The Radiologist directed to pay Rs.1.25 Crore as he did not do the Anomaly scan which otherwise his legal and ethical duty, even though the treating Gynaecologist or the patient didn't ask for. : Adv. ROHiT ERANDE. ©
The Radiologist directed to pay Rs.1.25 Crore as he did not do the Anomaly scan which otherwise his legal and ethical duty, even though the treating Gynaecologist and the patient did not ask for.
Surprisingly the earlier 3 judgments on somewhat similar issues related to USG and its limitations, were decided in favour of Doctors.
Adv. ROHiT ERANDE. ©
PUNE.
Case Details :
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION, NEW DELHI
CONSUMER CASE NO. 74 OF 2009
UDAYAN & ORS. V/s. M/S. IMAGING POINT & ORS, NAGPUR.
BEFORE:
HON'BLE MR. JUSTICE R.K. AGRAWAL,PRESIDENT
HON'BLE DR. S.M. KANTIKAR,MEMBER
Judgement Link :
http://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0%2F0%2FCC%2F74%2F2009&dtofhearing=2022-05-25
At the beginning of the Judgment, it has been observed as "The most common type of litigation involving ultrasound is missing a foetal anomaly. The other causes include the failure to communicate the results of ultrasonic investigation in a timely manner; consequently the main reason for litigation is failure to offer termination of pregnancy as a result of failure to diagnose the defects at early stage".
Short Facts of the case :
No doubt whatever is being suffered by the Child and the Parents, is irreversible and continuous predicament. The case is of 2006
1. On 07.10.2006, Mrs. Anita Shrouti the Complainant No.2 (hereinafter referred to as “the Patient”), during her second pregnancy, consulted Dr. Sarita Bhonsule, Gynecologist and Obstetrician for and was remained under her follow-up for Ante Natal Care (ANC) till delivery. On 08.11.2006 Dr. Sarita Bhonsule for Ultra Sonography (USG) of Pelvis referred the patient to M/s. Imaging Point- the Opposite Party No. 1, the scanning centre. The USG was performed by the Radiologist Dr. Dilip Ghike, (hereinafter referred to as the “Opposite Party No. 2”) and reported it as normal. Thereafter, subsequently the Opposite Party No. 2 performed 2nd USG on 08.01.2007 (17th to 18th week of pregnancy), 3rd USG on 12.03.2007 and 4th USG on 12.05.2007.
2. It was alleged that all the USG were reported as “no obvious congenital anomalies in the fetal head abdomen and spine”. The patient’s elective Caesarian Section was performed by Dr. Sarita Bhansule on 26.05.2007 at Vaishnavi Maternity Home, Nagpur. After delivery the mother (patient) and the attendants (parents and relatives of patient) were shocked to see the grossly malformed male newborn. The newborn had agenesis of fingers, right leg below knee and left foot below ankle joint. The Complainants alleged that it was due to the Opposite Party No. 2 who negligently performed the USG and issued wrong reports. It was further alleged that it was possible to detect the anomaly between 12 to 14 weeks of pregnancy, but the Opposite Party No. 2 failed to detect anomalies during 2nd, 3rd and 4th USG, most importantly at 17 to 18 weeks. The mother [Complainant No. 2] and Mst. Chidanand [Complainant No.3] were discharged on 30.05.2007.
2. It was further alleged that the baby was thoroughly examined by various Specialists across India and that Mast. Chidanand will have to undergo at least seven surgeries, two for webbing thumbs, two for Squint in eyes, one for jaw correction, for facial Palsy and one for removal of tongue tie. Child also needs speech therapy. The Complainants Nos. 1 and 2, being parents, always have a challenge and stress so much that they may need Psychiatric Counselling/Treatment by which their child never lead life.
3. Being aggrieved by the negligence, the couple, Mr. Udayan and Mrs. Anita, along with their son Chidanand, filed the instant Complaint of alleged medical negligence before this commission with the prayer for total compensation of Total Rs.10,08,80,637.62/- under different heads. In the support of their claim about future expenses they have filed estimate of different Otto Block prosthesis.
Defence
1. Dr. Dilip Ghike (Opposite Party No. 2) in his reply submitted that the Imaging Point (Opposite Party No. 1) was established in the year 1990 at Nagpur and it possesses sophisticated X-ray and Ultrasonography (USG) machines having adequate experienced staff.
2. That All types of USG scans are performed at the Centre. Initially the ‘Imaging Point’ was a partnership firm between him and Dr. Raju Khandelwal. The partnership was dissolved on 30.04.2006 in terms of the Dissolution Deed. Therefore, there is no prima facie case or cause of action against Dr. Raju Khandelwal, that he neither examined nor performed any Ultrasound of the patient.
3. The Opposite Party No. 2 denied highly inflated claim and denied any negligence to perform and report the USGs of the patient and raised jurisdictional issue as the preliminary issue. He admitted that he performed routine Level– 1 scans for the patient on 08.11.2006, 08.01.2007, 12.03.2007 and 12.05.2007. The Opposite Party No. 1 charged the patient accordingly as Rs. 300/- to Rs. 400/- for the basic sonography on each occasion. He further submitted that for an anomaly scan (Level-II), USG which is known as target scan, would be charged as Rs. 1200/- . At no point of time, neither Gynaecologist nor the patient (mother) asked the Opposite Party No. 2 to conduct the target scan. The patient was not charged for target scan. and in the instant case, the child (Complainant No. 3) had multiple congenital anomalies because of some genetic mutations.
Arguments:
The Complainant No. 2 argued the matter in person.
1. The Complainant No. 2 – Mrs. Anita submitted that the principle of res-ipsa-loqiutor is squarely applicable in this case. She further argued her husband and herself kept faith in qualification and skills of Opposite Party No.2 and throughout pregnancy got her periodic ultrasounds done from him at his Imaging Point. They have expected due diligence from him, but he failed which resulted the irreparable damage.
2. She argued that her child Mst. Chidanand (Complainant No.3) will have to face its consequences all through his life, for no fault of him. The Complainants, in their support, filed medical literature and text from the standard text books on Obstetrics & Gynaecology and Radiology and relied upon various judgments of hon. Apex Court and that of the national Commission.
3. The learned Counsel for the Opposite Parties vehemently argued and relied upon the different medical text books and in medical parlance, they are referred to as LEVELS and there is a vast difference between Level-I (Routine) scan and Level-II (Target / Anomaly) scan. Level-I sonographies are often referred to as a routine examination or a basic examination, and in contradistinction a Level-II scan is referred to as a Target scan or an Anomaly scan and is a specialized study which is undertaken to detect birth defects in the foetus.
Commonly all over the world, as a standard protocol during Level-I scan, the Radiologist will check for
a) Foetal presentation
b) Amniotic fluid volume
c) Foetal cardiac activity
d) Placental position
e) Foetal biometry
f) Maternal Cervix
g) Maternal adnexae
3. The charges, the reporting format of Level-I & Level-II scans are totally different. It was tried to be shown that it was the fault of the Gynaecologist not to refer for the Anomaly Scan or advise genetic sonogram/ 3D/4D sonography.
4. It was argued on behalf of the Opponents that unless and until there is a request from the referring doctor / patient for a Level-II (Target / Anomaly scan) the Radiologist will perform a Level-I scan regardless of the indication as a routine. He further submitted that on the basis of history, bio chemical abnormalities whenever foetal anomaly is suspected; level-II scan will be performed wherein detailed anatomical examination is performed when an anomaly is suspected on the basis of history, maternal serum screening tests.
5. It was argued that in the instant patient Anomaly scan was never done, as it was never asked by the treating Doctor. The treating doctor and the patient both had received four routine (Level-I) scan reports, but not raised any objections with the scan reports. Therefore, the treating doctor and the patient are now ESTOPPED from disputing the fact that a Level-II (Target / Anomaly) scan was not undertaken.
6. further it was argued that the treating doctor and the patient both had no reasonable apprehension that the baby was suffering from any anatomical abnormality and therefore they did not request for a Level II scan more so when the Triple Marker Test showed no abnormalities in the baby.
7. The learned Counsel for the Opposite Parties submitted that the anomalies are missed during Level-II scan, even with best hands and centres and he relied on the Manual of Diagnostic Ultrasound (WHO publication) in collaboration with the World Federation for Ultrasound in Medicine and Biology, it is stated:
Evaluation of feet and hands for anomalies is very difficult and that the lower part of each limb (tibia and fibula, radius and ulna) is the least easily visualized.
Further, in a study conducted at the Department of Orthopaedic Surgery, Southampton University Hospitals NHS Trust, Southampton, England, revealed that:
Many case of congenital limb abnormalities referred for orthopaedic treatment are not diagnosed prenatally, despite ultrasound scanning.
And the Opponents relied on many other Articles too, in their support.
8. It was submitted further that the detection of anomalies necessarily depends on several factors inter alia, a) The physical condition of the mother (particularly obesity which greatly reduces the chances of an anomaly detection and admittedly the Mother in this case was Obese); b) Movement and position of the fetus; c) Abdominal scars; d) Extent of fluid and e) Prevalence and type of defect. These factors are only illustrative and not exhaustive.
An article "Effect of material obesity on the ultrasound detection of anomalous fetuses" authored by Dashe JS et al, which concludes-
"With increasing maternal BMI, we found decreased detection of anomalous fetuses with either standard or targeted ultrasonography, a difference of at least 20% when women of normal BMI were compared with obese women. Anomaly detection was even less in pregnancies complicated by pre-gestational diabetes. Counselling may need to be modified to reflect the limitations of ultrasonography in obese women."
9. It was also argued lastly that even if AIIMS medical board is assumed to be admissible, but prima facie the allegation of medical negligence is ruled out. The detection rate of LRD (Limb reduction defect) varies from 10% to 40%, it is achieved only when the ultrasonography is done with the conscious understanding that the patient is the high risk patient. The detection rate is attributable to several fortuitous circumstances like Gravid Uterus Foetal presentation, Amniotic fluid volume, Foetal cardiac activity, Placental position Foetal biometry, Maternal Cervix Maternal adnexae and not necessarily attributable to exceptional diagnostic skills.
Held by the National Commission :
1. The commission rejected the defence of the opponent no.2 that Opposite Party No. 2 that he performed the Level-I scan every time is not as an accepted standard of practice, as it was held that as per calculation mother's BMI was 28.7 kg/m2, she was overweight, but not obese. The role of Dr. Sarita Bhonsule was limited, she advised Triple Markers, which were reported as normal, however, admittedly she has sent the patient for USG without specifying routine or target scan.
2. On factual matrix, the Opposite Party No. 2 submitted that the first USG was performed on 08.11.2006, which showed single gestational sac with normal size and shape. Fetal heart was normal. It corresponds with the maturity of nine weeks.
On 08.01.2007, follow-up scan for maturity was performed, which revealed the grade-0 placenta. The fetal bi-parital diameter was 39mm, femoral length 23mm. The findings were corresponding with 17 to 18 weeks of gestation. There was no obvious anomaly seen in the fetal head, abdomen and the spine. Therefore, it was mentioned in the report, “not all anomalies can be detected on Sonography”. The next scan was performed on 12.03.2007, the parameters were corresponding to 26 to 27 weeks of gestation and not revealed any anomalies in the head, abdomen or spine. On 12.05.2007, for maturity, follow-up USG was performed, which was reported as normal findings without any anomalies in the fetal head, abdomen and spine.
The Expert Reports of the Opponents :
3. The Opposite Parties have filed two expert opinions in their support. One from Dr. Nitin Chaubal, having 22 years of experience, a practicing Ultrasonologists working at Jaslok Hospital at Mumbai and Thane Ultrasound Centre at Thane. The second opinion was from Dr. Pratibha Pendharkar, the Professor of Radiology and Dean, Indira Gandhi Medical College, Nagpur. In both opinions, they have commented upon the qualification of Dr. Dilip Ghike, the infrastructure of Image Point and various aspects of USG during pregnancy. According to both, there were no deficiencies in service or deviation from the established line of management of the Opposite Parties. Dr. Dilip Ghike performed the scans as and when prescribed by the referring doctor and correctly diagnosed that there were no congenital anomalies in the head, abdomen and spine of the fetus. They also noted that there was no request either from the patient or the treating doctor for anomaly scan.
The Expert Committee Report of AIIMS :
4. The Commission, called for an expert opinion from the Medical Board at AIIMS. The opinion dated 31.07.2009 revealed that Mst. Chidanand’s anomalies would be classified as "Limb reduction deficiencies”. The Board also expressed that, ‘Limb anomalies should be searched for in all standard obstetric ultrasound examinations performed in second trimester (vide Annexure 1), in this case, on 08.01.2007 & 12.03.2007. The said report, however, does not comment on the limbs.’ Finally, the Board was of the opinion that, ‘limb reduction anomalies can be detected in standard obstetric ultrasound, but the detection rate is low as detailed above.’
5. It was held that it is surprising to note that the Opposite Party No. 2 had performed only Level-I scan for all the times and his contention, which cannot sustain in law, that the treating Gynaecologist and even the patient did not ask for anomaly scan (Target scan level-II).
In our view, in absence of any referral from doctor, the ethical and legal duty casted upon Radiologist is to take proper history, ascertain the gestational age and perform the relevant USG scan (Level). and in the instant case the Opposite Party No. 2 failed in his duty of care and surprisingly, he performed all Level-I scan.
6. The commission referred to the International society for Ultrasound in Obst and Gyn (ISUOG) the “Practice guidelines for performance of the routine mid-trimester fetal ultrasound scan” that for Limbs and extremities systemic approach by the Radiologist necessary to know presence or absence of both arms/hands and both legs/feet and it should be documented. Counting fingers or toes is not required as part of the routine mid-trimester scan.
7. The commission relied upon various judgments of Hon. Apex Court an the gist of which says that :
a. the breach of expected duty of care from the doctor, if not rendered appropriately, it would amount to negligence.
b. If a doctor does not adopt proper procedure in treating his patient and does not exhibit the reasonable skill, he can be held liable for medical negligence.
c. The complainant is required to prove that the doctor did something or failed to do something which is the given facts and circumstances, no medical professional in his ordinary senses and prudence would have done or failed to do.
d. The Doctor owes to his patient certain duties which are (a) a duty of care in deciding whether to undertake the case; (b) a duty of care in deciding what treatment to give; and (c) a duty of care in the administration of that treatment. A breach of any of the above duties may give a cause of action for negligence and the patient may on that basis recover damages from his Doctor.
8. In the instant case the Opposite Party No. 2 failed to exercise the required ordinary skills and standards, thus held negligent based upon on the Bolam’s principle.
9. In conclusion it was held that the Opposite Party No. 2 liable for the negligence, who failed to diagnose the structural anomalies of the foetus at 17-18 weeks. The early and correct detection could have helped the parents to take a decision to continue or terminate the pregnancy within 20 weeks as per MTP Act and The unfortunate birth of amelic baby could have been averted. It is well settled principle of justice that in a case where negligence is evident, the principle of res ipsa loquitur operates and the Complainant does not have to prove anything as the thing (res) proves itself. In such a case, it is for the opposite party to prove that he has taken care and done his duty to repel the charge of negligence. Thus to reduce such errors and patient grievances, there is need for overall national guidelines from academic bodies (ICMR) or the government (health).
10. Compensation: The commission awarded Compensation of Rs.1.25 Crore, against the claim of Rs.10+ crores
The Commission relied upon the catena of judgments of Hon’ble Supreme Court, different methods to determine ‘just and adequate compensation’ were laid down. It was held that there is no restriction that courts can award compensation only up to what is demanded by the complainant. The Hon’ble Supreme Court in the case, National Insurance Co. Ltd. v. Kusuma, has held that payment of compensation to parents for the death of a child, including a stillborn, in an accident must be just and not be a pittance. A Bench of Hon’ble Justices D.K. Jain and R.M. Lodha said:
“The determination of the just amount of compensation is beset with difficulties, more so when the deceased happens to be an infant/child because the future of a child is full of glorious uncertainties.
The Bench, however, cautioned the tribunals, saying the amount of compensation awarded was not expected to be a windfall or bonanza, nor should it be niggardly or a pittance. “Whether there exists a reasonable expectation of pecuniary benefit” was always a mixed question of fact and law, but a mere speculative possibility of benefit was not sufficient.
11. It should be borne in mind that the Divine possible complications will make any amount of good care with good intention of a Doctor commiserating with existing practices and will make him to face the fate of self-decimation. There are certain possible for a grey areas to exist in patient care, where a professional is called upon to make a decision, when he possibly has to throw a dice and take a refuge in statistical possibility of particular event happening.
Can Damages be Capped ?
12 Perhaps for the first time the Commission has touched this important aspect. Many times the voice was raised about need for Caps on damages in medical negligence cases. In our view, a cap will often apply only to non-economic damages, while allowing a victim to recover any amount of economic damages that they can prove. The caps existed on the idea that they would restrict a victim’s ability to file medical negligence complaints. In our view, theoretically this would improve healthcare and reduce costs, but in reality this is a myth.
13. It was held that in this case, no doubt, the doctor (Opposite Party No. 2) could have helped the patient, had he been more careful in his reporting, though, how useful, it would have been considering MTP (Abortion) laws. It is not the intention of the Court or Commission to let go the Doctor for his mistake, which definitely need a rap on the knuckle, but that rap should not break his skull. Apparently, in the instant case, congenital anomaly is play of nature, one of nature’s wraths, which human kind is facing since time immoral. In alleviating this wrath of nature, this Doctor cannot be sacrificial lamb which would make whole profession to work under proverbial Damocles Sword.
14. While determining what would be "just" compensation, it referred to the words of Hon. Apex court, which said "The word ‘just' connotes something which is equitable, fair and reasonable, conforming to rectitude and justice, and not arbitrary" and most importantly this discretion should be exercised judiciously and rationally and not whimsically and arbitrarily.
The Commission rejected the claim of Rs. 3 crore towards mental pain and agony. But considering the actual expenses already incurred on medical treatment, travelling and emotional sufferings of the parents and artificial prostheses required by the child for his hands and legs throughout his life and to be changed periodically depending on age and growth, the Commission directed the Opposite Parties Nos. 1 and 2 to pay, jointly and severally, Rs. 1.25 Crore to the Complainants. Out of the said amount, Rs. 1 Crore shall be the compensation to the disabled Mst. Chidanand for his welfare, future expenses for treatment and purchase of limb prostheses. The amount shall be kept in the form of Fixed Deposit (FD) in any Nationalised Bank (preferably State Bank of India) in the name of Mast. Chidanand till he attains majority. The balance amount of Rs. 25 lakh shall be paid to the parents of Mast. Chidanand (Complainants Nos. 1 and 2) towards the mental agony and allied expenses. The parents can draw periodic interest on the FD for the regular health check-up, treatment and welfare of their child. The Opposite parties shall pay Rs. 1,00,000/- towards the legal expenses.
The Medical Fraternity has criticised this judgment. Surprisingly this judgment has not considered or same have not been brought no the notice of the commission, its earlier 2-3 judgments, in which the present Hon'ble Member was also the Commission member.
Case no.1 "All Anomalies can't be detected by the ultrasound Study." In this case also the allegations were similar that the Doctors did not advise for the Scan.
Case No.2 : "USG study been indicative and not confirmatory; it should not be construed as a wrong report" ,"the treating surgeon’s clinical assessment with relevant laboratory investigations should be given more credence".
Case Details : REVISION PETITION NO. 696 OF 2015, decided on 27/01/2021
S. MANIKANNAN, Tamilnadu (complainant) V/s. DR. T. PANDIARAJ & ANR.(Opponents)
Judgment Link :
http://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0%2F0%2FRP%2F696%2F2015&dtofhearing=2021-01-27
the blog Link :
https://advrohiterande.blogspot.com/2021/01/important-judgement-for-physicans.html
Case no.3 - Failure to diagnose Urinary Stones by USG does not amount to Medical Negligence, as the sensitivity and specificity of USG varies.
REVISION PETITION NO. 266 OF 2019
DAYA SINGH V/s. SHIVI DIGITAL X-RAY, ULTRASOUND, COLOUR DOPPLER AND MAMMOGRAPHY CENTRE & 3 ORS.
The Blog Link :
https://advrohiterande.blogspot.com/2022/02/failure-to-diagnose-urinary-stones-by.html
The above judgments seem to have not been cited before the Hon'ble Forum. No doubt, the sufferings of the child and the parents are unfathomable and every one wants his/her baby to be healthy.
Fortunately we are in India, wherein a woman has right to decide whether she wants to have a baby or not unlike in USA and now as per amended MTP Act upto 24 weeks MTP is permitted in appropriate cases.
However, for the academic discussion, no doubt the hon. Commission has right to deliver (contrary) judgments, with due respect, if the Hon'ble Commission would have considered its earlier judgments, then the decision perhaps would have been different.
Further the observations of the Hon. commission that "in absence of any referral from doctor, the ethical and legal duty casted upon Radiologist is to take proper history, ascertain the gestational age and perform the relevant USG scan" are contrary to its earlier own judgments and moreover it will become difficult for the Radiologists to practice and will be an additional financial burden on the patients. Further it may create a rift between the Gynaecologists and the Radiologists over referral.
With kind regards
Adv. ROHiT ERANDE. ©
PUNE.
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