Date of Filing : 07.02.2012

  Date of Order : 21.07.2012

BEFORE THE DISTRICT CONSUMER DISPUTES REDRESSAL FORUM, KOLAR

Dated 21^st JULY 2012

PRESENT

Sri. H.V. RAMACHANDRA RAO, B.Sc., BL,   …….                PRESIDENT

Sri. T.NAGARAJA, B.Sc., LLB.                        ……..     MEMBER

Smt. K.G.SHANTALA                                         ……..     MEMBER

CC No. 17 / 2012

Smt. J. Shilpareddy,

W/o. L. Jeevandareddy,

Aged about 28 years,

R/o: Chowdeshwari Nagar,

Tekal Road, Kolar Town,

Kolar.

(By Sri. K.V. Srinivas, Adv.)                                   ……. Complainant

V/s.

1. Dr. C. Vandana,

    MBBS, DGO, DNB (OBG),

    Obstetrician & Gynecologist,

    Shreya Maternity Center,

    Upstairs of Bajaj Show Room,

    M.B. Road, Beside Sharada Talkies,

    Kolar.

    (By Sri. Amarendra, Adv. for OP1)

2. Dr. N. Kalavathi, MBBS, DMRD,

    Ganesh Health Care, 1^st Cross, Gowripet,

    Kolar.

    (By Smt. Radha Pyari, Adv. for OP2)                …… Opposite Parties

ORDER

By Sri. H.V. RAMACHANDRA RAO, PRESIDENT

The brief antecedents that led to the filing of the complaint u/s. 12 of the Consumer Protection Act, seeking direction to the OPs to pay Rs.20,00,000/- as compensation are necessary:-

Since beginning of her pregnancy, Complainant was consulting and taking treatment from OP1.  As per the directions of OP1, Complainant went to OP2 on 01.05.2011, 10.06.2011, 29.07.2011, 12.09.2011, 26.09.2011, 17.10.2011 & 02.11.2011 and obtained Obstetric Ultrasound.  In the said report, OP2 has stated that “Single live intra uterine gestation are found, cardiac activity good, normal material abdominal study and ovaries is normal, adaexi is normal”.  In the report dtd. 17.10.2011, OP2 has opined that “single live foetus age of 29 weeks 4 days, foetal tone and movements are good and foetal breathing movements are good, liquor is adequate”. OP stated  that baby is good and there is no difficulty.  On 02.11.2011 when the Complainant brought the Obstetric report from OP2 to OP1, she gave shocking news to her stating that her condition is not good and directed her to go to K.R. Hospital, Bangalore and gave letter to Dr. Janaki, Obstetrician & Gynecologist, K.R. Hospital, Bangalore.  On 03.11.2011 at 12.41 PM by LSES a male baby was born which was weighing 1.44 Kg. of 34 weeks and it was referred to NICU for management of respiratory distress.  After the treatment, baby was discharged.  Baby was shifted to Narayana Hrudayalaya Hospital as there was a problem. On 22.11.2011 at Narayana Hrudayalaya, heart surgery was done and on 03.12.2011 baby expired.  In the death report, it is stated B/o Shilpa, 1 month old child was referred to us with cyanosis. Child was diagnosed to have congenital heart disease – Tetralogy of fallot with restricted PDA. Child underwent surgery (Midline innominate artery to RPA 3.5mm, BT shunt) on 22.11.2011. Child was requiring high ventilator and inotropic supports. Child was also on IV antibiotics and other supportive care. However, child continued to be in low cardiac output state for which maximal inotropic support was given. In spite of this, child progressively deteriorated and had a cardiac arrest and was resuscitated, but could not be revived. Child succumbed to his illness and was declared dead on 03.12.2011 at 6.15 AM.  In the report of K.R. Hospital & Narayana Hrudayalaya, it is clearly stated that heart of the baby is boot shape and problem in the baby’s heart since from beginning and this can be identified in the beginning of the pregnancy.  If this was identified in the beginning of the pregnancy would have taken steps aborting the baby, but that has not been done.  This is nothing but negligence on the part of the OPs.  Because of the wrong advise of the Ops, Complainant has suffered and Complainant was made to spend Rs.6,00,000/-   Complainant was suffered with heavy dosage of medicines and she has spent huge amount to get the child which is dead now.  Hence the Complaint.

2(a).   In brief the version of OP1 are:-

Complainant has suppressed certain material facts.  OP1 has given treatment to the Complainant according to the report of the Complainant in a right way as any Gynecologist will do  after seeing the Scan report of the expert i.e., OP2.  This OP taken care of monitoring Blood Pressure and other precautionary measures with respect to the Complainant and this OP referred the Complainant to take treatment at higher Center at the right time in the interest of the Complainant as the management of the premature baby was not feasible in the set-up of the OP1. As the Scan Report dtd. 02.11.2011 states that pregnancy is 30 week showed asymmetrical IUGR and Foetal Hypoxia with reduced liquor (AFI:7.9 CMS).  OP learnt that later the Complainant has been managed in the higher center according to their protocols. What is the treatment given at higher Center is not known to this OP.  Complaint is bad for non / mis-joinder of necessary parties.  All the allegations to the contrary are denied.

2(b)   In brief the version of OP2 are:-

Complainant was consulting OP1 for her pregnancy.  Complainant underwent 1^st Ultrasound scan on 01.05.2011 at Shreya Maternity Centre during her 8+1 week report of which showed normally.  Thereafter, Complainant was referred to OP2 for early pregnancy scan (nuchal translucency) wherein she underwent Ultrasound Scanning on 10.06.2011 during 12^th week.  The report was normal. Subsequently, anamolus scan (meaning: screening scan for gross abnormalities in the baby) report dtd. 29.07.2011 at 19^th week showed four chamber view of foetal heart appears normal, thick maternal anterior abdominal wall precludes through visualization of the Foetus (meaning: baby was not seeing clearly due to obesity of the mother) and the Complainant was advised follow-up scan after 4 weeks which have to be in her 23^rd week of pregnancy.  After 4 weeks, Complainant did not turn-up for anamolus Scan i.e., 23^rd week as advised. But she was referred to this OP for growth scan i.e., to look for foetal weight, liquor, blood flow from mother to baby on 12.09.2011, on 26^th week, as the Complainant developed uncontrolled pregnancy induced hypertension.  Accordingly she developed only body swelling.  The report showed “just adequate liquor” and border line IUGR.  Liquor means fluid surrounding the baby in mother’s womb.  As there was adequate liquor and border line IUGR patient was again referred to follow-up for growth scan and subsequent scan report  on 26.09.2011 during 27^th week showed “just adequate liquor, increased PI in umbilical artery.  Scan on 02.11.2011 during 30^th week showed IUGR and foetal hypoxia (meaning: decreased oxygen to the foetus) with reduced liquor (AFI: 7.9 CMS).  All these Cans were done as per the advise and directions of OP1.  Complainant has missed the crucial scan at her 23^rd week which was very very important to diagnose foetal anomalies.  The said period is crucial because thereafter the detection rate of foetal abnormalities significantly decreases.  Subsequent Scan from 26^th week onwards are conducted only to observe the interval growth of foetus, because further increase in thickness of mother abdominal wall, low liquor volume, abnormal baby position, increase in period of gestation further worsened the clear visibility of the baby to look for minor abnormalities and also as referred by the OP1.  The role of Radiologist is to conduct Scans according to referring Doctors’ requirements and record the findings of the Scan in the report.  It is the Gynecologist who renders the treatment and advice based on such reports.  OP has no knowledge whatsoever about the facts and events that have taken place subsequent to the scan dtd. 02.11.2011.  All the allegations to the contrary are denied.

3.       To substantiate their respective cases, parties had filed their respective affidavits & documents.  In addition OP2 had filed affidavit of experts Dr. Sujatha & Dr. Rajeshwari.  In this case, my predecessor had ordered Karnataka Medical Counsel to look into the matter and submit the report to that. OP2 filed detailed objections.  Accordingly, Medical Council had submitted its report on 01.03.2012.  Arguments were heard.

4.       Points that arise for our consideration are:

(A)     Whether there is negligence or deficiency in service?

(B)     What order ?

5.       Our answers for the above points are as under:

(A)&(B)      As per detailed order for the following reasons

REASONS

6.       This is the case of medical negligence and deficiency in service by the Hospital.  Before looking to the facts it is better to consider the law on the point.  In a case between MARTIN F.D’SOUZA v/s MOHD. ISHFAQ reported in I (2009) CPJ 32 (SC), the Apex Court at Para-41 has ruled thus:-

“ A Medical practitioner is not liable to held negligent simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference to another.  He would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.  For instance, he would be liable if he leaves a surgical gauze inside the patient after an operation vide Achutrao Haribhau Khodwa & Others v. State of Maharashtra & Others, AIR 1996 SC 2377, or operates on the wrong part of the body, and he would be also criminally liable if he operates on someone for removing an organ for illegitimate trade”. 

At Para 44, it has ruled thus:-

“The standard of care has to be judged in the ligh of knowledge available at the time of the incident and not at the date of the trial.  Also where the charge of negligence is of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that point of time.

At Para 47, it has ruled thus:-

“Simply because a patient has not favourably responded to a treatment given by a doctor or a surgery has failed, the doctor cannot be held straightaway liable for medical negligence by applying the doctrine of resipsa loquitur.  No sensible professional would intentionally commit an act or omission which would result in harm or injury to the patent since the professional reputation of the professional would be at stake.  A single failure may cost him dear in his lapse”.

That is so say that a medical practitioner is not liable to be held negligent simply because thing went wrong from mischance or misadventure or through an error in judgment in choosing one reasonable course of treatment in preference to another course.  He will be liable only where his conduct fell below the standards of a reasonably competent practitioner in his field.  The standard of care has to be judged in the light of knowledge available at the time of the incident and not at the time of trial.  Accordingly because a patient has not favourably responded to a treatment given by the Doctor, the Doctor cannot be held to be liable.  No sensible professional would intentionally commit an act or omission which would result in harm or injury to the patient.

7.       Further in the same judgment at Para-52 it has been ruled thus:-

“The professional is one who professes to have some special skill.  A professional impliedly assures the person dealing with him (i) that he has the skill which he professes to possess, (ii) that skill shall be exercised with reasonable care and caution.” 

At Para-73 it has been ruled thus:-

“From the aforementioned principles and decisions relating to medical negligence, with which we agree, it is evident that doctors and nursing homes/hospitals need not be unduly worried about the performance of their functions.  The law is a watch-dog, and not a blood-hound, and as long as doctors do their duty with reasonable care they will not be held liable even if their treatment was unsuccessful”.

At Para-76 it has been ruled thus:-

“The basic principle relating to the law of medical negligence is the Bolam rule which has been quoted above.  The test in fixing negligence is the standard of the ordinary skilled doctor exercising and professing to have that special skill, but a doctor need not possess the highest expert skill.  Considering the facts of the case we cannot hold that the appellant was guilty of medical negligence”.

At Para-93 it has ruled thus:-

“It is evident from the fact that the respondent was already seriously ill before he met the appellant.  There is nothing to show from the evidence that the appellant was in any way negligent, rather it appears that the appellant did his best to give good treatment to the respondent to save his life but the respondent himself did not cooperate.

That means the law is a watch dog and not a blood-hound, and as long as doctors do their duty with reasonable care they will not be held liable even if their treatment was unsuccessful one.  In testing or fixing negligence the Doctor need not possess the highest expert skill only if he is a normal Doctor and his conduct is normal, he is not liable. If the patient was already seriously ill before he met the Doctor in question and there is nothing to show in the evidence that the Doctor has not done his best treatment then the Doctor or the Hospital cannot be held liable.

8.       Further in the same judgment, the Apex Court at Para-112 has ruled thus:-

“The Commission should have realized that different doctors have different approaches, for instance, some have more radical while some have more conservative approaches.  All doctors cannot be fitted into a strait jacketed formula, and cannot be penalized for departing from that formula.

At Para-115 it has ruled thus:-

“Hence, Courts/Consumer For a should keep the above factors in mind when deciding cases related to medical negligence, and not take a view which would be in fact a disservice to the public. The decision of this court in Indian Medical Association v. V.P. Shantha (supra) should not be understood to mean that doctors should be harassed merely because their treatment was unsuccessful or caused some mishap which was not necessarily due to negligence.  In fact in the aforesaid decision it has been observed (vide para 22)

“In the matter of professional liability professions differ from other occupations for the reason that professions operate in spheres where success cannot be achieved in every case and very often success or failure depends upon factors beyond the professional man’s control.

That means to say different doctors will have different approaches, Some Doctors approaches in a different way some are more radical while the others are conservative Doctors cannot be fitted into a strait jacketed formula, and cannot be penalized.  The law could not mean to harass the Doctors merely because of the treatment is unsuccessful. One in the matter of professionalism, professional will differ from the other professional.   An expert opinion should always be there in these types of matters.

9.       Further we may look to law regarding the negligence.

(a)  Negligence is the breach of a duty caused by the omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do. [See law of Torts, Ratanial & Dhirajlal Twenty-fourth Edition 2002, at PP 441-442.]

(b) Negligence means “either subjectively a careless state of mind, or objectively careless conduct.  It is not an absolute term but is a relative one; is rather a comparative term.  In determining whether negligence exist in a particular case, all the attending and surrounding facts and circumstances have to be taken into account” [See Municiapl Corpm. Of Greater Bombay v. Laxman Iyer, VI (2003) SLT 706=III (2003) ACC 551(SC)=(2003) 8 SCC 731, Para6; Adavanced Law Lexicon, P.Ramanatha Aiyar, 3^rd ed. 2005, p.3161]

(c) Negligence is strictly nonfeasance and not malfeasance.  It is the omission to do what the law requires, or the failure to do anything in a manner prescribed by law.  It is the act which can be treated as negligence without any proof as to the surrounding circumstances, because it is in violation of statute or ordinance or is contrary to the dictates of ordinary prudence.

(d) In Bolam V.Friern Hospital Management Committee, (1957), 2 All ER 118, the law was stated thus:-

   “Where you get a situation which involves the use of some special skill or competence, then the test……is the standard of ordinary skilled man exercising and professing to have that special skill.  A man need not possess the highest expert skill; it is well-established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art…

[A doctor] is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a skilled in that particular art…..putting it the other way round, a [doctor] is not negligent, it he [has acted] in accordance with such a practice, merely because with such a practice, merely because there is a body of opinion which [takes] a contrary view”

(e) It has been laid down that an ordinary skilled professional standard of care for determining the liability of medical professional should be followed:-

[See Maynard v.West Midland Regional Health, Authority, (1985) 1 All ER 635 (HL)].

(f) Recently Martin F.D. Souza v. Mohd.Ishfaq, 157 (2009) DLT 391 (SC)=II (2009) SLT20=I (2009) CPJ 32(SC)=(2009) 3SCC1, this Court laid down the precautions which doctos / hospitals, etc., should have taken, in the following terms:

(a) Current practices, infrastructure, paramedical and other staff, hygiene and sterility should be observed strictly..

(b) No prescription should ordinarily be given without actual examination.  The tendency to give prescription over the telephone, except in an acute emergency, should be avoided.

(c) A doctor should not merely go by the version of the patient regarding his symptoms, but should also make his own analysis including tests and investigations where necessary,

(d) A doctor should not make experiment unless necessary and even then he should ordinarily get a written consent from the patient.

(e) An expert should be consulted in case of any doubt…”

(g) We may refer to Bolitho v. City and Hackney health Authority, (1997) 4 All ER 771 (HL), where the court got away from yet another aspect of Balam case.  It was observed:

“The court is not bound to hold that a defendant doctor escapes liability for negligent treatment or diagnosis just because he leads evidence from a number of medical experts who are genuinely of opinion that the defendant’s treatment or diagnosis accorded with sould medical practice.  The use of these adjectives – responsible, reasonable and respectable – all show that the Court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis.  In particular in cases involving, as they so often do, the weighing of risks against benefits, the judge before accepting a body of opinion as being responsible, reasonable and respectable, will need to be satisfied that, in forming their views, the experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the mater” 

(h) In this regard it would be imperative to notice the views rendered in Jacob Mathew v. State of Punjab, 122 (2005) DLT 83 (SC)=III (2005) CCR 9 (SC)=VI (2005) SLT 1=III (2005) CPJ 9 (SC)=2005 6 SCC 1, where the court came to the conclusions:

(i) Mere diviation from normal professional practice is not necessarily evidence of negligence.

(ii) Mere accident is not evidence of negligence,

(iii) An error of judgment on the part of a professional is not negligence per se.

(iv) Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per so by applying the doctrine of res ipsa loquitur. 

10.     Further, in a case between KUSUM SHARMA & ORS. V. BATRA HOSPITAL & MED. RESEARCH CENTRE & ORS in Civil Appeal No.1385/2001 dated 10/02/2010, the Apex Court has ruled thus:-

            I.      Negligence is the breach of a duty exercised by omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do.

         II.      Negligence is an essential ingredient of the offence.  The negligence to be established by the prosecution must be culpable or gross and 50 not the negligence merely based upon an error of judgment.

     III.      The medical professional is expected to bring 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 judge in the light of the particular circumstances of each case is what the law requires.

      IV.      A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.

         V.      In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of other professional doctor.

      VI.      The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure.  Just because a professional looking to the gravity of illness has taken higher element of risk to redeem the patient out of his/her suffering which did not yield the desired result may not amount to negligence.

  VII.      Negligence cannot be attributed to a doctor so long as he performs his duties with reasonable skill and competence.  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.

VIII.      It would not be conductive to the efficiency of the medical profession if no Doctor could 52 administer medicine without a halter round his neck.

      IX.      It is our bounden duty and obligation of the civil society to ensure that the medical professionals are not unnecessary harassed or humiliated so that they can perform their professional duties without fear and apprehension.

         X.      The medical practitioner at times also have to be saved from such a class of complainants who use criminal process as a tool for pressurizing the medical professionals/hospitals particularly private hospitals or clinics for extracting uncalled for compensation.  Such malicious proceedings deserve to be discarded against the medical practitioners.

      XI.      The medical professionals are entitled to get protection so long as they perform the duties with reasonable skill and competence and in the interest of the patients.  The interest and welfare of the 53 patients have to be paramount for the medical professionals.  

These principles have to be considered in this case.

11.     The other decisions citied i..e, (2003) CPJ 311, IV (2003) CPJ 299, II (2005) CPJ 414, III (2005) CPJ 369, III (2005) PCJ 375.  have been considered and there is no dispute about the preposition of law stated therein.  However, these principles and these decisions are not applicable to the facts and circumstances of this case.

12.     Further let us look to the other fundamental of the law.  In AIR 1929 Lahore 868(2) it has been held thus:-

“It is for the plaintiff to prove his own case.  He can succeed only on the strength of his own title and not merely by picking holes in the defence and showing that it was a week one”.

That means it is for the complainant to prove his own case.  He can succeed only on the strength of his own title and not merely by picking holes in the defence and showing that it was a weak one.  

13.     Further in AIR 1971 Madras 422, it has been ruled thus:-

“A Plaintiff coming to the court with specific grounds cannot failing to prove it try to rely on the facts alleged by the defendant”

That means the party who has come to the court has proved his case by his evidence and he cannot merely by picking holes in the Opposite Party’s case and say that his case is proved.

14.     Further in AIR 1971 SC 1865, it has been ruled thus:-

“Mere marking of a document as an expert does not dispense with either the proof or deemed proved.

15.     In AIR 1975 Madras 257, it has ruled thus:-

“ The consent given by a party for marking a document does not dispense with either the proof of the contents of the document or the truth or otherwise of the contents.  

That means mere producing the documents or exhibiting, it will not mean it is proved or contents are true.

16.  Further in AIR 1976 Goa 49 it has been ruled thus:-

“specific plea taken in the written statement, not met by counter plea or evidence by plaintiff, held that defendant should succeed in his plea”.

That is to say if the Opposite Party has taken certain plea in his version if it is not made by counter evidence by the complainant, then on the strength of the plea of the Opposite Party his case is proved and the complainant’s case is to be rejected.

17. This is also the law laid-down in a cases between INS.MALHOTRA V.DR.AKRIPLANI  II 2009 CPJ (18) (SC), NIJAM INSTITUTE OF MEDICAL SCIENCES V. PRASANTH S.DHANANKA reported in II (2009) CPJ 61 (SC), AJAY KUMAR V. DR.DEVENDRA NATH reported in II (2004) CPJ 482, DR.(SMT)KUMUD GARG V.RAJA BHATIA, reported in I 2004 CPJ 369, AMAR SINGH V.FRANCES NEWTON HOSPITAL, reported in I (2008) CPJ8, ASHOK KUMAR V. DR.SURESH SHARMA, reported in I(2001) 478, DR.AKHIL KUMAR JAIN V.LALLAN PRASAD, reported in II (2004) CPJ 504, DR.HARKANWALJIT SINGH SAINI V.GURBAX SINGH and another reported in I (2003) CPJ 153, DR.KAMTA PRASAD SINGH V.NAGINA PRASAD, reported in III (2000) CPJ 28, LAXMAN V. TRIMBAK (SHELAT J.) reported AIR 1969 SC 128, INDERJEET SINGH V. DR.JAGEEP SINGH, reported in III (2004) CPJ 20, INDIAN MEDICAL ASSOCIATION V. V.P. SHANTHA & ORS., reported in III (1995) CPJ 1, JAI PRAKASH SAINI V. DIRECTOR, R.G.C.I. & R.C. REPORTED IN I (2003) CPJ 305, KANHAIYA KUMAR SINGH V.PARK MEDICARE AND RESEARCH CENTRE, reported in III (1999) CPJ 9, MAM CHAND V.DR.G.S.MANGAT OF MANGAT HOSPITAL, reported in I (2004) CPJ 79, between MARBLE CITY HOSPITAL & RESEARCH CENTRE V. V.R.SONI, reported in II (2004) CPJ 102, NIRMALENDU PAUL V.DR.P.K.BAKSHI, reported in III (2000) CPJ 79, between N.S.SAJITA V. NEW RUBY HOSPITAL, reported in II (2000) CPJ 345, between DR.P.K.PANDEY V.SURAJ NURSING HOME, reported in II (1999) 65, between RAJINDER SINGH V.BATRA HOSPITAL AND MEDICAL REEARCH CENTRE, reported in III (2000) CPJ 558, between SARDOOL SINGH v.MUNILAL CHOPRA & ANO., reported in I (1999) CPJ 64, between SMT.SAVITRI SINGH V. DR.RANBIR PD.SINGH, reported in I (2004) CPJ 25, between SMT.VIRLESH DIXIT V.DR.R.R.SINGHAL, reported in I (2004) CPJ 123, between SURINDER KUMAR (BADDI) & ORS. V.DR.SANTOSH MENON & ORS , reported in III (2000) CPJ 517, between VAQAR MOHAMMAD KHAN V.DR.S.K.TANDON, reported in II (2002) CPJ 169.  

18. In the case between Smt. Vimlesh Dixit V Dr.R.K.Singhal, I (2004) CPJ 123 (Uttaranchal), it has been ruled thus:-

“Every operation is not a case of negligence.  Failure of operation is also not a case of negligence.  Side effects are also possible.  Happening of side effects is also not negligence.  The term “negligence” is defined to mean absence of lack and care, which a reasonable man should have taken in the circumstances of the case.  Not even a single word has been told in the complaint, nor in the grounds of appeal about what care was desired from the doctor in which he failed.  It is not said anywhere that what negligence was done during the course of operation.  Nerves may be cut down at the time of operation and mere cutting of nerve does not amount to negligence.  It is not said that it has been deliberately done.  To the contrary it is also not said that the nerves were cut in the operation and it was not cut t the time of accident.   No expert evidence whatsoever has been produced.  Only the report of the Chief Medical Officer of Haridwar has been produced wherein it has been said that the patient is a case of post Havmatic Wrist Drop.  It is not said that it is due to any operation or the negligence of the doctor.  The mere allegation will not make out a case of negligence, unless it is proved by reliable evidence and is supported by expert evidence.  It is true that operation has been done.  It is further true that the complainant has met heavy expenses but unless the negligence of the doctor is proved she is not entitled to any compensation.

19.  What is the standard of case?  In the case between Dr.Kamata Prasad V.Nagina Prasad, III (2000) CPJ 283 (WB), it has been ruled thus:-

It is now a settled principle of law that a medical practitioner will bring to his task a reasonable degree of skill and knowledge and must exercise reasonable degree of care.  Neither the very highest nor the very low degree of care and competence judged in the light of circumstances in each case is what the law requires.  Judged from this yardstick, post-perative infection or shortening of the leg was not due to any negligence or deficiency in service on the part of the opposite party appellant.  Deficiency in service thus cannot be fastened on the opposite party.

20.  BURDEN OF PROOF: In the case between Ajay Kumar V.Dr.Devendra Nath, II (2004) CPJ 482:-

The Apex Court and the National commission have held in several cases including Dr.Laxman Balkrishna Joshi Vs. Dr.Triambak Bapu Godbole, AIR 1969 SC 128: (1986) 1 SCR 206, and in the leading case of Indian medical Association V. V.P. Santha, 1996 (1) CCJ 1 (SC) : III (1995) CPJ (1995) 6 SCC 651 : 1995 (3) CPR 412, it has been held that a doctor is not guilty of negligence since he acted in accordance with the practice accepted as proper by a reasonable body of medical man skilled in that field.  To make allegation against a doctor is easy but it is difficult to prove it.  His case is on different footing with the negligence act of a taxi driver.  Therefore, the evidence to prove negligence of a doctor must be of a high degree and must be an expert evidence which leads to the conclusion that it was the fault on the part of the doctor which he committed negligently which caused adverse to the patient. 

The above literature will regard to lariago clearly mentioned that the side effect of this medicine if taken for longer duration can be on eye sight but this is not a fact in this case besides there is no expert evidence on record to show that use of this medicine caused damage to his eye sight.  Even for argument sake if it accepted that this medicine has caused damage to his eye sight in that case also if the respondent-doctor who is qualified one has advised to use this medicine after examining the patient and found the patient suffering from malaria in that case also the doctor-respondent cannot be held guilty of negligence or deficient in his service.  However, as stated above in this case the medicine has been used by the patient in low doses for a very few days and there is no expert evidence to show that the use of medicine has affected his eyesight.  Therefore, the complainant-appellant has failed to prove that respondent was negligent and deficient in his duty as a doctor.

21.  PROOF AS TO MEDICAL NEGLIGENCE:- In the case between Dr.Akhil Kumar Jain V.Lallan Pradad, II (2004) CPJ 504.

It has been held in different judgments by the National Commission and by the Hon’ble Supreme Court that a charge of professional negligence against the doctor stood on a different footing to a charge of negligence against the driver of a motor car.  The burden of proof is correspondingly greater on the person who alleges negligence against a doctor.  The complainant-respondent has miserably failed to adduce expert evidence in support of his the best skill in the worldly things some time went wrong in medical treatment or surgery operation.  A doctor was not to be admitted fact that complainant’s eye sight was not restored after the operation conducted by the appellant but on this ground alone a doctor was not to be held negligent because even after adopting all precautions and care the result of the operation may not be satisfactory because it depends on various other factors.  The contention of the appellant that patient was suffering from diabetes and blood pressure and in many such cases the eye sight is not restored after the operation howsoever carefully it is done.  In the instant case there is nothing on record to show that something went wrong due to an act of the appellant-doctor.  There is no evidence to come to the conclusion that the appellant fell below the standard of a reasonably competent practitioner in their field, so much so that their conduct might be deserving of censure.  The appellant cannot be liable for negligence because someone else of better skill or knowledge would have prescribed a different method of operation in different way.  The evidence has come that appellant has performed the operation and acted in accordance with the practice regularly accepted and adopted by him in this hospital and several patients are regularly treated for their eye problems.  The Hon’ble Supreme Court in the case of Dr.Laxman Balkrishna V.Dr.Triambak, AIR 1969 Supreme Court page 128, has held the above view and his view has been further confirmed in the case of Indian Medical Association V.Santhana.  The Apex Court and the National Commission has held that skill of medical practitioner differs from doctor to doctor and it is an incumbent upon the complainant to prove that O.P. appellant was negligent in the line of treatment which resulted into the loss eye sight of the complainant.  A judge can find a doctor guilty only when it is proved that he has fallen short of standard of reasonable medical care.  The fact and circumstances of the case before us, show that appellant has attended the patient with due care, skill and diligence and if the patient’s eye did not work satisfactorily, on this account alone it would be difficult to hold the doctor to be guilty of negligence and deficient in his duty.  It is settled law that it is for the complainant to prove the negligence or deficiency in service by adducing expert evidence or opinion and this fact is to be proved beyond all reasonable doubts.  Mere allegation of negligence will be of no help to the complainant.

22.  In case between Amar Singh V.Frances Newton Hospital & Anr., I (2001) CPJ 8, it has been ruled thus:-

“All medical negligence cases concern various questions of fact, when we say burden of proving negligence lies on the complainant, it means he has the task of convincing the court that his version of the facts is the correct one”.

“No expert opinion has been produced by the complainant to contradict the report of the Board of Doctors.  All medical negligence cases concern various questions of fact, when we say burden of proving negligence lies on the complainant, it means he has the task of convincing the court that his version of the facts is the correct one.

23.  Ashok Kumar V.Dr.Suresh Sharma, I (2001) CPJ 478, it has been ruled thus:-

Admittedly no expert has been produced by the complainant to prove negligence of the opposite party.  After removal of the plaster, it was discovered that lower portion of patella had not united with the rest of the patella.  Plaster was changed twice on 18/11/1996 and on 18/12/1996 and the complainant had approached the opposite party for follow up action on 02.03.1997 and 05.12.1997 respectively.  The complainant was still to undergo further treatment by the opposite party by way of removal of wire and removal of lower fragment of patella in case it continued to cause pain and problem to the complainant, even after removal of the wire.  He stopped getting further treatment from the opposite party after removal of the wire, as advised.

Thus, it cannot be said with exactitude that treatment of the complainant by the opposite party was against the norms prescribed under the medical jurisprudence or that the opposite party in any way was negligent or deficient in performance of his duties.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

24. In the case between Chand V.Dr.GS Mangat of Mangat Hospital, I (2004) CPJ 79 (NC), it has been ruled thus:-

“Allegation of medical negligence is a serious issue and it is for the person who sets up the case to prove negligence based on material on record or by way of evidence” (At Para 6).

Complaint of medical negligence dismissed as applicant failed to establish and prove any instance of medical negligence.

25. In the case between Dr. (Smt. Kumud Garg V.Raja Bhatia, I (2004) CPJ 369, it has been held thus:-

“Merely because the operation did not succeed, the doctor cannot be said to be negligent (At para 13)

Appeal of the doctor allowed

26. IN the case between Vimlesh Dixit V.Dr.R.K.Singhal, I (2004) CPJ 123 (Uttaranchal)

          The mere allegation will not make out a case of negligence, unless it is proved by reliable evidence and is supported by export evidence (At Para 9)

27.  In the case between Harkanwaljit Singh Saini V.Gurbax Singh & anr, I (2003) CPJ 153 9NC)

“The commission cannot constitute itself into an expert body and contradict the statement of the doctor unless there is something contrary on the record by way of expert opinion or there is any medical treatise on which reliance could be based” (At Para 6)

Revision Petition of the doctor allowed.

28.  In the case between Na Sahota V. New Ruby Hospital & Ors, II (2000) CPJ 345, it has been held thus;

“The burden of proving the negligence act or wrong diagnosis was on the complainant” (At para 7) Appeal dismissed as no expert evidence was produced.

29.  NEED FOR EXPERT EVIDENCE IN MEDICAL NEGLIGENCE CASES.  In the case between Dr.Harkanwaljit Singh Saini V.Gurbax Singh & another, I (2003) CPJ 153 (NC), it has been held thus:-

The commission cannot constitute itself into an expert body and contradict the statement of the doctor unless there is something contrary on the record by way of expert opinion or there is any medical treatise on which reliance could be based.  In the present case Dr.Saini said that the X-ray report indicated a small opacity that such like opaque shadow become visible for many other causes than the calculus.  It could not be assumed that still stone existed on the right kidney which had not been operated upon by Dr.Saini.

In the circumstances, we do not think that any case of negligence has been made out by the complainant.  This petition is, therefore, allowed.

30. EXPERT EVIDENCE TO INDICATE NEGLIGENCE ON THE PART OF DOCTOR.  In the case between Sardool Singh V.Muni Lal Chopra & Anoother, I (1999) CPJ 64 (Punjab), it has been held thus:-

The present is not a case of apparent negligence on the part of the surgeon in conducting the operation.  As to whether the plate used was inferior quality, the complainant was required to lead expert evidence on that, without any test, it could not be held that such a plate was of inferior quality.  The other type of medical negligence cases are those where expert opinion is require to be produces to prove it.  In the present case, the complainant has not produced any expert witnesses to prove that there was any fault in the performance of the operations.  Fixation of the bones by using plates in one of the recognized modes of treatment in the case of aforesaid method, though subsequently plate has adopted the negligence cannot be attributed to the doctor.  This is not a case complication arose.  Breaking of the plate after about six months of doctor in performing the operation.  The District Forum rightly held that the complainant had failed to prove his case.

31. In the case between dr.Manjit Singh Sandhu V.Uday Kant Thakur & Others, III ( 2002) CPJ 242, it has been held thus:-

There is nothing on the record to suggest that there has been any negligence and or deficiency in service on the part of the appellant except the oral submission of the Respondent/complainant.  In such cases before coming to a positive finding, there must be an expert evidence on record as has been held both by the National Commission as well as the Apex Court.

32. In the case between Jai Prakash Saini V.Director, Rajiv Gandhi Cancer Institute and Research Centre and Ors, I (2003) CPJ 305 (Delhi), it has been held thus:-

In order to decide whether negligence is established in any particular case, the alleged act or omission or course of conduct, complained of, must be judged not by ideal standards nor in the abstract but against the background of the circumstances in which the treatment in question was given and the true test for establishing negligence on the part of a doctor is as to whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of it acting with reasonable care.  Merely because a medical procedure fails, it cannot be stated that the medical practitioner is guilty of negligence unless it is proved that the medical practitioner is guilty of negligence unless it is proved that the medical practitioner did not act with sufficient care and skill and the burden of proving the same rests upon the person who asserts it.  The duty of a medical practitioner arises from the fact that he does something to a human being which is likely to cause physical damages unless it is not done with proper care and skill.  There is no question of warranty, undertaking or perfection of a skill.  The standard of care and skill to satisfy the duty in tort is that of the ordinary competent medical practitioner exercising the ordinary degree of professional skill.  As per the (sic.) charged with negligence can clear himself if he shows that he acted in accordance with the general and approved practice.  It is not required in discharge of his duty of care that he should use the highest degree of skill, since they may never be acquired.  Even deviation from normal professional practice is not necessarily in all cases evidence of negligence.  As per settled law, the onus to prove that there was negligence / deficiency in service on the part of the opposite parties, while diagnosing and treating the complainant, lay heavily on the complainant.  The complainant in the given facts has failed to discharge the onus which was on him.  Moreover, in the case of medical negligence, again as per settled law as already discussed only a fair and reasonable standard of care and competence is expected from a medical practitioner while treating his patient.  A doctor while treating his patient is not to be held “As per the settled law, the onus to prove that there was negligence / deficiency in service on the part of the opposite parties, while diagnosing and treating the complainant, lay heavily on the complainant.  Complainant in the given facts has failed to discharge the onus which was on him. AT Para30.

Complaint dismissed as complainant failed to discharge the onus to prove negligence or deficiency in service.

33.  In the case between Marble City Hospital & Research Centre and Ors. V.V.R.Soni, II (2004) CPJ 102 (MP), it has been held thus:-

The respondent / complainant has not produced any expert medical opinion that there has been any negligence on the part of the appellant Doctor in performing the said operation.  The burden of proving negligence rests upon the person who asserts it.  In medical negligence cases, it is for the patient to establish his case against the medical man and not for the medical man to prove that he acted with sufficient care and skill.  See, the decision of Madhya Pradesh High Court in case of Smt.Sudha Gupta & Ors. V.State of M.P. & Ors. 1999 (2) MPLJ 259.

          The National Commission has also taken the same view observing that mishap during operation cannot be said to be deficiency or negligence in medical services.  Negligence has to be established and cannot be presumed.  See, the decision of the National Commission in case of Kanhiya Kumar Singh V.Park Medicare and Research Centre, III (1999) CPJ 9 (NC) – (2000) NCJ (NC) 12.  Similar view has been taken by the MRTP Commission in case of Dr.P.K.Pandey V.Sufai Nursing Home, II (199) CPJ 65 (MRTP) – 2000 NCJ (MRTP) 268. Followed by this Commission in Vaquar Mohammed Khan & Ano., V.Dr.S.K.Tandon, 2002 (II) 2004) CPJ 20 (NC).

Both the lower For a have held that there is no evidence brough on record by the complainant that there was any negligence shown by the respondent while implanting the lens in the eyes of the complainant resulting in persisting problem in the left eye.

34. IN the case between Nirmalendu Paul V.Dr.P.K. Bakshi & Anr., III (2000) CPJ 79:-

The complainant does not examine any expert on the subject to establish his allegation of negligence on the part of the doctor.  Unfortunate though the incident is, the complainant should establish negligence on the part of the doctor to succeed in a case like this.  We may observe that there is hardly any cogent material to substantiate the allegation contained in the petition of complainant.  Under the circumstances, we cannot but hold that the complainant has failed to prove the allegations against the opposite parties.

35.  EXPERT EVIDENCE: In the case between Surinder Kumar (Laddi) & Anr. V.Dr.Santosh Menon & Ors, III (2000) CPJ 517, it has been held thus:-

There is no evidence much less expert evidence produced on behalf of the complainants that the treatment given to the patient during this period was below the prescribed standard or otherwise not upto the standard skilled.  Dr.Santosh Menon from time to time, called physician from outside to have second opinion in the matter of providing treatment to the patient, whose condition was deteriorating and accordingly such treatment was given.  It will not be out of place to mention that doctors only treat whereas it is in the hands of the Almighty to cure.  Each failure or unsuccessful operation cannot be considered as a negligent act of the doctor.  Something more is required to be established by the complainants to prove negligent act of the doctor.  The present is not a simple case of medical negligence that this Commission couldstraighway give a finding of apparent negligence holding opposite parties liable.  Recently the Supreme Court in Indian Medical Association v. V.P.Shantha, 1996(1) CCJ 1 (Supreme Court) – III (1995) CPJ 1 (Supreme Court), has laid down the principles to be kept in view while deciding the cases of medical negligence.  The complainants have failed to prove from any medical expert evidence that there was any negligent act on the part of the opposite parties.  As held by National Commission in Sethuraman Subramanian Iyer V.Triveni Nursing Home and anr, 1998 CTJ 7: (1998) CPJ 110 (NC), in the absence of such evidence regarding the cause of death and absence of any expert medical evidence, the complainants have failed to prove negligence on the part of the opposite parties.

36.  In the case between Rajinder Singh V.Batra Hospital and Medical Research Centre & Anr, III (2000) CPJ 558, it has been held thus:-

“In order to decide whether negligence is established in any particular case, the alleged act or omission or course of conduct, complained of, must be judged not by ideal standards nor in the abstract but against the background of the circumstances in which the treatment in question was given and the true test for establishing negligence on the part of a doctor is as to whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with reasonable care, Merely because a medical procedure fails, it cannot be stated that the medical practitioner is guilty of negligence unless it is proved that the medical practitioner did not act with sufficient care and skill and the burden of proving the same rests upon the person who asserts it.  The duty of a medical practitioner arises from the fact that he does something to a human being which is likely to cause physical damage unless it is not done with proper care and skill.  There is no question of warranty, undertaking or profession of a skill.  The standard of care and skill to satisfy the duty in tort is that of the ordinary competent medical practitioner exercising the ordinary degree of professional skill.  As per the settled law a defendant charged with negligence can clear himself if he shows that he acted in accordance with the general and approved practice.  It is not required in discharge of his duty of care that he should use the highest degree of skill, since they may never be acquired.  Even deviation from normal professional practice is not necessarily in all cases evidence of negligence.

37.  CHARGE OF MEDICAL NEGLIGENCE AGAINST PROFESSIONAL DOCTORS.  In the case between Smt.Savitri Singh V.Dr.Ranbir PD. Singh & Others, I (2004) CPJ 25 (Bihar), it has been held thus:-

Since Lord Denning till now it has been held in several judgments that a charge of professional negligence against the medical men stood on a different footing to a charge of negligence against the driver of a motor car.  The burden of proof is correspondingly greater on the person who alleges negligence against a doctor.  It is known fact that with the best skill in the world, things sometimes went wrong in medical treatment or surgical operation.  A doctor was not to be held negligent simply because something went wrong due to an Act of OP No.1  & 2. There is also no allegation or evidence to come to the conclusion that both the doctors fell below the standard of reasonably competent practitioner in their field, so much so that their conduct might be deserving of censure.  The National Commission as well as the Apex Court in catena of decisions has held that the doctor is not liable for negligence because of someone else of better skill or knowledge would have prescribed a different treatment or operated in different way.  He is not guilty of negligence if he has acted in accordance with practice accepted as proper by a reasonable body of medical men.  The Hon’ble Supreme Court in the case of Dr.Laxman Balkrishna V.Dr.Trimba, AIR 1969 SC 128, has held the above view which is still considered to be a land-mark judgment for deciding a case of negligence.  In the case of Indian medical Association v. Santhana, the Apex Court has decided that skill of medical practitioner differes from doctor to doctor and it is incumbent upon the complainant to prove that OP was negligent in the line of treatment which resulted in the life of the patient.  Therefore, a judge can find a doctor guilty only when it is proved that he has fallen short of standard of reasonable medical care.  The principle of Res-Ipsa-Loauitur has not been generally followed by the Consumer Courts in India including the National Commission or even the Apex Court in deciding the case under this Act.  In catena of decisions it has been held that it is for the complainant to prove the negligence or deficiency in service by adducing expert evidence or opinion and this fact is to be proved beyond all reasonable doubts.  Mere allegations of negligence will be of no help to the complainant. 

38.     With these in the background let us consider the merit of the case.  Whether the conduct of the Opposite Parties amounts to medical negligence and deficiency in service.

39.     Reading the pleadings in conjunction with the affidavits and the documents on record of both the parties, it is an admitted fact that Complainant went to OP1 who is running Shreya Maternity Centre at Kolar on 09.05.2011 wherein she has disclosed to the OP1 that her last menstrual period was on 09.03.2011.  Accordingly, OP1 stated that expected date of delivery is 16.12.2011.  None of the parties have stated on what date the Complainant went to OP1 or what OP1 did on that day.  Anyway, records speak that on 09.05.2011, OP1 in her Shreya Maternity Centre has taken Ultrasound Scan i.e., Obstetric Ultrasound and issued report. It is produced by the Complainant.  It reads thus:

OBSTRETIC ULTRASOUND REPORT

Uterus: Gravid Uterus,             

Gestational SAC    : Seen

Embryo                 : Seen

Nuchal Translucency       -                  CORPUS LUTEUM CYST

Foetal Movements           -                  Rt. OVARY

CRL  : 16.7mm

GA    : 8+1 Wks                       GA BY LMP: 8+4 Wks

EDD  : 18/12/2011                    EDD              : 16/12/11

Cardiac Activity:    Good

Placenta: Decidual Reaction – Good

Cervix:Length        3.6 cms

Internal OS Closed

Ovaries        : Normal

Adnexa        : Normal

Impression   : Single Live Intra Uterine

Gestation C 8+1 Wks GA

It is not disputed by anybody including OP1.  That means, during 8^th week of pregnancy of the Complainant this Ultrasound Scan was done by the OP1in her Maternity Centre. According to this Ultrasound Scan, impression is “Single live intra uterine gestation with GA”, that means child was normal and it was single live.

40.     Further, it is an admitted fact that Complainant was referred to OP2 by OP1 on 10.06.2011 for Obstetric Ultrasound report.  The report reads thus:

OBSTRETIC ULTRASOUND REPORT

Uterus: Gravid Uterus.  No evidence of focal lesions

Gestational SAC    : Single, Intra Uterine

Embryo                 : Single in number

Nuchal Translucency Normal             

Foetal Movements      Seen                

CRL  : 5.9 cms

GA    : 12 Wks 3D          GA BY LMP: 13 Wks 2D

EDD  : 20--DEC--2011    EDD              : 14/12/2011

Cardiac Activity:    Good (170 bpm)

Placenta: Body Anterior

Cervix:Length        2.5 cms

Internal OS Closed

Ovaries        : Normal

Adnexa        : Normal

Impression   : Single Live Intra Uterine Gestation

  With GA 12 Wks 3D

  Cardiac Activity Good

#Normal maternal abdominal study

41.     This Scan was done at about 12^th week of the pregnancy.  Here also it is found that single live intra uterine gestation with GA 12 weeks 3D, cardiac activity good, normal maternal abdominal study.  There is no dispute about this report and there is no deficiency in service with respect to this report of OP2 or there is no deficiency with respect to this report and the report of OP1 dtd. 09.03.2011. This Scan was referred for just assessment that’s all.  Hence, it has been assessed by OP2.

42.     Further it is an admitted fact that on 29.07.2011 Complainant was referred by OP1 to OP2 for “anomalous scan”.  This is at 19^th week.  The report reads thus:

OBSTRETIC ULTRA SOUND REPORT

FOETUS:    Single live foetus with BREECH presentation

BIOMETRIC MEASUREMENTS

BPD  : 4.68 CMS                               HC              : 17.66cms

FL     : 2.78 CMS                               AC              : 14.05cms

AUA  : 19WKS3D                              GAbyLMP  : 20WKS2D

EDD by AUA: 20/DEC/2011               EDDbyLMP: 14-12-11

                                                          FL/AC         : 19.8

Nasal Bone length: 3.8mm

Nuchal fold thickness: 3.8mm

Transverse dimension of lateral ventricular atrium: 4.2mm

Foetal Cardiac Activity movements well seen

Foetal intracranium, spine, stomach, kidneys & urinary bladder normal

Four Chamberview of Foetal Heart appears normal

Anterior abdominal wall appears normal

Four limbs to the extent seen appears normal

LIQUOR: Adequate                  AFI: 11 CMS

PLACENTA:         Located in Body, Anterior, grade 1 to 2

                             Situated well above presenting part

CERVIX               : Length 3 cms. Internal OS closed

UMBLICAL CORD: Three vessel cord

IMPRESSION      : Single Live Foetus with Breech

  presentation with gestational age of 19

 WKS 3D

#NO E/O grossly detectable congenital abnormalities

Adv. Follow up scan after 4 WKS

Thick maternal anterior abdominal wall precludes through visualization of the foetus – Harmonic imaging used

NOTE: All anomalies cannot be ruled out by this scan, since assessment of foetal anomalies depends on fetal position, liquir volume & period of gestation at the time of scan.

I Dr. N. Kalavathi declare that while conducting ultrasonography on Ms. Shilpa Reddy, I have neither detected nor disclosed the sex of her foetus to anybody in any manner.

Impression in the report states that single live foetus with breech presentation with gestational age of 19 weeks 3D.  It says four chamber view of foetal heart appears normal.  Further it clearly states that “thick material anterior abdominal wall precludes thorough visualization of the foetus – harmonic imaging used, with a Note all anomalies cannot be ruled out by this scan since assessment of foetal anomalies depends on foetal position, liquor volume & period of gestation at the time of scan.  That means, there was thick material and anterior abdominal was there.  Hence, it precludes thorough visualization.  Foetus i.e., baby was not seeing and was not clear due to obesity of the mother and hence she was advised to go for scan on her 23^rd week f pregnancy. 

43.     It is also an admitted fact that 23^rd week of pregnancy on or around 04.08.2011 and the Complainant was neither sent to OP2 by OP1 nor she went to OP2 nor she went to OP1 on or around 04.08.2011 for that 23^rd week of pregnancy’s scan.  That means, Complainant was heavy built-up woman.  Because of her heavy body, the foetus could not be visualized in the scan properly and that is the report that has been given.  Hence, Complainant was also advised to go on or around 04.08.2011 for further scan, but she for her own reason did not go for the scan on or around 04.08.2011.  She has to be blamed for this.

44.     Further it is an admitted fact that on 12.09.2011 Complainant gone to OP1 who referred her to OP2 for clinical details / analysis.  Accordingly, OP2 conducted scan again and gave the report which reads thus:

OBSTRETIC ULTRA SOUND REPORT

FOETUS:    Single live foetus with Breech presentation

BIOMETRIC MEASUREMENTS

BPD  : 6.86 CMS                               HC: 24.87cms

FL     : 4.45 CMS(10^th percentile)        AC:21.08(10^th percentile)

AUA  : 26WKS1D                              GAbyLMP  : 25WKS5D

EDD by AUA: 18/DEC/2011               EDDbyLMP: 14-12-11

EFW  : 948 GMS                                FL/AC         : 21.1

          BIOPHYSICAL PROFILE:

                   Foetal tone & movements are Good

                   Foetal breathing movements Good

                   FHR: 140 bpm

                   U/S Biophysical scoring: 8/8

          LIQUOR: Just Adequate  AFI: 9.1 CMS

          PLACENTA: Located in body, Anterior grade 2

                                Situated well above presenting part

          CERVIX     : Length 3.2 cms, internal OS closed

          UMPLICAL CORD:       Three vessel cord

IMPRESSION:      Single Live Foetus with Breech Presentation with gestational age of 26 WKS 1 D             

It is found the liquor as just adequate (AFI: 9.1 CMS) and also stated border line IVGR

45.     Further it is an admitted fact that on 26.09.2011 Complainant was referred to OP2 for growth assessment Ultrasound Scan and at that time OP2 did Scan and gave report which reads thus:

OBSTRETIC ULTRA SOUND REPORT

FOETUS:    Single live foetus with Cephalich presentation

BIOMETRIC MEASUREMENTS

BPD  : 7.15 CMS                               HC: 26.11cms

FL     : 4.73 CMS                               AC:22.41 cms

AUA  : 27WKS3D                              GAbyLMP  : 28WKS5D

EDD by AUA:                                    EDDbyLMP: 14-12-11

EFW  : 1.1 KGS                                 FL/AC         : 21.1

          BIOPHYSICAL PROFILE:

                   Foetal tone & movements are Good

                   Foetal breathing movements Good

                   FHR: 150 bpm

                   U/S Biophysical scoring: 8/8

                   Umblical arterial flow: Increased (PI)

          LIQUOR: Just Adequate  AFI: 10.7 CMS

          PLACENTA: Located in body, Anterior grade 2

                                Situated well above presenting part

          CERVIX     : Length 3 cms, internal OS closed

          UMPLICAL CORD:       Three vessel cord

IMPRESSION:      Single Live Foetus with Cephalic Presentation with gestational age of 27 WKS 3 D   

          # Intervel growth normal

It is found liquor as adequate AFI: 10.7 CMS.  Again similar exercises were made on 17.10.2011 at 29^th week of gestation wherein liquor was found adequate and AFI were 12.6 CMS.  That means, IUGR was being increased in PI in umbilical artery and what the OP2 found he has reported to back to the OP1.  Analysis of this scan reports has to be made only by the OP1.

46.     Further it is an admitted fact that on 02.11.2011 Complainant was sent to OP2 for growth assessment only to OP2 where she did Ultrasound and found liquor reduced and AFI: 7.9 CMS.  That means IUGR also reduced at 30^th week of pregnancy i.e., 7 ½ months of pregnancy and the impression was foetus showed IUGR and Foetal Hypoxia with reduced liquor.  Accordingly, OP1 referred the Complainant to Dr. Janaki of K.R. Hospital with a covering letter on 02.11.2011 wherein Complainant delivered a baby on 03.11.2011 at 12.41 PM.  Because of the condition of the baby, baby was referred to Narayana Hrudayalaya where the baby was admitted on 18.11.2011 and operated on 22.11.2011 and died on 03.12.2011 stating that the baby died because of the low cardiac output. 

47.     Further it is an admitted fact that Complainant was shifted to K.R. Hospital on 03.11.2011 and she delivered the baby at 12.41 PM on that day.  It is observed in the K.R. Hospital thus:

          ON ADMISSION INNICU

Assessed Gestation         : preterm (34 wks)

          Weight                            : 1.44 kgs.

          Head Circumference        :

          Clinical Examination        : Baby not active & tachypnic

                                                  Vitals: HR-150/min RR-68/min

                                                  BP – 65 mm Hg  RBS-37mg/dl

                                                  Perfusion: Fair  Temp – 90° F

                                                  No Gross Congenital Anomalies

          Systemic Examination:

          RS: Nasal flare ++, Chest retraction ++, Grunt++, B/L equal airentry

          CVS: S1 S2 heard, No murmurs

          PA:    Soft, BS+

          CNS: AF level

                             Newborn Reflexes – not done

                             Other Significant findings: nil

          INVESTIGATIONS:

          Blood Group: B Positive

Arterial Blood Gases – monitored

          Peripheral Smear: Normal

          Chest X-Ray – Hazy opacities left upper & rt lower zone, boot

     shaped/egg on end app

          Blood Culture: No Growth

          ECHO – TOF, valvular, infundibular PS, confluent peripheral

                       artery Stenosis

          CSF – 08/11/11                                           16/11/11

                   Total count – 4                                   02

                   Cell Type – 100% lymphocytes          100% lymphocytes

                   Protein – 210 mg/dl                             160 mg/dl

                   Sugar – 58 mg/dl                                32 mg/dl

                   Gram Stain – no cells or organisms     no pus cells or

organisms

          COURSE IN THE HOSPITAL

          Baby was shifted to our unit in view of Preterm/Respiratory Distress on day 1 of life.  On admission, baby sick looking with grunting and retractions. Baby was started on CPAP with settings of 5/0.38.  Antibiotics were started empirically and Septic work up was done – positive and X ray showed pneumonia.  ECHO done on day 2 showed features suggestive of Tetrology of Fallot.  Baby was weaned of CPAP by day 7 and since day 8 baby became lethargic with poor sucking and moros.  Repeat septic work up showed partial response with increase in CRP.  DNA PCR showed Polymicrobial Sepsis – Acinetobacter and Candida.  Antifungals were added and Meropenem was started.  Baby developed desaturations and hence oxygen was restarted.  There was no respiratory distress.  Propranolol was started.  Since then baby’s condition has been the same and oxygen requirement has progressively increased to 5L/min.  Despite increase in oxygen administration SpO2 has been between 75 and 85%. In view of symptomatic TOF baby is being referred to Cardiac specialty centre (Narayana Hrudayalaya).

That means, baby was suffering from Tetrology of Fallot and with  pneumonia.  Because of that, baby of the Complainant was shifted to Narayana Hrudayalaya on 18.11.2011 itself and it was operated on 22.11.2011.  The diagnosis that was made at Narayana Hrudayalaya was “Tetralogy of fallot with smallish branch PAs, Congenital pneumonia, Polymicrobial sepsis on ventilatory support” and the cause of death that has been given as “Low cardiac output”.  That means, the baby was suffering from pneumonia and Tetralogy of fallot and Midline innominate artery to RPA 3.5mm, Modified Blalock Taussig’s shunt on CPB was done and Tetrology of fallot with smallish branch PAs, Congenital pneumonia Polymicrobial sepsis on ventilatory support was there and because of that child died.  This we have to note very much.  Tetrology of fallot is a minor obstruction in blood supply from heart lungs which manifest after the birth.  In tetralogy of fallot four chamber view of the foetal heart & cardiac activity appears normal in antenatal scan.  Normal appearance of four chamber view of heart in tetrology of fallot & absence of risk factors for congenital heart disease, presence of limitations for ultrasound, failure to come at 23 wks, absence of indications for foetal ECHO (detailed baby’s heart study) prevented the detection of abnormality in this case (Diagnostic Ultrasound, Vol. 2 by Johnson, Rumack & others, Pg. No. 1323 & 1324).  Tetralogy of fallot is not a fatal condition.  The prognosis in tetralogy of fallot mainly depends on the severity of pulmonary stenosis.  The surgical outcome will be good in the absence of pulmonary atresia.  In this case there is no pulmonary atresia & only smallish branch pulmonary artery stenosis was noted.  After correction, the quality of life is good.  Repeated surgical intervention is rarely needed in this case (Ref: Ultrasound Diagnosis of Foetal Anomalies by Michael Entzami & Others Page No. 96, Text Book of Diagnostic Ultrasound, Vol. 2 by Johnson, Rumack & others, Page No. 1344, 1345, 1324 & table 40-1).  Note that tetralogy of fallot never cause IUGR (Ref: Diagnostic Ultrasound, Volume 2 by Carol Rumack & others, Page No. 1507, table 45-13).  By diagnosing the tetrology of fallot after 26 wks which is not a lethal condition & has good surgical outcome either gynaecologist or radiologist cannot advice termination as per MTP Act.  The complication of PIH & IUGR which was seen in this baby before surgery at Narayana Hrudayalaya are (a) Congenital pneumonia (b) polymicrobial sepsis (acinetobacter & candida), (c) preterm (d) respiratory distress (e) respiratory failure (f) liver dysfunction (g) anemia (h) hypoglycemia (Ref: K.R. Hospital & Narayana Hrudayalaya Reports).  As per the discharge summary of Narayana Hrudayalaya, baby underwent surgery for Tetralogy of fallot (modified BT SHUNT) on 18^th day after birth.  Surgery was performed on the baby which had serious complications of IUGR & hospital  acquired infections.  In spite of successful surgery with good surgical outcome unfortunately the baby died due to complications of IUGR & hospital acquired infections on 3/12/2011.  It is pertinent to note that cardiac function was good before and after surgery and thereafter deteriorated on the 10^th day of surgery due to Polymicrobial Sepsis (due to ascineto bacter & candadia, multi drug resistance organisms).  IUGR causes multi-organ failure including cardiac, respiratory, liver failure, Low platelet count & anemia (Text Book of Obstetrics by D.C. Dutta Page No. 464).  Now we have to see whether there is medical negligence on the part of any of the Ops in this regard in the death of the child of the Complainant.

48.     Further, Complainant herself wanted the baby to be aborted if she had knowledge of heart problem of the baby.  Merely child had heart problem, it does not mean medical jurisprudence permits or Law permits termination of pregnancy in such an event.  In any event, because of the heart problem child died though operated. The intention of the Complainant was death of the child if it has heart problem, it died because of that.  Hence, how can any of the Ops would be termed deficient in service.  The object of the Complainant is achieved.

49.     Further, it is premature delivery.  Here what is the negligence of OP No. 1?  She is a Gynecologist.  When the Complainant has gone for consultation, she took first Ultrasound Scan and she referred the matter for further scan as under medical jurisprudence to OP2.  Basing on the report of the Scan she has treated and when it was alarming she referred the patient to the Higher Hospital where it was found deceased child was having pneumonia coupled with other problems developed during the delivery and also child was having Tetrology of fallot with smallish branch PAs, Congenital pneumonia Polymicrobial sepsis on ventilatory support and it died because of that.  Hence, OP1 can never be blamed for anything as she is only a Gynecologist and not a Creator.  Creator only knows what is there in the womb or its functioning?   There cannot and there is no negligence on the part of OP1. 

50.     Now we have to see whether there is negligence or deficiency in service on the part of OP2.  OP2 is only a Radiologist.  She is not a Doctor who treated. 

51.     It is seen from the Diagnostic Ultrasound 3^rd Edition & 4^th Edition by Corol M. Rumack, Ultrasound Diagnosis of Fetal Anomalies by Michael Etezami, Textboo of Obstetrics including Perinatology and Contraception 7^th Edition by D.C. Dutta, Textbook of Microbiology by R. Ananthanarayan & C.K. Jayaram Paniker, that during the period of pregnancy, according to the standard practice, Ultrasound Scan are done between 11^th to 14^th weeks for nuchal translucency, Second Ultrasound can is done between 18 to 22^nd weeks of pregnancy to look for congenital abnormalities in the baby, interval growth assessment, Third Ultrasound Scan will be done between 29 to 48^th week for biophysical profile, interval growth assessment.  These are the 3 major Ultrasound Scans that will be done and as & when it is required by the Gynecologist, Ultrasound Scan will also be done.

52.     Further it is seen from this Medical Textbooks that in the pregnancy of 18 – 22nd weeks, two types of Scans are done, one is routine, basis & standard, Level-1 Anomalous Scan performed routinely on pregnant patients and secondly detailed or high risk or targeted or level-2 scan usually done in which a specific abnormality are sought because the patient is at risk or an abnormality was suspected at earlier examination.  Foetal echo is an example of such study (according to the text book of Diagnostic Ultrasound, Volume-2 by Johnson, Rumack & others, Page No. 1044 & 1045).  First Scan was done by the OP2 on 10.06.2011 i.e., 13^th week of pregnancy which has been done for assessment.  Here nuchal translucency that is thickness behind the neck is to be known.  In this case cervix length is 2.5 cms, interval OS closed.  This is normal range and no abnormalities were found.

53.     In this case OP2 has done routine basic, standard, level-1 Anomalous Scan at 19^th week.  Everything was normal there.  There are no abnormalities seen.

54.     In this case, 2^nd Ultrasound Scan has to be done on 18 – 22^nd week.  In some cases, it may require repeat anamol scan at 23 – 24^th week as per  Textbook of Diagnostic Ultrasound, Volume-II by Johnson, Rumack & others, Page 1042-47 and Ultrasound Diagnosis of Foetal Anomalies by Michael Enterzami & others, Page 80.

55.     According to the standard Ultrasound studies, detection rate of major congenital abnormalities in the baby is  highest (maximum ultrasound sensitivity) in Anomalous Scans done at 18 – 23^rd weeks in comparison with the studies done after 24 weeks of pregnancy as per Text Book of Diagnostic Ultrasound, Volume II by Levine, Rumack & others, Page 1045, Johnson & others Page 1042.

56.     Further there are limitations for ultrasound examinations those are foetal position, low amniotic fluid volume, maternal body habitus (obesity), type of defect (smaller the defect more difficult is its identification), prevalence of particular defect, quality of equipment, number of studies done per pregnancy at 18 – 22^nd weeks, skill of the radiologist & gestational age of foetus vide Text Book of Diagnosis Ultrasound, Volume-II, Johnson, Rumack & others, Page 1043-1045).  With these in the background, let us proceed further.

57.     In this case, we find that there was one early pregnancy scan, one anomalous scan at 19^th week, 4 serial scans from 26 – 30^th week just to monitor the interval growth IUGR & PIH complications only.

58.     The anomalous Scan done at 18 – 20^th week does not reveal much significant information due to limitation of the Ultrasound Scan, repeat anomalous scan at 23^rd week is advisable according to standard medical practice vide Textbook Ultrasound Diagnosis of Foetal Anomalies by Michael Enterzami & others, Page 80.

59.     Further any Ultrasound Scan cannot capture all the foetal abnormalities. Over all detection rate of congenital abnormalities by Ultrasound is 61.4%, 56% of this before 24^th week of gestation.  There were marked differences in sensitivity for different malformation.  The best detected abnormalities were those of urinary system, central nervous system vide Textbook of Diagnostic Ultrasound, Volume 2 by Johnson, Rumack & others, Page 1042-1047.

60.     Further cardiac abnormalities are not well detected by the Ultrasound.  The sensitivity for major is 38.8% and for minor is 20.8% vide Textbook of Diagnostic Ultrasound, Volume 2, by Johnson, Rumack & others, Page 1042.

61.     In Ultrasound diagnosis of foetal anomalies by Michael Entezami & others, Page 80, they have described as the rate of detection of cardiac anomalies during prenatal screening is extremely variable.  According to literature, it ranges from 5% to 85% so that at best 17 out of 20 cardiac anomalies may be detected prenatally or at worst only one in twenty.

62.     Foetal echo meaning detailed ultrasound study of baby’s heart only.  It gives better details of the heart and its best timing is 21 weeks and in obese patients scan at 23 – 24^th weeks is advisable vide Textbook Diagnostic Ultrasound, Volume 2 by Johnson, Rumack & others, Page 1044 and Ultrasound Diagnosis of Foetal Anomalies by Michael Entzami & others, Page 80.

63.     In this case nobody has asked the OP2 to do or conduct foetal echo.  When that has not been stated by anybody and that is not even imaginable, how can the OP2 do foetal echo and find that whether there is problem in the heart of the baby to be born. 

64.     Further cardiac anomalies frequently go undetected due to foetal rib shadows, anterior position of spine of the baby and also general scan or foetal echo.  Further in this case, it is clearly stated by OP2 that since the Complainant was Obese, the scan could not revel anything and hence she was asked to come for Scan again at the 23^rd week of pregnancy.  Scan report did not reveal any abnormalities of anything, even then Complainant did not turn-up for scan at the 23^rd week of pregnancy.  When she has not gone for 23^rd week of pregnancy, how can any ailment of heart of the baby to be born could be found?  Hence, it cannot be said that OP2 is negligence.

65.     Child was having Tetrology of fallot.  When the child was having Tetrology of fallot since birth, this problem with heart could not be found by the Ultrasound Scan as stated in the Textbooks supra.  When the child was having Tetrology of fallot from the birth and child was having heart problem, it could not be detected by Ultrasound Scan.  Hence, finding of the heart problem of the child to be born by OP2 can never be termed to be medical negligence.

66.     Further it is seen in this case before issuing process to the Ops, this Forum has sought report from the Karnataka Medical Council in the matter and Medical Council has given the following report, behind the back of the Ops on 01.03.2012.

“Karnataka Medical Council during its Meeting held on 01.03.2012 perused the entire records pertaining to the case, including the treatment charts of K.R. Hospital, Bangalore and Narayana Hrudayalaya where the baby expired after surgery.  The baby was suffering from “Tetrology of Fallot” a congenital heart disorder.

The R(2) even after repeated Ultrasound examinations till the expected date of delivery failed to recognize the congenital anomaly.

OPINION: Karnataka Medical Council is of the unanimous Opinion that there is “Deficiency of Service” on the part of R(2).

Here even Medical Council has stated that baby was suffering from Tetrology of Fallot, a congenital heart disorder and stated OP2 failed to recognize congenital anomaly, that’s all and stated it is deficiency in service.  How can Karnataka Medical Council says that it is deficiency in service.  No reason has been given to say how OP2 was deficient in service.

“In AIR 1974 SC 87 it has been ruled thus: Reasons are linked between the materials on which certain conclusions are based on the actual conclusions.  Then disclose how the mind is applied to the subject matter for a decision where it is purely administrative or quasi judicial.  They should revead rational nexus between the facts considered and conclusions reached only in this way opinions or decisions relied be showed to be manifestly just and reasonable.”

67.     Here the opinion of the experts is without any reason.  This report has been objected by OP2 by filing detailed objections.  The said Medical Council has not asked any of the OPs anything in the matter and it has not sought  OP2’s opinion or OP1’s opinion in the matter.  It has violated the principles of natural justice.  When the entire records were sent to the Karnataka Medical Council, why it has not considered the matter against OP1? There is no answer.  This clearly goes to show report is biased and unacceptable one. 

68.     Complainant has not filed evidence of any other Doctors or Radiologists to show that action of the OP2 or OP1 as the case may be is deficiency in service or medical negligence.  Her evidence is of no consequence as she is neither a Doctor nor a Radiologist, but an ordinary human being. 

69.     OP2 has filed affidavit of expert Dr. Sujatha and Dr. Rajeswari.  They have given cogent reasons in their affidavits and also explained how the action of the OP2 is not negligent and not of any deficiency in service.  There is nothing to disbelieve the same.  Merely these two persons were known to OP2 does not mean that these two Doctors have filed false affidavits.  These two expert Doctors at Para 3 to 49 of their Affidavits have stated thus:

“3.        I submit that during the period of pregnancy, according to the standard practice, a minimum of three ultrasound scans one per each trimester is advisable as detailed below : (Reference - Text book of Diagnostic Ultrasound, Volume 2 by Deborah Levine, Rumack & others, Page No.1040)

First trimester scan – From 11 to 14 wks – for nuchal translucency

Second trimester scan – From 18 to 22 wks – to look for major Congenital abnormalities in the baby, Interval growth assessment

Third trimester scan – From 29 to 40 wks – For biophysical profile interval growth assessment

But not necessarily be limited to 3 scans. The number of scans varies depending upon individual risks, sometimes it may require weekly follow up scans.

4.         I submit that according to the standard guidelines two types of scans are done at 18 to 22wks

(a)        Routine (or) basic (or) standard (or) level 1 anamolous scan - performed routinely on pregnant patients;

(b)        Detailed (or) high risk (or) targeted (leve2 scan)-usually done in which a specific abnormality are sought because the patient is at risk or an abnormality was suspected at earlier examination. Foetal echo is an example of such study.(according to text book of diagnostic ultrasound, volume 2 by Johnson, Rumack & others, Page No. 1044 & 1045)

5.         I submit that in this particular case, the Radiologist has done routine (or) basic (or) standard (or) level 1 anomalous scan at 19  wks.

6.         I submit that Nuchal translucency means skin thickness behind neck. Normal range is up to 3 mm. It is done at 11 to 14 wks. Increased thickness is associated with abnormal babies. It is normal in this patient.

7.        I submit that Anomalous scan is a second – trimester screening ultra sound for the detection of major malformation in the baby. According to standard ultrasound practice, it is done from 18 to 22 weeks. In some cases it may require to repeat anomalous scan at 23 to 24 weeks. (Ref: Text book of Diagnostic Ultrasound, Volume 2 by Johnson, Rumack & others, Page No.1042 to1047 & Ultrasound Diagnosis of Foetal Anomalies by Michael Entezami & others Page No. 80).

8.        I submit that according to the standard ultrasound studies the detection rate of major Congenital abnormalities in the baby is highest (maximum ultrasound sensitivity) in Anomalous scans done at 18-23 wks in comparison with the studies done after 24 wks of pregnancy. (Ref. Text book of Diagnostic Ultrasound, Volume 2 by Levine, Rumack & others, Page No.1045 Johnson & others page no. 1042).

9.        I submit that there are limitations for ultrasound examination these are foetal position, low amniotic fluid volume, maternal body habitus (obesity), type of defect (smaller the defect more difficult is its identification), prevalence of particular defect, Quality of equipment, the number of studies done per pregnancy at 18 to 22 wks, skill of the radiologist & gestational age of foetus. (Ref. Text book of Diagnostic Ultrasound, Volume 2 by Johnson, Rumack & others, page No.1043 & 1045).

10.       I submit that the Radiologist has done:

a)         one early pregnancy scan

b)         one anomalous scan at 19 wks

c)         four serial scans from 26 wks to 30 wks were done specifically to monitor interval growth ,IUGR & PIH Complications that has been clearly mentioned in reports

11.       I submit that if Anomalous scan done at 18 to 20 wks does not reveal much significant information due to limitation of ultrasound, repeat anomalous scan at 23 weeks is advisable for better information according to the standard medical practice. (Ref. Ultrasound Diagnosis of Foetal Anomalies by Michael Entezami & others, Page No.80).

12.       I submit that in the instant case, the patient did not report for re-scan at 23^rd week as advised by the Gynaecologist. If she had come at 23 weeks, the chances for detection of abnormality was more, because when she came at 26 wks the visibility had worsened due to pregnancy induced hypertension.

13.       I submit that in this particular case, the Radiologist had made an attempt to look for abnormalities after 26 wks.

14.       I submit that Harmonic Imaging is a latest image enhancing modality in ultrasound machine which helps in better visualization in poor ultrasound images.

15.       I submit that according to the standard ultra sound practice any scan cannot capture all the foetal abnormalities. The over all detection rate of congenital abnormalities by ultrasound is 61.4%. 56% of these before 24 wks gestation, there were marked differences in sensitivity for different malformations. The best detected abnormalities were those of urinary system & central nervous system. (Ref. Text Book of Diagnostic of Ultrasound, Volume 2 by Johnson, Rumack & others, Page No.1042 to1047).

16.       I submit that according to the ultrasound studies cardiac abnormalities are not well detected by the ultrasound. The sensitivity for major is 38.8 % and for minor is 20.8 %. (Ref. Text Book of Diagnostic Ultrasound, Volume 2 by Carol Rumack & others, Page No.1042). In ultrasound diagnosis of foetal anomalies by Michael Entezami & others on Page No 80, they have described as - the rate of detection of cardiac anomalies during prenatal screening is extremely variable; according to literature, it ranges from 5% to 85 %, so that at best 17 out of 20 cardiac anomalies may be detected prenatally, or at worst only one in twenty.

17.       I submit that in antenatal scan four chamber view of the heart, cardiac activity & breathing movements appears normal in tetralogy of fallot. (Ref. Text Book of Diagnostic Ultrasound, Volume 2 by Carol Rumack & others, Page No.1344 to 1346).

18.       I submit that Boot shaped heart is only a chest x-ray (roentgenographi) finding in tetralogy of fallot after birth, the heart appears in the shape of a boot. This is called boot shaped heart. But within the baby, heart will not be in a boot shape. Boot shaped heart is not an ultrasound/echo finding before or after birth in tetralogy of fallot. (Ref. Nelson’s Text book of Paediatrics, Page No.1907 ).

19.       I submit that foetal echo meaning detailed ultrasound study of baby’s heart only. It gives better details of the heart. And its best timing is 21 weeks and in obese patients scan at 23 to 24 weeks is advisable. (Ref. Text book of diagnostic ultrasound, volume 2 by Johnson, Rumack & others, Page No.1044 & Ultrasound Diagnosis of Foetal Anomalies by Michael Entezami & others, Page No. 80).

20.       I submit that there are no risk factors for Congenital heart disease or indications for foetal echo in this particular case. (Ref. Text book of Diagnostic Ultrasound, Volume 2 by Johnson, Rumack & others, Page No.1324 table 40-1).

21.       I submit that in this particular case, the Radiologist was not called upon to conduct foetal echo.

22.       I submit that foetal anomalies frequently go undetected due to unfavourable foetal positions, low liquor volume, thick maternal abdominal wall, type of defect (smaller the defect more difficult is its identification). (Ref. Text Book Diagnostic Ultrasound, Volume 2 by Carol Rumack & others, Page No.1045 ).

23.       I submit that cardiac anomalies frequently go undetected due to foetal rib shadows, anterior position of spine and also as stated above vide Sl.No.22.

24.       I submit that in presence of poor ultra sound window, gross abnormalities like hand and leg abnormalities, skull and spine abnormalities, etc., are easily identifiable, minor abnormalities like isolated cleft palate, trachea oesophageal fistulas, tetralogy of fallot, abnormal pulmonary venous connections, small ASD, VSD are not easily identifiable.

25.       I submit that in tetralogy of fallot, the defect before birth will be near the out flow tracts of heart where aorta and pulmonary artery joins the heart. Aorta will be larger and pulmonary artery will be smaller and VSD near out flow tracts, in some babies, there may be progressive main and branch pulmonary artery narrowing, which is often associated with progressive pulmonary out flow tract obstruction. Normal Pulmonary artery will be 2.5mm to 3.0mm at 18 to 20 weeks pregnancy. (according to text book of diagnostic ultrasound, volume 2 by Carol Rumack & others, page no. 1344 to 1346).

26.       I submit that according to the standard guidelines, out flow tract of heart is imaged in technically feasible cases only in routine/basic/standard ultrasound scans. Out flow tract imaging is mandatory in detailed examination of the heart (foetal echo) in which a specific abnormality are sought or abnormality was suggested at an earlier examinations. (Ref. Text Book of Diagnostic Ultrasound, Volume 2 by Carol Rumack & others, Page No.1044).

27.       I submit that in the instant case thick maternal abdominal wall, minute defect, failure to come for re-anamolous scan at 23 weeks, reduced liquor from 26 weeks onwards, prevented the Radiologist to detect the abnormality in spite of best efforts.

28.       I submit that as Tetralogy of fallot is not a lethal condition, the Radiologist cannot advise the termination as per the standard medical practice after 26 wks of pregnancy. After surgical correction, the quality of life is mostly good. Repeated surgical intervention is rarely needed. (Ultrasound Diagnosis of Foetal Anomalies by Michael Entezami & others Page No. 96 ).

29.       I submit that as a standard medical practice Radiologist will conduct the scans/serial scans according to the need of the referring doctor. If any gross abnormalities were detected Radiologist can mention in the report.

30.       I submit that PIH (which is also called as pre eclampsia) has very fatal complications on the baby like IUGR, Intra uterine death, Asphyxia & Prematurity. (Text book of Obstetrics by Dutta Page No. 226).

31.       I submit that IUGR means Intra Uterine Growth Retardation/Restriction. The complications are Before birth - intra uterine death, chronic foetal distress & hypoxia. (Ref. Text book of Obstetrics by Dutta Page No.464 ).

After birth – asphyxia, Respiratory distress syndrome, meconium aspiration pneumonia, Multi organ failure & increased perinatal mortality & morbidity (up to 75% ). (Ref. Text book of Obstetrics by Dutta Page 464, Ultrasound Diagnosis of Foetal Anomalies by Michael Entezami & others, Page No 316 & Text Book of Diagnostic Ultrasound, Volume 2 by Carol Rumack & others, Page No. 1505 & 1506.).

32.       I submit that in this particular case, Tetralogy of Fallot has not led to IUGR (Ref. Text Book of Diagnostic Ultrasound, Volume 2 by Carol Rumack & others, Page No.1507).

33.       I submit that PIH causes generalized mother body wall Oedema, including mother abdominal wall & reduced liquor which significantly reduces the ultrasound visibility. Mother body wall oedema increases as weeks of pregnancy progress & comes down after delivery. (Ref. Text book of Obstetrics by Dutta, Page No. 225 and Williams Obstetrics page no 736).

34.       I submit that the object of Doppler study is for detection of IUGR – just adequate liquor & border line IUGR indicates on set of IUGR & Reduction of liquor volume levels for that gestational age.

35.       I submit that according to the standard of care Gynaecologist should treat appropriately & advice repeated ultrasound assessment including Doppler. Radiologist should do serial ultrasound growth assessments & Doppler measurements. (Ref. Ultrasound Diagnosis of Foetal Anomalies by Michael Entezami & others Page No. 316 & Text Book of Obstetrics by Dutta Page No.l463).

36.       I submit that the role of Radiologist while conducting the periodic scans is mainly to monitor the existing problem & record the relevant parameters.

Radiologist cannot disclose the ultrasound findings directly but has to be interpreted in the background knowledge of clinical history, relevance of ultra sound findings to the patients problem & its limitations, nature of the treatment taken etc. As standard medical practice it is done by the Gynaecologist (i.e treating / referring doctor).

37.       I submit that it is the Gynaecologist who renders treatment and advises to the patient for continuation / termination of pregnancy.

38.       I submit that the machine used for conducting Ultrasound scan in the instant case is of a standard quality.

39.       I submit that the Radiologist has exercised due care and skill while conducting the scans in the instant case as per the standard ultrasound practice.

40.       I submit that the Radiologist is not responsible in any manner for the condition of the baby featuring “tetralogy of fallot” as reflected in the Echocardiography (heart scan) on 2^nd day of its birth.

41.       I submit that Tetralogy of fallot is not a fatal condition. The prognosis in tetralogy of fallot mainly depends on the severity of pulmonary stenosis. The surgical outcome will be good in the absence of pulmonary atresia. In this case there is no pulmonary atresia & only smallish branch pulmonary artery stenosis is present. The peri-operative mortality lies between 2% & 7%. After correction, the quality of life is mostly good. Repeated surgical intervention is rarely needed. (Ultrasound Diagnosis of Foetal Anomalies by Michael Entezami & Others Page No. 96).

42.       I submit that for Tetrology of fallot with smallish branch pulmonary arteries, before birth there are no manifestations. After birth it can manifest as (a) asymptomatic (b) mild cyanosis, breathlessness on exertion or squatting, or hypoxic spells. (Ref. Nelson’s Text Book of Paediatrics Page 1907).

43.       I submit that the cause for baby acquiring infection is multifactorial. These are IUGR, foetal hypoxia, prematurity & hospital born infections. It is not attributable to the acts/omissions on the part of the Radiologist in any manner.

44.       I submit that IUGR babies / premature babies will have increased susceptibility to infection. They also have poor cardio respiratory regulations due to complications of under lying perinatal diseases. perinatal mortality (up to 75%) & morbity is high. Their mortality rate is 4 to 8 times than that of non IUGR infant. (Ref. Nelson’s Text Book of Paediatrics Page No.708, Ultrasound Diagnosis of Foetal Anomalies by Michael Entezami & others Page No 316 and according to Text Book of Diagnostic Ultrasound, Volume 2 by Carol Rumack & others, Page No.1506).

45.       I submit that the complication of IUGR which was seen in this baby before surgery at Narayana Hrudayalaya are (a) Congenital pneumonia, (b)polymicrobial sepsis (acinetobacter & candida), (c) preterm, (d) respiratory distress, (e) respiratory failure, (f) liver dysfunction & (g) anemia (Ref. K.R.Hospital & Narayana Hrudayalaya Reports).

46.       I submit that the reason for the consequence of the death after  surgery for Tetralogy of fallot in this particular case is multifactorial. Polymicrobial sepsis – ascineto bacter & candadia, multi drug resistance organisms, IUGR (which has caused multi-organ failure including cardiac, respiratory, liver failure, Low platelet count & anemia).

47.       I submit that due to birth of baby with tetralogy of fallot, mother cannot become infertile in future. Radiologist is not in any manner responsible for future infertility.

48.       I submit that as per the case records of Narayana Hrudayalaya cardiac function was good before surgery which is indicated by good biventricular function in echo report dated 19-11-2011.

49.       I submit that low cardiac out put means decreased cardiac pumping function (decreased biventricular function). Maximal inotropic support means maximal dose of medicine which is given to increase biventricular (cardiac) function.”

The affidavits of these Doctors and their opinions are fully corroborated by the Textbooks stated therein.  Hence, there is nothing to disbelieve the same.  That means, there is no negligence on the part of OP2 much less on OP1 even.  Instead of rewriting the reasons as of this Forum, this Forum reproduced the reasons given by these experts which is corroborated by dictum of Medical Authority.  This Forum adopts it with concurrence. Hence, under these circumstances, there is no negligence or unfair trade practice committed or deficiency in service committed by the Ops. 

70.     It is the case that since the complainant was obese, Ultrasound Scan could not reveal anything and hence she was asked to come again at 23^rd week.  She failed to appear for 23^rd week scan.  Hence, she has to blame herself.  Even otherwise, Ultrasound Scan is not God. It cannot reveal whole thing especially behind the neck of the baby, because of the obesity of Complainant.  Even as the baby was suffering from Tetrology Follet, in Scan it could not be revealed, heart problem of the child to be born.  Hence, there is no negligence on the part of Ops nor there is any deficiency in service.

71.     We understand the agony of the Complainant, though she was Obese, she delivered a baby that too prematurely and its death.  We sympathize with that. We humbly state that Almighty will give a child to the Complainant in the near future. 

72.     Hence, under these circumstances, we hold the above points accordingly and we pass the following order:

ORDER

1.       Complaint is dismissed.

2.       Send copy of this Order to the parties free of costs.

3.       Return extra sets to the parties concerned under the Regulation 20(3) of the Consumer Protection Regulations 2005.

(Dictated to the Stenographer, got it transcribed and corrected and pronounced in the open Forum on this the 21^st of July 2012)

T. NAGARAJA          K.G.SHANTALA           H.V.RAMACHANDRA RAO

    Member                         Member                                       President

SSS