Bare signature on pre-printed form without risk disclosure not valid informed consent: Consumer court slaps Rs 7 lakh compensation on eye surgeon

Mumbai: Holding an ophthalmic surgeon liable for deficiency in service for the failure in obtaining valid informed consent before performing cataract surgery, the Maharashtra State Consumer Disputes Redressal Commission directed him to pay Rs 7 lakh compensation and Rs 50,000 litigation expenses to a patient, who lost vision in her operated eye after the surgery.

Even though the Commission held that the complainant failed to discharge the burden of proof regarding the allegations of medical negligence during the procedure, it noted a deficiency in service on the surgeon's part in obtaining informed consent.

"To summarise our findings on Point No. 3: we hold that the opposite party is guilty of deficiency in service in not obtaining a proper and valid informed consent from the complainant before subjecting her to the surgery in question, by being content with a bare signature on a pre-printed consent form which did not, by any stretch, satisfy the requirements of disclosure laid down in *** and the line of decisions which has followed it. However, on the question of medical negligence in the actual performance of the surgery and in the post-operative care rendered by the opposite party, the complainant has failed to discharge the burden of proof which rested upon her, and, on that aspect, no case of medical negligence stands established against the opposite party," observed the Consumer Court.

"...we are of the considered opinion that a sum of Rs. 7,00,000/- (Rupees Seven Lakh only) would meet the ends of justice as just and proper compensation in the facts and circumstances of the present case, in addition to a reasonable amount towards the cost of litigation, which we quantify at Rs. 50,000/- (Rupees Fifty Thousand only)," it further noted.

Case Background:

According to the case details, the patient was suffering from a vision-related ailment in her eye, on account of which, she consulted the treating surgeon at his clinic. After examining the patient, the surgeon advised the patient to undergo surgery in the affected eye, with an assurance that the procedure was simple and routine, carried a high success rate, and that her vision would be restored upon its completion.

The complainant submitted that prior to the surgery, her signature was obtained by the doctor on a pre-printed consent form, which was placed before her as a routine formality. Allegedly, there was no meaningful discussion or disclosure by the opposite party of the nature of the procedure, the attendant risks, the possible complications, or any reasonable alternative line of treatment available to her. In particular, the complainant was allegedly at no stage informed that the surgery carried any risk of permanent loss of vision or of the eye itself, nor is any such risk mentioned anywhere in the consent form said to have been signed by her. It was submitted that had she been so informed, she would have had occasion to reconsider her decision or to seek a second opinion before subjecting herself to the surgery for the cataract of her right eye.

Further, it was alleged that immediately after the surgery, the patient developed severe pain, redness, watering and progressively diminishing vision in the operated eye, accompanied by general distress including repeated episodes of loose motions and weakness.

It was further claimed that when the surgeon was informed about it, instead of taking the issue seriously, he allegedly brushed them aside as ordinary post-operative reactions and continued the same conservative line of treatment, without subjecting the eye to any further investigation, without seeking a second opinion, and without referring the complainant to a higher centre or to a specialist in time, notwithstanding the rapidly deteriorating condition of the eye.

As the eye's condition continued to worsen, the complainant was referred to another specialist for further opinion and treatment. Upon examination and investigation, the patient was diagnosed with a serious post-operative complication, on account of which, she had to undergo further surgery and treatment, at Fortis Hospital at Mulund and incurred considerable expenditure.

Despite all these efforts, the vision in the operated eye allegedly could not be salvaged and the patient ultimately suffered permanent loss of vision in the said eye.

Attributing the said loss to the failure of the treating surgeon in obtaining proper and informed consent, and to the deficient and negligent manner in which the surgery and the post-operative care were rendered by him, the patient approached the consumer court praying for compensation on account of cost of loss of her eye, further medical treatment, physical pain and suffering, mental agony, loss of earning and earning capacity, and litigation expenses.

Regarding the issue of informed consent, the treating surgeon submitted that the nature of the procedure, the manner in which it would be carried out and its general implications were explained to the complainant in a language which she understood, and it was only thereafter that her signature was obtained on the consent form maintained by his clinic. It was contended that the consent so obtained was a valid consent in the eyes of law; that the printed consent form is the form ordinarily used in his clinic for all patients; and that the complainant, being a literate and adult person, signed the same with full understanding. The surgeon denied that any material fact, risk or complication was withheld from the complainant.

The surgeon further asserted that the surgery was performed by him with due care, caution and diligence, in accordance with the accepted standards of medical practice and under all aseptic precautions and the procedure was uneventful.

He further submitted that after the surgery, the complainant was duly examined by him on the post-operative follow-up visits and all such medication, eye drops, and advice were called for were duly prescribed and administered. It was further stated that the complaints of f pain, redness and diminution of vision, as and when reported, were attended to by him with due promptitude, and that there was no occasion or clinical indication for any earlier reference to a higher centre than was made by him.

Observations by Consumer Court:

The consumer court observed that regarding the failure to obtain proper and informed consent, the principles of law are by now well settled. "A medical practitioner, before subjecting a patient to any procedure or surgery, is under an obligation in law as well as in professional ethics to disclose to the patient, in language which the patient can understand, the nature of the proposed procedure, the manner in which it is to be performed, its attendant risks and reasonably foreseeable complications, the available alternative modes of treatment, if any, and the consequences of declining the procedure. It is only upon such disclosure being made that the patient can be said to have given a real, valid and informed consent to the procedure," it observed.

The complainant relied on the decision of the Hon'ble National Consumer Disputes Redressal Commission in Dr. Dilip C. Shah v. Subhashchandra, where the National Commission has, in turn, drawn upon the authoritative pronouncement of the Supreme Court in Samira Kohli v. Dr. Prabha Manchanda, which expounded the said principles in unambiguous terms and has been consistently followed thereafter, noted the consumer court.

Referring to this, the Commission observed,

"Tested on the bench mark of the said principles, the consent purportedly obtained by the opposite party in the present case is, in our view, plainly inadequate. The consent form placed on record by the opposite party is a pre-printed proforma carrying only the signature of the complainant. There is no mention anywhere in the said form of the specific nature of the surgery proposed to be performed on the complainant, the attendant risks, the possible complications, or, most importantly, of the fact that the complainant may, as a consequence of the procedure, lose vision in, or even lose, the operated eye. There is no recital that any of these matters was, in fact, explained to the complainant. The form, in substance, is no more than a bare signature obtained on a printed sheet — and, in the eye of law, that is not the consent which the law requires."

Further relying on other legal precedents, the Commission observed that the complainant lost vision in the operated eye and lost the eye itself.

"The consent form does not mention that the surgery carried any such risk. Had the complainant been told that the surgery could result in permanent loss of vision, or even loss of the eye, it cannot be said that she would still have agreed to undergo it at the hands of the opposite party. By failing to inform her of this risk and merely obtaining her signature on a printed form, the opposite party has not discharged his duty of disclosure. This, in our view, clearly amounts to deficiency in service. Point No. 3 is, to that extent, answered in the affirmative," it held.

However, addressing the allegations regarding sub-standard and negligent treatment and post-surgery care, the Commission observed,

"A doctor cannot be held guilty of medical negligence merely because the treatment did not give the desired result, or because, looking back, some other line of treatment may have been better. To hold a doctor liable for negligence, the complainant must prove, by reliable evidence and ordinarily by independent expert medical opinion, that the doctor either did not possess the skill he claimed to have, or that he failed to use, with reasonable competence, the skill he did possess, and that this act or omission fell below the standard of a reasonably competent doctor of the same class."

It held that the burden was on the complainant to establish, by acceptable evidence, that the treating surgeon fell below the standard of a reasonably competent ophthalmic surgeon in performing the surgery in question and in rendering post-operative care to her.

At this outset, the Commission further noted, "The complainant has placed on record her own affidavit, the prescriptions and bills, and the records of the hospital where she was subsequently treated. It is, however, conspicuous that no independent expert medical opinion has been brought on record on her behalf, nor has any reference been made to any medical board or specialist competent to opine on the question whether the surgery and the post-operative management by the opposite party fell short of the accepted standard of practice. The records of the subsequent treating hospital, by themselves, only establish that the complainant developed a serious post-operative complication and was thereafter treated for the same; they do not, on their own, establish that the said complication was attributable to any negligent act or omission on the part of the opposite party."

"The complainant has also pointed to the fact that she suffered from repeated episodes of loose motions and general weakness in the postoperative period. While these facts may go to show that her condition during the said period was distressing, no medical opinion has been placed on record to demonstrate that the same had any causative connection with the eye surgery, or with any act or omission of the opposite party. It is equally possible, and indeed not improbable, that the said symptoms had an entirely independent aetiology unrelated to the surgery in question. In the absence of expert medical evidence linking the said symptoms to the management of the case by the opposite party, no adverse inference on the notch of medical negligence can be drawn from the mere fact of their occurrence," it further observed.

Even though the Commission dismissed the allegations of medical negligence, it held the surgeon liable for deficiency in service for failing to obtained proper informed consent and ordered, "The opposite party — Dr. *** —is directed to pay to the complainant *** a sum of Rs. 7,00,000/- (Rupees Seven Lakh only) by way of compensation, on account of deficiency in service in not obtaining a proper and valid informed consent from the complainant...The opposite party is also directed to further pay to the complainant a sum of Rs. 50,000/- (Rupees Fifty Thousand only) towards costs of the litigation."

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/2026/06/06/maharashtra-scdrc-informed-consent-352301.pdf