National Consumer Disputes Redressal
Anmol Chitlangia vs Perfect Vision Lasik Laser Centre & Ors. on 7 September, 2015
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI CONSUMER CASE NO. 112 OF 2002 1. ANMOL CHITLANGIA S/o. Mr. Mohan Lal Chitlangia, R/o. 64, Block C, Sri Ganga Nagar Rajasthan ...........Complainant(s) Versus 1. PERFECT VISION LASIK LASER CENTRE & ORS. Through Its Managing Director/Chairman/Administrator,
Perfect Vision Lasik Laser Centre, 102, Shyam Anukampa Building Near Ahinsa Circle, Ashok Marg, C Scheme Jaipur Rajasthan 2. DR. VIRENDRA KUMAR AGGARWAL A A A 3. Dr. Anjali Kataria C 8, Moti Bagh, Bapu Nagar Jaipur - 15 Rajasthan 4. Dr. Sameer Sood A 28, West End New Delhi. 5. Dr. Kamal B Kapoor 8/9, Western Extention Area, Pusa Road New Delhi 6. United India Insurance Co. Ltd. Division Office No. 1, Dr. Jain Dharmatma Building, M I Road, Jaipur Rajasthan 7. United India Insurance Co. Ltd. Division Office No. 1, Dr. Jain Dharmatma Building, M I Road, Jaipur Rajasthan ...........Opp.Party(s)
BEFORE: HON'BLE MR. JUSTICE J.M. MALIK, PRESIDING MEMBER HON'BLE DR. S.M. KANTIKAR, MEMBER
For the Complainant : Mr. Bharat Sood, Advocate For the Opp.Party : For the opposite party No.1 : Mr. Bhupender S. Chauhan, Advocate
For the opposite party No.2 : Mr. O.P. Verma, Advocate for
Ms. Anjali Kataria, Advocate
For the opposite party No.3 : Mr. B.K. Sood, Advocate with
Mr. Gaurav Garg, Advocate
For the opposite party No.4 : Mr. Rohit Gandhi, Advocate
For the opposite party No.5 : NEMO
Dated : 07 Sep 2015 ORDER
DR. S. M. KANTIKAR, MEMBER
The eyes are probably the most important and interesting part of the human face. LASIK eye surgery is a routine procedure conducted to correct vision problems and grant people the opportunity to live a life free of contacts or glasses. Generally, the procedure is safe. However, when things go wrong, complications may be serious and the patients could be entitled to collect damages for their injuries.
1.The complainant, Mr. Amol Chitlangia ( herein referred as "Patient") came across the representation and advertisement of the Perfect Vision Lasik Laser Centre, Jaipur, the opposite party No.1 in the local newspaper. Allured by the advertisement, he approached the OP-1 in February 2000 and met Dr. Virendra Kumar Aggarwal, who assured that, the latest technology available by which spectacles used for myopia can be removed. He read the brochure and came to know that, myopia, hyper-metropia and astigmatism was treated by Dr. Virendra Kumar Aggarwal, a Chief Lasik Surgeon equipped with high ended machineries. The OP-1 assured that after surgery, the eye sight becomes normal, no stitches or bandage is required. It will take one to two minutes by Lasik surgeon and after operation the patient can go to house within 12 to 24 hours and perform his routine functions within 12 to 24 hours. Patient underwent Lasik surgery on 28.3.2000. As Dr.Virendra Kumar Agrawal was not available , the surgery performed by Dr. Sameer Sood, OP-4 assisted by Dr.Anjali Kataria(OP-3) and Dr.Kamal B.Kapoor (OP-5). Affter the procedure the complainant was advised to go and take rest in the hotel, avoid dusty conditions in his journey. He should not take bath for a week to avoid any infection and asked for follow up on 29-03-2000or for any assistance to contact Dr. Anjali Kataria. The complainant on 29-03-2000 complained about severe pain in the eye, headache and glare in the eyes. The OP-3 examined him in a casual manner and advised pain killers. The patient went to his hometown by AC train, but there was no improvement in his vision. Thereafter, the complainant became suspicious, contacted Rajasthan Laser Eye Centre Pvt. Ltd. at Jaipur for the assessment of the procedure. Dr. Nalini Sen ordered ORBSCAN on payment of Rs.1,000/- as scanning fee. The complainant was informed that the procedure was adopted on 6.5 mm pupil while the actual size of the pupil was 7 mm. Thereafter, the complainant tried to contact Dr. Sameer Sood and Dr. Kamal B. Kapoor who performed the procedure on him in March 2000 and learnt that both have been shifted to New Delhi, engaged in practice. It is further alleged that Dr. Sameer Sood stated that the surgery is irreversible and the patient has to live the rest of his life with partial vision. He told the complainant that in the pre-operative assessment, Dr. Anjali Kataria never prepared a report and informed him about neither larger pupil nor Dr. Kamal B. Kapoor, who assisted him in the procedure cared to see the report. Dr. Sood gave his opinion which clearly endorses the view that, the operation was wrongly conducted. Thereafter, the patient contacted various doctors in Jaipur and Delhi namely Dr. Ashok Puri and Dr. Sanjay Chaudhary who prescribed Pilocar eye drops for temporary relief from glare and headache. He was also advised not to use Pilocar for long time which may lead to retinal detachment and rise in IOP causing Glaucoma. The same was also informed by AIIMS, Safdarjung Hospital and Sucheta Kriplani Hospital. The complainant also contacted various research institutes in USA and Canada for his corrective surgery.
2. The complainant alleged that, as a result of negligence, reckless Lasik surgery performed by OPs, he became practically blind, unable to see anything in the broad day light, unable to operate computers for accounting or research purpose. Also he cannot drive or even walk alone without the assistance of an escort; he cannot supervise his agricultural operations or work as partner in the Finance Co. and is under constant threat of being removed from the partnership business of Finance/Accounting and marketing. That in spite of having such contacts, prestigious social reputation, a glaring future, he cannot even think of getting a suitable match congenial with the status of his family, several matrimonial alliances were forced to be withdrawn. Overall the complainant has been reduced just to vegetable and has lost all self esteems physical incapacitation resulting into loss in business. Thus he needs full time assistants, a driver for the rest of his life. Hence, the complainant filed a complaint on 26/3/2002 before this Commission and prayed for Rs.77,12,000/- with other reliefs as prayed in the prayer clause.
Defense:
3. In the defense the opposite parties denied all allegations of complainant and no cause of action to claim any amount. OPs filed their respective affidavits of evidence and interrogatories. OP-4-Dr. Sameer Sood submitted that, he is a qualified doctor and took training in USA for Lasik. He is an expert and has performed live surgeries on National TV Network during the year 2000-2001. He is actively involved in surgical training of fellow ophthalmologists and senior colleagues in Lasik Phaco procedures from all over India. Therefore, the OP-4 had necessary expertise in performing the Laser and Phaco surgery. The counsel for OP-5 submitted that OP-5, Dr. Kamal Kapoor is a renowned Ophthalmologist having nine years of experience. He took super specialty training in ophthalmic lasers from Sweden.
4. The AIIMS report, the documents and the CD placed on record completely demolish the case of the complainant. The OP-3 & 4 denied that, they have received any payment from the complainant. The complainant paid the charges to OP-1; therefore complainant cannot claim compensation from OP-3 and 4. The OP 3 and 4 submitted that size of pupil noted as "6.5 mm in both eyes" was incorrect, whereas the correct pupil size done by "Orbscan Topography" as 4.7 mm and 4.5 mm. Orbscan is one of the gold standard test to measure the pupil size. AIIMS report clearly indicates that, patient had a good/normal eye sight since 6/12 (Right) and 6/9 in left eye. (As per Annexure-B 6/6 to 6/18 is considered to be good/normal vision). Dr. Sameer Sood OP-3 relied upon the published work of Dr. Murray Mc Faddeen, MD, a renowned doctor of repute, (Annexure-R1).
Arguments:
5. The complainant filed the medical prescriptions, reports, medical record from the hospital, the relevant bills, medical literature and his Income Tax Returns. This Commission referred this case to Dr. Rajendra Prasad Centre for Ophthalmic Science at AIIMS, New Delhi twice for an expert opinion. As per the 1st report dated 31/10/2008, the pupil size was 6.5mm while the laser ablation diameter was 6.00 mm. However, the report was unable to give further findings since the notes of the operation were missing. Therefore, 2nd report was given on 12/9/2011, after extensive examination of the complainant. It is reported as patient had "Compound Myopic Astigmatism post Lasik surgery with significantly reduced glare acuity, in both eyes". The findings about pupil size and the laser ablation diameter were same as 1st report. Therefore, collectively considering opinion of Dr. Sameer Sood as well as the AIIMS report, in the instant case the ablation zone was smaller than the pupil size which had resulted in difficulties for the patient to see post operatively. The complainant mainly alleged that, the Lasik surgery was incorrectly/negligently performed. For Lasik the ablation zone should be larger than the pupil size under normal low light conditions. As per AIIMS report the area of ablation was smaller than the pupil size. AIIMS reported that there was a loss of eye sight of the complainant. The complainant was not informed about such effects after the Lasik surgery. Dr. Samir Sood expressed that the process is irreversible and complainant has to live with his problem throughout his future life. The counsel relied upon the judgment of the Hon'ble Supreme Court in Jacob Mathew Vs. State of Punjab 2005(6) SCC 1. In para 48 (3) of the said judgment it is specifically stated that;
a professional may be held liable for negligence if he did not exercise with reasonable competence in the given case, the scale which he did possess.
6. In the instant case, admittedly there was a fundamental error in the surgery itself, therefore, Dr. Sameer Sood and Dr. Kapoor, as well as the Perfect Vision Lasik Laser Centre is also liable. The Counsel put reliance upon, Savita Garg's case, 2004(6) SCC 56 in which, the hospital was held liable. Regarding the extent of liability the counsel took the basis of Charan Singh Vs. Healing Touch Hospital, 2000(7) SCC 668 and submitted that claim is quantified to Rs.2,77,12,000/-.
7. The counsel for OP denied the negligence. The Lasik surgery was performed properly. The patient was informed all the pros and cons of Lasik, it was performed after informed consent. He brought our attention to the income tax returns filed by complainant which indicate the payment of small amount .The IT returns are not indicative of prosperity or the earning capacity of the complainant, to claim such huge amount from OPs. The counsel for OP further argued that the observation of Dr.Nalini Das and Orbscan clearly establish that complainant had not suffered due to any medical negligence. He placed reliance upon, the scientific work pertaining to Lasik Laser Eye Surgery and it's procedure. He placed a document (Annexure R-1) on record , authored by Dr. Murray McFaddeen, M.D. who is a world's renowned eye surgeon. Therefore, the Lasik Laser operation was performed in consonance with the requisite parameters. Further submitted that, Orbscan is a test, is known as "Gold Standard Objective Test", which measures pupil at the largest physiological state and therefore, indicate the zone of ablation, which is required for performing Lasik Surgery. It is a cardinal principle of the Lasik Surgery that the ablation zone (diameter of optical zone) should be greater than the diameter of the pupil under normal low light conditions. The Annexure P-5, it shows that the complainant had contacted the Rajasthan Laser Eye Centre after one year of his Lasik Operation, thus it clearly indicates that the patient did not suffer from a complication. It appears to be a case of a malingerer (where the patient imagines rather than suffers the effects). The counsel submitted that, OP performed Lasik as per standards, but the entire case being misconceived is liable to be rejected.
Findings and Reasons:
8. We have perused the medical record and the evidence on file. It is pertinent to note that, there is no record or prescriptions about eye drop Pilocar which purchased by the complainant continuously from 12.3.2000 to 8.12.2001. Thus, it appears self-medication or he was under medication from other doctor. The preliminary report dated 08-02-2000 revealed an entry as "large pupil". The pupil size is normally measured by "ORBSCAN" which calculates the average size of the pupil in low light by exposing the eye to differing degrees of low light.
That in the instant case, on 8th February 2000 the complainant tested his pupil diameter manually, revealed "R 6.5 mm & L 6.5 mm", he was having spectacle power to the tune of - 5.25 for both his eyes.
9. After the said Lasik operation, the complainant approached the Rajasthan Laser Eye Center Pvt. Ltd. for assessment of the Lasik procedure performed on him, which informed him that the procedure was performed on 6.5 mm pupil, while the size of the pupil was 7 mm and hence complainant had problem in his vision. It is interesting to note that, the ORBSCAN performed on 14/5/2001,revealed following readings of pupil Pupil diameter of his left eye is 5.6 mm Pupil diameter of his left eye is 5.8 mm Further vision test revealed:
Right eye - 6/18 without spects (Connoting about 65% vision) Left eye - 6/6 without spects (Connoting perfectly normal 100% vision)
Therefore, it is clear that even on that date, the vision of the complainant was not substantially impaired. Preoperatively he was using glasses of - 5.25 power spects for both his eyes. He was advised to wear spectacles having power of - 0.5 SPE/-1.25 to correct the vision in his right eye to 6/5.
Therefore, we do not accept that the patient was completely blind/near blindness after Lasik.
Literature and Scientific basis:
10. We have perused the literature on the subject through the books on ophthalmology (Parsons), Mayo Clinic, and various websites. The procedural aspects of Lasik are that, the operational Area also known as (Ablation Zone) should be bigger than pupil size. Orbscan is a "Gold Standard Objective Test", which gives the actual resting size of pupil. As per Orbscan report dated 14/5/2001 furnished by the complainant himself, revealed diameter of Right eye pupil 5.8 mm, and left eye pupil as 5.5 mm. This report was taken almost 1 ½ years after surgery. It clearly establishes that ablation zone, was bigger than pupil size and, therefore, the Lasik surgery was done within the accepted parameter.
LASIK eye surgery is performed using a laser programmed to remove a defined amount of tissue from your cornea. With each pulse of the laser beam, a tiny amount of corneal tissue is removed. The laser allows your eye surgeon to flatten the curve of your cornea or make it steeper. Often, LASIK is performed on both eyes on the same day.
Your results depend on your specific refractive error and other factors. People with a low grade of nearsightedness tend to have the most success with refractive surgery. People with a high degree of nearsightedness or farsightedness along with astigmatism have less predictable results.
Many people have positive results and report high satisfaction after LASIK surgery. However, long-term results often aren't available, as many people are sufficiently satisfied after surgery. They don't feel a need for repeat examination, and they become lost to follow-up. Also, the LASIK procedure has evolved over time, and the procedure done today is different from the procedure done a few years ago.
Thickness of Cornea:
A good LASIK candidate has corneas of at least average thickness. Corneal thickness is hereditary and on average is about 540 to 560 microns (and a micron is one millionth of a meter). The usual minimum thickness required for LASIK is 410 microns.
The LASIK procedure, it is important to note, How thick is the cornea and what is the ablation depth? The ablation depth and corneal thickness are essentially integrated. As a medico-legal standard, a 250-μm residual stromal bed (RSB) is fairly accepted as the minimum tissue that must remain in place. Some surgeons are more conservative and require a 300-μm RSB. In the Leaming Survey 2011, 99% of surgeons surveyed would not operate on a cornea thinner than 250 μm of RSB, yet 37.7% place their cut off at 300 μm.
One important factor to consider when evaluating whether or not a patient is a good candidate for LASIK is how stable their visual result is likely to be following the procedure. Stability, in large part, depends upon the amount of remaining tissue after the flap has been lifted and the laser treatment has been performed. The thinner the remaining bed of tissue, the greater the risk of corneal instability.
The average central corneal thickness is between 500-550 microns. (500 microns = ½ millimetre) Most flaps are made between 160 to 200 microns thick to avoid irregularity. The tissue removed is directly correlated to the amount of prescription being treated. It is calculated by the formula, 12 microns per dioptre treated. For example, to correct .4 dioptres of prescription, the laser would need to remove 12 x 4 dioptres or 48 microns of tissue. Therefore, if one has a 500 micron cornea and a 180 micron flap is created, the remaining bed would be 500. (180. 48) = 272 microns.
Pupil Size Before you have any LASIK vision correction, your eyes will be diagnosed for their exact vision errors. LASIK needs to be done over a treatment area that is as large, or larger than, the size of your dilated pupil. The reason is that if your dilated pupils will be admitting light that has passed through a non-treated corneal area, your vision will be distorted. There is a maximum area where the LASIK laser can work without risking corneal damage, and if your pupils dilate larger than that area, you would not be a good LASIK candidate.
11. This commission referred this case for opinion to R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi on two occasions. On Second time, he was evaluated on 16th, 17th and 21st June by a team of Ophthalmologist(Prof.J.S.Titiyal,Dr.Tanuj Dada & Dr.Rajesh Sinha). They have given the report dated 12.9.2011 as below:
"He(patient) had chief complaints of glare in both the eyes with shadowing and diplopia. He was wearing glasses of -1.75 Dsph/ -2.0 Dcyl x 48º in the RE and -1.75 Dsph/ -0.50 Dcyl x 110 º in the LE. His visual acuity with glasses was 6/12 p and 6/9 in RE and LE respectively. A cycloplegic refraction was done and at post-mydriatic test his best corrected visual acuity was 6/9p with -4.0 Dsph/ -1.0 Dcyl x 40º in the RE and 6/9 with -1.75 Dsph/ -1.25 Dcyl x 100º in the LE. His glare acuity was 20/400p in the RE and 20/150p in the LE. The pupil size as detected on Orbscan Topograpy was 4.7 mm and 4.5 mm in RE and LE respectively. The Central Corneal Thickness on Orbascan was 427 and 407 microns in the RE and LE respectively. The simulated Keratometry was 42.9 D @ 16º in the RE and 41.5 D @78º/41.0 D @ 168º in LE. On clinical examination of Anterior Segment as well as Posterior Segment, there were no significant abnormality found. The Central macular thickness on Ocular Coherence Tomography was 273 and 272 microns in RE and LE respectively.
Conclusion : On examination, it is concluded that he has Compound Myopic Astigmatism. Post LASIK Surgery with significantly reduced glare acuity in both the eyes."
12. The patient consulted one Dr. Mahipal S. Sachdev who issued a certificate, it is reproduced as;
December 21, 2005 TO WHOMSOEVER IT MAY CONCERN This is to certify that night glare and halos may be encountered after Laser Refractive surgery. It tends to settle down over time.
In addition, in patients who may still be complaining of the same problem, a wave front guided enhancement procedure may be undertaken to alleviate these symptoms.
Truly yours, Dr. Mahipal S. Sachdev Sr. Consultant (Ophthalmology)
13. The complainant admitted that, he does not have any car, but he possesses driving license which was obtained with assistance of agent. It is only for Photo ID purpose used in various offices like banks and other places. We have perused the CD submitted by OP, which clearly revealed the complainant drives the car, can walk and attend his duty. Hence, the submissions of complainant are false.
14. Catena of judgments from Supreme Court and this commission discussed the medical negligence. In Jacob Mathew V State of Punjab & Anr, (2005) 6 SSC 1 had concluded that, "a professional may be held liable on one of two findings : either he was not possessed of requisite skill which he professed to have possessed, or, he did not exercise reasonable competence in given case, the skill which he did possess."
15. In Achutrao Haribhau Khodwa vs. State of Maharastra - 1996 (2) SCC 634, Hon‟ble Supreme Court held :
"The skill of medical practitioners differs from doctor to doctor. The nature of the profession is such that there may be more than one course of treatment which may be advisable for treating a patient. Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution. Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession on and the Court finds that he has attended on the patient with due care skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence. In cases where the doctors act carelessly and in a manner which is not expected of a medical practitioner, then in such a case an action in torts would be maintainable."
16. As per literature, negligence in LASIK procedure is by failure to screen the patient properly. The issue is not with how the surgery was performed. Rather, it was because the surgery never should have been performed at all. Surgery is not appropriate for patients who have ectasia or suspicion for similar diseases of the cornea. Also, patients with thin corneas may not be suitable candidates for LASIK surgery. The decision whether a patient is a suitable LASIK needs to be carefully assessed by a knowledgeable and competent LASIK surgeon. Errors occur when the surgeons are too busy or delegate such decision making to less-trained staff.
17. In the instant case, the corneal thickness was sufficient for Lasik, and the OPs kept the RBS to more than 340 micron. It was careful procedure adopted by the OPs. Hence we do not find any negligence.
18. During the course of arguments on 25-08-2014 an offer was made by the counsel of OP-3 that OP will make an attempt to know the condition of the eyes at present and chances of any treatment at this stage. Therefore, the complainant was directed to approach Dr. Sameer Sood at Sharp Sight Laser Centre Pvt. Ltd., New Delhi. The complainant was examined there and a case report was sent by Dr. Kamal B. Kapoor. It is stated that "After our clinical evaluation and cross consultation we recommend either Femtolasik or PRK to treat and reduce the problems faced by Mr. Amol. With Femtolasik his refractive error can also be improved using wavefront laser profiling. Also with PRK the chances of his refractive error improvement are higher."
19. Therefore, on the basis of the forgoing discussion, the negligence is not proved by the complainant. Accordingly, we dismiss the complaint. However, as discussed in para 18 supra, the complainant may approach to Sharp Sight Laser Centre Pvt. Ltd., New Delhi for his treatment and the Centre is requested to treat the complainant's visual problems sympathetically free of cost or at nominal charges.
......................J J.M. MALIK PRESIDING MEMBER ...................... DR. S.M. KANTIKAR MEMBER