Dr. Dilip B. Walke
Chairperson, Ethics & Medico Legal Committee, FOGSI
Sameera kohli Vs Dr Prabha Manchanda
16th Jan 2008
Jst B N Agarwal/Jst Naolekar/Jst Ravindran
Why is it “The case of the month”?
- It’s a landmark case because a three judge bench has finally defined consent in the context of medical negligence in Indian scenario
- It deals with laproscopic surgery which is a commonly performed surgery these days.
Facts of the case
- Unmarried 44yrs old patient with bleeding PV with USG evidence of Chocholate cyst of right ovary with fibroid was posted for laproscopy.
- Consent was taken for admission, laproscopy & SOS operative steps for endometriosis including laparotomy but there was no mention of hysterectomy
- On table however, hysterectomy however was done after taking oral consent from her old mother who was waiting outside the operation theater
- The fiancée of the patient created a scene in the hospital and took away the patient without paying the bill for which a police complaint was made by the hospital.
- The allegation was that hysterectomy was done without consent of the patient. It has lead to she becoming prematurely menopausal for which she would now need HRT for a long period of time. Such alternatives should have been discussed before the surgery.
- The case shifted from State forum upwards due to appeals to the Supreme Court
- Judges agreed to the well fought argument that doing TAH BSO in this case was not negligence. This fact was well supported by book references and expert witness. She was considered to have acted in good faith in the interest of the patient. The only problem she would suffer was the need for long term HRT.
- However it was done without valid consent and that amounts to tortuous act of assault and battery
- Allowed only Rs 25,000/- + bill amount + 5000/- legal cost
Supreme Courts view on consent
- Consent of the patient before commencing a “treatment” (this includes surgery) should be real and valid
- Patient should have capacity and competence to consent.
- It means that the patient should be adult and of a sound mind
- If both are not fulfilled the guardian has to give consent
- His consent should be voluntary
- It means that no one else can consent on behalf of the patient (unless minor or insane) and they can only consent as witness
- Should be based on knowledge. It means that “adequate information” about
- Nature of treatment
- Possible side effects
- Available alternatives
- Consequences of refusal of treatment
- A balance communication is expected
- Consent given only for diagnostic procedure cannot be considered as consent for therapeutic procedure.
- Consent given for specific treatment procedure will not be valid for other treatment procedure.
- The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expenses, or would relieve the patient from pain and sufferings in the future, are not grounds of defense in an action in tort for negligence or assault or battery.
- The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes decision
- There can be a common consent for diagnostic and operative procedures where they are contemplated.
- There can also be common consent for a particular surgical procedure and an additional or further procedure that may be required during the course of the surgery.
- Consent can be taken by assistant doctors.
Does SC expect us to talk about all possible complications?
- There is no need to explain remote or theoretical risks involved, which may frighten or confuse the patient and result in refusal of consent for necessary treatment
- Similarly there is no need to explain remote or theoretical risks of refusal of treatment, which may persuade the patient to undergo a fanciful or unnecessary treatment
- A balance should be achieved
This case has been referred to as a case law several times subsequently
NCDRC ( Jst K S Gupta/ Dr Shenoy) 29th Sept 2008.Ram Gopal Varshney Vs Lasor Sight India Pvt Ltd
- Cataract surgery was done on a 76 yr old patient but consent was taken only from grand son.
- Case of loss of vision was well defended and no negligence found
- 25,000/- + 10,000/- cost awarded because patients consent was not taken
NCDRC.Mrs Zeba Hamid Vs Hajela Hospital and ors.Jst Kulshreshta/Mrs Pramila S Kumar.31st Oct 2008
- Primary infertility patent was posted for diagnostic laparoscopy + Hysteroscopy
- Ovarian drilling and Salpingectomy was done without consent
- Rs 25,000/- + Rs 2000/- awarded
NCDRC.Mrs Chandoke V Sir Ganga Ram hospital
- Patient with DUB with 2 previous LSCS was posted for TAH
- On table doctor decided to do vaginal hysterectomy
- Laparotomy had to be done because of bleeding from ovarian stump
- Patient ultimately landed up with nephrectomy and suffered
- Bleeding is no negligence
- Deviation from route not acceptable in unless life saving
- 5 lacs awarded