COVID-19 and Medical Negligence: The need for comprehensive guidelines

The COVID-19 pandemic has brought the healthcare sector under unprecedented focus. On the one hand, healthcare professionals are being hailed as “Corona Warriors”, but on the other, there have been reports of patients being denied medical assistance and the non-observance of safety protocols endangering the life of both health care professionals and the patients.

Has COVID-19 increased the probability of medical negligence cases? What are the reasons for the overall increase in medical negligence cases in recent years? What is the role of the judiciary in keeping a check on such cases? This article is an attempt to answer these questions.

Medical negligence cases are on the rise partly due to the rapidly proliferating number of healthcare providers with inadequate infrastructure, and partly owing to the inadequate skills and outdated knowledge of healthcare professionals. The laxity of the regulating body - the Medical Council of India - in enforcing strictly established protocols regarding diagnostics and treatment has made matters even worse. The regulator is often found circling its wagons and protecting healthcare professionals of their wrongdoing. As a result, patients and their families are increasingly seeking recourse to judicial remedies.

However, even the courts are unable to provide uniform justice owing to their lack of subject matter expertise and the absence of comprehensive guidelines. As a result, contradictory and conflicting judgments are given by various courts and, at times, by co-equal benches of the same court, including the Supreme Court.

A recent ruling by the Supreme Court has effectively diluted the threshold for fixing accountability in medical negligence cases by observing that even in case where a healthcare professional might have made a wrong diagnosis, the same will not tantamount to medical negligence.

In the matter of Vinod Jain v. Santokba Durlabhji Hospital, the wife of the petitioner, a cancer patient who was immunosuppressed due to her past chemotherapies, was admitted to a multi-specialty hospital on October 15, 2011 for chills and fever. A preliminary diagnosis showed a White Blood Cell (WBC) count of 15,030, indicating infection. Even the blood culture report received on October 18 showed the presence of an infection causing organism "Methicillin Sensitive Coagulase Negative Staphylococcus Aureus” (CONS).

Medical literature submitted by the respondents reflected that the said organism is recognized as an infection causing agent (pathogen) and can become life threatening if not treated properly. The same is to be treated as a pathogen and not a contaminant for immunosuppressed patients and/or patients with prosthetic device implants. Further, intravenous Vancomycin is the main stay in the treatment of a CONS infection.

The treating doctor, however, treated the organism as a contaminant, thereby making a wrong diagnosis. Consequently, intravenous Vancomycin was ignored and an oral tablet Polypod was prescribed to be administered through the nasal feed tube after dissolving it in water. Subsequently, even despite the WBC count (16,050) of the patient being on a rising curve, the patient was prematurely discharged and the patient went into a coma at her home on October 23, as the infection has risen to uncontrollable levels. She died on October 31 due to septicaemia resulting in multi-organ failure despite desperate attempts by multiple hospitals to lower the WBC count. Thus, wrong diagnosis and the following treatment proved fatal for the patient.

Aggrieved, the petitioner approached the State Consumer Dispute Redressal Commission, which directed the hospital to pay the petitioner a sum of Rs 15 lakh as compensation. The said order was, however, set aside by the National Consumer Dispute Redressal Commission. Aggrieved by the same, the petitioner approached the Apex Court, which dismissed the petitioner’s SLP. While doing so, the Court observed that while there might have been a possibility of wrong diagnosis, the same would not tantamount to medical negligence.

The same was held despite an earlier judgment of the Court in Malay Kumar Ganguly v. Sukumar Mukherjee, where the maladministration of the steroid “Depomedrol” owing to a wrong diagnosis was held to be medical negligence. The Supreme Court, while discussing medical negligence opined that:

"Failure to act in accordance with the standard, reasonable, competent medical means at the time would not constitute a negligence. However, a medical practitioner must exercise the reasonable degree of care and skill and knowledge which he possesses. Failure to use due skill in diagnosis with the result wrong treatment is given would be medical negligence."

It was further held that,

“The law on medical negligence has to keep up with the advances in the medical science as to treatment as also to diagnostic...Duty of the doctor is to prevent further spread of infection...Blood tests and cultures should be regularly performed to see if the infection is coming down.”.

The above was a landmark ruling, as it advanced the jurisprudence relating to medical negligence and took note of the consequences of a wrong diagnosis, which include wrong medication and the resultant risk to the health of the patient.

However, the Court in Vinod Jain (supra) observed that.

“There was no evidence to show any unexplained deviation from standard protocol and that the deceased was medically compromised by the reason of her post illnesses.”

The Court opined that there were no unexplained deviations from protocol and endorsed a departure from the established protocols ignoring its earlier rulings. Apart from being a setback to the advancement of medical jurisprudence, the same is also violative of the doctrine of judicial procedural propriety and decorum enunciated by the Court in Central Board of Dawoodi Bohra Community v. state of Maharashtra, which summed up the legal position on judicial procedural propriety as follows:

"It will be open only for a bench of co-equal strength to express an opinion doubting the correctness of the view taken by the earlier bench of co-equal strength, whereupon the matter be placed for hearing by a bench consisting of a quorum larger than the one which pronounced the decision laying down the law of correctness of which is doubted."

The correct approach in the matter of Vinod Jain (supra), therefore, would have been to either refer the case to the Chief Justice of India to set up a larger bench or follow the procedure as laid down by the Supreme Court in the Dawoodi Bohra Community case to prevent the miscarriage of justice.

Correct diagnosis followed by correct treatment as per the established protocol is the bedrock of Western medical science. In the absence of correct diagnosis, the treatment would be a blind treatment and would certainly harm the patient.

At a time when the healthcare professionals of the country are being lauded for their effective response to the COVID-19 pandemic, decisions such as Vinod Jain erode the faith of the people in the healthcare sector and the judiciary. It is a given that the healthcare sector will continue to hold centerstage in our lives for weeks and possibly years to come. The possibility of instances of medical negligence owing to this increased pressure on the medical system cannot be ruled out.

Therefore, the time is ripe for the Supreme Court to lay down comprehensive guidelines in relation to medical negligence cases. The following suggestions may aid the Supreme Court in this regard:

1. A committee of representatives of the Supreme Court and the Medical Council of India (MCI) be constituted to dove-tail the various statutes of law and the guidelines issued by the MCI and issue comprehensive guidelines for adjudicating medical negligence cases.

2. Specialized courts can be set up to adjudicate medical negligence cases, or alternatively, the ethics committee of the National Medical Commission be headed by a serving/retired Supreme Court Judge.

3. Section 1.2.3 of the MCI Act, which provides for 30 hours of continuing education every five years followed by a written examination, must be strictly implemented and a doctors’ license should be renewed subject to clearing the same.

4. Strict enforcement of Sections 191, 192 of the Indian Penal Code, 1860 in medical negligence cases.

Amidst the uncertainty created by the COVID-19 pandemic, the judiciary remains the sole icon of hope to redress the genuine concerns of citizens aggrieved by the lack of adequate medical infrastructure and the rising instances of medical negligence. There is hope that necessary measures will be taken by the Supreme Court, to preserve the faith and hope of the people.

The author is an Advocate. He appreciates the inputs from Vinod Jain (IAS) (Retd.).