Non-Compliance of DeAngelis Protocol: NCDRC holds Apollo Hospital's oncologist guilty of medical negligence

The top Consumer Court noted that although the doctors made correct diagnosis and took decision to adopt DeAngelis protocol for treatment of PCNSL, the treating Oncologist at the Apollo Hospital, Hyderabad, didn't monitor the patient's pH urine and took a presumptive approach that urine might be alkaline i.e pH 7 or more based on the clinical signs of the patient.

"Such customary, usual or routine practice itself proves that the method was not within the standard of care in this case," observed Dr. S.M. Kantikar (presiding member) and Dinesh Singh (member) of NCDRC.

The judgment dated 10.06.2021mentioned the observations of the Commission members, "Though the doctors made correct diagnosis and took decision to adopt DeAngelis protocol for treatment of PCNSL, but it was an act of omission from the Opposite Party No.1 who failed to follow the DeAngelis protocol by not monitoring the patient's urine pH."

Also Read: Patient dies post Liver transplantation: NCDRC dismisses medical negligence charges against Surgeon, Indraprastha Apollo Hospital

The case goes back to 2009 when the complainant's mother consulted two doctors at Apollo Hospital. Following the investigations advised by the doctors, the MRI revealed high-grade Glioma of the brain. The PET scan 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) lymph node. Later, a biopsy from the brain lesion confirmed the diagnosis of Primary Central Nervous System Lymphoma (PCNSL).

The oncologist at the Apollo Hospital decided to adopt the DeAngelis protocol for treatment which gives less neurocognitive impairment and increase the chances of survival about 24 to 36 months. In fact, the Complainant submitted that the oncologist assured the facility to treat the patient with DeAngelis protocol was available at Apollo Hospital and for this, the Complainant dropped to take his mother to the USA for treatment.

Consequently, the patient got admitted to the hospital on 06.10.2009, and gradually the 1^st cycle of chemotherapy started. 2700mg High Dose of Methotrexate (HDMTX)was infused during this. The complainant alleged that the MTX level needed to be monitored to check for MTX toxicity and it was not done. It was further alleged that as per protocol, to minimize the MTX toxicity and complications 'Leucovorin' rescue was to be started at 24 hours after HDMTX administration. However, it was also delayed for 48 hours.

The complainant also submitted before the Commission that the treating doctor also didn't monitor the Urine pH, serum creatinine, blood urea nitrogen, and electrolytes.

Soon after being discharged from the hospital, the patient developed dizziness and drowsiness. After being re-admitted to the hospital the patient was diagnosed with Hyponatremia(low blood Sodium). The hospital took 9 days to bring back the balance and correct the Sodium level and after that, the 2^nd cycle of chemotherapy started. 4600 mg of HDMTX was administered this time

However, the urine pH level, serum creatinine, blood urea nitrogen, and electrolytes were not tested or monitored by the doctor, the Complainant submitted adding that it was a violation of the DeAngelis protocol.

A few days later, the patient was again taken to the hospital due to MTX toxicity which caused bone marrow suppression and low blood counts. The kidneys got affected badly and dialysis was done. However, the patient developed renal failure and septicemic shock. Finally, after suffering from minor cardiac arrest the was put on ventilator and ultimately died.

Claiming that his mother died an untimely death due to the medical negligence of the doctor at the Apollo Hospital, Hyderabad, the Complainant sought compensation after filing a complaint at the State Commission.

The State Commission held that case of medical negligence was established and an amount of Rs. 7 lakh was awarded to the Complainant by way of compensation, together with the cost of Rs.10000/-.

Challenging the decision of the State Commission, the treating doctors and the hospital approached the NCDRC and submitted that there was no medical negligence on their part. The best possible line of treatment following the DeAngelis protocol was adopted and the complications of the chemotherapy were also explained to the patient and her attendants. In fact, the treatment started only after taking the due consent.

The counsel for the doctors and hospital further submitted that estimation of serum MTX level was not available in the Apollo Hospital and even at many reputed institutions in India. However, he submitted that the Leucovorin rescue was started at 24 hours from the time of MTX administration and Leucovorin 15 mg was given every 6 hourly for 72 hours to make serum MTX level below the risk.

Alleging that Pancytopenia (anemia, neutropenia and thrombocytopenia) was a known complication of chemotherapy the counsel for the doctors and hospital further contended that the complications occurred despite the best possible care. On the other hand, learned counsel appearing on behalf of the complainant reiterated the facts and brought the Commission's attention to the findings of the two expert opinions and AIIMS report.

After perusing the evidence on record, the medical literature regarding the treatment of PCNSL and the DeAngelis protocol, the opinion from the board of medical experts from AIIMS and two separate expert opinions filed by the Complainant, the Commission noted that monitoring the pH level, MTX level, and Serum Creatinine level were essential parts of the DeAngelis Protocol.

Taking note of the expert opinion given by the Board of experts from AIIMS, the Commission observed that the MTX dose was appropriate. The top consumer court also noted that although monitoring serum methotrexate level is desirable, but methotrexate can be administered with reasonable safety without serum methotrexate level monitoring, if proper hydration, alkalinization, and urinary pH monitoring is done with timely administration of Leucovorin rescue. In fact, the Commission didn't find any delay in administering Leucovorin rescue as well, which is taken in an effort to "rescue" the normal cells in the body from the side effects of methotrexate.

However, the Commission noted that the AIIMS board did not find records of pH monitoring and post methotrexate renal function test as mentioned in the protocol.

Although the Commission accepted the submission on the behalf of the doctors that due to non-availability of instrumentation, the MTX estimation was not possible, not testing the Urine pH was a breach of a reasonable standard of care according to the Consumer Court.

"The urine pH test is a simple routine test, but the nd Opposite Party No. 1 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," noted the Commission.

Considering the aspect of medical negligence, the Commission observed,

"It is well settled from many legal precedents that the skill of medical practitioner differs from doctor to doctor and may be more than one course of treatment which may be advisable for treating a patient. However, negligence cannot be attributable as along as the doctor if he has performed his duties to the best of his ability and with due care and acceptable to the medical profession. However in the instant case we find though the doctors made correct diagnosis and took decision to adopt DeAngelis protocol for treatment of PCNSL, but it was an act of omission from the Opposite Party No.1 who failed to follow the DeAngelis protocol by not monitoring the patient's urine pH."

"In the instant case the Opposite Party No. 1, based on clinical signs of the patient, made a presumptive approach that urine might be alkaline i.e pH 7 or more. Such customary, usual, or routine practice itself proves that the method was not within the standard of care in this case," noted the Commission.

Dismissing the appeal the Commission thus concurred with the view taken by the State Commission.

To view the original court order, click on the link below.