Use Of Pre-Printed, Fixed Forms To Record informed Consent: RG Urology and Laparoscopy Hospital directed to deposit Rs 10 lakh

New Delhi: Holding that Use Of Pre-Printed and Fixed Forms To Record Patients' Consent by hospitals amounts to 'Unfair Trade Practice'; the National Consumer Disputes Redressal Commission (NCDRC) has directed R G Urology and Laparoscopy Hospital, Delhi, to deposit Rs 10 lakh in the Consumer Legal Aid Account of the Commission. The court further directed the hospital to discontinue its said "unfair trade practice" with immediate effect.

A two-member bench comprising Dr. S.M. Kantikar and Dinesh Singh, pronounced the decision while deliberating on a case of alleged medical negligence against the hospital, and its doctors.

The case related to a senior patient who was rushed to Fortis hospital after he complained of some pain in the abdomen and related difficulties. Later, due to financial crunches, he moved to the R G Urology and Laparoscopy Hospital.

It was alleged that the surgery so performed there caused some complications, wherein, the penetration of the needle through the common wall of the rectum and urinary bladder has facilitated a way to urine to make a passage through the rectum. The patient accusing the hospital and the doctor who treated him for medical negligence and approached the State Consumer Redressal Commission, Delhi. The State Commission had disposed of the complaint on the ground of lack of pecuniary jurisdiction.

The complainant then moved NCDRC. On approaching the NCDRC, the national commission observed 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. 

The Commission did not agree with the submission, and on the claim of Medical Negligence and deficiency in service, the commission ruled in favour of the Hospital.

The court noted, "as per medical literature, the injection pricks do not cause fistulae or grave injury. Commonly to drain prostatic abscess transrectal needle aspiration is used.

The court further considered expert opinion to deliberate the matter, and stated,

"We have perused the report (opinion) of the medical board constituted three independent doctors at Maulana Azad Hospital, New Delhinamely (1) Dr. R.K Jindal, Director Professor (Surgery) as Chairman, (2) Dr. M.K Daga, Director Professor (Medicines) and (3) Dr. Anubhav Vindal, Associate Prof (Surgery) as members. The board examined the medical records of the case in detail and had not found any negligence in this matter."

Though the allegations of medical negligence were rejected, the Commission perused "the consent form and found that the deroofing surgery performed by the doctor was after taking due informed consent."

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 further noted.

The Commission while directing the hospital to deposit the said amount and immediately halt the unfair trade practice observed;

"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 ".

"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 a consent form fits into any procedure, any doctor, and any patient. Thus, it will take the 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 a 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, " the court added.

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