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.

Advise for abortion

Advise for abortion

REVISION PETITION NO. 2398-2399 OF 2018 DAKSH HOSPITAL & ANR.  Versus MANJU SAINI & ANR pronounced by the Hon’ble National Consumer Disputes Redressal Commission on  18 March, 2020        

"Pregnancy isn't always easy, but, just knowing your baby is growing inside of you is one of the most rewarding experience a woman can enjoy. Life's biggest miracle is the gift of having life growing inside of you.  Moreover, any woman who has felt a baby stir inside her and any man, who has seen the tiny heart pulsating on an ultrasound screen, know that abortion is about ending a life."

FACTS:On 04.07.2011 Smt. Manju Saini approached Dr. Monika Gupta, Gynecologist at Daksh Hospital. After examination, the Urine Pregnancy Test (UPT) was positive and Ultrasonography (USG) was performed at OP-1 Hospital. It was alleged that, USG was reported as the fetus was dead. There was danger to patient's health also. The OP-2 gave advice to undergo Dilatation and Curettage procedure (D&C), but the complainant denied for the D&C. Therefore, for aborting the fetus OP-2 gave medicines (tablets).  The complainant was under fear and stress due to advice of OP-2, therefore for her further treatment she got admitted in Rajkia Mahila Hospital at Alwar. Again on 05.07.2011, USG was got done at Cure well Diagnostic Centre and reported as healthy fetus of 6 weeks 2 days. The complainant got scared   because of the error made by OP-2 and under apprehesion that if she   continued the medicines for aborting the child she might have suffered more serious problems. She would have lost her life as well as the fetus.  Thereafter, she continued her pregnancy and gave birth to a healthy male child on 18.02.2012. Being suffered by physical and mental agony due to the careless duty of OP-2, the complainant filed a consumer complaint before the District Forum, Alwar, for seeking compensation of Rs. 75,000/- along with Rs. 10,000/- as cost of litigation. The District Forum on hearing the parties, allowed the complaint and directed the OPs to pay Rs. 75,000/- alongwith cost of litigation of Rs. 5,000/- within one month failing which the entire amount of Rs. 80,000/- shall carry interest @ 9% per annum thereafter.    Being aggrieved, the OPs-1 & 2 filed first appeal no. 87/2017 and the United India Insurance Co. (OP-3) filed first appeal no. 103/2017 before the State Commission Rajasthan at Jaipur.   The State Commission dismissed the appeal filed by the hospital and doctor, whereas allowed the appeal of the insurance co and the claim against the insurance co. was set aside.

FINDINGS: The prescription of the OP-1 hospital dated 04.07.2011 revealed that 22 years patient - primi-gravida with history of two month's pregnancy and occasional bleeding PV.  The UPT was positive. The USG done at OP-1 hospital revealed the gestational age 5 week 6 days and reported as "products in uterine cavity". The OP-1 suggested  D & C procedure for evacuation of products but not opted  by the patient, therefore   OP-1 prescribed  medicines  namely Tab  Anofer SP10 tablets and Prestakind 200 mg  4 tablets.  We further note the patient on next day (05.07.2011), got done another ultrasound at Cure Well Diagnostic Centre on advice of Dr. Uttara Aggarwal for fetal well-being. It was reported as Embryonic heart is positive, " single live uterine pregnancy of 6 weeks 2 days size". The USG was performed by qualified radiologist.   In our view, it was glaring failure of duty of care and negligence on the part of the OP-2 who merely on the symptoms of bleeding PV concluded that it was a case of miscarriage. Moreover, the USG report performed at OP-1 is unsigned and whether it was done by qualified radiologist. The report is devoid of findings of fetal heart and stated to be 5 weeks 6 days of pregnancy. In our view, directly advising D&C  to  the patient  is the failure of duty of care on the part of the OP-2.   We further note that the OP-2 advised 4 tablets of  Prestakind 200mg for abortion of the fetus.   On the next day only,  2nd USG   was done at Curewell Diagnostics, it was performed by a qualified Radiologist Dr. Rajesh Chandak  who confirmed a single live uterine pregnancy. We note the complainant was 22 years and primi gravida i.e. first pregnancy. The treating doctor OP-2 should be more  careful and cautious to decide D & C. In our view, advising either D&C or  abortifacient   drug Prestakind was unwarranted to the primi.  Certainly such advise creates a fear and agony in the mind of primi having a precious pregnancy.  We have gone through the Pharmacology and the drug literature on Tab. Prestakind 200 mg.  The OP-2 prescribed Tab. Anofer SP (elemental iron, folic acid, cyanocobalamin and zinc) used for anemia. The drug Prestakind Tablet is a Misoprostol - an abortifacient is used for pregnancy termination and legal abortion. The drug Misoprostol is likely to harm an unborn baby, can cause birth defects and premature birth. The drug can also harm the pregnant woman, causing uterine rupture, uterine bleeding, miscarriage, or an incomplete miscarriage.   Despite the fear the patient continued her pregnancy and delivered healthy baby on 18.02.2012. In the instant case admittedly from the hospital pharmacy the patient purchased the Tab. Anofer SP and   Prestakind four tablets on the advice of OP-2. However, the complainant is silent on whether she has consumed those tablets or not. In our considered view the advice of D & C and prescribing Prestakind certainly a cause of mental agony to the primi- gravida. 

HELD:      Based on the foregoing discussion and in the obtaining facts, in our considered view, it was not an error of judgment, but it was failure of duty of care, negligence per se.   We find no misappreciation of evidence, or jurisdictional error, or a legal principle ignored, or miscarriage of justice, in the impugned Order of the State Commission. The Order dated 15.05.2018 of the State Commission is affirmed. The Award made by the State Commission is confirmed. The revision petition is dismissed.

Anesthesia, Bradycardia

Anesthesia, Bradycardia)

FIRST APPEAL NO. 101 OF 2016     PANKAJ R. TOPRANI Versus        BOMBAY HOSPITAL AND MEDICAL RESEARCH CENTRE Decided by the   National Consumer Disputes Redressal Commission  New Delhi  on 04.07.2019

FACTS: Mr. Ranjit Toprani was operated in the Hospital by Dr. Desai, Patient was 73 years old and died during the pendency of the Complaint. He was admitted in the Hospital on 26.06.2004  and operated for Carcinoma of the Sigmoid Colon, was recommended to Dr. Desai by Dr. J.C. Kothari, who is attached to the Hospital, was certified fit for Surgery by the In-House Intensivists of the Hospital and Physician Dr. Wagle , who went through the Patient's history, which include urticaria, glaucoma tension in the eyes, chronic depression, for which the Patient was under medication since the past 20 years. The ECG report showed that there was an old septical MI  and the 2D ECHO displayed 60% pumping heart rate. It was averred that  Dr. Wagle went through all the medications and prescriptions of the Patient and certified him fit for the Surgery scheduled to be performed on 28.06.2004 by Dr. Desai. After the Surgery, the attendants and the Patient were informed by Dr. Desai that the Operation was successful and that the Patient would be transferred to the ward. While the Patient and his family members  were waiting for the personnel to shift the Patient to the ward, to their shock, the Patient was shifted to the post-operative ICU, which was situated on the third floor of the Hospital building, that the shifting was being done to keep the Patient under observation THOUGH the daily notes of the Anaesthetist showed that the Patient was supposed to be shifted to the ward. But Dr. Desai in his report noted that the Patient be shifted to the post-operative ICU, though he  had earlier informed the Patient and his family Members that he would be shifted to the ward. The Patient was awake and was mentally disturbed and questioned as to why he was brought there. On the next date, i.e. 29.06.2004 the Patient complained of lack of sleep and pain in the abdomen and requested for a pain killer. At 8.45a.m., the Patient complained of throat pain, breathlessness and of a choking sensation.  While the Patient's attendant, waited outside the ICU, unaware of the Patient's condition, suddenly there was a commotion inside the ICU and they saw the Patient having convulsions and was being helped to breathe with the help of  an Ambu bag. The attending Doctor, who is the assistant of Dr. Desai informed the attendants that the Patient had suffered a Bradycardia Attack and had to be resuscitated. The Ambu bag was replaced with the ventilator, the only one available in the ICU. The Patient's family members were worried and requested the attending Doctor to call for the Cardiologist immediately and administer necessary treatment but they were informed that he would have to wait for the Intensivists i.e. Dr. Wagle to call for a Cardiologist. But Dr. Wagle was not available and did not turn up for a long period of time. It was only after about 2 ½ hours, that the Patient was instructed to be shifted to the ICU on the 12th floor. It is averred that there was no reference made to the Cardiologist. The family members of the Patient were helpless seeing their father continuing to have convulsions. Thereafter, the Cardiologist Dr. Satyavan Sharma arrived after Mr. Janak Toprani, the Patient's son requested him to attend to the Patient. He observed in his remark that the cause of Bradycardia Attack cannot be explained. According to him the cause of Bradycardia Attack was due to sudden pain,  fear or anxiety. The matter was referred to a Neurologist. The family members of the Patient averred that Dr. Wagle, did not find it a fit case to refer the Patient to Neurologist, despite the fact that the Patient was having convulsions.  The Patient was shifted to the ICU on the 12th floor of the new building without the use of any portable ventilator in spite of his being on the ventilator earlier and in spite of his being in a state of convulsions. He was given the support of only an Ambu bag and an oxygen cylinder. Once taken to the 12th floor ICU, the Neurologist Dr. N.E. Bharucha gave the Patient some medicines to stop the convulsions. It was averred that as the Patient's condition was critical, the Complainants did not give permission for a CT Scan as the Patient was in a state of convulsions and it is not possible for a CT to be performed. The Patient remained in the ICU of the 12th floor till 07.07.2004 and thereafter he was shifted to a ward on the same floor. The Patient was unconscious and he was examined by a team of doctors including Dr. Wagle. On 15.11.2004, the Doctors examined him at around 9.30 a.m. and noted that there was no change in the Patient's condition at around 11.30 a.m. The relatives were informed by physiotherapist Dr. Ashaben Andhyal, that the Patient has developed congestion in the lungs and Dr. Wagle shifted the Patient to the 12th floor ICU, where the Patient was put on a ventilator. He remained in the ICU for 8 days and thereafter was shifted to the ward on 22.11.2004. It was averred that the Patient never regained his consciousness and remained in the Hospital till 14.02.2005 and thereafter he was brought home and has been on the support of an oxygen concentrator. In the discharge summary given on 14.02.2005, it was stated that the 'Patient is unconscious in a vegetative state'. It was pleaded that there was no apprehension of the surgeon prior to the operation that the Patient would suffer from any such post-operative complications. The vegetative state is an outcome of severe brain injury and the Patient's heart did not show any signs of  any problem for about 17 months subsequent to the discharge. It was only on account of negligence of the Hospital and the doctors that the Patient developed a brain injury and died during the pendency of the Complaint, based on the following grounds:

Though the Anaesthetist and Dr. Desai has initially remarked that the Patient would be shifted to the ward, he had shifted to the ICU.

The cause of the alleged Bradycardia was not explained, the respiratory problem was not attended to immediately.

There was negligence in stopping the Patient's anti-depressants abruptly without consulting a Psychiatrist.

Though the Patient complained of lack of sleep and pain and did not sleep till 2 a.m., the Doctors did not administered proper dose and did not consult a Psychiatrist.

The Patient was kept in an inadequately equipped and mismanaged ICU without proper qualified Doctors, on account of which the Patient has to be shifted from one ICU to another.

There was negligence in shifting the patient from one ICU situated on the third floor of one building to another ICU situated on the 12th floor of another building without the support of a portable ventilator, which resulted in the Brain condition deteriorating.

Though the Patient's condition became critical at 9 a.m., Dr. Wagle arrived belatedly only at around 11:30 a.m. and the shifting was done at 1 p.m., by which time, the Patient's condition worsened.

The physiotherapy session given at 8.45 a.m. was improper and within 15 minutes the Patient complained of breathlessness and was allegedly diagnosed of Bradycardia.

There is gross negligence in the diagnosis and the treatment of the Patient, who was active till his Surgery and was a practicing tax advocate.

DEFENSE:   Dr. Desai filed his Written Version stating that the Patient had undergone Surgery on 28.06.2004, he was absolutely normal subsequent to the Surgery; that the Surgery went on smoothly, stitches healed nicely and therefore there is no negligence on his behalf as the Surgery was performed by him and it was successful, allegation against the Doctor was that post Surgery he had directed the Patient to be shifted to the post-operative ICU, when the Anaesthetist has recommended that the Patient be shifted to the ward. It was averred that since the Patient was 72 years of age, it was only as a matter of abundant caution that he has suggested that the Patient be shifted to ICU for monitoring for  a day or so. Drugs that were administered from the time of admission till the time of operation: T. Cilentra 1 od - 8am T. Primox ½ bd - 10 am : 10pm T. Alprax 0.5 mg bd - 8am : 8pm T. Trazine H - ½ od - 8 pm T. Mitaz 7.5 mg old - 10 pm.  These drugs were withheld because of anaesthesia, which was administered and the decision was taken by the Anaesthetist, subsequent to the Surgery the Patient was given pain relieving injections and sedition with Tramadol and an injection of Calmpose and Patient was stable throughout the night, that administration of physiotherapy was not done on his instructions and that it is a normal post-operative procedure, which is carried out after all surgeries and does not require recommendation of any doctor; the Patient collapsed due to severe Bradycardia and it appears from the case sheet that immediate resuscitative measures were taken and that necessary drugs were administered; that a senior Doctor from the adjoining ICCU was summoned, who promptly  inserted the endotracheal tube to maintain his breathing; the Patient was stable and upon the advice of Dr. Wagle, he was transferred to 12th floor ICU, which had better facilities where one nurse is dedicated to each Patient; that on 04.07.2004 the Doctor had performed 'Tracheostomy' on the Patient by bedside; that the role of the surgeon is a back seat role and the Intensivist takes over and looks after the recovery of the Patient; that despite the same, the Doctor and his team repeatedly visited the Patient to make sure that he was being monitored properly; that the  usual pain medication (tramadol 100 mg and calmpose 10 mg) were given at 4 p.m., 10 p.m. and 2 a.m., respectively; that the Patient was shifted to ICU on the 12th floor with an Ambu bag to continue his oxygen supply, which is a normal practice and thereafter he was put on the ventilator; Bradycardia developed due to unexplained reasons, which cannot be attributed to Surgery or any post-operative complications. Dr. Wagle filed his Written Version stating that he was not aware as to what had transpired between the Complainant and his family members and the junior Doctor assisting  Dr. Desai; that Dr. J. C. Kothari was called to the post-operative ICU before he had reached the ICU; that he was not aware that the Patient demanded that the Cardiologist be called immediately; that it was only on his instructions, the Patient was shifted from post-operative ICU to the ICU on the 12th floor; the Doctor denied that he did not refer the case to the Cardiologist; the Patient was given support of Ambu bag and oxygen cylinder, which is a normal practice; the medicines to stop convulsions had been started before the Patient was shifted to the 12th floor; the Complainants did not give permission to perform a CT Scan; denied that on 15.11.2004 at about 11.30 a.m., he confirmed that the Patient had severe congestion in the lungs as a result of which the Patient would be required to be shifted to the 12th floor; that the Doctor noted in the case papers that the Patient was suffering from lung pneumonia  on that day and for the purpose of observation he was shifted to the 12th floor ICU; that he had no occasion to examine the Patient after June 2005;that he is not aware of the subsequent treatment and the discharge of the Patient as he did not examine the Patient after June 2005; that the actual cause of the complication remained undetected because the Complainants did not cooperate with respect to CT Scan; that on 29.06.2004 at about 10.15 in the morning, when he was taking his rounds he received a call from the post-operative ICU on the third floor, at 10.20 a.m. he examined the Patient; he was in the Hospital since 8.15 a.m. but only received a call at 10.15 a.m.;  that before he reached the ICU the Patient  was also resuscitated by Dr. Shaikh as can be seen from the noting made by him on 29.06.2004; the Patient was unconscious and hemodynamically stable and the ECG did not show any fresh changes and the blood gas examination showed acidosis. It is averred that at around 10.45 a.m.  the Cardiologist Dr. Satyavan Sharma reached the ICU and confirmed his finding, the same treatment was continued and no further drug was added. The Patient was referred to Dr. N.E. Bharucha, Neurologist who also advised to continue Eptoin, Midazolam and added Clonazepam. The Doctor averred that the case papers show that two hours prior to the transfer of the Patient from post-operative ICU to the 12th floor ICU, the Patient was in a stable condition, his blood pressure was normal, his oxygen saturation was 60%, he was administered anti-convulsions, his heart rate was monitored throughout the transport and the Patient's condition did not deteriorate during the transfer, that the Patient was ventilated with an Ambu bag, as the Patient did not require PEEP or high IE ratio to maintain oxygenation and the transport time was short. It was a standard procedure to transport the Patient with a hand ventilator or an Ambu bag and a portable ventilator was not used at that stage. On 15.11.2004, the Patient developed lung infection and not severe congestion as alleged, the chest X-ray taken confirms this finding,  it is not unusual for a Patient with tracheostomy for five months to develop such an infection, even after the Patient was discharged and till June 2005, whenever the Complainants messaged him, he visited the Patient's residence and examined the Patient and suggested appropriate treatment. His advice was sought whenever necessary and he had adhered to all standards of due care and caution and there is no negligence on his behalf.

FINDINGS: The Complainants submitted that there was a variation in the oral and written communication of Dr. Desai and the Anaesthetist regarding the decision to shift the Patient to the ICU. The Complainants family contended that Dr. Desai specifically mentioned to the attendants that the operation had gone well and the Patient would be shifted to the ward. Even in the operation report the Anaesthetist remarked that the Patient to be shifted to the ward. But once again in the same report Dr. Desai had directed to shift the Patient to the ICU. It was the Complainants' case that the Doctors failed to apply their mind with respect to shifting of the Patient. It was also the contention of the Complainants that the process of shifting per se was not as per standards of protocol and also that there was a time lapse in the shifting, which caused deterioration in the condition of the Patient. The Patient was ordered to be shifted at 10.30 a.m. but was finally shifted around 1 p.m. It is the Complainants' case that the Hospital and the Doctors were negligent in shifting the Patient from one ICU, which is situated on the 3rd floor in one building to another ICU, which is situated on the 12th floor of another building, while the Patient's condition was unstable and critical. It was further contended that when the facilities in both the ICUs, listed in the Hospital rate card are the same, there are no substantial grounds for the Patient to be shifted from one ICU to another in this critical condition. The Complainants who were present in person further contended that there were no qualified doctors in the first ICU and therefore they had to shift the Patient to another ICU; the reasons for transfer was not given; that records of ICU from 8 a.m. to 9 a.m. were missing; that when amount paid is the same, the Patient is under the impression that both ICUs have the same facilities. The Complainants further argued that the cause of the alleged Bradycardia was never explained to them and that it had occurred due to the possible respiratory problems in the ICU and known cause of any heart induced problem. It is their case that only because timely assessment of the respiratory problem was not done, that the Patient went into a brain dead situation because of deprivation of oxygen.  Learned Counsel appearing for  the Hospital and the Doctors vehemently contended that the medical record made it abundantly clear that the Patient developed Bradycardia, i.e. a medical condition of slowing of the heart rate, due care and caution was taken as per standards of normal medical practice, which include immediate resuscitation measures, administration of drugs, which were administered by the attending nurses in the ICU under the supervision of a senior doctor who was immediately summoned from the adjoining Intensive Critical Care Unit (ICCU). It is submitted that the Patient was stable with the heart rate, respiration and oxygenation being stable. Dr. Wagle  was consulted and all the drugs suggested by him were administered. The material on record evidences that the cause for the Bradycardia was admittedly not explained. The Hon'ble Supreme Court in Smt. Savita Garg Vs. Director, National Heart Institute (2004) 8 SCC 56, has laid down the principle that the onus shifts on the Hospital to explain the exact line of treatment rendered and as to why a particular condition had occurred. In the instant case, it is for the Hospital and the team of Doctors to explain as to how the condition of Bradycardia had occurred. The contention of the Hospital and the treating Doctors that the Complainants did not give consent for CT Scan and therefore, there could not be any diagnosis and further that no expert evidence was led in the case is untenable in the light of the fact that admittedly the Patient had convulsions and was in a critical state and hence the Complainants had admittedly not given consent for the CT Scan. The Hon'ble Supreme Court in V. Kishan Rao Vs. Nikhil Super Speciality Hospital & Anr. (2010) 5 SCC 513, have observed that no expert evidence is necessary for every case and that the Consumer Fora can adjudicate the aspect of medical negligence based on the material on record, the medical literature and the submissions made by the parties. The necessity of expert evidence depends on facts and circumstances of each case and in the instant case we do not find it a fit case to refer it to any expert. Thought it is an admitted fact that the Complainants did not agree to the conduction of the CT Scan as the Patient was having continuous convulsions, yet we are unable to understand as to why the Hospital and the treating Doctors could not give any reasons for the onset of Bradycardia. There is no material on record to evidence that only the conduction of CT Scan could have explained the causes for the Bradycardia.  At the cost of repetition, admittedly there is no reason given for the onset of Bradycardia which has occurred post-operatively, when the Patient was in the ICU. In this aspect, we find the Hospital and the treating Doctors negligent, since the onus is on them to explain the reasons for the occurrence of Bradycardia. Now we address ourselves to whether there was any negligence on behalf of the Hospital in the process of shifting of the Patient from ICU of the third floor of one building to the ICU of the 12th floor of another building. It is the Hospital's case that the Patient was stable for the purpose of shifting from one ICU to another; the Patient was monitored throughout the transport; that even in the present ICU there were proper qualified Doctors and the only reasons for shifting to another ICU was because not that it was inadequately equipped as alleged by the Complainant, but only because there was one nurse attached to each bed and better care could be taken. It is the Complainant's case that the 3rd floor ICU was ill equipped and the Patient was shifted to the 12th floor in the critical condition and if both the ICU had the same facilities and rates, there are no reasons for shifting the Patient in such a critical condition. The Complainants argued that the Patient was not stable and having convulsions during the process of shifting to the 12th floor. A brief perusal of the ICU record of 29.06.2004, the date on which the Patient was taken to the 12th floor ICU, it is observed that the nurse has recorded that his condition was unsatisfactory, therefore the contention of the Hospital and the treating Doctors that the Patient's condition was stable, is untenable. It is also the Complainant's case that the submission of the Hospital and the treating Doctors that there would be better care in the 12th floor ICU, where one nurse is dedicated to each Patient, should not be taken into consideration as the Patient was being billed by the Hospital for provision of extra nurse. A reading of the bill, wherein extra charges were provided for the nurse evidences the same. Further reliance was placed on the brochure which mentioned that the same facilities would be provided in both the ICUs. Though we are of the considered view that the decision to shift  from one ICU to another, is the Doctors prerogative based on the Patient's condition, it is to be seen whether during the process of transporting the Patient any time lapse had taken place and the ' golden hours' as defined in the medical  dictionary have been lost. The record shows that the decision to shift the Patient was taken at 10.30 a.m. but the Patient was only shifted at around 1 p.m. The reasons for this 2 ½  hours gap is unexplained. For adjudicating this issue, we find it relevant to further take into consideration the contention of the Complainants that the Patient was transported only with an Ambu bag which is alleged is not in conformity with the standard protocol.It is the case of the Complainants that when the Patient was having convulsions, he was being helped to breathe with the help of an Ambu bag as there was only one ventilator in the said 3rd floor ICU. The Ambu bag was later replaced by a ventilator.

Learned counsel for the Hospital relied on the compilation regarding Ambu bag (Bag Valve Mask), given by the Complainants in which  it is stated as follows:

"A bag valve mask, abbreviated to BVM and sometimes known by the proprietary name Ambu bag or generally as a manual resuscitator or "self-inflating bag", is a hand-held device commonly used to provide positive pressure ventilation to patients who are not breathing to not breathing adequately. The device is a required part of resuscitation kits for trained professionals in out-of-hospital settings (such as ambulance crews) and is also frequently used in hospitals as part of standard equipment found on a crash cart, in emergency rooms or other critical care settings. Underscoring  the frequency and prominence of BVM use in the Unites States of American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiac Care recommended that "all healthcare providers should be familiar with the use of the bag-mask device". Manual resuscitators are also used within the hospital for temporary ventilation needs to be examined for possible malfunction, or when ventilator-dependent patients are transported within the hospital."

The question arises here is whether the Patient, who had a fit of convulsions and admittedly required better care as per Doctors' own admission was shifted in a timely and proper manner or not. When ,it is an admitted fact that the Patient was on drip and breathing with the support of an Ambu bag, it cannot be construed that the Patient was in a very stable condition. The submission of the learned Counsel read together with the medical literature relied on, establishes that the Ambu bag is used within the hospital for temporary ventilation and during emergency cardiac care, and therefore it cannot be construed that the Patient was in a stable condition, when he was being shifted from one ICU to another. Though as per the medical literature the Ambu Bag is used for Hospitals for transport within the Hospital area, it is also stated that manual resuscitator is not a suitable device for accurate ventilation. Strictly construed, this act of using an Ambu Bag cannot be termed as negligence perse attributable to a Doctor, merely because the Doctor thinks one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession.  Be that as it may, we are of the view that while shifting the Patient who was admittedly not in a stable condition from 3rd to 12th floor ICU due care and caution ought to have been taken with respect to ventilation of the Patient and in a timely manner, specially keeping in view the fact that the cause for Bradycardia, which the Patient had developed was never explained and thereafter the Patient had slipped into a coma and remained in a vegetative state for a period of almost three years. At the cost of repetition, the time lapse of 2 ½  hours from 10.30 a.m. to 1 p.m. has not been explained. The medical records do not show any substantial reasons for the lapse of these 'golden hours' which was critical.

The next contention of the Complainants is that Dr. Wagle has not been recognised as an 'Intensivist' by the Hospital as per their own brochure dated March 2015. It is argued that in both the brochures his name was included 'General Medicine' whereas the names of the other Doctors are shown against 'Intensivist' and he was only asked to step in as an Intensivist because the regular Intensivist was not present in the third floor ICU, when the Patient was taken after the Surgery on 28.06.2004. Though the Hospital is advertised as a Super Speciality Hospital, Dr. Wagle contracted as a physician and performed also the role of Intensivist and Anaesthetist by doing a pre-investigative examinations on the Patient. It was argued that the ICU Registrar is not a senior Doctor and cannot deal with medical emergency. The meaning of Registrar as per the medical dictionary is that he is an official keeper of records, a resident specialist, who acts as an assistant to the chief or attending specialist; and administrative officer whose responsibility is to maintain the records of an institutions and that he is not equipped to deal with any emergency moreover, he was not present in the ICU at the time when the complication arose. It is also submitted by the Complainants that no ICU Registrar had examined the Patient either on the date he was admitted i.e. on 26th or even when the complication i.e. on 29th, when the Patient was in the 3rd floor. The Complainant drew our attention to the noting in the medical record made when the Patient was in the 12th floor ICU, where whenever the ICU Registrar had examined the Patient a specific noting was made. It is the Complainant's case that it was only because no senior Doctor was present at that point of time, a senior Doctor had to be summoned from the adjoining ICCU, who promptly inserted endotracheal tube to maintain the Patient's breathing and sustained his heart. It is their case that as no senior Doctor was present in the ICU, when the complication arose, precious time was lost. Learned counsel appearing for the Hospital and the treating Doctors strongly contended that there was no time lost and that the Patient was adequately resuscitated in the post-operative ICU on the 3rd floor by the ICU Registrar Dr. Sheikh and necessary notings were made in the medical record of the Patient at 10:30 a.m. The Patient was treated with all care and caution till 12:30 P.M. and subsequently was transported to the   ICU on the 12th floor. We do not wish to address to the issue as to whether the Doctors name was included under 'General Medicine' and the other Doctors' names  were included under 'Intensivist'  and that the said Doctor was asked to step in as an Intensivist because the regular Intensivist  was not present. We find it more relevant to address the issue of medical negligence with respect to whether the treatment was rendered as per standards of Normal Medical Parlance.

At this juncture we find it a fit case to place reliance on the catena of judgements of the Hon'ble Supreme Court with respect to medical negligence.

The "Bolam test" has been the subject of academic debate and evaluation in India and other jurisdictions.  Among scholars, the Bolam test has been criticized on the ground that it fails to make the distinction between the ordinary skilled doctor and the reasonably competent doctor (Michael Jones, Medical negligence, Sweet and Maxwell, Fifth Edition (2017).

In a catena of judgements, the Hon'ble Supreme Court has laid down the essential components of 'Negligence' as follows:-

The existence of a duty to take care which the defendant owes to the plaintiff;

The breach of that duty towards the plaintiff and Damage or injury by the complainant as a result of such breach.

 The 'Duty of Care' for a medical professional starts from the time the patient gives an implied consent for his treatment and the medical professional accepts him as a patient for treatment, irrespective of financial considerations. This duty starts from taking the history of the patient and covers all aspects of the treatment, like writing proper case notes, performing proper clinical examination, advising necessary tests and investigations, making a proper diagnosis, and carrying out careful treatment.

 In 1969, the Supreme Court in the case of Dr.Laxman Balakrishna Joshi v. Dr. Trimbak Babu Godbole AIR 1969 SC 128 held:-

A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for that purpose,

1.  he owes a duty of care in deciding whether to undertake the case,

2.  he owes a duty of care in deciding what treatment to give and,

 3. he owes a duty of care in the administration of that treatment.

 A breach of any of these duties gives a right of action for negligence to the patient.

 This means that when a medical professional, who possesses a certain degree of skill and knowledge, decides to treat a patient, he is duty bound to treat him with a reasonable degree of skill, care, and knowledge.  Failure to act in accordance with the medical standards in vogue and failure to exercise due care and diligence are generally deemed to constitute medical negligence.

In the instant case, the nurse record shows that when the Patient developed complications the Doctor was called by the nurse; that Dr. J.C. Kothari was called by the Complainants, who is a chest specialist and not an Intensivist; he was referred to at 10:30 a.m. on 29.06.2004 and he was present when Dr. Wagle had arrived; Dr. Satyavan Sharma, who is a Cardiologist arrived at about 11.45 to 12.00 noon. Dr. Bharucha was referred to only past 2 p.m. and arrived at about 5.30 p.m., which was noted in the ICU record. Between 9 a.m. and 10. 30 a.m., it is the Complainants case that the Patient  was not attended to by any senior Doctor, leave alone the Intensivist. As can be seen from the medical record once Dr. Wagle had arrived, he had increased 'minute ventilation'. The medical record does not evidence anywhere as to whether the Patient had received appropriate supply of oxygen from 9 a.m. till post 10.30 a.m. when Dr. Wagle had arrived at the post-operative ICU. There is no recording of the ICU Registrar as long as the Patient was there in the post-operative ICU on the 3rd floor. It is an admitted fact that the Patient suffered Bradycardia which caused Hypoxia of the brain on account of lack of supply of oxygen to the brain. The reasons with respect to Hypoxia and the treatment rendered between 9 a.m. to 10.30 a.m. with specific reference to ventilation being maintained is to be answered by the Hospital based on the principle laid down by the Hon'ble Supreme Court in Savita Garg (Supra). The Hon'ble Supreme Court held that "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 which is in better position to disclose that 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 by not impleading a particular doctor will not absolve the hospital of their responsibilities."      As can be seen from the record Dr. Wagle instructed only at 10.30 a.m. to repeat ECG and the blood tests and prescribed intravenous fluids. He also increased minute ventilation, which is a Respiratory Minute Volume or Minute Volume given by the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lung per minute. It is not understood as to how the ICU Registrar had not thought it fit to repeat the ECG and the blood test which were prescribed by Dr. Wagle at 10.30 a.m. It is also evidenced from the record that the resident Doctor assisting Dr. Bharucha has examined the Patient at 1 p.m. and Dr. Bharucha the Neurologist examined the Patient  only at 5.30 p.m. of 29.06.2004. Hence, the principle laid down in Savita Garg (Supra), once again squarely applies as we are of the view that explanation with respect to ventilation given between 9 a.m. to 10.30 a.m. has not been sufficiently given and we are of the view that the Hospital is negligent with respect to this issue.

It is the case of the Complainants that the sedative calmpose, being a schedule 'H' drug, under the Drugs and Cosmetics Rules, 1945, could not have been administered by the Hospital and the treating Doctors without a proper prescription. It is the Hospital’s case that the Patient was given a proper dose i.e. 10mg at 10 p.m. on 28.06.2004; that the provisions of Drugs and Cosmetics Rules, 1945 only prohibits the sale of schedule 'H' drugs in retail and that the said medicine was administered on the prescription of the treating Doctor. It is the Complainants' case that because of Calmpose not being administered in the proper dosage the side effect of Bradycardia could have developed. The Complainant had relied on the protocol which is followed internationally and also some standards laid down by the Joint Commission International Accreditation Standards for Hospitals and also a National Accreditation Board for Hospitals and Healthcare Providers. Learned Counsel appearing for the Hospital and also the Counsel for the Doctors vehemently contended that the international standards relied upon to be the Complainants cannot be construed by the Government standard protocol in India and that there are no such rules and regulations stipulated for the medical professional in most of the issues raised by the Complainants. We are of the view that the administration and the drug dosage of 'Calmpose'  do not fall within the essential components of Negligence namely 'duty', 'breach' and 'resulting damage'. We find force in the contention of the learned Counsel appearing for the Hospital and the Treating Doctors that Calmpose was administered as per standards of normal medical practice and as per prescription given by the treating Doctor and therefore we do not find any negligence regarding this aspect.

The next contention of the Complainants is that because of improper physiotherapy, the Patient complained of breathlessness causing him extreme pain which could have led to the complications. Having gone through the material on record, we find force in the contention of the Hospital and the treating Doctors that physiotherapy is a normal procedure which is carried out post-Surgery and does not require any specific recommendation. In the instant case, though the Complainants relied on international conventions followed, we are of the view that having regard to the fact that there is no documentary evidence to substantiate any connection between the physiotherapy session and the Bradycardia attack, we are of the considered view that merely because there is no specific prescription for physiotherapy, it cannot be construed as negligence per se on behalf of the Hospital or the treating Doctors.

We now address ourselves to the contentions of the Complainants that the Patient was suffering from chronic depression and was on anti-depressants for more than 20 years and that the anti-depressants were stopped abruptly before the operation without consulting a Psychiatric. It is the case of the Hospital and the treating Doctors that the anti-depressants were not stopped abruptly, were withheld only on the date of Surgery on the recommendation of the Anaesthetist. To adjudicate whether such a recommendation was made by the Anaesthetist or not we need to examine the pre-anaesthetic report of the concerned Doctor. It is pertinent to note that such a report is not placed on record. The Hospital treatment record does not evidence whether these anti-depressant drugs were given from the date of admission till the date when the complications arose. The medical chart depicting the drugs administered to the Patient do not include all these anti-depressants. Though the medical literature filed by the Complainants does show that there is a nexus between the two, it cannot categorically be stated that it was solely because of the abrupt stopping of the anti-depressant drugs that the said post-operative complication arose. Be that at it may, the fact remains that medical records do not evidence the administration of anti-depressant drug to the Patient except stopping of the same on the Surgery date. In the absence of the pre-anaesthetic report, we are of the considered view that the medical records filed by the Hospital does not depict whether the anti-depressants were administered/ tapered off from the date of admission till date of Surgery. Learned counsel appearing for the Hospital  vehemently contended that Complainants have sought to place guidelines of private associations,  the statement of purpose of the association of physicians of India and have also previously sought  to place certain standards issued by United States of America non-governmental organizations dealing with accreditation of Hospitals, despite it being an admitted position that the Hospital was never accredited to the said non-governmental organization and therefore any such standards are neither mandatory nor binding. He further argued that the documents which are placed on record have no applicability to them as regarding the submission of the Complainants that bed no. 385 has reflected in the medical records of the Patient was the bed of the post-operative Intensive Care Unit (ICU) where the Patient was taken after his operation on 28.06.2004. On the 12th floor ICU he was allotted bed no. 1252 and therefore there is no contradictory reports of the respective beds. We are of the considered view that the submissions made by the learned counsel regarding bed no. 385 and 1252 is satisfactory. We find force in his contention that though the medical records and case papers of the Patient  are maintained by different departments, at the time of discharge all medical records pertaining to the particular Patient are transferred to the medical records department and therefore the case papers of different departments have been arranged accordingly. We do not find any negligence or otherwise on behalf of the Hospital merely because the bed numbers are reflected differently in the ICU record. 

Learned Counsel appearing for Dr. Desai vehemently contested that the Surgery was successful and the role of the surgeon ended with the completion of the surgical procedure and that there is no specific allegation against Dr. Desai except for stating that he was shifted to post-operative  ICU instead of the ward. He contended that Dr. Desai cannot be held liable as no negligence has been attributed or proved against him.   

 In P.B. Desai vs State of Maharashtra & Anr. (2013)15 SCC 481, the 'Duty of Care' which a doctor owes towards his patient has been clearly explained as follows:- "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".Having regard to  what  the Hon'ble Supreme Court has laid down about the 'Duty of Care' to be followed by a medical  professional viewed from any  angle, it cannot be  construed that  'Duty of Care'  of  a treating doctor  ends with the 'Surgery'.                         This Commission has also held in P.D. Hinduja National Hospital & Medical Research Centre Vs. Mrs. Veera Rohinton Kotwal, II (2018) CPJ 342 (NC), that the 'Duty of Care does not end with the Surgery'. We find it a fit case to place reliance on the judgement of the Hon'ble Supreme Court in Arun Kumar Manglik Vs. Chirayu Health And Medicare Private Limited & Anr., 2019 (3) SCALE 333, in which the Hon'ble Apex Court has laid emphasis on 'Patient Centric Approach' and observed that the 'Standard of Care' as enunciated in the Bolam Case must evolve in consonance with its subsequent interpretation by English and Indian Courts. In Halsbury's Laws of England the degree of skill and care required by a medical practitioner is detailed as follows:-  "The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence, judged in the light of the particular circumstances of each cases, is what the law requires, and a person is not liable in negligence because someone else of greater skill and knowledge would have prescribed different treatment or operated in a different way; nor is he guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, even though a body of adverse opinion also existed among medical men.  Deviation from normal practices is not necessarily evidence of negligence. To establish liability on that basis it must be shown (1) that there is a usual and normal practice; (2) that the defendant has not adopted it; and (3) that the course in fact adopted is one no professional man of ordinary skill would have taken had he been acting with ordinary care." A doctor has a legal duty to take care of his patient. Whenever a patient visits a doctor for treatment there is a contract by implication that the doctor will take reasonable care to treat him. If there is a breach of that duty and if it results in injury or damage, the doctor will be held liable. The doctor must exercise a reasonable degree of care and skill in his treatment; but at the same time he does not and cannot guarantee cure.

HELD: The Hon'ble Supreme Court in Malay Kumar Ganguly v. Dr. Sukumar Mukherjee, (2009) 9 SCC 221, case has preferred Bolitho test to Bolam test. The Supreme Court redefined medical negligence saying that the quality of care to be expected of a medical establishment should be in tune with and directly proportional to its reputation. The decision also says that the court should take into account patient's legitimate expectations from the hospital or the concerned specialist doctor. In the instant case we are of the considered view that there is negligence in the treatment rendered to the Patient with respect to the time and manner in which the Patient was shifted from the 3rd floor ICU to the 12th floor ICU, the unexplained cause for Bradycardia, which is not in accordance with what was laid down by the Hon'ble Supreme Court in Savita Garg (supra), the absence of medical record specifying the treatment rendered to the Patient between 9 a.m. to 10.30 a.m. in the ICU.  Having regard to the fact that the Patient was in the Hospital for a period of 8 months; in a coma for a period of almost three years; the bills filed towards medical expenses amounting to ₹16,93,010.00 (excluding the medi-claim amount of ₹3,75,000/-) and the expenses incurred post discharge, when the Patient was in a coma, and also the mental agony suffered by the Patient's family, the aspect of restitutio in integrum, and the Patient's age, we are of the view that awarding an amount of ₹30,00,000/- (Thirty Lakhs)  to be paid by the Hospital would meet the ends of justice. We also award costs of ₹1,00,000/- (One Lakh) to be paid by both the Doctors jointly and severally as we hold that 'Duty of Care does not end with the Surgery'.  In the result, this Appeal is allowed in part and the order of the State Commission is set aside and we direct the Hospital to pay an amount of  ₹30,00,000/- (Thirty Lakhs)   and costs of ₹1,00,000/- (One Lakh) to be paid by both the Doctors jointly and severally. Time for compliance four weeks from the date of receipt of a certified copy of this order, failing which the amount shall attract interest @ 9% p.a. from the date of filing of the Complaint till the date of realisation.