Obtaining Signature On Widely Worded Consent Form Amounts To Signing On Dotted Lines: DSCDRC Explains "Informed Consent"
Consumer Commission says Informed consent means the patient has explained consequences of surgery in layman’s language.
The Delhi State Consumer Disputes Redressal Commission has held that merely writing 'informed consent' on the top of the form does not make it an informed consent and obtaining signature of a patient on such a form containing widely worded clauses amounts to obtaining signature on dotted lines.
Justice O P Gupta observed that 'Informed Consent' means that the patient has been explained consequences in layman's language so that he is able to take a decision to whether go for surgery or not.
The Commission said so while awarding a compensation of Rs. 8 lakh to the family of a city-based journalist who had lost vision of his right eye following a cataract surgery in 2008. The senior journalist Bhushan Raina, aged 60 years, had moved the Commission by way of a complaint filed against eye surgeons, Dr. S K Jain and Dr. Sudeep K. Jain (OPs).
Raina had visited the two doctors in March 2008 after he started seeing black objects flying in his right vision. The doctors diagnosed cataract symptoms in his right eye and suggested that he could wait for another 3-4 months taking medication and thereafter go for cataract removal surgery, which was inevitable. However Dr. S K Jain then suggested that he could go for surgery right away.
Raina underwent surgery on 31 May 2008 after which he suffered retinal detachment and was referred to another doctor by the two doctors themselves. Sensing a goof up, Raina underwent corrective surgery by another doctor; but the vision in his right eye could not be restored.
Raina claimed Rs.49 lakhs as compensation due to loss of vision, physical agony, loss of work and reduction in quality of life.
During pendency of the case, Raina passed away in January 2016. Dr. S K Jain also passed away in March 2016. The case proceeded with their legal heirs on record.
Dr Sudeep K Jain had contended that in case of mature cataract it was difficult to examine the retina beforehand and the same could be inspected only after removal of cataract. The Commission, however, rejected this argument and Justice Gupta observed thus:
"The science has advanced much, sensitive machines are available with the help of which the retina can be examined, the outer layer of cataract could be diluted by the use of medicines. The OPs should have ensured before conducting the surgery that there was no risk. They hurriedly decided to conduct the surgery. Initially they asked the complainant to wait for 3-4 months and in the next breath they fixed the surgery for next day itself."
When the doctor relied on the consent form signed by Raina, the Commission said that the consent has to be informed as per the decision in Vaidya Nath Chakraborty (DR) v. Chandi Bhattacharjee II [(2014) CPJ 601 NC]. "Informed consent means that the patient has been explained consequences in layman's language so that he is able to take a decision to whether to go for surgery or not. Merely writing 'informed consent' on the top of the form does not make it an informed consent. The form is one page fully printed form containing ten clauses. The clauses are so widely worded that virtually they do not leave any situation. Obtaining signature on such printed form amounts to obtaining signature on dotted lines. I have no hesitation in concluding that such consent is no consent in the eyes of law."
On the question of negligence and inability to examine the retina, the Commission made the following observation: "From the material on record I find that in case OPs were unable to examine the retina due to major cataract or advanced stage of cataract, they should have referred the patient for a second opinion before taking a decision of surgery but they did [the] same after doing surgery. His failure to do so is per se negligence".
The Commission noted that the cataract surgery is a simple preliminary surgery that is conducted in every small Nursing Home and Hospital. Still the surgeon who was a known doctor could not do the same successfully. The facts speak for themselves and the doctrine of Res ipsa loquitur applies.
Awarding a sum of 8 lakh to the family members of the deceased complainant, the Commission stated that the life of a person is almost like death without eye sight when he cannot see properly, cannot walk, cannot eat with comfort and would feel secluded from society. The complainant lived in such a state of affairs for approximately 8 years and therefore he must get a compensation of Rs.1 lakhs for every year (of distress he went through). Accordingly, the OPs were directed to pay Rs.8 lakh to the LRs of the complainant within 45 days from the date of receipt of copy of the order.