Indian Kanoon - Search engine for Indian Law

4.      In reply before the learned State Commission, the OP stated that the complaint was untenable due to defects in parties and was also barred by limitation. The OP vehemently denied any liability for the Complainant's blindness, attributing it to negligence in treatment. According to the OP, the patient visited the OP/Eye Foundation on 25.04.2011, seeking an "intravitreal Avastin" injection for his left eye, despite being advised for this treatment elsewhere. The injection was administered on 04.06.2011, following which the patient developed 'endophthalmitis' within 24 hours. Subsequently, on 05.06.2011, the patient was injected with intravitreal vancomycin ceftazidime and advised further treatment for endophthalmitis, with follow-up scheduled for the next day, and the prognosis was explained to the patient. The OP asserted that administering 'Avastin' injection on 04.06.2011 was done with the written consent of the patient. Dr. Avijit Dutta, a competent physician specializing in Retinal treatment, handled the case. The treatment provided was as per protocols outlined in standard Ophthalmology textbooks. Additionally, the OP emphasized that the Superintendent of the OP/Institution played no part in his treatment, yet was unjustly implicated, leading to unwarranted harassment of the institute and its office bearers.

"Reports of the members of the Expert Committee are as follows:

  An enquiry committee examined the complaint lodged by Sri Naresh Shah against Dr. Abhijit Dutta, alleging improper administration of intravitreal Avastin injection. It is alleged by the petitioner that he was suffering from his eye problem (diabetic macular edema) and met Dr. Abhijit Dutta at Nihar Munshi Eye Foundation. Dr. Dutta examined him and administered intravitreal Avastin injection on 4.6.2011, after explanation and obtaining informed consent about the adverse effects of such injection.

  As with any intraocular procedure, endophthalmitis is a dreaded complication leading to severe ocular morbidity and vision loss. Although the incidence is low (0.016-0.026%), with dramatic increase in the number of injections performed annually in India, post injection endophthalmitis (PIE) is a matter of grave concern since multiple patients undergo the procedure in the same operating theatre (OT) on the same day which increases the risk of cluster endophthalmitis throughout the country following intravitreal bevacizumab (Avastin®) and confirmed reports of such dreadful occurrences exist. Since multiple patients undergo the procedure in one sitting, any breach in asepsis, cold-chain or contaminated drug increases the risk of cluster endophthalmitis. One of the major reasons for increase in post intravitreal injection endophthalmitis is the procurement of counterfeit drugs and improper storage of drug/lapse in cold chain when the same vial is used more than once. This is, especially, true for intravitreal bevacizumab (Avastin®), available as 4-ml vial. Recently, a cluster of 21 patients suffering from endophthalmitis after being injected from a single vial of Avastin® on a single day was referred to our tertiary care center. A majority of these patients showed Stenotrophomonas maltophilia as the causative agent which was also isolated from the vial and is an emerging nosocomial infection causing endophthalmitis. Thus, to avoid such dreaded complication like cluster endophthalmitis, the best practice guidelines formulated and issued by VRSI, AIOS, and Dr. R.P. Centre (AIIMS, New Delhi) should be followed and the procedure should be carried out diligently with proper pre-, intra-, and post-operative precautions.

 An article on the appropriate preparation of bevacizumab for intravitreal injection by compounding pharmacies has been aptly titled - "Avastin does not blind people, people blind people." It is essential that we strictly follow the standard guidelines for intravitreal injections and minimize the avoidable complications related to this wonder drug."

17.    It is uncontested position that the Complainant was administered "Avastin Injection" in the left eye on 04.06.2011. Thereafter, certain complications arose towards restoring the normal eye and the patient suffered further decline in vision and it resulted in almost complete blindness. The Complainant averred that the Opposite Party Hospital attempted various corrective measures including further injections Vitrectomy and other different medications. However, there was no improvement in condition of the patient. The Complainant agitated medical negligence and deficiency in service against OPs attributing the damage of the eye due to severe reaction on account of administering Avastin Injection. He also brought out medical opinion of the Regional Institute of Ophthalmology, Kolkata and certain medical journals pertaining impropriety in administering Avastin Injections. Therefore, the case is centered on administering Avastin Injection to the patient in the given circumstances. On the other hand, the OPs have specifically asserted absence of any negligence or deficiency in service with respect to the treatment of the patient. He was diagnosed to be suffering eye problem (diabetic macular edema) and sought treatment in the form of Intravitreal Avastin injection in his left eye, despite being advised for treatment elsewhere. The injection was administered on 04.06.2011 and he developed certain complications. There no negligence or deficiency in service whatsoever in this regard. The treatment to the patient was given by Dr. Aviijit Dutta, a competent physician specialized in Retinal treatment.