The hospital claimed that it had obtained the patient’s consent, but the file was destroyed by water seepage in the room where the records were kept.
The National Consumer Disputes Redressal Commission (NCDRC) has imposed a fine of Rs 10 lakh on Fortis Hospital in Chandigarh in a case of medical negligence, saying that it failed to obtain ‘informed consent’ from the patient before performing an invasive procedure.
Setting aside an earlier order passed by the state commission, which had given a clean chit to the hospital, the NCDRC, headed by Justice R K Agrawal, has directed the hospital and treating doctor to pay Rs 10 lakh as compensation to the complainant under the Consumer Protection Act.
The NCDRC said “there is not even a whisper” to indicate that “the treating doctor had explained to the complainant the pros and cons: the material risks involved and the benefits of the procedure, particularly keeping in view her age and health condition.”
The case dates back to July 2012, when Manmohan Kaur (55), underwent colonoscopy, to treat a disorder in the digestive system. Colonoscopy is an invasive procedure, which involves endoscopic examination of the large intestine.
The complainant had alleged that the doctor did not take her consent before subjecting her to colonoscopy. She claimed that she felt severe pain on insertion of the colonoscope, and requested the treating doctor to discontinue the procedure. However, it was not stopped, and caused perforation in the colon, resulting in deterioration of her condition, she alleged. According to the complaint, she became unconscious and had to be admitted to the ICU.
The hospital claimed that it had obtained the patient’s consent, but the file was destroyed by water seepage in the room where the records were kept.
Ruling in favour of the complainant, the NCDRC on June 29, said: “In our opinion, apart from the fact that the explanation for non-production of the consent form, claimed to have been got signed from the complainant, does not inspire confidence, even on merits, the treating doctor and the hospital have failed to prove that a valid/ informed consent had been obtained from the complainant before subjecting her to colonoscopy procedure. We are, therefore, of the considered view that the treating doctor as well as the hospital had failed to obtain a valid consent from the complainant, and the colonoscopy procedure conducted on her was unauthorised, amounting to deficiency in service on their part.”
It also dismissed that hospital’s argument that the “consent form has been destroyed because of water seepage”. “The stand of the respondents that consent forms are got signed by the staff in the OPD room, in our view, leaves little scope for doubt in our mind that the consent forms were got signed by the staff before the procedure was conducted by the doctors, as a formality, and does not meet even the basic mandatory requirements of the treating doctor, making the complainant aware of material risks involved in the colonoscopy procedure,” it said.
The NCDRC also pulled up the state commission, saying the “finding in the impugned order to the effect that ‘it cannot be made out from the evidence produced by the complainant that she had not consented to undergo this colonoscopy’ is illegal.”
“Fundamentally, the law requires the disclosure to the patient, information relating to the diagnosis of disease, nature of the proposed treatment, potential risks of the proposed treatment and the consequences of the patient refusing the suggested line of treatment,” it said. “Disclosure/ explanation of such information to the patient by the treating doctor and the patient’s conscious decision, in this behalf, before venturing into the suggested procedure/ treatment, is the basic attribute of an informed consent, which is considered mandatory in every field of surgical procedure/ intervention,” said the commission.