NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION
Sailesh Munjal & Anr. … Complainants
All India Institute of Medical Sciences & Ors. … Opposite Parties
HON’BLE MR. JUSTICE M.B.SHAH, PRESIDENT
MRS. RAJYALAKSHMI RAO, MEMBER.
MR. B.K.TAIMNI, MEMBER.
HON’BLE MR. JUSTICE K.S.GUPTA, MEMBER.
HON’BLE MR. JUSTICE S.N.KAPOOR, MEMBER.
For the Complainants : Mr. M.K.Dua, Advocate.
For the Opposite Parties : Mr. Mukul Gupta, Mr. Ekram Ali,
Mr. Ankur Jain, Advocates.
Date : 20th May, 2004
The questions that require determination in this Original Petition are:
(a) Whether a complaint against the All India Institute of Medical Sciences (AIIMS) and the Doctor who carried out investigation is maintainable under the provisions of the Consumer Protection Act, 1986?
(b) Whether there was any deficiency in service by the concerned Doctor in extracting DNA from chorionic villus samples and sending the DNA to Dr.John M.Old, Consultant of National Centre for Haemoglobinopathies Institute of Molecular Medicine, Oxford, U.K for confirming as to whether the baby in the womb is suffering from Thalassaemia Major?
The main contentions of the Complainants are that (i) had the Opposite Party No.2 been careful enough and separated the contaminated mother’s tissue, and (ii) had Dr.John M. Old been vigilant before analysing the sample – the erroneous foetus diagnosis report could have been averted, and consequently the Complainants would not have gone ahead with the pregnancy. This lapse on the part of the Opposite Parties has resulted in onerous duties to the Complainants (parents) costing lakhs of rupees for the life time of the child. It is contended that the services rendered by the Opposite Parties are faulty, imperfect and inadequate in quality, hence compensation for a sum of Rs.1,95,00,000/- under different heads is claimed.
Re: Whether complaint under the Consumer Protection Act, 1986 (hereinafter referred to as ‘the Act’) is maintainable against the AIIMS?
A preliminary contention is raised that complaint against the AIIMS and the doctors who render their services is not maintainable under the provisions of the Act. It appears that there is some misconception about the implication of the Act. It should be properly understood that the Act does not create any new rights, liabilities or obligations. It has only constituted an additional forum for the benefit of consumers for speedy remedy and relief. Under the law, medical practitioners working either in private, public or in Government hospital were and are liable for negligence in discharge of their duties. The remedy is to approach the civil court. In addition to that remedy, apart from civil court, additional forum is constituted in favour of consumers who are covered by the definition clauses ‘consumer’ and ‘service’.
It is submitted that the Opposite Party No.1 is an autonomous body created by the Act of Parliament, called the AIIMS Act, 1956, and is an institution of national importance. Reference is made to the statement of objects and reasons which, inter alia, provide that it is established for improving professional competence among medical practitioners, to place a high standard of medical education, both post graduate and graduate, before all medical colleges and other allied institutions in the country; and that the institute is to develop patterns of teaching in medical education and also to carry out medical research on various aspects. It is, therefore, contended that the institute is established for the educational and research purposes as provided in Sections 13 and 14 of the AIIMS Act. Hence, it is submitted that the decision rendered by the Apex Court in the case of Indian Medical Association Vs. V.P.Shantha & Ors. (1995) 6 SCC 651 would not be applicable.
For appreciating the said contention we would refer to relevant part of discussion and conclusions in V.P.Shanta’s case. In the said case the Court has specified ‘in which set of circumstance services rendered by the medical practitioner would not be considered to be covered by the provisions of Section 2(1)(o) of the Act’, and ‘in which cases services rendered by the Government Hospitals would be or would not be covered by the provisions of the Act. In view of Section 2(1)(o) which provides that service does not include the rendering of any service free of charge’, the Court divided hospitals and nursing homes in three categories.
(i) where services are rendered free of charge to everybody availing of the said services ;
(ii) where charges are required to be paid by everybody availing of the services ; and
(iii) where charges are required to be paid by persons availing of services but certain categories of persons who cannot afford to pay are rendered service free of charges.
For the first category the Court held that Doctors and Hospitals who render service without any charge whatsoever to every person availing of services would not fall within the ambit of service contained in Section 2(1)(o) of the Act; the payment of token amount for registration purposes only would not alter the provision in respect of such doctors and hospitals. For the second category, there could not be any dispute and it was held that it would clearly fall within the ambit of Section 2(1)(o) of the Act. For the third category, the Court observed thus:
“The third category of doctors and hospitals do provide free service to some of the patients belonging to the poor class but the bulk of the service is rendered to the patients on payment basis. The expenses incurred for providing free service are met out of the income from the service rendered to the paying patients. The service rendered by such doctors and hospitals to paying patients undoubtedly falls within the ambit of Section 2(1)(o) of the Act.”
Thereafter, the Court pertinently held thus:
“All persons who avail of the services by doctors and hospitals in category (iii) are required to be treated on the same footing irrespective of the fact that some of them pay for the service and others avail of the same free of charge. Most of the doctors and hospitals work on commercial lines and the expenses incurred for providing services free of charge to patients who are not in a position to bear the charges are met out of the income earned by such doctors and hospitals from services rendered to paying patients. The government hospitals may not be commercial in that sense but on the over all consideration of the objectives and the scheme of the Act, it would not be possible to treat the government hospitals differently. We are of the view that in such a situation, the persons belonging to “poor class” who are provided services free of charge are the beneficiaries of the service which is hired or availed of by the “paying class”. We are, therefore, of the opinion that service rendered by the doctors and hospitals falling in the category (iii) irrespective of the fact that part of the service is rendered free of charge, would nevertheless fall within the ambit of the expression ‘service’ as defined in Section 2(1)(o) of the Act. We are further of the view that persons who are rendered free service are the ‘beneficiaries’ and as such come within the definition of ‘consumer’ under Section 2(1)(d) of the Act”.
The relevant conclusions (para 55) are as under:
(1) Service rendered to a patient by a medical practitioner (except where the doctor renders service free of charge to every patient or under a contract of personal service), by way of consultation, diagnosis and treatment, both medicinal and surgical, would fall within the ambit of ‘service’ as defined in Section 2(1)(o) of the Act. …….
(5) Service rendered free of charge by a medical practitioner attached to a hospital/nursing home or a medical officer employed in a hospital/nursing home where such services are rendered free of charge to everybody, would not be ‘service’ as defined in Section 2(1)(o) of the Act. The payment of a token amount for registration purpose only at the hospital/nursing home would not alter the position; ……
(9) Service rendered at a government hospital/health centre/dispensary where no charge whatsoever is made from any person availing of the services and all patients (rich and poor) are given free service – is outside the purview of the expression ‘service’ as defined in Section 2(1)(o) of the Act. The payment of a token amount for registration purpose only at the hospital/nursing home would not alter the position;
(10) Service rendered at a government hospital/health centre/dispensary where services are rendered on payment of charges and also rendered free of charge to other persons availing of such services would fall within the ambit of the expression ‘service’ as defined in Section 2(1)(o) of the Act, irrespective of the fact that the service is rendered free of charge to persons who do not pay for such service. Free service would also be ‘service’ and the recipient a ‘consumer’ under the Act.” ………….
Keeping the aforesaid principles in mind, it cannot be disputed that apart from registration fee, Respondent institute recovers various amounts such as Hospital charges, Diagnostic charges etc. from the patients.
This is admitted in the affidavit dated 10th December, 2003, filed by Dr. P.Venu Gopal, Director, the AIIMS. It has been pointed out that every year millions of people receive treatment in the AIIMS. The medical services at the AIIMS are free of charge. All routine pathology tests are done free of cost. However, cost of the consumables used in other complicated or the costly tests, such as cost of diagnostic kits, reagents, X-ray/CT films, contrast media, chemicals, dyes, oral/IV, are taken from the patients admitted to private ward; that only at Cardio Neuro Centre package charges are taken from the patients admitted in the general ward. In the private ward charges are taken only to cover the minimal costs. To the patients admitted to general ward samples are made available at a very minimal cost, i.e. almost free of charge. There is no question of making profit. However, the patients admitted to the private ward in Cardio Neuro Centre are required to pay in addition to the reimbursement of those consumables’ cost of additional facilities provided in the private rooms. It is also admitted that cost of consumables being recovered from the patients in respect of angiography at the AIIMS from general ward patients is Rs.4,000/-, and from the private ward patients it is Rs.6,000/-, as against Escorts’ charges at rs.18,000/- and the approved charges for other hospitals in Delhi under the CGH Scheme is Rs.12,000/-. No charges by way of food/stay etc., are taken in general ward at C.N.Centre as well and the same are free. It is pointed out that in the AIIMS, in all, there are 1,948 beds. Out of these beds, 178 beds are earmarked as private beds and the same are spread in the main hospital, Cardio Neuro Centre, Dr. R.P. Centre, etc. Finally, it pointed out as under:
“That for example, during the years 1999-2000, 2000-01 and 2001-02, the expenditure of the main hospital alone on material and supplies such as consumables, drugs, gases, linen, kitchen etc. are to the tune of Rs.54.22 crores and Rs.63.93 crores and Rs.66.64 crores. These figures do not include expenditure on other components, i.e. salary, pension, repairs, etc. That during the year 2000-01, 2001-02 and 2002-03 the entire hospital receipts are to the tune of Rs.11.34 crores, Rs.12,98 crores and Rs.13.29 crores. That these receipts include receipts by way of Registration Charges, Hospital Charges, Diagnostic Charges etc.”
Considering the aforesaid statement in the affidavit, it would be difficult to hold that services rendered by the AIIMS would not be covered by the provisions of Section 2(1)(o) of the Act as service is not free of charge – may be subsidised to a large extent. The decision rendered by the Apex Court is binding on all force, and, therefore, there is no alternative but to hold that the services rendered at the AIIMS would be covered by the provisions of the Act, despite the fact that it is established for educational and research purposes. The reason being - it is not covered by exclusion clause, namely, ‘service does not include the rendering of service free of cost’. Hence, we reject the first preliminary contention.
Re: Deficiency in service
For deciding this question, it would be necessary to narrate admitted facts. Undisputedly, the Complainants’ previous child was having Thalassaemia Major. As a precautionary measure, the Complainants came to the AIIMS on 28.11.1989 to confirm as to whether the second pregnancy should be continued. They contacted Opposite Party No.2, Dr. Ishwar C.Verma, who advised them for getting foetus tested for thalassaemia major. The Complainant No.2 was advised to undergo chorionic villus biopsy (CVB) from Doctor (Mrs.) J.S.Khurana X-Ray Clinic. She was asked to deposit Rs.9,500/- for pre-natal diagnosis. The CVB sample was sent for diagnosis to Dr.John M. Old. On the basis of the diagnosis report of Dr.John M. Old, Opposite Party No.2 advised the Complainant No.2 to go ahead with the pregnancy. After the birth, when haemoglobin level of the child went low, they came back to the AIIMS and consulted the Opposite Party No.2. The Opposite Party No.2 thereafter took the blood samples of all family members and sent to the laboratory of Dr.John M. Old, who in turn reported vide letter dated 31.5.1991 that Master Hemant Munjal has homozygous beta Thalassaemia (Thalassaemia Major). It is contended that because of the gross error in extraction of DNA from chorionic villus samples, by the Opposite Party No.2, test result was affected, therefore, there is deficiency in service by the Opposite Parties.
Contra, it is contended by the Opposite Parties that the Complainants were informed that test for pre-natal diagnosis of Thalassaemia Major was not carried out at the AIIMS, but it was carried out on DNA technology (deoxyribose nucleic acid technology) by Dr. John M. Old of Oxford, U.K.
The Complainants were further informed that the blood samples would be taken from all the family members while, the sample from the foetus would be obtained from the chorionic villus (CV), which is the tissue by which the baby is attached to the mother’s womb. The CV sample obtained was brought to Opposite Party No.2 on 28th Noveber, 1989 for extraction of DNA for despatch to Dr.John M. Old. Extraction of DNA from chorionic villus sample consists of two steps. The first step is to separate the foetal tissues from the mother’s tissues, both of which are intimately attached to each other. The separation is done under the view of a dissecting microscope, which provides magnified view of the tissues. The process takes about 2 to 3 hours. In the second step, the foetal tissues are treated with chemical to extract the DNA. This process takes about 24 hours.
It is contended that the Opposite Parties meticulously carried out their job of separating the foetal tissues from the mother’s tissues in the chorionic villus sample by using a dissecting microscope with a magnification of 36. Blood samples were also collected from the Complainants and their two sons and DNA was extracted from these four blood samples. The DNA samples obtained from the blood of the family members of the Complainant and from the chorionic villus (from foetus) were sent for analysis to Dr.John M. Old for analysis. By fax letter dated 12.12.1989 it was reported by Dr. John M. Old that the CVS diagnosis for Mrs. Kamlesh Munjal is Beta Thalassaemia trait by linkage analysis. There was no mention in the reports of the presence of or even suspicion of contamination of CVS by maternal tissues. At this stage, Dr.John M. Old had not raised any doubt about maternal contamination or unsatisfactory preparation of the DNA from the CVS.
It is also contended that Dr. Old’s report did specify in a foot note that “the chance of error from DNA recombination in diagnoses based on linkage analysis is approximately 0.3%, and that the technical error rate for all types of DNA analysis is approximately 0.5%”. This information was also conveyed to the Complainants.
It is therefore contended that the AIIMS only acted as an intermediary by collecting the samples, sending them to Dr.John M. Old and reporting the results to the Complainants. It is also contended that in the Genetic Unit the practice is to give non-directive counselling, i.e. the staff of the Genetic Unit explain the report and the options are available to the patient. Therefore, the choice whether to continue the pregnancy or abort the baby is entirely left to the patient. It is also contended by the Opposite Parties that the contents of the letter dated 31.5.1991 stating that error might have been due to the presence of maternal contamination in the foetal tissues, were merely conveying the opinion of Dr. John M. Old and not admission of guilt or negligence or error on their part. It is contended that wrong diagnosis was made because of a possible technical error in DNA diagnosis by Dr.John M. Old and not due to maternal contamination.
In the additional reply, it has been pointed out that on the basis of results of the research in our country and abroad it is now well settled that maternal cells (upto 5%) mixed with the foetal tissues do not interfere with the use of DNA technology to provide prenatal diagnosis using chorionic villus tissues.
In the supplementary written statement dated 25.4.2000 filed by the Opposite Parties No. 1 & 2, it has been stated that no scientific technology can be claimed to be 100% perfect; in all prenatal tests based on DNA technology a small percentage (1 to 2%) of error in the result is possible; the small error is inherent in the nature of the test itself, which may occur due to the various independent and contributory factors. This is a commonly and medically accepted phenomena of the DNA test acknowledged all over the world. It has been further pointed out as under:
“That the chorionic villus tissues, which are separated from the mother’s womb for making a prenatal diagnosis, are embedded in the maternal tissue called decidua, so maternal decidual cells are attached to the chorionic villus sample when it is separated from the womb. The operating staff take special steps/care in order that these ‘maternal’ cells do not interfere with the test result. These are as follows:
“(a) One is to view the tissue obtained by chorionic villus sampling (CVS) under the inverted microscope and separate the foetal from the maternal tissue. This was done very carefully, and to the extent possible, by Opposite Party No.2, and his operating staff, with the use of the inverted microscope.
(b) Before giving out the results of prenatal diagnostic tests “maternal contamination” or the presence of “maternal tissues in the chorionic villi” is excluded by DNA technology. This is the standard of care in all international laboratories.
(c) Thirdly, it is also a commonly known medical concept and has been shown by experts that some maternal cells (upto 5%) mixed with the foetal tissues do not interfere with the use of DNA technology to provide prenatal diagnosis using chorionic villus tissues.
Dr. Ishwar C. Verma has also filed evidence by way of affidavit wherein it has been, inter alia, pointed out that when the Complainant contacted the deponent for advise/consultation regarding pre-natal diagnosis of Thalassaemia Major on 28.11.1989, the prenatal diagnosis involving chorionic villus sampling of DNA technology was being attempted as a part of the ongoing research activity at the AIIMS and in different parts of the world. At the AIIMS it was at its infant stage. It is his say that he is fully competent and qualified to carry on DNA test and had used all skill and competence and has undertaken the entire process with utmost due care and abilities. There are certain processes in the DNA test which include separation of child’s tissues from that of mother’s tissues by naked eyes with the help of microscope. It is stated that international practice is to provide non-compulsive advice, especially in the genetic counselling and the counsellor never advises of a particular course of action and leaves the option to the person concerned.’
His further say is that with the help of his fellow researchers and staff, the foetal tissues from the maternal tissues were separated to the extent it was possible using the inverted microscope. It is his say that few maternal cells can remain sticking to the chorionic villus samples, which could not have been detected by any doctor of skill in the field, by the naked eye even by using inverted microscope. It is his say that Dr. John M. Old failed to identify the change in the beta globin gene in the father and the previous affected child he based the diagnosis on linkage studies. The said technique was introduced in early 1985 for prenatal diagnosis of thalassaemia, but was later superseded by direct detection of the mutation in beta globin gene. It is his say that the technique of linkage studies has more chance of error because of naturally occurring rearrangements in the DNA. It is his say that the small amount of maternal cells which may remain sticking to foetal chorionic tissue is an inherent part of this technology; this could not have been detected by naked eye even with the use of the inverted microscope, as it is only detectable by DNA or molecular techniques. It is his say that at present at the AIIMS medical scientists have acquired sufficient experience of performing the prenatal diagnosis of beta thalassaemiaand have carried out the tests in more than 800 cases.
In the further affidavit dated 10.8.2003 it has been stated by Dr.Verma that he had done his Post Graduation in Medicine from U.K., obtained the Membership of Royal College of Physicians, London in 1966. He worked in the AIIMS since 1967 and was Professor since 1985. He had gained vast experience in the field of Thalassaemia and was a recognised expert and received many awards for work in Thalassaemia. His research papers in Thalassaemia, in genetic disorders have been published in many important medical journals and have been well received by medical fraternity at large. It is his say that on the basis of the report received, he had advised the Complainant and his wife that the risk of the disease in the foetus was low (about 1%) which is inherent error rate in DNA-based prenatal diagnostic tests. The parents decided to continue with the pregnancy. It is his say that he and his colleagues had followed the standard medical procedure and observed the guidelines to the hilt and exercised all care and caution that are required in conducting the test of this nature. He has further stated that error in prenatal diagnostic analysis report can occur due to a number of reasons. Some of these have been studied and researched more intently than others. In brief reasons for misdiagnosis can be stated as follows:
- Maternal cell contamination
- Variation in the Chromosomal / Genetic make up of the Placenta as well as the foetus.
- Theory of vanishing twins.
The first reason is of maternal cell contamination. This risk is such that even the most advanced development in science and technology cannot eliminate it. So although the discrepancy in test result due to maternal cell contamination can be later on explained, it cannot be guarded against. The occurrence/non-occurrence of the same is beyond the control of man and definitely not visible to the naked eye. The phenomenon that occurs therefore is being detailed, examined and analysed.
Thereafter, he has discussed the other aspects in detail. But, all through he has emphasised that error rate of 1% is inherent in the nature of test itself and cannot be construed as negligence on the part of the Opposite Parties. He has pointed out that if these small errors were not accepted, there would be no progress in research and science.
The suggestion that error in analysis could have occurred due to contamination in DNA cannot be misconstrued and accepted to be detriment of the Opposite Party when there exist other explanations as to why the diagnosis was incorrect and wrong. The process of prenatal diagnosis is a complex process and genetic technologies have not developed to the extent that the same is free from all errors. For this purpose, some extracts are also produced on record and are referred.
Similar is the affidavit of Dr. Shubha R. Phadke. She is a medical practitioner since 19 years, having done M.D. in Paediatrics from Nagpur University. She is working as Associate Professor in Medical Genetics at Sanjay Gandhi Post-Graduate Institute, Lucknow. It is her say that on going through the report of Dr. John M. Old, she observed that Dr. Old had found the IVS 1-5 mutation of thalassaemia in the mother but did not find the same in the foetus (chorionic villi). This clearly shows that there was no maternal contamination. If there was maternal contamination the same mutation should be detectable in the mother as well as the chorionic villi, which is not so in the present case; that the first factor to give an erroneous result is one which is inherent in biological tests for prenatal diagnosis. It is stated that this risk factor is such that even the most advanced developments in science and technology cannot eliminate it. So although the discrepancy in test results can be later on explained, it cannot be ruled out completely. The occurrence/non-occurrence of this error (maternal cell contamination) is not visible to the naked eye; that misleading results may arise due to the test not working properly, or chemicals not functioning optimally. Such errors are eliminated or minimized when the test is performed by experts in the field.
It is her say that it is an accepted fact world over that the prenatal testing based on DNA technology contains a small percentage (1-2%) of error. This error is inherent in the nature of test itself and can occur due to a number of reasons.
Real test for determining deficiency in service:
Well laid down tests for determining deficiency in service are - whether there is failure to act in accordance with standard of a reasonable competent medical practitioner?
Whether there was exercise of reasonable degree of care?
The degree of standard or reasonable care varies in each case depending upon expertise of medical man and the circumstances of each case. On this aspect, it would be worthwhile to refer to the enunciation from Halsbury’s Laws of England .
“With regard to degree of skill and care required by the doctors, it has been stated as under in (pr.36, p.36, Vol.30, Halsbury’s Laws of England, 4th Edn.)
“The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. Failure to use due skill in diagnosis with the result that wrong treatment is given is negligence. Neither the very highest nor a very low degree of care and competence, judged in the light of the particular circumstances of each case, is what the law requires, and a person is not liable in negligence because someone else of greater skill and knowledge would have prescribed different treatment or operated in a different way; nor is he guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, even though a body of adverse opinion also exists among medical men; nor is a practitioner necessarily negligent if he has acted in accordance with one responsible body of medical opinion in preference to another in relation to the diagnosis and treatment of a certain condition, provided that the practice of that body of medical opinion is reasonable.”
The Apex Court aptly stated the said principles further in Dr. Laxman Balakrishna Joshi Vs. Dr. Trimbak Bapu Godbole, AIR 1969 SC 128, which reads as under:
“The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires: (cf. Halsbury’s Laws of England, 3rd ed. Vol. 26 p.17). The doctor no doubt has discretion in choosing treatment which he proposes to give to the patient and such discretion is relatively ampler in cases of emergency.”
Similarly in Poonam Verma Vs. Ashwin Patel (1996) 4 SCC 332, dealing with medical negligence, the Court observed that:
“14. Negligence as a tort is the breach of a duty caused by omission to do something which a reasonable man would do, or doing something which a prudent and reasonable man would not do.
15. The definition involves the following constituents:
(1) a legal duty to exercise due care;
(2) breach of the duty; and
(3) consequential damages.
16. The breach of duty may be occasioned either by not doing something which a reasonable man, under a given set of circumstances would do, or, by doing some act which a reasonable prudent man would not do.
17. So far as persons engaged in the medical profession are concerned, it may be stated that every person who enters into the profession, undertakes to bring to the exercise of it, a reasonable degree of care and skill. It is true that a doctor or a surgeon does not undertake that he will positively cure a patient nor does he undertake to use the highest possible degree of skill, as there may be persons more learned and skilled than himself, but he definitely undertakes to use a fair, reasonable and competent degree of skill. This implied undertaking constitutes the real test, which will also be clear from a study and analysis of the judgment in Bolam v. Friern Hospital Management Committee5 in which, McNair, J., while addressing the jury summed up the law as under:
“The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill at the risk of being found negligent. It is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art. I do not think that I quarrel much with any of the submissions in law which have been put before you by counsel. Counsel for the plaintiff put it in this way, that in the case of a medical man, negligence means failure to act in accordance with the standards of reasonably competent medical men at the time. That is a perfectly accurate statement, as long as it is remembered that there may be one or more perfectly proper standards; and if a medical man conforms with one of those proper standards then he is not negligent.”
18. This decision has since been approved by the House of Lords in Whitehouse v. Jordan; Maynard v. West Midlands Regional Health Authority; Sidaway v. Bethlem Royal Hospital; Chin Keow v. Govt. of Malaysia.
19. The test pointed out by McNair, J. covers the liability of a doctor in respect of his diagnosis, his liability to warn the patients of the risk inherent in the treatment and his liability in respect of the treatment.
20. This Court in Laxman Balkrishna Joshi (Dr) v. Dr Trimbak Bapu Godbole laid down that a doctor when consulted by a patient owes him certain duties, namely, (a) a duty of care in deciding whether to undertake the case; (b) a duty of care in deciding what treatment to give; and (c) a duty of care in the administration of that treatment. A breach of any of these duties gives a cause of action for negligence to the patient.”
In A.S.Mittal Vs. State of U.P. (1989) 3 SCC 223, the Apex Court observed that mistakes will occur on occasions despite the exercise of reasonable skill and care; that the law recognises the dangers which are inherent in surgical operations.
Applying the test laid down in the aforesaid decisions, can it be said that Opposite Party No.2 had not exercised the standard of ordinary skilled man exercising and professing to have that special skill? Can it be held that there was failure to act in accordance with the standards of reasonable competent man in separating the foetal tissues from the mother’s tissues, while carrying out DNA analysis?
In our view, it would be difficult to hold that there was any negligence or gross error or any error which would have not been committed by a reasonable man professing to have special skill. Admittedly, in the present case, the final test was not carried out at the AIIMS. Only the DNA extraction from chorionic villus sample was to be sent to U.K. for test.
In the Foetal Diagnosis Report, submitted by the National Haemoglobinopathy Reference Service, U.K., it has been specifically stated as under:
“Currently available data indicates that the chance of error from DNA combination in diagnoses based on linkage analysis is approximately 0.3% and that the technical error rate for all types of DNA analysis is approximately 0.5%. It is most important that all clinicians involved in the care of families requesting prenatal diagnosis, and the families themselves are aware of these data before decisions about termination of pregnancy are taken”.
By letter dated 31st May, 1991, the Opposite Party No.2 informed the Complainant as under:
“I have just received the reports on the studies carried out by Dr. John M. Old The results are as follows:
Mr.Suresh Munjal IVSI-5 trait
Mrs. Kamlesh Munajl IVSI-5 trait
Rohit Munjal IVSI-5 trait
Mohit Munjal IVSI-5 Homozygote
Hemant Munjal IVSI-5 Homozygote.
Thus, the analysis confirms that Hemant has homozygous beta thalassaemia. It appears that the error has occurred because of the contamination of DNA from the mother’s tissue. Usually every care is taken but sometimes the CVS samples received are such that admixture takes place.
However, we will reimburse the charges (Rs.10,000/-) that you paid for this analysis. Further, we will carry out parental diagnosis in a future pregnancy free of cost from our side (excluding charges of obstetrician).
In this connection, please send us a letter requesting that the charges paid by you be reimbursed, as the diagnosis on the foetus was incorrect. I will then process the same for reimbursement. I may only add that the diagnosis given in the other 30-35 cases has come out to be correct.”
(a) From this, it is apparent that such an error varying from 0.5% to 1% is likely to occur in a few cases. The relevant parts of the depositions of the Doctors, i.e. Dr. S.K.Sood and Dr. R.V.Phadke are as under:
Dr. S.K. Sood, a Laboratory Haematologist, for the last 47 years deposes that foetal DNA analysis by chorionic villus sampling of the placenta is ordinarily done in the first trimester. Although the process was established and found to be useful tool back in 1982, some degree of error has remained inherent in the procedure. In case of thalassaemia the risk of recurrence of the disease is 25%, and by doing this test the risk is reduced to 1% or so. Due to the inherent error in the procedure the risk of recurrence cannot be reduced to 0%, and remains at about 1%; it is further submitted that no scientific technology can be 100% perfect. It is an accepted fact the world over that the prenatal testing based on DNA technology contains a small percentage (1-2%) of error. This error is inherent in the nature of test itself and can occur due to various independent and contributory factors”.
Dr. Shubha R. Phadke, in her affidavit deposes to the effect that a small error (1-2%) in the results is an inherent part of all biological tests. From the ‘paper’ by W.Fischer & Colleagues from Germany, annexed with her affidavit, it is stated that in the international journal “Prenatal Diagnosis” (June 2001, Vol.21, pages 481-3) study of chorionic villi was normal, while the amniotic fluid as well as fetal blood showed abnormal karyotype; In another paper by W.A.Hogge and Colleagues in the Journal “Prenatal Diagnosis” 1985, Nov-Dec. Vol.6, pages 393-400, a discrepancy between the villus karyotype and that of the foetus was found in 2.0% of 600 cases”.
(b) Further, there is no evidence on record to show that Opposite Party No.2, Dr. Verma, has not taken due care and caution while carrying out the DNA analysis by separating the foetal tissues from mother’s tissue. As submitted by the Doctors for such errors in misdiagnosis, there can be various causes and the reasons which, in brief, can be stated as follows:
- Maternal cell contamination
- Variation in the Chromosomal / Genetic make up of the Placenta as well as the foetus.
- Theory of vanishing twins.
(c) In such cases, the principle of res ipsa loquitur cannot be applied for arriving at the conclusion that Opposite Party No.2 was negligent in separating the contaminated mother’s tissue, i.e. separating the foetal tissues from mother’s tissues. In such tests there is possibility of errors at two stages. 1) While separating mother’s tissue from foetal tissue and carrying out test for thalessaemia. The percentage of error in each case may be 1 to 2% and 0.5%, and such error, according to evidence of Doctors, is inevitable or to say, an inherent part of the technology. It has been pointed out that discrepancy in test results due to maternal cell contamination cannot be guarded against. The occurrence/non-occurrence of the same is beyond the control of man and definitely not visible to the naked eye.
(d) It is also pointed out that in any case on the basis of the test result it was for the complainants to decide a particular course of action and to continue or to abort the pregnancy as advised was non-compulsive.
The settled law in case of medical man, negligence means failure to act in accordance with the standards of reasonably competent medical men at relevant time. From the evidence discussed above, it would be difficult to arrive at a conclusion that even though error or imperfection has crept in, in bifurcating foetal tissues from the mother’s tissues, it amounts to negligence on the part of Opposite Parties No.2. No doubt, in such case, there is thin difference between the error, imperfection or fault and negligence.
What relief can be given :-
The question is how to do justice, when we are not in a position to hold that there was negligence on the part of the Opposite Parties No.2 in discharge of his duties, but at the same time, it is apparent that error has crept in, in bifurcating the mother’s tissues from that of the foetal tissues; or the error might have crept in at the time of carrying out the test by Dr. Johan M. Old. That error, fault or imperfection has resulted in onerous duties on the parents and their son would require continuous treatment of blood transfusion and medication. For such onerous duties, it is difficult to compensate in terms of money, but considering the fact that the error or imperfection has crept in by a reputed medical institute, where experts are supposed to be working, we suggested to the learned Counsel for the Opposite Parties to find out whether it would be possible for the Opposite Party No.1 to give free medical treatment to the child for ‘Thalassaemia Major’. However, there was no definite response from the Opposite Party’s Institute. Similarly, learned Counsel for the Complainant submitted that it will be difficult for the child to come to Delhi for blood transfusion, even though he has admitted that for medical treatment he is
required to come to Delhi approximately once in a month because without medical check up by doctors, proper medicines cannot be purchased and used by the son of the Complainants.
Considering the above said submissions, in the present case of unexpected situation arising due to imperfection in the test, for doing justice, we direct that the Opposite Party No.1 shall give medicines without any charges to the Complainant’s son for ‘Thalassaemia Major’ after getting him periodically examined by the consultant on the subject. For blood transfusion also the same may be given periodically, without any charges, if opted for the same by the Complainants, because learned Counsel for the Complainants was expressing difficulties in coming to Delhi for blood transfusion on the ground of distance. In any case, if the treatment is opted by the son of the Complainant it shall be given to him till it is required without any reservations. We are sure that there would be due compliance of this order by the institution without any reservation, which is established under the law for which funds flow from the public exchequer. For this, appropriate directions shall be given to the concerned Doctor and the staff by the Director of the Opposite Party No.1.
With these directions, the Original Petition stands disposed of. There shall be no order as to costs.