RASHTRASANT TUKADOJI MAHARAJ NAGPUR UNIVERSITY S. Dr. BABASAHEB AMBEDKAR COLLEGE OF LAW, NAGPUR MOOT PROBLEM 1

Transcription

1 RASHTRASANT TUKADOJI MAHARAJ NAGPUR UNIVERSITY S Dr. BABASAHEB AMBEDKAR COLLEGE OF LAW, NAGPUR 14 th JUSTA CAUSA NATIONAL LAW FESTIVAL MOOT PROBLEM 1 Ram Rahim Joseph (RRJ) is a right handed Indian Citizen who has been living in the city of Nagpur since quite some time. As of the year 2015, his age is 49 years. He is a respected member of the society and is a well known figure in the region around Nagpur. That, on 25 th December 2014, owing to Christmas, RRJ was celebrating Christmas at a social function which was organized by a charity association. During the function, RRJ suffered a small paralytic attack, which came to be diagnosed on 26 th December 2014 as a neoplasm in the left hemithorax, with erosion of ribs and vertebrae detected. That, RRJ was getting treated in the Government Owned and Controlled Medical College and Hospital at Sonegaon, (GOCMCHS) which is a suburban area of Nagpur and was in the vicinity to RRJ s house. The said neoplasm was not benign, in situ, or malignant in nature. That, the cardiothoracic surgeon as well as the neurosurgeon who were treating RRJ knew that the condition of RRJ was critical and also that in order to save RRJ s live some drugs which are not normally available within India would have to be administered, though their efficacy in RRJ s case was questionable. While having a casual chat with some friends over the weekend, one of the doctors happened to mention this to Mr. Matrix, in the presence of the other doctor. Mr. Matrix owns and controls a huge pharmaceutical company which is engaged in research and designing of new drugs as well as manufacturing them. During research, it came to be known that the special type of tumour that Mr. RRJ was suffering from is in fact curable by 100 % when a combination of specific drugs is administered to him. However, the said research was merely done via using computer stimulation and no animate objects were tested with this finding. Accordingly, a combination of Isothipendyl, Sotalol, Phencylidine and Paracetamol came to be prepared by Mr. Matrix s company. Subsequently, Devil s Cure Inc., Mr. Matrix s company, applied to the licensing authority for permission to manufacture this new combination drug by 1 Drafted by Deoul Pathak, Advocate, Nagpur Page 1 of 5

2 making necessary payments as well by doing necessary paper work. However, the data as is required to be submitted under clause (2) of the relevant section of the Drugs and Cosmetics Act, 1940 did not come to be submitted. The entire procedure came to be done on 2 nd February The said application came to be rejected on 3 rd February Thereafter, on 4 th, the next day, an application came to be made for conducting clinical trials. The said application came to be allowed. That, Devil s Cure Inc. sought the tests to be conducted at GOCMCHS. The same request was also allowed. The said trials at GOCMCHS were approved conditionally by the Ethics Committee, subject to the following conditions: a. That, consent of all patients being treated with the drug under testing was mandatory in writing, in the form of an affidavit before the duly qualified notary and the said affidavit was to be prepared in the language which was understood by the patient b. That, consent of patient s relative (necessarily a class one heir) was necessary in writing, in the form of an affidavit before the duly qualified Executive Magistrate and the said affidavit was to be prepared in the language which was understood by the patient as well as his relative in common c. That, the patient gave up his right to file any proceedings before any judicial / quasi judicial body, in case of any medical negligence d. That, the patient was made aware of all the treatment administered, in writing e. That, it would be mandatory for Devil s Cure Inc. to adhere to all provisions of necessary Indian laws regarding public liability insurance. That, needless to mention, RRJ was one of the subjects who was tested with the said newly prepared combination drug. That, unfortunately, due to complications arising in treatment, the DNA of RRJ underwent a small change, which resulted in his ability to do loco motor movements of the last toe of the left leg being hampered. This was despite of the ex majore cautela being taken by the Doctors treating RRJ. Unfortunately, the situation and condition of RRJ as demonstrated also required for administration of Imatinib Mesylate, which is a therapeutic drug for chronic myeloid leukemia, the sole marketing rights for which, then, due to some interim orders were with another company called as Baarish, whose drugs came to be known to the Doctors and Mr. Page 2 of 5

3 Matrix s company by way of their coming soon teasers, claiming cure to the said disease. Since, the drugs of Baarish were also under trials, with due permission from the Ethical Committee in Indian Institute for Medical Sciences (IIMS), it became mandatory for Devil s Cure Inc. to add Baarish as a co-applicant in its application for permission of clinical trials, by way of an amendment. The said amendment was permitted. Being aggrieved by this utter hopelessness, RRJ filed a criminal proceeding against both the Doctors - cardiothoracic surgeon and neurosurgeon Dr.Mr. Tea and Dr.Ms. Coffee alleging medical negligence and consequent attempt to murder, grievous hurt, hurt, bodily harm, et cetera. That, RRJ, through his relative Akku Yadav also filed a proceeding before the National Consumer Disputes Redressal Forum on the same grounds of medical negligence claiming a compensation of Rs. 8,00,00,000/- (Rupees Eight Crores Only). That, RRJ also filed a Writ Petition before the Nagpur Bench of the Bombay High Court praying that he should be granted a permanent sum of money for the harassment done to him on account of those medical trials out of the funds and proceeds of the income of the pharmaceutical companies as his share and contribution to the drugs being sold in the market cannot be negated. The said Writ Petition was dismissed. The Letters Patent Appeal before the Division Bench is pending. Additionally, another proceeding was also filed by RRJ against Dr.Mr. Tea and Dr.Ms. Coffee alleging breach of confidentiality and breach of right to privacy as his medical details were leaked to Mr. Matrix, without his consent. That, Baarish Pvt. Ltd. filed a infringement of patent suit against Devil s Cure Inc. before the Principal Civil Judge of Original Jurisdiction at Nagpur claiming that since they were co-applicants in the application for medical trials, the combination drugs cannot be exploited by Devil s Cure Inc. alone. In addition, they sought sharing of license / grant of compulsory licensing in their favour from the IPAB at Mumbai. Since the turnover of Baarish Pvt. Ltd. was more than INR 700,00,00,000/- (Rupees Seven Hundred Crores only) and that of Devil s Cure Inc. was barely INR 2,00,000/- (Rupees Two Lakhs only), and also since Devil s Cure Inc. felt that all the litigations were being sponsored by Baarish Pvt. Ltd., Devil s Cure Inc. filed an application before the Competition Commission of India alleging misuse / abuse of dominant position in the market. In the meantime, due to a lot of publicity / newspaper reports, Causes in Common, a very reputed NGO based in New Delhi, filed an application under Section 6(1) of the Public Liability Insurance Act, 1991, in the nature of a PIL, by using the proviso thereto, claiming compensation for RRJ and his family members. Similarly, owing to the widespread reporting in newspapers, the Medical Council of Page 3 of 5

4 India along with the Indian Medical Association jointly filed criminal proceedings against Baarish Pvt. Ltd., Devil s Cure Inc., the Ethics Committee of GOCMCHS, Dr.Mr. Tea and Dr.Ms. Coffee (jointly and severally) for offences punishable under the provisions of the Drugs and Cosmetics Act, read along with the Rules framed thereunder and also the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act, All this counter litigations drew the attention of the Medical Council of India and they approached the Supreme Court for appointing a special judge for deciding all the litigations together, regardless of jurisdictions, (territorial, pecuniary or otherwise), regardless of hierarchy of judges, et cetera. Considering the same to be a one of special case, and falling under the rarest of rare cases, (for RRJ died during the pendency of this application), the Supreme Court allowed the application and directed that all the matters shall be heard by the Special Division Bench of the Nagpur Bench of the Hon ble High Court of Judicature at Bombay. The composite matter is fixed for final arguments before the Special Division Bench in RRJ, MCI, IMA, CiC (versus) Devil s Cure Inc., Baarish Pvt. Ltd., Ethics Committee of GOCMCHS and Dr.Mr. Tea and Dr.Ms. Coffee, where all the above mentioned issues are sufficiently proved and other medical terms are to be covered using documentary evidence at the stage of final arguments. The said writ petition is listed for arguments on 6 th March 2016 as per High Court website. Devil s Cure Inc. and Baarish Pvt. Ltd. have filed a writ petition (Devil s Cure Inc. and Baarish Pvt. Ltd. (versus) State of Maharashtra, Union of India, RRJ and others) before the Nagpur Bench of the Bombay High Court inter alia challenging the applicability and constitutional validity on the following grounds: a. That the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and Drugs and Cosmetics Act, are in violation of the principles laid down under Article 14 and Article 19(1)(g) of the Constitution of India b. That, the petition filed by RRJ against them for breach of privacy and confidentiality is not maintainable, for the same is not a fundamental right under Article 21 of the Constitution of India c. That, another limb of arguments is that the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and Drugs and Cosmetics Act have been passed by the Central Government in complete violation of the law and especially the provisions of the Schedule VII to the Constitution of India as Health is a Subject at Entry no. 6 in List II and therefore, the Central Government had no locus to make the law in the first place. Page 4 of 5

5 That, the respondents have filed a reply and relied upon various factors, some of them being Entry 19 and 26, of List III of Schedule VII, amongst others and have invoked the Doctrine of Eclipse, Occupied Field, Pith and Substance, et cetera to support their arguments and opposed the writ petitions. Argue accordingly. Notes for Arguments: (Guidelines for Participants) 1. Teams are expected to argue the Writ Petition - (Devil s Cure Inc. and Baarish Pvt. Ltd. (versus) State of Maharashtra, Union of India, RRJ and others) before the Nagpur Bench of the Hon ble High Court of Judicature at Bombay only. 2. However, teams are expected to draft their arguments by keeping in mind the contradictory stances taken by each party, against each other, in other litigations as well. 3. Certain provisions of law have been intentionally not provided for / have been provided for in an incomplete manner. The teams are expected to fill up the same. Page 5 of 5