National Consumer Disputes Redressal
Master Vatsal Aniket Verma & Ors. vs Gupta Nursing Home & Ors. on 25 January, 2016
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI CONSUMER CASE NO. 308 OF 2001 1. MASTER VATSAL ANIKET VERMA & ORS. THROUGH HIS PARTNERS AND NATURAL GUARDIAN R/O 318 VIDYA VIHAR BORSI ROAD DURG CHHATISGAR ...........Complainant(s) Versus 1. GUPTA NURSING HOME & ORS. MATERNITY CENTRE 54 MOHAN NAGAR DURG CHHATISHGARGH 2. Dr. D.K. Gupta, 54, Mohan Nagar, Durg, Chhatisgarh. 3. Dr. Mrs. Vandana Gupta W/o. Dr. D.K. Gupta, 54, Mohan Nagar, Chhatisgarh ...........Opp.Party(s)
BEFORE: HON'BLE MR. JUSTICE J.M. MALIK, PRESIDING MEMBER HON'BLE DR. S.M. KANTIKAR, MEMBER
For the Complainant : Dr. A. Mehta, Advocate For the Opp.Party : Mr. Arvind Kumar Ray, Advocate
Dated : 25 Jan 2016 ORDER
ORDER
DR.S.M. KANTIKAR , Member For most women, the birth process, although difficult, is an exciting and life-changing experience. The emergence of a healthy baby after many hours of intense labour is truly a miraculous event. For some, however, the experience can be extremely frightening particularly when complications arise.
This complaint is filed by Master Vatsal Aniket Verma as Complainant No1, mother of Vatsal, Mrs. Leena Verma as Complainant No 2 and father Mr.Ajay Verma as Complainant No 3 against the opposite parties M/s. Gupta Nursing Home as OP No.1, Dr.D.K.Gupta, OP No.2 and Dr. Mrs. Vandana Gupta, OP No.3 alleging medical negligence during the delivery of Mrs. Leena Verma, complainant No. 2.
Complaint:
1. Mrs. Leena Verma, complainant No.2 (herein referred as a "patient") during her 1st pregnancy was going through regular medical check-up under Dr.Vandana Gupta Gynecologist, (OP-3), at Gupta Nursing Home ( OP 1). She was assured of good progress of her pregnancy and that there was no need to worry about health of the mother and child. On 28.05.1999, she underwent ultrasound (USG) as per the advice of OP -3. On 11.10.1999 another USG was also done, i.e. just five days prior to the date of delivery, which revealed the feotal weight to be 3563 gms. (Ex. C/1= Annexure P-1) (colly). On 15.10.1999, patient developed labour pains , the OP No.2 admitted the patient in her nursing home. On admission, OP-3 Dr. Vandana Gupta assured that the condition of mother and baby were fine and she will have normal delivery. As the patient was unable to bear the prolonged and difficult labour pain, therefore, she repeatedly requested the OP-3 to perform caesarean operation (LSCS), but, the repeated requests did not yield any response. Complainants further alleged that due to lack of facilities for LSCS operation, the OP-3 proceeded to deliver the child with FORCEPS. A male baby was delivered at mid-night of 16.10.1999, by use of forceps. No pediatrician or anesthetist was available during delivery, but the OP- 3 informed the patient and her husband there was nothing to worry. The Complainant 3 i.e. father of child noticed, the right hand of baby was absolutely limping and senseless. It was just hanging and inactive. Thus, he immediately informed the OP-3, who at that time, disclosed about forceps delivery in her case. Even, despite several requests OP No.2 did not call any pediatrician to examine the child and assured that child would become normal in the due course of time and nothing to worry. Intentionally, the mother/patient was discharged on the same day, without any discharge slip to conceal the paralytic right hand of the child. Thereafter, the complainant No 3 immediately consulted Dr. Uma Chaturvedi, Pediatrician, she expressed the child needs admission in ICU for proper treatment and investigation. She diagnosed it as 'ERB's PALSY', i.e. nerves of right hand of the child were severely damaged due to excessive pressure applied through forceps delivery. The discharge slip /report of Dr.Uma Chaturvedi is Annexure P-2, with the advice to consult a neurologist, for further treatment.
2. Thereafter, The Complainants consulted various reputed neurologists in the prime institutes of country, like NIMHANS at Bangalore and AIIMS, New Delhi. Everyone expressed about no apparent conventional treatment available, except a major surgery. The parents have communicated and consulted Dr. Rahul Nath, MD (USA) , he expressed in his letter dated 08.10.2002 (Ex. C/9) that, in most of the cases, Caesarean section is preferred to deliver Macrosomic fetus to avoid the Branchial plexus injury. He also, informed that its quite expensive surgery at the tune of 50,000 to Rs.75,000/- USD. For the purpose of further treatment and surgery in the USA, the complainants had sold their property (sale deed is annexed as Annexure-P5). On 8.10.2001, the child at the age of 22 months underwent reconstructive surgery at The Institute for Rehabilitation and Research (TIRR) in Houston, Texas USA. Despite huge expenses on the treatment in USA and further follow up and treatment in India at various hospitals, there was no cure to the child. Therefore, alleging medical negligence, the complainants filed this complaint before this Commission, on 26.09.2001 and prayed for 65 lakhs as compensation from the opposite parties.
3. OPs filed their written versions, affidavits and resisted the complaint. OP-3 submitted that, in the present case, the patient was examined 5 days' before the delivery i.e. 11 days', before the expected date of delivery (EDD). The weight of foetus was 3563 grams; it was quite an average weight as per USG. Moreover, weight and size of the baby alone are not the criteria for taking decision of LSCS operation much before the full term. In the instant case, all the signs were favorable for a normal delivery. The head was engaged which was a favorable sign in primi for normal delivery and pelvis was roomy, there was no cephalo pelvic disproportion (CPD). Hence, advising normal delivery under those circumstances was neither negligence nor deficiency in service. Therefore, patient was called after one week for check-up or informed to come when the labour pains started. The patient approached OP-1 on 16.10.1999, at 2.30 a.m. with mild labour pains, which appeared to be of no need for LSCS. The patient was also not willing for LSCS, but she preferred normal delivery. OP-3 delivered the patient normally, with support of outlet forceps. The delivery was performed with utmost care, caution and skill. There was no negligence on the part of the OPs.
4. The OP-3 further submitted that, as the patient, Mrs. Leena Verma was having stronger labour pains, with regular foetal heart sounds, the internal checkup was done at 11.30 A.M. She was found to have 3/5th dilatation of cervix which is about 7-8 centimeters with well taken up cervix, the bag of waters were bulging and head had come more down below the ischial spine which is "+1" station at this stage she was shifted to operation theatre for delivery. After shifting the patient, the active, management by giving syntocinon drip and injection epidosin for faster dilatation of cervix. By 12 noon patient was fully dilated and head came down to "+2" station that is perineum and was stretching the out let and the perineum. OP3 asked the patient to bear down, waited for 15 to 20 minutes, found that patient was not cooperating and was not able to push out the baby and getting exhausted. So, to avoid undue delay and pressure of perineum over the head which could cause asphyxia in the baby, to facilitate OP3 gave episiotomy and decided to apply outlet forceps. It was a very easy forceps application and the head came out. Due to episiotomy there was more space in the perineum the left shoulder which was posterior, was delivered out first and the right shoulder which was anterior, delivered out easily, there was no shoulder dystocia and the delivery was quite smooth. Baby cried, immediately and there was no injury to the mother's perineum which would have been the only complication of outlet forceps. Spontaneously, the placenta and membranes were removed completely.
5. The OPs further submitted that, all the deliveries are conducted in labour room. The hospital infrastructure is good , having operation theatre, with all facilities to tackle emergency LSCS. The Anesthetists are always on call and available, within 10 to 15 minutes, as practiced in all the hospitals and nursing homes in this area, including the District hospitals and the reputed hospital of Bhilai Steel Plant. It was not a case of Shoulder Dysocia, OP-3 further denied that the shoulder dystocia was the direct cause of ERB's Palsy. Therefore, there was no negligence on the part of the OPs and prayed for the dismissal of complaint.
On Behalf of Complainants:
6. We have heard the learned counsel for both the parties. The counsel for the complainant, Ms.A. Mehta, vehemently argued that there was gross medical negligence committed by OP Nos. 2 & 3. The counsel submitted that Dr. D.K. Gupta, the OP 2 is an Eye Surgeon, who looks after the administration and management of the nursing home. Hence, he could have no role of assisting the delivery of the child. The nursing home was running, since 1994 and it was not registered, as per Act, till 2004, not having all facilities but conducted caesarean deliveries. The OP-3 was not qualified to do private practice, as per the Government norms, thus OP 3 was illegally practicing. In this context, the counsel also brought our attention towards the Madhya Pradesh Upcharyagriha Taha Rajopchar Sambandi Sthapanaye (Ragistrikaran Tatha Anugrapan) Adhiniyam, 1973 and Notification of Madhya Pradesh, Government, regarding restriction of private practice of the Government doctors. The OP-Nursing home is a private nursing home and established for a profit making business. It is not a charitable or a government hospital. The patient, Leena Verma was admitted in OP 1-Nursing Home for a safe delivery. There was no liaison/ relation between Dr. S.R. Banchore and the OP doctors/OP hospital. Dr. Banchore was never present at the nursing home. There was dereliction of duty on the part of Dr. Vandana Gupta and Dr. D.K. Gupta. Therefore, the complainant is still suffering and is undergoing treatment in USA. The OP 3 has not assessed the USG report obtained before five days of the delivery.
7. The counsel further contended that, it was a difficult delivery, OP 3, single handedly conducted it. No opinion or assistance of another Gynecologist was sought to conduct the delivery, no Specialist, such as an Anesthetist and or a Pediatrician, was available, no sufficient number of nurses and infrastructure was available in the hospital. During labour pain, the ward boy gave pressure on the abdomen of patient. Therefore, it was clear negligence and deficiency in service on the part of the OP-3. The counsel relied upon the judgment of V.Kishan Rao vs. Nikhil Super Speciality Hospital, (2010) 5 SCC 513 in which it is stated as under:
"A person who holds himself out ready to give medical advice and treatment impliedly undertaken that he is possessed of skill and knowledge for the purpose. Such a person when consulted by a patient owes him certain duties, viz. (i) a duty of care in deciding whether to undertake the case, (ii) a duty of care in deciding what treatment to give, and/or (iii) a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care".
The second limb of argument was that the ultrasound (USG) report dated 11.10.1999; revealed the weight of baby was 3563 grams. It was done 5 days prior to delivery. The counsel brought our attention to the post-delivery medical record, the weight of baby on record was around 4 kg, it is accepted by opposite party also. It was a critical delivery for the mother, having a large baby. OP-3 must have resorted to caesarean section, looking to the heavy weight of the baby. Counsel submitted that patient was admitted with the labour pain and it was a prolonged labour. The baby was delivered after 24 hours of admission. OP-3 failed in her duty of care by not performing LSCS, at proper time, but OP-3 performed forceps delivery with excessive force to the over-weight baby. OP-3 was the only doctor present in the labour room. There was neither an Anesthetist nor any arrangement for LSCS ready. OP-2 failed to recognize the warning signals of shoulder dystocia, which was the main cause of 'ERB's PALSY'. It was the duty of opposite party to call for a Pediatrician, after delivery, but she discharged patient, on the same day, itself. Baby's weight was not normal. The birth certificate produced by OP-Nursing home itself, clearly states that the baby was 4 kg., at the time of delivery. Thus, it was overweight in the Indian context i.e. macrosomia, which can lead to shoulder dystocia. In the instant case, there was forcep delivery, without any due diligence and care by which the baby suffered Erb's palsy of right hand. As per the medical expert, the infants with Brachial Plexus Injury are more common in macrosomic babies. Such babies are also likely to suffer from shoulder dystocia and if delivered by forceps, these kinds of birth injuries will continue to occur, unless the obstetricians are diligent. The liberal use of LSCS, instead of forceps and vaginal breech deliveries may help to lower neo-natal morbidity, mortality and major birth injuries.
The learned counsel for the complainants denied that the complainants were forced by Dr. S.R. Banchore to OP-Nursing home for delivery. It appears that the OPs are trying to shift the burden on Dr. S.R.Banchore, a child specialist. There was no professional liaison between Dr.Banchore and OPs. The OP-hospital is neither fully equipped to meet the emergency nor have a team of expert doctors, such as Gynecologists, Anesthetists, Pediatricians etc., to deal with the complicated labour, as in the instant case. Hence, it was a callous attitude of the OPs. It was necessary to avoid risk of birth trauma. The forceps technique is an outdated and unsafe for delivery. The OP-3 was responsible for lack of degree of skill and care. After delivery, the OP 3 advised the parents to show the child to Orthopedician or Neurophysician. This itself indicates that she had knowledge of the defect in the right hand of the new born. She had concealed the fact from the parents, prescribed medicines, without calling the specialists to take immediate care of the child. The OPs neither provided any receipt of payment or discharge slip to the complainant. The OP gave only false assurances that child would be normal, after some time. As per the birth certificate, both mother and child were normal. The OPs have falsely submitted that, the regular pediatrician was not called because Dr. S.R. Banchore was present to examine the baby, who told them to take the baby to Sector 9 BSP Hospital , Bhilai. The discharge slip (Annexure 2) dated 28-10-1999 issued by Dr.Uma Chaturvedi, the Pediatrician of said hospital, clearly depicts about Erb's palsy in the baby's right hand due to forceps delivery and hyper-bilirubinemia with septicemia. Thus, it confirms unhygienic conditions of the nursing home. During the stay in Sector 9 hospital, baby was given phototherapy and antibiotics. The jaundice and septicemia got cured, but the Erb's palsy of the child persisted and needed treatment for a longtime, in USA.
The counsel further relied upon the medical literature and research internet articles namely, Erb's Palsy- Who is to blame and what will happen?, Obstetric brachial Plexus injury Obstetric Brachial plexus palsy: the medico legal view He brought our attention towards the text from the Friedman Gynecology. It is reproduced as under:
"In addition, it is submitted that according to Friedman, who recommends that when shoulder dystocia is diagnosed, one must not touch the baby's head again until after the shoulder impaction is corrected putting on the head, even gently, merely risks brachial plexus injury."
On Behalf of Opposite Parties:
11. The learned counsel for OPs Mr. Arvind Kumar Ray, submitted that, Dr. Vandana Gupta (OP-3), is a senior consultant and worked as a Specialist in District Hospital, conducted complicated vaginal and operative surgeries, referred from all over the interior places of surrounding districts. The nursing home is fully equipped with modern equipments with sufficient staff to deal with the emergency LSCS. Dr. A.P. Sawant (Child Specialist) and Dr. H.R. Vaidya (Anesthetist) are associated with their nursing home. Counsel brought our attention towards, the statement (RR4) showing number of deliveries conducted, its mode and the other major operations, conducted by OP during 1994 to 2001. Further submitted that, the Chief Medical and Health Officer of Durg, inspected their nursing home for the infrastructure, staff and other medical facilities. Accordingly, the recognition order was given on 19.07.2001 (Annexure RR5, RR6). The counsel further submitted that Dr. Banchore, a Pediatrician, is relative of the patient. Therefore, OPs have not taken any charges for the treatment of patient. The patient was brought at 2.00 A.M. in the night, on 16.10.1999, along with Smt. Mukta Banchore. The OP-3 examined her in consultation chamber at her residence. Accordingly, the due date of delivery was 21.10.1999. There were favorable signs of normal delivery like
(a) Mild pains and mild contractions were present.
(b) Baby was L.O.A. (Left Occipital Anterior) and vertex was engaged. (c) Foetal heart sounds regular 140/minute. (d) The pelvis was roomy and adequate and there was no cephalo-pelvic disproportion. (e) Head was at "0" station i.e. at the level of ischial spines. (f) Membranes were intact. (g) Cervix was one finger loose and 50% taken up.
Therefore, patient was admitted in the nursing home. The operative graphic representation i.e. Partogram is also attached (Annexure RR7a & b).
12. It is submitted that, there was no concealment of baby's health, after delivery. There is no relation between neonatal jaundice and use of outlet forceps. After delivery, the Child Specialist Dr.Banchore , a relative of patient examined the baby and he told to take the baby to Sector 9, BSP Hospital, Bhilai, for further treatment and checkup. The birth certificate was issued for the registration of birth purpose under local Municipal Corporation. It is not to be considered as a medical or evidence certificate. The affidavit of Dr. Banchore is false and misleading because, he used to sit and practice in the chamber of OP's Polyclinic along with other doctors. His name is clearly mentioned in the pamphlet of polyclinic. Further, it is confirmed by the affidavits of Balkishore (Annexure RR15), Brijlal Sarwa, OT Assistant and Mr. K.R. Thumpi (Annexure RR 17) have affirmed that Dr. Banchore used to sit in Gupta Polyclinic. Therefore, those affidavits fully confirm the presence of Dr. S. Banchore, at the time of delivery. The counsel further submitted that, Dr. S. Banchore, is a highly greedy, dishonest and corrupt doctor and has no morals or medical ethics. He demanded a bribe of Rs. 100/- from physically handicapped (polio) patient Kumari Rukmani for issuing a physically handicapped certificate on 05-09-2001. Since she showed her inability to pay the amount due to poverty, Dr. Banchore refused to issue the certificate. She lodged a complaint in the State Vigilance Commission, Raipur (C.G.) and Dr. Banchore was caught red-handed, accepting the bribe in the raid.(Copy of complaint is Annexure RR18).Dr. S. Banchore is still under suspension after remaining in District Jail, Durg for two days. The charge sheet against Dr. Banchore is pending trial, in the court of Special Judge at Durg. (copy of the order sheet is Annexure RR19).
13. The counsel for OPs denied about the ultrasound features of macrosomia. As per the standard textbook "Ultrasonography in Obstetrics & Gynecology", the weight of baby falls near the 50th percentile. The weight falling within 10th - 90th percentile, is taken as appropriate, for gestational age".
14. Counsel further relied upon various textbooks like "Perinatology and Contraception" by D.C. Dutta, in the matter of elective forceps delivery. Counsel further relied upon the report given by Dr. P. Panigrahi, Joint Director and Head of Department, OBG in JLN Hospital, Bhilai, who confirmed that standard treatment was given to the patient. Same was the opinion of Dr. Ratna Gulati.
Findings:
15. From the medical record, it is an admitted fact that, since after birth the child took treatment from USA, and several other hospitals, like CMC, Vellore, Parijma Neuro Diagnostic and rehabilitation centre, AIIMS, NIMHANS and Medanta etc. Child was treated by several Specialist Doctors in Neurology, Rehabilitation. Dr.Rahul Nath from Texas, USA is as Associate Professor, Department of Surgery, Division of Plastic Surgery and Neuro surgery, who examined Mst. Vatsal and expressed that the brachial plexus injury was probably caused by traction on head and neck away from the impacted shoulder. He performed surgical reconstruction of contracture and shoulder dislocation at Texas Children Hospital and also advised to take future treatment for multiple muscle and tendon transfers, costing about $ 25000.
16. We have perused the entire medical record from OP hospital and various other hospitals, including TIRR, USA and different Neurological Centers, Physical Rehabilitation Centers in India, where the child took treatment, till date. We have gone through the standard medical text books on Obstetrics and Gynecology, Birth Injuries etc. We also, considered the opinion from the medical board of AIIMS. The medical board constituted under Chairmanship of Professor Dr.Nutan Agarwal, consisting of Professors from various departments like Obst & Gynec, Neuro-Surgery, Radio-diagnosis, Orthopedics, Pediatrics and Hospital Administration.
Opinion of AIIMS, Medical Board (15.07.2015):
On evaluation of the available records of labour and delivery the following observations were made:
She was a primigravida at 39w+2d period of gestation (POG) who came in spontaneous labour. The antenatal period seemed to be normal. Antenatal USG was done on 28/5/1999 which did not see any Congenital anomalies. A USG report at 38+5 weeks POG (on 11/10/1999) showed an estimated weight of 3533 gms which seems to be reasonable to allow a normal delivery. There is no record showing, whether or not, the mother was a diabetic.
According to the partogram, the onset of labour was at 2:30AM hours on 16/10/1999. She started active phase at 9:00AM hrs and delivered at 12:30PM hrs. The duration of first stage of labour was 9.5 hours and the duration of second stage was of 30 minutes. It was a forceps delivery, the indication being maternal exhaustion.
There was no antenatal indication for not conducting a normal vaginal delivery.
The records show that the duration of labor (first/second) stage was not prolonged.
The indication of forceps has been mentioned as maternal exhaustion and not a prolonged 2nd stage which is an indication of the fact that there was no cephalopelvic disproportion.
The occurrence of brachial plexus injuries is 0.3% of all deliveries.
Full returning of function occurs in 70-95% cases only. In remaining 5-30% full returning of function may not occur.
This is also called obstetrical palsy. This is more likely to occur, after instrumental delivery. But,may also occu,r after a normal delivery, especially in big babies.
The generally accepted mechanism in case of shoulder dystocia is traction to the neck caused by pull of the obstetricians hand or instruments like forceps or vacuum. However, birth brachial plexus injuries have occurred, following caesarean sections and also that shoulder dystocia does not always lead to such injuries. There is some electrophysiological evidence to show that birth injuries could have occurred in the intrauterine period, since denervation potentials are seen on day 1, after delivery, which is not possible, in case it occurred at the moment of delivery.
Thus, there is no agreement among the brachial plexus surgeons about the mechanism or active prevention of these injuries and the grievance filed by the complainant may not be supported by evidence available so far in the literature."
17. Reference to Medical Literature:
According to William's Obstetrics, (24th Edition-2014) the topic Shoulder dystocia, it's management and Brachial plexopathy is discussed as:
SHOULDER DYSTOCIA Following complete emergence of the fetal head during vaginal delivery, the remainder of the body may not rapidly follow. The anterior fetal shoulder can become wedged behind the symphysis pubis and fail to deliver, using normally exerted downward traction and maternal pushing. Because the umbilical cord is compressed within the birth canal, such dystocia is an emergency. Several maneuvers, in addition to downward traction on the fetal head, may be performed to free the shoulder. This required a team approach, in which effective communication and leadership are critical.
Consensus regarding a specific definition of shoulder dystocia is lacking. Some investigators focus on, whether, maneuvers to free the shoulder are needed, whereas, others use the head-to-body delivery time interval as defining (Beall, 1998). Spong and coworkers (1995) reported that the mean head-to-body delivery time in normal births was 24 seconds compared with 79 seconds in those with shoulder dystocia. These investigators proposed that a head-to-body delivery time > 60 seconds be used to define shoulder dystocia. Currently, however, the diagnosis continues to rely on the clinical perception that the normal downward traction needed for fetal shoulder delivery is ineffective.
Because of these differing definitions, the incidence of shoulder dystocia varies. Current reports cite an incidence between 0.6 percent and 1.4 percent (American College of Obstetricians and Gynecologists, 2012b). There is evidence that the incidence has increased in recent decades, likely due to increasing fetal birthweight (Mackenzie, 2007). Alternatively, this increase may be due to more attention given to appropriate documentation of dystocia (Nocon, 1993).
MANAGEMENT:
Because shoulder dystocia cannot be accurately predicted, clinicians should be well versed in its management principles. Because of ongoing cord compression with this dystocia, one goal is to reduce the head-to-body delivery time. This is balanced against the second goal, which is avoidance of fetal and maternal injury from aggressive manipulations. Accordingly, an initial gentle attempt at traction, assisted by maternal expulsive efforts, is recommended. Adequate analgesia is certainly ideal. Some clinicians advocate performing a large episiotomy to provide room for manipulations. Of note, paris (2011) and Gurewitsch (2004) and their colleagues reported no change in the brachial plexus injury rate for groups in which episiotomy was not performed during shoulder dystocia management.
After gentle traction, various techniques can be used to free the anterior shoulder from its impacted position behind the symphysis pubis. Of these, moderate suprapubic pressure can be applied by an assistant, while downward traction is applied to the fetal head. Pressure is applied with the heel of the hand to the anterior shoulder wedged above and behind the symphysis. The anterior shoulder is thus either depressed or rotated, or both, so the shoulders occupy the oblique plane of the pelvis and the anterior shoulder can be freed.
BRACHIAL PLEXOPATHY Injuries to the brachial plexus are relatively common. They are identified in 1 to 3 per 1000 term births (Baskett, 2007; Joyner, 2006; Lindqvist, 2012). In the study of more than 8 million singleton births reported by Moczygemba and colleagues (2010), the incidence of brachial nerve injury was 1.5 per 1000 vaginal deliveries and 0.17 per 1000 cesarean deliveries. Breech delivery and shoulder dystocia are risks for this trauma. However, severe plexopathy may also occur without risk factors or shoulder dystocia (Torki, 2012).
The injury with plexopathy is actually to the nerve roots that supply the brachial plexus - C5-8 and T1. With haemorrhage and edema, axonal function may be temporarily impaired, but the recovery chances are good. However, with avulsion, the prognosis is poor. In 90 percent of cases, there is damage to the C nerve roots causing Erb or Duchenne paralysis (Volpe, 1995). Injuries with breech delivery are normally of this type, whereas the more extensive lesions follow difficult cephalic deliveries (Ubachs, 1995). The C5-6 roots join to form the upper trunk of the plexus, and injury leads to paralysis of the deltoid, infraspinatus, and flexor muscles of the forearm. The affected arm is held straight and internally rotated, the elbow is extended, and the wrist and fingers flexed. Finger function usually is retained. Because lateral head traction is frequently employed to effect delivery of the shoulders in normal vertex presentations, most cases of Erb paralysis follow deliveries that do not appear difficult. Damage to the C8-T1 roots supplying the lower plexus results in Klumpke paralysis, in which the hand is flaccid. Total involvement of all brachial plexus nerve roots results in flaccidity of the arm and hand, and with severe damage, there may also be Horner syndrome.
Unfortunately, as discussed in Chapter 27 (p.541), shoulder dystocia cannot be accurately predicted. In most cases, axonal death does not occur and the prognosis is good. Lindqvist and associates (2012) reported complete recovery in 86 percent of children with C5-6 trauma, which was the most common injury, and in 38 percent of those with C5-7 damage. However, those with global C5-8-T1 injuries always had permanent disability. Surgical exploration and possible repair may improve function if there is persistent paralysis (Malessy, 2009).
18. The article "Shoulder Dystocia - Facts, Evidence and Conclusions" http://shoulderdystociainfo.com/index.htm".
The vast majority of obstetricians, including those who have done the most work on shoulder dystocia and brachial plexus injuries, have concluded that it is impossible with any degree of certainty to predict in which deliveries shoulder dystocia will occur. The key issue involved is "certainty". As will be shown, there are multiple "risk" factors for shoulder dystocia. Mothers and babies having these risk factors are, in an absolute sense, more likely than mothers and babies without these factors to experience shoulder dystocia. But whether the predictive value of such factors is high enough to be useful clinically, that is, to justify changes in labor management plans in hopes of avoiding shoulder, is what is at issue. Moreover, as with most statistical questions in medicine, the predictability of shoulder dystocia has to be looked at from two directions:
Sensitivity: Are the risk factors associated with shoulder dystocia able to accurately identify most babies who will have shoulder dystocia at birth?
Positive predictive value: What percentage of mothers and babies having these risk factors will, in fact, experience shoulder dystocia?
In the case of shoulder dystocia, its infrequent rate of occurrence (0.5%) and the low positive predictive value of risk factors for it severely impede the ability of obstetricians to utilize such information to advantageously alter clinical care.
Macrosomia is far and away the most significant risk factor for shoulder dystocia. It is the factor that has been most studied and most often proposed as a potential target for manipulation in hopes of reducing the number of shoulder dystocia deliveries. Some authors go so far as to claim that no other risk factor has any independent predictive value for the occurrence of shoulder dystocia.
There are various cutoff points used to define macrosomia have been 4000 gms, 4500gms and 5000 gms.
Thus the question: Can shoulder dystocia be reliably predicted by estimating fetal weight?
The problems with attempting to estimate which fetuses will be macrosomic and using this information as a tool for predicting shoulder dystocia are twofold:
In the first place, it is the general conclusion of mot obstetrical experts who have studied this issue that predicting macrosomia is unreliable. If macrosomia cannot be reliably determined, it is hard to try to use it to predict shoulder dystocia.
Secondly, only a very small percentage of babies, even of those who have macrosomia, go on to develop shoulder dystocia. This presents a significant obstacle to the use of estimates of fetal weight as a tool for deciding when to change clinical management in hopes of preventing shoulder dystocia deliveries. Therefore, macrosomia is major risk factor for shoulder dystocia, it is not possible to accurately predict shoulder dystocia by attempting prediction macrosomia.
Can shoulder dystocia and brachial plexus injury be prevented?
Up until this point we have been looking for various ways of predicting which babies and which labors will experience shoulder dystocia and possible brachial plexus injury. But such predictions, even if they can be made, are useless if there is no way to alter labor and delivery management so as to prevent shoulder dystocia and brachial plexus injury from occurring. Thus a most important question is this" Given what we know about shoulder dystocia and brachial plexus injury, is there anyway to prevent them?
From the options available to obstetricians for intervening in labor and delivery, the only possible means for preventing shoulder dystocia would be:
To perform elective cesarean sections for suspected macrosomia To induce labor in pregnant patient before their due dates in hopes of preventing babies from becoming macrosomic To attempt through diet or blood sugar control to limit maternal weight gain.
The literature also revealed that the consensus of the vast majority of obstetricians who have studied the subject that there is no real way to figure out which babies are likely enough to have shoulder dystocia to warrant changes in the management of their labors.
The entire issue is best summed up in Practice Bulletin #40 "Shoulder Dystocia" (2002) by the American College of Obstetricians and Gynecologists. They find the preponderance of current evidence consistent with the following positions (relevant paragraphs):-
3. Most cases of shoulder dystocia cannot be predicted or prevented because there are no accurate methods to identify which fetuses will develop this complication.
4. Ultrasound measurement to estimate macrosomia has limited accuracy.
5. Planned cesarean section based on suspected macrosomia is not a reasonable strategy.
6. Planned cesarean section may be reasonable for the nondiabetic with an estimated fetal weight exceeding 5000g or the diabetic whose fetus is estimated over 4500 g.
Force in deliveries Some investigators have actually used mechanical testing devices in an attempt to measure the pressure placed on the brachial plexus of an infant during shoulder dystocia deliveries - - with conflicting results.
Allen (1991) reported his use of tactile force sensing devices on the tips of gloves during a series of vaginal deliveries to measure the forces placed on a baby's head by an obstetrician's hands. The deliveries that were observed were categorized into three groups: Routine, difficult, and those involving shoulder dystocias. He found that twice as much force was applied to a baby's head during shoulder dystocia deliveries as compared with routine deliveries.
Pre-delivery (in-utero) injury There are multiple reports of brachial plexus injuries which appear to have occurred sufficiently prior to delivery so as to not be causally related to it. The evidence for the timing of such in utero injuries comes from electromyelographic studies, the measurement of electrical transmission in muscle fibers.It takes approximately ten days for a muscle to show an injury pattern on electromyography after the nerve innervation to that muscle is damaged. Therefore if muscle damage from a brachial plexus injury is measured by electromyography immediately after delivery, the injury had to have occurred at least a week or more before the delivery took place.
Brachial plexus injuries following the Cesarean section Reports of brachial plexus injury in the absence of shoulder dystocia are subject to the criticism that perhaps shoulder dystocias were under-reported or that "excess' traction might have been placed on the baby's head during the course of a routine delivery.
The phenomenon of brachial plexus injury following cesarean delivery - - and thus not related to shoulder dystocia - - is real. As has been shown, there is much evidence to suggest that not all instances of brachial plexus injury are due to shoulder dystocia deliveries or to the actions of a physician during such deliveries. Thus the automatic assignment of responsibility to an obstetrician or midwife for a brachial plexus injury whenever a shoulder dystocia delivery occurs is inappropriate and not supported by the literature..
19. In a medical negligence case, the complainant must prove that the respondent/doctor failed to exercise the reasonable degree of skill and knowledge and the reasonable degree of care expected of a normal, prudent physician of the same experience and standing. The OP's conduct is to be judged in light of the knowledge that ought to have been reasonably possessed, at the time of the alleged acts of negligence.
In analyzing a case of Brachial Plexus Injury (BPI) during delivery due to medical negligence, we have to consider both the breach of duty and causation and the complainant has to succeed on both, to win it.
Breach of duty:
Was there shoulder dystocia?
Was the shoulder dystocia potentially foreseeable in the antenatal period?
Was the shoulder dystocia potentially foreseeable in the intrapartum period?
Were the correct procedures undertaken, when the shoulder dystocia was encountered?
The main risk factors for Brachial Plexus Injury (BPI) are Macrosomia i.e. larger fetal size (often from maternal diabetes) and shoulder dystocia. When BPI is associated with dystocia (approximately two-thirds of cases), the position of the affected limb is most likely anterior, while BPI may be more common with either an extremely short or a prolonged second stage. It is commonly believed that Erb's palsy is caused by an inexperienced clinician applying too much lateral traction during delivery . In the instant case, the OP-3 was an experienced and a Senior Obstetrician. The medical record clearly reveals, the indication of forceps mentioned as maternal exhaustion and not a prolonged 2nd stage. There was no cephalo-pelvic disproportion.
20. The main crucial issue involved in this instant complaint is, whether the child suffered shoulder dystocia and at that time whether the OP-3 applied forceps? From the medical record, the delivery notes and the AIIMS opinion, it is clear that there was no Shoulder dystocia in the instant case as alleged by the complainants. The partogram and delivery notes clearly mentioned that due to maternal exhaustion, OP-3 used outlet forceps to deliver the head and thereafter, the shoulder was delivered, spontaneously. Therefore, we are of considered view that, it was not a case of shoulder dystocia. The complainant failed to prove the negligence on the part of OPs. As per several medical literatures, we are accepting that the baby was clearly macrosomic, because its weight was below 4000 gms. Also, BPI cannot be prevented, even with LSCS. We should not assume that brachial plexus injuries are necessarily the result of traumatic deliveries. Such injuries can also result from non-negligent factor, like intrauterine mal-positioning. The newborns, with brachial plexus injuries, need to be carefully assessed for comorbid conditions. In the instant case, after delivery of baby, the OP-3 had noted the weakness of right hand and advised to consult an Orthopedic or a Neurophysician. Therefore, on the basis of forgoing discussion, we do not find any fault or deviation of standard from OP-3, in decision making and conducting delivery of patient.
21. It is also necessary to obtain an opinion from an Expert, with appropriate paediatric expertise, such as, a Neonatologist or a Pediatric Neurologist. Expert evidence is most often employed to provide the court, with guidance, as to what constitutes the appropriate standard of care in the circumstances. It must be noted that, although, expert opinion serves as a guide to the court, the ultimate determination of the required standard of care in the relevant circumstances of the case rests in the hands of the judges. Therefore, we sought an expert opinion from Medical Board of AIIMS, which also opined that, standard treatment was given by OP-3.
22. During the course of arguments, it was brought to our notice that, presently, the child, Master Vatsal, attained age of 16 years. Therefore, we sought details about child's present health condition and opinion from Department of Neurology, AIIMS, Bhopal. It is reported that Nerve Conduction Study (NCV) was consistent with right brachial plexus injury and clinically it was C5-C6 involvement (? Erbs palsy). The MRI study was also done, on 28.02.2015. On the basis of this report, we cannot draw mere presumption about negligence during delivery.
23. The Hon'ble Supreme Court in the case Kusum Sharma & Others Vs. Batra Hospital & Medical Research Centre & Others (2010) 3 SCC 480; the bench comprising Hon'ble Justices Dalveer Bhandari and H S Bedi dismissing a complaint held that:
"Consumer Protection Act (CPA) should not be a "halter round the neck" of doctors to make them fearful and apprehensive of taking professional decisions at crucial moments to explore possibility of reviving patients hanging between life and death." Also said that "Doctors in complicated cases have to take chance even if the rate of survival is low. A doctor faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act," It further observed as, "It is a matter of common knowledge that after some unfortunate event, there is a marked tendency to look for a human factor to blame for an untoward event, a tendency which is closely linked with the desire to punish,"
In para 94 of the said judgment court has discussed eleven well known principles in holding the doctor guilty of medical negligence.
24. In Hucks v. Cole & Anr. (1968) 118 New LJ 469, Lord Denning speaking for the court, observed as under:-
"a medical practitioner was not to be held liable, simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference of another. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner, in his field."
In Achutrao Haribhau Khodwa & Others v. State of Maharashtra & Others (1996) 2 SCC 634, the Hon'ble Supreme Court noticed that, "in the very nature of medical profession, skills differ from doctor to doctor and more than one alternative course of treatment are available, all admissible. Negligence cannot be attributed to a doctor, so long as he is performing his duties to the best of his ability and with due care and caution. Merely because the doctor chooses 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.
In Roe and Woolley (1954) 2 QB66, Lord Denning said:
"We should be doing a dis-service to the community at large, if we were to impose liability on Hospitals and Doctors for everything that happens to go wrong".
25. To summarise, in our view, the OP-3, Dr. Vandna Gupta, is a qualified and a Senior Gynecologist, who conducted the delivery of patient. The delivery record and the partogram show that it was not a case of delayed second stage of labour. There was maternal exhaustion during labour; hence OP-3 used the outlet forceps to deliver the head. Therefore, it was not negligence on the part of OP-3. As per opinions from few senior gynecologists, OP-3 followed the standard procedure. The AIIMS medical board report also favors OP-3, has not pointed out any negligence on the part of OP-3 in conducting delivery of patient. Even as per the medical literature, the baby was not macrosomic and the shoulder dystocia is an unpredictable event. As such, it was not a case of shoulder dystocia. We do not accept the contention of the counsel for complainants' that estimated weight by USG, was more than 4 kg. As per medical literature, weight of more than 4 kg, is to be considered, as macrocosmic. On 20.10.1999, i.e. two days' after the delivery, the child was admitted to the BSP hospital, wherein, it was noted that child suffered Jaundice and also neurological deficit in his right hand. The complainant made unflappable misleading submissions like, the child was discharged on same day from OP hospital, consulted Dr.Uma Chaturvedi, immediately. We are unable to locate any negligence from the Annexure P-2. There is no correlation between neonatal jaundice neither to forceps delivery nor to BPI. As per the medical literature, the Erb's palsy is possible due to intrauterine medical adaptation. The intrauterine medical adaptation is not the factor for BPI. The OP performed a episiotomy, used outlet forceps, as a standard procedure. After delivery, OP-3 advised the patient to show the child to an Orthopedician or a Neurologist. Considering the facts and circumstances of this case, we cannot rely upon the affidavit of Dr. Benchore.
26. On the basis of forgoing discussion and keeping in view, all the above facts of the instant case, Dr. Vandana Gupta (OP-3) had reasonable degree of skill and knowledge. In view of the medical literature and the opinion from Medical Board of AIIMS and relying upon several judgments on medical negligence, Dr.Vandana Gupta (OP-3) cannot be held guilty of negligence, by any stretch of imagination. Therefore, we dismiss this complaint. There shall be no order as to costs.
......................J J.M. MALIK PRESIDING MEMBER ...................... DR. S.M. KANTIKAR MEMBER