Alarming rise in consumer cases/medical malpractice claims with huge compensation: How to safeguard medical professionals?

Dear Editor,

Medical professionals are now accountable to the public under the Consumer Protection Act (COPRA), 1986, which came into force in 1988. The act recognizes a consumer’s right to safety, information, choice, redressal, consumer education and to be heard. The inclusion of medical services under COPRA has evoked scathing criticism from the medical profession, which argues doctors will have to practice “defensive medicine” while treating/operating patients, and undertake multiple consultations. Medical professionals will also be forced to insure themselves heavily against malpractice suits.

India is witnessing an alarming rise in medical negligence cases filed in consumer courts against hospitals and medical professionals.[1-3] Heavy compensation was ordered in some of these cases. In a judgment given in October 2013 on medical negligence, the Supreme Court awarded compensation amounting to Rs. 11 crore to a victim, which was to be paid by the doctors and the private hospital deemed responsible for the wrongful death of a patient. This landmark decision is by far the largest compensation award in the history of Indian medical negligence litigation. The National Consumer Disputes Redressal Commission (NCDRC), New Delhi, on August 26, 2022, awarded an exemplary compensation of Rs. 1 crore to the parents of a 6-year-old child. The child was admitted for squint eye correction surgery and died while undergoing squint surgery at an eye hospital in Chennai. In July 2015, the Supreme Court ordered a compensation of Rs 1.7 crore to a girl who lost vision soon after birth due to medical negligence by doctors of a government hospital in Tamil Nadu.

The medical profession is considered to be one of the noblest professions in the world. While Indian medical infrastructure is being noticed and praised on the global map, yet within the country, the doctor–patient relationship is deteriorating and the medical setup is facing extensive problems with medical litigation fast becoming one of the most serious of all issues. Doctors are no longer regarded as infallible and beyond questioning. We live in a culture in which displeased patients have increasingly turned to litigation as a means of obtaining redress from perceived deficiencies in the quality of care received from their treating physicians. Consumer cases are increasing not only for the medical branches dealing with life and death (emergency medical branches) or dealing with two lives (such as obstetrics and gynecology), but doctors working in outpatient department (OPD)/daycare setup, like ophthalmology, dental surgery, dermatology, and diagnostic branches like radiology are also increasingly facing consumer cases/litigations.

The best way to handle consumer cases/medico-legal issues is by preventing them by 6 Cs: “Checklist,” “Cost,” “Consent,” “Counseling,” “Complications Management,” and “Coverage by Insurance.”

Despite the best possible care, best intentions, and best medical practices, some complications are bound to occur, and at these times, effective communication with the patients and attendants is the key to avoid these complications from becoming lawsuits. While communicating with these patients, we need to be honest and sympathetic, but not overly defensive. It helps to clearly admit that a problem has occurred, rather than being evasive. However, the responsibility does not end with good communication; we need to do our best to ensure that the complications are handled well or are referred to the right place. Support the patient at this time by explaining to the attendants, helping to take the patients elsewhere, and so on. The right attitude and communication at this crucial time can make a huge difference to the reaction of the patients and avoid litigation despite unfavorable outcomes.

Timely referral to an expert is important for managing a difficult situation or any specific disease. Never criticize or disapprove of treatment or surgery done by your professional colleague in front of patients or relatives as it can provoke them to file malpractice lawsuits. The increased cost of service delivery has ultimately led consumers to have higher expectations from medical providers. Combined with the increased awareness and the availability of means to vocalize their grievances, patients can highlight cases of negligence even for the smallest deficiency in the service.

Checklists, Cost, Consent, Counseling, Complications Management, and Coverage by Insurance

The World Health Organization (WHO) Surgical Safety Checklist is an often used example of a surgical checklist intended to ensure safe surgery and minimize complications. Train your entire team to follow the checklists and protocols. Examine each and every patient very carefully. Ask for the previous medical records, and never forget to take a complete history of systemic illness, drug allergy, previous surgery or trauma, and so on.

It is important to counsel and explain to each and every patient about the surgery, cost, outcome after surgery, need for follow-up, and possible complications. The preoperative stage entails taking valid informed consent (video consent in all high-risk cases) of the patient for executing the proposed treatment, taking and recording the history of the patient, carrying out a proper examination, diagnosis and investigations, pre-anesthetic checkup, detailed counseling, complete systemic investigations (and clearance for surgery), and then proceeding with treatment.

Always take the help of an anesthesiologist for monitoring vital parameters after taking patients to the operation theater (OT). The surgeon and the entire team should be vigilant to minimize the complications encountered during surgery in the OT; accidents, drug reactions, and mishaps experienced while operating (e.g., surgery in the wrong eye/the wrong side, implanting the wrong intraocular lens [IOL]/implant); death during operation; and other similar incidents. Always document all operative notes, follow-up advice, detailed instructions about using the medications/eye drops, communication about the postoperative complications, and others. Several ophthalmologists use abbreviations and short forms instead of detailed notes, and this needs to be avoided, especially in the instructions for the patients. Always explain the prognosis/complications/adverse outcomes in simple words using the language spoken by the patients. It may be helpful to write about the treatment details/prognosis/outcome in the Hindi (or other regional) language on the discharge/follow-up records, so that the patient (and his relatives) can read and understand clearly.

Coverage by Insurance (Professional Liability Insurance)

Ophthalmologists must cover themselves under professional liability insurance. One may take the help of medical societies for bulk purchases and to reduce the premium. A group of doctors can always negotiate better terms with the insurer than any individual. If the insurance company is being changed, one should always insist on retroactive cover.

Team Training and Periodical Checking

Periodical training/checking of your staff members and OT team is a must to ensure they follow the checklist and protocols to minimize any error(s) when the patient is taken for surgery. Double-check the patient records, investigation reports, consent signed by the patient, site of operation, medical records related to systemic illness, and so on. Before taking the patient to the OT, check the IOL type and its power, carefully inspect the irrigating solution for any floating particles, and always cross-check the date of expiry of drugs and devices. Train your OT team to always follow the practices to minimize postoperative endophthalmitis, such as application of adhesive drapes, preoperative cleaning of the eye and periocular area with 5% povidone-iodine solution, and instillation of one drop of povidone-iodine solution after completion of intraocular surgery. Avoid unnecessary conversation (including jokes, irrelevant talk, scolding your staff, etc.) in the OT premises in the presence of a patient (or relatives) scheduled for any procedure or surgery. Exercising utmost care while performing any surgery under topical or local anesthesia is important as the patient is actively listening to all conversations and may (wrongly) correlate negligence in case of a lack of desired results.

In summary, the number of cases against medical professionals for malpractice is increasing because of increased internet awareness (Dr. Google) among patients. While very few cases may be legitimate and based on clinical negligence exercised by doctors, most ophthalmologists are wrongfully accused because of the lack of public understanding. The ophthalmic professionals must communicate empathetically, emphasize diligent service delivery, and also maintain proper records about the patient history, consent, and treatment. This practice will bring down the alleged incidents of malpractice and protect ophthalmologists from fake lawsuits. It is imperative to take substantial measures to ensure due diligence while performing surgical procedures, follow the provided guidelines, and take all necessary measures before performing any surgery in the hospital. Following surgical checklists and protocols, proper documentation (maintaining medical records), taking informed consent, communication about the outcome of the procedure or treatment, timely referral of the patient (in case of any complication), and obtaining adequate professional liability insurance coverage are a few important tips to minimize the risk of litigation against ophthalmologists and medical professionals.

There is an urgent need to evaluate the manner in which India chooses to address medical negligence/errors. In addition to the fear of defensive medicine, increasing insurance premiums, and rise in costs for patients, it is time we are aware of the inequity that the present system perpetuates. Systemic deficiencies such as very heavy malpractice/litigation costs, delayed and protracted litigation, as well as dependence on judicial discretion do not provide effective justice to victims and could harm medical professionals and hospitals as well. In a developing country like India where there is an abysmally low investment in health, the paucity of trained human resources, a huge gap between urban and rural health care, and poor political/administrative will to improve the health sector, it would be wise to implement a no-fault liability system within the public health sector and also to have caps on the amount of of compensation after carrying out due research and discussion. The government also needs to act and invest in health care (at least 5% of gross domestic product [GDP]) before it is too late.[4-6]

India needs to overhaul the present system of addressing medical negligence using all of the above-mentioned solutions effectively. It is time for the Indian Medical Association (IMA), All India Ophthalmological Society, and other medical/ophthalmic societies to work together to sensitize the politicians to exclude medical services from the consumer protection act.