44-year-old Seema Rai died in Fortis Hospital on Bannerghatta Road in May 2010, due to complications after a pancreas transplant surgery performed on her. According to latest orders given by the Appropriate Authority and Appellate Authority, the surgery was done without an informed consent of the patient, and without a valid license.
Following a five-year-long legal battle over her husband Major Pankaj Rai’s complaint against the hospital to the Appropriate Authority, the Certificate of Registration granted to hospital in March 2010, permitting it to perform transplantation of liver, kidney and homograft, was cancelled.
KMC exonerates the doctors
While these proceedings were going on, Rai had opened another front by filing a complaint before Karnataka Medical Council (KMC), accusing the surgeon who performed the transplant, Dr. Ramacharan Thiagarajan, and the Nephrologist who treated Seema for renal failure, Dr. Rajanna Sreedhara, of negligence and violating Code of Medical Ethics by performing pancreas transplant without informed consent, in a hospital without license.
KMC issued a notice to the doctors and the hospital, which was followed by an enquiry. Dr. V. Raju, who is accused by police in a chargesheet filed on May 8th 2015 of committing forgery on the application form submitted by Fortis Hospital on Bannerghatta Road for the grant of license for organ transplant, was then a Member Secretary in the office of the Joint Director (Medical), Department of Health and Family Welfare Services.
In his oral evidence given before KMC, Dr. Raju stated that, “Fortis Hospital has a license to perform Pancreatic Transplantation as they already have a permission to perform Liver Transplantation which includes Pancreas and other Abdominal organs.”
On completing the enquiry, KMC held that Seema Rai had signed an “informed consent” and that the transplantation surgery was performed, “as an emergency in interest of the patient and not for the personnel gain,” and exonerated, in its order on June 2nd 2011, the hospital and the doctors from the allegations of negligence and violation of code of medical ethics.
MCI quashes KMC’s order
Rai appealed against the order of KMC to Medical Council of India (MCI), whose Ethics committee held a meeting on October 27th 2012, and concluded that the Dr. Ramacharan Thiagarajan, “operated in the hospital which was not possessing valid permission issued by Competent Authority for conducting the surgery for pancreas transplant and failed to take proper informed consent for the entire procedure of kidney and pancreas transplant surgery.”
MCI also stated, as evident in the minutes of this meeting, “The Fortis Hospital is found to have performed pancreatic transplant surgery without valid permission from the competent authority. The Government of Karnataka (Principal Secretary, Health and Family Welfare) is requested to take suitable action against the hospital management for conducting pancreatic transplant surgery without valid permission to do so.”
In its order dated February 14th 2013, MCI ordered Dr. Ramacharan Thiagarajan’s name be struck from Indian Medical Register as well as from the Register of State for a period of one year, which in effect prohibits him from carrying out medical practice for that period, as a punishment for violating Indian Medical Council regulations, especially clause 7.16 which states:
“Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed.”
High Court sets aside MCI’s order
Aggrieved by this order barring him from medical practice for a year, Thiagarajan filed a Writ petition at the high court, requesting it to quash MCI’s order on March 3rd 2013.
High court order on this writ petition released April 3rd 2014, stated that the MCI’s order, “is not sustainable as it does not disclose the reasons that weighed on the collective wisdom of the council, in reversing the recurrent findings of [KMC].”
The order further stated, “Having regard to the fact that the matter has been hanging fire for several years now, it is requested that the MCI expedite further consideration and pass appropriate orders in accordance with the law and in any event, within a period of four months from the date of receipt of a certified copy of this order.”
MCI reiterates decision to hold doctor accountable
As per the orders of the court, the Ethics Committee of MCI re-considered the matter in its meeting on September 30th 2014, and reiterated its earlier decision to strike out Dr. Ramacharan Thiagarajan’s name from Indian Medical Register and the Medical Register of Karnataka, barring him from medical practice for a year.
The reasons for arriving at this decision, stated in the MCI’s fresh order, are:
- In the judgment on the Writ Petition which quashed the MCI’s previous order in favour of the doctor, it is recorded that the Appropriate Authority, constituted under the Transplantation of Human Organs and Tissues Act, 1994, has, after considering the Report of the Technical Committee constituted by the Lokayukta, Karnataka had held that the hospital was not authorised to conduct transplantation of Pancreas
- “The case sheets and the case records of the deceased,” MCI’s order stated, “testify that [Seema] had sought for kidney transplantation only, whereas pancreas transplantation was also performed upon her and that led to her death…. Further, the case records clearly testify that the consent accorded by the patient was for kidney transplant only.”
- Consent in this for transplantation of pancreas was apparently obtained from the daughter of the deceased which is not a valid consent in accordance with the provision of Code of Medical Ethics, and hence the doctor has committed misconduct.
- Nephrologist, Dr. Rajanna Sreedhara, has deposed before the Ethics Committee that he had not advised for pancreas transplantation along with kidney.
As stated in the judgment on the writ petition the doctor had filed against MCI’s previous orders, it was Dr. Thiagarajan, who first met the patient only a day before the surgery, that advised her to undergo pancreas transplant surgery.
On 20-11-2014, the executive committee approved the decision of the Ethics Committee to uphold its previous order for the above mentioned reasons. Taking note of the same, the KMC wrote a letter to Thiagarajan on December 20th 2014, informing him that his name has been struck from Karnataka Medical Registry for a period of one year with effect from 20-11-2014, as per the orders of MCI.
However, three months later, on February 19th 2015, Dr. Ramacharan Thiagarajan filed another Writ Petition at the High Court, asking it to set aside this order of MCI. The case is still ongoing before the court, and there is at present a stay on MCI’s order, allowing the doctor to carry on medical practice till the case is finally disposed.