The National Consumer Disputes Redressal Commission (NCDRC) has held that the use of fixed "informed consent cum undertaking" by the hospitals to record consent from the patients amounts to "unfair trade practice" within the meaning of Section 2(1)(r) of the Consumer Protection Act, 1986.
The Commission asserted that the uniform use of the pre-printed and fixed informed consent cum undertaking by the hospitals will help them gain an undue advantage and it is beyond doubt a practice of "administrative arbitrariness".
As the forms are pre-printed and fixed, with limited space for handwritten entries, they could be misused after the filling up of blank spaces, the Commission noted.
The Commission stated : "We but note that a pre-printed and fixed 'informed consent cum undertaking' form, with blank spaces for limited select handwritten entries and for the signatures has been used. The main body of the form is pre- printed and fixed. It can fit into any procedure, any doctor, and any patient, after filling up the blank spaces for the limited select handwritten entries and getting / affixing the signatures. We note this to be administrative arbitrariness and one-sided high handedness, and to be unfair and deceptive, on the part of the opposite party no. 1 (hospital), for which, though, the complainant has not been prejudiced in this particular case ".
The Commission made these observations while dismissing a complaint of medical negligence against R G Stone Urology and Leproscopy hospital, Delhi and its doctors, Dr. Anil Varshney.
Though the allegations of medical negligence were rejected, the Commission observed that it cannot ignore the peculiarity of use of pre-printed forms for recording informed consent.
"However, we cannot ignore the peculiarity of the 'informed consent' in the instant case which needs prompt and proper rectification. It is pertinent to note that it is a pre-printed form- 'informed consent cum undertaking' having blank spaces for limited selective handwritten entries and for the signatures. The main body of the form is fixed pre-printed.Such consent form fits into any procedure, any doctor, and any patient. Thus, it will take shape of informed consent if someone after filling up the blank spaces in handwriting and affixing the signatures of the patient and his sister as witness. This to be administrative arbitrariness and one-sided high handedness, and to be unfair and deceptive, on the part of the OP-1 (hospital); though the complainant has not been prejudiced in this particular case".
Determining the use of pre-printed consent form to be an "unfair trade practise", the two member bench comprising Dr. S.M. Kantikar and Dinesh Singh imposed a cost of Rs 10 Lakhs on the Hospital and directed it to deposit the same in the Consumer Legal Aid Account of the Commission within four weeks.
The hospital was also directed to discontinue its said unfair trade practice with immediate effect.
The basis of the dispute was that, a patient of aged 65 years with some pain in the abdomen and related difficulties had rushed to a private hospital in Delhi and due to financial difficulties, later moved to the opposite party private hospital and underwent a surgery. The surgery caused some complications and the patient alleged the hospital and the doctor who treated him for medical negligence and approached the State Consumer Redressel Commission, Delhi. The State Commission had disposed the complaint on the ground of lack of pecuniary jurisdiction.
On approaching the NCDRC, the national commission had found that the Consent obtained by the hospital was "informed consent", since the hospital authorities had communicated to the patient and the patient himself is aware of his prior medical complications. And on the claim of Medical Negligence and deficiency in service the commission had also favoured the Hospital.
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