Use of Metal Clips in Lap-Choley : Consumer forum Holds medical negligence

In a judgement that has drawn a strong resentment from the medical fraternity, a general surgeon and a hospital in Kolkata have been fined Rs 8 lakhs collectively, in an alleged medical negligence case

The case is that of a patient was visited the general surgeon at Genesis Hospital in Kolkata with complaints of upper abdominal pain in the year 2006. Ultrasound of the patient reported “A big intraluminal CALCULUS (Diameter 2.6 cms) seen casting distal acoustic shadow" which the doctor diagnosed as CHOLELITHIASIS and performed  L AP-CHOLEY on him and the patient was soon discharge.

Five years after the procedure, in 2011, the patient felt severe pain in upper abdomen in course of treatment of which by the local doctors, Jaundice was diagnosed. The CT scan of upper abdomen revealed

"LEVER, GALL BLADDER AND BILIARY TREE – There is presence of metallic foreign body (sutural clip) measuring about 9 mm in length in the distal part of the common bile duct…. A metallic sutural clip is seen at gall gladder fossa”

The patient was adviced ERCP by the surgeon ( Dr Aggarwal, Kothari Medical Centre) and reported the following

“Selective cholangiogram. Dilated bile duct with multiple calculi and 2 clips in CBD. Sphincterotomy done with removal of calculi and two cholecystectomy clips done. Stenting done with plastic stent”.

The patient then filed a complaint with the consumer court alleging deficiency as well as resultant medical negligence on the part of the doctor who conducted the cholecystectomy that led to the presence of two cholescystectomy clips in CBD  and demanding with claims of relief for refund of Rs. 80,000/- being the cost of treatment for the second operation and Rs. 23,00,000/- as compensation for mental agony and harassment and further Rs. 1,00,000/- as litigation cost. The hospital was also made party on account of vicarious liability.

The complainant's Advocate alleged that nowhere in the concerned treatment documents is there any noting about intimation to the patient concerned in respect of possibility of adverse effect or reaction of Lap-Choley as is required as per standard medical ethics .

The complainant also submitted literature citing that the migration of ‘Endo-Clips’ caused injury to the CBD and consequently caused the obstructive jaundice as is revealed from the Publication under the heading “Unusual Complications Caused by Endo-Clip Migration Following a Laparoscopic Cholecystectomy” by Dr. T.Sato, R.Denno and others as available on records

The counsel for the hospital and the doctor on the other hand argued that the surgeon performed Lap-Choley as per standard surgical protocol and that the possibility of migration of the clips is not unusual and hence, there is no deficiency in service as well as medical negligence. The counsel also pointed out that occurrence of obstructive jaundice after Lap-Choley is also not
unusual and in support of his submissions referred to some Publications which are placed on
records.

The counsel added that the patient concerned reported the complaint of further abdominal
pain after almost six years of operation indicating thereby that the patient was in stable condition
for the last six years after Lap-Choley and hence, such fact indicates absence of negligence

After going through both the arguments, the court observed

The aforesaid documentary evidences, duly signed by the concerned doctors, unambiguously indicate that the Clips used at the time of Lap-Choley were migrated to CBD and thereby caused injuries of leakage to common bile duct which ultimately caused jaundice. The copy of the Publication under the heading “Hem-o-Lock Clip Found in Common Bile Duct after Laparoscopic Cholecystectomy and Common Bile duct Exploration” by Yahui Liu and others, as available on records, indicates that thread ligation or use of absorbable ligatures instead of metallic clips is a safe method and the OP No. 1 neither followed the said method nor did inform the patient
concerned about the probable risk of migration of clips used in Lap-Choley.

The relevant Publications reveal further that due to ineffective/incomplete clipping, the Clips may be migrated to Common Bile Duct causing injury and bile leakage. This biloma causes necrosis of the cystic duct stump by inducing chronic inflammatory jaundice.

The treatment records, as available on records, do not reveal that “End-GIA Reticulator 4.8 or 3.5” which is frequently used stapler for closing the CD stump, as revealed from the Publications, was used in the case on hand.

The foregoing facts, evidence and observation indicate that three essential components of medical negligence, i.e. ‘duty’, ‘breach’ and ‘resultant damage’, as observed by the Hon’ble Supreme Court in the decision of Jacob Mathew Vs. State of Punjab & Anr., reported in (2005) 6 SCC 1, are present in the case on hand.

Holding the doctor and the hospital guilty of medical negligence, the court directed them to refund to the Complainant Rs. 80,000/- being the cost of the second operation and also to pay to the Complainant Rs. 4,00,000/- each, within 45 days from the date of the order, as compensation which appears to be reasonable for suffering from pain and mental agony, failing which interest @ 9% per annum shall be payable for the entire period of default.

Attached is the judgement below