Every medical intervention requires an order or protocol that is both legally and expert-backed. Here, Dr. Mukesh Yadav shares a case-based example of what could possibly happen in the absence of adherence to protocol and what the legal consequences may be.

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Facts of a case

The complainant mother 54 years (since deceased, ‘patient’) on 22.09.2009 consulted doctors at a city hospital. The MRI revealed high-grade glioma of the brain. The PET scan advised by the doctor revealed small activity in the lymph nodes near the lungs, however, the lymph node biopsy ruled out any malignant deposits and it was suspected as tuberculosis (TB) of the lymph node.

Then a biopsy from the brain lesion confirmed the diagnosis of Primary Central Nervous System Lymphoma (PCNSL). The doctor, the medical oncologist, and the treating medical oncologist decided to adopt DeAngelis protocol for treatment which gives less neurocognitive impairment and increase the chances of survival by about 24 to 36 months.

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Alleged medical negligence

• Failure of DeAngelis protocol
• Delay in investigations
• Delay in diagnosis/correction of hyponatremia
• Issue of known complications
• Issue of discharge and prescription treatment
• Stand of hospital/doctor on the issue of protocol

There was no negligence during the diagnosis and treatment of the patient. The PCNSL is a high-grade malignancy that needs aggressive treatment with chemotherapy.

Commonly DeAngelis protocol is one of the best protocols used to treat CNS lymphoma and the same was adopted by the doctor. The complications of chemotherapy were explained to the patient and her attendants. After consent from the complainant and his father, the treatment was started.

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Is it necessary to follow the protocol for treatment?

Yes. The case involving a doctor who failed to follow the DeAngelis protocol by not monitoring the patient’s urine pH was held negligent by NCDRC (judgment delivered on: 10.06.2021).

The question before NCDRC was whether there was an omission from the doctor during treatment with the DeAngelis protocol. In this case, NCDRC ruled that a higher degree of skill is required of a specialist than of one who does not profess to be so qualified by special training and ability.

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What is the degree of care and skill required from a general practitioner/specialist?

With regards to the case mentioned above, NCDRC ruled that the doctors are bound to exercise a degree of care and skill which could reasonably be expected of a normal, prudent practitioner of the same experience and standing. If a practitioner presents himself or herself as a specialist, a higher degree of skill is required than of one who does not profess to be so qualified by special training and ability.

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What is the standard of care expected from a doctor?

NCDRC further added that it is well settled from many legal precedents that the skill of a medical practitioner differs from doctor to doctor and maybe more than one course of treatment which may be advisable for treating a patient. However, it is clarified that negligence cannot be attributable as long as the doctor has performed his duties to the best of his ability and with due care that is acceptable to the medical profession.

However, in this case, NCDRC found that though the doctors made the correct diagnosis and took the decision to adopt the DeAngelis protocol for the treatment of Primary Central Nervous System Lymphoma (PCNSL), it was an act of omission from the doctor who failed to follow the DeAngelis protocol by not monitoring the patient’s urine pH.

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Does a presumptive approach to treatment hold good?

According to NCDRC a presumptive approach does NOT hold good. In the above case the doctor, based on clinical signs of the patient, made a presumptive approach that urine might be alkaline i.e. pH 7 or more. NCDRC emphasised that such customary, usual or routine practice itself proves that the method was not within the standard of care in this case. 

As the DeAngelis protocol mandates monitoring of MTX level, serum creatinine, blood urea nitrogen level, urine pH regularly and adequate hydration. NCDRC observed that we may accept that due to the non-availability of instrumentation, the MTX estimation was not possible. NCDRC concurred with observations of APSCDRC and the Complaint was partly allowed holding medical negligence during the treatment and directed the Doctor/Hospital to pay Rs. 7 lakh plus Rs. 10000/- towards the cost.

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Another case which NCDRC relied on

This case deals with the importance of the issue of difference of opinion, degree of skill, and standard of care. NCDRC relied on the Jacob Mathew Case, 2005, Medical Literature, Opinion of Medical Board, AIIMS Report while holding the doctor negligent. This case emphasises that protocol should be followed for any disease if recommended by experts or reported in the medical literature.

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Discussion

Was there was any omission from the doctor during treatment with the DeAngelis protocol?

The following points are for consideration:

• Monitoring of MTX level and dosage of MTX
• Delay in leucovorin rescue
• Hyponatremia and chemotherapy
• Hydration and alkalinisation

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Summary and conclusion

Thus, in NCDRC’s considered view before starting the 2nd chemotherapy cycle it was necessary to correct the patient’s hyponatremia which was done by the doctor. It was a reasonable delay in the correction of the sodium level.

As the DeAngelis protocol mandates monitoring of MTX Level, serum creatinine, blood urea nitrogen level, urine pH regularly and adequate hydration. NCDRC observed that we may accept that due to the non-availability of instrumentation, the MTX estimation was not possible. NCDRC further noted that the patient’s intake and output were adequate and for alkalinisation, soda mint tablets orally and sodium bicarbonate in normal saline IV was given.

Therefore, clinically the doctor felt that the urine became alkaline and therefore urine pH was not repeated prior to the 2nd cycle. The urine pH test is a simple routine test, but the doctor failed to test it, but he presumed the urine pH might be alkaline or more than 7; in our view, such presumption was not a reasonable standard of care.

The appeal was dismissed based on the entirety of the discussion above, and considering the reasoned appraisal made by the AP State Commission, as also giving careful thought to the report of experts from AIIMS, NCDRC did not find any merit in the Appeal and NCDRC concurred with the view taken by the A.P. State Commission[AS1] [DMY2].

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Was the doctor held guilty?

APSCDRC relying on case law referred, medical literature, expert opinion and facts of the case APSCDRC found doctor and hospital deficient in service/medical negligent and awarded an amount of Rs.7 lakh as compensation to the complainant together with costs of 10000/-. The same was endorsed by the NCDRC.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The writer is a professor at the Forensic Medicine & Toxicology, U.P.