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Improving Retinopathy of Prematurity Care: A Medico-Legal Perspective

Vinekar, Anand MD, PhD; Gangwe, Anil MD; Agarwal, Samarth MD; Kulkarni, Sucheta MD§; Azad, Rajvardhan MD

Author Information
Asia-Pacific Journal of Ophthalmology: September-October 2021 - Volume 10 - Issue 5 - p 437-441
doi: 10.1097/APO.0000000000000388
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Abstract

INTRODUCTION

Retinopathy of Prematurity (ROP) is the leading cause of preventable infant blindness in the world. India and other middle-income countries are tackling the “third epidemic”. Asia has the highest estimated incidence, where visual loss from ROP is over twice as high per million live births compared with established market economies.1 The higher rate has been attributed to 3 factors: high preterm birth rates, suboptimal neonatal care which places more mature infants at risk, and inadequate coverage of high-quality programs for the screening and treatment of ROP.

India is reporting ROP to compound the problem in infants from rural and outreach areas whereas previously only urban babies survived.2–5 This has resulted in several new challenges that have been previously summarized2 and include, an unknown disease burden with lack of community data, a large at-risk population, limited number of experts available nationwide, suboptimal awareness among the pediatrician and nursing cadres for timely screening and logistic difficulties in setting up comprehensive ROP screening programs.

The number of ROP specialists in India is abysmally low. With approximately 20,000 ophthalmologists of which 2,000 are vitreo-retinal specialists, the number of those practicing comprehensive ROP management were estimated to be between 150 and 200 in 2019.6,7 Annually, 3.5 million babies are born premature and would require screening if they survive. This has created a skewed demand vs supply challenge. With a majority of these “at-risk” babies now being born rurally where there are even fewer specialists to screen, the problem is only compounded. A significant number of babies in our country do present late8–11 or do not follow-up as advised12 resulting in advanced, stage 5 ROP, leading to bilateral, irreversible blindness due to this absent or delayed ROP screening. A similar presentation has been reported from Northwest China.13

With this scenario, the landmark judgment by the Honourable Supreme Court of India, in July 2015 which held a tertiary care public hospital liable for a child who went “blind” with stage 5 ROP, because screening was not performed or referred “on time”,14 opens up the proverbial “Pandora's box” of medico-legal problems in our country. Previous to this judgment, concurrently and subsequently, there had been other cases15–18 which were held against the treating pediatrician(s) and/or ophthalmologist(s) related to ROP screening.

The purpose of this manuscript is to detail some of these legal cases, summarize the key learning points, and suggest good clinical practices for various key steps involved in ROP care to help mitigate future litigations as well as protect the clinical interest of the infants who require ROP screening and treatment.

METHODS

This manuscript reviews jurisprudence literature relating to ROP from India in the past decade. The key clinical lessons learned from these judgments relating to ROP screening and treatment are summarized. All details of these legal cases and judgments are available in the public domain and are referred to as cases in this article. As a disclaimer, the authors want to declare that this manuscript is not meant to substitute for legal advice, nor is it a guideline nor comprehensive account of legally sound ROP management.

CASES AND JUDGMENTS RELATING TO ROP

Although there were judgments before the 2015 case, we enlist them in the order of impact or quantum of compensation awarded to the litigant. The details of these cases are summarized in Table 1.

TABLE 1 - Summary of Important Legal Cases Relating to Retinopathy of Prematurity Care in India (2012–2019)
Sl. no Details of the Case Allegations / Counter Argument ROP Status Compensation (Indian Rupees) Lessons Learnt
1 Mumbai, 201215 Against the pediatrician: Failure to inform parents about ROP screening Detected stage 5 ROP 7 months after birth (BW 1280 g, GA 28 weeks) 5 lakhs Document referral of timely ROP screeningEyes “WNL” is not adequate documentation. Details must be recorded
2 Ludhiana, 201216 Against the pediatrician: Failure to inform parents about ROP screening Detected stage 5 ROP 4 months after birth (BW 1340 g, GA 31 weeks) 7.5 lakhs One ROP screening done at day 8 – “No ROP” mentioned.Infant was not called for follow-up
3. Chennai, 201514 Against the Govt. hospital pediatrician: Failure to inform parents about ROP screening Accidentally detected with stage 5 ROP during vaccination visit 4.5 months later (BW 1250 g,GA 29 weeks) 1.8 croresCalculated based onPrinciple of “Restitutio in integrum” Aggrieved person should get that sum of money that will put him in the same position as he would have been had he not sustained the wrong Compensation is calculated as:1) Past medical expenses + future medical expenses + compensation for mental agony and lifelong dependence and care2) Annual interest and inflation also added
4 New Delhi, 201617 Against pediatricians AND ophthalmologists Alleged, ”“Negligent care of premature baby, casual improper ROP screening by ophthalmologist” 64 lakhs Ophthalmologists can also be held liableDocument: who screened, how, drugs for dilatation and detailed anterior and fundus findingsFollow current published guidelines
5 Indore, 201618 Against pediatricians Alleged “too much oxygen” and “improper care of the twins (1040 g and 1160 g, 28 weeks) 43 lakhs + 6% p.a. interest for 23 years (1993 – 2016)Approximately 1.2 crores Referral on time according to the prevailing guidelines and oxygen details must be mentionedReferral to a ‘specialist’
G: grams; ROP: retinopathy of prematurity.

Case 1: Chennai, 201514

The Infant was born in 1996 with a birth weight of 1250 g and 29 weeks of gestation and was admitted to the neonatal unit for approximately 25 days. Approximately 4 to 5 months later during a vaccination visit, stage 5 ROP was accidentally detected. This case was against the treating pediatricians serving in a tertiary care public hospital. The allegation made by the complainant was that no advice for ROP screening was made at the right time. The judgment was delivered 13 years later in 2009 by the National Consumer Forum and another 6 years later in 2015 by the Honourable Supreme Court of India. The compensation of INR 500,000 (USD 7,000) in 2009 was enhanced to INR 1.8 crores (USD 245,000) in 2015 by the apex court.

The jurisprudence of this case include, 1) absence of disclosure in the discharge summary for timely ROP screening or proof of “preventive care” taken for ROP; 2) absence of proof of advice to visit an ophthalmologist (specialist); 3) although one of the arguments was that the occurrence of ROP was not known then (1996), the judgment noted that, “Whether the consequences were foreseeable or not must be measured with reference to knowledge at the date of the alleged negligence not with hindsight, thus ROP was reasonably foreseeable to the doctors” and “No reason why ROP screening—an accepted practice—was not done”

This judgment has given us an insight into the mathematical modeling the court used to calculate the quantum of compensation. The principles used were: 1) “Restitutio in integrum” which means that the aggrieved person should get that sum of money that will put him / her in the same position as he / she would have been had he / she not sustained the wrong. 2) It must compensate for the financial loss, pain, suffering undergone and liability to incur disability affecting future normal life. 3) The heads of calculation were: past medical expenses + future medical expenses + compensation for mental agony and lifelong dependence and care. 4) A 6 percent annual interest was levied from the time since the case was first filed and Reserve Bank of India's rate of inflation for future was used to assess the total value.

Case 2: Mumbai 201215

The infant was born in 2007 at 1280 g at birth and 28 weeks of gestation and was admitted to the neonatal intensive care unit (NICU) for 24 days. Seven months later, a relative who was an ophthalmologist, detected stage 5 ROP. The case was filed against the pediatrician for failure to inform the parents about timely ROP screening. The judgment was delivered 5 years later for an amount of INR 500,000 (USD 7000).

The jurisprudence involved in the case include: 1) the pediatricians claimed they had advised the parents about ROP screening, but the parents did not go to a retina specialist for it. However, they could produce no evidence to support this claim and the parents filed an affidavit denying the same. 2) Contrarily, the pediatrician's records of the baby showed a written record of “Eyes –WNL” (within normal limits), which further weakened their case. The court pronounced that, “the failure of the accused to inform the inherent known risk of ROP can be considered as their failure in their professional conduct and such gross negligence amounts to deficiency in service on their part within the meaning of Consumer Protection Act, 1986.”

The lessons learned from this case are, 1) ROP screening must be advised and the same documented in writing; 2) casual statements on external eye examination must be avoided; 3) short forms like “WNL” must be avoided.

Case 3: Ludhiana, 201216

The infant was born in 2001 at 1340 g at birth and 31 weeks of gestation and was admitted to the NICU for 38 days. Four months later, stage 5 ROP was detected. The case was filed against the pediatrician for failure to inform the parents about timely ROP screening. The judgment was delivered 11 years later for an amount of INR 750,000 (USD 12,000).

The jurisprudence of this case highlights 2 potential deficiencies in the records: 1) apparently, ROP screening was done by an eye specialist at 8 days of age and it was recorded as there was ‘no ROP’. It was alleged that further follow-up was not asked for; 2) there was no documented evidence of the above-mentioned ROP screening and no evidence that follow-up was advised.

The judgment pronounced mentioned that “there was gross deficiency in service on the part of the appellants who forgot about this disease which was so serious in nature that it made the infant blind for life. The appellants were duty-bound to indicate in the discharge summary mandatory ROP screening and follow up”. They were held guilty of “deficiency in service”.

Case 4: New Delhi, 201617

The infant was born in 2005 at 1500 g at birth and 32 weeks of gestation and was admitted to the NICU for 28 days. Eight months later, stage 5 ROP was detected. The case was filed against the pediatrician and the treating ophthalmologist for ‘negligent care of the preterm and casual, improper diagnosis of ROP by the ophthalmologist’. The judgment was delivered 11 years later for an amount of INR 64 lakhs (USD 95,000).

This was a controversial judgment that involved more than 1 party. The jurisprudence involved 1) the hospital initially refused to provide the medical records to the Delhi Consumer Forum which was viewed unfavorably by the National Forum. 2) the hospital later submitted documents to the National Forum, stating that ROP screening was done by their senior retina surgeon at 24th day of life with “no ROP”. 3) the hospital alleged contributory negligence of the parents for missing follow-up. 4) All India Institute of Medical Sciences (AIIMS), New Delhi was asked for a medical report which upheld the contributory negligence by the parents. However, this was not agreed upon by the court. 5) The court found a “scribbled note in illegible handwriting” in the corner of the hospital record noted as “26/4 by Dr XX, No ROP, Review, 2 wks”. The court opined that the evidence was deficient with respect to: No details of ROP examination, who performed it, the method used, drugs & anesthesia used, details of pupillary dilation, details of indirect ophthalmoscopy findings and other intraocular or extraocular findings. The court opined that standard ROP screening guidelines must be adhered to and documentation of the findings must be more detailed.

The lessons learned include that 1) ophthalmologists are also liable once they commence screening a baby for ROP, 2) ROP screening findings must be meticulously documented and must include—who screened and using which method (indirect ophthalmoscopy or imaging), details of the pupillary dilatation, anterior and posterior segment findings using standard accepted terms that are published in accepted guidelines or journals, and 3) the courts give more credence to published literature and guidelines than experts’ medical opinion.

Case 5: Indore 201618

The twin infants were born in 1990 with birth weights of 1040 g and 1160 g respectively at 28 weeks of gestation and were admitted to the NICU for 40 days. Three months later, stage 5 ROP was detected. The case was filed against the pediatricians for ‘improper care and too much use of oxygen’. The judgment was delivered in 2016 for an amount of INR 1.2 crores (USD 165,000)

The district court's compensation of INR 21 lakhs with 6% interest was challenged by the parents at the Madhya Pradesh High Court alleging that “the compensation amount was too less and the court did not consider the fact that the twins have lost their vision for life, cannot marry and their quality of life would be compromised.” The courts found negligence on account of 2 deficiencies: 1) the pediatrician did not refer the twins for ROP screening to the concerned specialist and 2) not mention the quantity of supplement oxygen that was given to the infants.

Summarizing the key lessons from these 5 important judgments, the potential touchpoints in ROP care with respect to the 3 stakeholders, that is, pediatrician/neonatologist, ophthalmologist, and parent/guardian are enumerated in Table 2.

TABLE 2 - Potential Legal Touchpoints in ROP Care for the Respective Stakeholders that Need to be Identified and Improved
Pediatrician / Neonatologist related:1. No established screening program in the Special Newborn Intensive Care Units (SNCUs)2. Delayed referral for ROP screening3. No follow-up appointment when infant is still under the care of the neonatal team4. No clear education of parents about the implications of failed screening5. Protocol and documentation of the oxygen supplement used not mentioned
Ophthalmologist related:1. Improper, inadequate or inappropriate documentation2. No appointment or counseling about follow-up screening visits once screening is initiated3. Failure to treat on time, or inadequate treatment4. Failure to explain about ocular comorbidities and need for “long term” follow up
Barriers faced by parents/caregiver related1. Lack of awareness2. Distance to screening center3. Cost of travel and treatment4. Others – gender bias and other factors that increase attrition of follow-up especially in rural areas which may not be modifiable in all cases12

Caveats to Strengthen Practices in ROP Screening

Based on the legal cases, the judgments, and potential pitfalls in ROP screening, we recommend the following practices to help improve and strengthen the processes of the treating physicians which may help reduce further litigations. However, this must not be regarded as legal advice and serves only to provide broad guidelines that must be considered based on the limitations of the given scenarios. In India, the “real-world” scenario is fraught with potential pitfalls and gaps8–10,23 both for screening and treatment.

SCREENING

  • 1. Use the most recent and accepted ROP screening guidelines. At the time of this publication, the National Operational Guidelines (2018)19 which replaced the National Neonatology Forum guideline of 2010 is the most widely accepted.
  • 2. ROP screening is safe and possible for infants even inside an incubator and on a ventilator. Even treatment may be successfully performed through the incubator wall.20 So the neonatologist must not delay ROP screening as much as possible.
  • 3. A consent form for screening is mandatory and must be explained and obtained in all screening sessions from the parent(s) or guardian. If the model is telemedicine with imaging, this must be mentioned in the consent.
  • 4. Document the method of screening, the time, and the details of pupillary dilatation drops used in the charts especially in inpatients.
  • 5. Counsel the parents about the need for ROP screening, the safety, the method to be used and the expected findings before the screening and the diagnosis following screening along with the need for subsequent follow-up. This should be recorded in the ROP card given to the parent and also in the hospital/outpatient record/electronic health record.
  • 6. Enquire about multiple gestations and inform the parents the need for examining all the infants if one/many are not screened at that time.
  • 7. Good, scientific, legibly recorded, written documentation is most important and can prevent most legal cases. Draw diagrams, use appropriate terminologies, for zone, stage, and plus, avoid abbreviations, write complete diagnosis for both eyes, and describe aggressive posterior ROP qualitatively, associated findings of the anterior and posterior segment wherever applicable.
  • 8. Retinal photography may further support the diagnosis and the record of the specialist. Images can also be used to educate the parents about the findings which also serves to enhance follow-up compliance.
  • 9. Although discharging an infant from ROP screening, record the findings, need for long term follow-up for ocular and retinal structural, visual and refractive outcomes and specify the date for such visits.
  • 10. The “ROP card” that is given and explained to the parents must contain the summary of each visit and date for future follow-up.
  • 11. Communicate with the treating neonatologist about the findings and comply with the record-keeping policy of the NICU. Relevant to the ROP diagnosis, discuss with the treating neonatologist about weight gain, weaning of oxygen, anemia, thrombocytopenia and other risk factors that influence the outcome of the disease.
  • 12. Obtain and maintain a good professional indemnity coverage.

TREATMENT

  • 1. Treat ROP only based on the most current recommendations. Be aware of new recommendations with respect to timing and stage of treatment. During certain time periods like the COVID-19 lockdown, modifications to the existing screening and treatment guidelines were suggested and must be adhered to.21
  • 2. Treat only after a detailed oral and written consent. Explain the procedure, possible need for supplement therapy, success and failure rates, alternate therapies, duration and method of treatment, type of anesthesia, systemic and ocular outcomes both short and long term and follow-up requirements before the procedure is performed. Document this communication.
  • 3. Treat in the presence of a neonatologist, pediatrician, anesthetist or a pediatric nurse with an emergency kit and with continuous, meticulous monitoring of vitals and also hypothermia, hypoglycemia, and pain management.
  • 4. Antivascular endothelial growth factor (VEGF) when chosen as the treatment modality requires special consideration, consent and precautions. At this time, laser is still considered the gold standard for ROP treatment.
  • 5. Where possible, pre- and post-treatment retinal images help documentation and parent education.
  • 6. Where in doubt, obtain an additional opinion from peers or seniors. Images may serve as the most objective tool for this communication. Telemedicine rules and regulations in India are evolving especially after the COVID-19 pandemic.

CONCLUSIONS

The risk of medico-legal cases in retinopathy of prematurity is not unique to any country or region. Moshfeghi22 reviewed the cases of malpractice litigations relating to ROP in the United States and concluded that the top 5 pitfalls arose from systemic errors that prevent timely screening. A coordinated effort of the hospital staff and the parents that pro-actively ensure timely screening is of paramount importance. The risk can be reduced by updating with the current screening and treatment guidelines. It was suggested that it is important to maintain a high level of suspicion when dealing with infants known to be predisposed to poor outcomes.23

In some western nations, there are a declining number of specialists who are willing to undertake ROP screening or treatment. One of the reasons is fear of medico-legal litigations. In our country, which has the highest number of preterms in the world, with pre-existing scarcity of trained human resources, our infants cannot afford a further reduction in caregivers. Like all spheres of medical care, it is imperative to promote clinically and ethically sound practices in ROP management as well. This will not only reduce the risk of litigations but also provide the standard of care to our tiny citizens and prevent blindness in them.

REFERENCES

1. Blencowe H, Moxon S, Gilbert C. Update on blindness due to retinopathy of prematurity globally and in India. Indian Peds 2016; 53: (Suppl 2): 89–92.
2. Vinekar A, Dogra M, Azad RV, et al. The changing scenario of retinopathy of prematurity in middle and low income countries: Unique solutions for unique problems. Indian J Ophthalmol 2019; 67:717–719.
3. Hungi B, Vinekar A, Datti N, et al. Retinopathy of Prematurity in a rural Neonatal Intensive Care Unit in South India--a prospective study. Indian J Pediatr 2012; 79:911–915.
4. Vinekar A, Jayadev C, Mangalesh S, et al. Role of tele-medicine in retinopathy of prematurity screening in rural outreach centers in India - a report of 20,214 imaging sessions in the KIDROP program. Semin Fetal Neonatal Med 2015; 20:335–345.
5. Vinekar A, Gilbert C, Dogra M, et al. The KIDROP model of combining strategies for providing retinopathy of prematurity screening in underserved areas in India using wide-field imaging, tele-medicine, non-physician graders and smart phone reporting. Indian J Ophthalmol 2014; 62:41–49.
6. Vinekar A, Azad RV, Dogra MR, et al. The Indian retinopathy of prematurity society: a baby step towards tackling the retinopathy of prematurity epidemic in India. Annals of Eye Science, North America, 2, June 2017. Available at: <http://aes.amegroups.com/article/view/3727>. [Accessed January 30th, 2021].
7. Vinekar A, Azad RV. The Indian Retinopathy of Prematurity (iROP) society: Challenges ahead. Indian J Ophthalmol 2019; 67:722.
8. Sanghi G, Dogra MR, Katoch D, Gupta A. Demographic profile of infants with stage 5 retinopathy of prematurity in North India: implications for screening. Ophthalmic Epidemiol 2011; 18:72–74.
9. Azad R, Chandra P, Gangwe A, et al. Lack of screening underlies most stage-5 retinopathy of prematurity among cases presenting to a tertiary eye center in india. Indian Pediatr 2016; 53: (Suppl 2): S103–S106.
10. Gopal DP, Rani PK, Rao HL, et al. Prospective study of factors influencing timely versus delayed presentation of preterm babies for retinopathy of prematurity screening at a tertiary eye hospital in India The Indian Twin Cities ROP Screening (ITCROPS) data base report number 6. Indian J Ophthalmol 2019; 67:855–859.
11. Kulkarni S, Gilber C, Zuurmond M, et al. Blinding retinopathy of prematurity in western, India: characteristics of children reasons for late presentation and impact on families. Indian Padiatr 2018; 55:665–670.
12. Vinekar A, Jayadev C, Dogra M, et al. Improving follow-up of infants during retinopathy of prematurity screening in rural areas. Indian Pediatr 2016; 53: (Suppl 2): S151–S154.
13. Dou GR, Li MH, Zhang ZF, et al. Demographic profile and ocular characteristics of stage 5 retinopathy of prematurity at a referral center in Northwest China: implications for implementation. BMC Ophthalmol 2018; 18 (1):307.
14. V. Krishnakumar vs State Of Tamil Nadu &Ors.; https://indiankanoon.org/doc/86607695/. [Accessed August 21, 2020].
15. Akash Mayur Shridharani vs 1. Dr Sharmila Mallya And Others, https://indiankanoon.org/doc/60366700/. [Accessed August 21, 2020].
16. Dmc vs Sanjiv Bhasin, https://indiankanoon.org/doc/40136277/. [Accessed August 21, 2020].
17. Maharaja Agrasen Hospital. vs Master Rishabh Sharma; https://indiankanoon.org/doc/35792279/. [Accessed August 21, 2020].
18. Shikhar Chand Jain vs Ku Dimple; http://www.scconline.com/DocumentLink/1wC77c8y. [Accessed November 8, 2020].
19. Project operational guidelines. Prevention of Blindness from Retinopathy of Prematurity in Neonatal Care Units. Available from: https://phfi.org/wp-content/uploads/2019/05/2018-ROP-operational-guidelines.pdf. [Accessed May 21, 2019].
20. Dogra MR, Vinekar A, Viswanathan K, et al. Laser treatment for retinopathy of prematurity through the incubator wall. Ophthalmic Surg Lasers Imaging 2008; 39 (4):350–352.
21. Vinekar A, Azad RV, Dogra MR, et al. for the Indian Retinopathy of Prematurity Society. Retinopathy of Prematurity screening and treatment guidelines during the COVID-19 lockdown 2020 available online; https://sites.google.com/view/iropsociety/newsroom?authuser=0. [Accessed April 5, 2020]
22. Moshfeghi DM. Top five legal pitfalls in retinopathy of prematurity. Curr Opin Ophthalmol 2018; 29:206–209.
23. Azad R, Gilbert C, Gangwe AB, et al. Retinopathy of prematurity: how to prevent the third epidemics in developing countries. Asia Pac J Ophthalmol (Phila) 2020; 9:440–448.
Keywords:

guidelines; litigation; malpractice; medico-legal; retinopathy of prematurity; screening

Copyright © 2021 Asia-Pacific Academy of Ophthalmology. Published by Wolters Kluwer Health, Inc. on behalf of the Asia-Pacific Academy of Ophthalmology.