Order by Maharashtra State Consumer Disputes Redressal Commission

(Consumer Court)

Order in Civil Suit before Maharashtra State Consumer Disputes Redressal Commission; They too have implicated serious ADRs of Cipla injection Rokfos [Evidence documents pages 68-87].

OP1 & OP2 (Treating doctor, Dr. Mihirgiri Goswami and Maruti Nursing Home):

Were negligent in prescribing and administering injection Rokfos.
On the day of admission in the evening, she was given injection Rokfos.
Without ascertaining indications as per special literature provided by manufacturer Cipla company, this injection was given.
At Maruti Nursing Home, blood was checked daily and reports were available. From the date of admission on 9th June 2014 to 14th June 2014, there was progressive reduction in the values of white blood cells, platelets and haemoglobin. These values were not reviewed in time by the treating doctors which later on surfaced as pancytopenia due to bone marrow failure and led to Aplastic Anaemia.
OP1 & 2 failed to diagnose bone marrow failure in time with subsequent Aplastic Anaemia.
Maruti Nursing Home purchased medicines and sold to the patient when it was not having valid license to hold stock of medicine.
Maruti Nursing Home did not hold pharmacy licence to procure and sell medicines.
We are of the opinion that Rokfos was prescribed Ad Hoc and was given to the patient without looking into the indications for the injection.
There were manipulations in record as the later on submitted medical record was different from the one that was handed over by the sister in the ward.

Opposite Party No.3 (Dr. Aafaque Dolare)

Dr. Dolare examined deceased patient on 12th June 2014 and gave fitness for surgery provided advised investigation CRP report comes normal.
OP3 did not review the blood reports and thus failed to consider diagnosis of bone marrow failure.

Opposite Party No.4 (Dr. Satyen Mehta).

Dr.Satyen Mehta, the neurosurgeon, who was supposed to operate upon the patient in Platinum Hospital examined the patient and advised investigations and medical fitness.
Dr.Satyen Mehta clinically diagnosed that patient was in septicaemia.
Since OP No.4 was the treating neurosurgeon, he should have reviewed the patient and should have informed the nature and seriousness of the disease. There is no document supporting his role in this regard.

Opposite Party No.5 (Platinum Hospitals).

OP No.5 failed to deliver the Indoor case records in time and also manipulated the medical records.
At Platinum Hospitals, the initial admission process on 14th June 2014 was not as per protocol. Discharge card from Maruti Nursing Home did not mention the serious nature of the disease.
For the copy of medical records Platinum Hospital was requested by complainant through application. He did not receive the same for more than a week period. He had to apply again.
There was incompleteness of medical record and also manipulation. The admission paper is incomplete, no plan of treatment mentioned, no documentation of serious condition of the patient informed to relatives, no documentation support that the patient was admitted in ICU of Platinum Hospital.
There is failure to maintain good record that is helpful in knowing the condition of the patient in the hospital, treatment planned and given, proper information given to the patient relatives and condition at the time of discharge, may it be against medical advice found lacking.

Opposite Party No.6 (Jupiter Hospital).

There was no act of commission or omission, deficiency in service or medical negligence by OP No.6.

There is no difference in Order by Maharashtra State Commission and Order by Maharashtra Medical Council.
That injection Rokfos was the cause of the disaster.

False Cause of Death in Death Certificate and how the serious ADRs were hushed up by around two dozen doctors at three hospitals; Maruti Nursing Home, Platinum Hospitals and Jupiter Hospital.

Bone Marrow biopsy report says ‘aplastic bone marrow’ [Evidence document page 88].
Cause of death given by Jupiter Hospital was septic shock with multi-organ failure [Evidence document page 89].
Death Summary – Aplastic Anaemia was not included in death summary by Jupiter Hospital. Death Summary lists the immediate and antecedent causes of death [Evidence document page 90]. ADRs which were responsible for death of my wife were also conveniently excluded in in-patient records of Jupiter Hospital as well as in death summary.
The weapon (meaning ADRs of injection Rokfos) that caused death of my wife was hidden by around two dozen doctors at three hospitals and by Cipla Ltd in collusion with FDA authorities.
Email from treating doctor, Dr. Mihirgiri Goswami dated 01/08/2014 to the Complainant [Evidence documents pages 91-93].
Diagnosis of Aplastic Anaemia was in bone marrow biopsy report. Sample for bone marrow was taken on 16/06/2014 i.e. next day after shifting the patient from Platinum Hospitals on the night of 15/06/2014 to Jupiter Hospital at 10.30 p.m.
The first line says “We are aware of the sad demise of Mrs Kamini Barkur at Jupiter ICU following diagnosis of Aplastic Anaemia leading to complications” [Evidence document page 91].

Written submissions are before Maharashtra Medical Council by treating doctor, Dr.Mihirgiri Goswami that the drug did not suit the complainant’s wife and that he immediately discontinued it [Evidence document page 1078].
Discontinuing the drug is a bizarre statement as the injection was infused within 15 minutes and reactions started after 20 hours. How could he discontinue it?
Reply to RTI Query by IPC (Indian Pharmacopoeia Commission) that Cipla Ltd has finally reported the ADRs to DCG(I), IPC (PVPI) and FDA [Evidence documents pages 252-254].
There was no need to hide known side-effects of an injection unless “Foul Play” was involved in manufacture or trial conducted on innocent patients.
Adulterated drugs manufactured at Cipla Goa Plant is exposed in USFDA warning to Cipla Ltd dated 25-02-2020 [Evidence documents pages 243-251].
There were more warnings by USFDA subsequently which means that Cipla Ltd is a perennial offender playing with lives by manufacturing adulterated drugs.

7. Trial on my wife is in the statements of doctors at Maruti Nursing Home in a meeting held on 22^nd August 2014 to discuss how the death was caused. [Evidence documents pages 549-673] submitted in my police complaints and before the State Commission and Maharashtra Medical Council.

The meeting lasted for two hours and forty-three minutes and was recorded by me without the doctors’ knowledge. Present were relatives of the deceased, Dr.Mihirgiri Goswami, Dr.Aafaque Dolare and Maruti Nursing Home ‘Accounts Officer’, Dr.Dubey. Dr.Satyen Mehta after agreeing to attend the meeting skipped it as also family doctor, Dr.S.L.Korgaonkar. Dr.Dubey was an ayurvedic doctor working for TPA Health Services involved in mediclaim business. He was also involved in selling Rokfos to other doctors and orthopaedics. The doctors admitted to the serious ADRs of injection Zoledronic acid never seen before.

Crucial points to decipher nexus between Cipla Limited and Maruti Nursing Home in transcripts of the meeting are the following :

The doctors admitted that Zobone was their regular brand of Zoledronic acid and Rokfos was their new brand which caused the disaster [Evidence document page 586].
The treating doctor said that it had been given to his mother also. That safe it is in all cases. It will turn out to be like this, who will understand? [Evidence document page 588].
Further said that he will never give now. That he will not give anyone. It has been given to his mother also, you can understand why he should be so much worried about giving it? [Evidence document page 588].
When questioned why did he give the drug, said that he planned for one day admission – Give today and discharge tomorrow. MRI was also not planned. Hence there was no MRI on admission. [Evidence document page 606].
Mediclaim doctor, Dr.Dubey said that he goes to 25 hospitals and three-four orthopaedics and gives Rokfos with full responsibility. His target was to ensure that there is no problem to treating doctor as well as the patient. That he had to balance both [Evidence document page 640].
Further said that, for bone support, this is a yearly injection and is commonly given but he never realized that this can cause such dramatic allergy or reaction. That he had never seen such serious adverse drug reactions of Rokfos ever before [Evidence document page 642].

8. Inferences drawn from the doctors’ statements :

It is clear that Cipla induced Maruti Nursing Home to switch to their brand of Zoledronic acid, Rokfos while their regular brand was Zobone. The treating doctor said that he will never give anyone again. Why should he be worried about giving it? This proves that Cipla Ltd was instrumental for Maruti Nursing Home administering drug Rokfos for minor bone problems like stiff neck, joint pains and bone pain.
That Rokfos was administered as a one-day admission to treat stiff neck. Obviously, this drug was given as an unauthorised ‘Clinical Trial’ to cure stiff neck in one day. Stiff neck is not in the indications of use of Rokfos.
Since the ADRs were so serious and never seen before, it mandated Cipla Drug Safety to investigate Rokfos all the more seriously rather than suppress the ADRs.
Cipla Ltd violated legal provisions; Schedule ‘M’ of Drugs and Cosmetics Rules. They were aware that Rokfos batch was sub-standard, specially manufactured for ‘Trials’ on vulnerable, innocent patients.
Who was Dr.Dubey to take responsibility of a drug manufactured by International Pharma Company, Cipla Ltd? What did he mean when he said that it was his target and responsibility that neither the patient nor doctor had any problem? What did he mean by saying that he had to balance both?
Obviously, these were specially manufactured batches for patients admitted to Maruti Nursing Home as well as for onward sales to other hospitals and orthopaedics. These were given for treating minor bone problems like stiff neck, joint pains, bone pain, etc. and given as ‘Clinical Trials’. It was Cipla who gave this responsibility to doctors at Maruti Nursing Home.
The statements by the doctors prove the excellent vendor-customer relationship between Cipla Ltd and Maruti Nursing Home.

9. Standard medical textbooks on Aplastic Anaemia.

These were produced by the Complainant as evidence before Maharashtra State Commission [Evidence documents pages 518-548] and key points were the following

The characteristic features of aplastic anaemia include pancytopenia.
Secondary aplastic anaemia is associated with exposure to certain drugs, chemicals, radiation or infectious agents.
Petechiae (rash) was observed by physician, Dr. Aafaque Dolare (Opposite Party No.3).
Petechiae may occur secondary to thrombocytopenia (low platelets) and pancytopenia is typical. Platelets are decreased.
Severe aplastic anaemia requires immediate treatment to prevent the dire consequences of serious pancytopenia.
Drug-Induced Thrombocytopenia – Many drugs have been associated with thrombocytopenia. A predictable decrease in platelet count occurs after treatment with many chemotherapeutic drugs due to bone marrow suppression. All drugs should be suspect in a patient with thrombocytopenia without an apparent cause.

Note : Drug Rokfos (Zoledronic acid) is a drug given only once in a year even to treat cancer diseases. It was administered to my wife for treating ‘Stiff Neck’.

More frequent in bone marrow failure is pancytopenia: anaemia, leukopenia and thrombocytopenia. It is important that the internist recognise the marrow failure syndromes as their prognosis may be poor if the patient is untreated.
Prognosis – The natural history of severe aplastic anaemia is rapid deterioration and death. Historically, provision first of RBC and later of platelets transfusions and effective antibiotics were of some benefit, but few patients show spontaneous recovery. The major prognostic determinant is the blood count.
All of the above were facts that occurred in death of my wife.