JUDGMENT : NAVANITI PRASAD SINGH, J. 1. Dr. S. Ganapathy has brought this public interest litigation primarily to draw the attention of the court to an alleged malpractice in declaring a patient to be brain dead when he, in fact, is not brain dead, only with the intention to facilitate harvesting of organs for transplantation. He had drawn the attention of this Court to the fact that the most common easy test was EEG, but that was not being resorted to. Instead, insistence is upon apnea test, which is not properly done and by concealing the actual state of affairs to the near relatives. In simple words, what he submits is that even though a person may not be brain dead, to facilitate organ transplantation, the doctors declare a patient brain dead and then persuade the family to donate the organs. Initially, this Court evinced interest in his submissions noticing that one of the highest organ transplantations in any State is being done in the State. We, therefore, noticed the Union of India and the State of Kerala to respond to the allegations. 2. On behalf of the Union of India, an affidavit has been filed pointing out the provisions of the Transplantation of Human Organs and Tissues Act, 1994 and the Rules, 2014 made therein and in specific, referring to Rule 5 and Form 10 of the Rules. In their affidavit, reference has also been made to the guidelines issued by the World Health Organisation (WHO) being International Guidelines for the Determination of Death-Phase I, May 30-31, 2012 Montreal. A reference to that shows one thing which supports the contention of the petitioner. It notices as under: "6. Ancillary and Supplemental Testing xxxx xxx xxxx In some jurisdictions, brain death requires the use of a supplementary or confirmatory test. The most commonly recommended supplemental tests are EEG, 4 vessel cerebral angiography or radionuclide testing. Newer tests-inconsistently recommended-include CT angiography, CT perfusion, MR angiography and trans-cranial Doppler. There is insufficient evidence to determine if newer ancillary tests accurately confirm the cessation of function of the entire brain." "7. Apnea test xxxx xxx xxxx Due to theoretical concerns about the effect of hypercarbia on cerebral blood flow in potential brain death, many guidelines recommend performance of the apnea test after all other clinical testing has been completed." 3.
There is insufficient evidence to determine if newer ancillary tests accurately confirm the cessation of function of the entire brain." "7. Apnea test xxxx xxx xxxx Due to theoretical concerns about the effect of hypercarbia on cerebral blood flow in potential brain death, many guidelines recommend performance of the apnea test after all other clinical testing has been completed." 3. One thing we could understand was that the guidelines of the WHO point out that apnea test would be the last test after the other tests are performed which would included EEG. Therefore, the recommendation is not to exclude EEG. 4. The State of Kerala has also filed an affidavit. They have formed a committee and laid down guidelines as to who all would be the member of that committee and how brain death certification has to be done. Learned Senior Government Pleader appearing for the State points out that as per the directives of the State Government in respect of brain dead declarations where apnea test is to be done without exception, the whole procedure should be video graphed and maintained. This clearly answers the apprehension of the petitioner that without properly conducting apnea test, patients are being declared as brain dead. 5. Once video-graphy is there, if any person finds any mistake, then it would be open for him to take suitable action which the law would permit and evidence would be readily available for that purpose. It is not that EEG is totally an unreliable evidence, as the report itself suggests that those are tests which would be done prior to resorting to the EEG and as we understand that EEG is simply a common procedure where even the wards of the patient can easily see and make out. There may be occasions where it may draw up a different result, but that does not mean that a common test which even otherwise is done, should be avoided. We would thus, recommend to the Central Government and the State Government to consider the issuance of directives in that regard. It would only be an additional safeguard to be done and can easily be done by any hospital which admits neurological cases. Otherwise, we are satisfied that steps that have been taken by the Central Government and the State Government are sufficient for the time being, but then it is time for them also to be cautious. 6.
It would only be an additional safeguard to be done and can easily be done by any hospital which admits neurological cases. Otherwise, we are satisfied that steps that have been taken by the Central Government and the State Government are sufficient for the time being, but then it is time for them also to be cautious. 6. We would like to thank Dr. Easwer H.V., Professor, Department of Neurosurgery, Sree Chitra Tribunal Institute for Medical Science and Technology, who is a specialist in the field of Neurology and was produced by the State. Dr. Ganapathy had no objection to the said doctor addressing the court. 7. In the course of arguments, Dr. Ganapathy drew our attention to different cases which we need not refer. They related to patients who, according to him, ought not to have been a candidate for transplant, but hospitals performed transplant surgery which ended with fatal results. This is a matter of malpractice. If any specific case is brought to the notice of the authorities concerned by anyone, including Dr. Ganapathy, then the appropriate authority would be required to take suitable action in the matter. 8. Patients and their wards are desperate. They can easily be misled into believing things which may not be correct. The State have a responsibility to protect such people from such exploitation. The State would have to take such allegations seriously to avoid medical fraud and malpractice. It would have to have to take special or extra-ordinary care in these matters to ensure that hospitals stick to highest level of medical ethics and follow the law strictly, and any failure or slip in the process or the procedure must be dealt very seriously. With these observations and directions, we do not propose to proceed further in the matter. We hope and trust that the Central Government and the State Government would realise their responsibility in the matter and act accordingly. 9. Writ petition is closed accordingly.