State Consumer Disputes Redressal Commission
Satish Bhardawaj vs Fortis Healthcare Ltd. on 18 May, 2021
STATE CONSUMER DISPUTES REDRESSAL COMMISSION,
PUNJAB, CHANDIGARH
Misc. Application No.2710 of 2018
In/and
Consumer Complaint No. 303 of 2018
Date of Institution : 18.04.2018
Reserved on : 11.05.2021
Date of decision : 18.05.2021
Satish Bhardwaj, aged 66 years, son of Sh. Madan Lal, resident of
2663 B, MIG Flats, Sector 70, Mohali (since deceased), now
represented through his LRs:
1. Dinesh Nandni Bhardwaj w/o Late Sh. Satish Bhardwaj, R/o 45,
Dormington DR, Toronto, ON MIG3N1, Canada.
2. Puneet Bhardwaj S/o Late Sh. Satish Bhardwaj, R/o 45,
Dormington DR, Toronto, ON MIG3N1, Canada.
.... Complainant(s)
Versus
1. Fortis Hospital, Sector 62, Phase VIII, SAS Nagar, Mohali, Distt.
SAS Nagar, Mohali Punjab-160062, through its authorized
representative.
2. Dr. Rudra Prasad Doley, Consultant General Surgery, Fortis
Health Care Ltd., Sector 62, Phase VIII, SAS Nagar, Mohali,
Distt. SAS Nagar, Mohali Punjab-160062.
3. Fortis Health Care Ltd., Having registered office at Sector 62,
Phase VIII, SAS Nagar, Mohali, Distt. SAS Nagar, Mohali
Punjab-160062, through its Director.
.... Opposite Parties
4. Nidhi Dixit W/o Sh. Karan Dixit, R/o Villa 21, Centro Courtyard 4
Centro, The Villa Dubai Land, Dubai.
.... Performa Party-LR of Complainant
Consumer complaints under Section 17 of
the Consumer Protection Act, 1986 as
amended up to date.
Consumer Complaint No.303 of 2018 2
Quorum:-
Hon'ble Mr. Justice Paramjeet Singh Dhaliwal, President
Mr. Rajinder Kumar Goyal, Member
Mrs. Kiran Sibal, Member.
1) Whether Reporters of the Newspapers
may be allowed to see the Judgment? Yes/No
2) To be referred to the Reporters or not? Yes/No
3) Whether judgment should be reported
in the Digest? Yes/No
Argued by:
For the complainant(s) : Sh. P.M. Goyal, Advocate
For OPs No.1 to 3 : Sh. Munish Kapila, Advocate
For Performa Party : None.
JUSTICE PARAMJEET SINGH DHALIWAL, PRESIDENT
Misc. Application No.2710 of 2018
Instant application has been filed by the complainant for placing on record material documents such as prescription slip of Dr. Parminder Singh, prescription slip of Dr. Jitender Syal, prescription slip of Sharma clinic Annexure A-1(Colly.) and report of MRI abdomen dated 24.10.2018 Annexure A-2 for just decision of the case.
We have heard the Ld. counsel for the parties and perused the record.
The above prescription slips and MRI abdomen are relevant and necessary documents for just decision of the consumer complaint.
In view of the above, they are taken on record as Ex.C-13 (colly.) and Ex.C-14, for just decision of the case, subject to all just exceptions.
Consumer Complaint No.303 of 2018 3Main Case The instant complaint was originally instituted by Satish Bhardwaj (hereinafter to be referred as "the Patient"), alleging deficiency in service and medical negligence on the part of Opposite Parties No.1 to 3 in rendering treatment to him. During the pendency of present complaint, he expired and now he is represented by his legal representatives. His wife and son have been arrayed as his Legal Heirs and his daughter has been arrayed as Performa Party in the amended Memo of Parties.
Averments in the Complaint:
2. The averments in brief, as averred in the complaint, are to the effect that the patient consulted Opposite Party No.2-Dr. R. P. Doley for the first time on 27.02.2017 at Fortis Hospital Mohali. Dr. R. P. Doley advised him Laparoscopic Ventral Mesh Hernioplasty. Since the patient was apprehensive about undergoing surgical procedure; he was assured by the doctor that the surgery is a very simple procedure and has got cent percent success. The patient was allegedly informed that the surgery would be performed on the day of admission and the patient would be discharged on the third day post-surgery; and that total treatment costs would be to the tune ₹2,10,000/- (approx.). The patient, thereafter, underwent ultrasound whole abdomen on 01.04.2017. He was referred for cardiology consultation to Dr. Arun Kochar and for Pulmonology consultation to Dr. Navreet Kaur Sandhu.
After related clearances and having been found fit for undergoing surgery, the patient deposited a sum of ₹3,000/- towards operation Consumer Complaint No.303 of 2018 4 theatre booking charges and was assigned 07.04.2017, as date for surgery.
3. The patient was admitted in Fortis Hospital, Mohali on 07.04.2017 and underwent surgery on the same day and post-surgery he was found to be stable. However, in the same breath patient alleges that on the first day of post operation, he repeatedly reported of being un-well but the doctors of Opposite Party-Hospital noted that the patient was stable and was responding well to the procedure underwent. The patient alleges that on the second post-operative day, he complained of nausea and constipation. However, the doctor and the nursing staff ignored his complaints. They informed that it is normal to have such complaints and advised the staff on duty to prepare for his discharge. However, later on without looking into the complications and without carrying on further investigations, the doctor on duty added normal treatment medication for nausea. On the third post- operative day, due to patient's worsening condition, the doctor diagnosed possibly post-operative ileus. In view of his complaint about nausea he was put on liquid diet via Ryles tube. The patient alleges that during this time his blood pressure was dropping and despite that the doctors noted his vitals to be stable. The patient alleges that his family suspected some wrong doing on the part of doctors and many times requested them to supply the treatment records, so as to enable them to get another opinion and to shift the patient to some other hospital. As per the patient, his blood pressure dropped on 11.04.2017 creating a life-threatening condition for him. Resultantly, the patient Consumer Complaint No.303 of 2018 5 was shifted to SPICU, where he was put on mechanical ventilation. The patient alleges that the doctors at Fortis Hospital, Mohali informed him and his wife that that there was a risk to his life and owing to this fact, the patient and his wife informed their children, who were residing in Canada and Dubai. Consequently, the patient's children visited him in India after spending heavy expenses to the tune of ₹3 lac. According to the patient, Opposite Party No.2 claimed himself to be an expert in his field, but "he grossly failed to stick to the standards of medical treatment and he negligently injured the underlying soft tissue of the intestine or sutured the mesh with small bowel, which resulted in further complications, prolonged stay and patient underwent severe pain by undergoing another surgery."
4. The Patient has further alleged that the doctors at Fortis Hospital, Mohali, did not investigate the cause of his complications till 14.04.2017 and repeatedly told him that the same are normal and will go away in few days, whereas the CT scan suggested dilated loops and paralytic ileus. The patient's condition improved for a few days and on 19.04.2017, another CT Scan was performed, upon which it was noticed that there was no significant improvement. Finally, the doctors realized that something had gone wrong while performing the surgery and that it could only be corrected by another surgery and, thus, a decision for undertaking Exploratory Laparotomy was taken.
5. The patient was again subjected to an Exploratory Laparotomy on 19.04.2017 "to remove the Intra Peritoneal Mesh and Adhesiolysis which was got negligently attached with the underlying soft tissue of Consumer Complaint No.303 of 2018 6 the small bowel causing small bowel compression, which resulted into the paralytic ileus." As per the complainant, this resulted into causing him immense pain and loss of health. The patient suffered many problems after unwarranted surgeries. The patient also alleges that thereafter, he continued to suffer pain, swelling in various organs, which were making difficult for him to walk even for a little distance. The patient further alleged that he was having constant pain in his thigh, legs and pelvic area. These have almost made him disabled and he was unable to continue his work; had made him dependent upon others. He was living under shadow of recurrent hernia and in case any further complication arises, he would be forced to go abroad for further treatment which would cost him crores of rupees. On the basis of these allegations, the patient attributed negligence to Opposite Parties No.1 to 3 and claimed that they are deficient in their service, on account of which the patient and his family suffered immensely. Earlier, the complainant had filed CC No.226 of 2018, which was dismissed as withdrawn, vide order dated 03.04.2018, with liberty to file fresh complaint on the same cause of action. Hence, the present complaint, claiming following reliefs against Opposite Parties No.1 to 3:
i) Pay a sum of ₹4,05,598/- along with interest @ 18% per annum from the date of payment till realization being expenses paid by the complainant during his stay in the Hospital, Consumer Complaint No.303 of 2018 7
ii) Pay compensation of ₹5,00,000/- towards cost of treatment of present and future complication which the complainant had to bear from his own pocket,
iii) Pay ₹5,00,000/- for loss of work, that the complainant had suffered due to prolonged stay in the opposite party-Hospital and pay compensation of ₹10,00,000/- for permanent disability caused to him because of which he was not able to work as efficiently as he was doing before admission in the Hospital.
iv) Pay compensation to the tune of ₹5,00,000/- for mental agony and physical harassment suffered by the complainant;
v) To pay ₹3,00,000/- towards the expenses incurred on the unplanned visit of the children of the complainant, whose condition became critical at the hands of Opposite Parties No.1 to 3; and
vi) To pay litigation expenses to the tune of ₹50,000/-. Or
vii) Any other relief, which this Commission deems fit in the interest of Justice and Equity, as per the circumstances of the case, may be awarded.
Defence of the Opposite Parties
6. Upon notice, Opposite Parties No.1 to 3 appeared and filed their joint written statement, taking preliminary objections to the effect that the complaint has been maliciously instituted to harass, malign and black mail the answering Opposite Parties. In fact, the patient had consulted Dr. R.P. Doley on 27.12.2016, with complaints of swelling in the Umbilical and the Epigastric region, which was gradually increasing in size. On clinical examination, the patient was diagnosed to have umbilical and epigastric hernia. Opposite Party No. 2 recommended ultrasound abdomen and surgery (laparoscopic ventral Consumer Complaint No.303 of 2018 8 hernioplasty), which is standard treatment protocol for this medical condition. The patient was advised to undergo pre-anaesthesia check up (in short, "PAC") in preparation for surgery. The patient did not report back to OP No. 2 till 27.02.2017. On the said date, he got his preliminary PAC done. The necessary investigations were advised and he was suggested to report back to PAC clinic after getting reports of the recommended investigations. The patient reported to the PAC clinic on 01.04.2017. Nearly 4 months after the first visit, the patient visited again. After due clearances, he was advised to get a date for surgical procedure, which was planned for 07.04.2017. The patient was admitted in the hospital on 07.04.2017 and underwent Laparoscopic Mesh Hernioplasty, as per standard medical protocol. The whole procedure went smoothly. The first post-operative day was uneventful and his pulse rate, blood pressure, respiratory rate and urine output were normal. His progress was satisfactory, so a plan for discharge was made in the coming days. On second post-operative day, the patient had three episodes of vomiting. He was administered antiemetic medications to relieve his vomiting. On the third post- operative day, in view of the persistent vomiting, a possibility of post- operative ileus was considered. His blood pressure was normal and had no respiratory issue. He was administered intravenous fluids. On the fourth post-operative day, as vomiting persisted, a nasogastric tube was inserted for stomach decompression. He was administered intravenous fluids. He had an episode of low blood pressure: 80/50 mm Hg. He was shifted to ICU for monitoring and was administered Consumer Complaint No.303 of 2018 9 oxygen and fluid therapy continued. On adequate hydration, the blood pressure of the patient gradually improved to 107/64 mm Hg. In view of high nasogastric aspirate, a plain x-ray abdomen was done, which revealed dilated bowel loops and multiple air fluid levels. Subsequently, the blood pressure, pulse rate and urine output of the patient remained normal and he was afebrile. On sixth post-operative day, his vitals were normal. The nasogastric tube aspirate remained persistently high and the patient did not pass either flatus or motion and abdominal CT scan was planned to rule out any intra-abdominal cause of the persistent high nasogastric aspirate. Subsequently, CT scan revealed dilated proximal of bowel loops. There was no intra- abdominal collection. On seventh post-operative day, the patient had bowel movement. His pulse rate, blood pressure, urine output and respiratory rate were normal. He continued to remain stable. On ninth post-operative day, he was shifted to the ward. As his nasogastric aspirate remained persistently high, a repeat of abdominal x-ray was done on 11th post-operative day, which showed dilated loops of bowel and multiple air fluid levels. At this stage, second opinion was sought from senior surgical colleagues. A repeat radiological study in the form of abdominal x-ray revealed dilated bowel loops and multiple air fluid levels. An abdominal ultrasound study done at that stage revealed dilated loops of bowel and no intra-abdominal collection.
7. The issue at this stage was persistently high nasogastric aspirate, intermittent absence of passage of flatus or motion, imaging studies have been revealing dilated bowel loops and multiple air fluid Consumer Complaint No.303 of 2018 10 levels and non response to convert the management for a period of 12 days. Ultimately, it was decided to explore the patient. On 19.04.2017, the patient was re-explored and the operative findings revealed adhesions between loops of small bowel and a loop of bowel was adherent to the mesh, which was placed at the time of previous surgery. The bowel proximal to this adherent loop was dilated. A careful adhesiolysis (separation of the adhesions) was undertaken. The mesh, placed at the time of previous surgery, was removed along with absorbable tackers used to fix a mesh.
8. Post-operatively, the patient was shifted to ICU. His post- operative recovery was uneventful and his persistently high nasogastric aspirate decreased. He eventually had bowel movements. He was gradually started on oral fluids and throughout, he remained afebrile. He was started on oral diet later on, which he tolerated well and was discharged on 30.04.2017 in a stable and satisfactory condition. He had a superficial gaping wound around umbilicus, which healed in few days with dressing in OPD of Opposite Party No.2. Thereafter, the patient visited the hospital on 22.06.2017 for complaint not related to hernia repair. He revisited on 23.12.2017 for unstable gait, for which he was referred to a neurosurgeon. However, he never complied with the advice of the neurosurgeon, nor did he get the investigations done as suggested by neurosurgeon. After December, 2017, patient never contacted Opposite Party No.2.
9. On merits, it is admitted that the patient was an advocate and he had undergone treatment at opposite party No.1-Hospital. For the first Consumer Complaint No.303 of 2018 11 time, the patient had visited Opposite Party No.2 on 27.12.2016. It is averred that he was suffering from umbilical and epigastric hernia (ventral hernia). The treatment was given as per standard medical protocol. Herniation happens due to increased intra abdominal pressure. The content of hernia sac may be pre-peritoneal fat tissue, omentum.
10. The patient had given a history of his being a smoker and suffering from hypertension. Dr. R.P. Doley, on physically examination diagnosed him to be suffering from umbilical and epigastric hernia. After discussing his diagnosis, Dr. R.P. Doley explained to the patient that surgery is only option and waiting is not advisable for adults with umbilical hernia. The patient was informed that there are two approaches for doing hernia repair surgery i.e. Open & Laparoscopic approach. After discussing pros and cons of each procedure, the patient was advised to undergo Laparoscopic Ventral Hernioplasty, which is a preferred surgical treatment and is considered the gold standard of minimally invasive technique. The patient was asked to undergo an ultrasound of the whole abdomen and a Pre-Anesthesia Check up. The prescription slip issued to patient is Ex.OP-2/2 at page No.1692 of the paper book. Thus, the averment made by the patient in his complaint that he had consulted Dr. R.P. Doley for the first time on 27.02.2017 is totally belied, in view of the said prescription. Further, Dr. Doley diagnosed the patient to be suffering from umbilical and supra umbilical hernia, contrary to the patient's assertion in para-4 of the complaint that he was diagnosed with umbilical hernia. This fact is Consumer Complaint No.303 of 2018 12 also corroborated from the USG report, dated 04.01.2017 conducted at Fortis Hospital, Mohali, Ex.OP-2/2B (at page No.1694 of the paper book).
11. Despite having been advised surgery in December 2016 and the patient having been specifically asked to undergo Pre-Anesthesia Check, yet the patient, for almost two months, did not care to get the same done. Finally, on 27.02.2017, the patient underwent Pre- Anaesthesia check (PAC). The PAC Form is dated 27.02.2017 is Ex.OP-2/4A (page Nos. 1736 to 1738 of the paper book). The Anaestheologist, who performed patient's Pre-anaesthesia check-up, specifically noted that the patient had hypertension for the last 5 to 6 years and he used to smoke 5 to 6 cigarettes per day. Besides this, it was also noted that patient occasionally consume alcohol as well. The Anestheologist advised certain investigations and advised the patient to undergo certain tests and review, along with his reports. However, once again for almost one month, the patient did not turn up for follow up. The patient reported for PAC review on 01.04.2017 and he was given a cardiac and pulmonology clearance by the Cardiologist and the Pulmonologist concerned for undergoing surgery. Thereafter, the patient took 07.04.2017, a date of his choice for his admission and surgical procedure.
12. On 07.04.2017, the patient was admitted for surgery in Fortis Hospital, Mohali and after taking due consent and clearances, he underwent standard Laparoscopic (minimal access) Ventral (umbilical and epigastric/supra umbilical) hernia repair with mesh (Composite Consumer Complaint No.303 of 2018 13 Paritex mesh) being inserted to reinforce the weak areas. This surgery is also known as laparoscopic intraperitoneal on lay mesh repair (hereinafter to be referred to as "IPOM"). The patient signed high risk informed consent form (page No.1522-1523). Informed consent is at page No.1520-1521. The whole surgical procedure went smoothly. The umbilical defect was 2 cm x 2 cm and the supra umbilical defect was 4 cm x 2 cm. The contents of the hernial sac were reduced and a compatible paritex mesh was laid. was fixed to the anterior wall of the abdomen with tackers to reinforce the weak areas. The operative notes are at page No.1506-1507 of the paperbook. Various case law citations and medical literatures have been referred in the reply, which will be considered at the appropriate place.
13. It is further pleaded that Opposite Party No.2 is a qualified doctor, having done his M.B.B.S. from Assam Medical College, Master in Surgery and M. Ch in Surgical Gastroenterology from PGIMER, Chandigarh. Opposite Party No.2 is duly skilled for performing such like complex procedures. He followed the standard medical protocol for treatment of ventral umbilical/supra umbilical/epigastric mesh hernioplasty. It is denied that he did not follow the proper procedure. OPD prescription slips and insurance pre-authorisation form and ultrasound report placed on record clearly refer to the fact that proper care was taken. The patient had presented with a complaint of swelling in umbilical reason for last three months. The swelling was gradually increasing in size. The umbilical hernia is caused by weakening of fibres connective tissues in umbilical ring and lump is observed around Consumer Complaint No.303 of 2018 14 umbilicus. Many hernias occur above and below umbilicus to weak points of the abdominal wall. The neck of the umbilical hernia is usually narrow compared with the size of herniated masts and strangulation (gangrene of entrapped intestine) is common complication. Therefore, elective repair after diagnosis is always advised. The patient and his relatives were duly explained the benefits of surgical intervention. They were advised that waiting is not generally recommended for adult umbilical hernia due to anticipated complications, as cutting of blood supply leads to emergency surgery and resultant increased morbidity. There was no negligence on the part of opposite parties No.1 to 3. In a series of 407 patients, the hospital stay was average 1.8 days and pain in 2%. The prolonged and persistent ileus has been reported in 2.21% patients. The patient was given estimated cost for the entire procedure and stay. Clinical examination, laboratory testing, ultrasonography imaging are standard practice in clinical medicine for evaluation of a patient. Ultrasonography, computed tomography and magnetic resonance imaging are all helpful to assess the anatomical details of ventral hernia of commenting the physical examination. After mandatory check-up and clearance from other related departments, PAC was done. The Cardiac and pulmonary clearances were taken.
14. There are still many different treatment strategies for umbilical hernia repair. Both mesh and suture repair are used for treatment of anterior abdominal wall/ventral hernias. The problem with suture repair is high recurrence rate to the extent of 30%. Mesh repair is advocated Consumer Complaint No.303 of 2018 15 in all patients with umbilical hernia with a diameter of at least 1 cm. It shall have its own complications as well as unforeseen complications. The laparoscopic ventral hernia repair is a standard method for repair of ventral hernia and use of mesh for reinforcement of the weak areas is a recommended method. The patient was advised to start oral liquid and ambulate. Injectable medications were stopped. Since the patient was indicating normal blood pressure, pulse rate and respiratory rate, hence conscious decision was taken to discharge him. However, on third postoperative day, patient complained of vomiting and decision was taken not to discharge the patient and to continue with conservative treatment. Patient had few episodes of vomiting. Nasogastric tube aspirate was high and possibility of post-operative ileus was considered. The post-operative ileus is most common form of functional bowel obstruction and may occur after most of intra- abdominal operative procedures. It is not unusual for a patient to have nausea, vomiting and constipation in the early post-operative period. Proper treatment was provided to the patient and decision to conduct repeat surgery in the shape of laparotomy was taken in view of the peculiar circumstances of the present case. The plain x-ray particularly done on 12th of April 2017 showed multiple air field dilated small bowel loops with multiple airfield levels. On 13.04.2017, whole abdomen CECT revealed that small bowel loops were dilated, maximum calibre of small intestine was 4.2 cm (normal is less than 3 cm). There was a gradual change of calibre of the dilated bowel loops in the distal ileum with terminal ileum seen in the collapsed state. No abrupt zone of Consumer Complaint No.303 of 2018 16 transition was noted, nor there was any evidence of small bowel ischaemia. There were no small bowel faces signs. The radiological diagnosis revealed likely post-operative ileus, however clinical co- relation was suggested by the radiologist. Many times, plain x-ray abdomen was done and post-operative ileus was being managed, as per standard medical protocol and waiting expectantly for resolution. Early post-operative bowel of obstruction is managed initially with resuscitation and investigation. The same was done in the present case. Appropriate treatment was given to the patient. There is no deficiency in service or medical negligence on the part of opposite parties No.1 to 3. All other allegations levelled in the complaint have been denied and it has been prayed that the complaint be dismissed. Evidence of the Parties
15. The complainants, in support of their claim, tendered affidavit of Sh. Satish Bhardwaj, complainant (since deceased) dated 23.07.2018 as Ex.C-A, along with copies of documents i.e. Bill-cum-Receipt dated 27.02.2017 Ex.C-1, Bill-cum-Receipt dated 01.04.2017 Ex.C-2, Bill- cum-Receipt dated 03.04.2017 Ex.C-3, Bill-cum-Receipt dated 04.04.2017 Ex.C-4, Receipt dated 05.04.2017 Ex.C-5, In-Patient History and Physical Record Ex.C-6 (colly.), Passports and Air Tickets Ex.C-7 (colly.), Treatment Record Ex.C-8 (colly.), Bills Details Ex.C-9 (colly.), Certificate issued by Opposite Party No.2 dated 14.04.2017 Ex.C-10, Certificate issued by Opposite Party No.2 dated 17.05.2017 Ex.C-11, Post-operative Prescription Slips 05.05.2017 Ex.C-12 (colly), Consumer Complaint No.303 of 2018 17 Prescription slips Ex. C-13 (Colly) and MRI abdomen report dated 24.10.2018 Ex. C -14.
16. Opposite Parties No.1 to 3, in support of their defence, tendered affidavit of Mr. Abhijit Singh, Zonal Director of Fortis Hospital as Ex.OP-1/A, affidavit of Dr. R.P. Doley, Ex.OP-2/A, affidavit of Mr. Jatinder Katoch Ex.OP3/A, along with copies of documents i.e. Power of Attorney as Ex.OP-1/1, certificate issued by Joint Commission International Ex.OP-1/2, NABH Certificate of Accreditation Ex.OP-1/3, Bill dated 04.05.2017 Ex.OP-1/4, Curriculum Vitae of Dr. R.P. Doley Ex.OP-2/1, OPD prescription slip Ex.OP-2/2, Cashless Pre- Authorization Request Note Ex.OP-2/2A, Ultrasound report dated 04.01.2017 Ex.OP-2/2B, medical literatures titled as "Anatomy and Embryology of Umbilicus in newborns: a review and clinical correlations" Ex.OP-2/3, "Anterior Abdominal Wall" Ex.OP-2/4, Pre- Anaesthesia Check-up (PAC) record Ex.OP-2/4A, "Adult Umbilical Hernia Repair" Ex.OP-2/5, "A case of incarcerated umbilical hernia in an adult treated by laparoscopic surgery" Ex.OP-2/6, "Current options in umbilical hernia repair in adult patients" Ex.OP-2/7, "A review of available prosthetic material for abdominal wall repair" Ex.OP-2/8, "Sabistan Textbook of Surgery" Ex.OP-2/9, "Shackelford's Surgery of the Alimentary Tract" Ex.OP-2/10, "Hernia Surgery" Ex.OP-2/11, "Maingot's" Ex.OP-2/12, Guidelines for laparoscopic ventral hernia repair by Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Ex.OP-2/13, Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Consumer Complaint No.303 of 2018 18 Endohernia Society {IEHS}-Part-II Ex.OP-2/14, "Laparoscopic versus Open Repair of Para-Umbilical Hernia-A Prospective Comparative Study of Short Term Outcomes" Ex.OP-2/15, "Umbilical Hernia with Evisceration, two cases and a review of the literature" Ex.OP-2/16, "Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial Ex.OP-2/17, "Zollinger's Atlas of Surgical Operations" Ex.OP-2/18, "Baileys & Love's Short Practice of Surgery" Ex.OP-2/19, "Umbilical Hernia Repair: Overview of Approaches and Review of Literature" Ex.OP-2/20, "Laparoscopic treatment of an umbilical hernia using a new composite mesh" Ex.OP- 2/20A, "Long-term follow-up results on umbilical hernia repair" Ex.OP- 2/21, Daily Doctor's Progress Notes of Fortis Hospital Ex.OP-2/22 (colly.), "Laparoscopic Ventral and Incisional Hernia Repair in 407 patients" Ex.OP-2/23, "Postoperative Pain after Laparoscopic Repair of Primary Umbilical Hernia: Titanium Tacks versus Absorbable Tacks:
A Prospective Comparative Cohort Analysis of 80 Patients with a Long Term Follow up" Ex.OP-2/24, Daily Doctor's Progress Notes Ex.OP- 2/25 (colly.), "Maingot's: Small Bowel Obstruction" Ex.OP-2/26, "Defining Postoperative Ileus: Results of a Systematic Review and Global Survey" Ex.OP-2/27, "Defining Postoperative Ileus: Results of a Systematic Review and Global Survey" Ex.OP-2/28, "Postoperative Ileus following major colorectal surgery" Ex.OP-2/29, "Postoperative Ileus in colorectal surgery: is there any difference between laparoscopic and open surgery" Ex.OP-2/30, "Postoperative Ileus in the lower extremity Arthroplasty Patient" Ex.OP-2/31, "Definition, Consumer Complaint No.303 of 2018 19 incidence, Risk Factors, and Prevention of paralytic Ileus following Radical Cystectomy: A systematic Review" Ex.OP-2/32, "Management of Postoperative Ileus" Ex.OP-2/33, "Maingot's Abdominal Operations"
Ex.OP-2/34, "Postoperative Ileus: Etiologies and Interventions" Ex.OP-
2/35, X-ray Abdominal-Spine & Erect Ex.OP-2/36, Whole Abdomen CT (Contrast) Ex.OP-2/37, "Current Management of Small-Bowel Obstruction" Ex.OP-2/38, X-ray Abdomen-Spine and ERECT Ex.OP-
2/39, x-ray abdomen report Ex.OP-2/40, "Sabistan Textbook of Surgery" Ex.OP-2/41, "Non-operative management of adhesive small bowel obstruction: Should there be a time limit after which surgery is performed" Ex.OP-2/42, "Mesh-Related Early Small Bowel Obstruction Following Laparoscopic Incisional Hernia Repair Ex.OP-2/43, "Laparoscopic Treatment of Early Small Bowel Obstruction After Laparoscopic Ventral Hernia Repair" Ex.OP-2/44, "ParietexTM Composite mesh versus DynaMesh® IPOM for laparoscopic incisional and ventral hernia repair: a retrospective cohort study" Ex.OP-2/45, "Two cases about mesh adhesion to intra-abdominal cavity tissue after using mesh to repair an incisional hernia" Ex.OP-2/46, "A rare cause of intestinal obstruction: dual mesh migration into the small intestine following laparoscopic umbilical hernia repair" Ex.OP-2/47, "Intra Peritoneal Polyprophylene Mesh and Newer Meshes in Ventral Hernia Repair: What EBM Says?" Ex.OP-2/48, "Prevalence and Mechanisms of Small Intestinal Obstruction Following Laparoscopic Abdominal Surgery" Ex.OP-2/49, "Incisional hernia rate 3 years after midline laparotomy" Ex.OP-2/50, medical record qua "Evaluation and Care Consumer Complaint No.303 of 2018 20 Plan' Ex.OP-2/51, "Harrison's Principles of Internal Medicine" Ex.OP-
2/52, "Gastrointestinal and Liver Disease" Ex.OP-2/53, "Baileys & Love's Short Practice of Surgery" 27th Edition Ex.OP-2/54, "Maingot's Abdominal Operations 12th Edition" Ex.OP-2/55, "Adhesiolysis, Chapter 4.5 Operative Surgery of Colon, Rectum and Anus 6th Edition"
Ex.OP-2/56, Patient's after discharge OPD follow up record Ex.OP- 2/57 (colly.), "Consensus Guidelines for the Management of Postoperative Nausea and Vomiting' Ex.OP-2/58, Nasogastric tube aspirate record (after first surgery) Ex.OP-2/59, Discharge Summary Ex.OP-2/60, application dated 02.02.2018 Ex.OP-3/1 and envelopes Ex.OP-3/2 (colly.).
Contentions of the Parties
17. We have heard the Ld. counsel for the parties and perused the written arguments submitted on behalf of the parties as well as record.
18. The Ld. counsel for the complainant/patient vehemently argued on the lines of averments in the complaint as well as written arguments. The sum and substance of the written and oral arguments of the Ld. counsel for the complainant is that the MRI Abdomen report dated 24.10.2018 revealed that problem of umbilical hernia, for which Opposite Parties No.1 to 3 have treated the patient, still persisted and the consultant Doctor had advised the patient to undergo another surgery. Opposite Parties No.1 to 3 have deliberately concealed the radiological reports/slides/CDs from the patient and this Commission, to save their skin. The patient had applied for medical record, Opposite Parties No.1 to 3 did not supply copies of the radiological Consumer Complaint No.303 of 2018 21 reports/slides/CDs. Opposite Parties No.1 to 3 removed the mesh, which was put at the time of first surgery. The patient was repeatedly shifted to ICU/SICU and Opposite Parties No.1 to 3 have charged more than ₹10 lacs for the treatment, but still the problem persisted in spite of two earlier surgeries. The patient was promised that he would be discharged within two or three days but he had to stay in OP hospital for many days for treatment. The repeat surgery and the pain, which the patient suffered, resulted into his worsened condition subsequently. The mesh was never correctly inserted and the problem for which treatment was taken still subsisted. Thus, there is apparent deficiency in service and medical negligence on the part of Opposite Parties No.1 to 3.
19. The written arguments submitted on behalf of Opposite Parties No.1 to 3 are on the lines of pleadings in their reply. The sum and substance of the oral and written arguments is that the patient visited Opposite Party No.2 for the first time on 27.12.2016 with problems of swelling in the umbilical and epigastric region, which was increasing in size. He also gave history of smoking, occasional drinking and suffering from hypertension. After examining him, Opposite Party No.2 told that the surgery is only option, either open or laparoscopic. After discussing, all the pros and cons of both those procedures, it was decided to conduct Laparoscopic Ventral Hernioplasty, which is considered as gold standard treatment of minimally invasive technique. Although the surgery was advised in December, 2016, but the patient did not undergo pre-anesthesia check-up for a long time. Consumer Complaint No.303 of 2018 22 He underwent PAC only on 27.02.2017. It was reported that the patient had hypertension for the last 5 to 6 years. He used to smoke 5/6 cigarettes daily. Thereafter, various investigations were conducted and the patient took the date of his choice to undergo surgery as 07.04.2017, Laparoscopic Intra-peritoneal onlay mesh repair was performed after taking informed consent of the patient. After the surgery, necessary investigations were done and the vitals of the patient such as BP, pulse rate, respiratory rate, urine output etc. were within permissible range. The incident of vomiting and nausea on 09.04.2017 is considered normal after surgery, as per medical literature Ex. OP-2/8. The other issues arose after surgery were well monitored and managed by Opposite Party No.2 and hospital staff. Repeat x-ray was done on 11th post-operative day, which showed dilated loops of bowel and multiple air fluid levels. Hence, Opposite Party No.2 sought second opinion from his senior surgical colleagues, namely Dr. J.D. Wig, Former Professor and Head of Surgery at PGIMER, Chandigarh and Dr. Rajeev Kapur, Former Professor and Head, Christian Medical College, Ludhiana. A repeat radiological study in the form of abdominal x-ray revealed dilated bowel loops and multiple air fluid levels. At that stage, abdominal ultrasound study was done, which revealed dilated loops of bowel and no intra-abdominal collection. These facts are evident from X-rays Abdomen done on 18.04.2017 and 19.04.2017, Ex. OP-2/39. Accordingly, the patient was again subjected to an Exploratory Laparotomy on 19.04.2017 and mesh placed at the time of previous surgery, was removed, along with Consumer Complaint No.303 of 2018 23 absorbable tackers used to fix the mesh. His postoperative recovery was uneventful and he was discharged on 30.04.2017 in stable and satisfactory condition. Therefore, the treatment was provided to the patient, as per standard medical protocols and there is no medical negligence or deficiency in service on the part of Opposite Parties No.1 to 3. The complaint deserves to be dismissed. In support of his contentions, the Ld. counsel for Opposite Parties No.1 to 3 has placed reliance on various medical literatures produced in evidence and case law, reproduced in their reply.
Consideration of Contentions:
20. We have given our anxious thoughtful consideration to arguments of the learned counsel for the parties and perused the record, with their able assistance.
21. Before we deal with the case on merits, it would be appropriate to examine about competency of the surgeon Opposite Party No.2.
Opposite Party No.2 is M.B.B.S., M.S. (PGI), M. Ch (Surgical Gastroenterology) from PGI. He is a super specialist and is duly skilled at performing such complex surgical procedures. Even, there are no pleadings in the complaint about the incompetence of Opposite Party No.2. Opposite Party No.1-Hospital is also a tertiary care hospital, which has adequate modern infrastructure and latest equipments.
22. The patient was diagnosed with umbilical, supra umbilical and epigastric hernia, so, it would be appropriate to understand about the disease with reference to medical literature placed on record and possible complications and cure, before, we deliberate on the merits of Consumer Complaint No.303 of 2018 24 consumer complaint. The word 'hernia' is derived from the Latin word 'for rapture'. Hernia is defined as an abnormal protrusion of an organ or tissue through a defect in its surrounding walls. Although hernia can occur at various sites of the body, these defects most commonly involve the abdominal wall, particularly the inguinal region. Abdominal wall hernias occur only at sites where the aponeurosis and fascia are not covered by striated muscle (Chapter 44: "Hernias" at page 614 of the paper book). Umbilical Hernia is caused by weakening of fibrous of the connective tissue in the umbilical ring (A case of incarcerated umbilical hernia in an adult treated by Laparoscopic surgery: Ex.OP- 2/6 page 1741). A lump is observed around the umbilicus (Current options in umbilical hernia repair in adult patient: page 598 of the paper book). Herniation happens due to increased intra-abdominal pressure (Anatomy and embryology of Umbilicus in new borns: a review in clinical correlations: page 1695, Ex.OP-2/3). The contents of the Hernial sac may be preperitoneal fat tissue, omentum (covering over the abdominal content-intestine) and small intestine in majority. The neck of the hernia is usually narrow compared to the size of the herniated mass; hence strangulation (gangrene of the entrapped intestine) is common. Therefore, elective repair is always advised. Thus, waiting is not recommended for adults with umbilical hernia (Adult Umbilical Hernia Repair: page 1739, Ex.OP-2/5).
23. There are two methods of repairing hernias, one is Laparotomy (open approach) and the other is laparoscopic approach. Laparoscopic repair (along with mesh placement) is superior to open mesh repair Consumer Complaint No.303 of 2018 25 and has fewer operative and post-operative complications, like post- operative pain and reduces the chances of overall mortality and morbidity. In laparoscopic repair, contact between mesh and skin is very minimal and there are less chances of mesh infection and wound infection. Thus, laparoscopic repair is safe and effective procedure (Ex.OP-2/15 Laparoscopic Vs. Open Repair of Para umbilical hernia at page 1909 & 1911 of the paperbook). Not surprisingly with the advent of minimally invasive surgery, the use of laparoscopy for ventral hernia repair has become standard protocol. It has several benefits like avoidance of large incisions, substantially reduced wound complications, faster convalescence (recovery), fewer complications and low recurrence rate. Mesh hernia repair should be done as suture repair has a recurrence rate of 54.5%. Mesh repair is a gold standard repair for umbilical hernia's (Ex.OP-2/17: Mesh Vs. Suture repair of Umbilical Hernia in Adults: a randomised, double-blind, controlled, multicentre trial: at page 1917 of the paper book). French Authority published a study in 2008 showing that reinforcement with mesh, decreased recurrence rate (<1.5%) in comparison to repair without mesh wherein the recurrence rate could be 50% according to study (Ex.OP-2/8: A review of available prosthetic material for abdominal wall repair at page 1748 of the paper-book).
24. Now, we proceed to examine the issue of deficiency-in-service and medical negligence in the present case. The patient was presented on 27.12.2016 for the first time in the hospital and was examined by Opposite Party No. 2. The patient gave history that he Consumer Complaint No.303 of 2018 26 was a smoker, occasional drinker and suffering from hypertension. He complained of swelling in umbilical and epigastric region, which was increasing in size. Opposite party No. 2 diagnosed the patient to be suffering from umbilical and epigastric hernia. Opposite Party No. 2 explained to the patient that surgery is the only option and waiting is not advisable for adults with umbilical hernia. Thus, the patient came for an elective surgery pertaining to umbilical, supra umbilical and epigastric hernia, the history of which dates back to about four months. The treating doctor advised the patient surgical intervention (laparoscopic ventral hernia repair with mesh), wherein a mesh would be put to strengthen weakness in the abdominal wall. Prescription slip Ex. OP-2/2 is at page 1692. The fact that patient visited Opposite Party No 2 for the first time on 27.02.2017 is factually incorrect, in fact he visited Opposite Party No. 2 on 27.12.2016. The ultrasound report dated 04.01.2017 Ex.OP-2/2B at page 1694 proves the same. It is also an admitted fact that the patient had been delaying the pre- anaesthesia check-up (PAC). All this stands proved from the notes on the prescription slips. The anaesthetist noted that patient had a history of hypertension for 5/6 years and smoking 5/6 cigarettes per day. It was also noted that he used to consume alcohol as well. The investigations and clearances were advised, but patient delayed the same and reported for PAC review only on 01.04.2017. On getting reports of cardiac, pulmonary clearances and other lab investigations and tests, patient was admitted in the hospital. The patient after due consent and clearances underwent surgery on 07.04.2017 i.e. Consumer Complaint No.303 of 2018 27 standard laparoscopic ventral Hernia Repair (umbilical, supra umbilical and epigastric hernia repair) with the mesh (composite paritex mesh) inserted to reinforce the weak area. The informed consent and high- risk informed consent forms signed by the patient are at page 1520 to 1523. The medical record reveals that whole surgical procedure went smoothly, the umbilical defect was 2 cm x 2 cm and supa umbilical defect was 4 cm x 2 cm. The contents of hernia sac were reduced and a compatible paritex mesh was laid and fixed with interior wall of abdomen with tackers to reinforce the weak area. The operating notes are at page 1505-1507. He was started on full diet on 08.04.2017 (Post operative day-1) as noted on page 54 and 55. But on the next day, i.e. 09.04.2017 (page 60) the condition of the patient started worsening, the same was noted, as the patient had symptoms of vomiting and constipation. Further on 10.04.2017, multiple episodes of vomiting were reported and duly noted in the hospital records. It was diagnosed as persistent paralytic ileus. The general condition of the patient worsened with the blood pressure falling to 80/50 mm hg, but vitals noted as 'stable'. Alongside, it noted bowel sounds absent. Ryles tube was inserted not for feeding but for decompression to reduce the patient's discomfort. On 11.04.2017, at 12 P.M. (Page 68), the patient's vitals became even more unstable and he was put on inotropic support. Further, there was low urine output and probable acute kidney injury. The patient was shifted to ICU in v/o dehydration, shock, abdominal distention, hypokalaemia and paralytic ileus. The patient passed stool on 14.04.2017 and was shifted to the room again Consumer Complaint No.303 of 2018 28 15.04.2017. With bowel movements coming to normal, the patient started recuperating and recovering, a re-surgery discussion took place between the patient's relatives and the team of doctors. But as bowel sounds were absent again, the re-surgery was put on hold. As per page 122, re-surgery was discussed again due to "lack of improvement". On 19.04.2017, exploratory laparotomy with removal of mesh with adhesiolysis and small bowel decompression was performed. At page 169, "blood in urine" was noted on 27.04.2017 at 3.40 A.M. and 7.30 A.M. This was followed by fever and chills. Finally, he was discharged on 30.04.2017, as per Discharge Summary at page
48.
25. It is true that patient had persistently high nasogastric aspirate and was being managed for persistent postoperative ileus since third postoperative day. Opposite Party No 2 ascertained the cause of the problem with the help of various imaging studies. The imaging studies, subsequently done clearly show that treating doctor was aware of the problem and was diligently managing the patient (Ex.OP-2/36 & Ex.OP-2/37). A plain X-ray abdomen done on 12.04.2017 showed multiple air filled, dilated small bowel loops with multiple air fluid levels (Ex.OP-2/36). Whole abdomen contrast enhanced computed tomography (CECT) was done on 13.04.2017. It revealed that small bowel loops were dilated, maximum calibre of small intestine was 4.2 cm (Normally less than 3 cm). There was gradual change of calibre of the dilated bowel loops in the distal ileum with terminal ileum seen in collapsed state, no abrupt zone of transition was noted, no evidence of Consumer Complaint No.303 of 2018 29 small bowel ischemia, no small bowel faeces sign. Some common causes of postoperative obstruction and/or ileus such as intra- abdominal abscess are easily visualized on CT scan and this was not shown in this CT scan (Ex.OP-2/9, Ex.OP-2/36, Ex.OP-2/37, Ex.OP- 2/38). A repeat plain X-ray abdomen done on 18.04.2017 showed air filled dilated small bowel loops with multiple air fluid levels (Ex.OP- 2/39). A repeat plain X-ray abdomen done on 19.04.2017 again showed air filled dilated small bowel loops with multiple air fluid levels (Ex.OP-2/40). It is incorrect to say that abdominal computed tomography scan was done on 14.04.2017. Instead, it was done on 13.04.2017 (Ex.OP-2/37). Plain X-rays abdomen done on 18.04.2017 and 19.04.2017 revealed persistent air filled dilated small bowel loops with multiple air fluid levels (Ex.OP-2/39 & Ex.OP-2/40). Postoperative ileus was being managed as per standard protocol and waiting expectantly for resolution. Computed tomography scan revealed dilated small bowel loops with maximum diameter of 4.2 cm. At this juncture, the possibility of early postoperative bowel obstruction was suspected. Early postoperative bowel obstruction is also managed initially with resuscitation and investigation: The same was done in case of this patient for a period of 7-14 days, the patient remained stable, clinical and radiological improvement occurred. Surgical intervention is only considered, if there is no improvement (Ex.OP- 2/41: Sabiston Textbook of Surgery 20th Edition page No. 2153-2158). Persistence of high nasogastric tube aspirate, persistence of dilated bowel loops with air fluid levels on abdominal X-Rays and CT Scan Consumer Complaint No.303 of 2018 30 findings of dilated proximal bowel loops and collapsed distal ileal loops were the factors for subsequent surgical intervention. Early small bowel obstruction after laparoscopic ventral hernia repair is well reported. High index of suspicion and early re-exploration is important. Adhesion of small bowel to the mesh contributes to the obstruction. The adhesions were released and small bowel freed. High index of suspicion of a serious problem is a safe approach when a patient presents with early abdominal symptoms following laparoscopic surgery. Obstruction, intestinal injury and infectious complications are reported in the literature and require careful management approach (Ex.OP-2/44). Post-operative adhesive intestinal obstruction was considered in view of persistently high nasogastric aspirate and non- passage of flatus or bowel movement, in spite of conservative management for more than 10 days and a decision to re-explore was taken. The patient had not shown any improvement despite a fair trial of non-operative management for a period of nearly 12 days. The possibility of ileus was considered by Dr. Doley on third post-operative day. Post-operative ileus is one of the most common problems after abdominal surgery (Ex.OP-2/26, Ex.OP-2/28 to Ex.OP-2/35). Appropriate treatment included nothing by mouth, nasogastric tube insertion, correction of electrolyte imbalance and intravenous fluid along with Total Parenteral Nutrition (TPN). This is a standard treatment protocol to deal with such sort of situation occurring in the early post-operative period (Ex.OP-2/11 & Ex.OP-2/41). Early, postoperative mechanical bowel obstruction usually occurs within first Consumer Complaint No.303 of 2018 31 6 weeks after operation. Most are partial and can be expected to resolve spontaneously. Sometimes, it tends to respond and behave differently from classical mechanical bowel obstruction and is very difficult to distinguish from postoperative ileus. Patients, who first have postoperative ileus, can advance to bowel obstruction over a time and are more likely to require surgical intervention (Ex.OP-2/53: Harrisons Principles of Internal Medicine, Gastrointestinal & Liver Disease Chapter 123 page No. 2218 - 2237 of the paperbook). It is reported that in patients with early postoperative obstruction, the opportunity to temporarily stabilize the patient and delay surgery a while longer into the postoperative period may be an advantage. Caution may be taken, however, because several series have reported an especially high rate of missed strangulation in patient with early postoperative obstruction (Ex.OP-2/38:Advances in Surgery Page No. 2116-2150 of the paperbook).
26. The wisdom of the treating doctor is to prevail for treatment options. The patient was on conservative treatment for 12 days and that is a recommended protocol. Patients with adhesive intestinal obstruction can at times be dehydrated, which requires fluid resuscitation and monitoring which was done in the case of the index patient. In this regard, the Opposite Parties have relied upon medical literature, which is Ex.OP-2/52 to Ex.OP-2/55.
27. Opposite Party No. 2, even sought opinions from Prof. J D Wig, former Professor and Head of the Department of General Surgery at Postgraduate Institute of Medical Education and Research (PGIMER), Consumer Complaint No.303 of 2018 32 Chandigarh as well as Prof. Rajeev Kapoor, former Head of the Department of Surgery at Christian Medical College and Hospital (CMC), Ludhiana. Both of them concurred with Dr. Doley that patient was not showing resolution of post-operative ileus despite effective non operative treatment. A conscious decision was taken to re-explore the patient. Thus, taking assistance from senior colleagues demonstrates that all efforts were made by Dr. Doley for the benefit of the patient, which is duly supported by medical literature Ex.OP-2/56:
page 2267-2269.
28. The allegations levelled by the patient of damage to the intestine and the soft tissue do not corroborate the intra-operative findings in second surgery. There was no injury to the bowel nor to the soft tissues of the abdomen. The intestine was not sutured to the mesh. In the operation for repair of umbilical hernia, the mesh is fixed to the anterior abdominal wall with tackers. Precaution is taken to cover the abdominal viscera (intestine) with omentum to prevent adhesion to the mesh. In this case, mesh repair had been performed and mesh was completely secured to the anterior abdominal wall with tackers along with trans fascial fixation sutures during the surgery. Usage of composite mesh is now mesh of choice in laparoscopic ventral hernia repair by IPOM technique. Suture repair has high recurrence rate (Ex.OP-2/42 to Ex.OP-2/47). Adhesion after laparoscopic ventral hernia repair is a common phenomenon, the result of trauma after surgery, and a reaction to the mesh and/or fixation devices. No technique or device completely prevents the formation of adhesions Consumer Complaint No.303 of 2018 33 (Ex.OP-2/14: Guidelines for Laparoscopic Treatment of Ventral & Incisional abdominal wall hernia Page No. 1883-1908).
29. We are of the view that due diligence was used by Opposite Party No 2, in dealing with the situation, as is evident from rapid recovery of the patient after the second surgery. All the standard protocols were followed in the management of the complainant. Imaging findings and intraoperative findings of second surgery do not corroborate with the allegations levelled by the complainant. Rapid recovery following second surgery further accentuates that there was no damage to the underlying tissues including the intestine. The patient failed to substantiate from medical record that Opposite Party No.2 had accidently sutured the mesh with the underlying tissues of the small bowel resulting in immense pain and loss of health of the complainant/patient.
30. It is the stand of the complainant that diagnosed surgery of hernia was never done, for which he was admitted to the hospital. The same problem still remained and is proved from Ex.C-14, MRI Abdomen report dated 24.10.2018 at page 2321. We have examined the record and also perused the medical literature. The recurrence rate following suture repair alone is 43% as compared to 24% following suture repair with mesh re-enforcement. In order to support this, the Opposite parties are relying upon following articles from medical literature, the extract of which is reproduced as under : Consumer Complaint No.303 of 2018 34
"Article by Harlaar J. J. Development of incisional herniation after midline laparotomy. British Journal of Surgery. 2017; 1:18-23:
Despite many decades of research there is little information about the aetiology of incisional hernia formation. Several hypotheses have been proposed to explain the development of these hernias. Surgical technique seems important, and two clinical trials have suggested that an increased distance between the rectus abdominis muscles (RAM distance) 1month after surgery predicts later incisional hernia formation. A recent RCT demonstrated that a running suture technique with small tissue bites resulted in a reduced incidence of incisional hernia compared with that after use of a running suture technique with large tissue bites. In that study, small tissue bites were defined as placement of a suture every 5mm from the wound edge at 5-mm intervals, based on preclinical studies that suggested small bites induced wound healing, collagen type l formation and higher bursting strength. The question of whether incisional herniation is an early complication, and how the small-bites technique may reduce its formation, is still unanswered.
The aim of the present study was to determine whether the RAM distance 1month after surgery could predict incisional hernia formation, and whether this distance was related to the small-bites technique.
Discussion : This study has confirmed that incisional hernia develops as an early complication after abdominal surgery. Compared with large bites, the small-bites suture technique resulted in a smaller RAM distance, which was associated with a lower incidence of incisional hernia. This finding confirms the hypothesis that the small-bites suture technique would result in less separation of the fascial edges. A linear correlation was found between an enlarged RAM distance at 1month and the likelihood of incisional herniation being present at 1 year of 14 per cent per centimetre of widening. In the present study, a RAM distance above 20mm appeared to be the cut-off point, although earlier studies suggested that 12-mm and 15-mm separation of the fascial edges or RAM distance represents cut-off points for risk of incisional hernia formation. These differences may be caused by differences in methodology of radiological examination, although it has been shown that a RAM distance of 20mm at the level of the umbilicus is normal in an unoperated population.Consumer Complaint No.303 of 2018 35
Lassandro F, et al. Abdominal hernias: Radiological features World Journal of Gastrointestinal Endoscopy. 2011, 3:110- 111 INCISIONAL HERNIAS:
Incisional hernia is one of the most common complications of abdominal surgery at sites of a previous laparotomy, with a reported occurrence rate of up to 20% after laparotomy but may be as high as 41% after aortic surgery. Most incisional hernias develop during the first months after surgery, a critical period for the healing of transacted muscular and fibrous layers of the abdominal wall; however, 5%-10% may remain clinically silent for up to 5 years until detection.
The above medical literature proves that in abdominal surgery cases, recurrence rate of hernia following suture repair alone is 43% as compared to 24% following suture repair with mesh re-enforcement.
The same can reoccur immediately post-surgery and upto 10 years.
Hence, in the instant case, possibility of reoccurrence after more than 1 year and their visibility in MRI abdomen report dated 24.10.2018, after the previous surgery, cannot be ruled out. The contention of the complainant, that during previous surgery needful treatment was not given, is meritless. Hence, rejected.
31. In the present case, the observations of Lord Denning in Roe's case [(1954) 2 QB 66)] to the following effect are very relevant:
"It is so easy to be wise after the event and to condemn as negligence that which was only a misadventure. We ought always to be on our guard Consumer Complaint No.303 of 2018 36 against it, especially in cases against hospitals and doctors. Medical science has conferred great benefits on mankind, but these benefits are attended by considerable risk. Every surgical operation is attended by risk. We cannot take the benefit without taking the risk. Every advance in technique is also attended by risk. Doctors, like the rest of us, have to learn by experience; and experience often teaches in a hard way. Something goes wrong and shows up a weakness, and then it is put right. That is just what happens here. The doctor did not know that there could be undetectable cracks in ampoules, but it was not negligent for him not to know it at that time- We must not look at the 1947 accident with 1954 spectacles."
Lord Denning M.R. pointed out in Hucks V. Cole.
(1968 (118) New Law Journal 469) as follows:
"A charge of professional negligence against a medical man was serious. It stood on a different footing to a charge of negligence against the driver of a motor car. The consequences were far more serious. It affected his professional status and reputation. The burden of proof was correspondingly greater. As the charge was so grave, so should the proof be clear. With the best skill in the world, things sometimes went amiss in surgical operations or medical treatment. A doctor was not to be held negligent simply because something went wrong. He was not liable for mischance or misadventure or for an error of judgment. He was not liable for taking one choice out of two or for favouring one school rather than another. He was not liable when he fell below the Consumer Complaint No.303 of 2018 37 standard of a reasonably competent practitioner in his field so much so that his conduct might be deserving of censure or inexcusable."
32. In view of the above discussion and the evidence on record, preponderance of probability and inferences, we hold that the complainant/patient is unable to prove his case of deficiency in service and medical negligence against Opposite Party No. 2. It is true that medical negligence cases do sometimes involve questions of factual complexity and difficulty and may require the evaluation of technical and conflicting evidence. However, in the present case, the complainant has failed to discharge the onus of proving on a balance of probabilities, the medical negligence and deficiency in service averred against Opposite Party No.2. It is crystal clear that the surgical approach followed in the complainant's disease of Laparoscopic Ventral Hernioplasty with reinforcement of the anterior wall with Mesh is a correct scientific approach associated with advantages over any other method. Thus, an appropriate course was followed in the complainant's case by Opposite Party No.2-Dr. R. P. Doley. Thus, there is no medical negligence on the part of the Opposite Party No. 2 so for the surgeries are concerned.
33. Now coming to the other contentions, such as information and charges for treatment specifically of subsequent surgery and stay in hospital, our findings are as under:
a) Lack of adequate information: On page 413: a sum total of expected costs for the first surgery noted is approximately Consumer Complaint No.303 of 2018 38 ₹2.1 Lac, but a similar document is not on the record w.r.t to the 2nd surgery. While in the first surgery, the relatives were provided with adequate information regarding the costs of the treatment, but such information was not provided before the second procedure. This kept the patient in the dark about the prospective costs of treatment, thereby limiting their option of shifting the patient based on economic wherewithal (page 426- billing activity for exploratory laparotomy). Though the consent was taken on page 364. But it can be stated that the consent for the second surgery does not qualify the ingredients of 'Informed consent'. With proper information regarding the cost of the re-surgery and subsequent care, the patient's family could have taken better decisions. It is nowhere said that the cost of treatment should not be charged. But it must be duly informed to the patient/relatives in a more transparent manner. This non-supply of information is not medical negligence. For this, some liability can be fastened on the Hospital, not on the surgeon. Instead of acting more fairly and transparently, the hospital kept the patient's relative in the dark about the hospital charges for the second surgery. The hospital caused mental and financial distress for the family. The total bill of the patient swelled to the tune of ₹8,83,000/-. Out of this a sum of ₹6,80,000/- was paid by ICICI Lombard General Insurance Company and remaining sum of ₹2,03,000/- had to be paid by complainant. Consumer Complaint No.303 of 2018 39
The bill is Ex.OP-1/4 at page No. 1656 of the paperbook. The complainant was not explained about total expenses for the second surgery. Since the patient was provided inadequate information to take proper and informed decisions, there have been lapses on part of the hospital. Hence to that extent hospital is deficient in service and it also indulged in unfair trade practice. Such act of the hospital amount to unfair commercial practice of the corporate sector hospital.
b) Iatrogenic injury: There was no injury of iatrogenic in nature.
c) Lastly, complainant has claimed that post surgery, he was not able to do his professional practice efficiently. No proof supporting this allegation has been annexed with the complaint. Moreover, during the pendency of the complaint, original complainant had died and now legal representatives are contesting.
34. Since we have come to the conclusion that there is no deficiency in service and medical negligence on the part of opposite party No.2, so the complaint against him is liable to be dismissed. However, we find that there was some deficiency in service on the part of opposite parties No.1-Hospital with regard to giving the complete information about the charges of package amount.
35. So far as performa party No.4- Nidhi Dixit, is concerned, she is daughter of deceased complainant Satish Bhardwaj and has been arrayed as performa party. She, being the legal heir of deceased Consumer Complaint No.303 of 2018 40 complainant, is entitled to the proportionate share of the compensation to be awarded in this case.
36. In view of the above discussion and the evidence on record, preponderance of probability and inferences, we hold that the complainant/patient is able to prove his case of deficiency in service against Opposite Parties No.1 & 3 to the extent of non-supply of details of expenses for the second surgery. Therefore, we deem it appropriate that a lump sum compensation of ₹3,00,000/- be awarded for this lapse on the part of Opposite Parties No.1 & 3, along with interest at the rate of 9% per annum from the date of filing of the complaint till realization.
37. In view of our above discussion, the complaint is partly allowed against Opposite Parties No.1 & 3 and the same is dismissed against Opposite Party No.2. Following directions are issued to Opposite Parties No.1 & 3:
i) to pay a lump sum compensation of ₹3,00,000/- (Rupees Three Lac only), along with interest at the rate of 9% per annum from the date of filing of the complaint till realization, for the deficiency in service on their part, with regard to giving the complete information about the charges of package amount, due to which the complainant had suffered mental agony and harassment and financial loss; and
ii) to pay ₹11,000/- (Rupees Eleven Thousand only) as litigation costs and other expenses.Consumer Complaint No.303 of 2018 41
iii) It is made clear that the awarded amount shall be paid to all the legal heirs of deceased complainant Satish Bhardwaj, including performa party No.4- Nidhi Dixit, who is his daughter.
38. The compliance of this order shall be made by Opposite Parties No.1 & 3 within a period of 30 days of the receipt of certified copy of the order.
39. The complaint could not be decided within the stipulated timeframe due to heavy pendency of Court Cases and the pandemic of COVID-19.
(JUSTICE PARAMJEET SINGH DHALIWAL) PRESIDENT (RAJINDER KUMAR GOYAL) MEMBER (MRS. KIRAN SIBAL) MEMBER May 18, 2021.
(Gurmeet S)