Case Study

Informed consent is to be EXECUTED BETWEEN THE PATIENT & THE TREATING DOCTOR

Manmohan Kaur v. Fortis Hospital, First Appeal No 832 of 2015. Decided on 29th June 2018 by The National Consumer Disputes Redressal Commission, New Delhi


FACTS: In the month of December 2006, the Complainant, a lady, aged about 55 years, started having stomach pain and disorder in the digestive system (irritation in the stomach/food pipe). She consulted one Dr. Neeraj Nagpal at Hope Gastrointestinal Diagnostic Clinic, Chandigarh. Treatment continued between the period from February 2007 and April 2008.  Since, she did not get complete relief, she went to M/s Fortis City Centre, Sector-9, Chandigarh, Opposite Party No. 2 in the Complaint and consulted Dr. Arvind Sahni, Opposite Party No. 3, in the Complaint, in the month of May 2008.  Even though the Complainant took treatment for about nine months and underwent several diagnostic tests, including Gastroscopy, she did not get complete relief.  Then, she consulted another Specialist, Dr. Sandeep Dhavan at Dhavan’s Jeevandeep Nursing Home at Chandigarh, where also she was subjected to several tests, including Video UGI Endoscopy on 29.07.2011 and 03.03.2012.  Still she did not get complete relief. On 16.05.2012 the Complainant again consulted the Treating Doctor, who advised her to undergo various tests from time to time, including blood tests, Histopathology, Endoscopy, Barium tests, food allergy tests.  On 20.06.2012, the Treating Doctor advised her full-length colonoscopy to rule out colonic malignancy or colitis.  MRCP was done on 21.06.2012.  According to the Complainant, though she was reluctant to undergo colonoscopy as it was an invasive procedure, performed with the help of a Colonoscope through the anus, but on the assurance of the Treating Doctor that it was a safe procedure and no harm would be caused to her, she agreed for the said test.  Colonoscopy procedure was ultimately planned for 04.07.2012. As advised on 02.07.2012, the Complainant took Peglec powder on 03.07.2012, to clean the colon. Colonoscopy procedure was conducted on 04.07.2012 by the Treating Doctor. According to the Complainant, on insertion of colonoscope, she felt severe pain and requested the Treating doctor to discontinue the procedure.  However, it was not stopped, which resulted in perforation in the colon, resulting in deterioration in her condition. Her abdomen swelled like a football; there was acute pain; and she became unconscious, necessitating her transfer to the ICU. She was put on oxygen and other devices/life-saving drugs.  The Treating Doctor informed the family members of the Complainant that it was a case of pneumoperitoneum, which required Exploratory Laparotomy in order to save her life.  The said operation was conducted in emergency by Dr. J.D. Wig, a Surgeon, Opposite Party No. 4 in the Complaint. As per the operation notes the  pain/distension in the abdomen was felt by the Complainant immediately after the Colonoscopy procedure: on opening of the abdomen, a perforation of the size 0.5 x 1.0 c.m. was noticed in the sigmoid colon, resulting in pneumoperitoneum (collection of air in peritoneal cavity), which was sealed by performing the said surgical procedure.  Before the procedure, she was asked to deposit a sum of `1,30,000/-.  The Complainant remained admitted in the hospital for 5 days.  Some further amounts were charged at the time of discharge, which the Complainant claims to have paid under protest.    In the said background, alleging medical negligence on the part of the Treating Doctor on account of: (i) in not taking due precautions while performing colonoscopy on 04.07.2012, by use of force while inserting the colonoscope; (ii) not abandoning it when she complained of acute pain; (iii) prescribing unnecessary investigations, like  abdomen CT, bone mineral density etc. in order to make money; (iv) the test reports as well as the prescription slips did not correlate with each other; (v) charging  excess amounts by Fortis Hospital, Opposite Party No. 2, under several heads, (v) the Complainant was still under treatment and was unable to lead normal life, inasmuch as she was unable to walk properly and take proper food: her capacity to work had also decreased, and she had become dependent on others, the afore-noted Complaint came to be filed before the State Commission.  The Complainant prayed for a direction to the Opposite Parties, to pay to her, jointly and severally a total compensation of `51,73,565/- under different heads, along with interest @ 18% p.a. from the date when Colonoscopy was done i.e. 04.07.2012, till realization, as also a sum of `25,000/- towards litigation costs.

DEFENCE:  Taking into consideration the fact that she was suffering from abdominal pain since the year 2006, the Treating Doctor advised various tests, including Colonoscopy, to detect ulcer, colonpolyps, tumor and areas of inflammation or bleeding, as also screening  for any malignancy in the colon or rectum; as per the report, Sigmoid Diverticulum were noticed in the sigmoid colon area; the Complainant never requested for discontinuance of the colonoscopy procedure nor she was unconscious. As regards the pain, which the Complainant complained of, there were contradictory statements in the Complaint, in as much as, while in para-5 of the Complaint, the Complainant had stated that it was during the procedure that she felt pain and asked for discontinuance of the procedure but in para-6, she had averred that she had felt pain after the colonscopic procedure. In fact, it was only after the procedure was completed that she showed signs of pain and distension in the abdomen, which was immediately attended to. Thereafter, the Complainant was taken for x-ray, which showed pneumoperitonaeum (air in the abdominal cavity). She was immediately admitted as an indoor patient and, after managing her condition with a number of medicines – IV as well as oral, she was taken for surgery by the General Surgeon, under general anesthesia, as there appeared to be a sigmoid perforation. The said operation was conducted without any post-operative complications:  the Complainant was stable, and was discharged on 09.07.2012.  When the Complainant came for follow-up, her clips were removed and the wound had healed.  It was pleaded that Sigmoid perforation during Colonoscopy, is a well-documented complication, which was managed as per the standard protocol, accepted all over the world: she was immediately attended to and treated accordingly: no medical procedure, major or minor, is devoid of risks: complications do occur in the best of institutions during the course of medical or surgical treatment and it can, in no manner, be termed as a negligent act on the part of the Doctor: the Treating Doctor is well-qualified to handle the case and he did so correctly; and the complication was promptly diagnosed and a known and well-documented medical procedure was followed by the General Surgeon.  It was asserted that tested on the touchstone of the principle laid down in ­­Bolam v. Friern Hospital Management Committee, (1957) 1 WLR 582, the Opposite Parties were not guilty of any kind of negligence, as the Treating Doctor and the General Surgeon had acted in accordance with an accepted and proper practice, recognized all over the world:  while the Treating Doctor, a very qualified Gastroenterologist, having vast experience of performing 35000 endoscopy/ colonoscopy procedures successfully, had been in practice since 1984; Dr. Wig, the General Surgeon, had been the Head of Surgery, PGIMER, Chandigarh; no doctor would intentionally commit an act of omission which would result in loss and injury to a patient.  As regards negligence and use of force by the Treating Doctor, it was pleaded on behalf of the answering Opposite Parties that various studies carried out on colonoscopic perforations clearly reveal that several factors make the bowel segment vulnerable to injury. These factors include a sharp angulation at either the rectosigmoid junction or the sigmoid-descends colon junction and the great mobility of the sigmoid colon. Further, diverticulum formation and pelvic adhesions are also contributory factors leading to incidents of sigmoid perforation.  As regards the allegation that the Complainant was unable to walk properly and take her proper food etc., it was averred that no prescription of any doctor, stating the said fact, had been produced by the Complainant. In fact she had been visiting the Treating Doctor post-operatively as well and had been walking normally to his clinic and hence, the Complaint was wholly devoid of any merit and deserved to be dismissed.

OBSERVATIONS/ EVIDENCE OF CONSENT: Case of the hospital was that consent was duly taken but the consent form has been destroyed because of water seepage.

Held: but pertinently, the Respondents have not chosen to produce even the soiled file, stated to be containing Complainant’s consent form along with other similar consents obtained in the OPD room.  Besides, a very significant fact emerges from the afore-extracted explanation on point No.1, viz. the consents are got signed in the OPD room, where Colonoscopy procedures are conducted, “by the staff” and the same were kept together with the other consent forms of other patients. The stand of the Respondents that consent forms are got signed by the staff in the OPD room, in our view, leaves little scope for doubt in our mind that the consent forms were got signed by the staff before the procedure was conducted by the Doctors, as a formality and does not meet even the basic mandatory requirements of the Treating doctor, making the Complainant aware of material risks involved in the Colonoscopy procedure, before she was subjected to the same. It is true that advances in endoscope design, array of instruments and technique available, have made Colonoscopy one of the safest of invasive procedures, yet, complications and adverse effects still happen, so much so cases of unanticipated deaths, during or after the Colonoscopy have been reported, even in ideal circumstances.  According to the medical journals, death can occur from any complication of Colonoscopy: the electrolyte imbalance caused by sodium phosphate preparation; the Cardiac events brought on hypoxia from over-sedation; the sepsis that may follow perforation; or blood loss that can occur with haemorrhage, though proper management of these complications can minimise mortality. It is universally accepted that Colonic perforation is rare but known complication of Colonoscopy.  That being so, the basic principle of “Consent” demands that before opting for Colonoscopic procedure, the patients must be clearly apprised of the balance of risks and benefits that apply in their own particular situations and participate in the decision-making process that flows from this balance.  On facts at hand, in the entire defense put up on behalf of the Respondents, there is not even a whisper that the Treating doctor had explained to the Complainant the pros and cons: the material risks involved and the benefits of the procedure, particularly keeping in view her age and health condition, now being highlighted. In our opinion, Respondent’s reliance on the averment in the Complaint to the effect that though initially she was hesitant but on the assurance of the Treating doctor, she had agreed to go for the test, the Treating doctor was not required to prove the ‘consent’, is of no avail to them and does not establish that ‘informed consent’ as understood in legal parlance, was obtained from the Complainant before subjecting her to the said procedure. In our view, the finding in the impugned order to the effect that “it cannot be made out from the evidence produced by the Complainant that she had not consented to undergo this colonoscopy” is per se illegal, inasmuch in the light of Complainant’s categorical stand that no informed  consent had been taken from her before the procedure was performed, onus was on the Respondents, in particular the Treating doctor, to prove that it was infact taken, which, evidently, they have failed to discharge. In our opinion, apart from the fact that the explanation for non-production of the consent form, claimed to have been got signed from the Complainant, does not inspire confidence, even on merits the Treating doctor and the Hospital have failed to prove that a valid/informed consent had been obtained from the Complainant before subjecting her to colonoscopy procedure. We are, therefore, of the considered view that the Treating doctor as well as the Hospital had failed to obtain a valid consent from the Complainant and the colonoscopy procedure conducted on her was unauthorized, amounting to deficiency in service on their part. We hold accordingly. Nevertheless, in so far as Dr. J.D. Wig is concerned, we do not find any negligence/deficiency on his part. Accordingly, we exonerate him. For the view, we have take above, we deem it unnecessary to deal with other afore-noted issues viz. whether: the Treating doctor had failed to follow the standard protocol in the performance of the colonoscopy procedure; he should have abandoned the procedure when the Complainant claims to have complained of pain at the start of the procedure; the Treating doctor lacked requisite experience to conduct such a procedure; the Treating doctor did not take due precautions while performing the said procedure, resulting in pneumoperitoneum requiring emergency laparotomy. That brings us to an intricate question, viz, what compensation deserves to be awarded to the Complainant for the afore-stated sufferings undergone by her.  We shall consider the question, bearing in mind the fact that we have not returned any final finding of negligence on the part of the Treating doctor in the performance of the procedure on her but have found deficiency on the part of the Treating doctor and the Hospital for not obtaining a valid consent for colonoscopy. In the Complaint, the Complainant has prayed for compensation amounting, to `50,00,000/- on the ground that she has suffered mentally, physically and financially on account of the aforenoted conduct of the Respondents. However, no cogent material has been placed on record to show her source(s) and scale of income. we are of the opinion that the award of a lump sum compensation of `10,00,000/- in favour of the Complainant, which would include the medical expenses, stated to have been expended, for the physical and mental agony undergone by her, would meet the ends of justice. The Treating doctor and the Hospital shall be liable to pay the said compensation to the Complainant, jointly and severally, as apart from the fact that it is well settled that the Hospital is vicariously liable for the negligence of its attending doctors, in the present case, the Hospital being responsible for preservation of the record of the Patient, was equally deficient in not preserving and producing the requisite document(s).  The said amount shall be remitted to the Complainant within four weeks, from the date of receipt of a copy of the order, failing which it shall carry interest @9% p.a. from the date of filing of the Complaint till actual realization.

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