1. Background: My wife Seema Rai expired on 6May 2010 after kidney-pancreas transplant surgery at Fortis Hospital. I complained to Karnataka Medical Council (KMC) and Appropriate Authority for Organ Transplantation (AA) of negligence and violation of Transplantation of Human Organs Act (TOHA) by Fortis Hospital and its doctors. AA accepted two of the three points in the complaint viz surgery without license and post-operative infection but not ‘informed consent’. KMC exonerated doctors/hospital of violation of THOA. They issued a warning to Fortis hospital for post-operative infection. Post-operative infection is a violation of the terms and conditions of the transplantation licenseand has not been challenged by the hospital. In Malay Kumar Ganguly vs Dr Sukumar Mukherjee and Ors (07.08.2009) Hon’ble Supreme Court had observed, “It is the duty of the doctors to prevent further spreading of infections. Hospitals or nursing homes where a patient is taken for better treatment should not be a place for getting infection”.
2. The doctors of Fortis ' Dr Rajanna Sreedhara and Dr Ramcharan Thiagarajan did not report the death of my wife within the stipulated period of 7 days but after ten months. They did not suggest post-mortem even though she died on the sixth day of hospitalization. The cause of death described is ‘natural’ in the Form No 4 ‘Medical Certificate – Cause of Death’ of the hospital dated 7th May 2010 signed by Dr Ananda.
3. The misleading arguments of Dr Rajanna Sreedharaof Fortis Hospital are being refuted below:
High Court Orders: The quoted order of 23rd December 2011 has been superseded by the following: orders of the Division Bench of Karnataka High Court. .
a. Order dated 19th March 2012: The Court observed that Fortis was trying to protract litigation since they got a stay order
b. Order dated 17th April 2012: Fortis is restrained from doing any organ transplant surgery
c. Order dated 30th May 2012: Stay to continue till the date of next hearing ' 30th August 2012; Fortis cannot do organ transplant surgery.
5. Fortis’ Organ Transplant License:Registration is organ specific.No hospital can do transplant of any organ not specifically mentioned in their registration (Form 12). Violation is a criminal act. Fortis did not apply for pancreas transplant in the form prescribed (Form No 11), nor was it considered and permitted. The Inspection Team recommended kidney, liver and homograft only. The statement that Dr Ramesh told them that liver includes pancreas is untrue. This is confirmed from the replies by the Appropriate Authority for Organ Transplantation of Human Organs Act in March 2011, July 2011 and the orders of the Appellate Authority dated 24th November 2011. By not challenging the grant of license, Fortis and its doctors have allowed the order to reach finality. There is no ‘deemed provision’ in the Act. Hospitals which have license for pancreas are:
· Kameneni Hospital, Hyderabad: Kidney/Heart/Liver/Pancreas
· Global Hospitals Hyderabad: Kidney/Liver/Pancreas/Small Intestines/Bone Marrow/Heart/Lung
· Asian Institute of Gastroenterology Hyderabad: Liver/Pancreas/Islet Cell Transplantation
· Global Hospitals Chennai: Liver/Pancreas (Regn No 19/2008 dt 14 May 2009)
· BGS Global Bangalore: Kidney/Liver/Pancreas (MDM/20/07-08) dt 31 Oct 2008
· Narayana Hrudalaya: Pancreas (MDM/31/2007-08) dt 6 Sept 2008
· Columbia Asia Hospital: Liver/Kidney/Pancreas (MDM/121/80-09) dt 3 Dec 2008
· AIIMS New Delhi: Kidney/Liver/Heart/Cornea/Pancreas
· IP Apollo Hospitals: Kidney/Heart/Liver/Pancreas.
Fortis has committed an offence under Section 18 punishable with ten years imprisonment. The term ‘liver includes abdominal organs’ refers to Rule 9C and is not relevant to licensing/registration of hospitals as evidenced from the reply of DGHS and Bombay High Court ruling in 2011. That Rule 9C refers to experts and its qualifications only, is also evident from Hon’ble Bombay High Court ruling in WP 3321/2011.
6. Informed Consent:This can only be given by the patient (Supreme Court ruling in Samira Kohli Vs Deepa Manchanda and Section 12). This was not done. The statement of Dr Sreedhara that risks were explained is untrue. He has himself stated that he did not recommend pancreatic transplantation. The stance has now changed. The question of pancreas transplant was raised only hours before the patient was taken for operation. The license conditions stipulate that a booklet containing risks/benefits have to be given to the patient 14 days prior to surgery. The patient has also to be evaluated by a psychiatric. This was not done.Dr Sreedhara had in his notes dated 1 May 2010had directed that the patient be evaluated by a cardiologist before evaluation. He admitted in his deposition at KMC that this was not done. Now, out of the blue a certificate from Dr Venkatesh is reported to have surfaced. This is another offence against the patient under Section 12 of the Act. The doctors misrepresented that they had a license for pancreas. This matter is the subject of a writ petition that I have filed before Hon’ble Court of Karnataka.Fortis has also not said that there then legal counsel Dr Joga Rao who represented them at KMC/High Court was also a faculty at National School of Law from whom the Government sought an opinion on ‘informed consent’. National School of Law has said that they have not verified whether the patient herself signed and whether risks/benefits were explained in the manner specified in the license conditions. When the subject of pancreatic transplantation was first broached on 1st May 2010 because an organ was available and even though the patient had not registered for that, where is the question of explaining risks 14 days prior to surgery? By no stretch is pancreatic transplantation an emergency surgery. Hon’ble High Court of Karnataka has allowed a writ petition praying that the Government findings on ‘informed consent’ be set aside. Can any consent be valid when the object of it is illegal transplant surgery?
7. Testimony by other doctors: Dr Gokul Nath of St John’s Hospital did not represent St John’s Hospital but in his personal capacity sent his affidavit to KMC. I was not permitted to cross-examine him. His evidence therefore is inadmissible. None of the doctors who have testified on behalf of Dr Sreedhara have stated that a hospital can do illegal transplant pancreatic transplant surgery and without patient’s consent and violate patient rights.
8. Dr Sreedhara has referred to earlier enquiries (Dr Raju/Appropriate Authority) in December 2010 where they were exonerated. He has suppressed the fact that these enquiries are irrelevant in view of Hon’ble High Court of Karnataka orders in WP 6523/2011 which has reached its finality. All the arguments put forth by Dr Sreedhara were trashed by the Hon’ble High Court. On the contrary Dr Sreedhara and his hospital have shown disrespect for the Court by raking these arguments again. It is also pointed out that KMC is not competent to investigate violations of Transplantation of Human Organs Act and has traversed beyond its destination, but it is the Appropriate Authority constituted under Section 13 of the Act.Are people aware that elections have not been held in KMC for the past 17 years? It is also relevant to take note of the Hon’ble Lokayukta findings about Fortis and Dr Raju’s behavior which is under scrutiny at the office of Hon’ble Lokayukta. The orders of KMC have also been challenged at MCI. Hon’ble High Court has issued emergent notices to MCI as to why the appeal should not be disposed off in three months.
9. Other violations of Transplantation of Human Organs Act:
a. Dr Ramcharan Thiagarajan (transplant surgeon) was also a part of the authorisation committee – ‘conflict of interest’ and violation of Rule 4A of Transplantation of Human Organ Rules. This by itself is an offence punishable under the Act.
Summing Up: In our country we respect doctors next to God and rightly so. Here we are not talking about medical negligence but breach of trust by resorting to deceit, lies and treachery. To sum up:
1. How can a nephrologist suggest a pancreatic transplant surgery to a patient who had not registered for pancreatic transplant merely because an organ was available without ever referring the patient to an endocrinologist?
2. How can doctors betray the trust of an innocent patient by suppressing the fact that they wanted to perform an illegal transplant surgery? (Section 18)
3. Why were risks not explained and informed consent taken from the patient as prescribed in Section 12 of the Act?
4. Why was the transplant surgeon a member of the authorisation committee?
5. Why was post mortem not suggested? Under what circumstances was the death described as ‘natural’?
6. Why was the matter not reported to the authorities for 10 months?
7. Why is a reference to Karnataka Medical Council being made time and again it is not the competent authority to investigate violations of Transplantation of Human Organs Act?
8. Why are enquiries conducted by Dr Raju/Mr Nayakstill referred to when Hon’ble High Court of Karnataka order of September 2011 supersedes them?
How does one respect doctors whose defence is lies and suppression of facts?