”There is none so blind as one who will not see” is a famous proverb. How true this saying is in today's world of modern scientific medicine in India. The profession in India is being decimated by outside forces but we continue to live in the make-believe world where we imagine ourselves to be practicing a “noble” profession. We continue to live in a fantasy world where we trust the dictum that if we work ethically, honestly and compassionately no harm will come to us. Unfortunately, “harm” has come as is seen from the multiple court judgments penalizing ophthalmologists. Our associations and leaders need to recognize the growing danger and need to take steps to defend the members in their hour of need.
Our desire to serve the society at all costs stems from the training ingrained in us from medical college days. However, the world has in the meanwhile changed and what was once a noble profession was turned into a trade and the art of healing has become a “service” which the consumer pays for and expects complete cure in lieu of payment made. The irony was that this was done legally and with approval of majority of the civil society. The mute spectator like response of the medical profession did not help the deteriorating situation. Nowhere is this dichotomy more evident than in the field of ophthalmology where cataract surgery has been reduced to status of a minor procedure and ubiquitous “Mass surgery assemblies” also known as “free eye camps” are the norm even for those in core “private” practice. Unfortunately, the phacoemulsification-cataract surgery, however fast and easily it may be performed, is still a surgery and like any other surgery has its own set of risks and complications and liabilities thereof. Even patients who receive treatment free of cost in India remain “consumers” and can seek compensation from their service providers for any perceived deficiency.
While the judiciary and lawmakers are protected from being held accountable for actions having been done in “Good faith” no such protection is afforded to doctors who undertake these free eye camps in good faith only to be asked to pay compensations in millions and being hounded by the police should a case go wrong. This is despite the fact that Indian Penal Code itself provides protection under Section 88 which states that Act not intended to cause death, done by consent whether express or implied in good faith for person's benefit is not an offense even by reason of any harm which it may cause. Section 92 of IPC also provides protection for an act done in good faith for benefit of a person even without consent. Despite these provisions Doctors including ophthalmologists in India are frequently prosecuted for criminal negligence.
The ophthalmological societies have a responsibility and a need to step in when obvious injustice is done to an individual ophthalmologist. Recently Kerala High Court in 2018 reduced the compensation awarded by the sessions court against a hospital in Tamil Nadu from 92 million rupees to 22.5 million rupees for victims of negligence in a eye camp which was partially funded by District Blindness Control Society. The order also however left it open to those who thought they deserve higher compensation to pursue further appropriate legal remedy to seek the same. Criminal charges against the doctors and administrators of the hospital were thankfully dropped. The reason given by the honorable court to award compensation was that there was no approval to run the hospital, consent to operate was not taken from the State Pollution Control board, there was no proper design and maintenance of the operating Room. There was no anesthetist, no pharmacist and no facility to do preoperative laboratory tests and there was no formalin which was indented despite it being out of stock by the head of the hospital. The court also frowned upon the fact that knowing fully well that the Intra Ocular Lens cost only Rs. 56 for the purpose of enticing the villagers had distributed pamphlets stating that they will be implanted with Intra Ocular Lens worth Rs. 1000 to Rs. 3000. Despite Pseudomonas having been cultured from the ringer's lactate being used the manufacturing company was absolved of any wrong doing because a sample of different batch number examined from company stocks was found to be as per required standards.
This however is not the first or only case where doctors who have operated or organized eye camps have been penalized. A S Mittal vs State of UP, was a landmark judgement of 1989 which was also on a similar case where 84 persons in Khurja and 15 in Moradabad lost their vision due to endophthalmitis which lead to guidelines being laid for eye camps. Despite the huge compensations being awarded in cases where cataract surgery was performed either free or subsidized through an eye camp ophthalmologists persist and in fact depend on these camps to source their patients. The legal problems aside, these free or subsidized eye camps also devalue the very services provided by these ophthalmologists.
The Consumer Protection Act 1986 in its definition had excluded free service from the purview of consumer protection act but the honorable Supreme Court in its wisdom decided that doctors providing free service also would be covered within the purview of Consumer Protection Act. This decision has never been reviewed thereafter and the implications on the free medical and eye camps are being realized belatedly and very slowly.
With exceptionally high compensations being granted today by the Indian courts, for loss of vision, even against Government hospitals the alarm bells should have started ringing a long time ago. The V Krishnakumar vs State of Tamil Nadu judgment delivered by honorable Supreme Court awarded more than 26.5 million compensation including the 6% interest in this case for failing to diagnose Retinopathy of Prematurity. Though the case and the award was not against ophthalmologists but against pediatricians who treated the premature baby and the hospital plus the State of Tamil Nadu but the implications of this judgment for ophthalmologists in term of quantum of compensation being awarded for loss of vision is enormous. In another recent case where a patient of dengue developed intraocular hemorrhage and was seen by ophthalmologist after 13 hours the complainant who finally lost his vision was awarded 3.5 million compensation despite correct treatment having been given by the doctors. Delhi Medical Council and a medical Board formed by Maulana Azad Medical College had both exonerated the treating doctors but the court disagreed with both these reports.
Recently a patient following lasik surgery for high myopia underwent Toric implantable collamer lens and for unsatisfactory results claimed a sum of 60 million plus as compensation. Thankfully the court did not agree to such exorbitant claim specially when the boy completed higher education after surgery and was gainfully employed and active on social media as found by an investigator hired by the hospital.
Free eye camps
If the thinking is that we should encourage giving professional services in charitable camps, as something to be promoted among members then it is mandatory that the association takes steps to protect them against any undue prosecution following a mishap. Obviously, these camps are held in suboptimal conditions and if we want the kudos for having helped hundreds of thousands regain sight then we also need to be prepared for causing complications in a few. If we wish to reduce the incidents of infection then no surgery should be done outside a modular OT which then makes it inevitable that the costs of surgery rise exponentially and no eye camps should be conducted in rural interiors. Even the best of centers with their high tech gadgetry, hepa-filters and all systems in place are not spared the ignominy of occasional endophthalmitis. Why then should we not protect those who in good faith go and operate in suboptimal conditions to reach out to the vast rural population which is devoid of medical services. It does not mean we throw all caution to winds but to follow guidelines laid down for such camps. But if the guidelines have been followed and still a mishap occurs protection under action taken in good faith should be extended to the doctors involved.
Spurious, contaminated and off label use of drugs
It has been repeatedly seen that the cause of infection and endophthalmitis in cases of multiple surgeries at eye camps is linked to the use of the Ringer's lactate and eye drops which are sometimes spurious or of dubious quality. However, if newspapers and TV news anchors are to be believed the ophthalmologist operating in these camps deliberately inoculated dozens of patients’ eyes with Pseudomonas and other microbes even though he knows fully well that it is he who would be blamed for the same! No company manufacturing the drug used in these eye camps has to date been prosecuted despite being implicated many times. Charging a doctor with negligence and portraying him as a demon is so much more beneficial to the bottom line of the print and electronic media that it is reprinted and re-run ad nauseum leaving the reputation of the ophthalmologist in tatters. For some reason the professional associations prefer to maintain golden silence in the matter leaving the ophthalmologist to deal with the problem himself.
For ophthalmologists there was also the issue regarding the off label use of Intravitreaous injection Avastin (Bevacizumab) rampantly by ophthalmologists and retina specialists because of cost issues across India. It is well established as per Bolam's test that a doctor might be able to avoid a claim for negligence if he can prove that other medical professionals would have acted in the same way. Since the drug has been used extensively by ophthalmologists across India it would appear to a lay person as a fit case for protection under the Bolam's test. However, knee jerk reactions following sporadic incidents of endophthalmitis at least one of which was allegedly due to spurious drug resulted in an alert notice issued by Indian drug regulator. It was shown that the vial of Avastin in this case was infected with Pseudomonas and Klebseilla. Compensation however was awarded for use of “Off label drug”. Again this was a case in which the ophthalmologists involved should have been defended and supported by the association. It is well-accepted legal principle that even if two schools of thought exist regarding treatment of a particular condition a doctor cannot be prosecuted for following one particular line of treatment. Roche the company manufacturing the drug played safe by stating that it promotes Avastin only for carcinoma colon and does not support use of drug through routes of administration for which it was not developed or registered. A Hospital in Gujarat and another Hospital in Varanasi also reported loss of vision following Avastin Injections. An individual doctor would find it difficult to pursue legal route on an issue so complex and if its members were using Avastin for an indication and the Societies closed its eyes to it for whatever reason it was imperative that they take up the cudgels and support the use of Avastin or issue a white paper against its use by members some of who still use the same. The implications of this judgment on research and development in medical science is something which is beyond the scope of this article.
Given the relative safety and low risk involved in cataract surgery as well as the desire to cut costs, competing in a cut-throat environment, most ophthalmologists in India do not insist on preoperative tests except maybe a Blood sugar. This has been frowned upon frequently by courts and recently in a State Consumer Dispute Redressal Commission of Maharashtra case The Article “Medical tests before eye surgery- when you need them - and when you don’t” published by American Academy of Ophthalmology in the year 2017 was referred to and quoted. Compensation was awarded in this case for not doing preoperative tests as well as not taking proper consent. There is a tendency to overlook necessity of taking informed consent from patient given the fact that cataract surgery has been reduced to a “minor Procedure” given the speed with which it is performed and the assembly line fashion in which some high volume ophthalmologists operate.
Another area where ophthalmologists falter is in taking indemnity insurance. It is frequently seen that insurance of a less than a million rupees is taken if at all. This indemnity insurance of a few lacs is useless in today's era where compensations of more than 10 million are being frequently awarded. Even as far back as in 2002 there was a case involving LASIK laser where compensation claimed was of 10 million for not informing about striae which can develop in the corneal flap following LASIK laser while taking consent. The Consumer Protection Amendment Bill 2018 passed in the Lok Sabha (lower house of parliament) but pending in Rajya Sabha (Upper house) increased the pecuniary jurisdiction of the district and state consumer dispute redressal commissions enormously which if passed is expected to increase both the number of cases filed as well as increase the amounts of compensations being asked for. This Bill may have lapsed for now but given the recent electoral victory of the incumbent Government it is expected to again be placed before the newly constituted Parliament.
Some surgeons working in Government institutions do not take indemnity insurance at all which is foolhardy but worse is that they do not ask the resident doctors who come to them for training to indemnify themselves. As clarified repeatedly in a catena of judgments Government institutions are not immune from the vagaries of Consumer Protection Act. Not taking indemnity insurance can have disastrous consequences both for the resident doctors who handle the emergency services routinely as well as the institution later if a problem arises. Even the consultant may be held vicariously liable for actions of the resident doctors who may have left the institution and gone by the time the case comes to court.
Not taking time out to fill the proposal form of indemnity insurance properly is something all doctors, irrespective of their specialization, are universally guilty of. This results in the insurance agent filling the blank signed proposal form which leads to problems later. If one does not mention that he operates in different hospitals or that he also operates in eye camps the insurers may deny liability on the ground that while issuing the policy they were not made aware of this fact as happened in a case recently. Another problem arises when doctors take only professional indemnity insurance and do not take error and omissions policy for the establishment. This problem came to the fore recently when after successful cataract surgery a ward attendant while putting eye drops accidently injured the cornea. Case was filed against the hospital and not against the operating surgeon. Insurance companies provide insurance even for unqualified attendants on payment of an extra loading of only 7.5% of basic premium. If, however, the establishment or hospital only is made party then the insurer may deny liability if only doctor is insured personally for his negligent acts.
No ophthalmologist in India today should take an indemnity insurance of less than 5 million and should pay additional premium to cover unqualified attendants. Ideally insurance should be taken through a medical group or organization like Association of Medical Consultants Mumbai (AMC), Medicos Legal Action Group (MLAG) Chandigarh, Indian Medical Association (IMA), and other professional organizations. A group of doctors can always negotiate better terms with the insurer than any individual. Insurance company if is being changed one should always insist on retroactive cover. It is also better if two insurances of 2 million and 3 million are taken from the same insurer rather than one single policy of 5 million.
Medical records and ophthalmologists
Ophthalmologists like doctors of other specialties use abbreviations and short forms instead of detailed notes. This was highlighted in a recent case where the ophthalmologist on 24th day of birth had examined the premature child and written in notes “No ROP Seen”. The child was thereafter discharged and advised to come for follow up in special clinic where such children are closely monitored. The court observed that “The OP-5 should have performed retinal examination with binocular indirect ophthalmoscope on dilatation of pupil with scleral depression to ascertain avascular zone at periphery of retina. Nothing is forthcoming from the medical record that this was done. Therefore, it appears to be only a bare visual examination done by OP 5 in haste to cover up” The court's view was that neither had the doctors done examination for ROP nor had they advised follow up for ROP for the child. 6.4 million compensation was awarded in this case.
In another similar case a 9 years old child, underwent ophthalmic surgery for squint. The patient suffered cardiac asystole towards the end of the surgery. Successful resuscitation was done but the patient continued to have episodes of asystole and bradycaria, for which pacemaker wire was placed. The patient subsequently expired while in the ICU. NCDRC concluded that (a) The consent obtained from the mother of the child was just a routine consent and not really an informed consent (b) Although the anesthesiologist claimed that retrobulbar block was given by the surgeon, the three documents viz; the anesthesia notes, the ophthalmic surgery notes or the physician's progress notes had any mention of retrobulbar block. Hence, the NCDRC concluded that no retrobulbar block was given. c) The word “glyco” was written instead of “glycopyrrolate” in the OT record and use of confusing abbreviations in medical records is deficiency in service. Compensation was awarded on these grounds.
Even improper OPD prescriptions, specially if postoperative instructions are not properly written, can result in damages being awarded by courts. Post-surgery for pterygium the doctor advised him to use Mitomycine-C but committed error by not prescribing the medicine was to be used for how many days. Appellant instead of coming back for check up continued using Mitomycine-C without consulting the doctor which lead to damage caused to his eye. Compensation was awarded as limited negligence of the doctor for not writing a complete and proper prescription. Contributory negligence by patient was held by the court in this case because he continued to take medicine on his own without consulting doctor.
In another case a Post cataract surgery patient, who was a coolie, did not take rest. Patient developed corneal injury due to working in his fields. The court held that “He should have been instructed about postoperative care and follow up precautions. But the medical record was devoid of such instructions”. Compensation awarded by lower courts upheld by National Consumer Dispute Redressal Commission.
Despite repeated condemnation and penalization by courts and consumer commissions ophthalmologists continue to be minimalistic when it comes to medical records and continue to use abbreviations and short forms to denote the visual acuity, procedure done and follow up precautions. Though aggressive in promotion of technology among its members ophthalmological societies and organizations rarely focus on improving documentation skills of their members or art and methodology of communication and taking consent. This is partly because continuing medical education today is driven by pharma companies and medical equipment giants who have no interest beyond their bottom line. So, they will sponsor any number of events where use of 3D technology in Phaco is demonstrated but an association will be at pains to find a sponsor for a seminar on how to keep members out of jail and out of courts. It is inevitable that given the aggressive promotion of progressively low cost of surgery with the gradual but persistent rise in quantum of compensations being awarded, there is bound to be a catastrophe in near future. Those who are today boasting of 25 surgeries a day assembly line may face bankruptcy due to generosity of the courts. A time to introspect and to factor the cost of litigation and compensations into the cost of surgeries has come. With huge compensations being awarded even where cataract surgeries have been done free of cost or on concessional basis, the desire to do charitable service should be curbed and should be balanced with the need to full-fill the responsibilities towards the ophthalmologist's family and secure the future of their dependents.
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Conflicts of interest
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