Tuesday, April 7, 2020


Postpartum Hemorrhage

CONSUMER CASE NO. 85 OF 2003, MRS. ANUJA CHAUDHARY    Versus         SHIVAM HOSPITAL & RESEARCH INSTITUTE & ORS.  VIDYAPURI PATRAKAS NAGAR    KANKANBAGH    PATNA  Pronounced by the Hon’ble NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION on 18th March 2020

“Emergency obstetric hysterectomy (EOH) remains an essential weapon in any Obstetrician's armoury and it is most vital to decide the perfect time to use this weapon. EOH is generally performed as a lifesaving procedure in cases of postpartum haemorrhage, rupture uterus, morbid adhesions of placenta and uterine sepsis. On one hand, it is used as a last resort to save the lives of mothers and on the other hand women's reproductive capability is sacrificed. Often it is a difficult decision and requires good clinical judgment. The maternal outcome greatly depends upon the timely decision, the surgical skill and the speed of performing the surgery.”

FACTS:  Mrs Anuja Chaudhary, was availing prenatal care during her first pregnancy from one experienced gynaecologist in Delhi. However, for the proposed delivery reposing faith and trust in Dr. Shanti Roy  the leading practicing Gynaecologist in Patna,  the patient's in-laws took an appointment with O. P. No. 2 who agreed to perform delivery on her own in   Shivam Hospital & Research Institute ( for short 'the hospital- O.P. No 1).   On 4.5.2002 the patient with her husband Mr Sanjay Kumar (the complainant no.2) reached Patna and visited O.P. No. 2. The ultrasound (USG) was performed and, the condition of baby and mother was normal as per USG report.  The expected date of delivery (EDD) was 13.06.2002. The O.P. No. 2 informed that the delivery shall be normal and patient was called after 20 days.  Accordingly, on 25.05.2002, the patient visited the O.P. No. 2 who examined her and reassured the complainants that she shall perform the delivery on her own and do not worry everything is normal. The O.P. No. 2 called the patient again on 03.06.2002.  On 03.06.2002, though the patient was normal without any gynec or obstetric related problems, the O.P. No. 2 asked the patient to get admitted at 9 am. It was alleged that on the same day, a nurse gave enema to the patient to clear bowel. The O.P. No. 3 Dr. Sarikar Roy started the treatment of the patient without consent of her husband or other family members. They paid Rs. 100/- for admission fee and Rs. 20/-for administration of enema, but payment receipt was not given. On 04.06.2002 at about 2.00 P.M., the mother-in-law of the patient on hearing patient's screaming and cries went to the labour room and found the patient was crying with severe pain in stomach because of some medicine applied by O.P. No. 3. The mother-in-law of the patient found a packet of "Cerviprime Gel" lying on the ground, which was to be used to induce artificial labour pains. The patient alleged that as O.P. No. 3 applied that medicine and soon after the child's movements in womb were stopped. The patient's father in law was extremely surprised to know that O.P. No. 2 induced labour needlessly even when everything was normal. The patient's in-laws contacted O.P. No. 2 doctor at her residence, but to no avail. The normal delivery was conducted by O.P.No.3 at around 5.15 pm and she left the labour room after directing the nurse to stitch the patient's wound. O.P. No. 2 at about 6.00 pm came to hospital and went inside her chamber adjacent to the operation theatre without seeing the patient.  It was alleged that after the delivery the new born was in serious condition and was kept on oxygen as its body was turning blue. The patient was crying with pain, which her mother-in-law saw the patient was bleeding profusely and her body was getting cold. The mother-in-law came running out and apprised the condition of patient to her husband. The father in law of patient requested O.P.No.2 to see the patient, but she sent O.P.No.3 who could not stop the bleeding nearly for one hour. O.P.No.3 asked the attendants to arrange 5 bottles of blood immediately. Thereafter, O.P.No.2 took the patient in the OT without informing patient's relatives and after 2 hours brought the patient outside the OT in unconscious state. On enquiry nothing was come out from the doctors. On the next day i. e. on 5.6.2002, only after perusing the medical record /the patient notes of last night, the father-in-law of patient came to know that the operation for removal of uterus was performed by O.P. No. 2 in the last night without knowledge and consent of the complainants or their family members. Upon enquiry about the episode the O.P. No. 2 got infuriated and on her direction, the patient's husband, his brother and father were humiliated and driven out of her chamber. The O.P. No. 2 and her staff also threatened them of dire consequences.   At about 3 PM on 08.06.2002 the transfusion of blood was going on, the patient's attendants were beaten up by 20-25 people of O.P. No. 2. The henchman of O.P. No. 2 inter alia took away all documents and papers of patient. The father in law of patient lodged a police complaint for aforesaid incident however the police were influenced and trying to side with the O.P. No. 2, therefore he  had a to file a protest petition before the Hon'ble Court of Chief Judicial Magistrate, Patna, which is still pending there. That interestingly as an afterthought, the security guard of the O.P.s also lodged a false & frivolous complaint with the police against the patient's attendants. The aforesaid incident and tragedy was widely covered by electronic (TV channels) as well as print media. As a result on 08.06.2002 the relatives of the Complainants shifted the patient to M.G.M. Hospital and treated further under care of the Gynaecologist Dr. Pragya Mishra.The complainants filed the complaint before this commission on being aggrieved by the treatment of O.P. No. 2 who unlawfully removed the uterus of the patient and deprived of another child in future. They have to suffer great mental agony throughout their lifetime. The complainants sought total compensation of 35,51,690/- from the opposite parties.

DEFENCE:  The opposite parties - Dr. Himanshu Roy, the President and Board of Director of Shivam Hospital (O.P. No.1), Dr. Shanti Roy (O.P. No. 2) who is mother of Dr. Himanshu Roy and Dr. Sharika Roy (O.P. No. 3) wife of Dr. Himanshu Roy  filed  common written statement and  along with their affidavits. O.P.s denied any deficiency or negligence on their part.   O.P.s submitted that, on 03.06.2002 O.P.s No. 2 and 3 examined the patient and found that she had mild contractions but the cervix was not dilated. The rectum was loaded, therefore she was admitted. On the next day, i.e. on 04.06.2002, as labour pain did not increase, the pregnancy period had already reached more than 39 weeks and as use of Cerviprime gel has no contra-indication, it was applied at about 1 pm to induce pain. It is an accepted standard practice. It was done with full knowledge and consent of the patient and her mother-in-law. They were aware that labour was not progressing and there was no foetal distress. O.P. No.2 conducted normal delivery and a healthy male was born. The suturing of the episiotomy wound was done by the O.P. No. 2 with the help of O.P. No. 3. While suturing the episiotomy wound the patient started bleeding, it was the post-partum haemorrhage (PPH). Therefore, immediately steps were initiated to stop the bleeding by uterine message and use of Oxytocin injections eg. Ergometrine, Prostaglandin. The Oxytocin drip was started, but the bleeding did not stop completely. On examination, the blood was coming from the uterus; there was neither laceration nor tear of cervix or in the genital passage. The condition of the patient was deteriorating, therefore it became mandatory to open the abdomen to control uterine bleeding. Patient's mother-in-law who was present outside the labour room was apprised of the situation and explained that even hysterectomy might be required. In the meanwhile another senior colleague  Dr. Alka Pandey a practicing senior Obstetrician and Gynaecologist who was already called by the Opposite Parties who also expressed the need for opening the abdomen of the patient. Dr. Alka Pande and O.P. No. 2 opened the abdomen and performed the Bilateral Internal Iliac artery ligation and the uterine Branch of Ovarian Arteries. However, the bleeding stopped only for 8-10minutes. Then B-lynch sutures were inserted but it also failed, the bleeding did not totally stop. The condition of patient gradually became very serious. She was on continuous cardiac monitoring. Her pulse rate was fluctuating (140-160/min) the systolic Blood Pressure dropped to 70 mm of Hg. Under such dire circumstances, main aim of the O.P. No. 2 was to save life of the patient Anuja at any cost. Therefore, the emergency hysterectomy was performed as an accepted practice. It was not a medical negligence.

Arguments on behalf of the Complainants:
The learned counsel for the complainants submitted that the EDD was 13.06.2002 and as per the ultrasound report, the mother and foetus were normal. There was no need for premature induction of labour pain, but O.P. No. 3 - Dr. Sarika Roy induced labour with 'Cerviprime Gel' on 04.06.2002 i.e. 23 days before the EDD. The patient did not give consent for the said treatment. The O.P. No. 3 performed the normal delivery on 04.06.2002 at 05.15 P.M. The condition of the child was not good. The  counsel further submitted that due to application of 'Cerviprime Gel', there was foetal distress and rapture of the uterus after the delivery. There was continuous profuse bleeding after delivery and as a result, without knowledge and without consent of the patient or their relatives the OP 2 and 3 removed patient's uterus illegally and made vague statement in their written statement that a verbal consent was taken from the mother of the patient.   The opposite parties were in possession of the treatment record of the patient but deliberately have not produced the relevant record before this Commission with a view to camouflage the truth and mislead this Commission. Thus, the opposite parties violated the MCI Regulations. Thus, the question why patient was induced prematurely remains unanswered. The counsel brought our attention to the opinion (Annexure-P-7) and affidavit filed by Dr.Rajinder Thakur, a Gynaecologist and Obstetrician who was the father-in-law of the patient and he was cross examined also. The patient and their relatives were kept under dark, the hysterectomy done by O.P.s in to light when Dr.Rajeinder Thakur saw the treatment papers on the next day of delivery. The opposite parties have not mentioned the presence of Dr. V. K. Sinha and Dr. Parmod during of hysterectomy operation. Dr. Alka Pandey, has filed a false affidavit of evidence to save O.P. No. 2 as admittedly, she was her teacher under whom O.P. No. 2 had worked in Patna Medical College Hospital.  Counsel further submitted that O.P. No. 3 is a daughter in law of O.P. No. 2, who has no experience in such treatment.

Arguments on behalf of the Opposite Parties:
The learned counsel for the opposite parties reiterated their affidavits of evidence. He further submitted that the delivery of child was uneventful, but the patient developed Atonic PPH, which was not controlled by conservative methods, therefore, emergency hysterectomy was performed. The O.P. No. 2 doctor gave various Oxytocic, like injection Ergometrine, Prostodin   and Oxytocin drip was administered besides other IV infusions. There was no evidence of laceration in the genital passage like cervical or vaginal tears or uterine perforation. The O.P. No. 2 performed 'B-Lynch suturing' but that too did not stop bleeding. The patient became very serious having low BP and high pulse rate. The patient was given few units of blood transfusions. The best line of treatment was adopted by the opposite parties and it is an accepted medical practice. It is further submitted that the patient's mother was informed about the serious condition and requirement of the removal of the uterus. After the Hysterectomy operation, the patient was continuously observed for the post-operative complications like, renal failure, coagulation failure, embolism, etc. Lastly, the learned counsel submitted that  the present complaint  was filed maliciously against the doctors, it is not maintainable as the complainants are not come within the definition of the 'consumers' as under section 2(1)(d) of the Act,1986.and the claim made by the complainants is totally arbitrary.

FINDINGS AND REASONS:
The patient Anuja was admitted for delivery under care of Dr. Shanti Roy (O.P. No. 2) at O.P. No. 1 hospital. The O.P. No. 3 Dr. Sakira Roy a gynaecologist who is a daughter in law of O.P. No. 2 also assisted during the delivery and thereafter. We note the patient at the time of admission has already reached 39 weeks and having weak labour pains. O.P. No. 2 waited for spontaneous labour, and as there was no increase in labour pain on 04.06.2002 Cerviprime Gel was applied at 1.00 pm which was not contraindicated. The delivery was conducted smoothly by O.P. No. 2 with an episiotomy also performed.  The healthy male baby (APGAR score 10/10) was delivered and thereafter, suturing of episiotomy was done by O.P. No. 2. At that time of suturing patient started bleeding, therefore O.P.s No. 2 and 3 initially started the conservative method like uterine message with uterotonic injections (Ergometrine, Prostalandin), with Oxytocin drip, but the bleeding did not stop. There were no genital injuries, however the blood was coming from uterus thus it was diagnosed as "Atonic PPH". After the uterine and cervical packing, the bleeding was stopped for ½ an hour, but it recurred again. Thereafter, immediately the colleague gynaecologist of O.P. No. 2, Dr. Alka Pandey was called to assist O.P. No. 2. The patient's abdomen was opened (laparotomy) and performed bilateral internal iliac artery ligation. B-lynch sutures were inserted, but the bleeding did not stop completely. The patient's condition was deteriorating, the pulse was fluctuating and there was fall in blood pressure. Therefore, to save the life of the patient O.P. No. 2 took decision of emergency hysterectomy. The mother of the patient available near OT was called and informed about need for emergency hysterectomy. The bleeding was stopped after hysterectomy and the patient started improving. Thereafter, patient was kept under observation of O.P.s No. 2 and 3 to for the unexpected complications like thrombo-embolism, renal failure and DIC etc.  We also note few number of blood units were transfused the patient. It is pertinent to note that   Dr. Rajinder Thakur, a senior Gynaecologist and a father in law of patient gave his opinion in the instant case. However, as per the medical literature   for induction of labour, the doctor can take decision for induction of labour in case of delay in spontaneous labour. Certain medicines and use of Cerviprime Gel is not contraindicated. In the instant case O.P. No. 2 waited till 1.00 pm on 04.06.2002, but the pain/ uterine contractions were not increasing, therefore Cerviprime gel was used for induction of labour. It is an accepted standard of practice. Also, performing an episiotomy by the O.P. No. 2 was not wrong. As per the literature during first delivery to avoid perineal tear, about 90% cases require episiotomy.  The opinion of Dr. Rajinder Thakur is not acceptable to us, as it was given to support the complainants' case, a biased one, he was an interested party (father in law of the patient).   In the instant litigation the complainants have raised few unwanted and unwarranted issues   like media coverage of the tragedy, the manhandling by the sides, the income tax raid on O.P. hospital, non-maintenance of medical record and non-issuing birth certificate of the baby etc. It is not subject matter and is not relevant to this consumer complaint; therefore we refrain and not so inclined to discuss it.   Complainant may seek remedy from as per law through the proper authorities.

 In the instant case, in our view the O.P.s have performed their duties to their best of ability with due care, caution and diligence  We do not find any deficiency / negligent in removal of uterus, as it was essential in that condition to save the life of the patient - mother. Moreover, as the patient's ovaries had been left intact; she has not lost totally her chance to have another child, through available advanced medical techniques like assisted reproductive technology/ surrogacy etc.  It is also significant that both, the baby boy, and the patient mother, survived, and leading normal life.  Notwithstanding the afore, in our opinion, the O.P. No. 2 had not done any deficient or negligent act by removing the uterus, in the facts and circumstances of this instant case, and principally to save the life of the patient, which decision the operating gynaecologist took in her considered professional wisdom, in consonance with the Hippocratic oath ("I will use treatment to help the sick according to my ability and judgment, but never with a view to injury and wrong-doing."). In the present case the line of treatment adopted by the O.P. doctors was in accordance with practice accepted as proper by the medical men skilled in that particular branch. The complainants did not allege about the ability and skill of the doctors. The operating gynaecologist in her defence has averred in a straightforward manner that her duty was to save the life of the patient. In her opinion, in the operation theatre, seeing the condition of the patient, removal of her uterus was in the best interest of the patient, to save her life. She could, and should, have done the procedure in her considered professional wisdom. Still, she momentarily came out of the operation theatre and took the oral consent of the mother of the patient, who readily told her to do whatever is required to save the life of her daughter; at that time, the patient's husband and father-in-law were not available outside the operation theatre. We do not agree with the opinion given by Dr. Rajendra Thakur, who, though himself a gynaecologist, is the father-in-law of the patient. 

Medical literature:
On the subject of normal delivery, the PPH and the Management of Obstetric & Hysterectomy we have gone through the standard text books and few medical articles. [William's Obstetrics and Text book of Dr. D.C. Dutta] Postpartum haemorrhage (PPH):
Obstetric haemorrhage is associated with increased risk of serious maternal morbidity and mortality. Postpartum haemorrhage (PPH) is the commonest form of obstetric haemorrhage, and worldwide, a woman dies due to massive PPH approximately every 4 min. As per WHO the PPH is generally defined as blood loss greater than or equal to 500 ml within 24 hours after birth, while severe PPH is blood loss greater than or equal to 1000 ml within 24 hours. PPH is the most common cause of maternal death worldwide. Most cases of morbidity and mortality due to PPH occur in the first 24 hours following delivery and these are regarded as primary PPH whereas any abnormal or excessive bleeding from the birth canal occurring between 24 hours and 12 weeks postnatally is regarded as secondary PPH. PPH may result from failure of the uterus to contract adequately (atony), genital tract trauma (i.e. vaginal or cervical lacerations), uterine rupture, retained placental tissue, or maternal bleeding disorders. Uterine atony is the most common cause and consequently the leading cause of maternal mortality worldwide. WHO Recommendation: If bleeding does not stop in spite of treatment with uterotonics, other conservative interventions (e.g. uterine massage), and external or internal pressure on the uterus, surgical interventions should be initiated. Conservative approaches should be tried first, followed - if these do not work - by more invasive procedures. For example, compression sutures may be attempted first and, if that intervention fails, uterine, utero-ovarian and hypogastric vessel ligation may be tried. If life-threatening bleeding continues even after ligation, subtotal (also called supracervical or total hysterectomy) should be performed. 

(extracts from WHO guidelines for the management of postpartum haemorrhage and retained placenta) Postpartum Hysterectomy:
Postpartum hysterectomy refers to hysterectomy done e. ther after vaginal delivery or caesarean delivery. In modern obstetric practice, it is a major operation being associated with a high rate of morbidity and mortality. The major indications for emergency postpartum/obstetric hysterectomy (EOH) include placenta previa; placenta accreta, increta, and percreta; and uterine rupture. Thus, most of such hysterectomies are unplanned and often performed as an emergency for obstetric haemorrhage which doctors are unable to stop or there is undiagnosed abnormal placentation. The most common indication of EOH was uterine atony (25%) followed by morbidly adherent placenta (21%) and uterine rupture (17%).In spite of the availability of uterotonics agents and a variety of uterus sparring surgical interventions, the obstetrician will be faced with the dilemma to choose a conservative or an aggressive management. The treating doctor/surgeon is sometimes in a dilemma whether to sacrifice a woman's reproductive capability especially if she is of low parity. It also depends upon the woman's desire for preserving fertility but further delay in emergency postpartum hysterectomy may lead tosevere morbidity or maternal death. If all attempts at arresting bleeding have failed, subtotal or total hysterectomy is attempted as a last resort and life-saving measure.

The preoperative risk factors include previous history of caesarean section, placenta previa and accreta. Obstetric shock index may help in avoidance of under estimation of blood loss and the use of tranexamic acid, oxytocic and timely peri-partum hysterectomy will help to save lives. Due to the complexity of the surgery and decision making, the involvement of an experienced obstetrician at an early stage is desirable.

The life-threatening haemorrhage i.e. in cases of haemodynamic instability the decision to perform a hysterectomy should not be delayed. Therefore subtotal hysterectomy is preferred because it is associated with minimal risk of visceral injuries and blood loss. It needs short operating time and hospital stay. It is known that women with abnormal placental adhesion were approximately two times more likely to undergo total than subtotal hysterectomy. The decision to escalate surgical management to hysterectomy should be made by the most senior and experienced obstetrician.

HELD: It is pertinent to note that, that regular antenatal care, identification of high risk factors, close monitoring of labour, active management of the third stage of labour, and to avoid difficult vaginal delivery the timely decision to do caesarean can reduce the incidence of EOH. In the instant case, on the basis of medical record, it is evident that   the patient was under care of O.P. No.3 during antenatal period and as per standard protocol patient was monitored.  In our view the O.P. No. 3 Dr. Sarika Roy adopted conservative measures till the patient was   hemodynamically stable. Patient was transfused about 10 units of blood, but the intractable obstetrical haemorrhage of the patient was unresponsive to all measures and, thus, to save the life of patient from obstetric shock, OP No.3   performed an emergency subtotal hysterectomy.     Based on the foregoing discussion, in the obtaining facts and circumstances, we do not find it feasible to attribute negligence / deficiency on the opposite parties. The Complainants have failed to establish deficiency / negligence against the treating doctors. On the contrary, we find the Complaint to be frivolous and vexatious. We are however refraining from imposing cost. The Complaint, sans merit, is dismissed.


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