By Smt. C. S. Sulekha Beevi, President,
A minor boy, aged 7 years, undertook treatment under opposite parties. This complaint is filed alleging medical negligence and the complaint is filed by his father. For convenience, the minor who was treated is referred to as patient, and his father who represents him is referred to as complainant hereafter. 1. Facts:- The patient suffered from diminishing vision and he approached first opposite party hospital for treatment. After examination his disease was diagonised as lamellar cataract to both eyes. He was advised to undergo cataract surgery to both eyes. Doctors at opposite party hospital simplified the surgery and offered 100% success. Complainant decided to take treatment under opposite party believing that the disease will be cured. The patient was admitted on27-4-2006 and a surgery named vitrectomy was done to his right eye. Even though the patient was subjected for surgery at 9am, he was detained in the operation theatre till late night. Doctors of opposite party hospital availed advise from various doctors outside after conducting the surgery. Opposite party also brought doctors from outside to attend and treat the patient. All these were done without the consent of the complainant. It was revealed later that in the course of surgery, while fixing the lens, (IOL) it dropped into the vitreous of the eye. That opposite parties attempted to remove the lens with assistance of other doctors. That the delay to remove the complainant from the theatre was due to this. Opposite party refused to disclose the same to complainant and relatives. All acts were done without obtaining permission. He was discharged on 01-5-2006. The patient had severe pain, irritation and other inconveniences. The various modes of treatment to relieve pain yielded no result. On opening the eye it was found that vision was reduced considerably. Though patient went for reviews there was no relief. On detailed discussion with doctors at opposite party hospital it is revealed that IOL dropped into vitreous and the same caused haemorrhage to the eye and the patient has l;lost eyesight in the operated eye for ever. The haemorrhage caused is irreparable. IOL dropped due to negligence of the doctor. That opposite party hospital deputes inexperienced and unqualified doctors for conducting surgery and fixing IOL to bring the cost of surgery to the minimum. The possibility to drop IOL is nil and it has happened due to inexperience and negligence. Opposite parties tried level best to suppress the inefficiency. With much compulsion opposite party issued a case summary on 22-02-2006. There was nothing abnormal to the eye before surgery. Haemorrhage was caused after surgery and this was due to dropping of IOL. That proper mode is not adopted for surgery. Though opposite party claims to have modern facilities, instead of resorting to modern equipments, the surgery was done opting manual mode. It is also the reason for the unfortunate incident. The patient lost vision to the right eye for ever. Complainant apprehends further negligence in operating the other eye. He is thus prevented from availing treatment to the ailment to the other eye. Opposite party is responsible for this. Patient underwent much pain and sufferings. Hence this complaint alleging medical deficiency. Complainant prays for Rs.1,00,000/- towards pain and sufferings, Rs.4,00,000/- towards the loss of right eye, Rs.50,000/- for treatment, transport etc. The eye is reduced in size and has caused disfigurement. He claims Rs.25,000/- for disfigurement and Rs.25,000/- towards mental tension and inconveniences together with 18% interest. 2. All three opposite parties have field a combined version. It is stated that the averments in the complaint are purposefully framed for undue financial advantage by suppressing true facts. Opposite party states the true facts to be as under: Complainant was brought to opposite party hospital on 21-4-2006 with complaints of diminution of vision of both eyes noted since 1 year. The Third opposite party examined the complainant and was diagnosed to have congenital lamellar cataract with amblyopia in both eyes. His vision was 6/36 in both eyes and intra ocular pressure measured was 17.3 mmHg in the right eye and 12.2 mm Hg in the let eye and ducts were patent in both eyes. Fundus examination was within normal limits. The complainant was duly advised to undergo cataract surgery under guarded visual prognosis, in view of amblyopia. Third opposite party explained to the relatives of the complainant about the nature of the congenital anomaly and its required treatment by cataract extraction with primary posterior capsulotomy with anterior vitrectomy and IOL implantation. The complainant was informed about all possible complications associated with paediatrics cataract surgery. After fully conversant with the pros and cons of the surgery the relatives of the complainant voluntarily agreed to the surgery and the father of the complainant gave a written informed consent. Under all aseptic care and precautions, the third opposite party had conducted cataract extraction of right eye with anterior vitrectomy and IOL implantation under general anesthesia on 28-4-2006. During the procedure the IOL dropped in the vitreous cavity which is a medically known complication of the said surgery. Immediately the Vitreo – Retina surgeon Dr. Kalpana attached to the hospital attended the patient and she successfully retrieved the dropped IOL and the IOL was implanted in the sulcus. Vitrectomy was done by the Vitreo – Retina surgeon with due care and caution. Intra operatively vitreous haemorrhage was noticed and it was managed by non expensile C3 F8. The complication occurred in the case of the patient during surgery was not the result of any negligence or carelessness on the part of the third opposite party or on the part of the Vitreo – Retina surgeon who had done Vitrectomy. The fact of occurrence of the complication was well explained to the relatives of the patient and they were fully conversant with the factual situation and the methods of management done by the third opposite party. Post operatively on 29-4-2006 the patient had mild pain due to post operative inflammation and corneal oedema. His visual acuity was perception of light + and projection of light normal which was due to vitreous haemorrhage. The patient was treated with Apdrops dx eye drops, Homatropine eye drops, Nebracin eye ointment, Iotim eye drops, and Tab Diamox and Tab Vitamin C. On 30-4-2006 patient's pain considerably reduced and cornea DM folds also reduced, A/C well found, flare present, cells++, PC IOL in situ, fundal glow faint + and based on the indications the patient was advised to continue the same treatment. Post operatively the patient was kept under proper observation and care and Vitreo – Retina surgeon examined and monitored the condition of the patient. On 01-5-2006 the patient complained slight pain but the corneal oedema had reduced A/C flare present, cells++, PC IOL, in situ and there was minimal Hyphema, fundus hazy and thin membrane in pupillary area. Vitreo – Retina surgeon had attended the patient and B- scan was done which showed Vitreous haemorrhage. On that day the patient's father insisted for discharge of the patient and hence discharged on request. The patient was advised to continue oral tablet Wysolone. When the patient reviewed on 08-5-2006, he was examined by the Vitreo – Retina surgeon and at the time of examination the patient did not have pain. B- scan was repeated which showed resolving Vitreous haemorrhage. On 27-5-2006 the patient's vision was no PL, cornea clear, A/C trace flare, irregular depth, iris Bombe, Seclusio pupillo, IOP digitally very low. Vitreo – Retina surgeon reviewed the patient and advised VEP. VEP was done elsewhere on 01-6-2006 in which no wave form in VEP, the patient was explained about the very poor prognosis of the eye and was advised to have a second opinion. When the patient reviewed 22-6-2006 cornea was clear without pain and IOL in situ. The patient developed Pthysis bulbi a known complication of Vitrectomy. The third opposite party had done cataract extraction with utmost care and caution and the procedure was done according to standard protocol. During the course of surgery when IOL dropped into the vitreous cavity a Retinal Specialist was called to manage the problem. Vitreous haemorrhage is a known complication of vitrectomy and is widely described in text books and literatures. 3. That opposite party hospital has advanced and sophisticated facilities. Hospital is having specialised doctors and has been conducting all sorts of eye surgeries and other complicated treatments. The averment that opposite party hospital simplified surgery and offered 100% success is denied. That for the type of ailment suffered by the patient no doctor can offer 100% success. Risks were explained and discussed. The allegation that complainant was kept for long hours in the theatre is denied. He was taken to the operation theatre at 7.45am, and was given premedications and anesthesia. Surgery was completed at around 11.30am. At 11.45 the patient was extubated and kept in post recovery room and shifted to ward around 2pm, and not in the night. The allegation that advice and service of doctors from outside was availed is denied. The patient was attended by Vitreo – retina Surgeon, Dr.Kalpana who is attached to opposite party hospital. This surgeon did the procedure of retrieving the lens. Proper consent was taken. Nothing was suppressed. The allegation that opposite party refused to disclose is denied. The complaint shows that complainant was fully aware of the occurrence of vitreous haemorrhage and so allegation of suppression is false. The averments that the haemorrhage is irreparable is scientifically wrong as Vitreous haemorrhage gets absorbed on its own in due course of time. If it has not cleared in 2-3 months time, it can be cleared by doing repeat Vitrectomy later. The allegation that the IOL dropped in the course of fixing the same because of gross negligence of the doctors is made with ulterior motive of undue advantage and hence denied. The third opposite party had done the surgery in strict regard to the accepted procedure. After performing anterior continuous curvilinear capsulorrehxis, the cataract was evacuated with Bimanual I/A probe and then primary posterior capsulorrehxis with anterior vitrectomy was done and IOL was implanted in the capsular bag. While removing the vesicoelastic material with I/A the IOL slipped in the vitreous cavity. The dropped IOL was immediately retrieved with the help of Vitreo – Retina surgeon. The allegation that the opposite party deputed in experienced unqualified doctors for conducting the surgery and for fixation of IOL in order to bring cost of surgery to the minimum is highly ill-motivated and hence denied. The doctors working in the opposite party hospital are well qualified and experienced in ophthalmic surgery and its treatment. Further allegation that possibility of drop of IOL to the eye is nil and the same is happened because of inexperience and negligence is also purposely stated with ulterior motive and hence denied. The possibility of drop of IOL to vitreous cavity during cataract extraction is a scientifically known complication well described in standard Text books and journals of Ophthalmology. The statement that the opposite parties tried their level best to suppress the deficiency from the complainant is highly ill-motivated and hence denied. There was no deficiency in service from the part of the opposite parties and nothing was suppressed from the complainant and his relatives. It is stated with ulterior motive that the opposite parties issued a case summary with much compulsion and is denied by opposite party. The averment that there was nothing abnormal to the eye before surgery is not true. Patient was suffering from a congenital cataract with amblyopia in both eyes when he came for treatment. It is absolutely wrong to state that opposite parties adopted manual system and did not resort to modern equipments. The allegation that surgery was done by in experienced doctors is denied. Other allegations have been specifically denied. There is no deficiency on the part of opposite parties. That the claims put forward are baseless. 4. Evidence consists of the oral evidence of the complainant who was examined as PW2. An expert was examined on behalf of complainant as PW1. Exts.A1 and A2 marked for complainant. On the side of opposite parties, third opposite party was examined as DW1. The case sheet produced from opposite party hospital is marked as X1 and the case sheet of Aravind Eye Hospital is marked as X2. 5. Points for consideration:- (i) Whether opposite parties are deficient in service. (ii) If so, reliefs and costs.
6. Point(i):- Though manifold allegations of negligence are raised by the complainant against opposite parties, some of them have been given a go-by at the time of evidence. The main allegations can be summed up as under: (a) While doing cataract surgery, the operating doctor (third opposite party) dropped IOL into vitreous. Dropping of lens into vitreous is per se negligence. This caused haemorrhage in the eye and resulted in loss of eye sight to the operated eye. Opposite party has not offered reasonable explanation for the falling of lens. (b) Dropping of lens and consequent complications were not informed or disclosed to the complainant and relatives. Opposite party suppressed the complications and thus prevented the patient from availing better treatment. It is further stated that opposite party suppressed the occurrence of retinal detachment. (c) Patient was diagnosed to have lamellar cataract with amblyopia. The ailment of lamellar cataract alone was mentioned in the case summary issued to the patient. The non-mention of amblyopia in the case summary is negligence. (d) Opposite party obtained consent to perform cataract surgery only. But opposite party doctor performed another surgery called vitrectomy also. This surgery was performed without obtaining consent. It is also stated that opposite party called doctors from other hospitals to examine and attend the patient and this was done without consent. 7. Denying the allegations of negligence, the submissions put forward on the side of opposite parties are as follows: (a) Third opposite party doctor conducted the cataract surgery under all care and precautions. During the procedure, the IOL dropped into the vitreous. This is a medically known complication and has not happened due to any lack of care or negligence. Immediately the Vitreo – Retina Surgeon, Dr. Kalpana attached to opposite party hospital was called. She attended the situation and successfully retrieved the dropped IOL. It was then implanted in the sulcus. Vitreous haemorrhage was then noted and this was managed by inexpensile C3F8. Vitreous haemorrhage can occur after vitrectomy. These complications are well described in medical texts. (b) That fall of lens into vitreous and all complications were informed and discussed with complainant and relatives. All events were stated in the case summary issued to the patient. Retinal detachment has occurred much later. That opposite parties have not concealed or suppressed anything. (c) The patient had lamellar cataract with amblyopia. Amblyopia develops due to cataract which is interfering in the stimulation of optic nerve. Opposite party diagnosed lamellar cataract (developmental) with amblyopia and it was mentioned in the case sheet. In the case summary issued tot he patient it was omitted to mention amblyopia. That all paediatric patients with cataract usually have amblyopia. (d) The procedure of cataract surgery includes anteriors vitrectomy and IOL implantation. Vitrectomy is done as part of cataract surgery. Dr. Kalpana had done vitrectomy for retrieving the IOL and implanting it. Vitrectomy is part of surgery for cataract for which proper consent was obtained. Doctors from other hospitals were not called. Dr. Kalpana is attached to opposite party hospital and the patient was reviewed after discharge also by this doctor. The complainant had disputed the qualification and experience of opposite party doctor. But this allegation is seen to have been given a go-by at the time of evidence. No challenge is made in this regard. DW1 who is the treating doctor has affirmed that he took M.B.B.S. Degree in 1992 from Government Medical College, Ambeijogi, Maharastra. He did post graduation D.O.M.S. in 1998 from Government Medical College, Aurangabad. He also did DNB (Ophthalmology) from Little Flower Hospital, Angamaly. DW1 is working as a consultant ophthalmologist in first opposite party hospital. As there is no evidence adduced countering these affirmations we hold that third opposite party doctor possesses the requisite qualification and experience to undertake and treat the ailment presented by the patient. 8. It is pleaded by the complainant that opposite party doctor adopted manual method instead of using modern techniques and facilities. Again no challenge is made at the time of evidence regarding the method of treatment adopted by opposite party. The complainant has not put forward any evidence to show that the method adopted by opposite party is wrong or that opposite party ought to have adopted another method. Allegation that manual method was used instead of modern techniques is also given a go-by and therefore does not arise for analysation. 9. The main allegation levelled against the treating doctor is that he dropped the IOL into the vitreous and this resulted in loss of eyesight in the right eye. Counsel for complainant vehemently argued that opposite party has not properly explained the reason for drop of IOL. That the reasons stated by opposite party in the version, chief affidavit, case summary and case sheet are inconsistent to each other. The vivid explanations would establish that IOL was dropped due to lack of care and negligence on the part of third opposite party doctor. It is submitted that in the version opposite party has stated that IOL dropped in the course of implanting. In Ext.A1 which is the case summary issued to the patient it is stated that IOL dropped during the course of surgery. In Ext.X1 case sheet it is stated that IOL dropped due to extension of PPC (Posterior Capsule). That in cross examination DW1 deposed yet another reason. He stated that IOL dropped due to inadequacy of posterior capsular support. That it is also stated by him that IOL was dropped while removing vesico elastic material. It is further submitted on the side of complainant that if the posterior capsular support was inadequate, the doctor ought to have ascertained it before surgery and take necessary precaution to prevent dropping of lens. 10. Drop of IOL into vitreous is admitted by opposite party doctor. It is the case of opposite party that this occurrence is an accepted and well documented complication of cataract surgery and that it has not happened due to any negligence or lack of care on the part of operating doctor. 11. On perusal of Ext.X1 case sheet of opposite party hospital it is seen that the patient was first seen at opposite party hospital on 21-4-2006. He was admitted on 27-4-2006. Surgery was done on 28-4-2006 and was discharged on 01-5-2006. 12. On 28-4-2006 the complaints noted in Ext.X1 are:- 'c/o Dimunition of vision noticed since 1 year. Was told cataract elsewhere. Mother says child was able to see distant things till 2 to 3 years of age. No H/O trauma'.
It is seen entered in Ext.X1 that pupil in both eyes show no reaction. The lens has lamellar cataract 5-6 mm in both eyes. The vision noted in both eyes on this date is 6/36. From Ext.X1 sit is seen that he is admitted for 'Right Eye – cataract extraction with IOL implantation. The treatment/ surgery noted is – cataract extraction -- Right Eye -- with PPC with Ant. Vit (anterior vitrectomy) with PC IOL (posterior chamber IOL) under general anesthesia under guarded visual prognosis. The operation notes are as under: “Ant (ccc) done -- lens removed with automatic I & A (Irrigation and Aspiration) PPC done – Anterior vitrectomy done -- IOL placed in bag. While doing automatic I & A to remove viscoelastic in A/C (anterior chamber) the PPC (primary posterior capsule) extended and IOL dipped in vitreous cavity. Case referred immediately to Vitreo – Retina Surgeon, Dr. Kalpana who did vitrectomy and removed IOL. 6 mm IOL placed in sulcus.................Vitreous cavity haemorrhage noted for which retina surgeon managed C3F8...........(Explained to patient's father) Explained that post -- op vision recovery will take time as haemorrhage has to resolve. Patient reevaluated by V.R. Surgeon.” On scrutiny of the above operation notes, with the contention stated in version, chief affidavit and Ext.A1 case summary we fail to understand any inconsistency. The case of opposite party is that the IOL dropped into vitreous during the procedure. The reason has been sufficiently stated in the operation notes. Aspiration is done for removing visico elastic material. During aspiration the posterior capsule extended and the IOL dipped into the vitreous. The evidence of PW1 who is an expert in the field is as under: “Posterior capsule of lens is very thin. It easily ruptures or tears. Posterior capsule opening may extend or enlarge on putting IOL and while irrigation and aspiration. In such cases it is correct to say that IOL can drop down to the vitreous cavity. I agree that this is a known complication to the medical literature. It is mentioned in the text books and journals. It is correct to say that IOL can drop into the vitreous cavity if the posterior capsule support is inadequate. This is also documental. If such thing happens the cataract surgeon will call the retinal surgeon if available. For removal of IOL from the vitreous the retinal surgeon has to do pars plana vitrectomy before removal of the IOL. I agree that vitreous haemorrhage can occur during vitrectomy. I agree that vitreous haemaorrhage is also a well documented fact in medical literature. It is correct that vitreous haemorrhage will get absorbed within 2 to 3 months. I do not agree that vitreous haemorrhage alone by itself will not cause blindness because there may be temporary blindness.” PW1 is an ophthalmologist working in the District Hospital, Manjeri. She deposed that she has 27 years of experience as doctor and 23 years of experience as an ophthalmologist. She stated that she has done around 10,000 surgeries. 13. The evidence of expert supports the case of opposite party explaining the reason for dropping of IOL, and also the cause of vitreous haemorrhage. PW1 has further deposed as under: “I agree that any negligence in the implantation of lens may cause falling of lens into the vitreous. It is also correct to say that falling of lens into the vitreous may cause complications in the surgery. It is also correct that in such situation it may cause haemorrhage to vitreous, inexplanting a dropped IOL. Whether any further lens can be implanted without removing the dropped lens (Q) It can be implanted. But it is always ideal to remove if retinal surgeon is available(A).” “In Ext.X1 the clinical examination of the patient shows that he has lamellar cataract to both eyes. It is correct that except lamellar cataract, no other complaints are noted. It is correct to say that falling of lens into the vitreous in this case has caused complication. Whether vitrectomy was necessitated int his case due to fall of lens. (Q) Vitrectomy is done as part of cataract surgery in children. (A) It is stated as seen from Ext.X1 that Dr. Kalpana has done the removal of IOL.” “I do not agree that explantation of IOL can be done by cataract surgeon. Usually cataract surgeon does not do it. They refer to retina surgeons. I do not agree to the suggestion that falling of lens into the vitreous may cause vitreous haemorrhage.” 14. After perusing Ext.X1 case sheet the expert has opined that falling of lens is the complication caused in the present case. She has deposed that vitreous haemorrhage may occur while explanting a dropped IOL and also after vitrectomy. That falling of lens and vitreous haemorrhage are accepted complications. This doctor has stated that in her professional experience she had two occasions when the IOL dropped into vitreous. That she left it alone and implanted another lens. The evidence of PW1 in this regard is as under: “In my professional experience I had two occasions of lens falling into the vitreous. I left it alone and inserted another lens.” 15. In order to retrieve the dropped lens the patient will have to be referred to a retina surgeon at some other center. So the doctor (PW1) has inserted another lens. She deposed that it is always advisable to retrieve the dropped lens if retina surgeon is available. This evidence of PW1 categorically establishes that dropping of lens into vitreous during cataract surgery is a known complication. Opposite party has placed several medical literature before us to support this contention. The following pages were relied by opposite party from the Medical text 'Phacoemulsification, Laser Cataract Surgery and Foldable IOLS' -- 2nd edition by Jaypee publishers. Page 378: “Pediatric cataract are soft. Phacoemulsification is rarely if ever needed. Lens cortex and nucleus usually aspirate easily with an irrigation/aspiration or vitrectomy hand piece.” Page 379: “Dahan and Salmenson have recommended posterior capsulotomy and anterior vitrectomy in every pediatric cataract patient younger than eight years.” “In most cases an anteriors vitrectomy is performed simultaneously with the posterior capsulectomy.” 16. In this book chapter 55 deals with management of dislocated implants. This chapter deals with the vitreo – retinal approach to manage dislocated lens. It is seen that dislocation of implant is more frequent in posteriors chamber than anterior chamber. Page 530: “A dislocated PC IOL may occasionally be left undisturbed without causing a problem. However, it is usually best to remove or reposition a posteriorly dislocated PCIOL to avoid a sight-threatening retinal injury. The removal of the dislocated PCIOL represents a simple and direct approach. Mittra et al reported favourable visual results and minimal complications with the removal of the dislocated PCIOL.” Chapter 56 in this book deals with techniques to remove dropped lens. 17. Quotings relied by opposite party from 'Modern Ophthalmology' Vol.II -- 3rd edition – Jaypee Publications – by L.C.Dutta, Nitin Dutta is as under: Page 801: “Decentration of an IOL can occur because of traumatic Zonular loss and/or inadequate capsular support. Capsular bag placement of the IOL is the most successful way to reduce this complication. Posterior capture of the IOL optic also resulted in better centration of the implanted IOL. Incidence of lens malposition in pediatric eyes following posteriors chamber IOL implantation was reported as high as 40%.” 'In Vol. III of the same book page 1627 reads as under: Page 1627: “Iatrogenic Following different ocular surgeries like retinal detachment surgery, vitrectomy, cataract and glaucoma surgery, etc. vitreous hemorrhage may occur as a complication.” “Spontaneous resolution of vitreous hemorrhage may occur. It involves clot formation, fibrinolysis, red blood cell hemolysis, and absorption of blood by-products by marcrophage assisted phagocytosis. Page 1629: “TREATMENT -- There is a chance of spontaneous absorption of vitreous hemorrhage. Bed rest and bilateral patch are recommended, but their role is doubtful. If the blood does not get absorbed within 10 days of bed rest the latter should be considered unnecessary. Non clearing vitreous hemorrhage requires vitrectomy and treatment of underlying pathology. The surgery may be delayed up to six months or more. However, the surgical decision depends on the merit of individual cases.” Page 1630: “VITREOUS HEMORRHAGE IN VITRECTOMIZED EYES -- Hemorrhage in vitrectomized eyes is generally divided into two categories. In one group hemorrhage occurs within first week following surgery and in other group it occurs within 1 to 6 months or more following vitrectomy. The first type is due to release of erythrocytes trapped in the vitreous base or results from intra operative inadequate homeostasis. Delayed hemorrhage occurs from the rapidly growing neovascular tissue particularly on the remnants of posterior cortical vitreous attached to pre-existing neovascular tissue. Iris neovascularization or fibrovascular in-growth at the internal aspects of the sclerotomy sites can also cause such hemorrhage.” “Hemorrhage in vitrectomized eyes clears spontenously and in about 30 percent cases repeated hemorrhage occurs. The absorption of blood in aphakic and pseudophakic eye is thought to be more rapid than phakic eyes, as crystalline lens acts as a barrier against anterior migration of erythrocytes and blood by-products. In significant number of cases hemolytic or ghost cell glaucoma develops.” “Many a times intraoperative vitreous hemorrhage occurs. The common sources are the cut ends of the fibrovascular proliferation, avulsed retinal vessels, iatrogenic retinal tear, cut iris vessels, and vascularized preretinal membrane. Such bleeding clears spontaneously with vitreous wash or following temporary raising of intra ocular pressure. Otherwise endodiathermy or liquid perfluocarbonis used to arrest the bleeding. Thrombin has been used for the control of intraoperative hemorrhage during diabetic vitrectomy, but it enhances postoperative inflammmation and increased the incidence of recurrent membrane formation. Hyaluronic acid has also been applied to the surface of the retina at the conclusion of vitrectomy with an idea to prevent postoperative hemorrhage but the long-term result of this technique is doubtful. Otherwise, management includes observation, with careful ultrasonographic examination to exclude coexistence of retinal detachment, which would be an indication for early surgical intervention. Hemorrhage that does not clear up after 3 motnhs of observation are usually treated with repeat vitrectomy and intraoperative identification and treatment of the bleeding site.” The excerpts from internet relied by opposite party reads as under: “There are many alternatives available to the vitreoretinal surgeon in the management of posteriorly dislocated introocular lenses (IOL). The lens may be repositioned in the cilliary sulcus if there is adequate capsular support, but if this support is absent, it must either be sutured in place (to the sclera or iris) or exchanged for an anterior chamber (AC) IOL. Scleral-sutured IOLs canbe associated with hemorrhage, cystoid macular edema, retinal detachment, and endophthalmitis (through the suture tract), and use sutures that must last for the lifetime of the patient. Anterior chamber IOLs (ACIOLs) are easier to implant but require a limbal incision for insertion. The authors sought to determine the safety and efficacy of combining removal of posteriorly dislocated IOLs with ACIOL placement. DESIGN: A retrospective chart review, in which all cases of dislocated IOLs managed at the authors' institution over the last 5 years were reviewed. Patient characteristics, pre-existing ocular conditions, preoperative visual acuity (VA), introcular pressure (IOP), type of lens dislocated, operation performed, postoperative VA and IOP, and length of follow-up were recorded. RESULTS: A total of nine cases were identified.” “Management of posteriorly dislocated posterior chamber intraocular lenses by vitrectomy and pars plana removal. PURPOSE: To report a large series of eyes in which there was a posterior dislocation of a posterior chamber intraocular lens (PCIOL). During vitrectomy, the dislocated intraocular lens (IOL) was removed through an enlarged pars plana sclerotomy. An anterior chamber IOL (ACIOL) was implanted primarily or secondarily. METHODS: We conducted a retrospective chart review of 59 eyes of 58 patients with posterior dislocation of a PCIOL. RESULTS: Fifty-four eyes (92%) had improved visual acuity after surgery. Sixty-six percent (39 of 59) of eyes achieved at elast 20/40 vision; 25% (15 of 59) of eyes achieved a visual acuity of 20/50 to 20/200; and 8% (5 of 59) of eyes achieved less than 20/200 vision. In 32 (54%) eyes, PCIOL removal was combined with primary implantation of an ACIOL. In 27 (46%) eyes, the PCIOL was removed and the referring ophthalmologist placed a secondary ACIOL. Intraoperative complications consisted of limited suprachoroidal hemorrhage in 2 (3%) eyes. Postoperative complications consisted of retinal detachment in 5 (8%) eyes, cystoid macular edema in 13 (22%) eyes, and vitreous hemorrhage in 3 (5%) eyes. CONCLUSION: Posterior dislocation of a PCIOL may be managed safely by removal of the dislocated PCIOL through the pars plana.” “Dislocation of an intraocular lens is an infrequent but serious complication of cataract surgery.” “In the event of intraoperative dislocation of a posterior-chamber IOL, it is generally preferable to perform anterior vitrectomy as necessary to avoid vitreous ` prolapse into the anterior chamber and wound. If the IOL may be readily retrieved with a limbal approach, it may be repositioned during the same surgery. Otherwise, the wound can be close standard fashion, and the patient can be referred to a vitreoretinal surgeon for IOL repositioning or exchange.” The volume of the medical literature palaced before us together with the oral evidence of PW1 clingchingly establishes that dropping of IOL into vitreous and occurrence of haemorrhage are known complications. When there is elaborate description of the methods and techniques to manage and retrieve dropped lens then we have to safely presume that instances of falling of lens is not uncommon in cataract surgery. Though counsel for complainant urges that the falling of lens can be prevented by exercising care there is no expert evidence in this regard placed before us to show what was the particular care or precaution oa doctor has to take to avoid dropping of lens in vitreous. It was argued by the counsel that at the time of fundus examination the doctor will be able to assess whether the posterior capsular support is adequate or not. Though fundus examination in normal eye can reveal the defects inside the eye, in the instant case, opacity is formed isnide the lens due to cataract. Further PW1 has stated that posterior capsule opening may extend or enlarge while putting IOL or while irrigation and aspiration. 18. The evidence of DW1 in this regard is as under: “In this case the posterior capsule support was inadequate during surgery. Before surgery it was not inadequate. Routinely only during surgery it can be found out that whether it is adequate or not. I have not noted that the posterior capsule of lens is then because it is a known fact. I deny to the suggestion that posterior capsule opening extended while putting IOL due sto my negligence in doing surgery. I do not agree that it was due to my negligence that IOL fell into vitreous. I agree that falling of the IOL into the vitreous was the complication in this surgery. I have not explained any cause for such fall of lens but I have mentioned that the lens fell into the vitreous.” Complainant contends that falling of lens caused vitreous haemorrhage which has caused blindness to the operated eye. The medical texts state that vitreous haemorrhage may resolve by itself within 2-3 weeks or sometimes may take 2-3 months. If not resolved it has to be treated with victrectomy surgery. As per Ext.A2 dated, 09-12-2008 the operated eye does not suffer from vitreous haemorrhage but has the ailment of after cataract. From the evidence and materials placed we are able to safely conclude that dropping of lens or occurrence of vitreous haemorrhage was not due to any act or omission on the part of third opposite party so as to constitute negligence. 19. It is further alleged by the complainant that opposite parties did not disclose the complication of falling of lens and related management done. That opposite party suppressed the complications and prevented the patient from availing better treatment. Against this it is submitted by opposite party that discharge card was issued at the time of discharge and later on request a case summary was also issued. That opposite parties had explained the details of complication on the date of surgery itself. In Ext.X1 case sheet it is seen written that the patient's father was informed about the falling of lens. The surgery was on 28-4-2006 and he was discharged on 01-5-2006. On 22-6-2006 the complainant has send his cousin Bhargavan to collect the medical report from opposite party doctor inorder to take thepatient for further reference. On the same day opposite party has issued Ext.A1 case summary. In Ext.A1 opposite party has disclosed the falling of lens and management done. Relevant portion in Ext.A1 is as under: “Patient was advised Cataract surgery RE. He underwent RE SICS with PPC with Vitrectomy under guarded visual prognosis on 28/4/06. During surgery there was an IOL drops into the Vitreous, Vitrectomy with IOL explanation was done by Vitero- Retina Surgeon. Intra operatively Vitreous hemorrhage was seen for which non- expensile C3F8 was put. IOL was implanted in the Sulcus.” Ext.A1 shows that opposite party has stated in detailt he treatment given at opposite party hospital upto 22-6-2006. The falling of lens and occurrence of Vitreous haemorrhage and the brief procedure is also stated by opposite party. This is consistent with Ext.X1 case sheet produced before Forum. Further PW2 who is the complainant and father of the patient is not a lay man. He is a tax practitioner. He has graduated in maths and has then done C.A. Articleship with 3 years traiing. PW2 has deposed that his wife's first cousin is a doctor. His name is Dr. Lakshmanan and is also an ophthalmologist. That Dr. Lakshmanan had seen the patient before the surgery. It is also deposed by him that third opposite party doctor had conversed over telephone about the surgery and the complciations to Dr.Lakshmanan. The evidence of PW2 in this regard is as under: “എന്െറ ഭാര്യയുടെ അമ്മാവന്െറ മകന് Ophthalmologist ആണ്. Madras-ല് practice ചെയ്യുന്നു. എന്െറ മകന് Gokul Krishna-യുടെ ചികിത്സയെ സംബന്ധിച്ച് ഒരു പ്രാവശ്യം മേല് പറഞ്ഞ cousin work ചെയ്യുന്ന hospital-ല് ചെന്ന് test ചെയ്തിരുന്നു. എതൃകക്ഷി doctor-റെ കാണിക്കുന്നതിന്നു മുമ്പാണ് അത്. വേറെ doctor-മാരെ കണ്ടിട്ടില്ല. Minor surgery ആണ് എന്ന് cousin പറഞ്ഞു. നാട്ടില് നിന്നും ചെയ്താല് മതി എന്നും പറഞ്ഞു. കുട്ടിക്ക് ജന്മനാ കാഴ്ച കുറവ് ഉണ്ടായിരുന്നില്ല. 4 വയസ്സില് school-ലെ teacher പറഞ്ഞപ്പോഴാണ് അറിഞ്ഞത്. അതിന്നു മുമ്പ് ശ്രദ്ധിച്ചിട്ടില്ല. Cousin ആയ Dr.Lakshmanan opposite party hospital-ല് ചികിത്സിക്കുവാന് പ്രത്യേകമായി പറഞ്ഞിട്ടില്ല. Dr.Lakshmanan-നെയല്ലാതെ മറ്റു doctor-മാരെ കുട്ടിയുടെ അസുഖം സംബന്ധിച്ച് കാണിച്ചിട്ടില്ല.” “Surgery സമയത്തുണ്ടായിട്ടുളള complications എല്ലാം അംഗീകൃത complications മാത്രമായിരുന്നു എന്നു പറഞ്ഞാല് എനിക്കറിയില്ല. Surgery-ക്ക് ശേഷം Dr.Lakshmanan-നോട് എതൃകക്ഷി doctor- മാര് telephone-ല് സംസാരിച്ചിരുന്നു എന്നു പറഞ്ഞാല് ശരിയാണ്. ഉണ്ടായ സംഭവങ്ങളെല്ലാം എന്നോടും Dr.Lakshmanan-നോടും പറഞ്ഞു മനസ്സിലാക്കിത്തന്നിരുന്നു എന്നു പറഞ്ഞാല് എനിക്ക് പറഞ്ഞുതന്നിരുന്നു. 3- എതൃകക്ഷിയാണ് പറഞ്ഞുതന്നത്.” It is later deposed by PW2 that on the date of surgery opposite party doctor did not talk to Dr. Lakshmanan, and had talked only after the discharge. Dr. Lakshmanan who is an Ophthalmologist and closely related to the patient would have been the best witness to speak about the allegations of negligence in this case. But Dr. Lakshmanan is not examined as a witness. In our opinion the courtesy shown on the part of third opposite party doctor to talk and confide to Dr. Lakshmanan about the falling of lens and complications together with the detailed case summary issued to the patient would reveal that third opposite party has not suppressed anything and has been sufficiently transparent to the complainant regarding the complications that occurred during surgery. As the child was discharged on 01-5-2006 and as third opposite party had covnersed with Dr. Lakshmanan after discharge, the case of complainant that by suppressing complciations opposite party prevented the patient from availing better treatment is untenable. Moreover what was the better treatment the patient could have achieved within this short period before discharge is snot put forward by the complainant. 20. Complainant is also aggrieved that opposite party suppressed the occurrence of retinal detachment (RD). That it is not stated in Ext.X1 case sheet or in Ext.A1 case summary. Against this opposite party submitted that RD occurred later and it will not find a place in case sheet. This allegation raised by complainant is not supported by any pleadings. It is correct that RD is not mentioned in Ext.X1 case sheet. PW1 has deposed that RD occurs after cataract surgery at a later stage and that it is a known complication of cataract surgery. It is also called after cataract. The evidence of PW1 in this regard is as under: “PCO (Posterior Capsular Opaccification) is a subsequent event of cataract surgery. I agree that in majority of paediatrics cases it occurs. PCO is also called as 'after cataract'. Amblyopia treatment will not be effective if there is PCO or 'after cataract'.” Ext.A2 is the disability certificate issued to the patient dated, 09-12-2008. In Ext.A2 it is seen stated that right eye has 'after cataract' and left eye has lamellar cataract. The disability assessed is 50%. Ext.A2 does not state that there is total loss of vision in the operated eye. Its stated that there is after cataract. The treatment for 'after cataract' is also deposed by PW1. 21. After discharge, the complainant was reviewed at opposite party hospital on 08-5-2006, 27-5-2006, 01-6-2006 and lastly on 22-6-2006. On all these occasions he was seen by third opposite party doctor as well as in the retina clinic. On all these days he consulted as out patient only. On 01-6-2006 third opposite party has referred for second opinion. On 14-6-2006 the patient has approached Aravind Eye Hospital. Ext.X2 is the case sheet from Aravind Eye Hospital. Ext.X2 shows that in the right eye the vision is HM (Hand movements) and in the left eye (unoperated) it is still lamellar cataract. Ultra sound scan was done and RD was noted in right eye. The counsel for complainant submitted that later on 22-6-2006 though the patient was examined by third opposite party doctor and Ext.A1 case summary was issued the doctor failed to note RD in the case summary and this was deliberate suppression of the occurrence of RD. This contention was confuted by counsel for opposite party. It is submitted on 22-6-2006 the patient was subjected only to clinical examination by the doctor and that no scan was done. DW1 deposed that on two occasions earlier the patient had come only with reports. As the patient had already consulted another hospital on 14-6-2006 and investigations were done at that hospital, the doctor did not do any further investigations. That RD can be detected only by scan. This submission is probable and believable. After 22-6-2006 the complainant has not consulted opposite party doctor. This complaint is filed on 25-4-2008. Counsel for opposite party relied on the decision rendered in Shri.M.A.Ganesh Rao Vs Dr. T.M. A Pai Rotary Hospital 2006(3) CPR 328 NC. The principle laid is squarely applicable to the case before us. From the above discussions we are not able to accord agreement to the submission of the complainant that third opposite party has deliberately concealed the occurrence of RD and has committed deficiency. 22. It is further alleged that though in Ext.X1 case sheet opposite party has stated the diagnosis of the diseases suffered by the patient to be lamellar cataract and amblyopia, third opposite party doctor failed to mention the diagnosis of amblyopia in Ext.A1 case summary. That non mention of the diagnosis of amblyopia in the case summary issued to the patient is deficiency. Again this allegation is not supported by any pleadings. The evidence of PW1 narrates the relation between these two ailments. PW1 deposes as under: “I agree that there are various types of cataract. Lamellar cataract is a common congenital type of cataract. I do not agree that more than 50% of cataract is lamellar cataract category. Witness adds. About 20-25% will be. I cannot cite any authority for this at present without reference. In Lamellar cataract the development of lens will be interfered in a later stage.” “It is true that almost all cases of pediatric cataract have amblyopia. In paediatric cataract with amblyopia the reduced visual activity is due to two reasons. One is cataract and second is amblyopia. So in paediatrics cataract cases if the cataract alone is removed and the amblyopia is left untreated then the patient will not get full vision. It is correct to say amblyopia treatment after cataract surgery is necessary for best results.”
It is submitted by the counsel for opposite party that most pediatric cataract have amblyopia. This amblyopia develops due to the cataract which is interfering in the stimulation of the optic nerve. To treat this type of amblyopia (deprivation amblyopia) first the cause has to be treated by cataract surgery and then spectacles and occlusion therapy has to be given after surgery. In this regard the evidence of PW1 is as follows: “In treatment of lamellar cataract with amblyopia the amblyopia can be treated only after cataract surgery.” DW1 has deposed as under: “I agree that amblyopia is a partial loss of vision. Witness adds. It can be partial or full also. Amblyopia cannot be congenital. It is acquired. It is reversible if properly managed or if it is not managed it can lead to permanent visual loss. By proper management I mean that there is a probability of getting full vision. It is not fully correct to say that I have not treated the patient for amblyopia because the surgery done was part of/initial step of treating amblyopia. I do not agree that there will be cataract in all cases of amblyopia. I do not agree to the suggestion that I have not advised the patient for treatment of amblyopia because the surgery was part of treatment of amblyopia. In this case the presence of amblyopia is an important factor. It is partly correct to say that after this surgery the amblyopia treatment has to be started.” 23. In Ext.X1 the diagnosis noted by opposite party is lamellar cataract (developmental) with amblyopia. Amblyopia is a medical terminology used for an eye with dull vision. In the instant case, the cause of amblyopia is congenital lamellar cataract. To a person lay to the medical field the two ailments may seen totally separate and different. To an ophthalmologist these ailments are connected or rather very closely linked. A professional who peruses Ext.A1 will not be misled by the non-mention of amblyopia as the mention of the disease of lamellar cataract is sufficient to him. This is more clear from the evidence of PW1 who after seeing Ext.X1 has deposed that the child is suffering from lamellar cataract and no other disease though in Ext.X1 opposite party has mentioned lamellar cataract and amblyopia. This is because to a professional the mention of lamellar cataract is more important disease. Amblyopia if present should be treated only after treating cataract. Complainant has no case that the diagnosis was wrong. Ext.A1 case summary was issued to the complainant when he requested for it to go to other centres. Most of the details of treatment including falling of lens is stated in Ext.A1. Further, there is no evidence brought out to establish that complainant suffered any injury or loss due tot he non-mention of amblyopia in the case summary. For these reasons we are not inclined to accept the argument that non-mention of amblyopia in the case summary is deficiency. 24. It is the further case of complainant that proper consent was not obtained. Counsel for complainant argued that opposite party did not obtain consent to do vitrectomy. That consent was taken for doing cataract surgery only and that opposite party has performed vitrectomy surgery without obtaining consent. Ext.X1 contains the consent letter. This is signed by the father of the patient, the patient being a minor. The consent is obtained for doing surgery for the ailment of cataract, and also for anesthesia. The words in the consent letter is as under: “പെരിന്തല്മണ്ണ അല്സലാമ കണ്ണാശുപത്രിയില് വച്ച് എന്െറ വലത് കണ്ണിന് തിമിര രോഗത്തിനുളള ഓപ്പറേഷന് ചെയ്യുന്നതിനും അനസ്തേഷ്യ നല്കുന്നതിനും എനിക്ക് പൂര്ണ്ണ സമ്മതമാണ്. പ്രസ്തുത ഓപ്പറേഷന്െറയും അനസ്തേഷ്യയുടെയും എല്ലാ വരുംവരായ്കകളെപ്പറ്റിയും ഡോക്ടര് പറഞ്ഞുമനസ്സിലാക്കിത്തന്നിട്ടുണ്ട്.”
The treatment for lamellar cataract adopted by opposite party is cataract extraction + PPC + anterior vitrectomy + IOL. PW1 has deposed that this is the standard protocol in the ailment presented by the patient. Complainant has not challenged this mode of treatment adopted by opposite party. The cataract surgery thus includes vitrectomy also. No separate consent is required as it is part of cataract surgery. It is sufficiently clarified by PW1 that it is advisable to do anterior Vitrectomy in pediatric cataract and that vitrectomy is done as part of cataract surgery. The vitrectomy done by Dr. Kalpana was also part of the cataract surgery as she did it part of the process of retrieving the lens during the cataract surgery. In our view there is no lack of consent in this case as vitrectomy is part of procedure Dr. Kalpana is attached to opposite party hospital and it is affirmed that no doctors were called from outside, opposite party hospital to attend to the patient. She being part of opposite party hospital can be approached in case of emergency. Moreover according to PW1 the lens can be explanted only by a retina surgeon. It is the duty of a doctor to refer the case to expert in necessary situations. As the expert was available at opposite party hospital the situation was manged together with the surgery. 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. The purpose of holding a professional liable for his act or omission, if negligent is to make life safer and to eliminate the possibility of recurrence of negligence in future. The counsel for complainant relied upon Suresh Gupta Vs N.C.T. Delhi 2004 (3) KLT 14 (SC) and argued that mere inadvertance or some degree of want of adequate care and caution would create civil liability. That the falling of lens was due to lack of care and inadvertance and hence opposite party is liable. The evidence placed before us do not substantiate that it was due to any inadvertance on the part of third
opposite party that the lens dipped into Vitreous. Moreover, the question is whether by holding the doctor liable the recurrence of falling of lens can be eliminated. Relying upon the evidence of PW1 we have to answer in the negative. PW1 who has done more than 10,000 surgeries has stated that she had two occasions of the lens falling into vitreous. This complication is sufficiently documented also. In our view, holding a doctor liable for such a well documented and explained complication would curb the inventive and challenging mind of a professional. The tendency in any profession is always to take up cases which are less risky. Only a few show the courage to attend complicated cases. PW1 has stated that she does not take complicated cases. In Ext.X1 case sheet opposite party has noted 'under guarded visual prognosis'. In Ext.X2 case sheet in regard to the treatment for the left eye (unoperated) the doctor from Aravind Hospital has again noted guarded visual prognosis explained. PW1 stated that, 'we surgeons in complicated cases note as 'under guarded visual prognosis' which means the result is not sure'. Opposite party doctor has attempted to relieve the child of his sufferings fully knowing the complication and the risk involved. There are no errors brought out in evidence regarding the diagnosis made, method of treatment adopted, procedure done and management of complication. On perusal of the evidence in it's entirety we do not find even a mere preponderance of probability to hold the treating doctor liable. We find opposite parties not deficient in service. 25. In the result we dismiss the complaint. There is no order as to costs. Dated this 26th day of October, 2010.
Sd/- C.S. SULEKHA BEEVI, PRESIDENT
Sd/- MOHAMMED MUSTAFA KOOTHRADAN, Sd/- MEMBER E. AYISHAKUTTY, MEMBER
APPENDIX
Witness examined on the side of the complainant : PW1 and PW2 PW1 : Dr.Bharathi.P.M., expert on behalf of complainant. PW2 : Babu Raj, Father of the complainant. Documents marked on the side of the complainant : Ext.A1 and A2 Ext.A1 : Case Summary dated, 22-6-2006 from opposite party. Ext.A2 : Certificate dated, 09-12-2008 given by Dr.K.V. Raju, Professor & HOD., Dept. of Ophthalmology,Medical college, Kozhikode. Witness examined on the side of the opposite parties : DW1 DW1 : Dr. Binu Balan Parambath, third opposite party. Documents marked on the side of the opposite parties : Nil Third party documents marked : Ext.X1 and X2 Ext.X1 : Case sheet produced from opposite party hospital. Ext.X2 : Case sheet of Aravind Eye Hospital,
Sd/- C.S. SULEKHA BEEVI, PRESIDENT
Sd/- MOHAMMED MUSTAFA KOOTHRADAN, Sd/- MEMBER E. AYISHAKUTTY, MEMBER
| [HONOURABLE MR. MOHAMMED MUSTAFA KOOTHRADAN] Member[HONOURABLE MRS. C.S. SULEKHA BEEVI] PRESIDENT[HONOURABLE MS. E. AYISHAKUTTY] Member | |