DR. S.M. KANTIKAR, PRESIDING MEMBER   

1.   This Revision Petition has been filed under section 21(b) of the Consumer Protection Act, 1986 by the Petitioner i.e. Fortis Health Management (North) Limited Escorts Heart Institute Research Centre, (hereinafter referred to as the ‘Opposite Party No.1’) against the Impugned Order dated 09.02.2011 passed by State Consumer Dispute Redressal Commission, Haryana (for short ‘the State Commission’) in First Appeal No. 1304/2003 wherein the Appeal was dismissed and the Order of the District Forum was confirmed.
2. The issue relates to alleged medical negligence with respect to dosage of Acitrom.
3.  The Case of the Complainant is that, on 03.02.1997 Santosh Modi (since deceased- referred to as ‘the patient’) for her respiratory problems was admitted under care of Dr. S.S. Bansal (OP-2) in Fortis (Escorts) Hospital & Research Centre (OP-1 Hospital). Prior to admission, the patient was taking tablet Acitrom 2 mg for her heart ailment as prescribed by Batra Hospital and it was informed by the patient’s husband to OP-2 but the OP-2 did not pay any heed to it. It was alleged that on 07.02.1997, the treating doctor OP-2 doubled the dose of tablet Acitrom from 2 mg to 4 mg. Thereafter, from the same day the condition of patient started deteriorating with some feeling of lower abdomen lump, Constipation and breathing problem. The treating doctors diagnosed it as twisting of intestine and advised immediate operation. She became critical further on 10.2.2007 and got discharged from the Hospital. Her husband immediately shifted her to the Apollo Hospital, New Delhi. The doctors at Apollo Hospital diagnosed it abdominal bleeding, but not twisted intestine or extension of flesh as diagnosed by the OP-2. The doctors at Apollo Hospital told due to the double dose of Acitrom (4 mg) was the reason for abdominal bleeding. Being aggrieved the Consumer Complaint was filed by the patient herself with her husband and other legal heirs. During the pendency of this case she expired and her legal heirs were brought on record.  
4. The Opposite Parties hospital and treating doctor filed their replies and denied the allegation of wrong treatment. It was submitted that,  Prothrobin Time (PT) test   was conducted on 4.2.1997, 5.2.1997, 6.2.1997 and 10.2.1997. The patient was closely monitored for the PT/INR values. If INR values below the optimum prescribed range, the dosage of ACITROM could be  safely increased. It would be without increasing risk of internal bleeding.   The OP-2 stated that on 7.2.1997 the dose of ACITROM was increased to 4 mg as the PT/INR  showed improvement on 8.2.1997, the Acitrom was continued. The OP-2 had suggested the Complainant to surgically open the abdomen in order to diagnose the cause of her problem for the proper treatment. Thus, the Opposite Parties prayed for dismissal of the complaint.
5. The District Forum allowed the Complaint and directed the Opposite Parties Nos. 1 & 2 to pay Rs.1,58,778/- to the Complainant alongwith the interest @ 12% p.a. from the date of filing of the Complaint.     
6. Being aggrieved by the Order of the District Forum, the Opposite Party No. 1 filed First Appeal No. 1304/2003 before State Commission, Haryana. The appeal was dismissed.
7. Being aggrieved by the order of the State Commission, the Petitioner/Opposite Party No. 1 preferred this Revision Petition.
8.  We have heard the arguments from the learned counsel for both the sides and gone through the material on record, the literature on Acitrom. The learned counsel on both the sides reiterated their submission made before the State Commission.    
9. We gave our thoughtful consideration and gone through the medical literature and text from Brauawald's Cardiology (10^th ed). It is pertinent to note that the patient already had undergone Mitral Valve Replacement (MVR) surgery and she had  high risk of the blood clotting which might be sometimes fatal.   Therefore,   the dosage of Acitrom from 2 mg to 4 mg. At the time of admission, PT/  INR was low 1.0,  which was abnormal in the instant patient. In our view, therefore it was not deviation from standard medical practice. It is evident that on 08.02.1997 INR value was 4.1, i.e. well within the therapeutic range for the patients with MVR.
10. The District Forum wrongly relied upon the discharge summary of Apollo Hospital. We note that the State Commission without considering the merits   affirmed the Order of District forum and dismissed the Appeal by relying upon the judgments of Hon’ble Supreme Court in the cases V. Kishan Rao's Case[1]   and Achutrao Haribhau Khodwa's case[2].   

11.     As per the literature[3]  the Thrombosis and Thrombo-embolsim   risks are greater with any mechanical valve in the heart, therefore,  higher doses of blood thinners are generally recommended. Without proper anti coagulation incidence of thromboembolism is 3-6 times higher. At the time of admission the patient was presented with breathlessness, a symptom of thromboembolism.   

12.     During the proceedings before this Commission an opinion from expert medical board of AIIMS was sought on the few points.  The opinion of AIIMS is reproduced as below:

1. Is ACITROM dose fixed?      Answer-NO
2. Does ACITROM dose required adjustment according to FT INR value?

         Answer-YES

3. Can bleeding occur with any dose of ACITROM? Answer-YES
4. Can PT with INR value change due to diet antibiotics and other    

          medicine etc.? Answer-YES

5. Was the cardiologist justified in increasing the dose with low

          prothrombin time INR value? Answer-YES

13.     In our view, considering the critical signs of the Patient, the dosage of Acitrom was increased. It was consistent with the international standards as laid down. The PT/INR  test was conducted by the Petitioner on a regular basis. The INR level   for the patients with Prosthetic Heart Valves,   should be in the therapeutic range of 3.5-4.5. Thus INR  value of 1.0 in the instant patient at admission was indication of  the blood was not thin enough to prevent coagulation. Therefore, there was need for increase dose of Acitrom  for further thinning of the blood.  It is pertinent to note that after on 8.02.1997 the INR value was 4.1 (within the limit of 3.5-4.5).

14.     We would like to rely upon the ratio laid down by the Hon'ble Supreme Court in Samira Kohli Vs Dr Prabha Manchanda & Anr[4]  case

“it is for the doctor to decide, with reference to the condition of the patient, nature of the illness and the prevailing established practices as to how much information regarding the risk and consequences should be given and how they should be couched in the best interest of the patient.  A doctor acting accordingly with normal care and in accordance with a recognized medical practice cannot be said to be negligent merely because body of opinion taken a contrary view.  In modern medicine and surgery dissection of the various things a doctor has to do in the exercise of his whole duty of care owned to his patient is neither legally meaningful nor medically practicable."

In the another recent judgment of Hon’ble Supreme Court in Bombay Hospital & Medical Research Centre Vs. Asha Jaiswal & Ors.[5] Hon’ble  Bench added that  

“In spite of the treatment, if the patient had not survived, the doctors cannot be blamed as even the doctors with the best of their abilities cannot prevent the inevitable...The doctors are expected to take reasonable care but none of the professionals can assure that the patient would overcome the surgical procedures.”

15.     Considering the entirety and relying upon the medical literature, following the law laid down by the Hon’ble Supreme Court, in our view the State Commission and District Forum failed to appreciate that the Patient already had undergone MVR surgery with Artificial Valve and at the risk of thromboembolism. Increase in the dose of Acitrom was justified. The act of OP-2 was neither act of commission nor any deviation from standard of practice. OP-2 is a cardiologist and took a decision with his acumen. 

16.     The Revision Petition is accordingly allowed and the Order of State Commission is set aside.

However, there shall be no order as to costs.

We express our gratitude to the learned amicus curie for his prompt assistance during the proceedings.