~ If a practitioner presents as a specialist, a higher degree of skill is required than the one qualified by special training & ability.
• Background of the case:
~ The complainant's mother was diagnosed with Primary Central Nervous System Lymphoma (PCNSL) after her biopsy at the hospital.
~ The oncologist decided to adopt the DeAngelis protocol for treatment which gives less neurocognitive impairment and increases the chances of survival by about 24 to 36 months.
~ Gradually the 1st cycle of chemotherapy started and after being discharged from the hospital, 2700mg High Dose of Methotrexate (HDMTX) was infused during this.
~ She developed dizziness and drowsiness and was diagnosed with Hyponatremia. A few days later, she was taken to the hospital due to MTX toxicity which caused bone marrow suppression and low blood counts.
~ However, the patient developed renal failure & septicemic shock and after suffering from minor cardiac arrest, she was put on the ventilator and ultimately died.
• Complainant's allegation:
~ The complainant alleged that the MTX level needed to be monitored to check for MTX toxicity and it was not done.
~ The treating doctor also didn't monitor the urine pH, serum creatinine, blood urea nitrogen, and electrolytes.
~ As per protocol, to minimize the MTX toxicity and complications 'Leucovorin' rescue was to be started at 24 hours after HDMTX administration and it was also delayed for 48 hours.
• Doctor's Defense:
~ The treating doctors and the hospital approached the state commission 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 relatives.
~ They submitted that estimation of serum MTX level was not available in the Hospital.
~ Leucovorin rescue was started at 24 hours from the time of MTX administration and 15 mg was given every 6 hourly for 72 hours to make serum MTX level below the risk.
• The Commission held that:
~ The Commission observed that the MTX dose was appropriate and didn't find any delay in administering Leucovorin rescue as well.
~ The Investigation panel did not find records of pH monitoring and post methotrexate renal function test as mentioned in the protocol.
~ Not testing the Urine pH was a breach of a reasonable standard of care according to the Consumer Court.
~ The commission found an oncologist guilty for not following the standard DeAngelis Protocol during the treatment of Primary CNS Lymphoma (PCNSL).
National Consumer Disputes Redressal Commission New Delhi