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Filling The Consent Form By One Person, One Pen, One Sitting – Mandatory, Not Merely Advisable.

Filling the consent form by one person, one pen, one sitting – Mandatory, not merely advisable.

Dr. J.S CHAHAL & Anr  V. JAGDEV SINGH & Anr

Punjab State Consumer Dispute Redressal Commission, Chandigarh

FACTS OF THE CASE :

The patient consulted the urologist (OP1) with the complaint of pain in the abdomen, was diagnosed with stone in the right ureter measuring 10x6 m (on USG and IVP), undervent surgery, and was discharged on 22.04.2011. The patient followed up with the urologist (OP1) on 10.06.2011 and 02.08.2011 with no complaints. Subsequently, the patient had complaint in passing urine and was diagnosed and treated for urine infection at another hospital from 01.09.2011 to 26.10.2011. The patient continued complaining of pain in the abdomen. Repeat USG showed a ureteric stone for which he was operated in yet another hospital on 08.11.2011.

PATIENT’S ALLEGATION OF MEDICAL NEGLIGENCE.

• It was alleged that the consent was fabricated.
• It was alleged that during the first surgery the stone was not completely removed; the failure was not disclosed to the patient; the pain reoccurred after 6 months which on repeat USG shoed the same stone and had to be surgically removed by another doctor.

DOCTOR’s DEFENCE.

• It was stated that during pre- consent counselling the patient was explained that a second intervention may be required, these facts were explained to the patient and his uncle in Punjabi, the patient agreed and thereafter the procedure was undertaken.
• It was pointed out that USG clearance of ureteric stones endourologically  can vary from 85% to 92% and not 100% according to medical texts. It was further pointed out that it is a known fact that stones can reoccur after urine infection. 
• It was stated that the stone removed in the other hospital measured 0.017g (4x4 mm) whereas as per medical records the earlier stone was measuring 15mm x 6 mm, which was bigger and hence the allegation of non-removal of stone in the first procedure was false.

FINDINGS OF THE COURT

• The court observed that the consent for the procedure was valid and complete and not otherwise as held by the lower court. The lower court had drawn adverse inference as the consent form was ‘filled by two persons in different writings’.
• The court observed that the patient was operated after many months for a stone much smaller in size that the earlier one and hence drew conclusion that it could be a ‘regrowth or a small residual stone from the earlier procedure’.
• Hence, the urologist (OP) was not held negligent.

SUGGESTED PRECUATIONS

1. It is advisable that the consent form should be filled by one person, in one ink, and in one sitting.
2. Explain and counsel in the language understood by the patient.
3. Take extra care in case of patients who are less literate/illiterate or do not understand English, as the consent forms are usually in English or have English terms.  Attestation by a witness on the consent or taking a simple declaration is always advisable.
4. Lack of valid consent may be the only cause of negligence or deficiency in service.
5. In appropriate cases, duly record the exact physical features such as shape, size, colour and such other parts of the effected part.