*The Tragic death of a full term pregnant woman and the foetus due to fall in the OT causing traumatic injury to the SI joint costed Rs.1.6 Crs to the Hospital.*
*The Tragic death of a full term pregnant woman and the foetus due to fall in the OT causing traumatic injury to the SI joint costed Rs.1.6 Crs to the Hospital.*
*The Court dismissed the Anaphylactic drug reaction theory and observed that Anesthetist conclusively failed to prove the theory of Sodium Pentothal anaphylaxis.*
*The Anesthetist is saddled with Rs.10 lakhs and the Hospital was vicariously held liable to pay rs.1.5 Cr !*
*(The total claim was of Rs. Rs.24,91,30,000/-)*
*A Case to ponder over by the ObyGyns (though saved in this case), Anesthetists and the Hospital Administration !!*
Case Details :
CONSUMER CASE NO. 89
OF 2012
PARIKSHIT DALAL & ORS.
V/s. SANTOSH HOSPITAL & 11 ORS,
BANGALORE
Judgment Link :
https://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0%2F0%2FCC%2F89%2F2012&dtofhearing=2023-05-23
BEFORE:
HON'BLE DR. S.M.
KANTIKAR,PRESIDING MEMBER HON'BLE
MR. BINOY KUMAR,MEMBER
The
Judgment starts with the following Para
“Deaths due to
anaphylactic shock are uncommon and it is a diagnosis based on findings which
may not always be present
and as such poses challenges for the forensic
pathologist or an expert in reaching certainty with regard to the cause
of death. A holistic view that all
findings need to be considered in the approach to reach a definitive cause of death”.
Factual
matrix in short :
1. The facts of the case go back to year 2010. The
Complainants – husband and parents of the deceased patient filed the case seeking compensation amounting to Rs.24,91,30,000/- for causing
death of wife –patient - and unborn child of the Complainant No. 1.
2.
The Complainant No. 1 - Parikshit
Dalal and his wife Mrs. Kapali Patne
(since deceased, hereinafter referred
to as the ‘patient”), on 13.04.2010, consulted Dr. Indira Rao (OP-2), the Sr. Gynecologist at Santosh
Hospital (OP-1) during her first pregnancy. The OP- 2, after examination, informed that the baby was large and
advised the couple for Caesarean Section
(LSCS) delivery. Accordingly, LSCS was fixed on 16.04.2010. The patient
informed the OP-2 about her
allergy to Sulpha drugs and also about her congenital (L5) birth defect. It was mentioned in her Ante Natal checkup (ANC) card.
3.
It was contended that on the day so
fixed, when the patient and her husband reached the Hospital, the in the Anesthetist Dr. P. Ashok (OP-3) met the Complainant No. 1 and discussed whether
General Anesthesia (GA) or
Epidural Anesthesia should be given, as he was very worried about GA, which was
not normally used for Caesarean
Section, but, as advised by OP-2- the
Sr. Gynecologist, he will give GA. Thereafter again the Complainant-1 spoke
to OP-2 about GA, who assured him that there
would be no complications. It was alleged that she did not advise any
pre-anesthetic tests. At 9.15 am, the patient was taken into Operation
Theater (OT), at the same time, the OP-2 also entered the OT. At around
10.15 am, the Complainant-1 suddenly noticed a flurry of activities and all the senior doctors, staff from the
hospital including the CMO Dr. Sharieff of Santosh Hospital rushed into the OT. At about 10.40 am, the OP-2
informed the Complainant-1 and his
friend that the patient was given GA and one-in-a million patient may react
violently to the drug.
4.
The
OP-2 informed that due to severe ‘Anaphylactic shock’ from Sodium Pentothal
(anesthetic agent), the condition of the patient became very critical and the
doctors were trying their level best
to revive her and shifted to ICU. The Complainant-1 repeatedly enquired with OP-2 and OP-3 about the
condition of his wife. The OP-2 expressed very slim chances of survival
in her words as - 'She is as good as gone'. The OPs-2 & 3 had shown little concern and anxiety while
monitoring the patient. It was further alleged that Dr. Indira Rao (OP- 2) was trying to selectively
isolating herself from the situation as she told the Complainant that, “look, I have not even touched your wife”.
5.
The patient was taken to the ICU at
around 11 a.m. and around 11.50 a.m., she and her unborn child were declared dead. Thereafter, the doctors and
hospital authorities insisted the Complainant-1
to take away the dead body of his wife at the earliest. It was further alleged that the OP-2 did not assess the condition
of the baby and failed to save the baby with the help of surgery.
6.
The Complainant alleged strongly that
his wife died in the O.T. itself. However, to
cover-up their negligence, the doctors tried to show it as shifted to
ICU. Therefore, the actual reading
of monitors was not available on record. The ICU monitor showed zero reading, which itself confirms
that the patient
and unborn child were already
expired in the O.T. at 11.30 a.m. The OP-2 made casual attempt
to note Foetal Heart Sound (FHS) on the dead
body and even the USG was actually
done at 12.05
to 12.08 p.m.,
which was 15 minutes after the death.
7.
The Complainant registered an FIR at
Pulakeshinagar Police Station, Bangalore as UDR
no. 15/10 u/s 174(3) of CrPC- Unnatural death on 16.04.2010 at around 4.30 p.m.
The copies of the medical papers,
seized by the police from the hospital, were handed over to the Complainant-1 on 23.04.2010. The cause
of death mentioned in the intimation letter was "cardio respiratory
arrest seconding to acute anaphylaxis reaction". The Post-Mortem (PM) was performed on 17.04.2010 and the
copy of the preliminary report was handed over
to the Complainant on 26.04.2010. The
preliminary PM report recorded following findings:
a. Fracture
of the Left Sacroiliac joint and plenty of clots into muscles in front of the
joint.
b. Peritoneal
cavity contained 1500 gms of clot and 200 ml of fluid blood.
c. The
mesentery (mesocolon), transverse and left mesocolon were contused.
8.The
viscera and blood were sent to forensic science lab for chemical analysis and
to find anesthetic drugs, sedatives
etc. and the organs were sent for histo-pathological examination (HPE). The HPE report received
on 13.05.2010 showed a mesenteric, mesocolon hemorrhages and severe congestion. The FSL report
received on 27.05.2010 revealed the anesthetic drug Thiopentone was not present
in detectable limits.
In the final PM report, the
cause of death was given as 'shock and hemorrhage as a result of the
injury to the pelvis sustained'.
9. Upon
receipt of the preliminary PM report, noticing the injuries, a further FIR was lodged
on 04.05.2010 and a case of medical
negligence CR158/2010 under
sections 304A, 315 and 201 of IPC was registered by Pulakeshinagar Police Station, Bangalore. The Complainant
alleged that the hospital case sheet was fabricated, with numerous over
writings and insertions, thus inconsistencies raised more suspicion
on OPs. The BP was not recordable as early as 10.10 a.m. At many places the time of death was changed from 10.50
a.m. to 11.50 a.m. In July 2010 the police arrested OP-2 & OP-3 and four
other medical staff and released on
bail. The Crime Investigation Department (C.I.D), Karnataka took over the investigations in August 2010 and after 9
months of investigations filed a charge-sheet under sections 304A, 315, 201 r/w 34 of the IPC making OP-2, OP-3, & other accused
staff. Further the above case
has been committed to the Court of Session and is being tired in Fast Track Court No. 7 in Bangalore as SC No.
1544 of 2012. A petition under section 227 CrPC filed by the OPs was dismissed by the Session Court vide Order
dated 24th November
2011. The said Order was challenged by the OPs in the Hon’ble High Court of Karnataka, which was dismissed vide Order dated
03.10.2016. The Order of the Hon’ble High Court was further challenged by the OPs vide SLP NO 9332/16 before the
Hon’ble Supreme Court, which vide
Order dated 09.12.2016 upheld the criminal prosecution against OPs.
10. On
07.08.2010 the Complainant filed a Complaint in the Karnataka Medical Council (KMC) against OPs under professional
misconduct and malpractice under Regulation. On 09.04.2012, he filed the Consumer Complaint before this
Commission for alleged medical negligence
and prayed total compensation of Rs.24,91,30,000/-.
11.
Defense:
a. The Opposite Parties filed
their written versions and respective evidences by the way of affidavits.
b.
The
OPs in their reply denied the allegations of negligence as the Complaint was
filed with ulterior motive. They
raised preliminary objections that instant complaint is premature, as the Complainants have filed Complaints
before KMC and Criminal Complaint, which are
pending.
c.
It
was submitted that the OP-1 hospital is a tertiary health care institute,
having state-of-art equipment and medical specialists. The infrastructure provided
by OP-1 was never substandard nor were the medical and
paramedical staff casual in their approach. There was no negligence or deficiency in the services
rendered by the OP-1. The Complainants have not
proved any specific allegations of an act of omission or commission of the
Hospital and treating doctors.
d. Evidence on behalf of OP-2- Dr. Indira Rao
:
The OP-2 submitted
that the patient told her about the allergy to sulfa drug and had spinal problem (back). Usually for the patient
with spinal problem, the spinal or epidural anesthesia avoided. Therefore, General Anesthesia (GA) was preferred for
elective LSCS. Accordingly, it
was decided to perform elective LSCS on 16.04.2010. She submitted that after
her clinical rounds, she went in OT
at round 9:15 a.m. Dr. Adil Pasha - Paediatrician (OP-10), Dr. P. Ashok – Anesthetist (OP-3) were already
present in OT. After scrubbing, OP-2
entered the OT to put on sterile gown
and gloves. With the permission of Anesthetist, OP-2 started painting the abdomen with Povidone. The OP-3 noticed the appearance of
allergic rashes which were
increasing. The allergic reaction was treated by OP-3 –Dr. Ashok, he gave IV Efcorlin 200 mg intravenously. The OP-3 told to OP-2, not to proceed for
surgery because he noticed
bradycardia, hypotension and fall of oxygen saturation. It was diagnosed as severe Anaphylactic shock due to the anesthetic drug – Thiopentol sodium which occurred before
the commencement of surgery.
e.
Evidence
on behalf
of OP-3- Dr.
P.
Ashok (Anesthetist) – He reported case of badycardia.
The patient was elderly primi with cord around
the neck and possibly a big baby. The patient had some congenital spinal problem and had a history of sulfa drug
allergy. He assured her that they do
not use sulfa drugs during or after anesthesia. Pre-operative instructions to
start IV fluids and Injection Rantac
1 amp. IV and Injection Emset 4 Mg IV were advised to be given at 08:30 am. He also spoke to the
patient regarding GA. After pre-oxygenation for about 5 minutes, the freshly
prepared 2.5% Thiopentone sodium 250 mg was given in increasing dosages of 25 mg
under observation for any untoward reaction. The full dose of Thiopentone was
given followed by IV 100 mg of
Suxamethonium. The patient was
intubated with 7 size oro- tracheal
tube without any difficulty and 100% oxygen was administered through the tube. Immediately the patient developed severe rashes over the chest and both the arms. He noticed bradycardia and hypotension.
The findings were informed to Dr. Indira Rao who was ready after wash and also painted the abdomen with Povidone Iodine.
Immediately hydrocortisone 200 Mg IV was given but there was no improvement in the BP and pulse rate. Rashes also increased
and patient started
to de-saturate in-spite
of 100 % of oxygen
with good ventilation of the lungs. The strong possibility of
anaphylaxis due to thiopentone was
considered.
Injection Atropine
was given to combat bradycardia. Injection IV Adrenaline 1 Amp and 1 Amp SC given. Injection
Hydrocortisone was repeated. In-spite of all these emergency drugs being given, the patient did not
show any signs of improvement. There was further fall in blood pressure, which became very low. The uterus was displaced manually to
the left side to prevent any pressure on the vessels( aorta). The other consultants including one more
anesthetist, physician and pediatrician were
called to assist resuscitation. External
cardiac massage was started. No LSCS surgery was commenced due to critical condition of the patient. At about
10:30 AM, the OP-2 informed the
patient’s husband about the critical condition of the patient.
Knowing this, the
patient’s husband Mr. Parikshit Dalal called his uncle Dr. Vipul Kapadia,
a Gynecologist in Ahmedabad. Meanwhile resuscitation was being
continued, DC shock was given to combat tachyarrhythmia.
Physician Mr. Quaisar Anwar shifted the patient to ICU at 10:40 AM with continuous ventilation on the Ambu bag, 100% oxygen through
endotracheal tube. In the ICU the patient was connected to the
ventilator and kept under monitoring. The
resuscitative measures were continued by the ICU doctors, but in-spite of all attempts
the patient succumbed
at about 11:50 AM.
It was submitted
that as per histopathology report, the patient had right ventricular dysplasia, which could be the reason for unsuccessful resuscitation. The anaphylactic reaction (Grade IV) led to patient
pulseless and cardiac arrest.
f. Evidence by OP-4- Dr. S. Bikkamchand (Medical Director)
It was the decision
of Gynecologist and Anesthetist, intensivist to shift the patient to ICU for
better management. Prime concern was
to save the life of mother. Therefore, the team of doctors was concentrating on the mother and the
resuscitation of cardiac arrest was continued for 45 mins to one hour. However,
all the resuscitative measures failed and the family
was informed about the death of the patient. Further,
Police intimation slip was sent to Frazer Town police station to inform the death of the patient and after the
preliminary investigations police took away
hospital case sheet at 2.30 pm on the same day (10.04.2010). Therefore, there
was no chance of fabrication of
records. He further submitted that after a gap of 4 -5 months police seized the hard disc for OT, ICU monitors
and Ultra Sound. Initially, the hard disk was sent for analysis to Hyderabad, therefore, there was no question of
tampering or fabrication of the records.
He further submitted that the OP-2 called Dr. Anil Kumar Saklecha to perform emergency USG of abdomen / pelvic scan to
ascertain the viability of foetus and to prepare for emergency Cesarean to save the baby. However, Dr. Anil conducted USG in ICU which revealed
non-viable foetus. Therefore, the patient’s resuscitation was continued, but she could not survive and declared dead at
11.50 am. The CMO wrote a brief history, the time of death. The probable
cause of death was mentioned as
secondary to Anaphylaxis as confirmed by the treating doctors
i. Evidence of OP-10 - Dr. Adil Pasha (Pediatrician)
-
The OP-10 submitted that his role starts only after delivery
of the baby, however, unfortunately, in the instant case, the
baby was never delivered. He was one of the doctors assisting the resuscitating team in saving the life of the mother and the unborn.
His involvement was purely on
humanitarian grounds and medical ethics.
j. Evidence of OP-11 - Dr. M. K. Inayathulla Sharieff (CMO)
The patient was
posted for Elective Caesarian section under GA has suddenly developed Severe Anaphylactic reaction
after giving IV pentothal. The patient, being actively resuscitated, needed to be shifted to ICU
for further management. Accordingly he was asked to get ICU bed ready
along with ventilator support, therefore, immediately; arranged ICU bed along with ventilator and the patient
was shifted to ICU. He submitted that it was not his responsibility to maintain OT records, but the same was
maintained by the OT in charge with well
documented. He further submitted that neither hospital nor he was responsible
for the delay in the settlement of
the LIC claim. Later it was learned that the complainant received the full compensation from LIC. So, the allegation of the complainant putting them responsible for the delay was absurd.
Expert Opinions
: Both the parties filed 3-4 Expert’s Reports fro each side and the NCDRC referred
these reports.
Expert Committee
Reports field by the Complainant :
Expert opinion of Dr. Behram S. Anklesaria
Dr. Anklesaria was
Chairman of Indian College of Obstetrics and Gynecology having more than 25 yrs. teaching experience as a professor
and HOD in NHL Medical
College, Ahmedabad.
According to Dr. Anklesaria, he never came across a case of anaphylaxis to lead to fracture of SI joint and such massive internal
bleeding. The patients L5-S1 defect
was unrelated to fracture sustained
in the operation theatre. According
to him, presence of hemorrhagic in a full
term patient, the only correct option for the surgeon is to treat is to
immediately perform an exploratory anatomy to arrest
the active bleeding
which could have save life of mother
and child. The mother’s vital signs not being recorded
or recordable, an immediate postmortem cesarean section within 15
minutes after death could have saved the life of unborn. Finally, he
opined that from the PM report and other medical records, it was shock and hemorrhage as a result of injury to
pelvis sustained was the actual cause of death
anaphylactic shock as claimed by the hospital and the doctors.
Expert opinion of Dr. Selvakumar &
Dr. Ragahvan (both the forensic experts) :
The cause of death was ‘shock and hemorrhage as a result of injury to the pelvis sustained.’ It was not due to anaphylactic shock. From the preliminary PM
report there was fracture of left SI
joint and blood into muscles in front of joint. It indicates fresh ante-mortem fracture. The other findings were 1.5 kg blood clots and 200 ml of blood
in the peritoneal cavity. The mesentery, transverse and left mesocolon
were contused. There was blood in and
around perinephric tissue which all
indicates a blunt trauma sustained on the left side of pelvis. In their
opinion they have collaborated the blunt trauma with the histo-pathological
findings as mesenteric hemorrhage,
fat necrosis, hemorrhage and congestion. Regarding
massive blood loss, the experts
stated that the SI iliac joint region consists of internal and external iliac arteries, veins and their branches which
got injured due to blunt trauma. They
further commented on the finding in
the preliminary PM report about confluence of reddish spots present around lower part of front and
sides of the neck and left side of the chest.
Those were petechial
hemorrhagic spots due to prolonged hypoxic stage or as a result of sustained CPR. Even
there was Laryngeal Edema was not
seen which is an important PM finding in anaphylactic/drug
reaction deaths.
Report of Expert Committee
constituted by Bangalore
Medical College and Research Institute (BMCRI)
As
per the records, Mrs. Kapali Patne had developed an anaphylactic reaction after
the administration of the intravenous
induction agent. The reaction had been immediately recognised and resuscitative measures had been instituted. The
anaphylactic reactions are known to occur
after the administration of induction agents.
After
having gone through the records and the post mortem report, the fracture of the
SI bone with a hematoma on the left
side, can occur following a trauma. This can also cause hemorrhage.
The
presence of blood clots (1500 ml), haemo peritoneum (200 ml) contusion to the transverse colon and to the left mesocolon, and associated perinephric collection, can be due to trauma, and the cause of death
due to hemorrhagic shock.
Following
a cardiac arrest of the mother, a post mortem caesarean section should be done within 4 to 5 minutes to save the
intra uterine foetus. In this case, it has not been attempted.
Expert
Opinions on behalf of OPs
Expert opinion of Dr. Rajeev Naik (Orthopedic surgeon)
Dr. Rajeev Naik had experience of 35 years and currently
practicing Orthopaedics at Dr. B.
R. Ambedkar Medical College Bangalore. He opined that :
“the displaced and
unstable sacro-iliac fractures usually are a result of high velocity injuries, usually secondary to road traffic
accidents or a fall from considerable height. In such cases apart from sacro-iliac joint fractures,
the adjacent structures like urethra, bladder, pelvis, femur too would get involved. Isolated sacro-iliac joint
fractures are rare, that too from a fall from
3 feet height which would not result in sudden death of the patient.”
Expert Opinion of Dr. K. Uma Devi (Obstetrician and Gynecologist)
Dr. K. Uma Devi a
visiting Professor and senior Consultant Obstetrician and Gynecologist at MS Ramaiah Hospital Bengaluru studied
the case record of the patient. In
her opinion the antenatal records
and the decision to do caesarean section
based on the indication cephalopelvic disproportion at maturity of
the baby is an accepted standard procedure. The decision about type of anaesthesia for the procedure depends on
contraindications for a certain type, patient's condition
and the combined decision of anaesthesiologist and obstetrician.
As the patient had history of a spinal problem, the spinal or epidural route of anaesthesia was avoided. The Obstetrician
did not proceed with the surgery waiting for the patient to recover from the shock. This is the standard agreed
procedure in the operation theatres
i.e. surgeon will not operate unless the anaesthetist instructs accordingly.
According to her, the postmortem
report did not correspond to the maternal anatomical parameters, and there are no established guidelines for
performing a postmortem caesarean section. She relied upon Green-top Guideline
No.56-January 2011 “Maternal collapse in Pregnancy and the Puerperium” and Guidelines from American college of Obstructions and Gynaecologist.
Expert Opinion of Dr. Manju Prakash,
Forensic Expert
Dr. Manju Prakash
is the Professor and HOD of Forensic Medicine at Aakash Institute of Medical
Sciences, Devanhalli, Bangalore. According to him, the Expert Committee of Bowring & Lady Curzon Hospitals does not consist
of Forensic Medicine
to critically analyse and certify the findings of the
Autopsy surgeon. The members were belonged to the same institution in which autopsy
was performed and they were colleagues of autopsy surgeon. They had never scrutinized the
findings but endorsed the final opinion based on autopsy findings without genuine attempts. He also commented on the expert opinion by
Dr. Selvakumar that it does not touch upon the forensic medicine
aspect at all, but goes into great detail to explain the anatomical
relations in the region. None of the forensic aspects were discussed. He further opined that Dr. Srinivas Raghavan’s
opinion was very similar to the opinion
of Dr. Selvakumar, without discussion of new issues.
Expert
Opinion of Dr. Radhika Dhanpai, Anesthesiologist
She is Professor of Anaesthesiology and Critical Care, St.
John's Medical College Hospital, Bangalore. In
her affidavit stated that any drug
can induce a life threatening anaphylactic reaction even in the absence of any risk factor in the
patient's medical history. The documentation of anaphylaxis is often lacking because the cause and
effect relationship is often hard to prove and because the diagnosis is not easy to make with the patient under
anaesthesia. Anaphylaxis can present as Grade 1-5 with skin rashes,
breathing difficulty or cardiovascular collapse
and can be fatal. According to her, in the instant
case the patient was anesthetised with Inj. Thiopentone Sodium and Inj. Succinylcholine intravenously for administration
of General Anaesthesia. Both these
drugs are known to cause anaphylaxis, thiopentone 1:30,000 and Succinylcholine 1:2018. Thiopentone Sodium is
redistributed from the blood into the tissues (muscle, fat) in 5-10 minutes and hence will not found in
the blood after this period. Succinylcholine is metabolized by an enzyme, pseudo cholinesterase in the blood
within 2-4 minutes of its administration.
Held :
i.
The NCDRC after perusing the entire
record, affidavits and arguments partly allowed the claim to the tune of Rs.1.6
Cr.
ii.
As per the PM Report issued by Dr. Havanoor,
the cause of death of the patient was ‘shock and Hemorrhage as a result of the injury to the Pelvis sustained’. The Commission also referred to the expert both parties’
the expert committee reports which were crucial to
decide the instant case.
iii.
It is pertinent to note that the
patient was full term and taken for elective LSCS on 16.04.2010. Admittedly,
the patient suffered certain complications and died subsequently within short span of time. The say of Complainants was that the
patient died due to fall from the
operation table which sustained fracture of SI joint leading to hemorrhagic
shock and death. Per contra the OPs contention that it was
due to severe anaphylactic reaction to the anesthetic
drug sodium pentathol, which subsequently led to cardiac arrest and death.
Defense of Anaphylactic drug
reaction dismissed :
iv.
The Commission said question before us
that why there was massive blood clots and intra-peritoneal bleed, if it was an anaphylactic drug
reaction. Such bleed could occur due to
fall or any blunt trauma to the
internal organs. We do not accept that anaphylactic reaction by any stretch of imagination will not cause such
traumatic hemorrhage. At the full
term pregnancy due increased
vascularity in the venous plexus the pelvic bones of the woman are more vascular and fragile. Any trauma may lead to vascular injury and
severe bleeding.
v.
The report of CFSL, Hyderabad
clearly establishes that the OPs deleted
the readings of OT Monitor, ICU Monitor and the Digital copy of USG. It was
an attempt of OPs who tried to
destroy the evidence. Thus, it was
unethical practice.
b.
As per the OPs, three congenital
defects in the patient could have contributed to the death. The first
defect was pars fracture L5-S1 which was detected in early 2008. The second
defect was the right ventricular dysplasia which could affect right ventricle
leads to thinning of ventricle. This causes right ventricular failure and
sudden death. Third defect was presence of arcuate ligament remaining
open to give a connection from thorax to kidney and perinephric areolar tissue and the base of transfer
mesocolon to the muscles of pelvis. Therefore, the blood might have collected
from the external cardiac muscles and fracture of 3 to 7 ribs. The blood flows down through open arcuate ligament towards
postero superior surface of kidney
only by areolar tissue and blood flows along areolar tissue surrounding the left kidney. The OPs relied upon the celebrated decisions of Hon’ble Supreme Court in Jacob
Mathew Vs. State of Punjab, Kusum
Sharma & Ors. v. Batra Hospital and Medical Research Centre & Ors.
c.
Medical Literature : The NCDRC relied upon various medical literature.
i.
The text books revealed the pelvic vessels (pelvic vasculature) play an important role in pelvic
support. There is significant anatomic variation
between individuals in branching pattern of internal iliac vessels. The pelvic vasculature is a high volume,
high flow system with enormous
expansive capabilities throughout reproductive life. The pelvic
vasculature is supplied with an extensive network of collateral connections that provides a rich anastomotic
communication between different major
vessel systems.
ii.
During pregnancy, there occurs
Hematological changes and increased vascularity in the pelvis. The patient is at more risk
for deep vein thrombosis and disseminated intravascular coagulation (DIC).
iii.
With respect to trauma during
pregnancy, the literature revealed Trauma in pregnancy can ranges from mild, for example trauma associated with a
single fall from standing height or
hitting the abdomen on an object such as an open desk drawer, to major, for
example trauma associated with
penetrating injury or high force blunt motor vehicle accident. This activity reviews the evaluation and
management of trauma in pregnancy and highlights the role of interprofessional team members in collaborating to
provide well-coordinated care and enhance outcomes for affected patients and
families. Evaluation and Treatment of the Pelvic fractures during pregnancy are associated with increased
maternal morbidity and mortality. One particularly significant physiologic
change is that, in the third
trimester, there is a relative maternal hypervolemia, and maternal blood loss of up to 1500 mL can occur before any signs of hypovolemia
can be detected. Therefore, any suspicion of maternal blood loss
should be treated vigorously and immediately, and, if necessary, application of external fixation for control of
bleeding from pelvic injury should not
be delayed. It must be emphasized that these measures are not relevant in the
first trimester, during which almost no change in the maternal anatomical or physiologic parameters occurs. However, the mother’s
resuscitation and initial treatment should not be compromised because of the pregnancy. Treatment priorities for
an injured pregnant patient remain
the same as for the non-pregnant woman. Fetal death rates in cases of maternal
pelvic fracture occur in 35% to 60%
of cases. The pelvic fracture in itself is not an indication for termination of pregnancy, and the decision
is usually based on other factors. It is a well- accepted principle that,
for optimal outcomes
for both mother
and fetus, the mother should
be assessed and resuscitated before the fetus. Usually, the worse
the maternal injury, the higher the
fetal risk, as reflected in parameters such as higher injury severity score
6-9, lower Glasgow Coma Scale(GCS) score,
and presence of DIC. However,
fracture severity does not always
correlate directly with fetal demise probability. In a case of a severely injured mother in the third
trimester, with low chances for survival, a pre-mortem caesarean section should be considered in an attempt to save the
fetus. Practically, this is not always possible, because of the mother’s
critical condition.
iv. In the instant case the
Obstetrician OP-2 was put on sterile gown and gloves and yet to start operation, but during painting of
abdomen, the alleged incident occurred in the OT. It was held that it was not at all a case of severe
anaphylactic shock due to Thiopental sodium.
Based on the PM findings
and expert opinions
the death of patient was due to the hemorrhagic shock which could be only due
to trauma inside the OT. Though even if we accept it was an anaphylactic reaction, but it is beyond our imagination that how the resuscitation will cause large amount of blood clots
(1500 g) and blood in the pelvic
cavity.
v. 
From
the research article Anatomical consequences
of “open-book” pelvic ring disruption: a cadaver experimental study[8]
Patients with
pelvic fractures, there is frequently concomitant blood loss, even in closed fractures. Intra-abdominal bleeding up to 40% of cases, but there also may be
intra-thoracic, retroperitoneal, or
compartmental bleeding in such injuries. Within the pelvis, bleeding is usually caused by shearing of the venous
plexus and can lead to hematomas holding up to 4L of blood. Posterior
pelvic fractures may also result in an arterial injury to the superior gluteal
artery, which constitutes a surgical emergency. The
Commission referred to the decision of Hon’ble Supreme Court in Smt. Savita Garg Vs. The Director, National
heart Institute, IV (2004) CPJ 40 (SC), wherein it has been held as below:-
“Once an
allegation is made that the patient was admitted in a particular hospital and evidence
is produced to satisfy that he died because of lack of proper care and negligence, then the burden lies on the
hospital to justify that there was no negligence on the part of the treating doctor or hospital. Therefore, in any case, the hospital is in a better position to disclose what care
was taken or what medicine was administered to
the patient. It is the duty of
the hospital to satisfy that there was no lack of care or diligence. The hospitals are institutions, people expect better and
efficient service, if the hospital
fails to discharge their duties through their doctors, being employed on job basis or employed on contract basis, it
is the hospital which has to justify and not
impleading a particular doctor will not absolve the hospital of its
responsibilities.”
The Gynecologists
was saved !
In the instant case, the death of
patient and her foetus was due to the negligence of the hospital and the OP-3. It was held that, prima facie we do not
find any negligence of the OP-2 -Gynecologists who did not start any operative
procedure (Caesarean). Moreover,
during resuscitation, the prime aim was to save the mother therefore the
team of doctors were focused on resuscitation. In addition to trauma,
umbilical was cord around the neck of foetus caused
death. Therefore, the baby could not be saved; it was not
a negligence of OP-2 or the team in
OT. It is pertinent to note that the patient was
under custody of doctors and the OT staff, but
she sustained left SI joint
fracture and suffered hemorrhagic shock resulted into death of the patient.
As discussed above and from the PM findings, the death was not due to anaphylactic reaction.
The OP-3 Anesthetist failed
to establish why there was large amount
of peritoneal / pelvic hemorrhage, whether it was due to anaphylactic
reaction.
The hospital was held vicariously
liable :
Considering the
entirety, in our view the OP-1 hospital is vicariously liable for the negligent
acts of its doctors or employees.
We would like to rely upon the Maharaja
Agrasen Hospital and Ors.
Vs. Master Rishabh Sharma and Ors 2019
SCC OnLine SC 1658, the case wherein Hon’ble Supreme Court observed:
“11.4.17. It is well established that a hospital
is vicariously liable for the acts of negligence
committed by the doctors engaged or empanelled to provide medical care. It is common experience that when a
patient goes to a hospital, he/she goes there on account of the reputation of the hospital, and with the hope
that due and proper care will be
taken by the hospital authorities. If
the hospital fails to discharge their duties
through their doctors, being employed on job basis or employed on
contract basis, it is the hospital
which has to justify the acts of commission or omission on behalf of their doctors.”
Thus hospital (OP-1) cannot escape
from its vicarious liability for the medical
negligence that has been meted out in the present
case. The hospital
is required to compensate
for the medical negligence and mental agony sustained by the patient’s family members.
The ‘Duty of Care’ towards the patient was clearly explained by the
Hon’ble Supreme Court in P.B. Desai vs State of Maharashtra &
Anr (2013)15 SCC 481 case as below: “Once, it is found that there is ‘duty to treat’ there
would be a corresponding ‘duty to take
care’ upon the doctor qua/his patient. In certain context, the duty acquires
ethical character and in certain
other situations, a legal character. Whenever the principle of ‘duty to take care’
is founded on a contractual relationship, it acquires
a legal character. Contextually speaking,
legal ‘duty to treat’
may arise in a contractual relationship or governmental hospital or hospital
located in a public sector
undertaking. Ethical ‘duty to treat’ on
the part of doctors is clearly covered by Code of Medical Ethics, 1972. Clause 10 of this Code deals with
‘Obligation to the Sick’ and Clause
13 cast obligation on the part of the doctors with the captioned “Patient must not be neglected”.
In the instant case glaring deficiencies are visible from the hospital
(OP-1). The Anesthetist and the assisting team in the OT have failed in their duty of care.
Compensation : No
Straight jacket formula can be used.
The
Hon’ble Supreme Court
in Malay Kumar Ganguly
vs. Sukumar Mukherjee
and Ors (2009) 9 SCC 221, clearly mentioned that there were problems with using a strait-jacket formula
for determining the quantum of compensation. It clarified about
the basis of computing compensation under common law lies in the principle
of ‘restitutio in integrum’ which refers to ensuring that the person seeking damages
due to a wrong committed
to him/her is in the position that he/she would have been had the wrong not been committed.
Thus the victim
needs to be compensated for financial loss, future medical
expenses and any suffering
endured by the victim. By no stretch
of imagination, the award shall not a paltry sum for gross negligence. It was held that there is no restriction that courts can award compensation only up to what is demanded by the complainant.
10. Conclusion:
In view of the peculiarity of this case, to meet
the ends of justice, we allow the lump- sum compensation of Rs. 1.6 Crore to be just and adequate.
The OP-1 hospital shall pay Rs.1.5
Crore and the OP-3 Anaesthetist shall pay Rs.10 lakh to the Complainants. We do
not find either negligence or failure of duty of care from the Obstetrician, thus OP-2 is exonerated. We also
allow Rs. 2 lakh towards the cost of litigation.
The Commission also
observed that in case if the
Complainant No.1 –husband remarries, the entire amount shall be paid to the
parents of the deceased.
Really a tragic
case and what more tragic is the amount of time it took to finally decide it. Currently
the Doctor –patient or Hospital –patient relationship is going through the vicious
circle and such cases puts a big question mark on the Trust Issue. The Doctor
and patient relationship is a Fiduciary relationship. The Case shows how
Doctors and the hospital administration should be very careful while treating
the patients. In medical cases, there is no second or third chance of Appeal,
like we have in Courts. If a person is gone, he’s gone –irreversible situation !
Thanks and regards
Adv. ROHiT ERANDE
Pune.
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