Maharashtra State Commission: Pre-Printed Consent Form Without Disclosure Of Surgical Risks Is Not Valid Informed Consent; Doctor Liable For Deficiency In Service

The State Consumer Disputes Redressal Commission, Maharashtra, comprising Mukesh V. Sharma (Presiding Member) and Poonam V. Maharshi (Member), held an ophthalmic surgeon liable for deficiency in service for obtaining consent through a pre-printed form without adequately informing the patient of the material risks associated with the surgery. The Commission partly allowed the complaint and directed the doctor to pay compensation. Brief FactsThe complainant, Smt. Rajani Prakash Malik consulted Dr. Ashok T. Bhole (Opposite Party), an ophthalmic surgeon, for a vision-related problem in her right eye. The OP advised her to undergo cataract surgery, assuring her that it was a simple and routine procedure with a high success rate that would restore her vision. Before the surgery, the complainant was asked to sign a pre-printed consent form as a routine formality. No meaningful explanation was provided regarding the nature of the procedure, available alternative treatments, or the possible risks and complications involved. The complainant contended that she was never informed that the surgery carried the risk of permanent vision loss or even loss of the eye, and the consent form itself contained no reference to such serious complications. The surgery was performed on 04-07-2011. Thereafter, the complainant immediately began experiencing severe pain, redness, watering, progressively diminishing vision, weakness, and loose motions. When the complainant brought these symptoms to the notice of the OP, he dismissed them as normal post-operative reactions and continued conservative treatment without carrying out further investigations or promptly referring her to a higher medical centre. As her condition deteriorated, she was referred to Dr. P. Suresh for further opinion and treatment, where she was diagnosed with a serious post-operative complication. Aggrieved by the alleged failure to obtain proper informed consent and negligent post-operative care, the complainant filed a complaint before the State Consumer Disputes Redressal Commission, Maharashtra, Mumbai, seeking compensation for the loss of her eye and damages.Arguments by the Party The opposite party argued that the cataract surgery was performed with due care and caution, and in accordance with accepted medical standards. He further submitted that informed consent had been properly obtained after the procedure and its implications were explained to the complainant. The counsel contended that appropriate treatment and medicines were provided as post-operative care and that there was no indication requiring earlier referral. He argued that the loss of the eye was a known complication and not proof of negligence, especially in the absence of independent expert medical evidence. Observations & DecisionThe Commission observed that the consent form did not disclose the specific nature of the surgery, attendant risks, possible complications, or the crucial risk of permanent vision loss or loss of the eye, containing only the complainant's signature. It held that a signature on such a printed form could not amount to valid informed consent, constituting a deficiency in service by the OP.Further, the Commission held that the complainant had failed to establish medical negligence against the Doctor. It observed that the burden of proving medical negligence in relation to the surgery and post-operative care rested upon the complainant. The Commission noted that the complainant had failed to place on record any independent expert opinion or other material from which any specific act or omission falling below the accepted standard of medical practice could be inferred against the opposite party. It further observed that the medical records merely established that the complainant suffered a severe post-operative complication, but did not prove negligence in the surgery itself. Concluding, the Commission observed that the consent obtained was plainly inadequate, as it was based merely on a pre-printed proforma containing the complainant's bare signature, without any meaningful discussion regarding the procedure. It held that, by failing to adequately inform the complainant of these material risks before obtaining her consent, the doctor failed to discharge his legal duty of disclosure, which amounted to a clear deficiency in service.Accordingly, the Commission partly allowed the complaint and directed the OP to pay Rs. 7,00,000 as compensation along with Rs. 50,000 towards litigation costs. Case Title: Rajani Prakash Malik vs Dr.Ashok T. BholeCase No: CC NO. SC/27/CC/13/2013 Click Here To Read/Download Order

Maharashtra State Commission: Pre-Printed Consent Form Without Disclosure Of Surgical Risks Is Not Valid Informed Consent; Doctor Liable For Deficiency In Service

Muhammed Razik

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Maharashtra State Commission: Pre-Printed Consent Form Without Disclosure Of Surgical Risks Is Not Valid Informed Consent; Doctor Liable For Deficiency In Service

Muhammed Razik

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INR 1099+GST

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