NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION, NEW DELHI
Dr. S.M. Kantikar, Presiding Member
Ravindra Dnyaneshwar Patil
and Anr. —Appellants
versus
Dr. Vinay Tule and Anr. —Respondents
First Appeal No.1291 of 2017
(Against the Order dated 03/05/2017 in Complaint No. 13/2015 of the State Commission Maharastra)
Decided on 17.7.2017

IMPORTANT POINT
Onus of proving alleged medical negligence in treatment or diagnosis lies with person alleging medical negligence.

Headnote:Consumer Protection Act, 1986—Sections 17, 19 and 21—Medical services—Medical negligence—Pathology—Blood Disorder (Sickle Cell disease)—Birth of sick baby—Complaint dismissed by State Commission for non-prosecution—OP was running genetic laboratory for more than two decades—He is qualified and experienced one to run genetic laboratory—CVB analysis performed by ARMS PCR DNA method, OP issued report that there was no likelihood of foetus suffering from disease—Process of taking tiny sample (4mg) itself is complicated one and combination of mother’s tissue and foetus tissue is a routine phenomenon—Presence of Sickle normal band could be attributed to mother’s tissue— Samples tested were CVB prenatally, whereas test on blood was performed in postnatal period—Both reports stand on different footing—Negligence cannot be attributed to a doctor so long as he performs his duties with a reasonable skill and competence—Onus of proving alleged medical negligence in treatment or diagnosis lies with person alleging medical negligence—Onus was upon Complainants/Appellants to prove that OP was negligent while testing or while recording results—No doctor was examined by complainants to comment on OP’s reports as to whether there was any negligence in procedure ARMS-PCR DNA analysis adopted by OP—No reason to interfere with view taken by State Commission—Appeal dismissed.

       Held: It is an admitted fact that OP was running the genetic laboratory for more than two decades. He is qualified and experienced one to run the genetic laboratory. The CVB analysis performed by ARMS PCR DNA method, the OP issued report that there was no likelihood of foetus suffering from the disease. It is also pertinent to note that, in the DNA diagnosis possible technical error rate is approximately 1-2%. The complainants have not produced any expert opinion on the possibility of maternal cell contamination (MCC) in CVB sampling. Due to MCC, there are chances of getting result (band in electrophoresis) as sickle cell carrier i.e. trait. I have perused the test reports of OP laboratory dated 13/15.09.2007 and 20.08.2010, and also perused the report of Deshmukh Laboratory dated 18.05.2010. The OP has performed the ARMS PCR for CVB sample and after analysis gel electrophoresis technique as on the basis of bands had appeared , that ‘it has only abnormal sickle gene, i.e the foetus was a sickle cell anaemia carrier’. It is pertinent to note that the process of taking tiny sample (4mg) itself is complicated one, therefore, the combination of mother’s tissue and foetus tissue is a routine phenomenon. Thus, in the present case, the presence of Sickle normal band could be attributed to mother’s tissue. Subsequently on 18.05.2010, Hb electrophoresis done by Dr.A.L. Deshmukh revealed Faint F band, and a Band S, thus he gave the impression as ‘SS’ pattern-Sickle Cell Trait. On 20.08.2010 the OP performed ARMS PCR on blood sample of child and found the presence of only mutant gene. It should be borne in mind that, the samples tested were CVB prenatally, whereas the test on blood was performed in postnatal period. Both the reports stand on different footing. The test results depend upon number of factors like type of sample, method of collection and the volume of sample. It should be borne in mind that, the CVB sample is collected by indirect method i.e USG guided, usually the sample volume will be very less and it will very tiny. It shows maternal cell contamination (MCC) also, whereas the blood sample is direct one, there is no chance of such MCC contamination. As discussed in the various articles (supra) due to MCC, the outcome of ARMS PCR will be single gene as of mother’s cell. The results are interpreted on the basis of appearance of bands and its size in the gel electrophoresis. In my view, OP has performed the test as per standard ARMS PCR protocol, and interpreted the Bands appeared in gel electrophoresis. I have perused the CVB report and the photograph of Gel electrophoresis, it shows a single Sickle mutant band, thus it was reported as “Carrier of Sickle Cell Anemia” i.e. Sickle Cell Trait. Therefore, I do not find any shortcomings or negligence on the part of OP either in conducting ARMS-PCR procedure or during its reporting.

       Catena of judgments of Hon’ble Supreme Court and from abroad had discussed about what constitutes medical negligence. In Kusum Sharma Vs. Batra Hospital (2010) 3 SCC 480, it is laid down that, Negligence cannot be attributed to a doctor so long as he performs his duties with a reasonable skill and competence. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the Medical Profession.

        In the case Maynard v. West Midlands Regional Health Authority the words of Lord President (Clyde) in Hunter v. Hanley 1955 SLT 213.

       Similarly, in the case of Achutrao Haribhau Khodwa and Ors. v State of Maharashtra and Ors (1996) 2 SCC 634, the Hon’ble Supreme Court, cceptable to the medical profession.”

       2 In Hucks v. Cole (1968) 118 New LJ 469, Lord Denning stated that:

        “a medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.”

       Relying upon the landmark judgments (supra), in the instant case, there was not an act of omission committed by OP. He has performed ARMS-PCR analysis as per standard protocol.

        Similarly, in the case of Martin F. D’ Souza vs. Mohd. Ishfaq, 2009 CTJ 352 (SC), the Hon’ble Supreme Court has held that, a doctor cannot straightway be held liable for medical negligence simply because a patient has not favourably responded to treatment or surgery has failed. The court has observed as,

       When a patient dies of suffers some mishap, there is a tendency to blame the doctor for this. Things have gone wrong and, therefore, somebody must be punished for it. However, it is well known that even the best professionals what to say of the average professional, sometimes have failures. A lawyer cannot win every case in his professional career but surely he cannot be penalized for losing a case provided he appeared in it and made his submissions.”

        A Bench consisting of Hon’ble Justices Markandey Katju and R.M. Lodha as his Lordship then was held that “A medical practitioner is not liable to be held negligent simply because things went wrong from a mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference to another. He would be liable only where his conduct fell below the standards of a reasonably competent practitioner in his field”. Hon’ble Justice Katju commented that;

        “While doctors who cause death or agony due to medical negligence should certainly be penalised, it must also be remembered that like all professionals doctors too can make errors of judgment, but if they are punished for this no doctor can practice his vocation with equanimity. Indiscriminate proceedings and decisions against doctors are counter-productive and serve society no good. They inhibit the free exercise of judgment by a professional in a particular situation.”

       The judgments noted above are squarely applicable in the instant case. It is settled legal preposition that, the onus of proving the alleged medical negligence in the treatment or diagnosis lies with the person alleging medical negligence. Therefore, in this case the onus was upon the Complainants/Appellants to prove that the OP was negligent while testing or while recording the results. Admittedly, no doctor was examined by the complainants to comment on the OP’s reports as to whether there was any negligence in the procedure ARMS-PCR DNA analysis adopted by the OP. As noted above, in several medical literatures it is observed that even low level of Maternal Cell Contamination (MCC) may interfere with correct molecular diagnosis. Thus, in my view, the complainants have failed to prove any on the part of the OP.

        For the reasons stated above, I concur with the State Commission that the complaint was barred by limitation and that there was no negligence or deficiency on the part of the OP while conducting aforesaid tests. Thus, there is no reason to interfere with the view taken by the State Commission. The appeal is accordingly dismissed. (Paras 16 to 23)

       Result: Appeal dismissed.