmitis cases are MRSA. Prophylactic use of mupirocin nasal ointment resulted in significant reduction of conjunctival flora and incidence of endophthalmitis. Use of silicone as opposed to an acrylic Intra Ocular Lens material is another great risk factor which would have been the etiology of Mr. Varrery Srinivas right eye endophthalmitis. The signs and symptoms presented by Mr. Varrery Srinivas on the first postoperative day will be any fresh ophthalmologist diagnosis to be endophthalmitis. Why has LVP appreciated the diagnosis only after three days? The treatment for this again is a combination of Injection Vancomycin + Ceftazidime + Dexamethasone universally followed. LVP is happy with only one antibiotic injected which is nothing to save endophthalmitis. LVP should withdraw their statements against ophthalmic principles and practice followed all over the world. Why did LVP appreciate the use of Injection Mannitol intravenously preoperatively which is not required for the patient since the intraocular pressure was normal? Since Mr. Varrery Srinivas had iridodialysis in his right eye which was evidential on gonioscopy the intraocular pressure is expected to be high because of the complication of iridodialysis leading to 100 day glaucoma which was surprisingly recorded to be normal and the clinical evaluation had no features of any of these complications. Therefore, giving him injection Mannitol preoperatively is a bad decision. Patient had 3/60 visual acuity preoperatively and only perception of light on the first postoperative day which directly speaks that the surgery done was a failure. The visual acuity that is expected preoperatively to be better than 6/12 is nowhere postoperatively in Mr. Varrery Srinivas". [All through emphasis supplied] Medical Literature
ON behalf of the appellant/OP, several pieces of medical literature were cited before the State Commission as well as this Commission. In our view, however, it will suffice if two of them, viz., Parsons'' Diseases of the Eye (18th Edition, 1991, pp 244) and the article titled "Complications of Intraocular Lens Implantation" by Dr. Renuka S. in the Chapter titled ''Pseudophakic Endophthalmitis'' (in some book whose title is not cited) are read in some detail. It may be added that these references are of a period either earlier than or the same as that of the year of the cataract surgery in question and that the author of the second-mentioned article is the same person as the Professor-in-charge at the JIPMER Hospital who conducted the cataract surgery on the complainant and directed the post-surgery treatment. In reproducing the texts, emphasis has been supplied by us. (i) Parsons'' Diseases of the Eye (pp 168 - 170, 18th Edition) Acute bacterial endophthalmitis Acute endophthalmitis is a devastating complication that occurs in about 1:1000 cases. Despite early treatment, about 50% of the eyes become blind. Introduction 1. Causative organisms, in order of frequency, are Staph epidermidis, Staph aureus, Pseudomonas sp., and Proteus sp. 2. Source of infection in most cases cannot be identified with certainty. It is thought that the patient''s own external bacterial flora of the eyelids, conjunctiva and lacrimal drainage passages are the most frequent culprit. Other potential sources of infection are contaminated solutions and instruments and environmental flora, including that of the surgeon and operating room personnel. 3. Prevention by the following measures may be beneficial in prevention of bacterial endophthalmitis: (a) Treatment before surgery of pre-existing infections such as staphylococcal blepharitis, conjunctivitis, dacryocystitis or infected contralateral sockets in patients with ocular prostheses. (b) Preoperative instillation of povidone-iodine. A 5% solution is prepared by diluting the full strength 10% Betadine aqueous solution used for skin preparation with 1:1 balanced saline solution. Two drops of the diluted solution are instilled into the conjunctival sac and the eyelids gently manipulated to distribute the solution over the ocular surface. Following preparation of the skin and draping, the eye is irrigated with saline solution. (c) Meticulous draping technique that ensures that the lashes and lid margins are isolated from the operative field. (d) Postoperative injection of anterior sub-tenon with antibiotics. Clinical Features The clinical features depend on its severity at the time of examination. 1. Severity (a) Severe endophthalmitis is characterised by pain, marked visual loss, lid oedema, chemosis, conjunctival injection, corneal haze, fibrinous exudate in the anterior chamber hypopyon, vitritis, absent red reflex and inability to visualise the fundus with the indirect ophthalmoscope. (b) Mild or early endophthalmitis may be associated with only slight pain, absent or very small hypopyon and preservation of some red reflex. 2. Time interval between the cataract extraction and the onset of symptoms can be useful in the prediction of probable offending organisms. For example: (a) Staph aureus and gram-negative organisms typically present between the first and third postoperative days with severe signs. (b) Staph epidermidis may present between the fourth and tenth postoperative days with relatively mild signs. 3. Differential diagnosis Management 1. Identification of the causative organism from the aqueous and vitreous confirms the diagnosis. However, a negative culture does not necessarily rule out the possibility of infection. The samples should be taken in the operating room as follows: 2. Vitrectomy is beneficial only in cases with very severe infection and a visual acuity reduced to ''light perception''. If visual acuity is a ''hand movements'' or better then vitrectomy is unnecessary. 3. Antibiotics which cover both Gram-positive and Gram-negative organisms should be administered. The currently recommended antibiotics are either amikacin or ceftazidime for cover against many Gram-positive and Gram-negative organisms, and vancomycin for coagulase-negative and coagulase-positive cocci. Amikacin acts synergistically with vancomycin but is potentially more retinotoxic than ceftazidime, which is not synergistic with vancomycin. (a) Intravitreal antibiotics should be given after the culture specimens have been obtained and the eye has been softened. Amikacin (0.4 mg in 0.1 ml) or ceftazidime (2 mg in 0.1 ml) and vancomycin (1 mg in 0.1 ml) are injected slowly into the mid-vitreous cavity using a 25 gauge needle. After the first injection has been given, the syringe is disconnected but the needle is left inside the vitreous cavity so that the second injection can be given through the same needle. (b) Periocular injections consist of an anterior sub-Tenon injection of vancomycin 25 mg and ceftazidime 100 mg or gentamicin 20 mg and cefuroxime 125 mg. The injections are repeated daily for 5-7 days according to the response to therapy. (c) Topical therapy consists of fortified gentamicin 15 mg/ml and vancomycin 50 mg/mg drops every 3-60 minutes. (d) Systemic antibiotics are not beneficial because of their relatively poor intraocular penetration. 4. Steroid therapy will not interfere with the control of the infection, provided the organisms are sensitive to the antibiotics. (a) Periocular injections of betamethasone 4 mg or dexamethasone 4 mg (1 ml) are given daily for 5-7 days according to response to therapy. (b) Systemic therapy with oral prednisolone 20 mg, given four times daily for 10-14 days may be considered only in very severe cases. (c) Topical therapy with 0.1% dexamethasone drops is given every 30 minutes. 5. Subsequent management is to a certain extent governed by culture results. If resistant bacteria are cultured, antibiotic therapy should be modified accordingly but it may be too late. (ii) Complications of Intraocular Lens Implantation (Article by Dr. Renuka S.) [Note: It is a long review article and the copy produced by the appellant has several pages missing. Hence we have reproduced only the concluding part, which is quite sufficient for our purpose.] " Summary of Management 1. Classify endophthalmitis into mild, moderate (those likely to be culture negative) or severe (hypopyon, vitreous opacity, loss of red reflex). 2. A diagnostic aqueous tap in anterior endophthalmitis and aqueous and vitreous aspirate in all others should be done and inoculated in appropriate media. Intravitreal antibiotic is also given. 3. Topical and subconjunctival antibiotics and steroids are given. The frequency of these is adjusted according to the clinical response. 4. In mild cases and those responding well as seen by reduction in the anterior chamber reaction and retraction of exudates, the same treatment may be continued. 5. In culture positive cases and those not responding adequately, a repeat intravitreal injection of an appropriate antibiotic may be given after 48 hours. This may have to be repeated several times. 6. In severe cases with very poor initial vision (light perception only) and those worsening despite the above treatment, vitrectomy may be done. 7. Topical, periocular and oral steroids may be given in all categories of cases to suppress the inflammatory reaction once the infection is getting under control. 8. Vitrectomy is always required in fungal endophthalmitis, as the response is conservative treatment is poor owing to inadequate penetration of antifungal agents. In addition to 5 mg amphotericin B intravitreally, oral ketoconazole 200 mg 3 time daily and topical natamycin have been advocated to aspergilla endophthalmitis. Prognosis Olson et al in a study of 40 cases reported a final visual acuity of 20/200 or better in 25 percent and loss of light perception in 35 percent. Endophthalmitis formed an important cause of the removal of the eye (29 out of 40) after IOL surgery in another study. Although the outcome of endophthalmitis has improved considerably, it is still one of the sight-threatening complications of cataract and IOL implantation surgery. Use of intravitreal antibiotics has greatly improved the prognosis but in many situations although the infection itself is eradicated, the patient is blind from the toxic effects of the antibiotic. This results in anatomical rather than functional success. Causes of Poor Vision in Pseudophakic Endophthalmitis The endophthalmitis vitrectomy study has identified the following causes for poor visual outcome in pseudophakic endophthalmitis. 1. Phthisis bulbi 2. Anterior segment medical opacities 3. Vitreous opacities 4. Macular involvement The endophthalmitis vitrectomy study has also revealed that the better the initial visual function, the better the final visual result regardless of whether the patient underwent vitrectomy and intraocular antibiotics or a vitreous tap and intravitreal antibiotics. The most important risk factor was poor initial vision. Twenty three percent of patients with visual acuity of light perception only achieved 20/40 final vision compared to 64 percent of those with initial vision more than light perception. Treatment Details
WITH this background of medical literature, we may now look into the details of the treatment given to the respondent during his in-patient stay at the Hospital. (i) The patient was admitted to the JIPMER Hospital on 08.071997 and discharged on 22/23(?).07.1997. (ii) The cataract surgery was done on 10.07.1997. The operation note records, inter alia, "Under all aseptic precautions, under local anaesthesia, right eye painted and cleaned with Betadine and draped. ... ... ..." There is, however, no record of any "preoperative instillation of ... ... ... 5% povidone-iodine solution ... ... ... into the conjunctival sac" and the eyelids being "gently manipulated to distribute the solution over the ocular surface." (vide Parson''s supra) (ii) There was no post-operative examination of the eye on 10.07.1997. (iii) The post-operative medicines ordered/administered on 10.07.1997 did not include any antibiotic eye drops or injections (vide Parson''s injunction on prevention, "Postoperative injection of anterior sub-tenon with antibiotics"). In fact, even non steroidal anti-inflammatory drugs were also not administered on 10.07.1997 after the surgery. (iv) On 11.07.1997, i.e., the very first post-operative day (POD 1), the patient developed severe inflammation in the anterior chamber of the eye along with uveitis and hypopyon. The Professor-in-charge, who saw the patient, directed treatment for endophthalmitis. Administration of topical antibiotic eye drops (genoptic B - gentamicin sulphate - and fortified gentamicin, gentamicin being an antibiotic of the aminoglycoside group), intravenous (i.e., systemic) injection of cifran (ciprofloxacin hydrochloride, ciprofloxacin being a second-generation antibiotic of the quinolone group) and tablets cifran and septran (sulphamethoxazole + timethoprim - a combination of two antibiotics of the sulphanomide group) was then started. Subconjunctival injection of genticin bd and betnesol (corticosteroid) was also planned for 12.07.1997. (v) On 12.07.1997 (POD 2), at the advice of Professor in-charge, topical ciplox and atroren P (atropine sulphate) eye drops were added to genoptic B and 0.5% timolol eye drops (the latter for ocular hypertension) and intravenous injections of cifran were continued. Right eye aqueous aspiration was done and intracameral injection of vancomycin and amikacin was also given. However, there is no record of subconjunctival injection of genticin/gentamicin and betnesol, though directed on 11.07.1997. (vi) The same treatment was continued on 13.07.1997 and there was no subconjunctival injection. (vii) On 14.07.1997, there was no mention of either aqueous or vitreous tap being taken but subconjunctival cephazolin (a first generation antibiotic of the cephalosporin group) was administered for the first time. Prednisolone (corticosteroid) tablet was also prescribed. (viii) On 15.07.1997, the treatment ordered on 14.07 was continued but prednisolone tablet was discontinued. (ix) On 16.07.1997, cephazolin eye drops were introduced in place of subconjunctival injection and cifran injection IV was replaced by cifran tablets. Chorlmet DM (mixture of chloramphenicol - a broad-spectrum antibiotic - and dexamethasone - a corticosteroid) eye drops were introduced. (x) The same treatment was continued on 17.07.1997. (xi) On 18.07.1997, prednisolone tablet was reintroduced and intracameral cephazolin injection was planned for 19.07.1997, as advised by Dr. Renuka S. (xii) On 19.07.1997, an aqueous tap was taken, intracameral injection of cephazolin was administered and the rest of the treatment was continued. (xiii) On 20.07.1997, subconjunctival betnesol injection was administered. (xiv) On 21.07.1997, the treatment was continued and topical pyricort (combination of gentamicin sulphate and dexamethasone) eye drops were added. A second ultrasonography (in addition to that of 16.07.1997) as well as an intravitreal injection of dexamethasone was also planned for 22.07.1997. However, there are no entries regarding these being done. (xv) The patient was discharged on 22/(23?).07.1997, according to the discharge certificate with medication and follow-up at the OPD.
WE may now compare the treatment given and the recommended/standard protocol as per the medical literature cited by the appellant/JIPMER: Sr. no. Standard Protocol Actual Treatment 1. PREVENTION i. Treatment of pre-existing infection ii. Pre-operative instillation of 5% povidone iodine solution in the eye, in addition to 10% betadine aqueous solution for skin preparation Note: Betadine is the trade name for a range of povidone iodine topical antiseptics iii. Post-operative periocular (sub-tenon) injection of antibiotics i. Thorough examination done; no infection found ii. Not done; Dr. Renuka''s article states (p. 73), "... ... ... 5 percent solution is reported to significantly reduce the conjunctival and perilimbal flora... ... ..." iii. Not done - in fact, no antibiotic, topical, systemic or by any other route was administered on 10.07.1997, after the surgery 2. MANAGEMENT i. Classification of severity of the endophthalmitis ii. Aqueous and vitreous fluid aspiration for culture to determine the aetiological agent and sensitivity tests for fixing the antibiotic to which the organisms are sensitive iii. The standard protocol for management of severe bacterial endophthalmitis consists of administration of antibiotics - intravitreal, sub-conjunctival topical - and also steroids from day 1, without waiting for results of culture of aqueous and/or vitreous aspirates and then modulating the antibiotics according to the results of culture and sensitivity tests. The recommendations are: a. Antibiotics Intravitreal injection: amikacin or ceftazidime and vancomycin Subconjunctival injection: vancomycin and ceftazidime or gentamicin and cefuroxime. The injections are repeated daily for 5-7 days according to the response to therapy Topical eye drops: Fortified gentamicin and vancomycin It is specifically noted in all medical literature that though systemic antibiotics are routinely administered (as IV/IM injections or oral pills), they are of little value in treating endophthalmitis b. Steroids Are recommended for topical (betamethasone eye drops), subconjunctival (dexamethasone or betamethasone injection) as well as systemic (oral - tablet prednisolone) administration i. It was clearly a case of severe endophthalmitis in view of the signs and symptoms that presented on POD 1 itself, though not recorded in so many words ii. Aqueous tap was taken on 12.07.1997 - result obtained on 13.07.1997 was recorded in the Discharge Summary as "13.07.1997 - coagulase negative staphylococcus." No record of sensitivity test Though there is no record in the treatment chart of both aqueous and vitreous aspiration being done on any date upto 14.07.1997, the Discharge Summary has an entry, "14.07.1997 - aqueous and vitreous tap sterile" and also of "19.07.1997 - vitreous tap sterile" though the corresponding entry in the treatment chart of 19.07.1997 is of aqueous tap being taken, not vitreous No record any intravitreal (i.e., posterior chamber - vitreous cavity of the eye) injection at all. Only one intracameral (i.e., anterior chamber) injection of vancomycin and amikacin given on 12.07.1997 Subconjunctival injection was of only cephazolin (a first-generation antibiotic of the cephalosporin group) - first on 14.07.1997, second on 15.07 and last on 19.07.1997; in Dr. Renuka''s article it is recorded (p.78), "Ceftazidime is a third generation cephalosporin which is a useful substitute for amikacin and other aminoglycosides and has gram-negative coverage as well." Topical eye drops of various types of antibiotics (gentamicin, fortified gentamicin - for only 1 day, ciprofloxacin, cephazolin) were administered, the combination of drugs being changed often; there is no record of any sensitivity test being done even of the aqueous tap taken on 12.07; on cephazolin, Dr. Renuka''s article states, "Cephazolin sodium has poor penetration by topical route but may be used intravitreally." All through the period, a variety of systemic antibiotics, both IV and oral, were administered The first administration of steroid eye drops (chlormet DM) was on 16.07.1997 and that by way of prednisolone tablets was on 14.07.1997 but the latter was stopped the next day and re-introduced on 18.07.1997. Subconjunctival betnesol injection was given for the first time on 20.07.1997 and on 21.07.1997 pyricort eye drops were introduced in lieu of chlormet DM
TO summarise, according to the record of treatment given to the respondent: (i) before the surgery (10.07.1997) 5% povidone iodine solution was not instilled in the affected eye; (ii) no antibiotic in any form was administered immediately post-surgery; (iii) there is no evidence of vitreous aspiration being at all done on any day though aqueous taps were taken on 12.07 and 19.07.1997 - thus, the two entries in the Discharge Certificate of sterile aqueous and vitreous taps on 14.07.1997 and sterile vitreous tap on 19.07.1997 are highly suspect; (iv) though vitreous exudates and partial retinal detachment were reported by the ultrasonograph done on 16.07.1997, there was no intravitreal injection of any kind throughout the stay of the respondent; (v) only one intracameral injection of amikacin + vancomycin on (12.07) and three sub-conjunctival injections of cephazolin (on 14.07, 15.07 and 19.07.1997) were given; and (vi) steroids were started late and given with unexplained breaks. Therefore, it is not surprising that, as shown by the daily progress reports (produced by the appellant before the State Commission), the patient''s visual acuity dropped to mere "PL", i.e., perception of light on 12.07.1997 and was "PL absent?" on 23.07.1997.
AS regards the question of the recorded consent for the surgery, we do not deem it necessary to go into the implications of the appellant not being able to produce the relevant document in respect of the respondent because, in his complaint, the respondent did not allege that his consent for this surgery was not taken after explaining the pros and cons. However, the content of the form of consent that was produced by the appellant would show that it does not at all qualify to be a document of real and valid consent, as required by law (vide Apex Court judgment in the case of Samira Kohli v Dr. Prabha Manchanda [(2008) 2 SCC 1]).
THUS, with full respect to the Medical Boards at both the RPCOS and LVPEI, we have no alternative but to conclude that they failed to appreciate/notice the glaring omissions and departures in the treatment given to the respondent vis a vis the standard protocol in this regard and, for reasons best left unsaid, gave a clean chit to the appellant. The deficiency in service/medical negligence is all the more inexplicable because the Doctor in-charge who conducted the surgery and guided the entire treatment was no "average practitioner" of the "Bolam" variety but a specialist of obviously a high order and herself the author of a scholarly review/research article on endophthalmitis which made specific professional recommendations on its treatment that she failed to follow. However, the fact remains that there was deficiency in the treatment given to the respondent who, having been a case of blunt trauma, needed to be treated with higher than ordinary care because of the predisposing risks.
IN conclusion, the appeal deserves to be dismissed. We order accordingly and direct the appellant (JIPMER) to pay to the respondent the amount awarded by the State Commission (Rs. 5 lakh) with interest @ 9 per cent per annum from 01.03.2003 till realisation and Rs. 25,000/- as cost of proceedings upto this stage. The payment shall be made within four weeks of the date of this order, failing which the rate of interest shall be raised automatically to 12% per annum.