State Consumer Disputes Redressal Commission
Vinod Sanghi Alias V.K. Sanghi, S/O. ... vs 1. Neo Retina Eye Care Institute, ... on 19 January, 2018
Cause Title/Judgement-Entry STATE CONSUMER DISPUTES REDRESSAL FORUM Telangana Complaint Case No. CC/275/2014 1. Vinod Sanghi alias V.K. Sanghi, S/o. Late Sri G.P. Sanghi Aged 78 years, Occupation Advocate, R/o.10-5-19/21, Flat No.501, 5th Floor, Major Residency, A Block, Masab Tank, Hyderabad 500 028. ...........Complainant(s) Versus 1. 1. Neo Retina Eye Care Institute, Represented by its Administrator, Dr. Purushottam, Aged about 50 years, Occupation Doctor, Situated at Ramachandra House, 5-9-83/B, Chappel Road, Opposite LB Stadium, Hyderabad 500 001. 2. 2. Dr.Srinivas Ambadipudi MD., FMRF, Consultant Retinal Surgeon, Neo Retina Eye Care Institute, Situated at Ramachandra House, 5-9-83/B, Chappel Road, Opposite LB Stadium, Hyderabad 500 001. 3. 3. M/s. Roche Products India Pvt. Ltd., Unit No.703 and 704, Peninsula Tower 1, Peninsula Corporate Park, G.K.Marg, Lower Parel, Mumbai 400 013, Rep.by Dr.Amid Qama, Senior Medical Manager. ............Opp.Party(s) BEFORE: HON'BLE MR. JUSTICE B. N. RAO NALLA PRESIDENT HON'BLE MR. Sri. PATIL VITHAL RAO JUDICIAL MEMBER For the Complainant: For the Opp. Party: Dated : 19 Jan 2018 Final Order / Judgement BEFORE THE STATE CONSUMER DISPUTES REDRESSAL COMMISSION OF TELANGANA : AT HYDERABAD CC NO. 275 OF 2014 Between : Vinod Sanghi @ V.K.Sanghi S/o late G.P.Sanghi, Aged 78 years Occ: Advocate, R/o 10-5-19/21, Flat No.501, Fifth Floor, Major Residency "A" Block, Masab Tank Hyderabad-500028 Complainant A N D Neo Retina Eye Care Institute Rep. by its Administrator Dr.Purushottam, Aged about 50 yrs Occ: Doctor, "Ramachandra House", 5-9-83/B, Chappel Road, Opp: LB Stadium, Hyderabad-500001 Dr.Srinivas Ambadipudi, MD., FMRF Consultant Retinal Surgeon Neo Retina Eye Care Institute "Ramachandra House", 5-9-83/B, Chappel Road, Opp: LB Stadium, Hyderabad-500001 M/s Roche Products (India) Pvt Ltd., Unit No.703 & 704, Peninusula Tower-1 Peninsula Corporate Park, G.K.Marg Lower Parel, Mumbai-400 013 Rep. by Dr.Amid Qama, Senior Medical Manager Opposite parties Counsel for the Complainant M/s Sharad Sanghi & Associates Counsel for the Opposite parties No.1&2 M/s M.V.Subba Reddy Counsel for the Opposite party No.3 M/s A.P.Venugopal QUORUM : HON'BLE SRI JUSTICE B.N.RAO NALLA, PRESIDENT & SRI PATIL VITHAL RAO, MEMBER
FRIDAY THE NINETEENTH DAY OF JANUARY TWO THOUSAND EIGHTEEN Oral Order : (per Hon'ble Sri Justice B.N.Rao Nalla, Hon'ble President) *** The complaint is filed under section 17 (1)(a)(i) of the Consumer Protection Act, 1986 by the Complainant to direct the opposite parties to pay Rs.30 lakhs towards loss of earnings for a period of five years; to pay Rs.20 lakhs towards loss of health, vision and to the mind, body and reputation and Rs.1,00,000/- towards expenses.
2. The case of the complainant in brief is that on 15.02.2014 due to problem in the left eye, the complainant visited the opposite party no.1 hospital for eye check up, after physical examination, the opposite party no.2 advised the complainant to take Intraveitreal Injection for his left eye and explaining about the options, schedule of the injections and the expenditure for undergoing the said treatment which used to be taken thrice. As per the avice of the opposite partyno.1, the complainant visited the opposite party no.2 on 20.02.2014 and took the injection in his left eye by paying an amount of Rs.9,000/- and advised to come for review on the next Monday. On the same day when the opposite party no.2 enquired about the condition of the complainant, he informed that his left eye is watering and there was severe pain with redness in the said eye. The complainant was asked to visit the hospital on the next day. On the next day after examination of the left eye of the complainant, the opposite party no.2 conducted operation for " Pars Plana Vitrectomy" with " intra Ocular Antibiotic" injection in his left eye and advised the complainant to come for review on the next day. The complainant visited the opposite partyno.1 hospital on 22.02.2014 and the opposite party no.2 after examination of his left eye advised to come on 23.02.2014. On 23.02.2014 again after examination of the complainant's left eye advised to come again on 24.02.2014. On 24.02.2014 after examination of the eye has given Posterior Subtenons Triamcinolone injection and advised the complainant to come for review on 27.02.2014. As the complainant was suffering with severe headache and unbearable pain, he has visited the opposite party no.1 on 26.02.2014 and after examination prescribed some medicines and advised the complainant to come for review on 28.02.2014. On 28.02.2014 after examination of the left eye of the complainant to come for review on 04.03.2014. On 04.03.2014 the opposite parties no.1 and 2 prescribed some medicines and asked the complainant come for review on 05.03.2014 and on 05.03.2014 after examination prescribed some more medicines.
3. On 07.03.2014 after conducting haemogram test the opposite parties no.1 and 2 again conducted another surgery and advised to come for review on 11.03.2014. Likewise, the opposite parties no.1 and 2 asked the complainant for reviews on 15.03.2014, 28.03.2014 and 16.04.2014 and every time after examination of his left eye the opposite parties no.1 and 2 prescribed some medicines but they did not mention the type of treatment they are giving during the said days. Without explaining the correct facts the complainant was kept in dark about the treatment given. The opposite partyno.2 being the retinal surgeon could not control the pain and revive the vision in the left eye of the complainant due to which the complainant lost the vision in his left eye. Thereafter the opposite party no.1 informed the complainant that it had complained to the police and to the Drug Inspector about the supply of spurious drug and also sent the drug to lab for analysis. On going through the documents supplied by the opposite party no.1 the complainant found that the injection Avastin from one Laxmi Medicals and General stores on 20.02.2014 ordered by the opposite partyno.2 was given to the complainant and other eight patients and all developed infection within 24 hours due to which the opposite parties no.1 and 2 have done multiple eye surgeries on all the patients including the complainant. The lab report shows that huge quantities of "Pseudomonas and Klebsiella bacteria" present in the drug. The opposite parties no.1 and 2 have not sent the medicine vial to the manufacturer for testing and confirmation which they should have in order to ascertain the genuinity and also to identify the persons involved in preparing and selling the spurious drug. Dr. Purushotham, Consultant Eye Specialist and Chief Administrator of opposite party no.1 hospital has got registered an FIR in the Central Crime Station vide FIR No.82/2014 on 04.04.2014 against one Mr.Quadir, Sales Person and delivery boy at MOR medicals. Dr.Purushotham, Administrator of opposite partyno.1 hospital also addressed a letter to the Director general, drugs Control Administration on 14.03.2014 wherein he has clearly stated that the drug was contaminated due to which the patients have to be operated twice to save the eyes and requested to investigate the matter and take necessary action against the seller and distributor.
4. Since the pain is continuing and as there is no improvement in the vision in the left eye, the complainant visited Sarojini Devi Eye Hospital on 23.04.2014 and the Assistant Surgeon after examination of the eye opined that the visual disability in the eye of the complainant was 30% and the complainant is a visually handicapped which shows that due to deficiency in service in using the spurious drug by the opposite parties no.1 and 2 the complainant lost his vision. The complainant complained to the manufacturer M/s Roche Scientific Co. (India) Pvt Ltd., by addressing letter dated 04.07.2014 about his loss of vision and informing about the spurious drug but the opposite party no.3 received evasive email dated 16.07.2014. The complainant got issued legal notices dated 08.08.2014 and 12.08.2014 to the opposite parties no.1 and 2 calling upon them to pay damages of Rs.50 lakhs towards deficiency in service on their part but the opposite parties no.1 and 2 neither issued any reply nor have complied with the same. Hence, the complaint with the prayers as stated in paragraph no.1 supra.
5. The opposite parties no.1 and 2 filed their written versions resisting the case and contended that the complaint is not maintainable either in law or on facts of the case. The complainant visited the opposite party no.1 hospital in the month of February 2014 for management of poor left eye vision. On complete examination he was diagnosed to have both eyes moderate diabetic retinopathy with left eye diabetic mocular edema. He was explained that the disease is a known complication of long standing diabetes leading to accumulation of fluid in the retina and light sensitive layer at the back of the eye. He was advised Intra Ocular anti VEGF injections therapy to reduce edema and good control of diabetes. The complainant was given options of two available anti VEGF drugs i.e., Lusentis and Avastin. The differences in terms of compound efficacy, risk, complication and its side effects are explained and discussed with the complainant. The drug Lucentis is very expensive compared to Avastin. The drug Avastin will be administered only on Thursday of every week as the single vial of Avastin can be used for 8 to 10 patients by withdrawing the drug into multiple syringes on the same day and administering to all the patients. The patients are pooled as sharing from a single vial substantially reduces the cost of treatment. The vial will be bought from the market on the same day and use it on all the patients. The drug Lusentis can be used for one patient only as the quantity available in single vial is sufficient for single use only and it will be administered on any day to the patient who opts for drug Lusentis. The drug Avastin is used worldwide by ophthalmologists to treat retina disorders and other eye problems. The drug was approved by the Government of India for intraocular use and it is a safe medicine and it is not toxic to the eye. However, any intraocular injection carries a risk of infection at the rate of 1:1000.
6. Prior to the visit of complainant to the hospital of the opposite parties on 29.11.2013 the complainant was seen by the doctors at Sarojini Devi Eye Hospital on 29.11.2013 the complainant was seen by the doctors at Sarojini Devi Eye Hospital, Hyderabad and he was diagnosed to have clinically Significant Macular Edema and was advised three doses of Injection Avastin (Bevacizumab) to the left eye. The complainant preferred Avastin and was present on 20.02.2014 for the injection. The drug was administered to the complainant under the supervision of Dr.Rajarami Reddy in the operation theatre under standard ascetic conditions. Special consent was taken for injection Avastin before the procedure. The complainant was clearly explained that he has to report immediately to the hospital in case of any pain, redness or reduced vision. On the same day seven other patients are administered injection using separate syringes in the operation theater under standard aseptic conditions. As one of the patients who was administered the drug came to the hospital on the same day i.e., on 20.02.2014 complaining pain, redness and decreased vision, all the patients are asked to report immediately for appraisal. Even the complainant was enquired about the symptoms of pain, redness and decreased vision. He confirmed the presence of symptoms. He was asked to report immediately for evaluation. The complainant ignored the request and presented on the next day morning. There is delay in coming to the hospital on the part of the complainant after noticing the symptoms and inspite of timely telephonic call and advise from the doctors of opposite party no.1 to visit them immediately. The five of the patients attended the hospital immediately after noticing pain, redness and decreased vision and they responded positively for the treatment. The complainant was present on the next day and he was immediately attended to by team of doctors headed by Dr.Rajarami Reddy, Intraocular infection was noticed and an emergency Vitrectomy surgery was performed. Before undertaking the surgery the complainant was explained the risks involved in the surgery. Informed consent for vitrectomy surgery was obtained. The vitrectomy surgery is the standard care in infections following intraocular injections. After surgery the complainant was asked to visit the next day for review.
7. The vitreous sample was obtained and sent to the laboratory for microbiology and drug sensitivity. From the report it is noticed that Klebsiella and Pseudomonas organism (bacteria) grew in the vitreous fluid. The bacteria are sensitive to Moxifloxacin. The complainant was explained about the necessity of use of Moxifloxacin to control infection and for relief from pain. Intravitreal Moxifloxacin injection was given on 22.02.2014. Meanwhile the drug was found contaminated. Immediately a complaint was given to the Director General, Drugs Control Administration and police report was given in Crime Branch Police Station at Saifabad at the instance of the parties regarding spurious drug. It is difficult to detect fake from the original on physical inspection of the vial. On physical inspection of vial, it is a clear fluid with no visible particulate matter. The complainant was regularly being followed up. ON 27.02.2014 Posterior Subtenous Triamcinolone injection was given to the left eye to control intraocular inflammation. As the complainant was having severe pain with no improvement in vision, the complainant was offered repeat Vitrectomy surgery with silicon oil injection to relieve pain and control of infection. The complainant and his attendants were explained about poor chances of recovery of vision. The complainant agreed to undergo Vitrectomy surgery and it was performed on 07.03.2014. The surgery was performed after obtaining consent from the complainant. The complainant was also advised to keep good control of diabetes. But after the adverse event his diabetes was under very poor control which added to the severity of the infection and he was not complained with the medications. With efficient management the opposite parties were able to control infection in the left eye. However there was total loss of vision to the left eye. The complainant was explained about the pros and cons with inherent risks and complications involved in every surgical step and obtained three informed consents for each intervention and was clearly explained about the condition of eye at every stage. While administering the injections every precaution was taken. There was informed choice of the complainant for all treatment procedures. Various treatments including two Vitrectomy surgeries, Intravitreal Moxifloxacin, Posterior Subtenous Triamcinolone Injections, multiple consultations and multiple ultra sound scans were done free of charge. Medications including eye drops and tablets are given free of cost. The total cost of managing the adverse event for the complainant was approximately rupees two lakhs.
8. The infection is not procedural related and that they acted in a manner acceptable to medical profession attended on the complainant with due care, skill and diligence. The opposite parties performed their duties with skill and competence and in the best interest of the complainant and there was never any negligence on their part while performing duties. All the allegations made in the complaint which are inconsistent with the stand of the opposite parties no.1 and 2 as stated in the complaint. The complainant was never assured by the opposite parties no.1 and 2 that he would regain vision and the consent forms clearly indicate the risks involved in the surgical procedure. At every stage the complainant was informed about the risk of losing vision. However, the complication arose because of spurious drug and not because of any lapse on the part of the opposite parties no.1 and 2. The complainant was never kept in dark about the treatment. At every stage he was informed about the nature of treatment and for all surgical procedures informed consent was also obtained. There is no deficiency of service on the part of the opposite parties no.1 and 2 and therefore they prayed for dismissal of the complaint.
9. The opposite party no.3 filed its written version denying the allegations made in the complaint and contended that the complaint is not maintainable. The complaint is misconceived, devoid of merits and is bad for non-joinder of the Drugs and Cosmetics Authorities under whose jurisdiction the allegations of the manufacturing defect fall being the competent and statutory authority and also of the retailer M/s Laxmi Medical and General Stores from whom the said vial is said to have been indented and procured being necessary parties for the adjudication of the present lis. This Commission has no territorial jurisdiction as against the opposite party no.3 nor there is any cause of action as against the opposite party no.3 to try the mater.
10. The opposite party no.3 submitted that Drug Avastin is not clinically approved for application to the eye conditions, but is approved for 'colorectal cancer' and other cancer related issues. On the complaint of Dr.Purushottam on 22.03.2014 the opposite party no.3 vide its email dated 09.04.2014 made it clear to him that " Avastin" is not approved for its use in Opthalmologic Indication and any such use is not approved. It was also further clarified that the drug is administered " intravenous" to the cancer patients and could not be administered through any other route of administration. The opposite party no.3 does not recommend the use of " Avastin" to treat any other conditions and cannot support the use of the product through any other mode. In addition it is also informed by way of literature annexed to the product, in the instant case, the injection vial, the complications/precautions/situations pertaining to usage of the drug " off label". Potential concerns about Off-label use of Avastin in Ocular conditions are that since Avastin was designed for systematic use for the treatment of cancer and was not designed for the eye, no ocular safety test has been done with Avastin. " Aliquoting" and " storing syringes" may result in contamination. The current Avastin formulation cannot be used a multi-dose preparation because it does not contain preservatives. It appears that the same vial was administered on the complainant and 8 others, which is contrary to the specific actions made clear on the label. Avastin is not approved for ocular uses by either the FDA or the EMEA or Indian Health Authorities. An ophthalmic formulation is required for usage in ocular indications administered via the intravitreal route e.g., for the investigations of Age related Macular Degeneration (AMD) and such formulation has not been developed by ROCHE. The product Avastin is not meant for any use other than for treating colorectal cancer and thus, ought not to have been used in ocular indications. On a complaint of complainant on 30.06.2014 to the opposite party no.3, the opposite party no.3 sent a mail to the complainant on 01.07.2014 requesting for details pertaining to pharmacy from where the product was purchased together with the acknowledgement copy/bill of purchase. On 07.07.2014 the complainant sent email to opposite party no.3 enclosing the copies of the purchase bill and the name of the medical stores and also expressed doubts about the genuinity of the bill and name of the stores from where it is purchased. After receiving letter dated 04.07.2014 from the complainant on 09.07.2014 the complainant was informed by email dated 16.07.2014 that Avastin was not approved for use in any eye indication and that it is only approved for use to various cancer treatments via intravenous route only. The opposite party no.3 is the importer of the drug Bevacizumab injection Avastin 100mg/4m 1 vial of 4ml, and the manufacturing company of the said drug is " Roche Diagnostics GmbH, Germany" for F.Hoffmann-LA Roche Ltd., from whom opposite party no.3 imports the drug. The drug Avastin is then sold by the opposite party no.3 to parties (having valid Drug license) on wholesale basis. The self-serving admissions of the complainant, it is evident that the opposite party no.3 is not a proper and necessary party and the claim as against the opposite partyno.3 is misconceived; without any basis; as the complainant has failed to prove any manufacturing defect in the produce' nor has he been able to prove any violations with regard to the product and in the absence of the same, the complaint is liable to be dismissed. Hence, the opposite partyno.3 prayed for dismissal of the complaint.
11. The complainant filed his evidence affidavit and got Exs.A1 to A24 marked. On behalf of the opposite parties, the Doctor and the Managing Director, Vishwanetra Health Services Pvt Ltd., has filed his evidence affidavit and got Exs.B1 to B4 marked, while on behalf of the opposite party no.3, the Group Medical Manager has field his evidence affidavit and got Exs.B5 to B13 marked.
12. Counsel for complainant and the opposite party no.3 present and were heard. No representation for opposite parties and 1 and 2. The counsel for both parties have filed their respective written arguments.
13. The points that arise for consideration are :
Whether the opposite parties no.1 and 2 committed any deficiency in service in administering Avastin Injection which is not clinically approved for ophthalmic use and if so what are the consequences that led to loss of vision of the left eye of the complainant? Whether the complainant is entitled to any compensation?
If so, to what amount?
14. POINTS NO.1 TO 3 The case of the complainant is that the complainant visited the opposite party no.1 hospital in the month of February 2014 for management of poor left eye vision and after physical examination the opposite party no.2 advised the complainant to take Intravetreal Injection for his left eye and explained about the options, schedule of the injections and the expenditure for undergoing the said treatment. On 20.02.2014 the complainant visited the opposite party no.2 who has given Avastin injection into his left eye and advised to come for review on the next Monday. However, the complainant received a call from the opposite party no.2 enquiring about the condition of the eye and the complainant informed that his eye is watering and there was severe pain with redness. The complainant was asked to visit the hospital on the next day and after visiting the opposite party no.2 on the next day he conducted operation to his left eye and advised to come for review on the next day. Like wise, the opposite party no.2 advised to come for reviews on several times and as and when the complainant visited the opposite party no.2 the opposite party no.2 used to prescribe medicines and injections. Thereafter on 07.03.2014 after going through the haemogram test the opposite parties no.1 and 2 again conducted another surgery to his left eye and asked and again asked for reviews. The complainant continued to visit the opposite parties no.1 and 2 as and when asked to visit them but they did not explain the correct facts about the mode of treatment given. Though the opposite parties no.1 and 2 gave treatment and conducted surgeries but there was no improvement in the left eye of the complainant and ultimately the complainant lost his vision.
15. It is further case of the complainant that on insisting about the prolonged treatment the opposite party no.1 furnished some documents wherein the opposite parties no.1 and 2 complained to the Police and also to the Drug Inspector about the supply of spurious drug Avastin which was administered to the complainant. Further on microbiological analysis on 02.02.2014 it was found that the fluid samples showed huge quantities of "Pesudomonas and Klebsiella bacteria" that is the drug is contaminated due to which the complainant has to undergo multiple surgeries and ultimately lost his vision. The complainant contended that the opposite party no.3 is the manufacturer of drug Avastin who without properly testing in the laboratories had supplied the same to the distributors.
16. On the other hand the opposite parties no.1 and 2 contended that on complete examination the complainant was diagnosed to have both eyes moderate diabetic retinopathy with left eye diabetic mocular edema. He was explained that the disease is a known complication of long standing diabetes leading to accumulation of fluid in the retina and light sensitive layer at the back of the eye. He was advised Intra Ocular anti VEGF injections therapy to reduce edema and good control of diabetes. The complainant was given options of two available anti VEGF drugs i.e., Lucentis and Avastin. The complainant preferred Avastin and was present on 20.02.2014 for the injection. The drug was administered to the complainant under the supervision of Dr.Rajarami Reddy in the operation theatre under standard ascetic conditions. Special consent was taken for injection Avastin before the procedure. The complainant was clearly explained that he has to report immediately to the hospital in case of any pain, redness or reduced vision. On the same day seven other patients are administered injection using separate syringes in the operation theater under standard aseptic conditions. As one of the patients who was administered the drug came to the hospital on the same day i.e., on 20.02.2014 complaining pain, redness and decreased vision, all the patients are asked to report immediately for appraisal. Even the complainant was enquired about the symptoms of pain, redness and decreased vision. He confirmed the presence of symptoms. He was asked to report immediately for evaluation. The complainant ignored the request and presented on the next day morning. There is delay in coming to the hospital on the part of the complainant after noticing the symptoms and inspite of timely telephonic call and advice from the doctors of opposite party no.1 to visit them immediately. The five of the patients attended the hospital immediately after noticing pain, redness and decreased vision and they responded positively for the treatment. The complainant was present on the next day and he was immediately attended to by team of doctors headed by Dr.Rajarami Reddy, Intraocular infection was noticed and an emergency Vitrectomy surgery was performed. Before undertaking the surgery the complainant was explained the risks involved in the surgery. Informed consent for vitrectomy surgery was obtained. The vitrectomy surgery is the standard care in infections following intraocular injections. The vitreous sample was obtained and sent to the laboratory for microbiology and drug sensitivity. From the report it is noticed that Klebsiella and Pseudomonas organism (bacteria) grew in the vitreous fluid. The bacteria are sensitive to Moxifloxacin. Intravitreal Moxifloxin injection was given on 22.02.2014. Meanwhile the drug was found contaminated. Immediately a complaint was given to the Director General, Drugs Control Administration and police report was given in Crime Branch Police Station at Saifabad at the instance of the parties regarding spurious drug. It is difficult to detect fake from the original on physical inspection of the vial As the complainant was having severe pain with no improvement in vision, the complainant was offered repeat Vitrectomy surgery with silicon oil injection to relieve pain and control of infection. The Vitrectomy surgery was performed after obtaining consent from the complainant. The complainant was also advised to keep good control of diabetes. But after the adverse event his diabetes was under very poor control which added to the severity of the infection and he was not complaint with the medications. With efficient management the opposite parties were able to control infection in the left eye. However there was total loss of vision to the left eye. Various treatments including two Vitrectomy surgeries, Intravitreal Moxifloxacin, Posterior Subtenous Triamcinolone Injections, multiple consultations and multiple ultra sound scans were done free of charge. Medications including eye drops and tablets are given free of cost. The total cost of managing the adverse event for the complainant was approximately rupees two lakhs.
17. The infection is not procedural related and that they acted in a manner acceptable to medical profession attended on the complainant with due care, skill and diligence. The opposite parties performed their duties with skill and competence and in the best interest of the complainant and there was never any negligence on their part while performing duties.
18. The opposite party no.3 contended that The opposite party no.3 submitted that Drug Avastin is not clinically approved for application to the eye conditions, but is approved for 'colorectal cancer' and other cancer related issues. On the complaint of Dr.Purushottam on 22.03.2014 the opposite party no.3 vide its email dated 09.04.2014 made it clear to him that " Avastin" is not approved for its use in Opthalmologic Indication and any such use is not approved. It was also further clarified that the drug is administered " intravenous" to the cancer patients and could not be administered through any other route of administration. The opposite party no.3 does not recommend the use of " Avastin" to treat any other conditions and cannot support the use of the product through any other mode. The current Avastin formulation cannot be used a multi-dose preparation because it does not contain preservatives. It appears that the same vial was administered on the complaint and 8 others, which is contrary to the specific actions made clear on the label. Avastin is not approved for ocular uses by either the FDA or the EMEA or Indian Health Authorities. The opposite party no.3 is the importer of the drug Bevacizumab injection Avastin 100mg/4m 1 vial of 4ml, and the manufacturing company of the said drug is " Roche Diagnostics GmbH, Germany" for F.Hoffmann-LA Roche Ltd., from whom opposite party no.3 imports the drug. The drug Avastin is then sold by the opposite party no.3 to parties (having valid Drug license) on wholesale basis. The self-serving admissions of the complainant, it is evident that the opposite party no.3 is not a proper and necessary party and the claim as against the opposite partyno.3 is misconceived. The opposite parties no.1 and 2 said to have purchased the drug from " M/s :Lakshmi Medicals" which is a fictitious vendor and so also the bill issued. The opposite parties no.1 and 2 were negligent in procuring the vials from a valid drugs vendor duly authorized by Drugs authorities and have purchased the drug knowing that such a fictitious vendor was supplying a drug to them for off-label use without bringing the same to the knowledge of the higher authorities.
19. The only question involved in the present complaint is as to whether the complainant lost vision of his left eye due to administering of off-label drug Avastin to the complainant without approval of FDA (USA) or EMEA or Indian Health Authorities constituting medical negligence on the part of the opposite parties no.1 and 2 and if yes, to what compensation the complainant is entitled.
20. The complainant reiterated the aforesaid case of the complainant in his argument and mainly argued that the opposite party no.2 administered Avastin through injection to the left eye of the complainant without approval of FDA, EMNA and DCGI and the drug Avastin ought not to have been administered to him. He also contended that it is not due to spurious drug used by the opposite parties no.1 and 2 but it was due to administration of off-label drug the complainant has lost his vision.
21. On the other hand the opposite parties no.1 and 2 in their written arguments contended that Avastin is used worldwide by ophthalmologists to treat retina disorders and other eye problems and it has been approved by the Government of India for intraocular use and it is a safe medicine and it is not toxic to the eye. As the drug is spurious the opposite party no.1 had given a complaint in FIR 82 of 2014 on 04.04.2014 and that the sample drug was sent for microbiological analysis on 20.02.2014 and the report showed huge quantities of Psedomonas and Klebssiella bacteria. The Chief Administrator of opposite partyno.1 hospital had addressed a letter to the Director General, Drugs Control Administration on 14.03.2014 and requested to investigate into the matter and for necessary action. The complication arose because of spurious drug and not because of any lapse on the part of the opposite parties no.1 and 2.
22. The opposite party no.3 in its written arguments contended that the allegation in the complaint pertain to usage of a spurious drug which has not been proven to have been manufactured by the opposite party no.3. It is the responsibility of the opposite party no.1 concerned to send the vial to the manufacturer/importer for analysis without which it will not be possible for the manufacturer/importer to say anything about the nature of the drug. Hence, in the absence of the vial being sent to the manufacturer for examination at their end there cannot be a general allegation of manufacturing defect. The opposite partyno.3 is the importer and marketer of the drug Bevacizumab injection Avastin 100mg/4m 1 vial of 4ml in India having factory premises at Roche Diagnostics GmbH, Germany. Avastin is not approved for its use in Ophthalmologic Indication and any such use is not approved. Ex.B.7 dated 18.04.2014 is the letter addressed by the opposite party no.3 to the Drugs Inspector stating that Avastin (Bevacizumab) is not approved for ocular uses by either FDA (USA) or the EMEA or Indian Health Authority. Avastin formulation was designed for intravenous use only for the treatment in approved uses in cancer. Roche believes that an ophthalmic formulation would be required for usage in ocular indications administered via the intravitreal route e.g. for the investigation of wet Age-related Macular Degeneration (AMD) and such formulation has not been developed by Roche till date.
Further would like to inform your Office that Avastin is approved in India for its marketing for the treatment of metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, metastatic renal cell cancer, advanced epithelial ovarian, fallopian tube and primary peritoneal cancer and for recurrent Glioblastoma multiforme. Accordingly the package insert for this Product includes information about these indications. The labels also states " To be sold under the prescription of registered Onclogist only". The Package insert of Avastin also includes below safety information derived out of off-label usage in eye:1 Section 2.4.1: Eye disorders adverse reactions have been reported from unapproved intravitreal use. These reactions included infectious endophalmitis, intraocular inflammation such as sterile endopthalmitis, uveitis and vitritis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular hemorrhage such as vitreous hemorrhage or retinal hemorrhage an conjunctival hemorrhage. Some of thse appeared as serious adverse reactions.
Avastin is not approved for its use in Ophthalmologic indication. In this regard, please find attached Roche position on the same. (Enclosure 2) Roche does not recommend the use of Avastin to treat any conditions other than approved indications and cannot support the use of the product through routes of administration different from that for which it was developed and registered.
23. The opposite party no.3 has also filed Ex.B8 which is Form-45 issued by Government of India, Central Drugs Standard Control Organization, Directorate General of Health Services wherein it is clearly mentioned that the said Avastin i.e., Bevacizumab Injection is for the treatment of colorectal cancer. Ex.B10 is the email dated 16.07.2014 sent to the complainant wherein it is clearly mentioned that in the absence of physical product vial in question the opposite party No.3 cannot confirm the genuinity of the vial. In Ex.B11 which is a Batch Certificate certifying that the batch of product has been fabricated/manufactured including packaging and quality control in full compliance with the GMP requirements of the local Regulatory Authority and with the specifications in the Marketing Authorization of the importing country. The batch processing, packaging and analysis records were reviewed and found to be in compliance with GMP.
24. The Drug Controller General of India has issued an alert notice to State regulators on the use of multinational drug maker Roche's cancer drug Avastin in an off-label use to treat the eyes. The drug has been used in the treatment of eye ailments and "this has lead to loss of vision" in certain patients at the Nagri Eye Hospital in Ahmedabad, the "alert notice" from the Indian drug regulator said. The drug is not approved in the country for intra-vitrieal use for ophthalmology purposes.
25. Responding to the development, Roche said that it did not promote the use of Avastin or any of its drugs in an indication for which it was not approved. "Avastin® (Bevacizumab) has not been approved for intra-ocular use by the US FDA (US regulator), EMA (European regulator) or the Government of India. When prepared for off-label use in the eye, a single vial of the original Avastin product is partitioned/aliquoted in a hospital or pharmacy for use in multiple patients. This process bears the risk of contamination and has already led to serious bacterial infections of the eye in other countries. This information is also included in our updated prescribing information inserted in each pack"
26. Off‑label use is the use of pharmaceutical drugs for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the drug. A regulatory agency (e.g., Drugs Controller General of India, United States Food and Drug Administration [USFDA]) approves a drug for a particular indication, in a particular dose, dosage formulation and route of administration based on data from clinical trials that have been submitted to and scrutinized by the regulatory agency. Thus, Avastin is approved for oncology indications only for intravenous use but not to be injected in to the eye. It is important to understand that off‑label use is not illegal. Off‑label use is considered as legal unless it violates ethical guidelines or other safety regulations. Avastin is in fact a single use vial without preservatives. In the instant the most probable root cause for contamination could be due to an inappropriate intravitreal administration or due to contamination of the vial during the "aliquoting" the product into syringest for its " intravitreal" administration. Therefore, the opposite parties no.1 and 2 committed gross negligence in administering off-label drug Avastin on the complainant and 8 others which is contrary to the specifications which were clear on the label. If for the arguments sake it is to be considered that the off label drug is safe for the use in ophthalmic use, the opposite parties no.1 and 2 ought to have used the said drug as a single use but not by withdrawing the drug into multiple syringes. Though the complainant has gave his consent for the use of Avastin which is said to be off-label drug yet as the complainant is not having any knowledge about what is off-label drug and also that due to his condition at that time he might have signed the said consent form. First of all it is the opposite parties no.1 and 2 who should not have used the off label drug for administration for the use of ophthalmic purpose and secondly, the opposite parties no.1 and 2 have stated that as the Lucentis is very expensive compared to Avastin they have used the Avastin in order to reduce the expenses. The complainant has stated in the complaint that he first visited Sarojini Devi Eye Hospital for the said treatment and when the doctors at the said hospital asked him to get admitted in the hospital the complainant preferred opposite party no.1 hospital with the belief that private hospital rendered best services and provide best care. If the intention of the complainant is to join in private hospital means he is ready bear the expenses of the costly medicines and also that the complainant has no where stated that he is a poor person so that he cannot bear the expenses of costly drugs. It is the opposite parties no.1 and 2 who advised the complainant the said drug which is to be administered only on Thursday of every week so that the opposite parties no.1 and 2 can use the medicine for 8 to 10 patients. Although some off‑label therapies can be beneficial and even lifesaving for some patients, in many cases, off‑label use can be problematic, especially if there is inadequate data regarding drug safety and effectiveness for the off‑label use. Off‑label use may be associated with a greater number of side effects, the benefits may outweigh the risks. The law is clear about the off-label use of drugs. In India it is illegal to use drugs for anything else other than what has been approved of by the DCGI.
27. The opposite parties no.1 and 2 themselves have admitted that various treatments including two Vitrectomy surgeries, intravitreal Moxifloxacin, Posterior Subtenous Triamcinolone injections, multiple consultations and multiple ultra sound scans were done free of charge. Further, medications including eye drops and tablets were given free of cost. The total cost of managing the adverse event for the complainant was approximately rupees two lakhs. Therefore, it can be said that the opposite parties no.1 and 2 have committed negligence in administering off-label drug Avastin by injecting in to the left eye of the complainant and also to 8 other patients and in that process as the said drug was contaminated. Avastin is a single use vial as stated by the opposite party no.3 without preservatives and is approved for oncology indications only. There is every possibility for causing the adverse events i.e., severe ocular inflations following intravitreal injections etc., was due to usage of off-label drug Avastin.
28. In case "V. Kishan Rao Vs Nikhil Super Specialty Hospital", (2010) 5-Supreme Court Cases-513(SC), Hon'ble Supreme Court discussed the relevant judgments from the years 1865 to 2009 and observed in Para Nos.50 & 51 as follows:-
50. In a case where negligence is evident, the principle of re-ipsa- loquitur operates and the complainant does not have to prove anything as the thing (res) proves itself. In such a case, it is for the respondent to prove that he has taken care and done his duty to repel the charge of negligence.
51. If the general directions in para 106 in D'Souza are to be followed then the doctrine of res-ipsa-loquitur which is applied in cases of medical negligence by this Court and also by courts in England, would be redundant".
29. Medical practitioners do not enjoy any immunity and they can be sued, if they have failed to exercise reasonable skill and care. Negligence is the omission to do something, which a reasonable man, guided upon those considerations, which ordinarily regulate the conduct of human affairs, would do or doing something, which a prudent and reasonable man would not do. Test for negligence is failure to exercise ordinary care and caution expected from prudent man in the circumstances in a given case. The definition involves the following constituents :-
1. A legal duty to exercise due care
2. Breach of the duty and
3. Consequential damages.
30. The breach of duty may be occasioned either by not doing something, which a reasonable man, in a given set of circumstances, would do or, by doing some act, which a reasonable prudent man would not to do.
31. We find that in view of the version of the opposite party no.3, as discussed above, the opposite parties no.1 and 2 have acted negligently in administering off-label drug Avastin and also that administration of the single vial to several patients by injecting the same drug in the vial due to that the drug was contaminated resulting the present situation to the complainant.
32. Therefore, we hold that the opposite parties no.1 and 2 are liable to pay reasonable compensation to the complainant. The complainant aged about 78 years lost vision to his left eye due to medical negligence on the part of the opposite parties no.1 and 2. The complainant has claimed total compensation of Rs.51 lakhs on various causes. However, considering loss of vision of his left eye at his old age due to gross medical negligence on the part of opposite parties no.1 and 2, we find that a lump sum compensation of Rs.5 lakhs would be just & proper to be imposed on the opposite parties no.1 and 2 along with costs.
In the result the complaint is allowed in part holding and directing the opposite parties no.1 and 2 liable to pay Rs.5,00,000/- to the complainant with costs of Rs.5000/-. The complaint against the opposite party no.3 is dismissed without costs. Time for compliance four weeks.
PRESIDENT MEMBER
DATED 19.01.2018
APPENDIX OF EVIDENCE
WITNESSES EXAMINED
NIL
EXHIBITS MARKED
For complainant
Ex.A1 Case Summary sheet of the complainant dated 19.04.2014
Ex.A2 Prescription sheet of opposite party no.1 dated 28.03.2014
Ex.A3 Prescription sheet of opposite party no.1 dated 07.03.2014
Ex.A4 Payment receipt issued by SD Eye Hospital dated 29.11.2013
Ex.A5 Outpatient ticket dated 29.11.2013
Ex.A6 Eye vision photos dated 29.11.2013
Ex.A7 Eye vision sheet of the complainant dated 15.03.2014
Ex.A8 Complete Haemogram of the complainant dated 07.03.2014
Ex.A9 Prescription sheet of opposite party no.1 dated 07.03.2014
Ex.A10 Prescription sheet of opposite party no.1 dated 04.03.2014
Ex.A11 Prescription sheet of opposite party no.1 dated 26.02.2014
Ex.A12 Prescription sheet of opposite party no.1 dated 22.02.2014
Ex.A13 Prescription sheet after surgery
Ex.A14 Payment receipt dated 20.02.2014
Ex.A15 Scan report dated 13.02.2014
Ex.A16 Payment receipt dated 15.02.2014
Ex.A17 Ophthalmology Medical Report dated 21.04.2014
Ex.A18 Letter dated 01.04.2014 of complainant to Op3
Ex.A19 Email of Op3 dated 16.07.2014
Ex.A20 Medical Certificate issued by SD
Eye Hospital dated 23.04.2014
Ex.A21 Office copy of legal notice dated 01.07.2014
Ex.A22 Reply notice dated 08.08.2014
Ex.A23 Office copy of legal notice dated 11.08.2014
Ex.A24 Acknowledgement dated 12.08.2014
For opposite parties No.1 and 2
Ex.B1 Copy of informed consent dated 20.02.2014
Ex.B2 Copy of informed consent dated 21.02.2014
Ex.B3 Copy of informed consent dated 07.03.2014
Ex.B4 Copy of Medical Record
For opposite party no.3
Ex.B5 Copy of product complainant/adverse event dated 22.03.2014
Ex.B6 Copy of reply dated 09.04.2014 by Op3
Ex.B7 Copy of letter dated 15.04.2014 by Drug Inspection
Ex.B8 Copy of License for usage of Avastin
Ex.B9 Copy of communication of complainant dated 30.06.2014
Ex.B10 Copy of clarification of complainant dated 07.07.2014
Ex.A11 Copy of reply dated 16.07.2014 by Op3
Ex.B12 Copy of Certificate of Analysis and Batch Certificate
Ex.B13 Copy of Board Resolution.
PRESIDENT MEMBER [HON'BLE MR. JUSTICE B. N. RAO NALLA] PRESIDENT
[HON'BLE MR. Sri. PATIL VITHAL RAO] JUDICIAL MEMBER