Printed Consent is no consent ? What is the law of Informed Consent ? - Adv. ROHiT ERANDE. ©

Pre-Printed Consent is no consent ? What is the law of Informed Consent ? 

- Adv. ROHiT ERANDE. ©

The Medical Fraternity was shocked to read a news in one of leading news paper which titled as "Consent forms for Medical procedures is unfair trade practice " Consumer Panel. 

After searching, it was revealed that this refers to observations of National Consumer Disputes Redressal Commission in the same judgment where allegations of Medical Negligence have been turned down. 

Let's see the judgment and the law of informed consent in nutshell.

Case Details :

VINOD KHANNA V/s. R.G. STONE UROLOGY AND LEPROSCOPY HOSPITAL & 2 ors. Consumer Case No.428/2018, decided on 06/07/2020

Coram : Hon. Dr. S.M. Kantikar, Presiding Member and Hon. Mr. Dinesh Singh, Member. 

Judgment Link :

http://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0%2F0%2FCC%2F428%2F2018&dtofhearing=2020-07-06

Facts in short :

1. The case goes back to January- 2010, when Complainant - 65 years old patient was suffering from  pain in abdomen and difficulty in passing urine, with history of prior surgery of hernia and appendix with history of tuberculosis and acquired immune deficiency syndrome (HIV), cryptococcal meningitis, Kaposi’s sarcoma. 

2. Initially he went  Fortis Hospital at Vasant Kunj, New Delhi and after cauterization urine was removed. Thereafter, due to financial difficulties, for further treatment, he approached Dr. Anil Varshney (Opponent No-2) at RG Stone Urology and Laparoscopy Hospital (Opponent No.1 – hospital). The Doctor after USG report,  advised the patient for removal of pus and if required, removal of prostate and it was performed accordingly. The patient was discharged with catheter placed in the bladder for five days. However,  After 3 days, the patient complained that he had started passing urine from the rectum instead of his urethra. The Doctor advised for natural healing and re-insertion of catheter for 6 weeks, but he feared and approached Indraprastha Apollo Hospital and got further treatment there for about 3 months, but he did not get cure and hence again reverted to Fortis Hospital. The medical record of Fortis Hospital, on 02/08/2010 showed  that “No urine per rectally, Fistula healed”.

 In all these treatments he had to spent around 3,50,000/- and he has been regularly visiting the Fortis Hospital thereafter. 

3. Hence he filed a compliant directly in National Commission as he claimed compensation of Rs.1,88,37,602/-.

Defense of Opponents.

1. The Compliant was  attacked as barred by limitation, as it was filed after 8 years from the date of operation. The Doctors also stressed upon the medical history of patient.  The USG confirmed grade III benign enlargement of prostate (BEP) with multiple abscess cavities and some of them found fluctuating and communicating to posterior side of nodules which might be due to immuno-compromised status of the patient.

2. On removal of Foley’s catheter, it was noted that the patient passing urine through rectum which was a rare complication. The patient was properly explained and counseled about such known rare complication. It was unavoidable because of the fistula with multiple cavities communicating to the posterior side. It was due to the necrosis of rectal wall due to the existing abscess cavity which facilitated urine passages communicating with rectum. The Opponents also contended that Majority of fistula heal on its own over a period of time and the healing depends upon patient’s immunity. 

Held :

1. The Commission condoned the delay as the compliant was initially filed before State Forum on 13/07/2010, but for want of pecuniary jurisdiction, it was disposed of on 16/08/2017 and the National Forum admitted the complaint as continuous cause of action. 

2. The Forum relied on various medical literature and expert committee report of  Maulana Azad Hospital, New Delhi. The Forum rejected the allegation of the Complainant that 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 rectum, as per medical literature the injection pricks does not cause fistula or grave injury. Commonly to drain prostatic abscess trans rectal needle aspiration is used.    

4. It was observed that despite such HIV positive status, the Opponent No.2 Doctor operated the patient with all due care and reasonable skill.However, the Complainant with his ill intention published a story against the hospital in the ‘Hindustan Times’ to influence the court. Thereafter, the hospital explaining the real facts, the Hindustan Times published the rejoinder and also sought apology from the hospital. Thus, the Complainant was trying to coerce the hospital and influence emotionally for out of court settlement.  

4. Lastly it observed that on the basis of affidavits of the Parties and the report of Expert committee, there was no any medical negligence and the complaint is frivolous, bereft of merit and ill-conceived.

However, it then moved to the topic of Informed Consent. Perhaps this was not the contention of the Complainant also.  It has been observed that the practice of using pre-printed consent forms which can fit into any procedure and later on filling the gaps, is procedural arbitrariness and amounts to unfair trade practice and imposed costs of Rs.10 lakhs on the hospital to be paid into consumer legal aid account. 

Informed Consent :

The Law of Informed Consent is now settled in India and perhaps by the  3 judges bench judgement of Hon. Apex court in the case of Samira Kohli V/s. Prabha Manchanda, AIR 2008 SC 1385.  In my one of the previous Article, i have dealt with this topic in detail and the link is as under 
https://advrohiterande.blogspot.com/2017/07/why-informed-consent-is-of-utmost.html
The word "informed' is very material. It means in simple words, taking consent should not be a mere empty formality of taking signatures of patient / relative on the consent form and perhaps this is what the National Commission wants to convey. The patient should be made aware in the language known to him all the pros and cons of doing/not-doing particular procedure, the alternative procedure, if any and known advantages-dis-vantages if any. Only emergency and life saving situation is saved from taking consent. 
Pre-printed Consent forms banned ?
With all due respects to their Lordships, I may submit that practice of pre-printed consent forms is prevalent in almost all the Govt./Private hospitals. It will be unfair to draw the conclusion that printed consent equal to empty formality. In many cases Doctors /Hospital do make aware the patient about the pros/cons of the treatment, even though the consent form is pre-printed. The aforesaid landmark judgment of Hon. Apex Court also did not say that pre-printed consent forms is not allowed, but it certainly said that the consent should not be an empty formality. 
One more aspect, as in the case in hand, it has been observed that the patient was not prejudiced on the ground of Informed Consent, then the observation of Hon. Commission can be treated as Obiter Dicta ? The law of precedents says that what is binding is ratio of the judgment and not the obiter. This Latin term 'Obiter- Dicta' in simple means observation /finding given by the Court on the subject, which is not related to the case in hand. So this could be the important point in challenging this judgment in the Apex Court. 
At some places, Hospitals are video recording the consent procedure, but it costs more and problem of storing such data is also a big problem. 
So now the Doctors / Hospitals may take print-outs of the consent forms by filling all the details, instead of using pre-printed forms. In any case Hospitals /Doctors have to see that consent is not an empty formality. 

Thanks and Regards,

Adv. ROHiT ERANDE
Pune. ©