Sri Kamal De, President
This case orbits over alleged medical negligence on the part of the OPs.
Facts of the Complainant’s case lie in moderate compass as under:-
Complainant’s wife, Mrs. Rupali Maity, gave birth to a child at the OP No. 1 Nursing Home through caesarian operation on 24-03-2014. Allegedly, the patient was released from the said Nursing Home on 30-03-2014 though she did not come round properly. It is also alleged that while performing such Caesarian Section, because of gross negligence of the concerned doctor, an abdominal wound developed for which, the patient had to be admitted to CMRI Hospital, Kolkata on 19-04-2014. After doing corrective treatment, the patient was released from there on 29-04-2014. It is the case of the Complainant that due to gross negligence of the OPs, he had to incur huge expenditure to cure his wife, not to speak about the resultant physical pain, mental stress and agony of the family members as well as his wife. Hence, this case.
On merits the OP No.1 has come up with the following version/pleas:
- That, after observing the complications and general condition of the patient, the OP No. 2 decided to perform Caesarean section for the delivery of the child. The OP No. 1 arranged for the best possible measures for such operation and primy L.U.C.S. was done with due care and caution on 24-03-2014 following internationally accepted medical rules and ethics.
- That, the operation as well as whole treatment of the patient, during her stay at the Nursing Home, was uneventful and the patient, after delivering a healthy baby gradually recovered in due course of time. So, she was discharged on specific advice of the OP No. 2 on 30-03-2014.
- That, the patient came to the Nursing Home again on 09-04-2014 and 13-04-2014 and routine checkup was done by the OP No. 2.
- That, till 13-04-2014, there was no sign of any wound or infection in the body of the patient which could be seen from the USG report dated 07-04-2014.
- That, subsequently, this OP came to know from the record that the patient developed wound infection at the stitching part for which she was taken to a private hospital in Kolkata, where only secondary suture was done.
- That, wound infection or formation of PUS etc. are very common complications in case of patients who undergo operation because of their life style, laxity on their part to take due care and caution at home and it is not at all fatal or serious.
- That, the Complainant did not bother to consult either of the OPs and choose a private hospital in Kolkata for management of his wife’s wound infection out of his own volition.
- That, for such minor and common complications which did not occur due to any sort of negligence/deficiency in service on the part of the OPs, there was no necessity to go to a luxury hospital in Kolkata and instead, the Complainant could have even got it treated at local Govt. hospitals.
- That, the Complainant has not made any specific complaint of medical negligence or deficiency in rendering services against this OP. Accordingly, this OP prayed for dismissal of the case.
OP No. 2 also contested the case by filing WV stating inter alia that he performed caesarean section upon the patient following internationally accepted medical rules and ethics. The operation and whole treatment of the patient at the OP No. 1 Nursing Home was uneventful and the patient gave birth to a healthy baby and herself recovered in due course of time gradually and so the patient was duly discharged on 30-03-2014. The patient visited him again on 09-04-2014 for routine checkup along with the USG report done on 07-04-2014, wherefrom it was evident that there was no infection in the body and only bulky uterus was there without any other complication. It is also stated that the patient visited this OP again on 13-04-2014 for further checkup and this time also no complication could be found and her scar was found to be healthy. Thus, it is contended by this OP that, as long as the patient was under his care, there was no complication in her vital bodily signs. Subsequently, he learnt from the record of this case that the patient developed wound infection at the stitching part for which she was taken to a private hospital in Kolkata, where only secondary suture was done. Like the OP No. 1, this OP has also contended that wound infection and formation of PUS are very common hazards being suffered by patients who undergo operation, depending on their life style, care and caution taken at home etc. and the same is not at all mortal or serious. This OP wondered, why the Complainant did not consult either of the OPs after 13-04-2014. The rationality of rushing the patient to a highly expensive private hospital instead of any local Nursing Home or Government hospital for such minor and common complications has been questioned by this OP. It is further stated by this OP that, save and except some vague and evasive averments, without any documentary support or evidence, the Complainant has not made any specific averment or allegation of any sort of medical negligence or deficiency in rendering service against him and as such, according to him, it is a fit case for summary dismissal.
Since the bone of contention of this case surrounds over the solitary point of alleged medical negligence on the part of the OPs, let us see, whether OPs are indeed guilty of any sort of negligence or not.
Decision with reasons
Be it mentioned here that the matter was initially referred to the CMOH, Purba Medinipur and thereafter, to the SSKM Hospital, Kolkata for expert opinion and both of them submitted necessary reports for our evaluation. For better illustration, the relevant portions of both the reports are appended below.
- CMOH, Purba Medinipur Report dated 08-01-2015
“The stitchline infection is one of the common complication following LUCS and it is not possible to opine about the time of infection and whether the patient had followed all advices of Dr. K. C. Mondal.
So, Dr. K. C. Mondal can not be held responsible for one of the common complications following L.U.C.S. and no definite medical negligence can be found on the basis of the statement of owner of Bimala Nursing Home and Dr. K. C. Mondal and documents of treatment of Smt. Rupali Maity”.
- IPGME&R-SSKM Hospital, Kolkata Report dated 10-09-2015
“Apparently it is a case of Post-operative wound infection and may be associated with Rectus sheath hematoma.
Post-operative wound infection is a not very uncommon complication following various forms of Surgery including Cesarean section. Various predisposing and other causative factors have been described. It may be the result of various factors not related to action of the Doctor or the quality of the Nursing Home. Even in United States the incidence has been found to be 1 – 9% and 14-16% in two different multicentric studies. Though poor surgical practice and improper aseptic measures in the hospital may be held responsible in some cases, in many other cases the causes are beyond the control of the surgical team or the Operation area set up.
The patient definitely suffered a lot, both physically and mentally and had to bear a heavy financial burden. She deserves full sympathy and support.
But, from the available documents, it cannot be concluded with certainty that her sufferings were due to professional negligence of the concerned Doctor or Nursing Home, in absence of conclusive evidence.”
As we find, it was a case of post-operative wound infection and may be associated with Rectus Sheath Hematoma. OPs have sought to make light of the situation stating that post-operative wound infection is a common phenomena. They also asserted that, it could have been easily managed by them, had the patient party reposed due faith in them. They also banked upon the report of the enquiry committee constituted by the CMOH, Purba Medinipur to shrug off any kind of medical negligence towards the patient, i.e., wife of the Complainant.
True, post-operative wound infection, following various forms of surgeries, including Cesarean Section, is not a very uncommon complication. However, at the same time, it is also true that such unwarranted developments is preventable to a great extent provided due care and caution is taken beforehand, what we can say specifically post-operative management.
The question is whether OPs took proper post-operative management of the patient?
With a view to educate ourselves about Surgical Site Infection (SSI) in case of Caesarean Section, apart from referring the articles forwarded by the Medical Superintendent-cum-Vice Principal, IPGMER-SSKM Hospital, Kolkata, we have also widely travelled through the guidelines for Prevention of Surgical Site Infection, 1999 and some relevant articles like, ‘Incidence & Predictors of Surgical Site Infection: A study at a Territory Care Hospital’ by ManishaDhamecha, Assistant Professor, Department of Microbiology, GCS Medical College Hospital & Research Centre, Gujarat&Ors.[GCSMC J Med Sci, Vol. III, No. (II) July-December 2014; ‘Caesarean section surgical site infection Surveillance’ by A. Johnson &Ors., The Queen Mother’s Hospital, Glasgow, UK, article in Journal of Hospital Infection-October, 2006; ‘Wound Infection in Gynecology Surgery’ by Aparna A. Kamat, MD.&Ors., Department of Obstetrics and Gynecology, West Virginia University Hospital; ‘Postoperative Complications after Gynecologic Surgery’ by Elisabeth A. Erekson, MD, Yale University, Section of Urogynecology, New Haven &Ors., published by National Institute of Health in October, 2011; ‘Reducing Surgical Site Infection’ by David E. Reichman, MD, Dept. of Obstetrics and Gynecology, Brigham and Women’s Hospital &Anr., [Reviews In Obstetrics & Gynecology, Vol. 2, No. 4, 2009]; ‘Infectious Morbidity after Cesarean Delivery: 10 Strategies to reduce risk’ by Kelley Conroy, MD, Dept. of Obstetrics and Gynecology, Tufts Medical Centre, Boston &Ors. [Reviews in Obstetrics & Gynecology, Vol. 5, No. 2, 2012].
Some of the salient features of SSI, as emerge from the afore-mentioned articles, are appended below:-
* That, post-operative wound infection is not a very uncommon complication following various forms of surgery, including Cesarean section. Surgical site infections (SSIs) are associated with substantial morbidity and mortality, prolonged hospital stay, and increased cost. The accurate identification of risk factors is essential to develop strategies to prevent these infections.
* That, the infection rate after cesarean delivery has been reported to be 4-15% although recent Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) data showed an infection rate of 2-4%.
* That, early identification of potential risk factors is of paramount importance to mitigate the increased risk. Certain issues, like obesity, are risks that are highly unlikely to be modifiable in the patient. Other issues such as colonization of the vagina or cervix by pathogenic bacteria can be detected and very effectively treated by administration of antibiotics.
* That, prevention of surgical site infections encompasses meticulous operative technique, surgeon-controlled factors such as sterile technique, blood loss and the operative time, excess vaginal manipulation, prolonged labour, premature rupture of membranes, manual extraction of the placenta, premature birth, timely administration of appropriate preoperative antibiotics, and a variety of preventive measures aimed at neutralizing the threat of bacterial, viral, and fungal contamination posed by operative staff, the operating room environment, and the patient’s endogenous skin flora, systematic illness like poor hygiene, obesity, HIV, severe anemia, gestational diabetes.
* That, generally C-section infection occurs due to entry of notorious bacteria from the surgical site.
* That common signs present in C-section are: pain or redness at the site, swelling at the site of incision or pain and swelling in legs, fever that rises to or above 100.4°F, any kind of discharge or drainage from the wound, advancing abdominal pain and discomfort, urinary problems such as burning, pain, difficulty in using the loo, foul smelling vaginal discharge, expulsion of clots from the vagina, sepsis or septicemia-a condition where the infection invades the blood circulation.
* The beneficial effect of antibiotic prophylaxis in reducing occurrences of infection associated with elective or emergency cesarean section is well established. Antibiotic prophylaxis is recommended for all operations involving entry into a hollow organ. The antibiotic should be administered pre-operatively, ideally within 30 min. of the induction of anesthesia. An adequate concentration of anti-biotic within the serum and tissues will reduce the risk of resident bacteria overcoming the immune system during the immediate postoperative period. Single dose antibiotic prophylaxis is recommended for Caesarean section following surgery clamping of the umbilical cord.
* That, antimicrobial prophylaxis plays an important role in reducing the rate of SSIs, other factors such as attention to basic infection-control strategies, surgeon’s experience and technique, the duration of the procedure, hospital and operating room environments, instrument sterilization issues, preoperative preparation (e.g., surgical scrub, skin antisepsis, appropriate hair removal), preoperative management (temperature and glycemic control), and the underlying medical condition of the patient may have a strong impact on SSI rates.
* That, preoperative screening for S. aureus carriage and decolonization strategies has been explored as means to reduce the rate of SSIs. Anterior nasal swab cultures are most commonly used for preoperative surveillance, but screening additional sites (pharynx, groin, wounds, rectum) can increase detection rates. Such preoperative surveillance swabs that can be cultured on selective or nonselective media or sent for rapid polymerase chain reaction (PCR)-based screening can be used to identify colonized patients in the preoperative period. When properly used, all of these techniques can identify MSSA and MRSA.
* Univariate analysis shows that the appropriate use of antibiotic prophylaxis is a protective factor for the occurrence of SSI, reducing the risk by 54% for any type of SSI.
* That, optimal management of surgical wounds is an important part of post-operative recovery and health care professionals should monitor the process of acute wound healing, prevent wound complications and treat appropriately if complications arise. The key elements of post-operative wound management include timely review of the wound, appropriate cleansing and dressing, and early recognition and intervention of wound complications.
* That appropriate treatment of established SSIs requires careful monitoring and communication between the multidisciplinary postoperative team (surgeons, intensivists, microbiologists, nurses) and the primary care team. If patients are to be returned home early then any SSI needs to be recognised and treated appropriately. Release of pus, debridement and parenteral antibiotics, if indicated, usually requires a return to secondary care. Extensive wound breakdown may need specialist wound management to reduce bacterial burden in the open wound. Wound bed preparation may be required to encourage healing by secondary intention or facilitate secondary suture.
* That, several cases of wound infection are diagnosed after discharge from the hospital. Careful and stringent follow-up of patients with specific instructions, on wound checks is needed if adverse infectious outcomes are to be addressed in a timely fashion.
* That, incidence of wound infection varies with the type of procedure, the premorbid condition of the patient, and the presence of various other risk factors. In old, malnourished, or immunocompromised patients, the rates of wound infection are higher. Finally, surgeon-controlled factors such as sterile technique, blood loss and the operative time, and use of prophylactic antibiotics are important determinants of wound infection rates.
* That, if wound infection is suspected, active management should be considered. In the first instance, wound swabs for culture and sensitivity should be taken. Next, empirical antibiotic therapy can be commenced on the basis of the suspected pathogen. Antibiotic therapy should be subsequently tailored once the offending pathogen and its sensitivity have been identified. Debridement of non-viable and infected tissue is another effective method of treating and preventing further extension. Wounds with equivocal signs do not require immediate antibiotic therapy but should be closely and regularly monitored for any progression of signs.
Let us now turn to the factual aspects involved in the case.
From the documents on record, it appears that Smt. Rupali Maity, 20 years, was admitted at Bimala Nursing Home, Panskura, Purba Medinipur (OP No. 1) on 24-03-2014 in a case of Primi, Post dated, with dribbling and irregular FHS and the patient was in labour at that time. She gave birth to a child on that day by L.U.C.S. The patient was discharged from there on 30-03-2014.
A discharge certificate was issued to the patient. However, a glance through the same simply caught us by surprise - it is not signed by either the OP No. 2 or any other treating doctor; it does not contain brief history of the patient’s case, (discharge summary) designation of the person, who wrote the same. All this is not ascertainable. Although some routine medicines, like Monocef, Aciloc, metrogyl, SN 15 were prescribed, we are perplexed to find that review advice was not given to the patient. Bluntly speaking, it was unlikely of a discharge certificate. It is an instance of negligence. We think that the patient is not properly advised what to do and what not at the time of discharge.
From the materials on record, it transpires that the patient consulted Dr. Apurba Mondal, (Gynae and Obst.) on 06-04-2014 at Satyam Shivam Nursing Home & Diagnostic Centre, Lowada, Paschim Medinipur, where she was diagnosed with abdominal wound following L.U.C.S. Dr. Mondal observed induration below umbilicus along with and around the abdominal wound with bloody discharge from the wound. The said doctor advised USG and other investigations.
We find that, the patient, subsequently, got admitted at Balaji Nursing Home, Tamluk Railway Station, Purba Medinipur under Dr. Sudip Gole, M.D. (Gynae) on 17-04-2014. The USG report dated 18-04-2014 of Sree Aurobindo X-Ray Clinic shows diffuse cellulitis at lower abdominal post-CS scar with large subcutaneous inflammatory collection involving the rectus sheath extending intra peritoneally with small pocket of collection at periuterine region along with moderate pyometra, POD collection and right sided Oophoritis. On 19-04-2014, the patient was referred to any Medical College for better treatment by the said Nursing Home.
OP No. 2 has stated that the patient came to him at the Nursing Home on 09-04-2014 for routine check-up along with USG report done on 07-04-2014. It is further stated that the patient again visited him for further check up on 13-04-2014. However, he did not notice any complication on both occasions.
It is worth mentioning here that, no prescription of dated 13-04-2014 is placed before us and so far as the other prescription is concerned, i.e., prescription dated 09-04-2014 - it is quite difficult to ascertain whether it was at all written by the OP No. 2. On a comparison of the signature and hand-written notes in the Indoor treatment sheets dated 24-30/04/2014 vis-à-vis prescription dated 09-04-2014, we find no parity in between the same. The handwriting and signature appearing in so called prescription dtd. 09-04-2014 differ from the handwriting and signature appearing in Indoor Treatment Sheet of the patient dtd. 24-04-2014 to 30-04-2014.
There is no tangible evidence on record to show either that the OP No. 2 advised routine check-up to the patient after her discharge from the OP No. 1 Nursing Home or that he wrote the discharge certificate himself or that it was written as per his instruction, or he himself or personally examined the patient on 09-04-2014.
Be that as it may, it is curious to note that on 06-04-2014, the patient was treated by Dr. Apurba Mondal at Satyam Shivam Nursing Home & Diagnostic Centre, Lowada, Paschim Medinipur with complain of blood stained discharge from the stitch line. From the prescription of Dr. Mondal it appears that there was induration below umbilicus along with and around the abdominal wound with bloody discharge from the wound. He also found foul smelling discharge from the stitch line and diagnosis of Rectus sheath hematoma was made and so, USG and hematological investigation was advised.
Further, it transpires from the referral note dated 19-04-2014 of Balaji Nursing Home, where the patient got admitted on 17-04-2014 that, she (the patient) developed Pyometra with collection at periuterine region.
Against this backdrop, we are totally at a loss, while other doctors detected several complications, e.g, infection, foul smell at the surgical site, how the same escaped the attention of the OP No. 2, when the patient reportedly met him on 09-04-2014 and 13-04-2014. To our utter surprise, the patient in the so called prescription dtd. 09-04-2014 was simply advised some medicines by the OP No. 2 and neither any clinical/pathological test was suggested, nor the patient was asked to re-visit the doctor for further check-ups – a clear pointer of the casual approach toward the patient by the OP No. 2, when it appears from the prescription dtd. 06-04-2014 of another Doctor, Dr. Apurba Mondal, that the patient had infection, foul smell at the surgical stich line.
According to leading medical journals, postpartum infectious complications are common after cesarean delivery. Endometritis (infection of the uterine lining) is usually identified by fever, malaise, tachycardia, abdominal pain, uterine tenderness, and sometimes abnormal or foul smelling lochia. In the instant case, we find – be it because of the casual attitude of the OP No. 2 or due to his poor diagnostic skill - he failed and/or neglected to properly evaluate the gravity of the situation and take appropriate steps to remedy the situation. As noted above, USG done on 18-04-2014, showed diffuse cellulitis at lower abdominal post-CS scar mark with large subcutaneous inflammatory collection involving the rectus sheath extending intraperitoneally with small pocket of collection at periuterine region along with moderate pyometra, POD collection and right sided oophoritis. It is hardly believable that the condition of the patient turned so serious within a span of just 4 days. We feel, had the OP No. 2 been little vigilant, he could have easily detected the poor condition of the stitch line and taken remedial steps to mitigate the sufferings of the patient to a great extent and thereby, saved the Complainant from the ignominy of spending his hard-earned money towards treatment of his wife.
Surveillance of post-operative infections is a vital step as it provides an insight into the magnitude of problem and thereby, helps the treating doctor to take radical measures to cure it. However, owing to the casual approach of the OP No. 2, conditions of the patient deteriorated further necessitating her re-admission in hospitals and endure unbearable pain and agony.
Documents on record reveal that on being transferred by Balaji Nursing Home, the patient got admitted at CMRI Hospital, Kolkata on 19-04-2014, wherefrom she was discharged on 29-04-2014. At that juncture, no surgical interference was done and she was only treated medically. On 13-05-2014, the patient was followed up by Dr. Ajoy Mondal, MS, DNB and stitches were removed. Afterwards, secondary suture was done on 06-06-2014 and the same was removed on 16-06-2014.
It is claimed by the OPs that treatment cost of secondary suture alone, under any circumstances, cannot be so much as claimed to have been charged by the CMRI, Kolkata to Mrs. Rupali Maity, the patient. It is significant to note that, despite having access to relevant treatment papers and bills, that contain details of medicines, injections administered to the patient, as well as clinical/pathological tests done by the treating doctor of CMRI, none of them could pick any hole in the line of treatment followed by the treating doctor of CMRI, Kolkata. As such, we are not inclined to attach any importance to such wild allegations.
The OP No. 1 has not come up with any cogent documentary proof or evidence to show that it strictly adheres to the clinical practice guideline for antimicrobial prophylaxis in surgery being developed by the American Society of Health System Pharmacists (ASHP) and the Infectious Diseases Society of America (IDSA), the Surgical Infection Society (SIS), and the Society for Healthcare Epidemiology of America (SHEA). Incidentally, these guidelines are intended at providing practitioners with a standardized approach to the rational, safe, and effective use of antimicrobial agents for the prevention of surgical-site infections (SSIs) based on currently available clinical evidence and emerging issues. No evidence is put forth from the side of the OP No. 1 to show that it religiously adheres to the guidelines set out by the afore mentioned internationally respected Institutions. Besides, in our considered opinion, the OP No. 1 cannot avoid vicarious liability for the apathetic attitude of the OP No. 2 towards the patient.
We are fully appreciative of the fact, so also contended by the OPs that, there are some patient-related factors associated with an increased risk of SSI, e.g., extremes of age, nutritional status, obesity, diabetes mellitus, tobacco use, coexistent remote body-site infections, altered immune response, corticosteroid therapy, recent surgical procedure, length of preoperative hospitalization, and colonization with microorganisms. No immaculate evidence is, however, put forth from the side of the OPs to prove that any of these factors contributed to development of SSI in the patient.
OPs rued the fact that the Complainant had chosen a private hospital over the OP No. 1 Nursing Home for undergoing second suture. Fact, however, remains that the Complainant did seek the assistance of OPs twice when the patient was suffering from abdominal pain and foul smell was oozing out of the stitching line after her discharge from the OP No. 1 Nursing Home. However, on both occasions, as we find, the OP No. 2 proved himself to be a square peg in a round hole in understanding the gravity of the situation and take remedial steps to mitigate the sufferings of the patient. So, in our measured opinion, there would hardly be any taker to buy such argument as advanced from the side of the OPs.
To sum up, Complainant’s wife, i.e., the patient, as ill luck would have it, fell victim of the utter carelessness of the OPs. Be it at the preoperative stage or postoperative, OP No. 2 failed and/or neglected to impart/exercise his professional skill that he presumably possess while treating Complainant’s wife. This is akin to medical negligence. On the other hand, as we know, hospital and operating room environments, instrument sterilization issues have a strong impact on SSI rates. However, OP No. 1 has not come up with any credible proof/evidence as regards maintenance of sterile aseptic condition at the Nursing Home, including the OT room. Mere claim, as made by the OP No. 1 as to conforming to International standards in rendering quality service to patients, is not suffice. There is nothing to show that OP No. 1 is an ISO certified organization. Moreover, as stated earlier, they cannot avoid vicarious responsibility for the slipshod conduct of the OP No. 2.
Now, let us decide the quantum of compensation. It appears from the record that the Complainant had to incur more than. Rs. 3,00,000/- to cure the SSI that developed in the stitch line of his wife following Cesarean Section. Besides, we cannot overlook the tremendous physical stress, trauma, mental pain and agony that the patient as well as her family members had to contain with for a considerable period of time. Considering all aspects, we feel a compensation of Rs. 4,00,000/- would be just and appropriate that the OPs should jointly pay to the Complainant in equal share along with litigation cost for a sum of Rs. 10,000/-.
Consequently, the complaint case succeeds.
Hence,
ORDERED
that C. C. No. 65/2014 be and the same is allowed on contest against the OPs. OPs are directed to pay, in equal share, a sum of Rs. 4,00,000/- as compensation and another sum of Rs. 10,000/- as litigation cost to the Complainant, within 40 days hence, i.d, Complainant would be at liberty to execute this order in accordance with law. In that case, the defaulting OP/OPs would be under obligation to pay interest @ 8% p.a. over the proportionate share of compensation amount from this day till full and final payment is made.
