State Consumer Disputes Redressal Commission
Sushil Kumar vs Javitri Hospital And Test Tube Baby ... on 21 February, 2023
Cause Title/Judgement-Entry STATE CONSUMER DISPUTES REDRESSAL COMMISSION, UP C-1 Vikrant Khand 1 (Near Shaheed Path), Gomti Nagar Lucknow-226010 Complaint Case No. CC/113/2018 ( Date of Filing : 27 Mar 2018 ) 1. Sushil Kumar S/O Sri Tulsi Ram R/O Gram Kalanderpur Post Pathwaliya Tehsil Sadar Distt. Gonda ...........Complainant(s) Versus 1. Javitri Hospital and Test Tube Baby Centre Raiberelly Road Telibagh Lucknow Through Dr. Rajul Tyagi ............Opp.Party(s) BEFORE: HON'BLE MR. Rajendra Singh PRESIDING MEMBER HON'BLE MR. SUSHIL KUMAR JUDICIAL MEMBER PRESENT: Dated : 21 Feb 2023 Final Order / Judgement Reserved State Consumer Disputes Redressal Commission U.P. Lucknow. Complaint Case No.113 of 2018 1- Sushil Kumar, aged 38 years, s/o Shri Tulsi Ram 2- Smt. Indra Kumari aged. 36 years, w/o Shri Sushil Kumar, both R/o Gram Kalanderpur, Post Pathwaliay, Tehsil, Sadar, District Gonda. ...Complainants. Versus Javitri Hospital & Test Tube Baby Center, Raibarelly Road, Telibagh, Lucknow through Dr. (Mrs.) Rajul Tyagi. ...Opposite party. Present:- 1- Hon'ble Sri Rajendra Singh, Member. 2- Hon'ble Sri Sushil Kumar, Member. Sri A.K. Mishra, Advocate for the complainants. Sri V.K. Mishra, Advocate for OP. Date : 15.3.2022 JUDGMENT
Per Sri Rajendra Singh, Member- This complainthas been filed by the complainants Mr. Sushil Kumar &anr. under section 17 of the Consumer Protection Act, 1986.
The brief facts of the complainant's complaint are that, that a camp was organized after due advertisement by the opposite party at Gonda who offered a package of Rs.75,000.00 for IVF (In Vitro Fertilization) i.e. to produce a child through test tube baby technique with condition that if anybody registered his name for the aforesaid treatment in the camp, he will be entitled for the benefits of the package and no extra payment shall be charged. Being infertile couple and impressed by the advertisement the complainant consulted Dr. (Mrs.) Rajul Tyagi for IVF. Papers of earlier treatment were shown to her. She assured for successful treatment i.e. to produce child through test tube baby technique. On the basis of assurance given by Dr. (Mrs.) Rajul Tyagi, complainants registered themselves and deposited Rs.2,000.00 as registration fees. Thereafter, on the date fixed in Javitri Hospital at Lucknow, complainants visited there for further consultation. The opposite party prescribed some pathological tests and investigations and also advised some medicines regarding the procedure. On the next visit the complainant no.2 examined for ovulation process and through ultra-sonography her eggs collected and fertilization done in laboratory.
The complainant paid the entire package amount of Rs.75,000.00 on various dates but the opposite party pressurized to pay extra amount for the treatment. After the period of few weeks her fertilized eggs (embryo) implanted to her uterus on 7.6.2016 and thereafter, the complainant no.2 was discharged. In the month of June and July, 2016, the complainant was examined and ultra-sonography was again done and thereafter, the patient was asked to go home with advice to take few relevant medicines. On 29.7.2016, the complainant no.2 was advised for NT SCAN and on 20.8.2016 her NT SCAN and DOUBLE MARKER tests performed and patient was asked to come on 29.8.2016 for follow up. The NT SCAN revealed no apparent congenital anomaly with regular cardiac activity. On 29.8.2016, when gestation period was 13 weeks USC performed and patient was advised for TIFA SCAN. On 20.9.2016, TIFA test was performed on gestation period of 16 weeks 3 days by Dr. T.P. Srivastava in the Javitri Hospital and in the SCAN report fetus was normal in all aspects i.e. neck, face, thorax, heart, kidney, lungs, bladder and all extremities (fetal bones). On 24.10.2016, at 21 weeks 3 days gestation period, 26 weeks 3 days gestation period, 27 weeks 3 days gestation period, patient went through a number of tests and ultra-sonography.
On 11.1.2017, the patient was admitted for delivery procedure through cesarean at a gestation period o 31 weeks. After delivery on 13.1.2017 it was noticed that the neonate was having multiple congenital anomaly (vacter association) with single umbilical artery, anal atrisia with anovestibular fistula with right radial aplasia. Thereafter, on the day of delivery neonate was referred to higher center for further management and mother was instructed to leave the hospital as soon as possible. After these incidents neonate was taken to emergency department of King Georges University, Lucknow on 18.1.2017 for treatment here at emergency department baby was seen by emergency doctors in neonatal unit and advised for a eccocardiograby of heart, blood tests, chest radiograph and ultrasonography lower abdomen (KUB), thereafter baby was recalled in OPD on next visit.
The chest radiograph and 2D echocardiography were also performed in Vivekanand Polyclinic and Institute for Medical Sciences, Lucknow on 19.1.2016. the 2D ECHO report revealed moderate tricuspid MR, Moderate Pulmonary hypertension with right to left and left to right SHUNTS. On further visits in King George Medical University, baby was examined in paediatric surgery department, plastic surgery department in plastic surgery department plaster casts given on both hands to correct the anomaly and date given for ano vestibular fistula surgery in paediatric surgery department. The complainants have prayed for following reliefs:-
1- Direct the opposite party to refund Rs.2,55,000.00 only towards expenses incurred in the IVF treatment of complainant no.2 and baby of complainant.
Directthe opposite party to pay Rs.15,00,000.00 only for future treatment of baby of complainants.
Directthe opposite party to pay a consolidated sum of Rs.20 lacs towards compensation and damages for the negligence committed by them.
Any other relief, which this Hon'ble Commission may deem fit and proper in the circumstances of the case may also be awarded.
The opposite party has submitted the written statement in which she stated that Dr. Rajul Tyagi is a highly qualified and well experienced Gynaecologist and Obstetrician together with a very pride academic career with several silver and gold medals and certificates of honours having a degree of Bachelor Of Medicines and Surgery and also Master of Surgery from reputed institution. The opposite party has done extensive training of infertility and trans-vaginal ultrasonography and has been regularly participating in the shop and conferences et cetera relating to infertility and associated reproductive techniques being held from time to time all over the world. She has undertaken advanced course from a well reputed institute in the field of infertility. The opposite party has been running Advanced Infertility Centre in a most professional manner since its incorporation in the year 2001 with avowed object to help the child less couples in India. It is also pertinent to mention that the fee and expenses charges by the Centre are most reasonable and competitive in nature as compared to the heavy investment and big infrastructure required to run the said institute. The present complaint Case filed by the complainant before this Hon'ble commission at the outset it is submitted by the answering opposite party, is totally misconceived and baseless - factually, legally and medically.
Under complete mistaken impression the complainant has made irrelevant and wild allegations against the opposite party without understanding the real medical situation and particularly that it is well documented that the outcome of IVF treatment cannot be guaranteed by the doctors and that there are known failure rates. In such a situation the opposite party once again strongly and emphatically denied the allegations of the complainant on the purported medical negligence as wrongly alleged against by the complainant. The appreciate facts of the case, a brief backdrop of the procedure of IVF becomes relevant. Infertility means failure to conceive within one year of unprotected intercourse. Concealment occurs when a sperm of husband (produced by ovary) inside the human body, i.e, in the Fallopian Tube of uterus of wife. 10 to 15% married couple is all over the world suffer from infertility, so infertility can occur due to any problem related to sperm formation and transport, or failure of ovary to produce quality egg or any obstruction or changed atmosphere of uterus and tubes. 80% of South America infertile couples are managed by conservative mean in form of counselling, drugs manipulation and other such minor procedures. However 20% patients are found to have blocked and irreparable damaged fallopian tubes or ovarian problems or bilateral tubal blocks, very low count and mortality or sperm (called Oligo - AsthenaoSpermia) .
Such are the patients who are helped by Assisted Reproductive Technologies called ART. Which include IVF - ET , ICSI etc. IVF-ET is known as In Vitro Fertilisation and Embryo Transfer commonly called Test Tube Baby. In this procedure good-quality sperms taken out of semen of the male and processed. Eggs are prepared by stimulating the ovaries of female by hormones. Then on a specified day action are retrieved transvaginally under ultrasonographic guidance. The eggs and sperms are then transferred to special IVF Lab where embryologists do washing of eggs . Eggs are inseminated with sperms (since it is being done outside your body, it is therefore called In Vitro). Fertilisation is assessed after 40 hours and resultant embryo is cultured in special carbon dioxide incubators so that it grows and divides. At a certain stage of growth it is transferred back to uterus of female (called embryo transfer) where it gets implanted of its own and the pregnancy continues for nine months of gestation as annexure case. This process of IVF-ET has success rate of 25% to 35% all over the world in best of the Centres. That means, out of 100 cases who go for IVF, only 25 to 35 get success and rest fail. Yet in another method of ART called ICSI (Intracytoplasmic Sperm Injection) single are fertilisation with better success rates in tube of about 40% however this technique is indicated in only certain specified conditions.
The answering opposite party is performing treatment of her patient in a most transparent manner so that all the probable patients of IVF become fully aware of the whole process of IVF - ET including the success rate factor before they give consent to the respondent and undertake the treatment. The answering opposite party has also to her credit and distinction the delivery of first test tube baby in a lady after four years of menopause (stoppage of menstrual period) in whole UP followed by consistent successes in form of first test tube baby twins and then triplets and first ICSI of baby, Lucknow. The answering opposite party has been using latest techniques in the process of Assisted Reproductive Techniques, e.g, ICSI and other latest drugs, falls ample drugs in the form of recombinant FSH drugs and as such other latest drugs and as such other latest techniques as Assisted Hatching and Blastocyst Culture. As far as the present case is concerned, it is submitted that the patient Smt Indra Kumari wife of complainant reported opposite party Hospital on December 2014 as a case of infertility and she was explained the concept of In Vitro Fertilisation treatment and thereafter the complainant formed a informed opinion and proceeded and the treatment of IVF with unconditional consent and after fully understanding the pros and cons of the treatment including the fact that there is a known failure rate in such types of treatment.
It is submitted that proper and detailed investigations and tests are inevitable in IVF procedure and it is very much a part of management of infertility where the couple has to undergo better of tests. It is further submitted that preparation for IVF itself entails sufficient time, medical profession, tests and other treatment and therefore the patient was planned for IVF accordingly. It is also pertinent to mention that the patient visited on December 2014 and the opposite party explained IVF method and the problem of the patient ( B/L tubes block, proximal part right side, left partial fibrial block) it is submitted that finally the IVF treatment was done in December 2014, she was given best embryo transfer treatment (it is evident from the doctors prescription/treatment details) perusal of doctors prescription will demonstrate that the IVF has failed, particularly medically speaking because a patient had some immunological problem and because of which the attempt failed. This type of experiences well-known in the sphere of medical science and several factors, contribute to said failures. At this stage it is pertinent to mention that immunological infertility is therefore well-known in medical science and it results in even repeated IVF failure. Keeping in mind the said situation also the answering opposite party took proper precautions as per standard protocol and appropriate combinations of medicines together with steroids were also prescribed to achieve success but notwithstanding their best effects the IVF procedure fails, because failure rates well-known in the history of IVF and such failure can under no circumstances be concluded any medical negligence as has been wrongly alleged by the complainant.
It is submitted that there is no question of any medical negligence as such in case of IVF failure because failure rates are documented in medical science and also because the answering opposite party diligently discharged their duty of reasonable care and skill while diagnosing and administering treatment on the patient and thus no case can be said to be made out against the opposite party. It is submitted that all the medical treatment always commenced with the hope and positive attitude and that there are several instances of successful IVF treatment and several hundred soft childless couples have benefited from this kind of treatment but obviously no treating doctors can guarantee the outcome. The hospital of opposite party is a hospital of repute and as per medical need of the patient complainant no.1 has been referred to the higher centre for further/better management and no doctor can guarantee for 100% result. In this case neonatal refer for better management.
We have heard ld. Counsel for the complainant Sri A.K. Srivastava learned Counsel for the opposite parties Sri V.K. Mishra and perused the pleadings, evidences and all documents on record.
IVF or In-vitro fertilization has been a boon to those infertile couples dreaming to start a family. IVF is a process where an egg from a female body is combined with her partner's sperm outside their body. The outcome of an IVF procedure varies from one couple to another and one clinic to another.
The success rate of IVF procedure depends upon varies factors as given below:
Age of the female partner Duration of infertility Type of infertility (primary or secondary) Cause of infertility Quality of the sperm, egg, and embryo The endometrial development Luteal phase post transfer With respect to the above-given factors, in India, the success rate of IVF ranges from 30% to 35%. Globally, the average IVF success rate is around 40% in young women. The chance of success rates also increases in women younger than 35 years of age. The success rate of this most commonly used assisted reproductive technology or ART is usually measured on the basis of live birth per embryo transfer. Live birth per embryo transfer is known as Live birth rate.
Nowadays, most of the clinics have adopted a "freeze all" technique, where the embryos generated after ICSI or conventional IVF are frozen and not eggs. With the use of new age reproductive techniques, the IVF success rates in India have increased considerably. Endometrial receptivity analysis (ERA) is one such technique that can be helpful in patients with recurrent implantation failure by studying the endometrium at a molecular level.
In case of advanced maternal age, most of the implantation failures happen due to the chromosomal abnormalities of the embryos, a Pre implantation Genetic Screening (PGS) is highly recommended to increase the chance of implantation.
In certain couples, the conventional IVF treatments may not be of much help. For them, the Intra Cytoplasmic Sperm Injection (ICSI) which is a further classification of IVF could be a ray of hope. It is a laboratory procedure where a single sperm is picked up and injected directly into an egg with a fine glass needle.
First of all we went to the website of opposite party. On their website we have downloaded the following write-up :
"Javitri Hospital Complete Women Care Division Hospital Javitri Best IVF hospital has been functional since last 28 yrs started in its present location in 2000. Now it is fully equipped hospital with specialized unit of ICU, NICU, dialysis & Trauma. It is famous for its infertility unit which is of international standards and protocols. The hospital is located inTelibagh at Lucknow on the bank of Sharda canal on Raebareli Road. It is about 10 km from Charbagh Railway station and 11 Km from Hazarat Ganj the center of Lucknow. Hospital has set up another infertility unit (Javitri Test Tube Baby center) at Badshah Nagar Lucknow.
The Best IVF lab is a modular lab following strict world class parameters.
The latest equipment provides advance services like freezing, laser hatching and availability of Embryoscope. With Embryoscope now it is possible to see your Embryos growing and select the best ones for implantation. Now with blastocyst culture in Embryoscope we are able to give successful result upto 80%."
So the opposite party has claimed 80% success rate but here the opposite party has stated success rate 25% to 35%. What about the success rate of 80%? But this case is not about success rate but here by this technology the complainant blessed with a daughter. We have seen the note of opposite party and also the discharge summary. The date of birth of the child has been mentioned as 13.01.17 , 04.24 PM. The birth time weight of the child is mentioned 1470 gms. This child was born through Caesarean operation as mentioned in the discharge summary. The condition on discharge has been mentioned as satisfactory. The handwritten note of opposite party is reproduced here.
The scanned copy of discharge summery is also reproduced here The complainant has filed three photographs of the child which is also necessary, in our opinion, to reproduce here As is clear from the picture filed that there is problem in the hands of the baby child. In this case the gestation period is 31 weeks . It means that the child born was premature. We have seen the written statement of the opposite party but she did not mention anywhere regarding the premature childbirth and also regarding shortcomings or underdeveloped or complications of the child. It is also not mentioned as to which Super Speciality Hospital she referred the child for further treatment . An affidavit has been filed by Dr. Isha Tyagi, MD, Javitri Hospital where she only glorified the work, hospital and experience of the opposite party but nowhere she has said anything about the immature baby and her ailments. Nothing has been said about the cause of the deformity of the baby child.
First we come to know about the test a baby, it's development, procedure, risk et cetera.
The term "test tube baby" was first used in 1978 with the successful birth of Louise Joy Brown in England, thanks to the development of the Assisted Reproduction Technique (ART) known as In-Vitro Fertilisation (IVF) by pioneering scientist Sir Robert Edwards and gynaecologist Dr. Patrick Steptoe. Soon after in 1983, Samuel Lee of Singapore became Asia's first test tube baby, through efforts of Prof. S.S. Ratnam and Prof. Ng Soon Chye - Sincere IVF Center's Medical Director - and his team.
However, despite its continued popular use, the term "test tube baby" continues to cause confusion among couples seeking medical intervention for their fertility problems. Some even believe that the conception of test tube babies involves a different ART procedure from IVF or that it is a kind of Intrauterine Insemination (IUI) technique.
What Is a Test Tube Baby?
The term "test tube baby" means a child that is conceived outside a woman's body. A more complete definition specifies test tube babies as being conceived in a laboratory through the scientific process of In-Vitro Fertilisation (IVF). The use of the words "test tube" is also erroneous because, right from the beginning decades back with Edwards and Steptoe, the lab instrument that they used to mix the eggs and sperm in is a Petri dish.
It can be stated therefore that "test tube baby" is an oversimplified term for a child born through IVF. Hence, there is actually NO difference between IVF and test tube baby.
If you are wondering what is test tube baby and IVF, whether both the terms are related, let us try to understand them in detail. Test tube baby is a term that refers to a child that is conceived outside the women's body by a scientific process known as In-Vitro fertilization or IVF treatment. This entire process is done in a laboratory. In this process the eggs are taken from the mother's ovary and fertilised by the sperms from the father.
The fertilised egg is cultured for 2-6 days and allowed to divided 2-4 times inside a test tube (hence the name test tube baby) These eggs are then returned back to the mother's uterus where it can be developed normally, this is done with the intention to establish a successful pregnancy.
Test tube baby procedure has greatly helped women having infertility problems that are untreatable to give birth to healthy babies.
The first Test tube baby The test tube baby procedure was made possible by scientist Robert Edwards and gynecologist Patrick Steptoe in 1978 when the first test tube baby, Louise Brown was born in England. In 2010, Robert G. Edwards was conferred the Nobel Prize in Physiology or Medicine for developing the IVF treatment.
Now, IVF treatment has given many couples who are suffering from fertility problems a hope of becoming a parent. Since the first test tube baby in 1978 to recent times there have been millions of children who are born with the help of IVF treatment. Now a days test tube baby process is widely followed through out the world,especially IVF in India is in great demand.
Having a baby is a boon, and the person help you to get this opportunity will be the most important person of your life for sure. So here we have listed few best IVF centres and infertility specialist in India, that will help you to get your child I your arms, when you plan test tube baby treatment in India.
Now let us understand the steps involved in test tube baby process. The steps for test tube baby break in four phases. People planning for IVF treatment should know the test tube baby procedure in depth.
What is test tube baby process ?
Step 1 - Egg stimulation: Patient is given fertility medications to stimulate the production of egg. To increase the success rate of the treatment multiple eggs are needed. Usually it not advisable to rely on single egg for which the doctor gives fertility drug to increase the production of eggs. Depending upon the patient's response medications are advised. There are various protocols for egg stimulation. Egg stimulation is guided by Transvaginal ultrasound to examine ovaries, blood samples and to determine the level of hormones.
Step 2 - Egg Retrieval: Imaging ultra sound is used to retain ovarian follicles with the help of hollow needle. Retrieval of egg is followed with minor surgery Complete procedure takes about half an hour. The follicular fluids are carefully seen by embryologist to trace the proof of available eggs. After the entire procedure eggs are preserved in incubator till insemination.
Step 3 - Culture of Fertilization and Embryo: For insemination male sperm sample is collected. Eggs are mixed with the sperms and stored in laboratory. If there are chances of low probability of fertilization, ICSI can be considered. To enable fertilization single sperm is infused in the egg. Fertilized eggs are considered as embryos only after the confirmation by an embryologist.
Step 4 - Transfer of egg and quality of Embryo: Embryo transfer is the quickest method done in overall treatment. Embryo is assessed on the basis of age and quality. Doctor is asked to keep the full history of the patient starting from age to previous treatment, but the end decision is taken by patient itself. Under normal situation, doctor suggests transferring single embryo with blastocyst and rest of them are preserved. Transfer of one high quality embryo decreases the risk of triplets or twins. During transferring, doctor inserts Cather and pushes pre determined embryos in the female uterus. This method is done under guidance of ultra sound. Patient is advised to take rest for 5- 6 hours after it. After this method, pregnancy test is conducted to know the exact situation.
Be aware of these issues before undergoing the test tube baby process (IVF Treatment) Test tube baby process drains you out physically, financially and emotionally. Also, there is no guarantee that it will be 100 % successful. Some of the best IVF centres in India such as Ivfcentres in Mumbai have high success rate which will increase your chances of conceiving. There are chances that it may not work out for you in the end.
The number of cycles required for test tube baby procedure may vary from patient to patient. The success of test tube baby in India depends on many factors such as the degree of infertility, the age of the woman and the quality of the egg and semen.Choosing the right fertility center is very important and luckily the metro cities in India especially the IVF center in Bangalore provides the best IVF and test tube baby treatment with reasonable cost and advanced technology. The process of test tube baby is very unpredictable as some may conceive in the first cycle itself while others may need several cycles to conceive. While there are some women who cannot conceive even after undergoing several test tube baby cycles.
There are different treatment options available depending on your fertility. To get more information about the treatment in brief you can watch test baby procedure video in hindi or other languages based on your preference. You can opt for mini-test tube baby process if your fertility issues are not very severe. Lower doses of fertility drugs are used during this procedure due to which even the cost of the treatment decreases. If ovulation is not a problem then you may be eligible for a natural cycle wherein no fertility drugs are involved.Test tube baby processes can be complex and should be done by experienced doctors. Ivfcentres in Delhi have some of the best fertility surgeons who provide this treatment with sincerity and compassion and also Delhi are emerging ad one of the best cities in IVF treatment Having a clear idea about the test tube baby price while going for this treatment will help you set the budget for your treatment and cause you less anxiety.Also, it will avoid any misunderstanding with the clinic regarding the cost of test tube baby procedure.If you are looking out for IVF treatment at an affordable price then you can visit the best Ivf centers in Chennai provides excellent treatment which is at par with international standards at an economic cost You have to be very patient during the procedure of test tube baby as only about 35 - 40% people conceiving in the first cycle itself. Age plays a very crucial role regarding the number of cycles you may need. Women in their forties may need multiple cycles to conceive.
Most important is the understanding between partners regarding the process of test tube baby.As this is a time-consuming treatment and you need to decide for how long you would persist with the treatment.Setting a definite goal will help maintain your relationship and not cause unnecessary tension.
It is necessary that you have a detailed information about the test tube baby procedure step by step and also the cost of the treatment before going for the treatment.You can also refer to the test tube baby images and videos given on the page to get a better idea.If you want any added information then visit such as Below are some of the common FAQ's regarding test tube baby process Who may not benefit from test tube baby treatment?
As egg production slows down as women starts approaching the age of 40, this even reduces the changes of getting pregnant with IVF. If you have crossed your age of 35yrs. then you can consider donor eggs. This would help you achieve the pregnancy rates all women have at all ages however there is greater risk of miscarriage.
How many IVF cycles are required for test tube baby process to be a success?
Usually about one third of the patients experience live birth after the first cycle. For women who undergo about 3 cycles the chances increase up to 70% to 75%. However, the success rate depends on lot of other factors as well.
What is test tube baby treatment budget ? what are the payment options you can have to afford the treatment ?
The average cost for test tube baby in India would be around Rs. 200000 to Rs. 400000. However, there are some government recognized hospitals like AIIMS and few others charge as low as Rs. 70000 to Rs. 85000 Other than this, a few private clinics charge on per cycle basis. Whereas some offering multiple IVF cycle packages. Always discuss with the clinic, the payment options you can get before starting the treatment.
What are the test tube baby treatment deciding factors ?
Patient's age : Success rates decreases as the age of the women increases especially above 40 years.
Embryo Quality : Embryos having chromosomal and genetic problems are extremely weak and are not suitable for this treatment Ovarian Response : If the ovaries do not react positively to the medications and are unable to produce multiple eggs.
Implantation problems : Around 50% of the cases fail due to implantation problems. This can happen when the embryo stops growing unknowingly.
Is test tube baby procedure painful?
Sometimes women find implantation to be painful.To conduct the implantation without pain,they are given pain killer tablets and injections.
What are the symptoms after the treatment ?
Usually IVF patients experience irregular periods or spotting after two weeks of implantation. As the embryo moves into the uterus it causes bleeding and pain. This shows pregnancy but it is not confirmed. Changes in the breast are the best symptoms for IVF pregnancy. Visit the best IVF centers in India for treatment to ensure greater success rates.
When is IVF required?
Problem with sperm: when male partner sperm is not in adequate quantity then IVF is required with ICSI, and IVF procedure is helpful to them, who need their sperm to be penetrated in the egg for fertilization.
Problem with ovulation: for releasing the healthy eggs IVF is required, when ovary is not working properly.
Problems with Fallopian tube: through uterus, egg travels in the fallopian tube, in some cases if the fallopian tubes gets blocked due to any disease, then the only option left with the couple is IVF.
Uterine problems: ART can be used to overcome uterine problems, and problems related to conceiving.
Cervix problem: sexual intercourse can be affected if the cervix response abnormally. In this case IUI (Intra-uterine Insemination) or IVF is required for a mother to get pregnant.
Genetic Testing: suppose a partner is suffering from certain disease, and if they have fear that the disease can be passed to the new born baby, then IVF technique is needed.
Death of partner : IVF treatment is very helpful in the case if the partner is not alive, and the couple has stored its sperm or egg before.
Surrogacy : surrogacy means, if the female partner is unable to conceive a child, then the baby is carried in the womb of another lady. IVF is useful so that sperm or egg produced by another partner can be transferred to surrogate uterus.
Egg freezing: in case of egg freezing egg stimulation and egg retrieval is needed. Frozen eggs are kept at cool place and is transferred to embryo after couple's decision for pregnancy.
Same sex : IVF is used for people with same sex also. Whether it is lesbian, gay couples. It is possible only if sperm of third person of opposite sex is taken.
Single parent : people those who don't want to get married; still want a baby, being single parent IVF can be useful to them, by donating the egg or sperm.
Success Rate Patient should understand the chances of conceiving and this depends upon various factors, from which the most important are:
Patient's age: The important role in conceiving is age. As your age increases or as you grow old your chances of getting pregnant lowers down.
Whereas, age factor is more in case of female as compared to males.
In order to know the effects of age on pregnancy through IVF, refer the following chart that is based on survey records till 2010 32.2% for women aged under 35 27.7% for women aged between 35-37 20.8% for women aged between 38-39 13.6% for women aged between 40-42 5.0% for women aged between 43-44 1.9% for women aged 45 and over There is an inverse relation between success rate and the age. Moreover, you can understand by this chart, that how much are the chance of success when you go for its treatment.
Some other factors:
Your level of fitness, previous medical history, presence of any complications, lifestyle, etc. Keeping all this condition in mind you must contact your fertility specialist to undergo some of the tests and assessment, so that your doctor can understand the situation.
Expertise of your clinic or hospital.
As you cannot change your age or past history but you can make your chances positive of being pregnant by getting nothing but the best treatment under the hands of IVF experts.
Advanced techniques which help in reproduction Intrauterine Insemination (IUI): During this treatment, the sperm is directly placed in the woman's uterus using a long narrow tube. It is mostly used in cases where the sperm count is low or has low mobility. It is also used for women who have a defect in the cervix.
Intracytoplasmic sperm injection (ICSI): ICSI is used in cases of severe male-factor infertility. A single sperm is injected directly into an egg by the embryologist to increase your chance to conceive successfully.
Donor egg or sperm: Donor eggs are used when the eggs produced by the woman is not healthy enough for fertilization. They are also used by the woman who has her ovaries removed, are a carrier of genetic diseases or has undergone radiation or chemotherapy. Donor sperm is used when the person is unable to produce any sperm or has a very low sperm count. Also, people having genetic diseases prefer using donor sperm.
Surrogacy: A surrogate is a person who carries the child of another couple in her uterus and gives birth to the child but is not the biological mother of the child. The couple may have to use a surrogate for several reasons such as the woman does not have a uterus, there are some issues with the uterus that makes it hard for her to conceive or has some medical issues that make the pregnancy dangerous for the woman.
Gamete intrafallopian transfer (GIFT): During this procedure, the sperm and the eggs are combined in the laboratory and are straightaway transferred to your fallopian tubes through a small incision in your abdomen. The eggs are fertilized inside your body and the implantation of the embryo takes place naturally.
Zygote intrafallopian transfer (ZIFT): During ZIFT procedure, the eggs are mixed with your sperm in the laboratory but the doctor waits for them to fertilize before transferring the embryo to the fallopian tube with the help of a small incision in the abdomen.
Cytoplasmic transfer: This procedure involves the transfer of the content of a fertile egg from a donor to the infertile egg of the patient along with the sperm.
Risks involved during the process of test tube baby Ovarian hyperstimulation syndrome: During the procedure of test tube baby, there is a risk of ovarian hyperstimulation syndrome due to the use of fertility drugs such as human chorionic gonadotropin (HCG). The drugs may cause the ovaries to overreact, due to which they swell up and are painful. The patient experiences bloating, vomiting, nausea, heartburn, loss of appetite, diarrhea and mild abdominal pain which may last for about a week. It is quite rare, but in severe cases, it may cause shortness of breath and rapid weight gain. However, the symptoms may last for several weeks if you have conceived. Do not let this complication scare you as most of the cases are mild and can be easily treated.
Complications during egg retrieval: During the process of egg retrieval, the doctor uses a hollow needle to collect the eggs which may cause infection, bleeding or damage to the blood vessels, bowel or bladder.
Ectopic Pregnancy: Ectopic pregnancy occurs if the fertilized egg implants itself outside the uterus in the fallopian tube. This can happen to around 2-5% women who have conceived with the help of test tube baby procedure. As it is not possible for the fertilized eggs to survive outside the uterus, the pregnancy has to be terminated.
Miscarriage: The chances of miscarriage in women who have conceived by the procedure of test tube baby using fresh embryos is similar to women who have conceived naturally. But the rate of miscarriage increases slightly if frozen embryos are used or if the age of the women is on the higher side.
Multiple births: It is one of the major complication of test tube baby process as it increases the risk of multiple births. This happens when more than one embryo is transferred to the uterus. Multiple births can cause lots of complications such as miscarriage, obstetrical complications, early labor and low birth weight.
Early labor and low birth weight: According to the researchers, the process of test tube baby may slightly increase the risk of the baby being born early or having low birth weight.
In this case, the result is successful. Here the main problem is that the baby took birth premature and thereafter she has been referred to hire a specialized centre for further treatment but there is no reason prescribed in the discharge slip as to for which ailment or deformity or shortcoming she has been referred to a super specialised hospital or higher centre. In this case regular tests were conducted through ultrasonography, anti-scan and double marker tests. TIFA test was also performed on gestation period of 16 weeks. TIFFA stands for Targeted Imaging for Fetal Anomalies. As the name suggests, this scan is performed to understand if the baby is growing fine. It is usually performed around the 18th week of pregnancy, and this test measures and reports a number of things. This test was continuously done from the very beginning till 27th week and 31st week. The patient was admitted on 11 January 2017 for delivery through cesarean at gestation period of 31 weeks. On 13 January 2017 the opposite party said that the neonate was having multiple congenital anamoly ( Vacter association) .
Sonographic detection of fetal abnormalities before 11 weeks of gestation D. L. Rolnik, D. Wertaschnigg, B. Benoit, S. Meagher First published: 11 November 2019 https://doi.org/10.1002/uog.21921 Citations: 4 SECTIONS PDF Introduction Ultrasound was introduced in clinical practice in obstetrics and gynecology in 19581 and has completely changed the way obstetric care is provided, allowing for antenatal detection of major fetal abnormalities and placenta-related disorders. This rapidly evolving field has led to the description of a series of sonographic signs of fetal abnormalities in the second trimester2. Following the technological advances and improvements in imaging resolution in recent years, a clear shift toward early detection of fetal malformations and pregnancy complications at 11-14 weeks' gestation was seen, to the point that a detailed morphology assessment of the fetus at this early stage has now become routine practice and has high detection rates for the majority of major structural defects3-6.
Traditionally, early first-trimester pregnancy ultrasound is performed to confirm a viable intrauterine pregnancy, to identify the number of embryos and to rule out ectopic pregnancy. In multiple pregnancy, chorionicity can be determined accurately at an early stage based on the number of gestational sacs seen; however, determination of amnionicity in monochorionic pregnancy may be challenging7 due to the difficulty in visualizing the thin intertwin membrane, particularly before 8 weeks' gestation.
Due to the increasing uptake of transvaginal ultrasound, the development of high-frequency transvaginal probes and our improved understanding of embryological pathophysiology, it is now possible to detect fetal malformations before 11 weeks' gestation. In addition, acquisition of three-dimensional (3D) volume blocks facilitates visualization of a growing number of major embryonic and early fetal defects. Recent data also suggest that early markers of aneuploidy at 8-10 weeks, including increased nuchal fluid, skin edema, hydrops and hydrothorax, may prove valuable in identifying fetuses at risk of both chromosomal and structural abnormalities8.
The unprecedented uptake and rapid clinical introduction of cell-free DNA (cfDNA) analysis, which has very high accuracy in screening for trisomies 21, 18 and 13, have led to an ever increasing uptake of pretest ultrasound scans performed at 6-10 weeks of gestation. The purpose of such a scan is, first, to confirm the gestational age, and second, to rule out situations in which the test should not be performed, namely miscarriage and the presence of a vanishing twin. This shift in the algorithm of antenatal screening now creates a window of opportunity for early screening and diagnosis of fetal anatomical defects by experienced ultrasound specialists. Early suspicion of lethal or severe fetal abnormalities allows not only for change in the diagnostic pathway (e.g. invasive genetic testing in preference to cfDNA), but also for timely reproductive choices and optimized clinical management. In these patients, early decision-making has the additional benefit of being associated with lower long-term psychological morbidity9.
In this Opinion, we illustrate two-dimensional (2D) and 3D ultrasound images of pregnancies with fetal abnormality identified between 6 + 0 and 10 + 6 weeks of gestation.
Image acquisition The detection of fetal abnormalities before 11 weeks of gestation relies not only on the experience of the operator but also on using high-resolution probes and transvaginal imaging. Use of different modalities of 3D ultrasound may also increase the diagnostic accuracy.
Here, images of normal embryonic (up to 9 + 6 weeks' gestation) and fetal (from 10 + 0 weeks' gestation onwards) development and of suspected defects were acquired in early pregnancy by experienced ultrasound specialists, using both transabdominal and transvaginal ultrasound. In most cases, the diagnosis was either suspected or established at transvaginal examination. In almost all cases, 3D volumes were obtained and either immediately analyzed or stored for later offline analysis. All images were obtained by one of the authors during routine viability examinations or pre-cfDNA testing ultrasound, in specialized ultrasound clinics in Melbourne, Australia, in Nice, France, or in the Principality of Monaco. All ultrasound images were obtained using Voluson E8 or E10 (GE Healthcare, Zipf, Austria) ultrasound systems, equipped with real-time high-frequency transabdominal curvilinear probes (4-8 MHz and 5-9 MHz), linear probes (9 MHz) and high-frequency transvaginal 3D/4D volumetric probes (5-9 MHz and 6-12 MHz).
In cases of suspected fetal abnormality, the fetal anatomy was reassessed thoroughly by the same professional at 11-14 weeks in most cases, and the clinical management regarding the method of screening for chromosomal abnormalities often changed (e.g. from cf DNA testing to chorionic villus sampling or amniocentesis). In all cases, the findings were confirmed by follow-up ultrasound examinations later in pregnancy or postnatally by visual inspection of the newborn or postmortem examination.
Normal embryonic and fetal development at 7 + 0 weeks to 10 + 6 weeks' gestation Between 7 and 11 weeks' gestation, the embryo undergoes rapid development and growth (Figure 1), and organogenesis is largely complete by 10 weeks. At 7 weeks of gestational age, the embryo is approximately 10 mm in length, the amnion around it becomes visible, and the head is strongly flexed anteriorly10. By 8 weeks' gestation, the embryo measures around 16 mm and individual body parts can be identified on ultrasound; the head can be distinguished from the trunk and the limb buds can be delineated clearly10, 11. The cranial vesicles and cleavage of the prosencephalon can be appreciated. At 9 weeks, the fetal trunk elongates and straightens, the extremities protrude ventrally and a midgut herniation into the base of the umbilical cord becomes apparent. By 10 weeks, the crown-rump length (CRL) is between 30 and 35 mm, the fetus is distinctly human-appearing, the frontal bones of the skull are ossified, the physiological midgut herniation is evident, the hands and feet are relatively opposed and the digits can be seen10. With the availability of higher-resolution ultrasound probes and improvement of 3D multiplanar techniques of image acquisition, early first-trimester assessment of normal anatomic structures has heralded the development of exciting methods of sonoembryology, allowing evaluation of selected patients at risk for embryonic/fetal malformations and early detection of defects10, 11.
Figure 1 Open in figure viewerPowerPoint 2D (a,c,e,g) and 3D (b,d,f,h) ultrasound images showing normal embryonic development between 7 and 10 weeks' gestation. (a,b) At 7 weeks, crown-rump length (CRL) measures around 10 mm, fetal head is relatively large in relation to trunk, and yolk sac (YS), vitelline duct (VD) and limb buds (arrows) are seen. (c,d) At 8 weeks, CRL is approximately 16 mm and visualization of brain vesicles (D, diencephalon; M, mesencephalon; R, rhombencephalon), spine (S), amnion (A), yolk sac (YS) and vitelline duct (VD) is clearer. (e,f) At 9 weeks, CRL is approximately 24 mm, fetus has more defined human appearance, and there is clear delineation of face and lengthened limbs (arrows). (g,h) At 10 weeks, CRL is around 30 mm, and digits (arrows) and physiological midgut herniation (MH) are clearly delineated.
General major abnormalities Some severe embryonic/fetal abnormalities can be seen as early as 7-8 weeks of gestation. Figure 2 shows 3D sonographic images with rendering mode of conjoined craniopagus twins at 7 and 8 weeks of gestation. Early recognition of this type of severe abnormality allows early reproductive choices and avoids the risks related to late recognition, such as delivery of a large fetal volume which is associated with increased maternal morbidity. Cases of early amniotic rupture that are likely to evolve to amniotic band sequence with fetal disruption and limb amputations can also present in early pregnancy (Figure 3). In the setting of monochorionic twin pregnancy, the occurrence of twin reversed arterial perfusion (TRAP) sequence can at times be detected (Figure 4) facilitating early treatment options including cord occlusion of the acardiac twin.
Figure 2 Open in figure viewerPowerPoint 3D sonographic images with rendering mode showing conjoined twins at 7 (a) and 8 (b) weeks' gestation.
Figure 3 Open in figure viewerPowerPoint 2D ultrasound image of early amniotic rupture at 8 weeks' gestation showing embryonic parts and yolk sac in extracelomic space. Amnion (A) can be identified clearly only close to cephalic extremity, and lower extremity of embryo is morphologically abnormal.
Figure 4 Open in figure viewerPowerPoint 3D ultrasound image of monochorionic twin pregnancy with twin reversed arterial perfusion sequence at 10 weeks' gestation, showing normal twin (left) and acardiac twin (right).
Increased nuchal translucency and subcutaneous edema In a recent series from our group, comprising 104 cases of nuchal or subcutaneous edema and fetal hydrops diagnosed in early pregnancy (unpublished data), the condition resolved in approximately 80% of the cases by the time of the 11-14-week scan. However, the incidence of chromosomal abnormalities and major structural defects in this group was 21.5%, necessitating detailed sonographic examination at 11-14 weeks and changing the screening or diagnostic pathway in many cases. This high rate of adverse pregnancy outcome in cases of early subcutaneous edema is similar to that reported by Votino et al.8. Figure 5 shows cases of nuchal and generalized subcutaneous edema at 10 weeks of gestation.
Figure 5 Open in figure viewerPowerPoint 2D (a) and 3D transparency mode (b) ultrasound images of fetus with increased nuchal translucency (NT) at 10 weeks' gestation (95th percentile for NT at 10 weeks is 2.2 mm). (c) 2D image of fetus with subcutaneous edema at 10 weeks' gestation; amnion (A) and skin (S) should be differentiated to avoid incorrect diagnosis. (d,e) 2D ultrasound images showing coronal (d) and sagittal (e) views of 8-week embryo with bilateral pleural effusions (arrows) inferior to lungs (L).
Central nervous system abnormalities Major abnormalities of the central nervous system can be detected as early as 8 weeks of gestation. High-resolution transvaginal ultrasound imaging and good knowledge of the normal development of the brain cavities between 6 and 10 weeks are key prerequisites for the detection of abnormal brain anatomy in early pregnancy. Figure 6 shows the normal development of the brain cavities (telencephalon, diencephalon, mesencephalon and rhombencephalon) at 8 weeks of gestational age. Since ossification of the frontal bones occurs at 10 weeks' gestation, abnormal and irregular head shape may suggest early stages of acrania-exencephaly-anencephaly sequence (Figure 7)12. In these cases, the amniotic fluid often appears more echogenic than the extracelomic space.
Figure 6 Open in figure viewerPowerPoint 3D virtual stretching demonstrating normal development of fetal brain cavities at 8 weeks' gestation. D, diencephalon; M, mesencephalon; R, rhombencephalon; T, telencephalon.
Figure 7 Open in figure viewerPowerPoint 2D (a) and 3D (b) sonographic images and postmortem image (c) of embryo with crown-rump length of 22 mm and acrania. (d) 2D image showing echogenic amniotic fluid in same case.
The cerebral falx can be seen in its entirety at 8-10 weeks. Other major brain abnormalities, such as alobar holoprosencephaly with fusion of the thalami and of the anterior horns of the lateral ventricles, can be identified at this stage (Figure 8) and early detection has been previously reported13. The association of alobar holoprosencephaly with trisomy 13 and poor neonatal outcomes may change the screening and diagnostic options for the woman, altering the management of the pregnancy. Similarly, in some cases, encephalocele with meningocele can also be detected before 11 weeks (Figure 9). Previous studies have shown an important association between dilated fourth ventricle in the first trimester and chromosomal defects14, and high-resolution transvaginal ultrasound now allows visualization of the posterior fossa spaces and structures. Using 3D rendering with transparency mode, dilatation of the brain cavities can be well visualized, especially dilatation of the fourth ventricle (Figure 10) and lateral cranial ventricles.
Figure 8 Open in figure viewerPowerPoint 2D ultrasound images showing coronal (a) and axial (b) views at 9 weeks' gestation in fetus with alobar holoprosencephaly with absence of cerebral falx (arrow) and fusion of anterior horns of lateral ventricles (V) and of thalami.
Figure 9 Open in figure viewerPowerPoint 2D ultrasound (a) and tomographic ultrasound (b) images showing axial view of fetal head in 10-week fetus with evident encephalocele (E). 4th, fourth ventricle; aos, aqueduct of Sylvius; m, meningocele.
Figure 10 Open in figure viewerPowerPoint
(a) 3D ultrasound image with glass rendering mode showing normal brain cavities in fetus at 9 + 2 weeks' gestation. (b) 2D ultrasound image showing fetus with hydrocephalus at 10 weeks' gestation. (c) 3D ultrasound image with glass rendering mode showing dilated fourth ventricle (4TH) in aneuploid embryo at 9 + 4 weeks.
Spinal defects Before 10 weeks of gestational age, the fetal spine can be seen on ultrasound as hypoechoic parallel lines (Figure 11); after this stage, the ossification process begins. Ossified vertebrae can be identified on ultrasound in coronal view of the spine after 10 weeks, but early diagnosis of spinal dysraphism before 16 weeks through direct visualization of the spine is challenging. The diagnosis of open spina bifida can be suggested by abnormalities of the posterior fossa in both sagittal and axial views of the fetal head5, 15. If a myelomeningocele is prominent in early pregnancy, the defect can be potentially visualized as early as 9-10 weeks (Figure 11), mainly with the use of high-resolution transvaginal ultrasound.
Figure 11 Open in figure viewerPowerPoint
(a) 2D ultrasound image showing normal appearance of embryonic spine at 8 weeks' gestation, appearing as three straight echogenic lines interpolated by two hypoechoic lines. (b) 3D ultrasound image showing prominent myelomeningocele in embryo at 9 weeks' gestation. (c) Postmortem image of fetus with open spina bifida at 10 weeks' gestation.
Heart abnormalities Fetal heart activity can be first identified at 5-6 weeks of pregnancy. The four-chamber view of the heart and the right and left cardiac outflows can be visualized between 8 and 10 weeks' gestation in a large proportion of cases8, particularly in the hands of experienced operators, with the use of high-resolution transvaginal probes and 4D ultrasound modalities, such as spatiotemporal image correlation (STIC) (Figure 12). Major heart defects, such as hypoplastic left heart syndrome, can potentially be seen as early as 10 weeks (Figure 12).
Figure 12 Open in figure viewerPowerPoint
(a) 2D ultrasound image with color Doppler showing four-chamber view of normal fetal heart at 10 weeks' gestation. (b,c) Visualization of right outflow of fetal heart and crossing of right and left cardiac outflows on 3D spatiotemporal image correlation (b) and tomographic ultrasound imaging (c) at 10 weeks' gestation. D, ductus arteriosus; LV, left ventricle; MPA, main pulmonary artery; RV, right ventricle; TAO, transverse aorta. (d) 2D ultrasound image of hypoplastic left heart with asymmetrical ventricles and subcutaneous edema in 10-week fetus.
Abdominal-wall defects Between 9 and 11 weeks of gestational age, physiologic bowel herniation through the base of the umbilical cord is evident and occurs because the growth rate of the intestines is higher than that of the abdominal wall in the embryonic period. This herniation usually resolves by 12 weeks (CRL of 54 mm). The stomach can be visualized by 8 weeks in approximately 80% of the pregnancies8. When the bowel herniation measures more than 7 mm in its largest diameter, or if it persists at the end of 12 weeks, a ventral-wall defect can be suspected16, 17. In the case of omphalocele (or exomphalos), the protruding mass is typically smooth and has a rounded contour since the abdominal contents are contained by the peritoneal membrane. An irregular protrusion is highly suggestive of gastroschisis, in which the bowel loops are not contained by peritoneal membrane and are floating freely in the amniotic cavity. Figure 13 shows a normal fetus with midgut herniation at 10 weeks, along with different abdominal-wall defects including omphalocele, cloacal exstrophy and body-stalk anomaly.
Figure 13 Open in figure viewerPowerPoint
(a) 3D surface-rendered ultrasound image showing physiologic midgut herniation through base of umbilical cord (arrow) in 10-week fetus. (b,c) 2D (b) and 3D (c) ultrasound images of 10 + 4-week fetus with large bowel herniation (> 7 mm), which is likely to persist as omphalocele after 12 weeks. (d) 2D sonographic image (sagittal view) of fetus with cloacal exstrophy at 10 + 6 weeks. (e) 3D ultrasound image showing 8-week fetus with body-stalk anomaly with large abdominal-wall defect and short umbilical cord (UC). (f) 2D ultrasound image showing abnormal embryonic shape in case of omphalocele, cloacal exstrophy, imperforate anus and spinal defect (OEIS) complex at 8 weeks' gestation. CRL, crown-rump length.
Urinary-tract abnormalities The fetal kidneys can be visualized at 9 weeks in approximately 50% of the pregnancies8 and appear as oval echogenic structures on either side of the spine in a coronal view. Utilizing 3D modalities, such as volume contrast imaging (VCI) and glass rendering with transparent minimal mode, may facilitate visualization of the kidneys. The bladder is seen as a small anechoic area within the pelvis and its longitudinal length should measure less than 6 mm in its largest diameter. Gross abnormalities of the abdominal wall and bladder exstrophy can be identified at these early stages (Figure 13). Figure 14 demonstrates a case of patent urachus connecting the bladder with the umbilicus.
Figure 14 Open in figure viewerPowerPoint 2D ultrasound images showing bladder (B) communicating with umbilicus (patent urachus; arrow) in axial view of fetus at 10 + 5 weeks (a) and in sagittal view of same fetus 2 weeks later (b).
Severe limb abnormalities The limb buds are first seen at approximately 7-8 weeks, though visualization of the digits is difficult at this stage. Evaluation of the digits of the feet is challenging given that the soles of the feet are apposed 'en-face' by 9 to 10 weeks, whereas the fingers of the hands are readily identified as the arms are held in a fixed flexed position across the fetal chest and hands are separated at this stage. At times, polydactyly may be evident in early pregnancy (Figure 15). All long bones are identifiable by 10 weeks. Major limb abnormalities, such as ectrodactyly, fusion of the inferior limbs (sirenomelia) and limb absence can be suspected between 9 and 10 weeks of gestational age (Figure 16).
Figure 15 Open in figure viewerPowerPoint 3D ultrasound image of fetus with post-axial polydactyly of foot at 10 + 6 weeks' gestation.
Figure 16 Open in figure viewerPowerPoint 2D (a,c) and 3D (b,d) ultrasound images showing fetus with ectrodactyly (split hand; arrow) at 9 + 4 weeks' gestation (a,b) and fetus with sirenomelia (fused inferior limbs) at 9 weeks' gestation (c,d).
Discussion With the advent of cfDNA testing, women are increasingly opting for pretest ultrasound assessment. High-frequency transvaginal ultrasound screening with 3D/4D technology can provide a definitive diagnosis in cases with certain fetal defects, such as acrania and conjoined twins. In others, a diagnosis may be suspected at 6-10 weeks and subsequently confirmed at 11-14 weeks or later in pregnancy. In patients with a suspected diagnosis of a fetal defect, it may be more appropriate that counseling is in favor of discouraging cfDNA testing and potentially proceeding with re-evaluation of the fetal anatomy at 11-14 weeks with consideration of definitive genetic testing via chorionic villus sampling or amniocentesis. In a study by Vora et al., ultrasound examination prior to cfDNA testing offered to women of ≥ 35 years of age identified findings that could have changed management in 16% of the cases18. Similarly, in a recent review of over 6000 pre-cfDNA scans, we concluded that findings that could potentially lead to change in management are observed in one in 10 pregnancies, and this proportion is even higher in women with advanced maternal age (unpublished data).
An additional benefit of screening before 11 weeks of gestation is the identification of cases with increased nuchal fluid, subcutaneous edema or hydrops fetalis, which comprised 1% of cases in our cohort. Indeed, our data suggest that this group of patients is at high risk of adverse pregnancy outcome and have a 1/5 probability of having an underlying aneuploidy or fetal malformation (unpublished data). Therefore, the introduction of routine early ultrasound screening for all patients may herald a new tier of fetal-malformation and aneuploidy screening in the future.
It is best to obtain maternal blood for cfDNA analysis at 10 weeks' gestation, rather than at 8 or 9 weeks, as the fetal fraction is greater at this time, which lowers the rate of test failure and increases its accuracy. This correlates well with the timing for identification of increased nuchal fluid, subcutaneous edema, fetal hydrops and fetal malformation, which is better at 10 weeks than at 6-9 weeks' gestation in our experience. The proportion of fluid in the amniotic and celomic cavities to fetus is greatest at 6-10 weeks' gestation compared to any other time in pregnancy, and this provides an ideal setting for 3D and 4D volume acquisition and analysis. Furthermore, the fetus is relatively inactive at this early stage when compared to the later stages of pregnancy, which facilitates anatomical review using both 2D and 3D analysis.
However, screening for aneuploidies and fetal abnormalities at 8-10 weeks' gestation needs to be considered with caution, as to date there is limited evidence regarding the detection rate, and many of the organ systems are still undeveloped or too difficult to visualize at this early stage. Moreover, there is no evidence that early pregnancy screening is cost-effective, and future research needs to evaluate carefully whether detection of fetal abnormalities before 11 weeks' gestation is cost-beneficial on a population level. Caution is recommended when a diagnosis is made at a very early gestational age and confirmation of fetal abnormalities later in pregnancy is frequently required, which is of importance as we progress through the learning curve in sonoembryology, just as occurred in the history of ultrasound diagnosis in the mid-trimester and, more recently, in the first trimester at 11-14 weeks. Given that patients may choose surgical termination of pregnancy if a fetal malformation is detected, other grounds for urging caution are that antenatal screening and diagnosis at this early stage may become difficult to audit.
Due to concerns regarding the possible biological effects of ultrasound and tissue heating, practitioners should observe the 'as low as reasonably achievable' (ALARA) principle. Although the increase in temperature seems negligible during first-trimester ultrasonography19, 20, exposure should be kept to the minimum necessary and the output display system should be monitored, aiming to maintain the thermal index below 1.0 (thermal index for soft tissue before 10 weeks and thermal index for bone thereafter)20, 21.
Finally, patients should be counseled with due care, as early identification of a suspected anomaly which requires later confirmation may prolong patient anxiety until a firm diagnosis is achieved in the first or second trimester.
Now let us see the oath taken be a doctor before entering the nobel profession of the Medical World. As per guidelines of MCI, Every member should get it framed in his or her office it should never be violated in its letter and spirit.
"I solemnly pledge myself to consecrate my life to service of humanity.
Even under threat, I will not use my medical knowledge contrary to the laws of Humanity.
I will maintain the utmost respect for human life from the time of conception.
I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
I will practice my profession with conscience and dignity.
The health of my patient will be my first consideration.
I will respect the secrets which are confined in me.
I will give to my teachers the respect and gratitude which is their due.
I will maintain by all means in my power, the honour and noble traditions of medical profession.
I will treat my colleagues with all respect and dignity.
I shall abide by the code of medical ethics as enunciated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002.
I make these promises solemnly, freely and upon my honour."
The complexity of the human body and the uncertainty involved in the medical procedure are of such great magnitude that it is impossible for a Doctor to guarantee a successful result; and the only assurance that he can give, or can be understood to have given by implication is that he is possessed of requisite skill in that branch of profession which he is practising and while undertaking the performance of the task entrusted to him, he would be exercising his skills with reasonable competence. An ordinary physician or surgeon is not expected to be either a clodhopper or feckless practitioner of profession, as much as, he is not expected to be a paragon, combining qualities of polymath or prophet as in the realm of diagnosis and treatment, there is ample scope for genuine difference of opinion; and a Doctor cannot be treated as negligent merely because his conclusion differs from that of other persons in the profession, or because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care. Furthermore, a golden principle of law has been laid down by the Hon'ble Apex Court in Jacob Mathew Vs. State of Punjab, (AIR 2005 SC 3180) that no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitor is not an universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors, else it would be counter productive. 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-se by applying the doctrine of res ipsa loquitor. Yet, another golden principle of law has been laid down by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha's III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, it has been observed in Malay Kumar Ganguli's case (AIR 2010 SC 1162) that" charge of professional negligence on a medical person is a serious one as it affects his professional statusand reputation and as such, the burden of proof would be more onerous. A doctor cannot be held negligent only because something has gone wrong. He also cannot be held liable for mischance or misadventure or for an error in judgment in making a choice when two options are available. The mistake in diagnosis is not necessarily a negligent diagnosis." In the instant matter, thus a simple test, in the light of aforesaid observations, needs to be conducted in order to ascertain whether the Doctor is guilty of any tortious act of negligence/battery amounting to deficiency in conducting a surgery in the delivery of child and not properly attending the patient, the complainant and consequently, liable to pay damages for leaving cotton mass in the abdomen / stomach due to failure in surgery and deteriorating condition of the patient.
Now, it is required to be seen whether an expert report is necessary in each and every case relating to medical negligence or not ? It has been observed by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, in B. Krishna Rao Vs. Nikhil Super Speciality Hospital 2010 (V) SCC513 at para 40 the Hon'ble Apex Court was pleased to hold that it is not necessary to have opinion of the expert in each and every case of medical negligence. The Hon'ble Apex Court was pleased to further hold in Nizam Institute of Medical Sciences Vs. Prashant S. Dhananka and others 2009 (VI) SCC 1 that "in a case of medical negligence, once initial burden has been discharged by the complainant by making of a case of negligence on the part of the hospital or the doctor concerned, the owner then shifts on the hospital or to the attending doctors and it is for the hospital to satisfy the court that there was no lack of care or diligence".
A doctrine or rule of evidence in tort law that permits an inference or presumption that a defendant was negligent in an accident injuring the plaintiff on the basis of circumstantial evidence if the accident was of a kind that does not ordinarily occur in the absence of negligencea plaintiff who establishes the elements of res ipsa loquitur can withstand a motion for summary judgment and reach the jury without direct proof of negligence-- Cox v. May Dept. Store Co., 903 P.2d 1119 (1995).
In Byrne vs Boadle, this maxim was used for the first time where the complainant was injured by a barrel that dropped from the window of the defendant. In the abovementioned case, Pollock, C. B., said "here are many incidents from which no presumption of negligence can arise, but this is not true in every case. It is the duty of persons who keep barrels in a warehouse to take care that they do not roll out and I think that such a case will, beyond all doubt, afford prima facie proof of negligence."
This doctrine intends to help direct the court proceedings to a conclusion, especially if it is established through the implication of this doctrine's rule that the injury caused to the claimant would not have occurred or taken place if the defendant wasn't negligent.This also gives enough cause and evidence to hold the defendant liable for his negligent actions.
The thing speaks for itselfis the gist of the maxim Res Ipsa Loquitur Maxim. What are the essentials of this maxim.
The injury caused to the plaintiff shall be a result of an act of negligence.
There is a lack of evidence, or the evidence presented before the court is insufficient to establish the possibilities of the fault of the plaintiff or third party.
The defendant owes a duty of care towards the plaintiff, which he has breached.
There is a significant degree of injury caused to the plaintiff.
Applicability of Doctrine of Res Ipsa Loquitur.
The maxim of res ipsa loquitur came into force to benefit the plaintiff as he can use circumstantial evidence to establish negligence.
Consequently, it shifts the burden of proof on the defendant, logic being, where there is an event of unexplained cause, usually, the one that does not occur without the defendant's negligence in controlling the action which has caused the injury to the claimant or destroyed his goods.
In this scenario, the court shall presume negligence on the part of the defendant in such a case unless it includes an appropriate explanation compatible with his taking reasonable care.
In AchutraoHaribhauKhodwa and Others vs. State of Maharashtra and Others, it was considered that the maxim should not be applied in the case of general incidences of neglect and shall only be reflected when there is a significant degree of injury caused.
Section 106 of the Indian Evidence Act Section 106 of the Act provides that when any fact is especially within the knowledge of any person, the burden of proving that fact is upon him.
Res ipsa loquitur is a Latin phrase that means "the thing speaks for itself." In personal injury law, the concept of res ipsa loquitur (or just "res ipsa" for short) operates as an evidentiary rule that allows plaintiffs to establish a rebuttable presumption of negligence on the part of the defendant through the use of circumstantial evidence.
This means that while plaintiffs typically have to prove that the defendant acted with a negligent state of mind, through res ipsa loquitur, if the plaintiff puts forth certain circumstantial facts, it becomes the defendant's burden to prove he or she was not negligent.
Res Ipsa Loquitur and Evidence Law Accidents happen all the time, and the mere fact that an accident has occurred doesn't necessarily mean that someone's negligence caused it. In order to prove negligence in a personal injury lawsuit, a plaintiff must present evidence to demonstrate that the defendant's negligence resulted in the plaintiff's injury. Sometimes, direct evidence of the defendant's negligence doesn'texist, but plaintiffs can still use circumstantial evidence in order to establish negligence.
Circumstantial evidence consists of facts that point to negligence as a logical conclusion rather than demonstrating it outright. This allows judges and juries to infer negligence based on the totality of the circumstances and the shared knowledge that arises out of human experience. Res ipsa is one type of circumstantial evidence that allows a reasonable fact finder to determine that the defendant's negligence caused an unusual event that subsequently caused injury to the plaintiff.
This doctrine arose out of a case where the plaintiff suffered injuries from a falling barrel of flour while walking by a warehouse. At the trial, the plaintiff's attorney argued that the facts spoke for themselves and demonstrated the warehouse's negligence since no other explanation could account for the cause of the plaintiff's injuries.
As it has developed since then, res ipsa allows judges and juries to apply common sense to a situation in order to determine whether or not the defendant acted negligently.
Since the laws of personal injury and evidence are determined at the state level, the law regarding res ipsa loquitur varies slightly between states. That said, a general consensus has emerged, and most states follow one basic formulation of res ipsa.
Under this model for res ipsa, there are three requirements that the plaintiff must meet before a jury can infer that the defendant's negligence caused the harm in question:
The event doesn't normally occur unless someone has acted negligently;
The evidence rules out the possibility that the actions of the plaintiff or a third party caused the injury; and The type of negligence in question falls with the scope of the defendant's duty to the plaintiff.
As mentioned above, not all accidents occur because of someone else's negligence. Some accidents, on the other hand, almost never occur unless someone has acted negligently.
Going back to the old case of the falling flour-barrel, it's a piece of shared human knowledge that things don't generally fall out of warehouse windows unless someone hasn't taken care to block the window or hasn't ensured that items on the warehouse floor are properly stored. When something does fall out of a warehouse window, the law will assume that it happened because someone was negligent.The second component of a res ipsa case hinges on whether the defendant carries sole responsibility for the injury. If the plaintiff can't prove by a preponderance of the evidence that the defendant's negligence cause the injury, then they will not be able to recover under res ipsa.
States sometimes examine whether the defendant had exclusive control over the specific instrumentality that caused the accident in order to determine if the defendant's negligence caused the injury. For example, if a surgeon leaves a sponge inside the body of a patient, a jury can infer that the surgeon's negligence caused the injury since he had exclusive control over the sponges during the operation.
In addition to the first two elements, the defendant must also owe a duty of care to protect the plaintiff from the type of injury at issue in the suit. If the defendant does not have such a duty, or if the type of injury doesn't fall within the scope of that duty, then there is no liability.
For example, in many states, landowners don't owe trespassers any duty to protect them against certain types of dangers on their property. Thus, even if a trespasser suffers an injury that was caused by the defendant's action or inaction and that wouldn't normally occur in the absence of negligence, res ipsa loquitur won't establish negligence since the landowner never had any responsibility to prevent injury to the trespasser in the first place.
Res ipsa only allows plaintiffs to establish the inference of the defendant's negligence, not to prove the negligence completely. Defendants can still rebut the presumption of negligence that res ipsa creates by refuting one of the elements listed above.
For example, the defendant could prove by a preponderance of the evidence that the injury could occur even if reasonable care took place to prevent it. An earthquake could shake an item loose and it could fall out of the warehouse window, for instance.
A defendant could also demonstrate that the plaintiff's own negligence contributed to the injury. To go back to the flour-barrel example, if the defendant shows that the plaintiff was standing in an area marked as dangerous it could rebut the presumption of negligence created by res ipsa.
Finally, the defendant could establish that he did not owe the plaintiff a duty of care under the law, or that the injury did not fall within the scope of the duty owed. For example, if the law only imposes a limited duty on the defendant not to behave recklessly, then res ipsa will not help the plaintiff by creating an inference of negligence since a negligent action would not violate the duty owed to the plaintiff.
According to the Blacks Law Dictionary the maxim is defined as the doctrine providing that, in some circumstances, the mere fact of accidents occurrence raises an inference of negligence so as to establish a prima facie (at first sight) case. It is a symbol for that rule that the fact of the occurrence of an injury taken with the surrounding circumstances may permit an inference or recipes omission of negligence, or make out a plaintiff's prima facie case and present a question of fact for defendant to meet with and explanation. It is merely a short way of saying that the circumstances attendant on the accident are of such a nature to justify a jury in light of common sense and past experience in inferring that the accident was probably the result of the defendant's negligence, in the absence of explanation or other evidence which the jury believes.
Its use in clinical negligence gained some traction before Bolam and Bolitho. Mahon v Osborne [1939] 1 All ER 535, is an early example of the application of res ipsa loquitur in a case where a surgical swab had been left inside a patient's body.
In Clarke v Worboys (1952) Times, 18 March, CA, a patient noticed burns on her buttock shortly after surgical excision of a breast tumour. The surgery involved cauterisation. The Court of Appeal held that this was a case where res ipsa loquitur applied. The outcome was not one that would ordinarily occur in the absence of negligence, and the surgical team were unable to explain how the injury was caused.
In Cassidy v Ministry of Health [1951] 2 KB 343, Denning LJ succinctly summarised the maxim's application to clinical negligence cases: "I went into hospital to be cured of two stiff fingers. I have come out with four stiff fingers and my hand is useless. That should not happen if due care had been used. Explain it if you can."
Ng Chun Pui Vs Lee Chuen Tat, the first defendant was driving a coach owned by the second defendant westwards in the outer lane of dual carriageway in Hong Kong. Suddenly the course across the central reservation and collided with a public bus travelling in the inner lane of the other carriageway, killing one passenger in the bus and injuring the driver and three others on the bus. The plaintiff could not prove that the defendants were negligent and had caused the accident. They however proceeded on the basis ofRes Ipsa Loquitur and shifted the onus on the defendants to prove that they were not negligent. However, they failed to do so. And the judicial committee of the Privy Council held the defendants liable for the plaintiffs injuries. { MarkLuney and Ken Opliphant, Tort Law Text And Materials (Oxford University Press, New York, 2000) pp 173-175 } In A.S. Mittal &Anr Vs State Of UP &Ors , AIR 1979 SC 1570 , the defendants had organised an eye camp at Khurja along with the Lions Club. 88 low risk cataract operations were undertaken during the period of the camp. It was however, disastrous as many of those who had been operated upon lost their eyesight due to post medical treatment. Proceedings against the government initiated for negligence of the doctors. Damages worth Rs.12,500/- were paid as interim belief to each of the aggrieved. The decision was on the basis of Res Ipsa Loquitur as the injury would not ave occurred had the doctors not been negligent in not having followed up with post-operation treatment. Res Ipsa Loquitur can be applied in matters where are the procedures have not been followed and is not just limited to the commission of an act.
We can define 'Medical negligence' as the improper or unskilled treatment of a patient by a medical practitioner. This includes negligence in taking care from a nurse, physician, surgeon, pharmacist, or any other medical practitioner. Medical negligenceleads to 'Medical malpractices' where the victims suffer some sort of injury from the treatment given by a doctor or any other medical practitioner or health care professional.
Medical negligence can occur in different ways. Generally, it occurs when a medical professional deviates from the standard of care that is required.
So, we can say that any kind of deviation from the accepted standards of medication and care is considered to be medical negligence and if it causes injury to a patient then the doctor who operated on him, other staff and/or hospital may be held liable for this.
Some of the common categories of medical negligence are as follows:
Wrong diagnosis - When someone goes to a hospital, clinic or medical room, etc. the first step after admittance is the diagnosis. Diagnosing symptoms correctly is critical and important to provide medical care to any patient. However, if a patient is not treated properly due to any mistake in diagnosis, the doctor can be made liable for any further injury or damages caused as a result of the wrong diagnosis.
Delay in diagnosis - A delayed diagnosis is treated as medical negligence if another doctor would have reasonably diagnosed the same condition in a timely fashion. A delay in diagnosis can cause undue injury to the patient if the illness or injury is left to worsen with time rather than being treated. Obviously, any delay in the identification and treatment of an injury can reduce the chance of recovery for the patient.
Error in surgery - Surgical operations require an enormous level of skill and it should be done with due care and caution because even the slightest mistakes can have profound effects on the patient. The wrong-site surgery, lacerations of any internal organ, severe blood loss, or a foreign object being left in the body of the patients, all this comes under Surgical error.
Unnecessary surgery - Unnecessary surgery is usually associated with the misdiagnosis of patient symptoms or a medical decision without proper consideration of other options or risks. Alternatively, sometimes surgery is chosen over conventional treatments for their expediency and ease compared to other alternatives.
Errors in the administration of anesthesia - Anesthesia is a risky part of any major medical operation and requires a specialist (anesthesiologist) to administer and monitor its effect on the patient. Prior to any medical procedure requiring anesthesia, the anesthesiologist has to review the patient's condition, history, medications, etc. to determine the most suitable of all the medicine to use. Anesthesia malpractice can happen even during the pre-operation medical review or during the procedure itself.
Childbirth and labor malpractice - Childbirth is a difficult event for a woman and it becomes worse if not handled properly by the doctors and nurses. There are many instances of medical negligence during childbirth including the mishandling of a difficult birth, complications with induced labor, misdiagnosis of a newborn medical condition, etc. Long-Term negligent treatment - Medical negligence can also occur in subtle ways over the course of a long treatment period. Usually, the negligence can take the shape of a failure to follow up with treatment, or a doctor's failure to monitor the effects of the treatment properly.
A standard of care specifies the appropriate treatment and medication procedure as per the requirements that should be taken into account by a doctor while providing the treatment to his patients. The care should not be of the highest degree nor the lowest. Here, the degree means the level of care an ordinary health care professional, with the same training and experience, would render in similar circumstances in the same community. This is the critical question in medical malpractice cases and if the answer is "no," and you suffered injury as a result of the poor treatment, you may file a suit for medical malpractice.
In the case of Dr. Laxman Balkrishna Joshi Vs. Dr. TrimbakBapu Godbole and Anr.[ 1969 AIR 128], the Supreme Court held that a doctor has certain aforesaid duties and a breach of any of those duties can make him liable for medical negligence. A doctor is required to exercise a reasonable degree of care that is set for this profession.
Dr. Kunal Saha vs Dr. Sukumar Mukherjee on 21 October, 2011 ( NC) original petition number 240 OF 1999 is one of the most important case regarding medical negligence. The brief facts of the case are-
Toxic Epidermal Necrolysis ( TEN ) is a rare and deadly disease. It is an extoliative dermatological disorder of unknown cause. A patient with TEN loses epidermis in sheet-like fashion leaving extensive areas or denuded dermis that must be treated like a larze, superficial, partial-thickness burn wound. The incidence of TEN has been reported at 1 to 1.3 per million per year. The female-male ratio is 3:2. TEN accounts for nearly 1% of drug reactions that require hospitalization. TEN has a mortality rate of 25 to 70%.
Smt. Anuradha Saha (in short Anuradha), aged about 36 years wife of Dr. Kunal Saha (complainant) became the unfortunate victim of TEN when she alongwith the complainant was in India for a holiday during April-May 1998. She and the complainant although of Indian original were settled in the United States of America. The complainant is a doctor by profession and was engaged in research on HIV / AIDS for the past fifteen years. Anuradha after acquiring her Graduation and Masters Degree was pursuing a Ph.D. programme in a university of U.S.A. She was a Child Psychologist by profession. Anuradha showed certain symptoms of rashes over her body and received treatment at the hands of Opposite Parties and some other doctors as outdoor patient uptil 10.05.1998 and she was admitted in Advanced Medicare and Research Institute Limited, Calcutta (for short, AMRI), on 11.05.1998, where she was treated by the above-named Opposite Parties and other doctors uptil 16.05.1998. As there was no improvement in her condition, she was shifted to Breach Candy Hospital, Mumbai, on 17.05.1998 by an air ambulance. She was treated in Breach Candy Hospital from 17.05.1998 evening till she breathed her last on 28.05.1998.
Our Complainant as husband of Anuradha felt that the doctors who treated Anuradha and the hospitals where she was treated were grossly negligent in her treatment and her death was occasioned due to gross negligence of the treating doctors and hospitals. Complainant, accordingly, got issued a legal notice to as many as 26 persons i.e. various doctors who treated Anuradha between end of April to the date of her death alleging negligence and deficiency in service on their part and claiming a total compensation exceeding Rs.55 crores from them. Complainant, thereafter filed the present complaint on 09.03.1999 before this Commission claiming a total compensation of Rs. Rs.77,07,45,000/- ( Seventy Seven Crores Seven Lakhs Fourty Five Thousand only). Later he also filed another complaint no. 179 of 2000 in this Commission against Breach Candy Hospital, its doctors and functionaries claiming a further compensation of Rs.25.30 crore ( though the said complaint was later on withdrawn), thereby making claim of compensation exceeding Rs.102 crores, perhaps the highest ever claimed by any complainant for medical negligence before any consumer fora established under the provisions of Consumer Protection Act, 1986 ( in short, the Act). These are some of the facts which make the present case extra ordinary.
The present complaint was filed by the complainant against the above-named opposite parties, namely, Dr. Sukumar Mukherjee, Dr. B. Haldar (Baidyanath Halder), Advanced Medicare and Research Institute Limited ( in short the AMRI Hospital ) and Dr. Balram Prasad and Dr.Abani Roy Chowdhury (physician) and Dr. Kaushik Nandy (plastic surgeon), the Directors of the AMRI Hospital and others claiming a total compensation of Rs. Rs.77,07,45,000/- under different heads alleging various acts of commission and omission on the part of the doctors and hospital amounting to negligence and deficiency in service. Complainant through his brother-in-law Malay Kumar Ganguly also filed criminal complaint against some of the doctors and the hospital under section 304A IPC.
The complaint was resisted by the doctors and the hospital on a variety of grounds thereby denying any medical negligence or deficiency in service on their part. Parties led voluminous documentary and oral evidence and testimonies of some of the witness were even recorded through video conferencing through a Local Commissioner. After a protracted trial and hearing and on consideration of the evidence and material so produced on record and taking note of the legal position governing the question of medical negligence, this Commission ( by a three Member Bench presided over by the then President) dismissed the complaint by an order dated 01.06.2006 holding as under:
In the result, we reiterate that Doctors or Surgeons do not undertake that they will positively cure a patient. There may be occasions beyond the control of the medical practitioner to cure the patients. From the record, it would be difficult to arrive at the conclusion that the injection Depo-Medrol prescribed by Dr. Mukherjee was of such excessive dose that it would amount to deficiency in service by him which was his clinical assessment.
Thereafter, with regard to the alleged deficiency in the treatment given to Mrs. Anuradha by Opposite Party Doctors 2, 3, 5 and 6, there is no substance. The contention against the hospital that it was not having Burns-Ward, and therefore, the deceased suffered is also without substance. Hence, this complaint is dismissed. There shall be no order as to costs.
Aggrieved by the dismissal of his complaint, the complainant filed Civil Appeal (No.1727 of 2007) in the Honble Supreme Court. It would appear that even before the said appeal was filed before the Hon'ble Supreme Court, the Supreme Court was seized of the matter in Criminal Appeal Nos.1191-94 of 2005 filed by Malay Kumar Ganguly, the complainant in the criminal complaint, against the Orders passed by the Calcutta High Court. Since the Criminal Appeals and the Civil Appeal filed by the complainant in the present complaint raised the same questions of fact and law, the Hon'ble Supreme Court heard all the appeals together and decided the same by means of a detailed judgment dated 07.8.2009. By the said order, the Apex Court dismissed the Criminal Appeals filed by Shri Malay Kumar Ganguly but allowed the Civil Appeal No. 1727 of 2007 filed by the complainant and set aside the order dated 01.6.2006 passed by this Commission dismissing the complaint and remanded the matter to this Commission for the limited purpose of determining the adequate compensation, which the complainant is entitled to receive from the subsisting opposite parties by observing as under:
So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on the part of the Hospital or the doctors. We, are, however, of the opinion, keeping in view the fact that Dr.KaushikNandy has done whatever was possible to be done and his line of treatment meets with the treatment protocol of one of the experts viz.. Prof. Jean Claude Roujeau although there may be otherwise difference of opinion, that he cannot be held to be guilty of negligence.
We remit the case back to the Commission only for the purpose of determination of the quantum of compensation. We, keeping in view the stand taken and conduct of AMRI and Dr. Mukherjee, direct that costs of Rs.5,00,000 and Rs.1,00,000 would be payable by AMRI and Dr. Mukherjee respectively.
We further direct that if any foreign experts are to be examined it shall be done only through video conferencing and at the cost of the respondents.
Summary In view of the foregoing discussion, we conclude as under:
The facts of this case viz., residence of the complainant and Anuradha (deceased) in USA and they working for gain in that country; Anuradha having been a victim of a rare and deadly disease Toxic Epidermal Necrolysis (TEN) when she was in India during April-May 1998 and could not be cured of the said disease despite her treatment at two superspeciality medical centres of Kolkata and Mumbai and the huge claim of compensation exceeding Rs.77 crores made by the complainant for the medical negligence in the treatment of Anuradha makes the present case somewhat extraordinary.
The findings given and observations made by the Supreme Court in its judgment dated 07.08.2009 are absolutely binding on this Commission not only as ratio decidendi but also as obiter dicta also, the judgment having been rendered by the Supreme Court in appeal against the earlier order passed by a three Member Bench of this Commission and, therefore, no attempt can be allowed to read down / dilute the findings and observations made by the Supreme Court because the Supreme Court has remitted the complaint to this Commission only for the purpose of determination of the quantum of compensation after recording the finding of medical negligence against the opposite parties and others.
The task entrusted to the Commission may appear to be simple but the facts of the present case and the voluminous evidence led on behalf of the complainant has made it somewhat arduous. Still difficult was the task of apprortionment of the liability to pay the awarded amount by the different opposite parties and perhaps it was for this reason that the Supreme Court has remitted the matter to this Commission.
Multiplier method provided under the Motor Vehicles Act for calculating the compensation is the only proper and scientific method for determination of compensation even in the cases where death of the patient has been occasioned due to medical negligence / deficiency in service in the treatment of the patient, as there is no difference in legal theory between a patient dying through medical negligence and the victim dying in industrial or motor accident. The award of lumpsum compensation in cases of medical negligence has a great element of arbitrariness and subjectivity.
The foreign residence of the complainant or the patient and the income of the deceased patient in a foreign country are relevant factors but the compensation awarded by Indian Fora cannot be at par which are ordinarily granted by foreign courts in such cases. Socio economic conditions prevalent in this country and that of the opposite parties / defendants are relevant and must be taken into consideration so as to modulate the relief. A complainant cannot be allowed to get undue enrichment by making a fortune out of a misfortune. The theoretical opinion / assessment made by a Foreign Expert as to the future income of a person and situation prevalent in that country cannot form a sound basis for determination of future income of such person and the Commission has to work out the income of the deceased having regard to her last income and future prospects in terms of the criteria laid down by the Supreme Court.
There exists no straight jacket formula for apportionment of the awarded compensation amongst various doctors and hospitals when there are so many actors who are responsible for negligence and the apportionment has to be made by evolving a criteria / formula which is just going by the nature and extent of medical negligence and deficiency in service established on the part of different doctors and hospitals.
On a consideration of the entirety of the facts and circumstances, evidence and material brought on record, we hold that overall compensation on account of pecuniary and non pecuniary damages works out to Rs.1,72,87,500/- in the present case, out of which we must deduct 10% amount on account of the contributory negligence / interference of the complainant in the treatment of Anuradha. That will make the net payable amount of compensation to Rs.1,55,58,750/- (rounded ofto Rs.1,55,60,000/-). From this amount, we must further deduct a sum of Rs.25,93,000/- which was payable by Dr. Abani Roy Chowdhury (deceased) or his Legal Representative as the complainant has forgone the claim against them.
In view of the peculiar facts and circumstances of the case and as a special case, we have awarded a sum of Rs. 5,00,000/- as cost of litigation in the present proceedings.
The above amount shall be paid by opposite parties no.1 to 4 to the complainant in the following manner:
Dr. Sukumar Mukherjee-opposite party no.1 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation].
Dr. B. Haldar (Baidyanth Halder)-opposite party no.2 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] AMRI hospital-opposite party no.3 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only ) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation .
(iv) Dr. Balram Prasad-opposite party no.4 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] The opposite parties are directed to pay the aforesaid amounts to the complainant within a period of eight weeks from the date of this order, failing which the amount shall carry interest @ 12% p.a. w.e.f. the date of default.
Now in this case the opposite party assured the complainant regarding test tube baby and this case is not a failure but after premature delivery, it was the duty of opposite party to provide all the post-operative care to the complainant's daughter. If there is a nursing home dealing with test tube baby procedure it should have all the equipments and measurements for the post-operative care. Post-operative care is most important aspect of operation theatre.
Immediate postoperative care:
Now an action arises whether there was proper post-operative care taken by the opposite parties after the operation and after the complication developed in the body of the patient.
Postoperative patients must be monitored and assessed closely for any deterioration in condition and the relevant postoperative care plan or pathway must be implemented.
The NCEPOD (2011) report found that patients whose condition was deteriorating were not always identified and referred for a higher level of care. Patients should be made ascomfortable as possible before postoperative checks are performed.
Postoperative patients are at risk of clinical deterioration, and it is vital that this is minimized. Knowledge and understanding of the key areas of risk and local policies will help reduce potential problems (National Patient Safety Agency, 2007; National Institute for Health and Clinical Excellence, 2007).
Track and trigger or early warning systems are widely used in the UK to identify deteriorating patients. These have been adapted by trusts for adults and children and are based on the patient's pulse and respiratory rate, systolic blood pressure, temperature and level of consciousness. Additional monitoring may include pain assessment, capillary refill time, percentage of oxygen administered, oxygen saturation, central venous pressure, infusion rates and hourly urine output.
The National Early Warning Score (NEWS) was developed by a working party to provide a national standard for assessing, monitoring and tracking acutely and critically ill patients (not for use with children under 16 years or in pregnancy); the intention was that trusts would use it to replace their locally adapted early warning systems (Royal College of Physicians, 2012). Like other early warning systems, NEWS has six physiological parameters:
Respiratory rate;
Oxygen saturation;
Temperature;
Systolic blood pressure;
Pulse rate;
Level of consciousness (this will be impaired in patients who have had recent sedation or are receiving opioid analgesia, which should be taken into consideration in assessment).
The system also includes a weighting score of two, which is added if the patient is receiving supplemental oxygen via a mask or nasal cannulas.
When assessing the postoperative patient using NEWS, it is vital that the patient is observed for signs of hemorrhage, shock, sepsis and the effects of analgesia and anesthetic. Patients receiving intravenous opiates are at risk of their vital signs and consciousness levels being compromised if the rate of the infusion is too high. It is therefore imperative that the patient's pain control is managed well, initially by the anesthetist and then the ward staff and pain team or anesthetist, to ensure that the patient has adequate analgesia but is alert enough to be able to communicate and cooperate with clinical staff in the postoperative period.
Many trusts have yet to implement NEWS, although it is beginning to be taught in pre-registration nursing programmes. Student nurses frequently perform postoperative observations under the supervision of a nurse; it is reassuring that they receive some insight and education as recommended by NCEPOD (2011).
Vital signs;
Vital signs should be performed in accordance with local policies or guidelines and compared with the baseline observations taken before surgery, during surgery and in the recovery area.
Nurses should also be aware of the parameters for these observations and what is normal for the patient under observation. When assessing patients' recovery from anaesthesia and surgery, these observations should not be considered in isolation; the nurse should look at and feel the patient. This also applies to children and should include observation of other signs and symptoms, for example abdominal tenderness or poor urine output, which could indicate deterioration (Royal College of Nursing, 2011). The RCN (2011) provides guidance on vital signs performed post-operatively on children. Many trusts now insist that vital signs are performed manually to provide more accurate recording and assessment.
All vital signs and assessments should be recorded clearly in accordance with guidelines for record keeping (Nursing and Midwifery Council, 2009). Handheld personal digital assistants (PDAs) are used at some trusts to store track and trigger data and calculate early warning scores, which can be accessed by the clinical and outreach teams.
When a patient's condition is identified as deteriorating, this information can be passed verbally to appropriate health professionals using the Situation, Background, Assessment and Recommendation (SBAR) tool advocated by the NHS Institute for Innovation and Improvement (2008).
Airway and respirations Respiratory rate and function is often the first vital sign to be affected if there is a change in cardiac or neurological state. It is therefore imperative that this observation is performed accurately; however, studies show it is often omitted or poorly assessed (NPSA, 2007; NCEPOD, 2005).
Nurses should observe and record the following:
Airway;
Respiratory rate (regular and effortless), rhythm and depth (chest movements symmetrical);
Respiratory depression: indicated by hypoventilation or bradypnoea, and whether opiate-induced or due to anaesthetic gases.
Oxygen therapy Oxygen is administered to enable the anaesthetic gases to be transported out of the body, and is prescribed when patients have an epidural, patient-controlled analgesia or morphine infusion. Nurses should ensure and record the following:
Oxygen therapy is prescribed;
Oxygen is administered at correct rate;
Continuous oxygen therapy is humidified to prevent mucous membranes from drying out;
The skin above the ears is protected from elastic on the mask.
Pulse oximetry Oxygen saturation should be above 95% on air, unless the patient has lung disease, and maintained above 95% if oxygen therapy is prescribed to prevent hypoxia or hypoxaemia. An abnormal recording may be due to shivering, peripheral vasoconstriction or dried blood on the finger.
Nurses should ensure that:
The finger probe is clean;
The position of the probe is changed regularly to prevent fingers becoming sore.
Heart rate, blood pressure and capillary refill time The following should be checked and recorded:
Rate, rhythm and volume of pulse;
Blood pressure;
Capillary refill time to assess circulatory status, along with the colour and temperature of limbs, also identifying reduced peripheral perfusion.
Particular attention should be paid to the systolic blood pressure as a lowered systolic reading and tachycardia may indicate haemorrhage and/or shock, although initially the blood pressure may not drop and will remain within normal limits as the body compensates. Tachycardia may also indicate that the patient is in pain, has a fluid overload or is anxious. Hypertension can be due to the anaesthetic or inadequate pain control.
Body temperature Children, older adults and patients who have been in theatre for a long period are at risk of hypothermia. Shivering can be due to anaesthesia or a high temperature indicative of an infection, while a drop in temperature might indicate a bacterial infection or sepsis.
Patients' temperature should be monitored closely and action taken to return it to within normal parameters.
Use a Bair Hugger (forced-air blanket) and blankets to warm the patient if their temperature is too low;
Choose an appropriate method to cool the patient if their temperature is too high (antipyretics/fanning/ tepid sponging).
Level of consciousness .
Postoperative patients should respond to verbal stimulation, be able to answer questions and be aware of their surroundings before being transferred to the ward and throughout the postoperative period.
A change in the level of consciousness can be a sign that the patient is in shock. The AVPU scale (Box 2) is appropriate for assessing consciousness in adults, children and young people unless they have had neurosurgery (RCN, 2011).
Fluid balance The NCEPOD (2011) found, in 30% of patient data reviewed, there was insufficient recording of postoperative fluid balance. Nurses should observe/undertake and record on the fluid balance chart the following:
IV fluids (colloids and crystalloids used to replace fluid loss postoperatively) and infusions;
Oral intake;
Urine output: catheter urine measurements should not be less than 0.5ml/kg/hour. Oliguria can be a sign of hypovolaemia and should be reported to medical staff immediately. Check that the catheter is not kinked or that the patient is not lying on the tubing if urine output is reduced;
Colour of stoma (where appropriate) and whether there is any bleeding;
Nausea and vomiting: if necessary, administration of antiemetics should be checked and vomit bowls and tissues should be within easy reach of the patient;
Oral care;
Nasogastric tube drainage (aspirate if patient feels nauseous unless otherwise indicated);
Colour and amount of wound drainage: large amounts of fresh blood could be an indication of haemorrhage; if there is no wound drainage, it is advisable to check that the drain has not fallen out.
Intravenous infusions The RCN (2010) and Health Protection Scotland (2012) recommend that peripheral venous catheters (PVC) are checked daily as a minimum, and consideration given to removing any PVC that has been in situ longer than 72 hours (Health Protection Scotland, 2012) or 72-96 hours (Department of Health, 2011).
A phlebitis scale can be used to help assess the PVC site; the Visual Infusion Phlebitis Scale (Jackson, 1998) is frequently used and recommended by the RCN (2010). These national guidelines should be used as resources in caring for PVCs. The following should be checked and recorded:
The PVC site when changing IV fluids, before administering IV medication;
Signs of phlebitis (redness, heat and swelling).
Conclusion The postoperative healthcare team is under constant pressure to discharge patients quickly. This can lead to vital signs being missed and result in a delay in recovery.
Patients can be discharged quickly only when they do not experience any post-operative complications, many of which can be avoided or identified with correct and thorough monitoring of signs and symptoms.
All health professionals must continually update their theoretical knowledge and clinical skills; those working in post-operative care can do this by relying less on electronic equipment and developing their ability to combine the use of assessment tools with good observational skills; feeling, listening for abnormal sounds and closely observing their patients.
There are guidelines issued by World Health Organisation for Post Operative Care - these are Postoperative care Post operative note and orders The patient should be discharged to the ward with comprehensive orders for the following:
• Vital signs • Pain control • Rate and type of intravenous fluid • Urine and gastrointestinal fluid output • Other medications • Laboratory investigations The patient's progress should be monitored and should include at least:
• A comment on medical and nursing observations • A specific comment on the wound or operation site • Any complications • Any changes made in treatment Aftercare: Prevention of complications • Encourage early mobilization:
o Deep breathing and coughing o Active daily exercise o Joint range of motion o Muscular strengthening o Make walking aids such as canes, crutches and walkers available and provide instructions for their use • Ensure adequate nutrition • Prevent skin breakdown and pressure sores:
o Turn the patient frequently o Keep urine and faeces off skin • Provide adequate pain control Discharge note On discharging the patient from the ward, record in the notes:
• Diagnosis on admission and discharge • Summary of course in hospital • Instructions about further management, including drugs prescribed.
Ensure that a copy of this information is given to the patient, together with details of any follow-up appointment .
(WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003 Postoperative Management) If the patient is restless, something is wrong.
Look out for the following in recovery:
• Airway obstruction • Hypoxia • Haemorrhage: internal or external • Hypotension and/or hypertension • Postoperative pain • Shivering, hypothermia • Vomiting, aspiration • Falling on the floor • Residual narcosis The recovering patient is fit for the ward when:
• Awake, opens eyes • Extubated • Blood pressure and pulse are satisfactory • Can lift head on command • Not hypoxic • Breathing quietly and comfortably • Appropriate analgesia has been prescribed and is safely established (WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003 ) Post operative pain relief • Pain is often the patient's presenting symptom. It can provide useful clinical information and it is your responsibility to use this information to help the patient and alleviate suffering.
• Manage pain wherever you see patients (emergency, operating room and on the ward) and anticipate their needs for pain management after surgery and discharge.
• Do not unnecessarily delay the treatment of pain; for example, do not transport a patient without analgesia simply so that the next practitioner can appreciate how much pain the person is experiencing.
Pain management is our job.
Pain Management and Techniques • Effective analgesia is an essential part of postoperative management.
• Important injectable drugs for pain are the opiate analgesics. Nonsteroidal antiinflammatory drugs (NSAIDs), such as diclofenac (1 mg/kg) and ibuprofen can also be given orally and rectally, as can paracetamol (15 mg/kg).
• There are three situations where an opiate might be given: o Preoperatively o Intraoperatively o Postoperatively • Opiate premedication is rarely indicated, although an injured patient in pain may have been given an opiate before coming to the operating room.
• Opiates given pre- or intraoperatively have important effects in the postoperative period since there may be delayed recovery and respiratory depression, even necessitating mechanical ventilation.
• Short acting opiate fentanyl is used intra-operatively to avoid this prolonged effect.
• Naloxone antagonizes (reverses) all opiates, but its effect quickly wears off.
• Commonly available inexpensive opiates are pethidine and morphine.
• Morphine has about ten times the potency and a longer duration of action than pethidine.
(continued next page) WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003) Post operative pain relief (continued) • Ideal way to give analgesia postoperatively is to:
o Give a small intravenous bolus of about a quarter or a third of the maximum dose (e.g. 25 mg pethidine or 2.5 mg morphine for an average adult) o Wait for 5-10 minutes to observe the effect: the desired effect is analgesia, but retained consciousness o Estimate the correct total dose (e.g. 75 mg pethidine or 7.5 mg morphine) and give the balance intramuscularly.
o With this method, the patient receives analgesia quickly and the correct dose is given • If opiate analgesia is needed on the ward, it is most usual to give an intramuscular regimen:
¾ Morphine: - Age 1 year to adult: 0.1-0.2 mg/kg - Age 3 months to 1 year: 0.05-0.1 mg/kg ¾ Pethidine: give 7-10 times the above doses if using pethidine • Opiate analgesics should be given cautiously if the age is less than 1 year. They are not recommended for babies aged less than 3 months unless very close monitoring in a neonatal intensive care unit is available.
Therefore it is clear that post-operative care is most important in a case of Surgery. If you have no infra or paraphernalia, you are not supposed to proceed further regarding operation. In this case when you go to peruse the total cases history of the patient, it is crystal clear that the opposite parties failed to provide the required post-operative care and also preoperative and operative care.
In this case the patient was being regularly checked with various examinations including sonography, ultrasound etcetc . The opposite party in his note (undated) has written that..... Baby was found to have multiple congenital anomalies (suspected VATER Association)... Single umbilical artery, Anal ..... ano vestibular fistula..with radial APLASIA...
VATER syndrome, also known as VACTERL association, is a complex condition that affects several parts of the body. VATER (VACTERL) is an acronym that stands for the affected parts of the body including the vertebrae, anus, heart, trachea, esophagus, kidney and limbs.
Congenital disorders can be defined as structural or functional anomalies that occur during intrauterine life. Also called birth defects, congenital anomalies or congenital malformations, these conditions develop prenatally and may be identified before or at birth, or later in life. An estimated 6% of babies worldwide are born with a congenital disorder, resulting in hundreds of thousands of associated deaths. However, the true number of cases may be much higher because statistics do not often consider terminated pregnancies and stillbirths.
Some congenital disorders can be treated with surgical and non-surgical options, such as cleft lip and palate, clubfoot and hernias. Others, including heart defects, neural tube defects, and down syndrome, can cause lifelong impacts.
Congenital disorders are one of the main causes of the global burden of disease, and low- and middle-income countries are disproportionately affected. These areas are also less likely to have facilities to treat reversible conditions such as clubfoot, leading to more pronounced and long-lasting effects.
A rectovestibular fistula, also referred to simply as a vestibular fistula, is an anorectal congenital disorder where an abnormal connection (fistula) exists between the rectum and the vulval vestibule of the female genitalia.
If the fistula occurs within the hymen, it is known as a rectovaginal fistula, a much rarer condition Colostomy is recommended by most surgeons, and has a good prognosis, with 90% of patients regaining normal bowel control. Since the rectal opening and anal orifice in a vestibular fistula tend to be short and narrow, a colostomy is usually performed to allow decompression of the bowel unless the orifice is wide enough to allow normal defecation. Colostomy is often followed by posterior sagittal anorectoplasty (PSARP), a surgical procedure to repair the anal orifice, at a later date. Some surgeons prefer to perform an immediate PSARP without a colostomy first, while others perform neither a colostomy nor a PSARP and instead opt for a simple dilatation of the orifice to allow stool to pass and the bowel to decompress. It has been suggested that only experienced surgeons should perform repair without an initial colostomy.
Now the question arises why did a party failed to diagnose these complexes or complications before delivery. Is it possible to know about the complications of a child in womb.
Ultrasound was introduced in clinical practice in obstetrics and gynecology in 19581 and has completely changed the way obstetric care is provided, allowing for antenatal detection of major fetal abnormalities and placenta-related disorders. This rapidly evolving field has led to the description of a series of sonographic signs of fetal abnormalities in the second trimester2. Following the technological advances and improvements in imaging resolution in recent years, a clear shift toward early detection of fetal malformations and pregnancy complications at 11-14 weeks' gestation was seen, to the point that a detailed morphology assessment of the fetus at this early stage has now become routine practice and has high detection rates for the majority of major structural defects3-6.
Traditionally, early first-trimester pregnancy ultrasound is performed to confirm a viable intrauterine pregnancy, to identify the number of embryos and to rule out ectopic pregnancy. In multiple pregnancy, chorionicity can be determined accurately at an early stage based on the number of gestational sacs seen; however, determination of amnionicity in monochorionic pregnancy may be challenging7 due to the difficulty in visualizing the thin intertwin membrane, particularly before 8 weeks' gestation.
Due to the increasing uptake of transvaginal ultrasound, the development of high-frequency transvaginal probes and our improved understanding of embryological pathophysiology, it is now possible to detect fetal malformations before 11 weeks' gestation. In addition, acquisition of three-dimensional (3D) volume blocks facilitates visualization of a growing number of major embryonic and early fetal defects. Recent data also suggest that early markers of aneuploidy at 8-10 weeks, including increased nuchal fluid, skin edema, hydrops and hydrothorax, may prove valuable in identifying fetuses at risk of both chromosomal and structural abnormalities8.
The unprecedented uptake and rapid clinical introduction of cell-free DNA (cfDNA) analysis, which has very high accuracy in screening for trisomies 21, 18 and 13, have led to an ever increasing uptake of pretest ultrasound scans performed at 6-10 weeks of gestation. The purpose of such a scan is, first, to confirm the gestational age, and second, to rule out situations in which the test should not be performed, namely miscarriage and the presence of a vanishing twin. This shift in the algorithm of antenatal screening now creates a window of opportunity for early screening and diagnosis of fetal anatomical defects by experienced ultrasound specialists. Early suspicion of lethal or severe fetal abnormalities allows not only for change in the diagnostic pathway (e.g. invasive genetic testing in preference to cfDNA), but also for timely reproductive choices and optimized clinical management. In these patients, early decision-making has the additional benefit of being associated with lower long-term psychological morbidity9.
In this Opinion, we illustrate two-dimensional (2D) and 3D ultrasound images of pregnancies with fetal abnormality identified between 6 + 0 and 10 + 6 weeks of gestation.
Image acquisition The detection of fetal abnormalities before 11 weeks of gestation relies not only on the experience of the operator but also on using high-resolution probes and transvaginal imaging. Use of different modalities of 3D ultrasound may also increase the diagnostic accuracy.
Here, images of normal embryonic (up to 9 + 6 weeks' gestation) and fetal (from 10 + 0 weeks' gestation onwards) development and of suspected defects were acquired in early pregnancy by experienced ultrasound specialists, using both transabdominal and transvaginal ultrasound. In most cases, the diagnosis was either suspected or established at transvaginal examination. In almost all cases, 3D volumes were obtained and either immediately analyzed or stored for later offline analysis. All images were obtained by one of the authors during routine viability examinations or pre-cfDNA testing ultrasound, in specialized ultrasound clinics in Melbourne, Australia, in Nice, France, or in the Principality of Monaco. All ultrasound images were obtained using Voluson E8 or E10 (GE Healthcare, Zipf, Austria) ultrasound systems, equipped with real-time high-frequency transabdominal curvilinear probes (4-8 MHz and 5-9 MHz), linear probes (9 MHz) and high-frequency transvaginal 3D/4D volumetric probes (5-9 MHz and 6-12 MHz).
In cases of suspected fetal abnormality, the fetal anatomy was reassessed thoroughly by the same professional at 11-14 weeks in most cases, and the clinical management regarding the method of screening for chromosomal abnormalities often changed (e.g. from cfDNA testing to chorionic villus sampling or amniocentesis). In all cases, the findings were confirmed by follow-up ultrasound examinations later in pregnancy or postnatally by visual inspection of the newborn or postmortem examination.
Normal embryonic and fetal development at 7 + 0 weeks to 10 + 6 weeks' gestation Between 7 and 11 weeks' gestation, the embryo undergoes rapid development and growth (Figure 1), and organogenesis is largely complete by 10 weeks. At 7 weeks of gestational age, the embryo is approximately 10 mm in length, the amnion around it becomes visible, and the head is strongly flexed anteriorly10. By 8 weeks' gestation, the embryo measures around 16 mm and individual body parts can be identified on ultrasound; the head can be distinguished from the trunk and the limb buds can be delineated clearly10, 11. The cranial vesicles and cleavage of the prosencephalon can be appreciated. At 9 weeks, the fetal trunk elongates and straightens, the extremities protrude ventrally and a midgut herniation into the base of the umbilical cord becomes apparent. By 10 weeks, the crown-rump length (CRL) is between 30 and 35 mm, the fetus is distinctly human-appearing, the frontal bones of the skull are ossified, the physiological midgut herniation is evident, the hands and feet are relatively opposed and the digits can be seen10. With the availability of higher-resolution ultrasound probes and improvement of 3D multiplanar techniques of image acquisition, early first-trimester assessment of normal anatomic structures has heralded the development of exciting methods of sonoembryology, allowing evaluation of selected patients at risk for embryonic/fetal malformations and early detection of defects10, 11.
Figure 1 Open in figure viewerPowerPoint 2D (a,c,e,g) and 3D (b,d,f,h) ultrasound images showing normal embryonic development between 7 and 10 weeks' gestation. (a,b) At 7 weeks, crown-rump length (CRL) measures around 10 mm, fetal head is relatively large in relation to trunk, and yolk sac (YS), vitelline duct (VD) and limb buds (arrows) are seen. (c,d) At 8 weeks, CRL is approximately 16 mm and visualization of brain vesicles (D, diencephalon; M, mesencephalon; R, rhombencephalon), spine (S), amnion (A), yolk sac (YS) and vitelline duct (VD) is clearer. (e,f) At 9 weeks, CRL is approximately 24 mm, fetus has more defined human appearance, and there is clear delineation of face and lengthened limbs (arrows). (g,h) At 10 weeks, CRL is around 30 mm, and digits (arrows) and physiological midgut herniation (MH) are clearly delineated.
General major abnormalities Some severe embryonic/fetal abnormalities can be seen as early as 7-8 weeks of gestation. Figure 2 shows 3D sonographic images with rendering mode of conjoined craniopagus twins at 7 and 8 weeks of gestation. Early recognition of this type of severe abnormality allows early reproductive choices and avoids the risks related to late recognition, such as delivery of a large fetal volume which is associated with increased maternal morbidity. Cases of early amniotic rupture that are likely to evolve to amniotic band sequence with fetal disruption and limb amputations can also present in early pregnancy (Figure 3). In the setting of monochorionic twin pregnancy, the occurrence of twin reversed arterial perfusion (TRAP) sequence can at times be detected (Figure 4) facilitating early treatment options including cord occlusion of the acardiac twin.
Figure 2 Open in figure viewerPowerPoint 3D sonographic images with rendering mode showing conjoined twins at 7 (a) and 8 (b) weeks' gestation.
Figure 3 Open in figure viewerPowerPoint 2D ultrasound image of early amniotic rupture at 8 weeks' gestation showing embryonic parts and yolk sac in extracelomic space. Amnion (A) can be identified clearly only close to cephalic extremity, and lower extremity of embryo is morphologically abnormal.
Figure 4 Open in figure viewerPowerPoint 3D ultrasound image of monochorionic twin pregnancy with twin reversed arterial perfusion sequence at 10 weeks' gestation, showing normal twin (left) and acardiac twin (right).
Increased nuchal translucency and subcutaneous edema In a recent series from our group, comprising 104 cases of nuchal or subcutaneous edema and fetal hydrops diagnosed in early pregnancy (unpublished data), the condition resolved in approximately 80% of the cases by the time of the 11-14-week scan. However, the incidence of chromosomal abnormalities and major structural defects in this group was 21.5%, necessitating detailed sonographic examination at 11-14 weeks and changing the screening or diagnostic pathway in many cases. This high rate of adverse pregnancy outcome in cases of early subcutaneous edema is similar to that reported by Votino et al.8. Figure 5 shows cases of nuchal and generalized subcutaneous edema at 10 weeks of gestation.
Figure 5 Open in figure viewerPowerPoint 2D (a) and 3D transparency mode (b) ultrasound images of fetus with increased nuchal translucency (NT) at 10 weeks' gestation (95th percentile for NT at 10 weeks is 2.2 mm). (c) 2D image of fetus with subcutaneous edema at 10 weeks' gestation; amnion (A) and skin (S) should be differentiated to avoid incorrect diagnosis. (d,e) 2D ultrasound images showing coronal (d) and sagittal (e) views of 8-week embryo with bilateral pleural effusions (arrows) inferior to lungs (L).
Central nervous system abnormalities Major abnormalities of the central nervous system can be detected as early as 8 weeks of gestation. High-resolution transvaginal ultrasound imaging and good knowledge of the normal development of the brain cavities between 6 and 10 weeks are key prerequisites for the detection of abnormal brain anatomy in early pregnancy. Figure 6 shows the normal development of the brain cavities (telencephalon, diencephalon, mesencephalon and rhombencephalon) at 8 weeks of gestational age. Since ossification of the frontal bones occurs at 10 weeks' gestation, abnormal and irregular head shape may suggest early stages of acrania-exencephaly-anencephaly sequence (Figure 7)12. In these cases, the amniotic fluid often appears more echogenic than the extracelomic space.
Figure 6 Open in figure viewerPowerPoint 3D virtual stretching demonstrating normal development of fetal brain cavities at 8 weeks' gestation. D, diencephalon; M, mesencephalon; R, rhombencephalon; T, telencephalon.
Figure 7 Open in figure viewerPowerPoint 2D (a) and 3D (b) sonographic images and postmortem image (c) of embryo with crown-rump length of 22 mm and acrania. (d) 2D image showing echogenic amniotic fluid in same case.
The cerebral falx can be seen in its entirety at 8-10 weeks. Other major brain abnormalities, such as alobar holoprosencephaly with fusion of the thalami and of the anterior horns of the lateral ventricles, can be identified at this stage (Figure 8) and early detection has been previously reported13. The association of alobar holoprosencephaly with trisomy 13 and poor neonatal outcomes may change the screening and diagnostic options for the woman, altering the management of the pregnancy. Similarly, in some cases, encephalocele with meningocele can also be detected before 11 weeks (Figure 9). Previous studies have shown an important association between dilated fourth ventricle in the first trimester and chromosomal defects14, and high-resolution transvaginal ultrasound now allows visualization of the posterior fossa spaces and structures. Using 3D rendering with transparency mode, dilatation of the brain cavities can be well visualized, especially dilatation of the fourth ventricle (Figure 10) and lateral cranial ventricles.
Figure 8 Open in figure viewerPowerPoint 2D ultrasound images showing coronal (a) and axial (b) views at 9 weeks' gestation in fetus with alobar holoprosencephaly with absence of cerebral falx (arrow) and fusion of anterior horns of lateral ventricles (V) and of thalami.
Figure 9 Open in figure viewerPowerPoint 2D ultrasound (a) and tomographic ultrasound (b) images showing axial view of fetal head in 10-week fetus with evident encephalocele (E). 4th, fourth ventricle; aos, aqueduct of Sylvius; m, meningocele.
Figure 10 Open in figure viewerPowerPoint
(a) 3D ultrasound image with glass rendering mode showing normal brain cavities in fetus at 9 + 2 weeks' gestation. (b) 2D ultrasound image showing fetus with hydrocephalus at 10 weeks' gestation. (c) 3D ultrasound image with glass rendering mode showing dilated fourth ventricle (4TH) in aneuploid embryo at 9 + 4 weeks.
Spinal defects Before 10 weeks of gestational age, the fetal spine can be seen on ultrasound as hypoechoic parallel lines (Figure 11); after this stage, the ossification process begins. Ossified vertebrae can be identified on ultrasound in coronal view of the spine after 10 weeks, but early diagnosis of spinal dysraphism before 16 weeks through direct visualization of the spine is challenging. The diagnosis of open spina bifida can be suggested by abnormalities of the posterior fossa in both sagittal and axial views of the fetal head5, 15. If a myelomeningocele is prominent in early pregnancy, the defect can be potentially visualized as early as 9-10 weeks (Figure 11), mainly with the use of high-resolution transvaginal ultrasound.
Figure 11 Open in figure viewerPowerPoint
(a) 2D ultrasound image showing normal appearance of embryonic spine at 8 weeks' gestation, appearing as three straight echogenic lines interpolated by two hypoechoic lines. (b) 3D ultrasound image showing prominent myelomeningocele in embryo at 9 weeks' gestation. (c) Postmortem image of fetus with open spina bifida at 10 weeks' gestation.
Heart abnormalities Fetal heart activity can be first identified at 5-6 weeks of pregnancy. The four-chamber view of the heart and the right and left cardiac outflows can be visualized between 8 and 10 weeks' gestation in a large proportion of cases8, particularly in the hands of experienced operators, with the use of high-resolution transvaginal probes and 4D ultrasound modalities, such as spatiotemporal image correlation (STIC) (Figure 12). Major heart defects, such as hypoplastic left heart syndrome, can potentially be seen as early as 10 weeks (Figure 12).
Figure 12 Open in figure viewerPowerPoint
(a) 2D ultrasound image with color Doppler showing four-chamber view of normal fetal heart at 10 weeks' gestation. (b,c) Visualization of right outflow of fetal heart and crossing of right and left cardiac outflows on 3D spatiotemporal image correlation (b) and tomographic ultrasound imaging (c) at 10 weeks' gestation. D, ductus arteriosus; LV, left ventricle; MPA, main pulmonary artery; RV, right ventricle; TAO, transverse aorta. (d) 2D ultrasound image of hypoplastic left heart with asymmetrical ventricles and subcutaneous edema in 10-week fetus.
Abdominal-wall defects Between 9 and 11 weeks of gestational age, physiologic bowel herniation through the base of the umbilical cord is evident and occurs because the growth rate of the intestines is higher than that of the abdominal wall in the embryonic period. This herniation usually resolves by 12 weeks (CRL of 54 mm). The stomach can be visualized by 8 weeks in approximately 80% of the pregnancies8. When the bowel herniation measures more than 7 mm in its largest diameter, or if it persists at the end of 12 weeks, a ventral-wall defect can be suspected16, 17. In the case of omphalocele (or exomphalos), the protruding mass is typically smooth and has a rounded contour since the abdominal contents are contained by the peritoneal membrane. An irregular protrusion is highly suggestive of gastroschisis, in which the bowel loops are not contained by peritoneal membrane and are floating freely in the amniotic cavity. Figure 13 shows a normal fetus with midgut herniation at 10 weeks, along with different abdominal-wall defects including omphalocele, cloacal exstrophy and body-stalk anomaly.
Figure 13 Open in figure viewerPowerPoint
(a) 3D surface-rendered ultrasound image showing physiologic midgut herniation through base of umbilical cord (arrow) in 10-week fetus. (b,c) 2D (b) and 3D (c) ultrasound images of 10 + 4-week fetus with large bowel herniation (> 7 mm), which is likely to persist as omphalocele after 12 weeks. (d) 2D sonographic image (sagittal view) of fetus with cloacal exstrophy at 10 + 6 weeks. (e) 3D ultrasound image showing 8-week fetus with body-stalk anomaly with large abdominal-wall defect and short umbilical cord (UC). (f) 2D ultrasound image showing abnormal embryonic shape in case of omphalocele, cloacal exstrophy, imperforate anus and spinal defect (OEIS) complex at 8 weeks' gestation. CRL, crown-rump length.
Urinary-tract abnormalities The fetal kidneys can be visualized at 9 weeks in approximately 50% of the pregnancies8 and appear as oval echogenic structures on either side of the spine in a coronal view. Utilizing 3D modalities, such as volume contrast imaging (VCI) and glass rendering with transparent minimal mode, may facilitate visualization of the kidneys. The bladder is seen as a small anechoic area within the pelvis and its longitudinal length should measure less than 6 mm in its largest diameter. Gross abnormalities of the abdominal wall and bladder exstrophy can be identified at these early stages (Figure 13). Figure 14 demonstrates a case of patent urachus connecting the bladder with the umbilicus.
Figure 14 Open in figure viewerPowerPoint 2D ultrasound images showing bladder (B) communicating with umbilicus (patent urachus; arrow) in axial view of fetus at 10 + 5 weeks (a) and in sagittal view of same fetus 2 weeks later (b).
Severe limb abnormalities The limb buds are first seen at approximately 7-8 weeks, though visualization of the digits is difficult at this stage. Evaluation of the digits of the feet is challenging given that the soles of the feet are apposed 'en-face' by 9 to 10 weeks, whereas the fingers of the hands are readily identified as the arms are held in a fixed flexed position across the fetal chest and hands are separated at this stage. At times, polydactyly may be evident in early pregnancy (Figure 15). All long bones are identifiable by 10 weeks. Major limb abnormalities, such as ectrodactyly, fusion of the inferior limbs (sirenomelia) and limb absence can be suspected between 9 and 10 weeks of gestational age (Figure 16).
Figure 15 Open in figure viewerPowerPoint 3D ultrasound image of fetus with post-axial polydactyly of foot at 10 + 6 weeks' gestation.
Figure 16 Open in figure viewerPowerPoint 2D (a,c) and 3D (b,d) ultrasound images showing fetus with ectrodactyly (split hand; arrow) at 9 + 4 weeks' gestation (a,b) and fetus with sirenomelia (fused inferior limbs) at 9 weeks' gestation (c,d).
Discussion With the advent of cfDNA testing, women are increasingly opting for pretest ultrasound assessment. High-frequency transvaginal ultrasound screening with 3D/4D technology can provide a definitive diagnosis in cases with certain fetal defects, such as acrania and conjoined twins. In others, a diagnosis may be suspected at 6-10 weeks and subsequently confirmed at 11-14 weeks or later in pregnancy. In patients with a suspected diagnosis of a fetal defect, it may be more appropriate that counseling is in favor of discouraging cfDNA testing and potentially proceeding with re-evaluation of the fetal anatomy at 11-14 weeks with consideration of definitive genetic testing via chorionic villus sampling or amniocentesis. In a study by Vora et al., ultrasound examination prior to cfDNA testing offered to women of ≥ 35 years of age identified findings that could have changed management in 16% of the cases18. Similarly, in a recent review of over 6000 pre-cfDNA scans, we concluded that findings that could potentially lead to change in management are observed in one in 10 pregnancies, and this proportion is even higher in women with advanced maternal age (unpublished data).
An additional benefit of screening before 11 weeks of gestation is the identification of cases with increased nuchal fluid, subcutaneous edema or hydrops fetalis, which comprised 1% of cases in our cohort. Indeed, our data suggest that this group of patients is at high risk of adverse pregnancy outcome and have a 1/5 probability of having an underlying aneuploidy or fetal malformation (unpublished data). Therefore, the introduction of routine early ultrasound screening for all patients may herald a new tier of fetal-malformation and aneuploidy screening in the future.
It is best to obtain maternal blood for cfDNA analysis at 10 weeks' gestation, rather than at 8 or 9 weeks, as the fetal fraction is greater at this time, which lowers the rate of test failure and increases its accuracy. This correlates well with the timing for identification of increased nuchal fluid, subcutaneous edema, fetal hydrops and fetal malformation, which is better at 10 weeks than at 6-9 weeks' gestation in our experience. The proportion of fluid in the amniotic and celomic cavities to fetus is greatest at 6-10 weeks' gestation compared to any other time in pregnancy, and this provides an ideal setting for 3D and 4D volume acquisition and analysis. Furthermore, the fetus is relatively inactive at this early stage when compared to the later stages of pregnancy, which facilitates anatomical review using both 2D and 3D analysis.
However, screening for aneuploidies and fetal abnormalities at 8-10 weeks' gestation needs to be considered with caution, as to date there is limited evidence regarding the detection rate, and many of the organ systems are still undeveloped or too difficult to visualize at this early stage. Moreover, there is no evidence that early pregnancy screening is cost-effective, and future research needs to evaluate carefully whether detection of fetal abnormalities before 11 weeks' gestation is cost-beneficial on a population level. Caution is recommended when a diagnosis is made at a very early gestational age and confirmation of fetal abnormalities later in pregnancy is frequently required, which is of importance as we progress through the learning curve in sonoembryology, just as occurred in the history of ultrasound diagnosis in the mid-trimester and, more recently, in the first trimester at 11-14 weeks. Given that patients may choose surgical termination of pregnancy if a fetal malformation is detected, other grounds for urging caution are that antenatal screening and diagnosis at this early stage may become difficult to audit.
Due to concerns regarding the possible biological effects of ultrasound and tissue heating, practitioners should observe the 'as low as reasonably achievable' (ALARA) principle. Although the increase in temperature seems negligible during first-trimester ultrasonography19, 20, exposure should be kept to the minimum necessary and the output display system should be monitored, aiming to maintain the thermal index below 1.0 (thermal index for soft tissue before 10 weeks and thermal index for bone thereafter)20, 21.
Finally, patients should be counseled with due care, as early identification of a suspected anomaly which requires later confirmation may prolong patient anxiety until a firm diagnosis is achieved in the first or second trimester.
So it is clear that in these complications can be very well known within 10 weeks gestation period as discussed above. Why did opposite party not disclose these abnormalities to the complainant within time. The pregnancy could be terminated in time. It shows that the complainant did not know anything about the complications of the child in womb and opposite party intentionally did not disclose it. In their written statement, the opposite party did not say a single word about these complications. This really shows the negligence of the part of the opposite party. When you're taking sonographic and ultrasound reports regularly, how can it be said that you did not know about these complications of the child in womb. You have no paraphernalia in your nursing home to treat these abnormalities. These abnormalities can come forward in case of test-tube baby and therefore it is your duty to have all these paraphernalia to overcome or treat these complications in time and not to refer the child to some other hospital or specialty Centre for treatment. So in this case we came to the conclusion that there is negligence and carelessness on the part of the opposite party and they failed to exercise due care and caution and timely treatment of the child in womb or after birth. Further the opposite party did not disclose these abnormalities to the father of the child so that he can take decision whether to carry forward with the test-tube baby or to get aborted. We're seeing the picture of the child which is really alarming.
The opposite party has cited the case law Senthil Scan Centre Vs the Shanthi Sridharan &Anr , III (2011) CPJ 54 (SC) , in which the Hon'ble Supreme Court has said, "The complaint filed by the respondent alleged that the deformity in question could have been cited by the doctor conducting the ultrasound but was not so detected on account of negligence on his part. The State commission accepted that version and awarded a sum of Rs.5 Lacs to the complainant holding that there was indeed a deficiency in service provided by the Centre. The National Commission dismissed the appeal preferred by the Centre and upheld the award made against it."
The Hon'ble Supreme Court has further said "it is common ground that the claimant had not placed any material on record in support of her case that the deformity could have been cited between second and third trimester. The claimant's case was entirely based on her own and assertion that the detection of the deformity was possible. There is also no evidence as to how this scan centre of the respondent number 2 did not do what ought to have been done or did something which a doctor possessing ordinary skill ought to have done. No expert evidence was led in to show that the scans conducted were not as per the medical norms or that the Centre was not properly equipped. The commission is also failed to appreciate that ultrasound is not a perfect depiction of the foetus and the scan result cannot be 100% conclusive. It is often difficult to examine some fatal areas. Difficulties may also be posed by the relative paucity of amniotic fluid in the third trimester, the hyper- flexed position of the foetus engagement of the head or compression of some fatal parts. An additional factor may be maternal of the city, which can make sonographic evaluation difficult at any time during pregnancy."
But in this case, the relief has not been sought against the scan Centre but against the nursing home doing test-tube baby procedure. The opposite party did not say a word in its written statement regarding these deformities. The opposite party did not file the BHT or case history of the complainant. We have discussed above that within 10 weeks, deformity or complication of the child in womb can be detected and it was the duty of the opposite party, who is a well qualified doctor, to know about it by different kinds of tests necessary for the test-tube baby. Thus, we see the deficiency on the part of the opposite party as well as negligence and carelessness on the part of the opposite party.
The complainant has prayed some reliefs and also prayed any other relief which this Hon'ble Commission may deem fit and proper in the circumstances of the case may also be awarded. In the said we are of the pain that a lump-sum amount of Rs.20 lakhs should be awarded for the mental agony and harassment, mental torture, depression. So we are of the opinion that the complainant is entitled for the following reliefs:
Rs.2,55,000/- towards expenses incurred in the IVF treatment, Rs.15 lakhs for future treatment of baby of the complainant, Rs.20 lakhs as compensation and damages for the negligence and Rs.20 lakhs towards mental agony torture, depression, cost of the suit. The complainants are will also be entitled to get interest on the amounts as per order.
ORDER 1- The opposite party is directed to pay Rs.2,55,000/- to the complainant towards expenses incurred in the IVF treatment of complainant no.2, with interest at a rate of 10% from 11.01.2017 within 45 days from the date of judgment of this complaint case otherwise the rate of interest shall be 15% from 11.01.2017 till the date of actual payment.
2- The opposite party is directed to pay Rs.15 lakhs to the complainants towards future treatment of the baby with interest at a rate of 10% from 11.01.2017 within 45 days from the date of judgment of this complaint case otherwise the rate of interest shall be 15% from 11.01.2017 till the date of actual payment.
3- The opposite party is directed to pay Rs.20 lakhs to the complainant towards compensation and damages with interest at a rate of 10% from 11.01.2017 within 45 days from the date of judgment of this complaint case otherwise the rate of interest shall be 15% from 11.01.2017 till the date of actual payment.
4- The opposite party is directed to pay Rs.20 lakhs to the complainant towards mental agony, torture, depression, harassment, cost of the suit with interest at a rate of 10% from 11.01.2017 within 45 days from the date of judgment of this complaint case otherwise the rate of interest shall be 15% from 11.01.2017 till the date of actual payment.
All the amounts are to be paid within 45 days from the date of judgment of this complaint case otherwise the rate of interest shall be 15% from 11.01.2017 till the date of actual payment.
If the order is not complied with, within 45 days from the date of judgment of this complaint case, the complainant shall be entitled to file execution case before this court on the cost of the opposite party.
The stenographer is requested to upload this order on the Website of this Commission today itself.
Certified copy of this judgment be provided to the parties as per rules.
(Sushil Kumar) (Rajendra Singh) Member Presiding Member Judgment dated/typed signed by us and pronounced in the open court. Consign to Record Room. (Sushil Kumar) (Rajendra Singh) Member Presiding Member Dated March 15 , 2023 JafRi, PA I, Court 2 [HON'BLE MR. Rajendra Singh] PRESIDING MEMBER [HON'BLE MR. SUSHIL KUMAR] JUDICIAL MEMBER