No Negligence in IVF Procedure- Consumer Court Exonerates Kerala Hospital, Doctor
New Delhi: The National Consumer Disputes Redressal Commission (NCDRC) recently exonerated a Thiruvananthapuram-based hospital and its doctor from charges of medical negligence while treating a patient, who was undergoing the In-vitro fertilization (IVF) procedure.
Upholding the State Commission's order, which had also dismissed the complaint, the Apex Consumer Court noted that the patient was not admitted to the hospital at the time of death and she was administered the injection by a third-party clinic on the day of her death.
The history of the case goes back to 2003 when the complainant along with his wife approached the treating hospital seeking assistance in conception after around 11 years of marriage.
After due counselling and tests, the IVF was mutually decided upon and accordingly treatment commenced after 2 1/2 years. On the second attempt at IVF, embryo transfer was done on 19.04.2006 as per the BETA-HCG blood test prescribed by the treating doctor and the results were positive. After 22 days, during which a period of complete bed rest was prescribed by the doctor, the petitioner's wife was administered an estrogen and progesterone (Progenova) injection. She was also advised to walk.
The complainant alleged that due to this, the patient collapsed soon after and died. The cause of death was mentioned to be "Pulmonary Embolism" in the post-mortem report dated 12.05.2006. It was also held that the deceased was not pregnant at the time of death.
Approaching the consumer court, the complainant alleged deficiency in service and negligence on the part of the doctor in providing proper care and failing to advise her properly regarding the required precautions.
While considering the matter, the State Commission recorded the expert evidence mentioning that the patient suffering from Deep Vein Thrombosis (DVT) was also not ruled out. Accordingly, the State Commission dismissed the complaint after hearing both sides and noting, "...the deceased was never an inpatient in the hospital of the opposite parties. The death occurred while she was at the residence of the complainant and probably, she never took bed rest. Oestrogen which is the component of Progenova is a hormone naturally produced in the ovaries of the female. It is administered only when there is deficit production of oestrogen to regulate the reproductive cycle. Show administration of this medicine is the accepted treatment procedure to correct infertility problems. Not only the opposite parties, any other doctor treating similar problems would have administered only this medicine."
"Several factors influence the development of DVT and consequent pulmonary embolism including the predisposition of the patient and the evidence is that often silent DVT and silent pulmonary embolism can develop. So, on an appreciation of the entire evidence available we have no hesitation to hold that the complainant has miserably failed to establish that there was any deficiency in service or error in treating the wife of the complainant. So, the complaint should fail," the State Commission had observed.
Challenging the State Commission's order, the complainant approached the NCDRC bench and demanded Rs 50 lakh as compensation. He argued that the treating doctor, Chief Physician of the treating hospital, had been negligent in not properly administering the medicines and maintaining post-medical care which caused his wife's death.
It was contended that the medicines, Estrogen and Progesterone should have been immediately stopped as the pregnancy was negative as per the BETA-HCG test. The failure of the doctor and hospital to discontinue the injection when the BETAHCG test was found to be negative was evidence of medical negligence, he argued.
Further, the complainant alleged that due to the lack of proper medical advice regarding the dos and dont's while under treatment, the patient was made to abruptly walk after the injections leading to Pulmonary Embolism. It was contended that fertility treatment increases the risk of blood clots in women and in this case, it was a consequence of the IVF treatment that was being provided to his wife. He also claimed that no medication was prescribed to dissolve the blood clot.
He also argued that even though the State Commission concluded that the patient died due to DVT, the post-mortem report stated clearly that it was due to pulmonary embolism. He argued that even if DVT was to be accepted as the cause, it was due to the doctor's instructions to continue with the medication after the pregnancy failed.
Apart from this, the complainant also relied on the post-mortem report mentioning that the deceased was not pregnant indicating that the embryo transfer was a failure.
On the other hand, the hospital and doctor denied that the pros and cons of the IVF treatment were not explained to the petitioner and his wife as they had undergone multiple rounds of counselling and were also provided with an information brochure for couples opting for IVF-ICSI-ET treatment which provided the details of the procedures and the associated risks.
They contended that as per the established protocol and standard of care for IVF involving intra cytoplasmic injection technique Oestrogen hormone through Progynova tablets and natural sterone through Gestone 100 mg tablets) were prescribed. BETA- HCG test was prescribed after 14 days. The same protocol had been followed in March 2005 with no adverse effects.
Further, they pointed out that the patient was not an in-patient with the hospital since in-patient facility was not available at the hospital till the end of 2006. The complainant also admitted that the injection was administered by a third party, Upasana Clinical, on the day of the patient's death, argued the hospital and doctor.
Apart from this, they also highlighted that the post-mortem indicated that the cause of death was pulmonary embolism while the evidence indicated that there needed to be pre-conditions for DVT which leads to pulmonary embolism. While admitting that pregnant women could develop it, they argued that pulmonary embolism was linked to medical symptoms and the incidence of pulmonary embolism was very low- of about 2 to 3 cases per 10,000 IVF cases. However, DVT was rare and could occur without symptoms for which the protocol does not prescribe daily scans.
While considering the matter, the NCDRC bench noted that the law relating to what constitutes medical negligence has been laid down by the Supreme Court in the case of Jacob Mathew Vs. State of Punjab & Anr. The Commission further noted that the test for medical negligence is based on the deviation from normal medical practice.
"In a claim of medical negligence, it was essential to establish that the standard of care and skill was not that of the ordinary competent medical practitioner exercising an ordinary degree of professional skill. For negligence to be actionable, it was held that it has to be attributable and the three essential components of “duty”, “breach” and “resulting damage” need to be met..." noted the consumer court.
"The essential components of negligence, as recognized, are three: existence of a duty to take care, which is owed by the defendant to the complainant; failure to attain that standard of care, thereby committing a breach of such duty; and “resulting damage”, which is both casually connected with such breach and has been suffered by the complainant. If these three ingredients are made out on the basis of evidence, the defendant should be held liable in negligence," it further observed.
NCDRC also relied on the Supreme Court orders in the cases of V. Kishan Rao Vs. Nikhil Super Speciality Hospital & Anr., and n Indian Medical Association vs V.P. Shantha & Ors.,
In this case, the Commission noted that the petitioner could not establish medical negligence due to the breach of duty of care or negligence attributable to the doctrine of res ipsa loquitur.
"It is evident that the deceased wife of the petitioner was not admitted in respondent no.1 hospital at the time of death. There is no evidence to establish that the hospital or its personnel were in any way liable for the demise of his wife," noted the Commission.
"The patient was also administered the injection by a third party according to the respondent which was not denied by the petitioner. While the report of the post-mortem states that the cause of death was “pulmonary embolism” it has not been established through evidence to be attributable to any act of commission or omission on part of the respondents. Therefore, the contentions of the petitioner cannot be sustained," it further observed.
Accordingly, the top consumer court upheld the State Commission's order and noted, "In view of the foregoing, we find no grounds that warrant our interference to disturb the finding of the State Commission and consequently hold that this first appeal is liable to fail. Accordingly, the appeal is dismissed and the order of the State Commission is affirmed with no order as to costs."
To view the order, click on the link below:
https://medicaldialogues.in/pdf_upload/ncdrc-no-medical-negligence-262253.pdf
