ARTICLE
28 October 2024

Penalization Of Assisted Reproductive Techniques (ART) Centres For Medical Negligence

SR
S.S. Rana & Co. Advocates

Contributor

S.S. Rana & Co. is a Full-Service Law Firm with an emphasis on IPR, having its corporate office in New Delhi and branch offices in Mumbai, Bangalore, Chennai, Chandigarh, and Kolkata. The Firm is dedicated to its vision of proactively assisting its Fortune 500 clients worldwide as well as grassroot innovators, with highest quality legal services.
Infertility affects about 10-15% of couples worldwide1, and since it gives hope to infertile couples of giving birth and nurturing their own biological child...
India Food, Drugs, Healthcare, Life Sciences

Infertility affects about 10-15% of couples worldwide1, and since it gives hope to infertile couples of giving birth and nurturing their own biological child, there has been an increase in the use of Assisted Reproductive Technology (ART) for the same. In recent decades, India has seen a tremendous increase in ART clinics and ART banks, and with this comes the need for strict supervision regulation and penalization of these ART centres so as to safeguard the rights of the patient undergoing treatment and to ensure that innocent infertile couples receive proper treatment.

One such case was highlighted in the matter of X & Anr. vs Bhatia Global Hospital & Endosurgery Institute & Ors.2, which involved many burning issues like medical ethics, unfair practices and misleading advertisement as noted by the Hon'ble National Consumer Disputes Redressal Commission.

Factual Matrix

In 2008, the couple, on advice of one of the Opposite Party doctors, approached the hospital for Intra Cytoplasmic Sperm Injection (ICSI) procedure which involves injecting a live sperm into a person's eggs in a laboratory. The hospital's doctors assured the couple about the success of the procedure. Accordingly, the couple got admitted in the month of October 2008 and the procedure lasted for 2 days. Thereafter, in the month of June 2009 the mother gave birth to female twins, however to the couple's shock, the blood group of one of the twins was AB (-ve) which could not have been possible as the blood group of the parents was B(+ve) and O(-ve). On conduction of the paternity test (DNA Profile) it was found that Complainant No. 2 was not the biological father, and aggrieved by this the couple approached the Hon'ble Commission with the present consumer complaint alleging negligence and deficiency in services giving rise to emotional distress, family discord, fear of genetically inherited diseases etc.

The opposite parties filed their replies denying negligence during the treatment, and resorted to cross-allegations between themselves, pointing fingers at each other to shift the blame.

Res Ipsa Loquitor: The Thing Speaks for Itself

The Hon'ble Commission, considering the entirety, noted that the present complaint is of Res Ipsa Loquitor. The opposite parties were collectively involved in the ART procedure, and it was not a case of error of judgment by the treating doctors, but unfair trade practices adopted by the Opposite Parties.

On the issue of who had actually done the alleged mixing of sperms, the Commission noted that the stand taken by the opposite parties appears to be hypothetical, lacking any cogent evidence, and it proves that no standard procedures were followed by opposite parties.

Compensation

In regard to compensation, the Commission observed that it is necessary to consider the ripple effects of gross negligence of the hospital. The couple was eager and anxious to have a child and the entire purpose of opting for ART was to have a good outcome. The negligence of the opposite parties has led to severance of genetic link between the parents and their children. Apart from its impact on several social and ethical issues, the medical history, future genetic disorders and lifestyle is also a cause of concern.

Placing reliance on the judgments passed by Hon'ble Supreme Court in Sarla Verma & Ors. vs Delhi Transport Corp. & Anr.3 and Dr. Balaram Prasad vs. Dr. Kunal Saha & Ors,4 the Hon'ble Commission noted that the twin babies are of 14 years now and healthy, and the parents have incurred the expenses in their upbringing. Due to uncertainty about quality of the sperm and its genetic profile, the possibility of genetic disorders cannot be ruled out. Therefore, the Commission fixed a total lump sum liability of Rs. 1.5 Crore against the opposite parties, out of which Rs. 1.3 Crore was awarded to the Complainants which was to be kept in a fixed deposit account named after the twins, in equal proportion till they attain the age of majority.

The Commission also observed that mushrooming of ART clinics has led to incorrect treatment being administered to the patients, and incorrect protocols are being used purely for commercial interests without taking into consideration that administration of incorrect treatment further increases emotional and financial distress experienced by the infertility patients. The opposite party hospital was duty bound to provide quality services, but they indulged in misleading advertisement to allure the anxious infertile couples for ART adopting unethical practices and is therefore liable for negligence and unfair trade practices.

Assisted Reproductive Technology (Regulation) Act, 2021

Taking cognizance of the rampant growth of ART clinics, ART banks and unethical practices being resorted by them, the parliament in December 2021 passed the Assisted Reproductive Technology (Regulation) Act, 20215 to regulate the functioning of the clinics and banks in the country. Before this Act, the clinics and banks were governed by guidelines issued by ICMR, and state accredited authorities had the power to penalize ART clinics for any violation of ICMR Guidelines. Further, the Act also deals with the controversial treatment of surrogacy and ensures that the rights of the surrogate mothers are protected.

It provides for a National and State Board to regulate assisted reproductive technology, and mandates that every ART clinic and bank must be registered with National Registry of Clinics and Banks. Registration will be granted only if there is an adherence to certain standards i.e. specialized experts, infrastructure and standard diagnostic facilities.

Therefore, the passing of the Act is a step in the right direction that will help in regulation and smooth functioning of ART clinics and banks, and in turn, protect the rights of infertile couples.

Shubham Tripathi, Former Associate at S.S. Rana & Co. has assisted in the research of this article.

Footnotes

1. Vander Borght M, Wyns C. Fertility and infertility: Definition and epidemiology. Clin Biochem, 2018:622.10.

2. X & Anr. vs Bhatia Global Hospital & Endosurgery Institute & Ors. C.C. No. 14 of 2010

3. Sarla Verma & Ors. vs Delhi Transport Corp. & Anr. 2009 (6) SCC 121

4. Dr. Balaram Prasad vs. Dr. Kunal Saha & Ors, (2014) 1 SCC 384

5. Act No. 42 of 2021

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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