Gujarat High Court
Chandravadan Rangildas Dhruv vs State Of Gujarat & 1....Opponent(S) on 25 April, 2017
Author: R. Subhash Reddy
Bench: R.Subhash Reddy, Vipul M. Pancholi
C/WPPIL/182/2016 ORDER
IN THE HIGH COURT OF GUJARAT AT AHMEDABAD
WRIT PETITION (PIL) NO. 182 of 2016
With
CIVIL APPLICATION NO. 3283 of 2017
In
WRIT PETITION (PIL) NO. 182 of 2016
With
CIVIL APPLICATION NO. 12008 of 2016
In
WRIT PETITION (PIL) NO. 182 of 2016
==========================================================
CHANDRAVADAN RANGILDAS DHRUV....Applicant(s) Versus STATE OF GUJARAT & 1....Opponent(s) ========================================================== Appearance:
PARTY-IN-PERSON, PERSONAL CAPACITY for the Applicant(s) No. 1 MS MANISHA SHAH, G.P., ADVANCE COPY SERVED TO GP/PP for the Opponent(s) No. 1 MR KAMAL B. TRIVEDI, SENIOR ADVOCATE WITH MS SK VISHEN, ADVOCATE for the Opponent(s) No. 2 NOTICE SERVED for the Opponent(s) No. 1 ========================================================== CORAM: HONOURABLE THE CHIEF JUSTICE MR. R.SUBHASH REDDY and HONOURABLE MR.JUSTICE VIPUL M. PANCHOLI Date : 25/04/2017 ORAL C.A.V. ORDER (PER : HONOURABLE MR.JUSTICE VIPUL M. PANCHOLI)
1. This writ petition, in the nature of public interest litigation, has been filed seeking the following reliefs;Page 1 of 13
HC-NIC Page 1 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER "(A) Your honor may kindly accept this appeal.
(B) Your Lordships may be pleased to consider the facts and contents of this application and to issue notice to the State Government to constitute new inquiry committee of experts of three Doctors from the Department of Health and Family Welfare, Govt. of Gujarat and submit the neutral report at the earliest.
(C) Your Lordships may be pleased to give necessary direction to take appropriate action against the negligence by Doctors and staff in the blindness issue as per law prevailing.
(D) Your Lordship may be pleased to issue necessary direction for stern action against three Doctors panel those who have not made proper inquiry and misused the power delegated as Expert Doctors and gave clean chit to all Doctors and staff without going into the merits.
(E) In this blindness issue, a departmental inquiry and criminal offence may please be registered against all those who are liable for causing such loss to the victims permanently and put their families in unavoidable trouble.
(F) Your Lordships may be pleased to issue necessary direction to Ahmedabad Municipal Corporation to take proper care for treatment and to protect patient's rights.
(G) to (I) ..."
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C/WPPIL/182/2016 ORDER
2. The facts in a nutshell are as under; On 13.01.2016 a news item was published in a local daily that about 16 patients, who had undergone treatment of the eyes at M/s. C.H. Nagri Eye Hospital [hereinafter referred to as "the Hospital" for short], had lost their vision, after being administered a drug, named, Avastin 100 Mg (Bevacizumab) during a followup visit on 12.01.2016. On the very same day, all the patients were admitted and given necessary treatment. For the purpose of investigating the incident, the respondentCorporation constituted a three member Inquiry Committee. The Directorate General of Health Services, Central Drugs Standard Control Organization, New Delhi issued an Alert Notice dated 21.01.2016 restricting the use of the drug - Avastin for ophthalmic treatment in the country as a precautionary measure.
2.1 It is the say of the petitioner that he had filed a complaint against the Hospital authorities before the Gujarat State Human Rights Commission. However, vide communication dated 01.03.2016, the Gujarat State Human Rights Commission refused to take any action in the matter on the ground that the petitioner was not a victim in the alleged incident and that he had not been authorized by the victims to represent their case.
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C/WPPIL/182/2016 ORDER
2.2 Being aggrieved by the inaction on the part of the respondentauthorities, the petitioner has preferred the present writ petition before this Court.
3. It is contended by the petitioner, partyin person, that the Doctors and paramedics, who gave treatment to the patients on 12.01.2016, had not exercised the required degree of care while treating them. They acted in a negligent and careless manner, which resulted into the loss of vision of the patients. It was submitted that if a medical practitioner fails to exercise reasonable skill and care, then he would lose immunity from an action in tort and he could be sued on such ground. However, the respondent authorities shielded the Doctors and paramedics and did not take any action against them. Hence, appropriate action deserve to be taken against the Hospital authorities for their negligence and inaction.
3.1 The petitioner further submitted that the Inquiry Committee constituted by the respondent Corporation gave a clean chit to the Doctors and paramedics, though it was found that the patients had lost their vision, after being administered the drug by the Doctors of the Hospital on 12.01.2017. It was contended that the Report submitted by the Inquiry Committee Page 4 of 13 HC-NIC Page 4 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER constituted by the respondentCorporation does not reveal the true facts, as the Members were handpicked by the respondentCorporation and were not independent. Further, the Gujarat State Human Rights Commission also refused to take any action in the matter. It was, therefore, submitted that appropriate directions deserve to be issued in the matter to safeguard the interest of the public at large and to restore trust in a Government managed Hospital.
4. Mr. Kamal Trivedi, learned Senior Advocate appearing on behalf of respondent no.2 Corporation, submitted that the present petition is filed on the basis of newspaper reports published on 13.01.2016. The alleged incident took place on 12.01.2016 whereas, the captioned petition was filed in the month of August 2016. If the petitioner was concerned about the health of the victims, then he ought to have filed the petition immediately after the incident was reported. The fact that the writ petition was filed belatedly speaks volumes about the conduct of the petitioner. This shows that the petitioner has not come before the Court with clean hands. It was, therefore, submitted that the present petition deserves to be dismissed on the ground of delay itself.
4.1 Learned Senior Advocate contended that the patients were given treatment after obtaining Page 5 of 13 HC-NIC Page 5 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER written consent and by following the standard protocol of treatment. Further, to ascertain whether the drug in question was of standard quality, the Food and Drugs Control Administration had sent the entire Batch of drug for Lab Testing. On such testing, it was found that the drug was of standard quality. Therefore, no fault can be found with the Doctors concerned or the medicine that was administered to the patients. The patients, who complained of loss of vision and other related issues, were diabetics, hypertensive, etc. and also suffered from age related issues. It was, therefore, submitted that Doctors and paramedics of the Hospital could not be held guilty in any manner whatsoever.
4.2 Learned Senior Advocate Mr. Trivedi further submitted that all the three members of the Inquiry Committee were independent and none of them were, in any manner, affiliated or associated with the Hospital. Therefore, it cannot be said that the report of the Inquiry Committee was influenced or that it was not impartial. It was, therefore, prayed that the present petition deserves to be dismissed.
5. Ms. Manisha Shah, learned G.P. appearing for respondent no.1State, adopted the arguments made by learned Senior Advocate Mr. Kamal Trivedi appearing for the respondentCorporation.
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C/WPPIL/182/2016 ORDER
6. We have heard learned counsel for both the sides and perused the material on record. The main grievance raised by the petitioner is that the 16 patients, who took treatment at the Hospital on 12.01.2016, suffered loss of eye sight owing to the drug administered to them.
7. Before we proceed further, it would be pertinent to note that in this matter, Notice was issued on 07.09.2016, making it returnable on 28.09.2016. Thereafter, the matter was listed on different dates. In February 2017, the petitioner, partyinperson, filed Civil Application No.3283 of 2017 with the prayer to direct the respondentauthorities to file reply affidavit in the main mater and other ancillary reliefs. In the said Civil Application, this Bench passed the following order on 08.03.2017;
"Today, when the matter is called, additional affidavit is filed on behalf of respondent no.2 in the main petition. In the said additional affidavit, it is categorically stated that all the sixteen patients are fully recovered from the temporary drop in the vision and nobody is blind amongst them. The same is disputed by the partyinperson, Mr. Chandravadan R. Dhruv and seeks time to file further affidavit. Stand over to 22.03.2017 in the caption "for orders"."Page 7 of 13
HC-NIC Page 7 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER 7.1 On 22.03.2017 the petitioner sought time to file further affidavit. However, the fact remains that until the matter was finally heard on 29.03.2017, no further affidavit was filed by the petitioner disputing the averment that the patients had completely recovered from the temporary drop in vision and that none of them had become blind.
8. In view of the aforesaid factual scenario, we find no merit in the allegation levelled by the petitioner that the 16 patients had become blind owing to the drug administered by the Hospital on 12.01.2016. In fact, the record shows that the Hospital authorities took prompt action in the matter by giving necessary treatment to the patients on the very same day. All the patients regained their eyesight by the time they were discharged from the Hospital after about a week, which is evident from the additional affidavit filed by respondent no.2 and which has remained uncontroverted. Though some of the patients complained of temporary loss of vision at the relevant time but, none of them lost it on permanent basis. Further, the record also reveals that the patients were suffering from different ailments like diabetes, hypertension, etc. and other agerelated issues, which would have a Page 8 of 13 HC-NIC Page 8 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER considerable bearing on the effect of the drug on the human body. All the patients had given written consent for undergoing the treatment and they were appraised about the sideeffects of the medicine and the course of treatment. Hence, we find no substance in the allegation that the patients lost their eyesight on account of the drug administered to them by the Hospital authorities on 12.01.2016.
9. The petitioner has also alleged that the Report submitted by the three member Inquiry Committee constituted by the respondent Corporation is not independent and is influenced. The petitioner has not produced any documentary evidence on record to substantiate the same. In fact, it appears from the record that no Member of the Inquiry Committee is/was associated with the Hospital in any manner whatsoever. All the Members were independent and were employed with different Hospitals/Medical Colleges. Therefore, it cannot be said that the report submitted by the Inquiry Committee is biased or is influenced by the respondentCorporation.
10. It is pertinent to note that the Inquiry Committee, after thorough examination, found no shortfall or lacunae in the procedure of standard protocol followed by the medical and Page 9 of 13 HC-NIC Page 9 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER paramedic staff of the Hospital. The Committee opined that after the incident was reported, the response of the Hospital was very prompt. This is evident from the fact that the affected patients were admitted in the Hospital on 13.01.2016 itself and were kept under constant supervision and were given necessary treatment. The services of Expert Doctors in the field was also taken on the same day and on subsequent dates and after about a week, all the patients were discharged from the Hospital with proper vision in both the eyes. The record also shows that on 15.01.2016 the officials from the Food and Drugs Control Administration collected informal samples from the Batch of Injections for analysis. After carrying out the tests, the authority opined that the Injection vial was of standard quality. Hence, it cannot be said that the drug administered by the Hospital authorities was of substandard quality.
11. Further, vide Notice dated 09.03.2016, the Directorate General of Health Services, Office of the Drugs Controller General (India), withdrew the Alert Notice dated 21.01.2016, on the basis of the recommendations of the Expert Committee constituted by the Government of India in pursuance of the incident in question. The relevant portion of the Notice dated 09.03.2016 Page 10 of 13 HC-NIC Page 10 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER reads as under;
"..The Committee examined and deliberated on the use of Bevacizumab Injection in Ophthalmologic conditions as an offlabel indication and following observations were made by the Committee:
1. Bevacizumab Injection is not approved by global regulatory authorities for intravitreal use due to nonapplication by the Innovator for this purpose. However, WHO (April 2015) has recommended Bevacizumab Injection by including in the list of essential medicines prepared as antivascular endothelial growth factor in ophthalmic section based on recommendation of International Council of Ophthalmology (ICO). Further, regulatory agencies of France and Italy have allowed its offlabel use as a Temporary Recommended Use (TRU).
2. The safety and efficacy of Bevacizumab injection in intravitreal use is stated to be proven by various independent studies (over 2500 studies published) conducted globally. It was discussed that rate of endophthalmitis is significantly lower after the injection of Bevacizumab Injection as compared to standard cataract surgery.
3. The Bevacizumab Injection is 40 times cheaper than other available drug (Ranibizumab Injection) for same use and equally effective in India. This would put less financial burden on patients and prevent blindness of many.
Based on the above facts, following recommendations were made by the Committee:
The Office of DCG(I) was requested to Page 11 of 13 HC-NIC Page 11 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER take necessary measures to withdraw the Alert Notice issued on 21.01.2016 which was primarily issued as a precautionary measure in the light of the incidences of blindness reported in Gujarat. Further, it was proposed that All India Ophthalmological Society (AIOS) and Vitreo Retinal Society of India (VRSI) will formulate guidelines for safe and effective use of Bevacizumab Injection for Ophthalmic purpose based on the written informed consent as practiced globally for offlabel use under appropriate environmental conditions by skilled ophthalmic surgeons based on riskbenefit analysis. They will further ensure that appropriate training and awareness may be imparted to its members.
The Ministry of Health and Family Welfare, Government of India has accepted recommendations of the Committee. Accordingly, this notice is issued."
12. In view of the above discussion, we find no substance in the allegations made by the petitioner in this petition. The Report of the Foods and Drugs Control Administration proves that the Drug administered to the patients was of standard quality. The record also shows that the Hospital authorities took prompt action in the matter by giving necessary treatment to the patients and though the patients complained of temporary loss of vision but, all of them regained their eyesight by the time they were discharged from the Hospital, which is established from the additional affidavit filed Page 12 of 13 HC-NIC Page 12 of 13 Created On Mon Aug 14 06:45:56 IST 2017 C/WPPIL/182/2016 ORDER by respondent no.2. The above aspect has not been controverted by the petitioner by filing any further affidavit or by producing any material on record to that effect. Hence, we do not find any merits in the present petition.
13. In the result, the petition is dismissed. Notice is discharged. Consequently, the Civil Applications stand disposed of.
(R. SUBHASH REDDY, CJ) (VIPUL M. PANCHOLI, J.) Pravin/* Page 13 of 13 HC-NIC Page 13 of 13 Created On Mon Aug 14 06:45:56 IST 2017