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~By Shaheen Parween
A Supreme Court bench comprising CJI Ranjan Gogoi and Justices Sanjay Kishan Kaul, K M Joseph on September 5, sought Centre’s response within two months to a PIL seeking stringent action against Johnson and Johnson and the Central Drugs Standard Control Organisation (CDSCO) officials who had given clearance without conducting proper clinical trials for the sale of faulty DePuy ASR hip-implants manufactured by Johnson and Johnson.
The plea had cited that the Central government did not take any action against the company despite finding of default on the part of Johnson and Johnson by the committee set up under the chairmanship of Dr Arun Kumar Agarwal in 2017.
Moreover the petition claimed that 14,525 patients most of them unaware of the after effects of the faulty hip implants and the poisonous contents they were carrying in their bodies are at high risk of medical ailments in future. Hence the petition sought that these patients be identified soon with the help of a special investigation team so that they can be given proper medical attention as soon as possible.
The expert committee set up by Union health ministry had suggested that regional and central committees could be set up which by means of advertisements in newspapers would identify the patients, register them and assess the impact on patients due to hip implants and then decide the compensation to be paid. The government had fixed Rs 2 million as minimum compensation to the patients affected by hip implant, however Johnson and Johnson wanted to set a ‘mutually agreeable’ amount which may not be in tandem with the government fixed amount.
In 2006, Johnson and Johnson introduced ASR XL Acetabular Hip System and ASR Hip resurfacing system in India, however owing to increasing cases of revision surgeries in Australia in the year 2009, Johnson and Johnson in 2010 began global recall of the device. However since 2006, 47,000 patients had already used the hip implants and out of 15,829 hip implants which Johnson and Johnson had imported to India only 1,295 were recalled. Though the device was recalled in 2010, however CDSCO placed a ban on the device only two years after the global recall. Hence the petitioner has indicted the central government through the Ministry of Health and Family Welfare, CDSCO, Mumbai Police, Johnson and Johnson and Deputy Orthopaedics of US as respondents.