APOLLO SPECIALTY HOSPITAL & ANR. vs R. MUTHUKRISHNAN

The present appeal under Section 19 of the Consumer Protection Act, 1986 is filed against the order dated 26.5.2015 passed by the Tamil Nadu State Consumer Disputes Redressal Commission, Chennai (in short, ''the State Commission'') in C. C. No. 47 of 2010.

The respondent/complainant, on 11.2.2008 Shri R. Muthukrishnan took his 12 years old son, Master R. M. Vijaram (herein after referred as "the patient") to Apollo Speciality Hospital, (the 1 OP). Dr. Mrs. Revathy Raj, (OP 2) examined the patient and diagnosed it as Acute Myeloid st Leukemia (AML), the patient was in remission, given chemotherapy treatment. Thereafter, till 12.12.2008, the patient was normal, no specific complaints. It was alleged that, the OP 2 compelled and prevailed upon the patient to undergo Haplo Identical Stem Cell transplantation (Bone Marrow Transplant (BMT)) treatment urgently. Therefore, patient got admitted in OP 1/Hospital for BMT treatment on 3.12.2008. The BMT was performed on 16.12.2008. Thereafter, during further treatment, patient developed different complications and died on 17.4.2009. The complainant alleged that, the death was due to post BMT Febrile Neutropenia, CMV Nephropathy and acute renal failure. It was happened due to negligence of OP 1/Hospital. The doctors failed to perform tests to rule out any possibility of the presence of CMV virus in the patient. CMV test was done at delayed stage i.e. 29 day of post BMT, it was detected on th 4.2.2009. After the said report, the specialist in infectious diseases Dr. Abdul Gaffar prescribed ''Foscarnet'' medicine but the same was not available in the pharmacy attached to OP 1/hospital. Even no steps were taken by OP-1 to procure the said medicine. The doctor/OP 2 advised Gancyclovir even though knowing that it was resistant to CMV in the patient. Ultimately, the boy/patient died on 17.4.2009. The complainant''s further alleged that the patient was referred to Dr. Chendi at CMC Vellore. He did not give any opinion but the doctors at OP 1 performed Haplo Identical Stem Cell transplantation (BMT). During the period from 10.4.2009 to 17.04.2009, OP 2 left for abroad, therefore, the patient was left without proper care. Thereafter, the doctors of OP 1 hospital instead of giving palliative treatment, adopted DNR (do not resuscitate) protocol, which ultimately led to the death of patient. It was further alleged that the hospital did not issue medical record within 72 hours of request, thus it''s violation as per MCI regulations. Hence, alleging medical negligence on the part of OPs, the complainant filed a complaint before the State Commission, Chennai.

The State Commission after going through the evidence and medical record, allowed the complaint and directed the OP to pay Rs. 20 lakhs as a compensation and Rs. 3 lakhs towards mental agony whereas, the State Commission dismissed the complaint against OPs 3 to 5 without any costs.

We have heard learned counsel for both the parties. Mr. S. Dayaleswaran, counsel for the complainant during argument made same submissions as stated in the complaint. He further submitted that there was no informed consent regarding the BMT. He brought our attention to the consent form, which depicts that the risk mentioned was 50% mortality within 100 days but, the OP in its written submission mentioned that, the survival rate in BMT procedure is only 5 to 10%. Thus, the OP took the consent by misrepresentation and suppression of material facts. OP/doctors failed to disclose necessary and adequate information to the complainants before consenting for BMT.

We have perused the order of State Commission, the medical text and the voluminous medical record, which is running in four volumes about 3000 pages.

The learned counsel for OP, further submitted that, even after two initial cycles of chemotherapy as per UKMRC AML Protocol, the patient did not respond. The specialist Dr. Jose and Dr. S. G. Ramanan was consulted by the complainant, according to them a very high risk schedule of treatment called CAT Chemotherapy used in refractory AML. The patient responded

to this treatment and was in remission but such a response is only for short period and is not curable. Therefore, the patient was sent for opinion from Dr. Chendi at CMC Vellore and thereafter it was decided perform Haplo Identical transplantation BMT. As the patient''s mother''s cell was half matched with the patient. The complainant was advised that the survival chance without transplant was close to 0% and even with high risk transplantation the survival was only 5% to 10%. The high risk involved in the BMT was also explained to the Complainant, who agreed for the same and signed the informed consent form (Ex. B37). A full matched stem cell was needed for doing the BMT. When the patient''s family members were checked as BMT donor but none of them matched with the patient. Dr. Jose made extensive worldwide search for the stem cell donor during 5.5.2008 to 12.12.2008 (6 months) about 20 million donors including cord and marrow were considered but no HLA matching was found with the patient. During the search period, chemotherapy cycles were continued to prevent a relapse. As time was an essence for treatment due to non-availability of a full matched stem cell donor, the patient was advised to undergo Haploid (half) identical stem cell transplantation. Since the patient''s mother''s cell half matched with the patient''s cell with the high risk, informed consent was taken before BMT. Special permission and special instruments were brought from Delhi and the transplantation was performed on 16.12.2008.

In the instant case, the OP 2 left for abroad, but in her absence, the patient was under palliative care of Dr. S. J. Ramanan, Senior Oncologist and Dr. M. Deenadayalan Paediatrics from 10.4.2009 to 17.4.2009. Therefore, we don''t accept that no specialist or penal doctor attended the patient during that period. Regarding the palliative care, it is a supportive care only and given to the patient when no longer response to the curative treatment. After BMT, even with the best efforts the patient died on 17.4.2009.

Regarding treatment of CMV infection, Gancilovir is a standard drug used. The Cidofovir and Foscarnet are second line drugs for CMV infection resistant to Ganciclovir and since Foscarnet was not available Cidofovir was started.

After our thoughtful consideration, it is an admitted fact that, the 2 OP Dr.Revathy, is a nd highly qualified specialist doctor, and the associated team of doctors are also experts in their field. The OP-2 has adopted UK MRC AML Protocol in treating the patient. Thus OPs have treated the patient as per standard medical protocol; therefore it was not a deficiency or negligence in the treatment.

Regarding the consent as alleged by the complainant that OPs made misrepresentation about utility of BMT Haplo Identical Stem Cell transplantation, we have perused the consent form. In our view, the consent was properly taken. It was the "Informed consent for Bone Marrow Transplanation of Haplo Identical Stem Cell transplantation" . The consent form clearly mention about advantage and disadvantages of different alternative treatment. It was taken by the consultant Dr. Ravathy Raj. It was properly signed by the patient''s father. It is pertinent to note that, a handwritten submission dated 4.12.2008 was made in the same consent form, it is reproduced as below: "High risk consent explained to father. Haplo graft relapse + infection can cause mortality of 50% in the first 100 days.

Sd/-

Dr. Ravathy Raj.

We have perused ''DO NOT RESUSCITATE" form. It was also signed by father of the patient on 8.8.2009 in presence of Dr. Ravathy Raj. It is reproduced as below:- "FOR "DO NOT RESUSCITATE"

I, Muthukrishnan, Parent of Vijay Ram admitted in Bed No. 1329 have been explained in detail by the Primary Consultant and the ICU team that my son is suffering from RELAPSED AML. I have also been explained in depth about the disease and its grave prognosis. It has also been explained to me in detail that my son, Vijay Ram can suffer a Cardio respiratory arrest which will be life endangering.

I after detailed discussion with the rest of the family have decided "NOT TO RESUSCITATE" MY SON Vijay Ram in the event of an arrest.

We know that "NOT RESUSCITATING" will result in the death of my son Vijay Ram. All the conditions and resulting consequences have been explained to me in detail in the language that I fully understand.

I will not hold the Doctors/Nurses or any other employee of Apollo Speciality Hospital responsible for the outcome what so ever. This undertaking I give of my own free will, being of sound mind without any duress what so ever.

Doctors Signature Signature Sd/-

Relationship father

Name : R. Muthukrishnan

Date & Time 08/04/2009"

We have gone through research literatures on this subject of Haplo Identical BMT. In the article " Advances in haplo-identical stem cell transplantation in adults with high-risk haematological malignancies [World J Stem Cells 2014 September 26; 6(4) : 380-390", it is mentioned as: "Allogeneic bone marrow transplant is a life-saving procedure for adults and children that have high-risk or relapsed haematological malignancies. Incremental advances in the procedure, as well as expanded sources of donor hematopoietic cell grafts have significantly improved over all rates of success. Yet, the outcomes for patients for whom suitable donors cannot be found remain a

significant limitation. These patients may benefit from a hematopoietic cell transplant wherein a relative donor is fully haplotype mismatched. Previously this procedure was limited by graft rejection, lethal graft-versus-host disease, and increased treatment ?related toxicity. Recent approached in haplo-identical transplantation have demonstrated significantly improved outcomes. Bases on years of incremental pre-clinical research into this unique form of bone marrow transplant, a range of approaches have now been studied in patients in relatively large phase II trials that will be summarized in this review."

In another article " Haploidentical vs. identical-sibling transplant for AML in remission: a multicentre, prospective study [BLOOD, 18 JUNE 2015 X VOLUME 125 NUMBER 25", it clarifies as :

"Acute myeloid leukemia (AML is a common hematologic malignant disease. HLA-identical sibling donor (ISD) hematopoietic stem cell transplantation (HSCT) offers significantly improved overall survival (OS) for intermediate-or high risk AML patients comparied with chemotherapy alone; thus, it is recommended as a first-line postremission treatment in this clinical situation. Recent progress in haploidentical donor (HID) transplantation provides the benefits of rapid and near-universal donor availability. However, whether haploidentical HSCT could serve as a first-line postremission therapy in intermediate or high risk AML remains to be determined."

Similarly, the article " Haploidential Stem Cell Transplantation Producing Good Outcomes, Expanding Transplant Pool" revealed same information.

As per medical text books on the Haematological malignancies and Bone Marrow Transplant, the disease AML is a dreaded disease of blood cancer, and due to suppression of immune system during the treatment, most of the patients develop several side effects like infections such as tuberculosis, CMV. Therefore, such patient needs a holistic treatment approach. In the instant case, the patient was monitored by CMV investigations and accordingly the medication was given. The patient was already immunocompromised, thus develops infections and there was no cure. In our view, it can''t be considered to be a medical negligence or deficiency in service by the treating doctors.

In the instant case, extensive search was made by OP for matching BMT but no matching donor was identified. Therefore, the expert opinion of Prof. Mammen Chandy from CMC Vellore was also sought for Haploidentical BMT. As per the medical literature, Haploidentical BMT is novel procedure where mismatch stem cells are treated with monoclonal anti bodies to prevent graft vs. host diseases a dreaded complication of mismatch transplantation. The over all survival rate in the cases of Haploidentical BMT is 5 to 10 %. The death of the patient was due to number of known complications, which are consequences of BMT. In our considered view, there was no medical negligence either in the procedure of BMT or in the care during post BMT complications. The patient was treated with proper informed as discussed by Hon''ble Supreme Court in Samira Kohli''s case 2008 (1) CTC.

Therefore, on the basis of forgoing discussion, we set aside the order passed by the State Commission and allow this appeal. Consequently, the complaint is dismissed. There shall be no order as to costs.