Newborn delivered with down syndrome: Consumer Forum exonerates Assisted Reproductive Technique Specialist

The President of the Commission Justice R.K. Agrawal and member Dr. S.M. Kantikar opined in the judgment dated 01.04.2021 that from the perusal of the medical records it would be clear that "counselling of the couple was done and advised for the invasive tests for prenatal diagnosis of Down's syndrome."

Giving the doctor relief the Commission noted in the judgment, "She had a previous missed abortion and after genetic counselling, she did not opt for the invasive investigations to avoid miscarriage or losing the existing pregnancy."

Also Read: No Need of Dialysis: Consumer Court grants relief to hospital, its three doctors

The case concerned a married couple who failed to conceive for about 15 years. Thus, after many failed attempts at treatment, the couple approached the treating doctor, a specialist in Assisted Reproductive Technique, at the Madras Medical Mission, Chennai.

At first, the doctor suggested In-Vitro Fertilization treatment but when the procedure failed twice for the couple, the doctor advised trying for Intra-Uterine Insemination (IUI). In the year 2001, during the 1^st cycle of IUI, the patient conceived but unfortunately, it resulted in missed abortion. In April 2002, during the 2^nd IUI cycle, the patient conceived again and it was twin gestation pregnancy, confirmed by Ultra-Sonography (USG). However, at the 5^th week of pregnancy, one embryo got destroyed internally – known as 'the vanishing twin syndrome'. The surviving embryo was monitored as a singleton pregnancy. However, when the baby was born to the couple, she was diagnosed with Down's syndrome.

Submitting that the child born with Down's syndrome carries various risks and a wide range of medical problems, and the medical cost in bringing up the child with Down syndrome would be huge, the couple approached the Commission and filed a Consumer Complaint praying for compensation of Rs. 2.5 Crores from the treating doctor and the hospital.

The couple alleged that although the doctor performed Nuchal Translucency (NT) to rule out the possibility of Down's syndrome, NT scan was not a diagnostic test for Down's syndrome and being super-specialty hospital, the doctors did not follow the standard procedures to manage such high-risk pregnancy.

It was further alleged by the couple that the treating doctor failed to provide genetic counselling to the couple as it was elderly pregnancy with previous history of missed abortion. Certain diagnostic tests like Amniocentesis or Cordocentesis for detection of Down's syndrome were not advised. They further contended that although the USGs were done by the Sonologist, the doctor being the Medical Director would be responsible in her personal capacity for the negligence.

The Counsel for the Complainants further submitted that the doctor didn't inquire about the past family history wherein the first cousin of the patient had a 15 years daughter with Down syndrome.

On the other hand, denying all these allegations the doctor submitted before the Commission that after the couple conceived she had advised genetic screening/ invasive techniques (CVS, amniocentesis and Cordocentesis) to confirm karyotyping. She further informed the couple that there were 1 in 100 chances of Down's syndrome and in the event of invasive investigation/procedures, the chance of losing the pregnancy was 1 in 100.

She further informed the Commission that as the final call was of the couple, they were happy with the long-awaited pregnancy after 15 years and they decided to continue the pregnancy without invasive procedures. This had been written on the medical prescription by the doctor as 'decided to leave, things all alone'.

The doctor further submitted that Nuchal Translucency (NT) scan was done at 11 weeks gestation, it was 1.4mm wherein the cut-off level of 2.5 mm for further evaluation. The option for Triple test was there but it was not the correct screening because the patient was conceived after ART which involved use of gonadotropins. During antenatal period the doctor also performed detailed anomaly fetal scan twice and found no obvious anomalies. The counsel for the doctor further submitted that the couple denied undergoing Triple Test.

After listening to all the contentions by both the parties, the Commission further looked at the Medical Record which showed that the patient signed 'Patient Protocol for IVF Form' on 13.11.2000, wherein it was clearly mentioned that she was given suitable opportunities to take part in counseling about the implications of the proposed treatment. The invasive techniques and Karyotyping were discussed.

The Medical Record further mentioned that in view of the advanced maternal age NT/Triple Screen was suggested, however the couple ' decided to leave things alone, patient did not agree for invasive procedures '. The Commission also noted that the couple suppressed the vital information that the daughter of patient's first cousin of about 15 years of age was detected with Down's syndrome.

The Commission also perused expert opinion from the Medical Board, AIIMS, New Delhi. It mentioned-

"1. Triple screening was suggested in view of her advance maternal age (Page 90) but the treatment record does not reveal any documentation of test being performed or laboratory report of the triple screen test.

2. Patient treatment record (Page 86) dated 18 June 2012 reveals that invasive techniques to confirm karyotyping was discussed – CVS/Amnio-cordocentesis but no follow-up could be traced in the records.

Thus, it confirms the treating doctor suggested triple screening which the patient did not do."

From the perusal of all these Medical Records and Expert Opinion, the Commission opined that "the patient was conceived after 15 years of infertility, it was, thus, precious pregnancy. She had previous missed abortion and after genetic counseling, she did not opt for the invasive investigations to avoid miscarriage or losing the existing pregnancy."

Further mentioning that during the year 2002, the treating doctor tried her best to attempt the diagnosis of Down's syndrome, the Commission further noted,

"It was the limitation of the screening test and quality of the then-available USG machines in India, which showed drastic changes and advancement in the last decade. The much higher performance can be achieved when ultrasound is combined with concurrent first-trimester four-marker biochemistry."

The Commission also referred to the Supreme Court judgment in Kusum Sharma and others v. Batra Hospital and Medical Research Centre and Others. There the Apex Court mentioned,

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

Again the Commission referred to Achutrao Harbhau Khodwa Vs. State of Maharashtra case where the Supreme Court mentioned,

"The skill of medical practitioner differs from doctor to doctor. The nature of the profession is such that there may be more than one course of treatment which maybe advisable for treating a patient. Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution. Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession and a court finds that he has attended on the patient with due care skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence."

Thus, noting that "the couple is highly qualified and had adequate knowledge of various methods and the pros & cons of Assisted Reproductive Techniques" and the medical record that mentioned that "counseling of couple was done and advised for the invasive tests for prenatal diagnosis of Down's syndrome" the Commission gave relief to the doctor finding no negligence committed by the treating doctor.

To view the original court order, click on the link below.