Level 1 or level 2 ultrasound


Rs 1.25 crore Compensation slapped on Radiologist for failing to diagnose Structural Anomalies in anomaly scan
By – Barsha Misra
Published On 2022-06-01 10:37 GMT |
Update On 2022-06-01 10:37 GMT
Rs 1.25 crore Compensation slapped on Radiologist for failing to diagnose Structural Anomalies in anomaly scan

New Delhi: Holding a Nagpur-based Radiologist guilty for his failure to detect structural anomalies of the foetus at 17-18 weeks, the National Consumer Disputes Redressal Commission (NCDRC) has directed him along with the scan centre to pay Rs 1.25 crore to the parents of the deformed child for his welfare, future expenses for treatment and purchase of limb prostheses.

Such a decision was taken by the apex consumer court after it considered all the relevant facts, evidence on record and also took note of the opinion given by the AIIMS expert medical board.

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“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 Mst. Chidanand till he attains majorityโ€ฆThe 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,” read the order.

Back in 2006, the complainant, who was pregnant at that time, consulted Dr Sarita Bhonsule, Gynecologist and Obstetrician and remained under her follow-up for Ante Natal Care (ANC) till delivery. Consequently, the doctor referred the patient to M/s. Imaging Point for Ultra Sonography (USG) of pelvis. The USG was performed by the Radiologist Dr Dilip Ghike, who reported it to be normal. Three more ultrasounds were performed by the Radiologist during different stages of the pregnancy. However, all the USG were reported as “no obvious congenital anomalies in the fetal head abdomen and spine”.

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Finally, the Ob-Gyn conducted the elective Caesarian Section and after the birth of the child, the mother and all the attendants 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.

It was the contention of the complainants that all of this had happened due to the radiologist who had performed the ultrasounds in an alleged negligent manner as it was possible to detect anomalies during 2nd, 3rd and 4th USG, most importantly at 17 to 18 weeks, which is also known as the anomaly scan.

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After discharge, the baby had been diagnosed by several doctors including a Child Specialist, and doctors at Mediscan Chennai. In fact, a Plastic Surgeon with specialisation in Hand Reconstructive & Microsurgery at Apollo First Med Hospitals had also been consulted. Further, an opinion had been sought an Ophthalmologist at Shankar Netralaya and an ENT Surgeon. These doctors had been consulted for multiple problems in the child including facial palsy with lagopthalmos and micrognathia, poor jaw opening, limb hypo-genesis syndrome having oro-mandlbuiar disability, watery fluid and hearing problems.

During the follow up check up in Chennai, the child had been advised leg prostheses for walking and the doctors also suggested various activities for grasping and holding small objects. For his leg prostheses, the child was later taken to Otto Bock in Mumbai and the expert team in there decided to fit bilateral transtibial prostheses.

Referring to the detailed treatment history of the child, the complainants had submitted that he 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. They also submitted that the Child also needs speech therapy and the parents may need Psychiatric Counselling/Treatment.

Therefore, approaching the NCDRC, they prayed for total compensation of Rs 10,08,80,637.62 under different heads in support of their claim about future expenses.

On the other hand, the Radiologist denied any negligence in the reports of the USGs of the patient. Referring to the bills paid by the patient for the USGs, he further pointed out that neither the Gynecologist nor the patients had ever advised for an anomaly scan, also known as target scan. He further submitted that because of genetic mutation, there are chances of major or minor congenital anomalies.

In order to support their arguments, the complainants relied on several judgments including Nizam’s Institute of Medical Sci v Prasanth S. Dhananka & Ors., Dr. Balram Prasad v Dr. Kunal Saha, Spring Meadows Hospital Vs. Harjot Ahluwalia, V.Kishan Rao Vs. Nikhil Super Spl. Hospital & Anr., and Anil Dutt & Anr. vs Vishesh Hospital & Ors.

The counsel for the Radiologist and the Scan Centre, on the other hand, referred to different medical textbooks and pointed out the vast differences 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, submitted the counsel.

He also referred to the standard procedure for Level-I scan and pointed out that in such a scan the Radiologist primarily checks for Foetal Presentation, Amniotic fluid volume, Foetal Cardiac Activity, Placental position, Foetal biometry, Maternal Cervix, Maternal adnexae. Further referring to the charges for USG of the patient, the counsel for the Radiologist submitted that the patient was charged for Level-I scan and not for Level II target scan.

Blaming the Ob-Gyn concerned, the counsel for the Radiologist submitted that the treating Obstetrician was aware that the patient was elderly & had Gestational diabetes mellitus, and therefore she should have told the possibility of congenital malformations to baby, as the incidence of congenital anomalies is 7-10 times more common in such patients. They also pointed out that the patient was obese which is one of the factors adversely affecting the detection rate.

After taking note of the submissions, the NCDRC bench noted that even though the 37 years old patient was overweight, she was not obese. Referring to the role of the Ob-gyn, the bench also noted, “The role of Dr. Sarita Bhonsule was limited, she 2 advised Triple Markers, which were reported as normal. However, admittedly she has sent the patient for USG without specifying routine or target scan. Thus, the defense of the Opposite Party No. 2 that he performed the Level-I scan every time is not as an accepted standard of practice.”

Apart from perusing the 4 USG reports, the bench also took note of the two expert opinions submitted by the Radiologist. 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.

Besides the expert opinion, the bench had also called for an expert opinion from the Medical Board at AIIMS. The opinion dated 31.07.2009 revealed that the child’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.’

After taking note of the reports, the NCDRC bench noted,

“It is surprising to note that the Opposite Party No. 2 had performed only Level-I scan for all the times. His contention was the treating Gynecologist and even the patient did not ask for anomaly scan (Target scan level-II). We do not find any merit in such vague submission. It appears Opposite Party No. 2 is shifting the blame on the Gynaecologist. 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). In the instant case the Opposite Party No. 2 failed in his duty of care and surprisingly, he performed all Level-I scan.”
At this outset, the NCDRC bench also referred to the “Practice guidelines for performance of the routine mid-trimester fetal ultrasound scan” by the International society for Ultrasound in Obst and Gyn (ISUOG) which clearly specify that for Limbs and extremities systemic approach by the Radiologist, it is necessary to know presence or absence of both arms/hands and both legs/feet and it should be documented.

Besides, the bench also referred to several Supreme Court orders specifying the duty of care expected from doctors. Such judgments include the orders in the case of Kusum Sharma and others v. Batra Hospital and Medical Research Centre & Others, Jacob Mathew v. State of Punjab & Anr., Dr. Laxman Balakrishna Joshi vs. Dr. Trimbak Bapu Godbole & Anr, and A.S. Mittal vs. State of U.P.

Referring to these judgments, the top consumer court held,

“Thus, collectively considering the facts, evidence on record, opinion from AIIMS expert medical board and the precedents (supra) of Hon’ble Supreme court, we have no hesitation to conclusively hold 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, 1983. 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).”
While considering the damages and deciding on the amount of compensation, the bench noted,

“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.”
Taking note of the present age of the child, the expenses incurred for his treatment the bench awarded Rs 1.25 Crore compensation and ordered,

“Based on the discussion above, the medical negligence is attributed to the doctor and his Imaging Centre. The Opposite Parties Nos. 1 and 2 are directed 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 Mst. Chidanand till he attains majority. The balance amount of Rs. 25 lakh shall be paid to the parents of Mst. 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 Order, in entirety, shall be complied within 3 months from today, failing which the entire amount shall carry interest @7% per annum till its realisation,” read the order.

To read the order, click on the link below.

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