Wednesday 7 May 2014

Medical Negligence;Importance of ante natal checks and medical care during pregnancy


ANTE NATAL CARE
It is well acknowledged that ante natal checks are an extremely important and integral part of medical care during pregnancy because these help in identifying, assessing and consequently reducing the risks to both the mother and the fetus.   Ante natal checks in most countries are conducted by not only doctors but also trained paramedical professionals, which include Auxiliary Nurse Midwives (ANMs) and staff nurses.  In India paramedical staff like ANMs, Lady Health Visitors (LHVs) and staff nurses have been trained as a part of their profession about the standard protocol of checks which have to be conducted/advised when a pregnant woman visits a health facility.  These include the following:  
·        recording medical history of the mother, including her height and weight (with the weight to be taken and recorded during each ante natal visit);
·        full blood examination, including tests for blood group, hemoglobin (to check for anemia), Hepatitis-B, blood sugar etc.;
·        ultrasound tests;
·        tests to check for gestational diabetes in the third trimester; and
·        Leopold’s maneuver in the third trimester to determine the size, consistency, shape and mobility of the fetus through palpating the woman’s upper abdomen with both hands*.   

*Source:  1. Guidelines for Antenatal Care and Skilled Attendance at Birth by ANMs/LHVs/SNs by National Rural Health Mission, Govt. of India;

                     2.  Antenatal Checks and Tests – National Health Services, UK extracted from Google

12.     In the instant case, from the documents of the ante natal checks on record, we find that the medical history as also the height and weight of Complainant No.3 were not recorded.  Further, though various blood tests, including for blood sugar, were prescribed, the findings of the blood sugar tests are not recorded in the ante natal documents.  On a specific query by us, OP-2 stated that tests were conducted and found normal but the reports were not placed in the medical records of Complainant No.3 since these had been taken away by Complainant No.2. This fact was denied by Complainant No.2. Even if what OP-2 states is correct and the blood sugar results were normal, it was necessary to have recorded the relevant finding for ready reference/monitoring in the ante natal sheet of Complainant No.3. There is also no record/evidence that the test for gestational diabetes was prescribed and conducted in the third trimester and also whether weight gain, if any, was noted.  As per medical literature on the subject*, these are extremely important tests since gestational diabetes and abnormal weight gain are associated with macrosomia, apart from being independent risk factors for new natal birth trauma.  Multiple studies have also demonstrated that shoulder dystocia as also brachial plexus injury is 5 times as frequent in women detected with diabetes mellitus during pregnancy.     
*Source :        (i) Acker DB, Sachs BP, Friedman EA. Risk factors for shoulder dystocia. Obstet Gynecol 1985;66:762-8; (ii) Langer O, Berkus MK, Huff RW, Summueloff A. Shoulder dystocia: Should the fetus weighing ≥ 4000 grams be delivered by cesarean section? Am J Obstet Gynecol 1991; 165:831-7).

Failure to conduct all the required ante natal tests, not keeping a record of the same and thus not having for ready reference the important physiological and clinical parameters assumes significance in the present case in view of Complainant No.2’s contention (backed by documentary evidence) that Complainant No.3 had gestational diabetes during her second pregnancy and that further she was of short stature and had become obese. 
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION
NEW DELHI

FIRST APPEAL NO. 217 OF 2007
(Against the order dated 06.03.2007 in Complaint No.48/SC/2004 of the
Uttar Pradesh State Consumer Disputes Redressal Commission)

1. M/s Singhal Maternity and Medical Centre

Versus
1. Master Nishant Verma
FIRST APPEAL NO. 223 OF 2007


Pronounced on   24th April, 2014                     




1.       First Appeals No. 217 of 2007, 223 of 2007 and 391 of 2007 have been filed by M/s Singhal Maternity and Medical Centre & others, Master Nishant Verma & others and National Insurance Co. Ltd. respectively against order dated 6th March, 2007 of the U.P. State Consumer Disputes Redressal Commission (for short “the State Commission”) passed in Complaint No. 48 of 2004.  The State Commission vide the impugned order had partly allowed the complaint of medical negligence and deficiency in service filed on behalf of Master Nishant Verma by his parents and awarded damages and compensation to the tune of Rs.17,00,000/- (i.e. Rs.15,00,000/- to be paid by National Insurance Co. Ltd. and Rs.2,00,000/- by M/s Singhal Maternity and Medical Centre & Dr.Pratibha Singhal). Since the facts and the parties are common/similar in respect of all these first appeals arising out of the same consumer dispute, it is proposed to dispose them of through a single order by taking the facts from First Appeal No. 223 of 2007.  The parties will be referred to in the manner in which they were referred to in the complaint i.e. Master Nishant Verma as Complainant No.1, Mr. Bijendra Singh Verma as Complainant No.2, Mrs. Renu Verma as Complainant No.3, M/s Singhal Maternity and Medical Centre as Opposite Party No.1, Dr. Pratibha Singhal as Opposite Party No.2, Dr. R.K. Singhal as Opposite Party No.3 and National Insurance Company Ltd. as Opposite Party No.4/Insurance Company.  
2.       FACTS :
It was contended by Shri Bijendra Singh Verma (Complainant No.2), father and guardian of Master Nishant Verma (minor), Complainant No.1, that he had taken his pregnant wife Smt. Renu Verma (Complainant No.3) to M/s Singhal Maternity and Medical Centre (Opposite Party No.1) for ante-natal care and delivery under Opposite Party No.2/Dr. Pratibha Singhal (Gynecologist), who alongwith her husband Opposite Party No.3/Dr. R.K. Singhal (an Anesthesiologist), who owned and ran the Medical Centre/Opposite Party No.1.  After tests, Complainants No. 2 and 3 were informed that a normal delivery was expected.  On 16th August, 2002 Complainant No.3 was admitted for delivery and consent of Complainant No.2 was taken for any emergency surgery. After the delivery on 16th August, 2002, Opposite Party No.2/Doctor informed Complainant No.2 that she had faced extreme difficulty in conducting a normal delivery due to the excessive weight of the baby and also since the shoulder did not expel normally, it became necessary to use forceps to complete the delivery.  In the process of extracting the baby with forceps, the nerves of his upper right limb appeared to have got damaged causing paralysis and his head had also been injured and heavily pulped on both sides.  His neck and shoulder had also turned blue due to bleeding under the skin.  Complainant No.2 thereafter got Complainant No.1 examined by various eminent Neurologists and specialists, including at the All India Institute of Medical Sciences, who confirmed that during the course of delivery all the five nerves of Complainant No.1, namely C5, C6, C7, C8 and T1 had got totally damaged due to paralysis/rupture.  Despite surgeries conducted in France and subsequently in the USA and other treatments, Complainant No.1 continues to suffer from various disabilities. This occurred because of the medical negligence and deficiency in service on the part of Opposite Parties at all stages of the medical treatment starting from the ante natal checks to neo natal care.  Complainants confined their claim of compensation to Rs.1,00,00,000/- with interest @ 24% per annum although the actual compensation justified would be over Rs.2,00,00,000/-.
3.       On being served, Opposite Party No.2/Doctor filed a counter affidavit on behalf of all Opposite Parties No. 1 to 3 and denied any medical negligence or deficiency in service on their part.  Being highly qualified professionals and running a well-equipped specialized medical centre providing gynecological and maternity services, Opposite Parties No. 2 and 3 denied that the necessary ante natal tests were not conducted.  These as also the three ultrasonography tests confirmed that there were no complications or adverse findings pertaining to either the health of Complainant No.3 or the progress in the growth of the fetus, including the possibility of its being macrosomic i.e. over 4.5 kg.  Progression of labour was also smooth to begin with until the 2nd stage when the heartbeat of the fetus dipped drastically, which is indicative of compression of the umbilical cord causing lack of supply of oxygen to the fetus’ brain, Outlet forceps delivery was, therefore, performed with due care and professionalism to avoid possible death of the fetus.  After delivery of the head, shoulder impaction occurred because of poor maternal effort on the part of Complainant No.3 leading to shoulder dystocia and known complication, namely, brachial plexus injury.  It is medically well established that both these are unpredictable events and can occur despite perfect obstetrical management, as in the instant case.  On detecting this condition, Opposite Party No.2 acted as per standard protocols by using McRoberts maneuver, widening of episiotomy and applying supra pubic pressure. Following delivery, both Complainant No.1 and Complainant No.3 received the best possible medical care and attention from a number of specialists, including a Pediatrician and a Neurologist.  Under the circumstances, the complaint of medical negligence and deficiency in service is not maintainable and deserves to be dismissed. 
4.       The National Insurance Company Ltd., Opposite Party No.4, while confirming that under the insurance cover taken by Opposite Parties No. 1 to 3, the legal liability, which professionals may incur due to error or omission while rendering service, is covered and which Insurance Company would be liable to indemnify as per the terms and conditions of the policy, also stated that as per the evidence on record, there did not appear to be any medical negligence or deficiency in service. 
5.       The State Commission, after hearing the parties and on the basis of evidence produced before it, including the medical literature cited by both the parties, and after taking into account what constitutes medical negligence, as ruled by the Hon’ble Supreme Court in its celebrated decision in Jacob Mathew Vs. State of Punjab and Anr. [(2005) 6 SCC 1], concluded that although Opposite Party No.2/Doctor had reasonable competence and skill she did not exercise this skill and competence in the medical treatment of Complainants No. 1 and 3 starting from the ante natal checks.  The relevant findings of the State Commission are reproduced:
“…  We conclude that the use of forceps with excessive force and excessive traction caused injury to the head, avulsion of head of humerus and blue scar on the chest.  The pitiable condition of the child, who was on the verge of mutilation, suggests that the forceps were not used according to prescribed norms.  The above discussion also concludes that the summary and recommendation of Acog practice bulletin and other studies mentioned above rebuts Henry Lerner’s suggestions.  We also conclude that the maneuver prescribed in literature, and the medical science was not used and applied by Dr. Pratibha Singhal.  Not only this, she has not made proper documentation and the discharge card only mentions supra pubic pressure applied and episiotomy widened but no important and necessary maneuvers as has been repeatedly suggested in medical literature mentioned above were applied by the doctor nor there is any documentation.  Dr. Singhal’s mentioning is also untrue when she avers in the affidavit that McRoberts maneuvers were used.  This does not find in discharge card nor any documentation. We are also concluding that the complainant’s contention about the stature and physic of the mother is more near to the truth, which suggests that prescribed several investigations to ascertain pelvic condition etc. of the mother were not carried out.  The contention is also true that the baby was certainly overweight in Indian condition and its birth weight was nearly 4.5 kg and caesarean section should have been more appropriate as has been suggested by Indian academics, which is apparent from the literature mentioned earlier.  It is also concluded that even if forceps were used for direct vaginal delivery it was not used according to prescribed norms and it was used with excessive force and faulty technique and without proper application of indication which has caused severe fetal injuries.  Excessive traction or traction with excessive force also caused severe fetal injuries.  Another deficiency is also clear.  The opposite party appears to suggest that due to compression of umbilical cord the resultant lack of oxygen supply to the brain prompted the doctor for outlet forcep delivery to prevent death of Baby Nishant.  This is a poor examination of the circumstances.  Had the doctor taken proper care to examine and investigate movement, the rotation, position of the umbilical cord etc. then by caesarean section she should have prevented the misery.”

The State Commission, therefore, partly allowed the complaint and ordered as under :
“… the complainants will be paid as damages and compensation of Rs 17 lacs (Rs 15 lacs from National Insurance Company Ltd. in terms of policy and Rs 2 lacs from Dr. Pratibha Singhal) for the deficiency in service caused by Opposite Parties No. 1 and 2.  The payment will be made within two months from the date of receipt of copy of this judgment, failing which they will also be liable for 12% per annum interest on the above amount.”
   
6.       Being aggrieved by the order of the State Commission, the present appeals have been filed by all the three parties; by Opposite Parties No. 1 and 2 for setting aside the order of the State Commission and Complainants against the lesser compensation of Rs.17 Lakhs awarded as against Rs.1 Crore sought by them.    
7.       Learned Counsel for Opposite Parties No. 1 to 3 Shri R.M. Aggarwal and Complainant No.2 in person made detailed oral submissions.  Learned Counsel for Opposite Party No.4/Insurance Company in his brief submissions essentially reiterated the stand as taken before the State Commission.     
ORAL SUBMISSIONS BY LEARNED COUNSEL FOR OPs 1 & 2

8.       While denying that there was any medical negligence or deficiency in service as ruled by the State Commission, Counsel for Opposite Parties No. 1 and 2 highlighted the following aspects in respect of the case :-
(i)      Ante natal care
          All the required ante natal tests were conducted on Complainant No.3 as also admitted by Complainant No.2 in his complaint before the State Commission.  Elaborating on the results of the three ultrasounds conducted as part of ante natal checks and which are the best available indicators of a fetus’s expected birth weight, Counsel for the Opposite Parties stated that as per the last ultrasound conducted on 24th July, 2002 the estimated birth weight of the fetus was 2.7 kg.  It is medically well accepted that 25 grams per day are added to the body weight of the fetus at this stage and calculating the expected birth weight accordingly at the time of birth the baby was expected to weigh 3.4 kg. (at the rate of 25 grams per day x 23 days).  Even after taking the 10 to 15% margin of error either way in calculating the exact birth weight, the weight of Complainant No.1 at birth would still be less than 4 kg.  In fact, the actual weight recorded was 3.9 kg. and as per medical literature on the subject both in India and in the developed world (USA etc.) only a baby that weighs more than 4.5 kg. can be termed as macrosomic.  The State Commission erred in concluding that the actual birth weight of the baby was 4.4 kg. by solely relying on a recording made by the Pediatrician (Dr. Bina Keith) on the fifth day after delivery that the birth weight of the baby was 4.00 kg. and since there is loss of weight in the first week following delivery, the baby at birth actually weighed 4.4 kg. and not 3.9 kg.  Dr. Bina Keith in her affidavit had confirmed that the weight at birth was 3.9 kg. and had attributed the variations recorded in the weight of Complainant No.1, including at her clinic and other hospitals i.e. Batra and Kailash Hospitals and All India Institute of Medical Sciences, because of minor variations in the different weighing machines used.   
(ii)      During delivery  
          Opposite Parties took the correct decision to opt for a normal delivery since there were no clinical or other medical conditions to indicate the necessity of a cesarean section e.g. suspected fetal compromise, placental disorder and maternal, medical and physiologic conditions (since the ante natal checks did not indicate any such abnormality).  The progress of labour had been meticulously recorded on a half hourly basis by Opposite Party No.2 herself.  A perusal of the same would confirm that everything was normal till the second stage of labour when the heartbeat of the baby dipped drastically indicating compression of the umbilical cord causing lack of supply of oxygen to the brain.  Therefore, in the interest of saving the life of Complainant No.1, an outlet forceps delivery had to be performed and it was during this process that impaction of shoulder occurred leading to shoulder dystocia.  In such cases what happens is that after the baby’s head has emerged, the neck suddenly retracts back against the mother’s perineum causing the baby’s cheeks to puff out.  Counsel for the OPs cited extensively from medical literature, including Williams*, to prove that in most of the cases shoulder dystocia cannot be predicted or prevented because there are no accurate methods and it can occur in both normal weight as also large weight babies.  Further, a team of medical experts from Maulana Azad Medical College appointed on the directions of this Commission had opined that from a perusal of the records of the three ultrasound tests done on Complainant No.3 at 8th, 21st and 37th weeks of gestation there was normal progress of the pregnancy with no evidence of macrosomia.   
*Source : Extracted from Williams Obstetrics 21st Edition

(iii)     Steps taken when shoulder dystocia was diagnosed
          When shoulder dystocia was noticed, the standard protocol/procedure to deal with such cases was undertaken.  The State Commission wrongly concluded that the McRoberts maneuver was not used merely because it was not specifically mentioned in the discharge certificate.  Counsel for the Opposite Parties highlighted that outlet forceps had to be used not because of shoulder dystocia but because the fetal heartbeat was decreasing drastically and the use of forceps was, thus, wholly unconnected with either the weight of the baby or with the brachial plexus injury (emphasis provided), which was caused because of shoulder dystocia, and not because there was any negligence on the part of the Opposite Parties in conducting the outlet forceps delivery.  Complainants’ contention that vacuum suction apparatus would have been a safer method in an emergency situation is not correct as also opined by Dr. D.C. Dutta in his textbook (Textbook of Obstetrics), wherein it has been stated that the use of forceps far outweigh the use of ventouse i.e. vacuum delivery since forceps operation can quickly expedite delivery in case of fetal distress whereas ventouse will be unsuitable as it takes a longer time.  Further, the chances of Cephalhaematoma and failure rate in forceps delivery is also less compared to ventouse.
(iv)     Care of Complainant No.1 after delivery
As per the medical evidence on record, the baby after birth was quickly resuscitated with an ambu bag OT and suction and was medically examined by Dr. Bina Keith (the Pediatrician) who diagnosed the baby with Erb’s Palsy caused by brachial plexus injury on the right shoulder and prescribed medicines and treatment for the same straightaway.  Even though there was no need to consult a Neurosurgeon, by way of abundant caution it was Dr. Bina Keith who recommended that a Neurosurgeon be also consulted.  Dr. Bina Keith in her affidavit also stated that there was no clinical evidence at the time of birth to suspect avulsed head of the humerous bone and other stated injuries. 
Thus, it is clear from the above facts that there was no medical negligence or deficiency in the treatment of Complainants No. 1 and 3 and the appeal filed by the Opposite Parties No. 1 to 3 may be allowed.    
ORAL SUBMISSIONS MADE BY COMPLAINANT NO. 2
9.       Complainant No.2 challenged the above submissions of Opposite Parties No. 1 to 3 and stated that the State Commission had rightly concluded that there was clearly medical negligence and deficiency in service in the treatment of both Complainants No. 1 and 3 as is evident from the following :  
(i)      Incomplete ante natal checks/care
          During ante natal checks, pelvic assessment of Complainant No.3 was never conducted and important physiological indicators, including obesity, short stature etc., were neither recorded nor taken into account.  Further, the required medical/clinical tests, including for blood sugar, were not conducted and, therefore, there were no findings of the same in the Complainant No.3’s ante natal care.  Even   the gestational diabetes test in the last trimester, which is a very important indicator for the prediction of a macrosomic baby was not conducted.  The ultrasound was also not correctly interpreted and there was a large difference of 26.1% between the estimated fetal weight and the actual weight at birth.  Most importantly, the ultrasound results were not clinically correlated with other parameters, including proper abdominal examination/pelvic assessment of Complainant No.3.  If this correlation had been done, the obvious error in the ultrasound findings would have been detected because by carefully examining the dimensions of the abdomen even a nurse/midwife can correctly assess whether the baby is large sized or normal and a more accurate weight of the fetus would have been known.  If all the above ante natal tests had been conducted, any diligent medical professional would not have ruled out conducting the delivery through a cesarean section – in fact it would have been the safest and, therefore, the only option.
(ii)      During delivery
          Complainant No.2 challenged the hand-written documentation of the delivery process purportedly recorded during delivery since it was unusual for the doctor conducting a difficult delivery to simultaneously write these reports herself.  It was further contended that as per medical literature, use of forceps was a wrong decision and Vacuum Suction Apparatus is a much safer and better option.  The specific advantages of ventouse over forceps have been convincingly enumerated in Munro Kerr’s well-known book “Operative Obstetrics”, wherein among the various advantages it has been stated that lesser traction force is needed and it is more comfortable with minimal risk to the mother and the baby.
After shoulder dystocia was noted, McRoberts maneuver was not used and, therefore, no mention of it had been made in the discharge certificate or in the notes purportedly recorded during delivery.  Complainant No.2 also produced medical literature to point out that shoulder dystocia can occur because of improper use of forceps during birth if the forceps are gripped too tightly and there is application of excessive lateral traction being applied to the baby’s neck so as to free the shoulder.  In fact, lateral traction only serves to push the baby’s head towards either of his shoulder and these get stuck thereby causing shoulder dystocia instead of helping it along (reference http://EzineArticles.com/620664).  It was obvious that following shoulder dystocia, the forceps were used with unnecessary excessive force because there is no other plausible explanation to explain the extensive brachial plexus injury, breaking all the five nerves of the upper right limb and damage to the face and head.  It was also stated that when confronted with serious problems during delivery, an emergency cesarean section could not be conducted since the operation theater was not kept readily prepared for conducting surgeries, which is clearly a deficiency in service.
(iii)     After delivery
          Even after delivery, due care was not taken and the Neurosurgeon was brought in only on the third day to examine Complainant No.1 and that too at Complainant’s insistence.  Because of the callous and indifferent attitude of Opposite Parties No. 1 to 3, Complainant No.1 had to be taken for treatment and further check-ups to a number of hospitals immediately after discharge from Opposite Party No.1/Medical Centre.  Complainant No.2 emphasized that treatment for various injuries and disabilities is continuing and despite continuous treatment, including surgeries, 60% permanent physical impairment persists. Keeping in view these facts, a compensation of Rs.1,00,00,000/- was the minimum required and had, therefore, been prayed for.  Unfortunately, the State Commission awarded a meager compensation of only Rs.17,00,000.  Thus, there is a strong case for enhancement of compensation to Rs.1,00,00,000/-.     
FINDINGS
10.     We have given careful consideration to the verbal submissions made by the parties/their counsel and have also gone through the voluminous records in evidence, including the medical literature on the subject.  
11.     What constitutes medical negligence based on the touchstone of the Bolam’s test [Bolam Vs. Friern Hospital Management Committee (1957) 1 WLR 582] is well settled through a number of judgments of the Hon’ble Supreme Courtincluding in Jacob Mathew Vs. State of Punjab & Anr. (supra) and Indian Medical Association Vs. V.P. Shantha and Ors. [(1995) 6 SCC 651].  Gleaned from these judgments, the issues pertaining to what constitutes medical negligence, inter alia, are (i) Whether the doctor in question possessed the medical skills expected of an ordinary skilled practitioner in the field at that point of time; and (ii) Whether the doctor adopted the practice (of clinical observation diagnosis – including diagnostic tests and treatment) in the case that would be adopted by such a doctor of ordinary skill in accord with (at least) one of the responsible bodies of opinion of professional practitioners in the field.  In this connection, the Hon’ble Supreme Court in Jacob Mathew (supra) elaborating on the degree of skill and care required of a medical practitioner quoted Halsbury’s Laws of England (4th Edn., Vol.30, para35), as follows:
“35.   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 case, 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 operation in a different way; …”

In the present case, the allegations of medical negligence have, therefore, been examined in the light of the above enunciated principles as cited by the Hon’ble Apex Court in their various judgments.
ANTE NATAL CARE
It is well acknowledged that ante natal checks are an extremely important and integral part of medical care during pregnancy because these help in identifying, assessing and consequently reducing the risks to both the mother and the fetus.   Ante natal checks in most countries are conducted by not only doctors but also trained paramedical professionals, which include Auxiliary Nurse Midwives (ANMs) and staff nurses.  In India paramedical staff like ANMs, Lady Health Visitors (LHVs) and staff nurses have been trained as a part of their profession about the standard protocol of checks which have to be conducted/advised when a pregnant woman visits a health facility.  These include the following:  
·        recording medical history of the mother, including her height and weight (with the weight to be taken and recorded during each ante natal visit);
·        full blood examination, including tests for blood group, hemoglobin (to check for anemia), Hepatitis-B, blood sugar etc.;
·        ultrasound tests;
·        tests to check for gestational diabetes in the third trimester; and
·        Leopold’s maneuver in the third trimester to determine the size, consistency, shape and mobility of the fetus through palpating the woman’s upper abdomen with both hands*.   

*Source:  1. Guidelines for Antenatal Care and Skilled Attendance at Birth by ANMs/LHVs/SNs by National Rural Health Mission, Govt. of India;

                     2.  Antenatal Checks and Tests – National Health Services, UK extracted from Google

12.     In the instant case, from the documents of the ante natal checks on record, we find that the medical history as also the height and weight of Complainant No.3 were not recorded.  Further, though various blood tests, including for blood sugar, were prescribed, the findings of the blood sugar tests are not recorded in the ante natal documents.  On a specific query by us, OP-2 stated that tests were conducted and found normal but the reports were not placed in the medical records of Complainant No.3 since these had been taken away by Complainant No.2. This fact was denied by Complainant No.2. Even if what OP-2 states is correct and the blood sugar results were normal, it was necessary to have recorded the relevant finding for ready reference/monitoring in the ante natal sheet of Complainant No.3. There is also no record/evidence that the test for gestational diabetes was prescribed and conducted in the third trimester and also whether weight gain, if any, was noted.  As per medical literature on the subject*, these are extremely important tests since gestational diabetes and abnormal weight gain are associated with macrosomia, apart from being independent risk factors for new natal birth trauma.  Multiple studies have also demonstrated that shoulder dystocia as also brachial plexus injury is 5 times as frequent in women detected with diabetes mellitus during pregnancy.     
*Source :        (i) Acker DB, Sachs BP, Friedman EA. Risk factors for shoulder dystocia. Obstet Gynecol 1985;66:762-8; (ii) Langer O, Berkus MK, Huff RW, Summueloff A. Shoulder dystocia: Should the fetus weighing ≥ 4000 grams be delivered by cesarean section? Am J Obstet Gynecol 1991; 165:831-7).

Failure to conduct all the required ante natal tests, not keeping a record of the same and thus not having for ready reference the important physiological and clinical parameters assumes significance in the present case in view of Complainant No.2’s contention (backed by documentary evidence) that Complainant No.3 had gestational diabetes during her second pregnancy and that further she was of short stature and had become obese. 
Opposite Parties No. 1 to 3 have relied on the ultrasound tests to prove that there was no evidence of the fetus being large in weight since the findings of the ultrasound were also confirmed by a team of specialists appointed by this Commission from Maulana Azad Medical College. However, it is well accepted that ultrasound tests by themselves are not the most accurate method of estimating the birth weight of the fetus.  According to the American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin on Macrosomia, the three methods of identifying a fetus with a weight of over 4000 grams are ultrasonography tests and clinical and maternal health status of the pregnant woman and correlating the information from all three sources to get a reasonably reliable estimate of the fetal weight.  Clearly, as per evidence on record, this correlation was not done  because  all  the  required antenatal checks, including those  pertaining to weight gain etc., were not conducted/noted.  Therefore, keeping in view these facts,  even if we  accept   Opposite Parties’ contention that Complainant No.1 weighed 3.9 kg. at birth, it needs to be noted that Dr.D.C.Dutta in his well-known “Textbook of Obstetrics” as also Suneet P. Chauhan, MD, William A. Grobman, MD, Robert A. Gherman, MD and others in their review article ‘Suspicion and treatment of the macrosomic fetus’ published in the American Journal of Obstetrics and Gynecology (2005) 193, 332-46 have taken the view that a macrosomic baby is one who weighs 4000 grams and more.  In the instant case, Complainant No.1 was only technically not macrosomic, being just 1 gram short of 4000 grams.    
We also have no doubt in our minds that there was a clear nexus between the failure to conduct the required ante natal tests and the unfortunate repercussions which occurred subsequently.  In this connection, it may be noted that Opposite Parties had stated that a cesarean section was not considered necessary because none of the conditions (including adverse maternal, physiological and clinical conditions) were present to warrant the same.  However, if all the tests, including the test for gestational diabetes, and keeping a record of the weight gain etc. had been done and thereafter the ultrasound findings correlated with the maternal, clinical and physiological conditions, it is possible that conducting a cesarean section would not have been so categorically ruled out by Opposite Party No.2.
13.     Taking the above facts in their totality while applying the principles of what constitutes medical negligence as cited in para-11 of this order, it is clear that so far as the ante natal care checks are concerned, even though Opposite Parties No. 2 and 3 were well qualified doctors, they did not exercise the reasonable degree of care and skill that was required in the instant case both in terms of conducting the ante natal checks and the diagnosis thereof.  These were basic and necessary tests, which even paramedical staff have been trained to advice/conduct.  Thus, it is clear that Opposite Party No.2 did not adopt the practice of clinical observation and diagnosis including diagnostic tests in the case that would have been adopted by a doctor, leave alone a specialist, and, therefore, she is clearly guilty of medical negligence. 
DELIVERY & POST DELIVERY CARE
14.     Other allegations of Complainant No.2 pertain to deficiency in service and medical negligence during delivery and in the post natal care wherein the following specific allegations were made:
(i)           Wrong decision to use forceps instead of vacuum suction apparatus;
(ii)          Excessive and unnecessary use of forceps during delivery, causing extensive brachial plexus and other injuries;
(iii)        Not using the McRoberts maneuver when confronted with shoulder dystocia during delivery;
(iv)        Not having the operation theatre ready and equipped to deal with an emergency cesarean section; and
(v)         Lack of medical care to Complainant No.1 born after delivery.

15.     Regarding the first allegation about the wrong decision to use forceps instead of vacuum suction apparatus, from the medical literature on the subject, we note that both procedures i.e. forceps delivery and vacuum suction apparatus delivery have their pros and cons and, under the circumstances, the decision of which procedure to adopt is best left to the professional judgment of the doctor conducting the delivery.  In this connection, it would be relevant to cite the judgment of the Hon’ble Supreme Court in Achutrao Haribhau Khodwa Vs. State of Maharashtra [(1996) 2 SCC 634], which states in support as follows:
“44.   … in the very nature of medical profession, skills differ from doctor to doctor and more than one alternative course of treatment is 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 the instant case, Opposite Party No.2, who was a qualified doctor, looking at all the facts, took a professional decision to opt for a forceps delivery and under the circumstances, respectfully following the judgment of the Hon’ble Supreme Court, which is relevant in this case, we conclude that there was no medical negligence or deficiency in service in Opposite Party No.2’s taking a decision to conduct a forceps delivery.      
16.     Complainant No.2 has attributed the large number of injuries of Complainant No.1 to the wrong and excessive use of force while using the forceps. Opposite Parties in their defence have cited medical literature*, which states that injuries like brachial plexus and avulsed head of humerous are unfortunate but common fetal complications of shoulder dystocia and are not related to wrong use of forceps.  Further, the injuries to the head, including cephalhaematoma, occurred during the use of forceps and do not have long term effects. Dr. Bina Keith, the Pediatrician, who was present during delivery, in her affidavit has stated in unequivocal terms that the forceps were skillfully used and there was no wrong or excessive use of the same. These are plausible explanations and we are, thus, unable to conclude that the injuries occurred because of wrong or excessive use of force while using the forceps.    

*Source :        Royal College of Obstetricians & Gynaecologists Article on Shoulder Dystocia - www.rcog.org.uk/womens-health/clinical-guidance/shoulder-dystocia-green-top-42


17.     Additionally, Complainant No.2 alleged that shoulder dystocia was not properly handled since one of the most important interventions namely McRoberts maneuver was not used as is evident from the fact that it was not stated in the discharge certificate or any other documents and was added as an afterthought in the counter affidavit of the OPs filed before this Commission. The State Commission had also reached a similar conclusion.  On a specific query from us, OP-2 stated that it was not mentioned in the discharge certificate by oversight and in fact suprapubic pressure admittedly applied is necessarily to be done in conjunction with the McRoberts maneuver, implying thereby that both procedures are interlinked.  However, as per medical literature on the subject*, these are two separate procedures.  The McRoberts maneuver alone is believed to relieve more than 40% of shoulder dystocias and when combined with suprapubic pressure relieves more than 50% of shoulder dystocias. If indeed in this case McRoberts maneuver had been used, there was no reason for not recording the same, particularly in the copious notes purportedly written by OP-2 during the course of delivery, wherein the other two procedures, namely, suprapubic pressure and episiotomy were mentioned in these documents as also in the discharge certificate.  We, therefore, find force in Complainants’ contention that by not using the single most effective procedure i.e. McRoberts maneuver, shoulder dystocia was not adequately handled. 

*Source :          Article on Shoulder Dystocia by Elizabeth G. Baxley, M.D., University of South Carolina School of Medicine, Columbia and Robert W. Gobbo, M.D., University of California at Davis Family Practice Network, Merced, California (www.aafp.org/afp/2004/0401/p1707.html)


18.     Regarding the deficiency in service alleged by Complainants in not having the operation theatre readily available for an emergency surgery since Opposite Party No.2 had admitted to them that it would require 45 minutes for preparing the same, Opposite Party No.2 while denying the statement has further pointed out that once fetal distress had occurred after the head had “crowned” during the second stage of labour, conducting a cesarean section was not at all a consideration since even a minor delay would be fatal for Complainant No.1.  We accept this explanation,  which is also supported by medical literature* on the subject.
19.     In respect of the medical care of Complainant No.1 after delivery, from the evidence on record we are unable to conclude that there was any medical negligence or deficiency in service on the part of Opposite Parties.  Dr. Bina Keith, a Pediatrician, was present during the delivery and despite fetal distress during delivery, Complainant No.1 was quickly resuscitated and the vital parameters were stabilized.  On medical examination, Dr. Keith detected that this was a case of brachial plexus injury or Erb’s palsy and she immediately started preliminary medical treatment for the same. A Neurologist was consulted within two days who confirmed the line of treatment, which had been initiated.   
*Source :  Extracted from the article ‘What is fetal distress? - www.fitpregnancy.com

20.     To sum up, so far as First Appeals No.217 of 2007 and 391 of 2007 filed by Opposite Parties No. 1 & 2 and Opposite Party No.4/Insurance Company respectively are concerned, we agree with the order of the State Commission that there was medical negligence on the part of Opposite Parties No. 1 & 2 in not conducting the required and important ante natal tests as per the standard protocols, which had unfortunate repercussions, and also in failing to use McRoberts maneuver in handling shoulder dystocia. However, we are unable to conclude as discussed in the foregoing paragraphs that there was any medical negligence or deficiency in service on the part of Opposite Party No.2 while using forceps and in the medical care and treatment of Complainant No.1.  Accordingly, the above first appeals are dismissed and the order of the State Commission is upheld with the above mentioned modification.
First Appeal No. 223 of 2007
21.     Complainants in their First Appeal No.223 of 2007 have sought enhanced compensation of Rs.1 Crore alongwith 24% interest on the ground that Rs.17 Lakhs awarded by the State Commission does not even cover the medical treatment undertaken so far, leave alone the continuing and future treatment as also adequate compensation for mental agony and loss of income of Complainant No.2 and future loss of


income to Complainant No.1 since several professions will be “blocked” for him because of his various disabilities.  We have carefully considered these submissions.  We find that the State Commission has taken note of all the above aspects and given detailed reasons while awarding a compensation of Rs.17,00,000/-.  We specifically asked Complainant No.2 whether any additional interventions, including surgery, had been undertaken on Complainant No.1 after the order of the State Commission and he stated (as stated in his written submissions) that one more surgery had been done on 15th June, 2011 wherein two tendon transfers and one muscle procedure had been conducted.  However, no proof of the expenditure incurred on the same has been filed before us.  On another query by us whether Complainant No.1 attends a regular school for normal children, Complainant No.2 replied in the affirmative, which indicates that the physical injuries at the time of delivery have fortunately not impacted on his IQ and general mental development.  Keeping these facts in view and because we have found Opposite Parties No. 1 and 2 guilty of medical negligence on lesser counts than concluded by the State Commission, we are not inclined to interfere with the order of the State Commission, awarding compensation of Rs.17,00,000/-, and confirm the same.  First Appeal No. 223 of 2007 is accordingly dismissed.   No costs.


Sd/-
                                                                                             (D. K. JAIN, J.)
PRESIDENT


Sd/-
(VINEETA RAI)

MEMBER



Sd/-
(VINAY KUMAR)
MEMBER

Mukesh                    


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