--classstrugggle-flipmag CS Dec-2018 MKP - Page 18

neglect and a systematic conspiracy played by all concerned in this game who had willfully ignored their responsibility towards patients. It was the commissioner of Food and Drugs Administration of Maharashtra (FDA) Mahesh Zogade who first gave the alert against ASR implant of J&J by lodging an FIR for not making a series effort to inform patients about their defective implant. He also reported the issue to the central Drugs standered control organization (CDSCO) asking to take corrective action about this. Even then, either the CDSCO or the FDAs in other states have not plunged into action against errant company to make it liable for its faulty devices. It took 2 years for the CDSCO to put out a ‘medical device alerts’ on its website. It took more than six years to obtain an ‘expert committee report’ on the faulty hip implants manufactured by the subsidiary of Johnson and Johnson. And though the expert committee report was submitted in February, 2018, it has been put up only in public domain after 6 months in the last week of August 2018. This too had occurred after the CDSCO has been under attack for not being pro-active is seeking compensation for patients who got faulty hip implants. Thus the government had neglected the issue for around eight years to take any concrete stand in obtaining relief to the aggrieved patients despite being engaged with the company. The affected patients allege that the government presently is taking steps to ‘eye-wash’ them, by making the governmental panel of union health and family welfare ministry to asking the company to pay a minimum of Rs.20 lakh each to every patient as compensation. Aggrieved and suffering patients allege that the government panel set up for the assessment process 18 was “non-transparent and biased towards the pharma giant”. They claim that the governments action is too hasty and are distressed to see the government continuing to closely consult with J&J, while patients who have suffered grievous injuries have not been consulted even a simgle time.’ The allegations of the patients are not only just but are correct too. Such a callous negligence of the governments and rulers of their responsibility towards the patients (victims) is not new. Such a gross callous negligence was exhibited by our rulers and successive governments are well known towards the victims of Bhopal gas disaster created by the union carbide corporation of U.S.A. While J&J has paid hefty compensation to patients in other parts of the world following a global recall of ASR hip implant device in 2010, it did nothing to the patients in India leaving them out. Even after the advise of FDA of Maharashtra to CDSCO to take corrective action nobody stopped the act through a class action suit for example. The J&J has agreed to pay $2.5 billion as compensation to nearly 8,000 patients in the US. But it has not taken the responsibility to pay compensation to the Indian patients. It is argued that since in India the drugs and cosmetics act. 1940, which also regulates medical devices has not expressly provide for compensation of adverse and serious reactions, such a legal loophole has made the regulators (both central and state) weak in seeking compensation from the errant company and to make it liable for its faulty devices. Such arguments hold no water. As a sovereign country Indian government can always work out a mechanism to book J&J like bringing out an ordinance for instance and make it liable. But such a course of action was not taken by our rulers and governments intentionally since they are working with an unheard zeal to make the country, the best for the transnational corporations to do easy benefits in India even at the cost of lives of Indian people including the sick patients. On the other hand the J&J did whatever it can to evade its responsibility and avoid any help to the grievously suffering patients. It claims that it had sent an “urgent field safety notice” dated August 24, 2010 to surgeons informing them about the higher than expected revision rates involving ASR, directing them to stop implanting the ASR devices and provide for details about the reimbursement process and the ASR Help-line. But the surgeons state that they were not in receipt of any such notice either from J&J or any such alert notice from CDSCO. Some surgeons state that the implant maker got in touch with them about three to four years after the global recall and when they tried to get in touch with their patients they were unable to reach them to alert. The ASR helpline that was supposed to have provided Deputy was of no help in anyway to the patients. The patients claim that the company was not at all cooperative and complain when they reached out to the helpline the response they get was “call back when you have severe problem” and they rudely said to the patients contracted them that “nagging problem was not a big enough problem”. Thus the company deliberately evaded from its liability and responsibility. Even after the exposure of its heinous crime of concealing the information about its totally faulty ASR hip-implants and looting the patients of India amply, J&J has never attempted to redeem from its crime and come to the aid of patients affected by its faulty ASR Class Struggle