PER HONBLE MRS. M. SHREESHA, MEMBER Aggrieved by the order dated 08.06.2016 in CC/03/21, passed by the Maharashtra State Consumer Disputes Redressal Commission (in short the State Commission), Dr. R.C. Patel (hereinafter referred to as the Treating Doctor) and Allergan India Private Limited (hereinafter referred to as the Manufacturer) preferred these First Appeals No. 1058 of 2016 and 207 of 2017, respectively, under Section 19 of the Consumer Protection Act, 1986 (in short the). By the impugned order, the State Commission has allowed the Complaint in part directing the Opposite Parties jointly and severally to pay an amount of 5,00,000/- as lump sum compensation, reimburse 1,64,364/- towards medical expenses and pay cost of 20,000/- within 45 days failing which the amount would attract interest @ 9% p.a.

2. The facts in brief are that the Complainant approached the Ophthalmic Department of Bombay Hospital and Research Centre in the month of October, 2000 when he was diagnosed to be having a cataract problem in both the eyes and was advised to undergo surgery for the same. He was admitted as an indoor patient at the Hospital and was taken for eye surgery on 16.01.2001 by the Treating Doctor, after conducting the necessary pre-operative tests. It is stated that Intraocular Lens (IOL) of M/s Allergan Surgical (U.S.A.) having serial No. 1259070010 -3- purchased through M/s Shivneh Phaco & Eye Micro Surgery, Mumbai (hereinafter referred to as the Dealer) for consideration of 3,200/- was inserted and the Complainant was discharged on

20.01.2001. During the course of post-operative examination by the Treating Doctor, it was found that the inserted lens was opaque and ineffective. It is averred that the same was brought to the notice of the Complainant by the Treating Doctor and he was advised to under a second surgery. It is stated that the Treating Doctor immediately contacted the Manufacturer, the Manufacturers representative Mr. Sharma agreed to bear the cost of the second surgery. Thereafter the Complainant was taken for the second surgery on 01.05.2001 and another lens was inserted and the Complainant was discharged on 02.05.2001.

3. It is pleaded that despite the second Surgery, the Complainants eye sight instead of improving became worse day by day. It is further averred that it is only because of multiple surgeries that was conducted, the Complainants eye sight had become worse affecting the conduction of his normal duties in his daily life. A Legal Notice dated 11.12.2002 was addressed by the Complainant to the Manufacturer and the Treating Doctor, which was not replied by the Manufacturer. The Treating Doctor vide reply dated 31.12.2002 admitted that the first IOL became opaque necessitating the second surgery on 01.05.2001, on account of which the left eye cornea was affected considerably. Thereafter the Complainant approached the State Commission seeking a direction to the manufacturer and the Treating Doctor to pay an amount of 15,00,000/- for the defective services and negligence, which resulted in physical and mental trauma together with costs and other reliefs.

4. The Manufacturer, though duly served did not choose to appear or represent before the State Commission.

5. The Dealer and the Treating Doctor have filed a joint Written Statement admitting the conduction of the first cataract surgery on 16.01.2001; that the Complainant paid a sum of 3,200/- for the lens; that the IOL being opaque and ineffective found during the post-operative visits; that the Manufacturer having agreed to bear the entire cost of the surgery and that the Complainant was advised to undergo second surgery during which the defective opaque lens was removed and replaced by another lens of different company. It is averred that after the second surgery the Complainant was having a good vision for almost 1 years and it was only thereafter the vision in his left eye deteriorated. It is pleaded by the Treating Doctor that it is not possible to check the functional ability and the quality of the said lens by ordinary and physical examination, same has to be tested using specialised equipments which are available only with the manufacturers. It is further stated that before the packing of the lens it is the Manufacturers duty to check the quality of the functional ability and certify their safety. It is presumed that such lens supplied by a reputed company like the Manufacturer herein would confirm to the best possible quality design and safety. The box containing The lens are not opened till implantation as there is strong chance of them getting contaminated, hence the box containing the lens was intact and not opened till just prior to the surgery.

6. It is pleaded that the defective lens was sent to the manufacturer by the Treating Doctor to conduct various tests. It was sent to their laboratory in USA, but there was no response despite repeated oral reminders.

7. In the left eye where the lens was implanted, the Complainant was having a vision of 6/4 (90%) immediately post operative, which deteriorated to 6/24 (30%) at the end of two years. It is pleaded by the Treating Doctor that the Complainant was an aged person and was also diabetic, which could have led to the deterioration of the vision.

8. It is stated that a corneal changes may have occurred on account of the second surgery, which was necessary to replace the defective lens. The second surgery was done without charging the Complainant and no deficiency of service can be attributed to the Treating Doctor as all effective steps under normal medical parlance was taken by him. It is denied that the Complainant was having total blindness and that his professional earning was affected. It is stated that no negligence can be attributed to them and they seeks dismissal of the Complaint with cost.

9. The State Commission based on the evidence adduced allowed the Complaint in part with the aforenoted reliefs.

10. All parties were heard at length.

11. Learned Counsel appearing for the Manufacturer submitted that IOL business unit was sold by Allergan group to Advance Medical Optics on worldwide basis and the Indian arm of IOL business was with Abbott Medical Optics Limited, who in turn sold the business to Johnson & Johnson on going concern basis. Since the Manufacturer had shifted their office to the address now given, they had no knowledge of the Consumer Complaint and therefore could not appear before the State Commission. It is submitted that no evidence could be placed by them for the alleged defective IOL. Learned Counsel appearing for the Manufacturer, vehemently, contended that the Treating Doctor had declared that IOL was defective even before extracting the alleged defective lens from the patients eye and the negligence if any is solely of the Treating Doctor and the Manufacturer cannot be held liable. The second surgery also failed due to delayed corneal decompensation without taking any second opinion. The contention of the Treating Doctor that there was corneal damage on account of second surgery could be applied to the first surgery as well and it is only the negligence of the Treating Doctor which has led to the failure of both the surgeries. Learned Counsel further argued that they were not in the knowledge that Mr. Sharma had paid an amount of 40,000/- in cash and had agreed to bear the entire cost of the surgery only on account of the lens being defective.

12. It is pleaded that there are several reasons for failure of cataract surgery and loss of vision and therefore the sole argument of the Treating Doctor that the second surgery was necessitated because of the lens being opaque cannot be taken into account as a final reason for the failure. The patient was diabetic and moreover opacification of IOL and corneal decompensation are individual reasons from each other and if the patient had regained 90% of the vision immediately post the second surgery and thereafter delayed decompensation led to the deterioration in vision to 30%, the State Commission ought not to have come to the conclusion that the Manufacturer is liable for the alleged defective lens, which could have caused failure of the surgery. Learned counsel relied on the Medical Literature Post-Operative Capsular Opacificaiton: A Review, by Shetal M. Raj, Abhay r. Vasavada, S.r. Kaid Johar, Vaishali A, Vasadava, and Viraj A. which is classified into Anterior Capsule Opacification (ACO) and Posterior Capsular Vasavada, Opacification (PCO) and reads as under: Anterior Capsule Opacification (ACO) Opacification of the residual peripheral anterior capsule is known as anterior capsule opacification (Figure 2A). this is pronounced in eyes in which a continuous curvilinear capsular opening overlaps the IOL edge and peripheral anterior IOL surface (5,6). This opacification sets in by the first postoperative month and continues under 6 months (7). Some studies have cited the IOL material and the IOL design as influencing factors for ACO (8,9). An analysis of the opacified anterior capsule lying over the IOL can provide inference on the chemical and physical properties of the different IOL materials.. Posterior Capsular Opacification (PCO) Posterior Capsular Opacification, referred to as secondary cataract or after cataract, develops over the clear posterior capsule a few months to a few years after an uneventful cataract surgery (Figure 2A, 2B, 2C). PCO results from the growth and abnormal proliferation of LECs on the capsule at the time of cataract surgery. These cells migrate to the posterior capsule where they approach the central visual axis and cause visual axis obscuration, resulting in dimness of vision. The PCO has two forms, fibrous and pearl. Sometimes a combination of both is also found (Figure 2B). the LECs that line the anterior capsule are believed to be responsible for fibrous PVO (Figure 2C). clinically it is seen as a wrinkling on the posterior capsule at the site of fusion of the anterior and posterior capsules

13. Learned Counsel appearing for the Treating Doctor has submitted that it is only on account of the opaque lens that the second surgery was necessitated, which was performed free of cost. It was also averred that the first surgery conducted on 16.01.2001 was attended by the Complainants daughter, who is also a Doctor; that only the Manufacturer is responsible for the defective lens and for the loss of vision after the second surgery, which could be due to delay decompensation on account of the performance of the second surgery and therefore no negligence can be attributed to the Treating Doctor.

14. The admitted facts are that the Complainant was admitted for cataract on 16.01.2001 by the Treating Doctor in Bombay Hospital and Research Centre; that the Treating Doctor during post-operative care found that the lens inserted was being opaque and ineffective and advised the Complainant to undergo second surgery, which was conducted by the same Treating Doctor on

01.05.2001 and the initial IOL was removed and a second lens was inserted. It is also an admitted fact that the Complainants vision deteriorated from 6/4 (90%) to 6/24 (30%) by the end of two years. In the joint Written Version filed by the Dealer and the Treating Doctor, it was also stated that the defective lens was sent to the manufacturer for lab tests to USA, but there was no response. The deterioration in the Complainants vision was also admitted in Para J of the Written Version together with the reason being delayed decompensation. It is the case of the Treating Doctor that when imported lens are purchased from a reputed manufacturer, it is assured that all required tests and quality control are done before supplying the lens and also that the lens box is opened just before the surgery to avoid contamination and it is not possible for the Treating Doctor to examine the quality of lens prior to the surgery. It is specifically pleaded that photograph of the said lens was taken by the treating Doctor and that the entire treatment cost of the second surgery was agreed to be borne by the Manufacturer. Learned Counsel appearing for the Manufacturer vehemently denied this submission and stated that there is no evidence on record to establish that the failure for the cataract surgery and for the loss of vision is on account of the alleged defective lens. The contention of the learned Counsel, placing reliance on the medical literature filed by him with respect to Anterior Capsule Opacification (ACO) and 1. 2. 3. Posterior Capsular Opacification (PCO) is not relevant to the facts of the instant case as discharge summary and the Hospital treatment record does not anywhere note the same.

15. The Complainant filed some abstracts downloaded from the website, which showed that usage of lens manufactured by Allergan Inc. resulted in Phacoemulsification on come patients. Since this material is not supported by any documentary evidence we are of the considered view that this material alone is not of any evidentiary value.

16. As can be seen, from the discharge summary, the Patient remained in admission for five days from 015.01.2001 to 20.01.2001 on account of the complications which arose because of the failure of the first surgery. In the Written Version and Affidavit filed by the Treating Doctor and the Dealer of the Manufacturer herein, we are of the considered view that the first lens was indeed opaque. The discharge summary, which is the first medical record immediately after the discharge, clearly stated that the lens was opaque. Even in the second discharge summary dated

05.02.2001 in the patients history and examination it is clearly written history of H.O. Opaqueness of IOL after cataract surgery and in the operation notes it is clearly written replacement of the lens, therefore the contention of the counsel appearing for the Manufacturer that the reason for failure of surgery was not the lens manufactured by them is unsustainable and more so, when the observation regarding the lens being opaque was made by the Treating Doctor immediately during post-operative care. Having observed so, we now address ourselves to the contention of the Treating Doctor that the loss of vision even after the second surgery cannot be attributed to any negligence on his behalf.

17. In a catena of judgements, the Honble Supreme Court has laid down the essential components of Negligence as follows:- The existence of a duty to take care which the defendant owes to the plaintiff; The breach of that duty towards the plaintiff and Damage or injury by the complainant as a result of such breach. The Duty of Care for a medical professional starts from the time the patient gives an implied consent for his treatment and the medical professional accepts him as a patient for treatment, irrespective of financial considerations. This duty starts from taking the history of the patient and covers all aspects of the treatment, like writing proper case notes, performing proper clinical examination, advising necessary tests and investigations, making a proper diagnosis, and carrying out careful treatment.

18. The Medical definition of decompensation of cornea is a nonspecific response to In mechanical injury from incidental corneal contact by intraocular instrument during surgery. the present case where the Complainant is a senior citizen, as per the medical literature, the most common cause of decompensation of cornea is cataract removal.

19. At this juncture, we are of the view that the question whether the Treating Doctor could verify the opaqueness or otherwise of the lens, just prior to the surgery, needs to be taken into consideration. In the medical literature seen by us, it is stated that whether the lens were opaque or not can be verified if it is an open lens and that at the time of cause of action preloaded lenses were not ordinarily used. We place reliance on the article Human Error during Cataract wherein the protocol has Surgery: Right Patient, WRONG LENS, written by : Laura J. Ronge, been explained as adopted by a few world renowned. The relevant portion is reproduced as hereunder: Protocol Per the Academy , cornea and external diseases, University of Dr. Richard L. Abbott, MD Professor California, San Francisco, and secretary for the Academys Quality of Care and Knowledge Base Development, suggested that a good starting point is the recommended policy of the Academy. All the experts stressed the importance of taking a time-out in the operating room before surgery during every case to double-check everything, as suggested by the Academy policy. Make sure that the patient identity is correct, that the medical record is in the OR, and that the A-scan and IOL calculation forms are correct, Dr. Abbott advised.

The lens should be matched to what has been requested in the medical record, and this should all be confirmed in the OR during the time-out period. When the lens is opened, the details of lens power, type of lens, etc., should be stated verbally by the scrub nurse to the surgeon,

he said. MD Professor of Verify, reconfirm, double-check. Dr. Douglas D. Koch, ophthalmology, Baylor College of Medicine, Houston, described a similar protocol at his institution:

During the time-out in the operating room, we verify the implant power and the patients identity. We announce the patients identity and the procedure, and check the power of the implant by looking at the IOL calculation sheet. Finally, we reconfirm the IOL power by looking at the IOL box before it is opened. Our nurses pull the intraocular lenses the night before and place them with the surgical In this way, there is no mixing of the lenses that will be supplies for that given patient. used during the day,

he said.

The task of selecting the implant power can be delegated to a reliable assistant, but I prefer to verify the IOL selection.

Dr. Koch The surgeon is ultimately responsible, said. MD Clinical professor of ophthalmology, Protocol Per Dr. David F. Chang, University of California, San Francisco, and in private practice, Los Altos, Calif. Dr. Chang described the universal protocol for the 12 ophthalmologists using his ASC:

The circulating nurse, the scrub tech and the surgeon are all involved in confirming that the proper IOL is being implanted. The IOLs are ordered using a standardized fax sheet listing the days scheduled patients alongside their required IOL. If this sheet lists 10 names, then a copy of the form is cut into 10 strips, each containing one patient name and the matched IOL. This paper strip serves as an ID tag, and is taped to the IOL box that has been pulled for that patient. The surgeon checks all of these IOLs (with their paper ID tags) against his or her patient charts before the start of surgery. This would identify any clerical error made during Before opening ordering, or whether the wrong IOL model or power has been pulled. the IOL box during surgery, the circulating nurse announces the patient name written on the ID tag on the box, allowing the surgeon to verify that this matches the patient undergoing surgery,

he said. (Emphasis supplied)

20. From the aforenoted standard protocol it is clear that it is the surgeon, who has to verify the quality of the lens, which includes the power and the suitability. The quality of the lens includes checking the opaqueness, if any, in the subject lens. Therefore the contention of the Doctor that the quality/ opaqueness or otherwise can be examined only by the manufacturer alone cannot be sustained.

21. The Honble Supreme Court in the case of Dr.Laxman Balakrishna Joshi v. Dr. Trimbak has held:- Babu Godbole AIR 1969 SC 128 A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for that purpose,

1. he owes a duty of care in deciding whether to undertake the case,

2. he owes a duty of care in deciding what treatment to give and,

3. he owes a duty of care in the administration of that treatment. A breach of any of these duties gives a right of action for negligence to the patient. This means that when a medical professional, who possesses a certain degree of skill and knowledge, decides to treat a patient, he is duty bound to treat him with a reasonable degree of skill, care, and knowledge. Failure to act in accordance with the medical standards in vogue and failure to exercise due care and diligence are generally deemed to constitute medical negligence.

22. From the aforenoted law laid down by the Honble Supreme Court the Doctor owes a duty of care in the administration of the treatment and any breach of these duties gives a right of action for negligence to the Patient. In the instant case we are of the view that the Treating Doctor could ascertain by looking at the lens, the opaqueness or otherwise just prior to the insertion of the lens. The fact remains that the second surgery was necessitated only because of opaqueness of the lens which was inserted. Hence, we are of the considered opinion that there is a manufacturing defect in the lens, the manufacturer is liable for the same and also contributory negligence by the Doctor in not examining/ verifying the same prior to insertion. Further, in the grounds of Appeal preferred by the Manufacturer there is no specific averment with respect to the steps taken by them to conduct inquiry regarding the defective lens and also the reasons for not having responded to the Treating Doctors request for examining the lens that was sent to them. The stand of the manufacturer that they were not aware of any allegedly defective lens was sent to them for tests has no legs to stand as their own Dealer had filed a joint Written Statement and supported the submission of the Treating Doctor regarding the dispatch of the opaque lens to the manufacturer.

23. For all the aforenoted reasons, i.e. discharge summary, the admission made by the Treating Doctor and the medical literature we do not seen any grounds to interfere with the observation made by the State Commission regarding the defective lens. Hence the Appeal preferred by the Manufacturer is dismissed.

24. To reiterate, we are of the view that there is contributory negligence on behalf of the Treating Doctor in not examining the lens prior to the insertion and has admittedly the failure of the first surgery on account of opaqueness of the lens has necessitated the second surgery, which also failed due to delayed decompensation, we are of the view that the Treating Doctor did not exhibit reasonable standard of care and caution as required under law pertaining to medical negligence. However, we hold that there is no negligence in the conduction of the second surgery . We find the Treating Doctor negligent only in not examining the opaqueness or otherwise per se of the lens prior to insertion before the surgery.

25. In the result both the First Appeals stand dismissed. The statutory amount in both the Appeals stand released to the Complainants with interest accrued, if any.

26. Vide order dated 16.05.2017 in First Appeal No. 1058 of 2016, this commission, while granting conditional stay, directed the treating Doctor to deposit 50% of the awarded amount with the State Commission and vide order dated 16.05.2017 in First Appeal No. 207 of 2017, this Commission, while granting conditional stay, directed the Manufacturer to deposit the 50% of the awarded amount with the State Commission. Subsequently, vide order dated 26.02.2018, this Commission directed the amount be released to the Complainant on furnishing undertaking to refund the same, if so directed at the time of final disposal of the case. We clarify that the said amount shall stand released to the Complainants, if not already released. The balance amount, if any, shall be paid by the Manufacturer to the Complainant within four weeks from the date of receipt of a copy of this order together with cost of 25,000/-, failing which, the amount shall attract interest @ 9% p.a. from the date of filing of the Complaint till the date of realisation. This liability is being fastened upon the manufacturer based on the statement of their own Dealer in the Written Version that the lens was indeed sent to the manufacturer for testing and no inquiry/ report is forthcoming till date. ......................J R.K. AGRAWAL PRESIDENT ...................... M. SHREESHA MEMBER