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Judgment
Dr. S.M. Kantikar, Member
Infection is a risk of all surgeries. Endophthalmitis is a particularly worrisome type of infection because it can lead to severe vision loss, blindness, and loss of the eye. Some types of complications are hard for patients to understand. The common knowledge of occurrence of infection after surgery makes it harder for the complainants to allege lack of informed consent in endophthalmitis claims. In order to successful claim, the complainant must show that the treatment was below the standard of care.
Facts:
Mr. Upendra Kumar is the Complainant (hereinafter referred to as the ‘Patient’), a senior Surveyor working in the Insurance Company. He underwent cataract surgery with implantation of intra ocular lens (IOL) to his right eye in Nayandeep Eye Research Centre (hereinafter referred to as the ‘Opposite Party No. 1’) at Muzaffarpur. It was performed by Dr. Arun Kumar Sinha, (the Opposite Party No. 1) allegedly without pre-operative evaluation of position of cataract and eye infection. It was alleged that pre-operatively few medicines were given and same were repeated after operation, which indicates eye infection was there. The Cataract operation was done on 07.03.2007 by phaco method. It was alleged that IOL was fixed without considering the supplier’s instruction which was supplied by Alcon Advance Medical Optics. The Complainant was discharged on the same day at 4.00 p.m. Few days later in spite of regular checkup and medication, the condition of operated right eye started deteriorating. It was alleged that at the time of operation the cornea was healthy. The infection in eye noticed after five days of the operation, but the Opposite Party No. 2 did not advise culture and sensitivity test for conjunctivitis and any tests to rule out fungal infection. The Opposite Party No. 2 because of his greed for money and negligence failed to manage the infection. Till 30.03.2007 the Opposite Party No. 2 gave some anti-viral and anti-bacterial drugs. The injections like Vanca Sipra, Vanco were injected in the right eye. He did not refer the patient to any vitreo retinal surgeon for further management. On 31.03.2007, on request and pressure from the patient’s attendants, the Ultrasonography test for eye was performed. It revealed post-operative Endophthalmitis. Thereafter, on 06.04.2007 the patient approached Centre for Sight, at New Delhi. The doctors advised for immediate surgery to the badly infected right eye. However, the patient on the same day, approached Shrof Eye Centre at Delhi, wherein immediate Vitreo-retinal surgery of right eye was advised. Accordingly, after investigations, the patient underwent operation on his right eye at Shrof Eye Centre and discharged on 08.04.2007. Even thereafter, there was no improvement in the eye. Till 20.04.2007 he took regular follow up check-up at Shrof Eye Centre. Again, infection was developed and on 24.04.2007 and Vitreo- retinal surgery was performed, but no improvement in the vision of right eye. Thereafter, on 27.04.2007, the patient approached PGI Chandigarh, the doctors there refused to give any suggestion for further operation and informed that he lost vision in his right eye. The complainant consulted at Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi on 03.05.2007. Thereafter, he consulted LV Prasad Eye Institute at Hyderabad on 05.05.2007. The doctors at both the places told that he has lost his vision in right eye. Being aggrieved by the the alleged gross negligence of the Opposite Party No. 2 the Complainant filed a police complaint on 10.05.2007. The patient was taken to SK Medical College, Muzaffarpur, wherein, it was confirmed that the patient had complete loss of vision in the right eye. Therefore, the Complainant filed the Consumer Complaint before this Commission u/s 21 of the Consumer Protection Act and claimed Rs. 1,97,50,000/- as compensation from the Opposite Parties. Defense:
The Opposite Parties filed their respective written versions and denied the allegations of negligence. It was submitted that the Opposite Party No. 2 is reputed and experienced eye surgeon and conducted more than 5 lakhs eye operation successfully during his 33 years of practice. It was submitted that on 21.01.2007 the patient was registered with a unique Reg. No. 6312/07 and the complete record was maintained in the hospital, which was updated at each visits. At the time of discharge, the complete medical record was handed over to the patient and a copy was kept with the hospital. The medication such as Toba DM and Milflox Eye drops antibiotics routinely prescribed before and after any Ocular surgery. Such prescription does not imply existence of ocular infection. The hospital as a routine before surgery provides a leaflet to all patients, which consists of the list of antibiotic drops to be instilled prior to surgery. Prior to surgery Dr.O. P. Singh conducted physical examination of the patient. In any hospital, routinely the Culture & sensitivity of the Conjunctiva is not done but under only special circumstances any visible infection cultures advised.
Arguments:
We have heard the arguments from the learned Counsel for both the sides. Perused the material on record, inter alia, the Medical Record and gave our thoughtful consideration.
The learned Counsel for Complainant submitted that the decision of the Opposite Party No. 1 to do the cataract operation was only a shot in the dark that did not bother to rectify the treatment modalities. Though, the Complainant again approached the Opposite Party No. 2 on 31.03.2007 for pain and visual problem in his right eye. The Opposite Party No. 2 referred the Complainant for Ultrasonographic test of eye only after the pressure from the family members. He further submitted that the Opposite Parties deliberately filed their written statements without complete Medical Record having forged and fabricated entries. In the case of infection, Vitrectomy should be performed immediately but the Complainant lost his vision in his right eye because of deliberately delayed referral to the higher medical institute for Vitrectomy. Thus, it was a gross negligence of the Opposite Parties who stated treatment of infection at late stage. Though the infection was detected on 29.03.2007, but after 6 days the Opposite Party No.2 on 03.04.2007 advised the patient to consult Shrof Eye Centre, Delhi or Shankar Netralaya, Chennai. The delay in referral was fatal.
The learned Counsel for the Opposite Parties reiterated their evidence and the treatment aspects of the patients. He submitted that the Opposite party hospital was the first eye hospital in Bihar which uses flash autoclave to achieve proper sterilization. Even for "scrubbing" (washing hands) before any surgery aqua guard purifier water was used instead of tap water and then the hands of doctors and other staffs are washed with sterilized (autoclaved) distilled water. He further submitted that on the direction of L.V. Prasad Eye Institute, Hyderabad , the Opposite Party hospital started using "Vapor Line" sterilization indicators which are superior to biological indicators. Therefore patient developing endopthalmitis was not due to any deficiency from the opposite parties.
Discussion:
We gave our thoughtful consideration to the arguments of the parties. As per the evidence of the Opposite Parties - the complainant was given special attention, as he was relative of Dr. O.P. Singh the physician at Nayadeep Eye Research Centre (Opposite Party No. 2) who was present in the operation theatre during cataract surgery.
It is apparent from the medical record that on 07.03.2007, Dr. Arun Kumar Sinha (Opposite Party No. 2) after taking an informed consent of the patient performed an operation at 'Nayandeep Eye Research Centre' for removal of cataract by phacoemulsification and implanted a foldable IOL. The post-operative recovery was satisfactory. There was no infection from 5th day till 15th day. On the 5th post-operative day patient’s recovery was 6/6 normal vision and it was same on the 15th day. On 30.03.2007 (after 3 weeks), the infection was suspected in right eye and immediately treated with IV injection of antibiotics ciplox and Gentamycin. On the next day 31.03.2007 the Patient was referred to Dr. Shalabh Sinha a Vitreo-Retinal Surgeon. Thus, based on clinical signs, referring the patient for better management was not negligence of the Opposite Party No. 2.
On 15th post-operative day i.e. on 21.3.2007, same clinical findings were noted in the right eye. He was advised for 2 eye-drops only viz Toba DM & Tear Drop, 2-3 times a day for about 2 months. He was also given certain instructions to take soft and normal diet. He was further advised not to rub eyes and to wear dark glass, whenever during exposure of sunlight. But unfortunately he did not follow the instructions given by Dr. A. K. Sinha (the Opposite Party No.2). On 23rd post-operative day i.e., on 29.3.2007, the patient approached Dr.A.K. Sinha with the complaints of redness in the eye, decrease in vision and pain. On examination his vision was found to be 6/36 with mild inflammation in eye. He was immediately advised Tear Drop, Pred acetate, Toba DM and other oral medicines and called for check-up on the next day for check-up. On 30.03.2007 at 10 A.M. the patient was again examined, but his condition did not show any sign of improvement, he was able to make only finger counts, therefore he was advised further treatment with Tear Drop, Pentol, Milflox and Pred acetate ocular eye-drop, all 8-10 times a day and in addition patient was given medicines Ava, Medrol, Itral, Arsar-D all the above twice a day and Gatiquin, and Vitamin 'C once a day. Further intraviteral injection of Vanco +Cefta +Amphoterian-B was given under local anesthesia through pars-plana route. The anterior chamber (AC) tap was done and the fluid sent for culture sensitivity. The patient was kept under observation of Dr. A.K. Sinha (Respondent No.2) in the nursing home. In the evening at 6 p.m. on examination there was no deterioration or improvement. Patient was given intravenous injections Ciplox and Gentamicin. On next day 31.3.2007 the Vitreo-Retinal Surgeon Dr. Salabh Sinha seen the patient and treated for 2 days, however on 3.4.2007 surgery was advised as there was no improvement in patient’s right eye. In our view the patient was treated with reasonable standards and as per the guidelines of All India Ophthalmological Society.
It is known that there exists inherent risk in every treatment either medical or surgical; wherein possibility of unforeseen mishap may not be ruled out. The Hon'ble Supreme Court in catena of judgments elaborated on medical negligence. In case of Achutrao Haribhau Khodwa and others vs. State of Maharashtra it was observed that-
"A medical practitioner has various duties towards his patient and he must act with a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. This is the least which a patient expects from a doctor. The skill of medical practitioners differs from doctor to doctor. The very 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 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 permanent ailment, it would be difficult to hold the doctor to be guilty of negligence."
In the recent judgment (20.04.2022) of Hon’ble Supreme Court in Dr. (Mrs.) Chanda Rani Akhouri & Ors. Vs. Dr. M.A. Methusethupathi & Ors. in paragraph 27 observed that; 27. It clearly emerges from the exposition of law that a medical practitioner is not to be held liable simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference to another. In the practice of medicine, there could be varying approaches of treatment. There could be a genuine difference of opinion. However, while adopting a course of treatment, the duty cast upon the medical practitioner is that he must ensure that the medical protocol being followed by him is to the best of his skill and with competence at his command. At the given time, medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.
Based on foregoing discussion, we do not find any negligence or deficiency either during the cataract surgery or post-operative follow-up treatment with proper antibiotics and anti-inflammatory drugs. The patient was referred to VR surgeon at proper time to Delhi, there was no delay. The Complainant failed to show that the treatment was below the standard of care. Therefore, it is difficult to attribute medical negligence against the Opposite Parties. The Complaint is dismissed. There shall be no Order as to costs.